Member Of Speakers Research Articles

P041 Health-related quality of life in patients receiving glucocorticoids for a rheumatic disease and associated factors : a cross-sectional study

Abstract Background/Aims Glucocorticoids (GCs) used in the treatment of inflammatory rheumatic conditions can impact on patients in different ways. The objective of this study was to identify socio-demographic and clinical factors associated with health-related quality of life (HRQoL) in patients undertaking GCs for a rheumatic disease. Methods This was a cross-sectional study using online survey methods. Participants taking GCs for a rheumatic disease from Australia, United Kingdom and the United States of America were included. HRQoL was measured using the EQ-5D-5L converted into a linear EQ5D index value. Eight explanatory factors (age, sex, country, educational level, employment status, disease group, self-reported disease state, and dose of GCs) were tested for potential association with HRQoL using univariable and multivariable (hierarchical) analyses. Factors found to have a significant association with EQ5D index at a P < 0.05 level in the multivariable model were considered to be independently associated with HRQoL. Results A total of 945 patients completed the EQ-5D-5L with no missing values: UK n = 742 (79%); USA n = 139 (15%); Australia/New Zealand n = 64 (7%); mean age 57.6 (SD = 13.6); 833 (88%) women. Participants with inflammatory arthritis n = 197 (21%), connective tissue disease and/or vasculitis n = 402 (43%), giant cell arteritis and/or polymyalgia rheumatica n = 346 (37%) were included. Those with self-reported active disease were 726 (77%). Mean (SD) EQ5D index was 0.64 (0.25); there were significant differences between groups in EQ-5D-5L index by age (median split, t=-3.77, p < 0.001); sex (t = 3.40, p < 001); educational level (F[3]=10.51, p < 0.001); employment status (F[6]=37.67, P < 0.001); disease group (T[2]=20.23, p < 0.001); disease state (T=-8.46, p < 0.001); and the dose of GCs(T = 2.95, p < 0.001). Worse HRQoL was associated with older age, being female, low educational attainment, being unemployed, having an inflammatory arthritis or a CTD, disease being active, and taking a higher dose of GC. Of the eight factors that were tested in the multivariable model, five were found to be independently associated with HRQoL. These were: disease state (β = 0.12, p < 0.001), disease group (β = 0.06, p < 0.001), employment status (β = 0.05, p < 0.001), sex (β = 0.05, p < 0.001), and educational level (β = 0.04, p < 0.001). This 5-factor model explained 18% of the variance in EQ5D index scores (F[1, 926] = 4.97, P = 0.026). The excluded factors in the model were age, dose, and country. Conclusion In our data, we identified 5 factors independently associated with worse HRQoL in patients being treated with GCs. Over 80% of the variance was not explained by our model likely due to use of a generic HRQoL measure (EQ-5D-5L) as outcome variable, and the small number of explanatory variables tested within this survey. Further research is required to identify potential targets to support interventions. Disclosure S. Janagan: None. K. Lim: None. R. Bhogal: None. S. Bridgewater: Grants/research support; Vifor pharma. C. Silverthorne: None. P. Richards: None. J. Dawson: None. E. Dures: Grants/research support; Vifor pharma. C. Hill: None. S. Goodman: Consultancies; UCB. Grants/research support; Novartis. S.L. Mackie: Consultancies; Consultancy on behalf of her institution for Roche/Chugai, Sanofi, AbbVie, AstraZeneca, Pfizer. Other; Investigator on clinical trials for Sanofi, GSK, Sparrow, speaking/lecturing on behalf of her institution for Roche/Chugai, Vifor, Pfizer, UCB, Novartis and AbbVie, ; chief investigator on STERLING-PMR trial, funded by NIHR; patron of the charity PMRGCAuk, No personal remuneration was received for any of the above activities. Support from Roche/Chugai to attend EULAR2019 in person and from Pfizer to attend ACR Convergence 2021 virtually., SLM is supported in part by the NIHR Leeds Biomedical Research Centre., The views expressed in this article are those of the authors and not necessarily those of the NIHR,the NIHR Leeds Biomedical Research Centre, the National Health Service or the UK Department of Health. M. Ndosi: Grants/research support; Vifor pharma. J.C. Robson: Consultancies; Vifor Pharma. Member of speakers’ bureau; Vifor Pharma. Grants/research support; Unrestricted Grant/research support from: Vifor Pharma.

E067 Bimekizumab maintained efficacy responses through 52 weeks in biologic disease-modifying antirheumatic drugnaïve patients with psoriatic arthritis who were responders at week 16: results from BE OPTIMAL, a phase 3, activereference study

E067 Bimekizumab maintained efficacy responses through 52 weeks in biologic disease-modifying antirheumatic drugnaïve patients with psoriatic arthritis who were responders at week 16: results from BE OPTIMAL, a phase 3, activereference study

P014 Treatment response in psoriatic arthritis: a comparison between the disease activity scores psoriatic arthritis response criteria and disease activity score-28

Abstract Background/Aims Despite NICE guidelines recommending the use of the PsA response criteria (PsARC), to assess response to biologic therapies in patients with psoriatic arthritis (PsA), some clinicians use the Disease Activity Score (DAS-28) criteria, developed for rheumatoid arthritis. However, whether the two scores are interchangeable and/or capture similar information has not yet been explored. Here, we investigate the differences and overlap between these two disease activity scores, in identifying good/poor responders, in PsA. Methods Utilising treatment response data from the OUTPASS cohort; a UK based multi-centre observational study, PsA patients assessed with PsARC and DAS-28 scores were calculated at baseline (pre-treatment), 3-months and 6-months (3M),(6M), following treatment, where available. EULAR good/moderate response was combined and compared with PsARC responder status. Subgroup analysis of patients with both PsARC and DAS-28 scores at either 3M or 6M, were tested for agreement using the Cohen’s Kappa test. Statistical tests were also used, as appropriate, to investigate differences between the baseline subcomponents, in the observed concordant and discordant data. Results Response data from 418 patients was available. An average of 76% were classified as responders according to PsARC, and 80% according to the EULAR response criteria, for both 3M and 6M, with 12% discordance. A subgroup analysis of 218 patients assessed with both scores, (up to 6M), revealed 17.9% responder discordance between PSARC and DAS-28, and 82.1% concordance. The Cohen’s Kappa test defined the assessment of responder/non-responder outcome, as an ‘almost perfect agreement’ (0.82) between the two criteria. Further statistical analyses, of baseline subcomponents, of both response criteria, between these discordant/concordant subsets, showed no significant difference, except for PsARC Physician’s and Patient’s Global Assessments (PhGA), (PGA), (P = 0.01, P = 0.02, Table 1). Conclusion PsARC and EULAR response criteria show ‘almost perfect agreement’, strongly supporting clinical use for either score. PhGA, (not a subcomponent of DAS-28) and PsARC PGA were the only significantly different (P < 0.05) components between the discordant and concordant groups, highlighting the importance of considering psychosocial factors which may affect pain tolerance and treatment response. Comparative analyses with other widely used scores, such as DAPSA, would also be informative for future work. Disclosure K. Patel: Grants/research support; This project has received support from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101007757 (HIPPOCRATES), the JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA, the results reflect only the author's view and the JU are not responsible for any use that may be made of the information it contains.. N. Nair: None. M. Jani: None. H. Chinoy: Consultancies; H.C. has received Consulting for PTC Therapeutics. Member of speakers’ bureau; H.C. has received fees as a speaker for GSK, UCB. Other; H.C. for Advisory Board member for Astra Zeneca, Pfizer, Argenx, Galapagos; Data and Science Monitoring Board chair for Horizon Therapeutics. J. Bluett: Grants/research support; J.B. has received a research grant award from Pfizer and travel/conference fees from UCB, Fresenius Kabi, Pfizer and Eli Lilly. (Pfizer: WI239449). A. Barton: Grants/research support; A.B. has received research grants from Bristol Myers Squibb and Pfizer and speaker fees from Galapagos.. P. Curry: None.

E089 Effect of secukinumab on radiographic progression and inflammation in sacroiliac joints and spine in patients with non-radiographic axial spondyloarthritis: 2-year imaging outcomes from a Phase III randomised trial

E089 Effect of secukinumab on radiographic progression and inflammation in sacroiliac joints and spine in patients with non-radiographic axial spondyloarthritis: 2-year imaging outcomes from a Phase III randomised trial

E087 Reduced joint synovitis assessment versus the global EULAR OMERACT synovitis score (GLOESS) to predict the response to secukinumab in patients with active psoriatic arthritis and inadequate response to conventional disease-modifying anti-rheumatic drugs: exploratory results from the ULTIMATE trial

Abstract Background/Aims The combined use of Power Doppler and B-mode ultrasound (PDUS) allows visualisation of morphological and pathophysiological changes of the synovium. ULTIMATE (NCT02662985) was the first large, randomised, double-blind, placebo-controlled PDUS phase IIIb study in psoriatic arthritis (PsA) to demonstrate that the validated Global OMERACT EULAR Synovitis Score (GLOESS), an ultrasound score at patient level, could detect the early and continuous decrease in synovitis in a multicentre setting using different ultrasound devices and examiners. Since the ultrasound assessment for GLOESS is time-consuming owing to the number of joints assessed, we investigated the ability of various reduced joint sets to predict GLOESS. Methods ULTIMATE was a 52-week study of secukinumab with a 12-week, double-blind, placebo-controlled period followed by a 12-week, open-label treatment period and 6-month open-label extension period. GLOESS for 24 paired joints was calculated, with a resultant potential score ranging from 0 to 144. Based on their composite PDUS scores, highly correlated joint clusters were identified with a Spearman’s rank correlation matrix and a Clustered Image Map. Representative joints were then selected from each group by various approaches (best correlation, model optimisation, etc.) yielding several joint combinations. For these reduced joint sets, GLOESS was predicted with linear models based on data from 60% of randomly selected patients from ULTIMATE. The remaining 40% of patient data were used for model validation and diagnostics. Results Five models were established with reduced pairs of joint sets (9-13 pairs) for PDUS-detected synovitis. The joints included in each linear model are summarised in the Table. All five reduced joint set models demonstrated scores very close to full 48 joint GLOESS (R2 ∼0.95); models 1-3 (based on 9 joint pairs) were less accurate at predicting GLOESS than models 4 and 5 (based on 13 and 12 joint pairs, respectively) for the secukinumab cohort in the open-label part (data to be shown in poster). Conclusion All models of reduced joint sets for PDUS-detected synovitis predicted GLOESS well. The next steps will be to document responsiveness and ability to discriminate between active and placebo treatment. Disclosure P.G. Conaghan: Consultancies; P.G.C. has received consultancy fees from AbbVie, AstraZeneca, BMS, Eli Lilly, Galapagos, Janssen, Merck, Novartis and Pfizer, Stryker and UCB. Member of speakers’ bureau; P.G.C. has received speakers bureau fees from AbbVie, Novartis and Pfizer. M. D'agostino: Consultancies; M.A.D'A. has received consultancy fees from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Roche, Sanofi, and UCB. Member of speakers’ bureau; M.A.D'A. has received speakers bureau fees from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Roche, Sanofi and UCB. M. Boers: Consultancies; M.B. has received consultancy fees from Novartis. E. Naredo: Honoraria; E.N. has received honoraria for clinical trials from AbbVie, BMS and Novartis. Member of speakers’ bureau; E.N. has received speakers bureau fees from AbbVie, BMS, Celgene GmbH, Janssen, Lilly, Novartis, Pfizer, Roche and UCB. Grants/research support; E.N. has received research grants from Eli Lilly. P. Mandl: Member of speakers’ bureau; P.M. has received speakers bureau fees from AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Roche and UCB. Grants/research support; P.M. has received grant/research support from AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Roche and UCB. P. Carron: Consultancies; P.C. has received consultancy fees from AbbVie, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Gilead, Merck Sharp Dohme, Novartis, Pfizer and UCB. Member of speakers’ bureau; P.C. has received speakers bureau fees from AbbVie, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Gilead, Merck Sharp Dohme, Novartis, Pfizer and UCB. Grants/research support; P.C. has received grant/research support from Merck Sharp Dohme, Pfizer and UCB. M. Backhaus: Consultancies; M.B. has received consultancy fees from BMS, Galapagos, Jonsson, MSD, Novartis, Pfizer, Roche and UCB. Member of speakers’ bureau; M.B. has received speakers bureau fees from BMS, Galapagos, Jonsson, MSD, Novartis, Pfizer, Roche and UCB. Grants/research support; M.B. has received grant/research support from BMS, Galapagos, Jonsson, MSD, Novartis, Pfizer, Roche and UCB. A. López-Rodríguez: Consultancies; A.L.R. has received consultancy fees from Eli Lilly, GSK, Janssen, Novartis, Roche and UCB. Member of speakers’ bureau; A.L.R. has received speakers bureau fees from Eli Lilly, GSK, Janssen, Novartis, Roche and UCB. P. Hanova: Consultancies; P.H. has received consultancy fees from Novartis. P. Goyanka: Other; P.G. is an employee of Novartis. B.G. Sahoo: Other; B.G.S. is an employee of Novartis. C. Gaillez: Shareholder/stock ownership; C.G. is a shareholder of Novartis and BMS. Other; C.G. is an employee of Novartis. W. Bao: Shareholder/stock ownership; W.B. is a shareholder of Novartis. Other; W.B. is an employee of Novartis.

P169 Treatment effects of ixekizumab and adalimumab at the individual digit level with nail and distal interphalangeal joint involvement in patients with psoriatic arthritis

Abstract Background/Aims Psoriatic nail disease is intimately linked to adjacent distal interphalangeal joint (DIP) disease, and it is important to ascertain whether DIP-nail complex behaves differently under different biological therapies. The aim of this analysis is to assess the effect of ixekizumab (IXE) and adalimumab (ADA) at the individual digit level using the Nail Psoriasis Severity Index (NAPSI) and NAPSI resolution in patients with psoriatic arthritis (PsA) with concomitant nail involvement. Methods This post hoc analysis included patients from SPIRIT-H2H (NCT03151551) treated with either IXE or ADA who had baseline nail disease (NAPSI total score >0) and DIP involvement, with either tenderness or swelling, at the individual digit level for each hand. Nail disease was assessed using the NAPSI scoring system, a measure of nail bed and nail matrix involvement combined for a total maximum score of 80. Proportions of patients having a NAPSI total score >0 were evaluated at baseline, week 24 and week 52; post-baseline assessments were compared between treatment using Fisher’s exact test. Results Of 566 patients in the intent-to-treat SPIRIT-H2H population of, 354 patients (IXE, N = 186; ADA, N = 168) had NAPSI total score >0 and DIP involvement in at least 1 of 10 digits simultaneously at baseline. At week 24, the proportion of patients with nail disease (NAPSI >0) was lower among patients who received IXE versus ADA across all 10 digits and was significantly lower versus ADA for 9 out of the 10 individual digits (p < 0.05; Table) with additional improvements out to week 52. On average, a 10% difference in the proportion of patients with NAPSI >0 at week 24 between IXE and ADA at the individual digit level was observed, favouring IXE. Similarly, numerically greater improvements were observed with IXE compared to ADA regardless of whether nail bed, nail matrix, or NAPSI total score was assessed. Conclusion These data demonstrate that in patients with PsA with nail involvement, there was a significant advantage of IXE over ADA in resolving nail involvement at the individual digit level as measured by NAPSI. Disclosure D. McGonagle: Consultancies; Eli Lilly and Company, AbbVie. Member of speakers’ bureau; Eli Lilly and Company. Grants/research support; Eli Lilly and Company. Other; BSR attendance support from Eli Lilly and Company. A. Kavanaugh: Consultancies; AbbVie, UCB, Janssen, Novartis, Pfizer. I. McInnes: Consultancies; AbbVie, Amgen, BMS, Causeway Therapeutics, Cabaletta, Eli Lilly and Company, Gilead, Janssen, Novartis, Pfizer, Sanofi Regeneron, UCB. Grants/research support; AbbVie, Amgen, BMS, Causeway Therapeutics, Cabaletta, Eli Lilly and Company, Gilead, Janssen, Novartis, Pfizer, Sanofi Regeneron, UCB Pharma. Other; University of Glasgow, Vice Principal & Head of College, NHS Greater Glasgow & Clyde, Non exec board member, Evelo, Board of Directors, Non Exec director, Versus arthritis, Trustee. L. Kristensen: Consultancies; Pfizer, AbbVie, Amgen, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly and Company, Janssen. Member of speakers’ bureau; Pfizer, AbbVie, Amgen, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly and Company, Janssen. Grants/research support; Pfizer, AbbVie, UCB, Gilead, Biogen, Novartis, Eli Lilly and Company, Janssen. Other; study grant from Novo Nordisk A/S, institutional grant from The Oak Foundation, Cambridge Weight Plan, delivery of dietary supplements. J.F. Merola: Consultancies; Amgen, Bristol-Myers Squibb, AbbVie, Dermavant, Eli Lilly and Company, Novartis, Janssen, UCB, Sanofi, Regeneron, Sun Pharma, Biogen, Pfizer, Leo Pharma. B.E. Strober: Consultancies; AbbVie, Alumis, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Immunic Therapeutics, Bristol-Myers-Squibb, Connect Biopharma, Dermavant, EPI Health, Evelo Biosciences, Janssen, Leo, Eli Lilly and Company, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Pfizer, UCB Pharma, Sun Pharma, Regeneron, Sanofi-Genzyme, Union Therapeutics, Ventyxbio, vTv Therapeutics. Shareholder/stock ownership; Connect Biopharma, Mindera Health. Honoraria; Editor-in-Chief (honorarium): Journal of Psoriasis and Psoriatic Arthritis. Member of speakers’ bureau; AbbVie, Eli Lilly and Company, Incyte, Janssen, Regeneron, Sanofi-Genzyme. Other; Investigator: Dermavant, Investigator: AbbVie, Investigator: CorEvitas Psoriasis Registry, Investigator: Dermira, Investigator: Cara, Investigator: Novertis. J.R. Lisse: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. J. Pustizzi: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. C. Sapin: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. R. Bolce: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. C. Ritchlin: Consultancies; AbbVie, Janssen, Novartis, BMS, UCB. Member of speakers’ bureau; Pfizer, UCB, AbbVie. Grants/research support; Pfizer, AbbVie.

P119 The Use of Exposure-Adjusted Event Rates versus Exposure-Adjusted Incidence Rates in Adverse Event Reporting: Insights from Filgotinib Integrated Safety Data in Rheumatoid Arthritis

Abstract Background/Aims Reporting of treatment-emergent adverse events (TEAEs) in rheumatoid arthritis (RA) clinical trials can be summarized as exposure-adjusted incidence rates (EAIRs) or exposure-adjusted event rates (EAERs). Censored EAIR (EAIR), weighing exposure up to a patient’s first event, is commonly reported; uncensored EAIR (EAIRu), using total exposure time for all patients, can also be used. For EAIR, exposure time can vary by event. In contrast to EAIR(u), the total number of events are used to calculate EAER. The three methods account for different exposures and/or multiple events, which can impact the outcome evaluation. Studies of filgotinib (FIL) in RA report safety data as EAIR/100 patient-years of exposure (PYE) for TEAEs, which is uncensored. Objective: To describe the outcome of long-term FIL integrated safety data in RA by applying different statistical methodologies: EAER, EAIRu and EAIR. Methods Integrated FIL safety data from seven clinical trials were assessed. Predefined adverse events of special interest (AESI) included serious infections (any), herpes zoster (HZ), major adverse cardiac events (MACE), malignancies (excluding nonmelanoma skin cancer [NMSC]), NMSC and venous thromboembolism (VTE). The number of patients with an event, number of events, EAER, EAIRu and EAIR were summarized. The data extraction date was January 2021 for the DARWIN 3 (NCT02065700) long-term extension (LTE) and November 2020 for the FINCH 4 (NCT03025308) LTE. Results In total, 3691 patients received ≥1 FIL dose for 8085 PYE. In this population, 176 serious infections were reported in 137 patients, 125 HZ events were reported in 112 patients, 39 MACE were reported in 33 patients, 20 cases of VTE were reported in 15 patients, 60 malignancies excluding NMSC were reported in 49 patients and 21 cases of NMSC were reported in 20 patients. Within each treatment arm (FIL 200 mg [FIL200], FIL 100 mg [FIL100] or combined FIL), rates for most AESI were similar when reported as EAER, EAIRu or EAIR. For serious infections, EAER was higher than EAIRu or EAIR. The total exposure time to first event (censored PYE) was high and comparable to total exposure (PYE) (>2700 years and >5100 years for the total populations in the FIL100 and FIL200 groups, respectively). Conclusion These data confirm that using different methods to analyze FIL safety data (EAER, EAIRu, EAIR) does not result in different safety outcomes, reinforcing the previously reported FIL safety profile in patients with RA. As the AESI reported in the long-term safety database with FIL are rare, patients commonly have long exposure times before experiencing an event, which are often associated with end of treatment. As such, EAIRu, EAIR and EAER are similar. Disclosure P. Durez: Member of speakers’ bureau; AbbVie, Galapagos, Lilly. E. Feist: Consultancies; AbbVie, Galapagos, Lilly, Novartis, Pfizer, Roche, and Sobi. Member of speakers’ bureau; AbbVie, Galapagos, Lilly, Pfizer, Roche, Novartis and Sobi. Grants/research support; Lilly, Pfizer and Roche. R. Blanco: Consultancies; AstraZeneca, Galapagos, Janssen, Novartis and Pfizer. Member of speakers’ bureau; AbbVie, Amgen, Bristol-Myers, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and Sanofi. Grants/research support; AbbVie, Roche. V. Rajendran: Other; Galapagos. N. Verbruggen: Other; Galapagos. K. Van Beneden: Shareholder/stock ownership; Galapagos. Other; Galapagos. J. Galloway: Consultancies; AbbVie, Galapagos, Gilead, Janssen, Lilly, Novartis and Pfizer. Member of speakers’ bureau; AbbVie, Biogen, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche and UCB. Grants/research support; AstraZeneca, Celgene, Gilead, Janssen, Medicago, Novavax and Pfizer.

OA14 Non-steroidal anti-inflammatory drugs reduce sacroiliac joint inflammation in axial spondyloarthritis

Abstract Background/Aims MRI evidence of active sacroiliitis (sacroiliac joint bone marrow oedema (BMO)) is commonly used to assist diagnosis and classification of axial spondyloarthritis (axSpA). Non-steroidal anti-inflammatory drugs (NSAIDs) are used as first-line therapy, and for persistent clinical symptoms continuous treatment is recommended. Prescribed in primary care, and widely available over-the-counter, many patients are already taking NSAIDs when first presenting to rheumatology. We hypothesised that among patients with axSpA, NSAID use would lead to an underestimation of sacroiliac joint BMO. Methods Adults with axSpA were recruited from NHS rheumatology clinics and asked to discontinue their NSAIDs for 1-2wks before undergoing a sacroiliac joint MRI (Scan 1) using a standardised protocol. All participants then re-started their NSAIDs. Those who scanned positive for BMO lesions, as determined using internationally recognised (ASAS) definitions, underwent a second scan 6wks after restarting NSAIDs. Scans were read independently by 2 readers (adjudicated by a 3rd, if required), blinded to participants’ clinical characteristics and timepoint. We determined the proportion of participants who scanned negative at Scan 2 (on NSAIDs) who had previously scanned positive at Scan 1 (off NSAIDs). Results 311 participants were recruited from 34 centres. Table 1 shows participants’ baseline characteristics. Almost all participants (296; 95%) completed the NSAID washout and underwent Scan 1. However, 135 (50%) reported an increase in spinal pain (median increase: 2 points on a 0-10 numerical rating scale; inter-quartile range: 1-3), and 166 (61%) reported worsening of disease activity (median increase in BASDAI: 0.9; 0.5-1.6). At Scan 1, 149 (50%) were positive for BMO lesions. 131 (88%) participants underwent the six-week follow-up scan, of whom 31 scanned negative (24%; 95%CI: 17-32%). Conclusion These findings suggest that NSAIDs influence sacroiliac BMO and, where sacroiliitis is present, around one-in-four show resolution of lesions when NSAIDs are present - with important implications for axSpA diagnosis and classification. If patients with axSpA (or suspected axSpA) are willing to attempt NSAID washout prior to MRI, this should be considered. There may be concerns about increases in disease activity or spinal pain, but we also provide evidence that almost all patients who attempt washout can successfully achieve it. Disclosure G.T. Jones: None. A.N. Bennett: Consultancies; Abbvie, Eli Lilly, MSD, Novartis, Pfizer, UCB. Honoraria; AbbVie, Biogen, Novartis, Pfizer, UCB. Grants/research support; Pfizer. R. Sengupta: Consultancies; AbbVie, Biogen, Eli Lilly, Novartis, Pfizer, UCB. Member of speakers’ bureau; AbbVie, Biogen, Celgene, Eli Lilly, Novartis, Pfizer, UCB. Grants/research support; AbbVie, Celgene, Novartis, UCB. P.M. Machado: Honoraria; AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche, UCB. H. Marzo-Ortega: Consultancies; Eli Lilly, Janssen, MoonLake, Novartis, Pfizer, UCB. Member of speakers’ bureau; AbbVie, Biogen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Takeda, UCB. Grants/research support; Janssen, Novartis, UCB. L. Aucott: None. G.J. Macfarlane: None.

OA02 Real-world experience of dose tapering TNF inhibitors in rheumatoid arthritis: Long-term results

Abstract Background/Aims If sustained disease control is achieved in RA then tapering is supported by recommendations. However, this may cause loss of disease control with subsequent damage. A problem in assessing tapering is the short-term nature of studies. We wanted to explore the long-term use of tapering strategies. Methods Our biologics database has collected information since 2005. Our approach, refined with PPI, for people receiving TNF inhibitors (TNFi) has been to dose taper by one-third and then 50% if remission was achieved (DAS28<2.6 on 2 occasions >6 months apart, no corticosteroids). We initially required absence of power doppler (PD) in the hands (stopped in 2017). Failure of tapering was defined as a flare (DAS28>2.6, PD synovitis or patient-reported) resulting in a return to full dose, stopping the TNFi, or changing to another advanced therapy (bDMARD, tsDMARD). We explored associations between time on dose-reduction therapies and individual characteristics. Results 1180 patients started biological therapies during 2005-2021 with 668 receiving a TNFi. 119 (18%) were dose-tapered by one-third and of these 40 (30%) then by one-half. Over median follow-up of 2.2 years (IQR 0.7,5.9) with maximum follow-up of 8.93 years, tapering failed in 88 (74%). Of those failing, 50% achieved DAS28 remission, 18% low disease activity (LDA), 32% moderate (MDA) and none high (HDA) within 12 months. A Kaplan-Meier plot showed one-third of individuals failed tapering within the first year with two-thirds by 3 years. Logistic regression showed (Table 1) no significant effect of age, sex, time between diagnosis and TNFi, seropositivity, smoking, or DAS28 score. However, there was an association between concomitant use of methotrexate and reduced failure of tapering (HR 0.60 (CI 0.39,0.94) p = 0.03). Conclusion In a real-world setting, tapering is well accepted and occurred in around 20% of individuals. Two-thirds maintain tapering after 1 year with around one-third by 3 years. Predictors of success are limited although concurrent methotrexate use appears associated with continued tapering. However, around a third of patients who fail tapering do not return to remission/LDA when the full dose of TNFi is restarted. Disclosure M. Lwin: None. N. Nooh: None. C.R. Holroyd: Member of speakers’ bureau; Abbvie, BMS, Celltrion, Chugai, Galapagos/Gilead, Janssen, Lilly, Napp, Novartis, Pfizer, Roche and UCB. Other; Sponsorship / advisory board: Abbvie, BMS, Celltrion, Chugai, Galapagos/Gilead, Janssen, Lilly, Napp, Novartis, Pfizer, Roche and UCB. S.X. Lin1: None. D. Culliford: None. S.D. Fraser: None. C.J. Edwards: Member of speakers’ bureau; Abbvie, Astra Zeneca, BMS Celltrion Chugai, Gilead, Galapagos, GSK, Janssen, Eli Lilly, Pfizer, Roche, Sandoz, Samsung. Grants/research support; Abbvie, Astra Zeneca, BMS Celltrion Chugai, Gilead, Galapagos, GSK, Janssen, Eli Lilly, Pfizer, Roche, Sandoz, Samsung. Other; Advisory boards: Abbvie, Astra Zeneca, BMS Celltrion Chugai, Gilead, Galapagos, GSK, Janssen, Eli Lilly, Pfizer, Roche, Sandoz, Samsung.

P193 Bimekizumab improves key symptoms, disease activity and function in patients across the full spectrum of axial spondyloarthritis up to week 24: results from two phase 3 studies

Abstract Background/Aims Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. BKZ demonstrated rapid and clinically meaningful improvements in disease activity across the full spectrum of axial spondyloarthritis (axSpA; active non-radiographic axSpA [nr-axSpA; BE MOBILE 1, NCT03928704] and ankylosing spondylitis [AS] / radiographic axSpA [r-axSpA; BE MOBILE 2, NCT03928743]). Here we present clinical outcomes from the ongoing phase 3 studies up to week (wk) 24. Methods BE MOBILE 1 and 2 have similar study designs: 16-wk double-blind period followed by a 36-wk maintenance period. Patients were randomised (1:1 in BE MOBILE 1 and 2:1 in BE MOBILE 2) to BKZ 160 mg every 4 wks (Q4W) or placebo (PBO). All patients received BKZ 160 mg Q4W from wk16. ASAS40 and BASDAI50 rates, mean change from baseline (CfB) in BASDAI (total and components) and BASFI scores are reported up to wk24. Missing data is imputed using non-responder or multiple imputation. Results Overall, 240/254 (94.5%; nr-axSpA) and 313/332 (94.3%; r-axSpA) patients completed the studies up to wk24. Both studies met their primary (ASAS40) and ranked secondary endpoints at wk16. Higher BASDAI50 response rates and larger mean reduction in BASDAI and BASFI scores were seen at wk16 for BKZ versus PBO (Table). After switching to BKZ, mean changes in BASDAI and BASFI scores for patients in the PBO group reached levels similar to BKZ-treated patients. 50.8% of nr-axSpA and 55.5% of r-axSpA patients had ≥1 treatment emergent adverse events (TEAE) and incidence of serious TEAEs was low up to wk24 (0.4% and 3.6%). No systemic candidiasis, MACE or deaths were reported with BKZ in either study up to wk24. No IBD was reported in BE MOBILE 1 (nr-axSpA), there was low incidence of adjudicated IBD in BE MOBILE 2 (r-axSpA: 0.3%). Incidence of uveitis was low in both studies (nr-axSpA: 4.8% [PBO], 1.6% [BKZ]; r-axSpA: 4.5% [PBO], 0% [BKZ]) at wk16. Conclusion Dual inhibition of IL-17A and IL-17F with BKZ provided significant improvement in key signs and symptoms, disease activity and physical function across the full spectrum of axSpA. No new safety signals were observed. Disclosure K. Gaffney: Consultancies; KG has received honoraria or consultancy fees from Novartis, AbbVie, UCB Pharma, Eli Lilly and Pfizer. Shareholder/stock ownership; KG is a shareholder of Rheumatology Events. Member of speakers’ bureau; KG has paticipated in speaker's bureau for Novartis, UCB Pharma, AbbVie and Eli Lilly. Grants/research support; KG has received grants/research support from NASS, Versus Arthritis, AbbVie, Pfizer, UCB Pharma, Norvartis, Eli Lilly, Cellgene, Celltrion, Janssen, Gilead and Biogen. Other; KG has received meeting expenses from AbbVie, Eli Lilly, Roche, Novartis, Pfizer and UCB Pharma. N. McKay: Member of speakers’ bureau; NM has received Speaker' bureau from Gilead. Other; NM has received travel fees from UCB Pharma and Gilead. R. Sengupta: Consultancies; RS has honoraria or consultancy fees from Abbvie, Biogen, Novartis, Celgene, Lilly, Chugai, MSD and UCB Pharma. Grants/research support; RS has received grants/ research support from AbbVie, Celgene, Novartis and UCB Pharma. Other; RS is on the advisory boards for AbbVie, Biogen, Chugai, Lilly, Novartis and UCB Pharma. C. Fleurinck: Other; CF is an employee of UCB Pharma. C. de la Loge: Consultancies; CdlL is a consultant to UCB Pharma, Brussels, Belgium. U. Massow: Other; UM is an employee of UCB Pharma. V. Taieb: Other; VT is employee of UCB Pharma. S. Zhao: Honoraria; SZ has received honoraria from UCB Pharma. H. Marzo-Ortega: Grants/research support; HMO has received grants/research support from Janssen, Novartis and UCB Pharma. Other; HMO has received honoraria and/or consultancy and/or speaker fees from Abbvie, Biogen, Celgene, Janssen, Eli-Lilly, Moonlake, Novartis, Pfizer and UCB Pharma.

P165 The incidence of cancer in SLE patients receiving biologic therapy: Results from the British Isles Lupus Assessment Group Biologics Registry (BILAG-BR)

Abstract Background/Aims Patients with systemic lupus erythematosus (SLE) are known to have an increased risk of certain cancers, such as lymphoma, compared to the general population. We aimed to characterise the incidence of cancers in patients with moderate-severe SLE receiving biologic and standard of care (SoC) therapies. Methods The BILAG Biologics Registry (BILAG-BR) is a large prospective observational register of patients with SLE. Participants receiving rituximab, belimumab and SoC therapies from 2010-2021 were included. Data relating to malignancy were collected from study centres and the UK national cancer register. Overall cancer risk was assessed using a Cox proportional hazards model in Stata V14. Results There were 114 previous cancer diagnoses in 108 patients recorded. The most common cancer sites were cervical (43/114), non-melanoma skin cancer (20), breast (15) and lymphoma (13). All cervical neoplasms were carcinoma in situ. Five patients had more than one cancer diagnosis recorded; three had >1 non-melanoma skin cancer and two individuals had unrelated malignancies. During follow-up, (1437 patients with 5,738 person years [pys]), 33 incident cancers occurred in 32 individuals at a median of 477 (IQR 218-1265) days after registration. Incidence rates were 5.9 (95% CI 3.9-8.8) in rituximab, 7.8 (2.5-24.2) in belimumab and 4.16 (1.7-10.0) per 1,000 pys in the SoC group. Using rituximab as the comparator, the age and gender adjusted hazard ratio (HR) was 1.62 (0.48-5.52) for belimumab and 0.63 (0.24-1.65) for the SoC group. Patients who developed an incident cancer were older at registration (HR 1.07 [1.04-1.09] per year) and more likely to be of male sex (HR 2.95 [1.31-6.57]). Caucasian ethnicity was associated with increased risk in univariate analysis (HR 4.25 [1.46-12.32]), but not after adjusting for age and sex (HR 2.60 [0.86-7.83]). There were 6 cancer-related deaths which all occurred in the rituximab group a median of 2.3 (IQR 1.4-3.2) years from registration. Conclusion Although overall cancer numbers are low, the findings of this study are reassuring. The incidence of cancer in this cohort of SLE patients with moderate-to-severe disease appears to be broadly similar between those on biologic and standard of care therapies. Disclosure M. Rodziewicz: Grants/research support; North West England MRC Fellowship Scheme in Clinical Pharmacology and Therapeutics. Award Ref. MR/N025989/1, UCB. S. Dyball: Grants/research support; North West England Medical Research Council Fellowship Scheme in Clinical Pharmacology and Therapeutics. Award Ref. MR/N025989/1, UCB, Eli Lilly. E. Sutton: None. B. Parker: Honoraria; Fresenius-Kabi, AbbVie. Member of speakers’ bureau; Eli Lilly, Roche. Grants/research support; Genzyme/Sanofi, GSK. I.N. Bruce: Consultancies; AstraZeneca, Eli Lilly, ILTOO, GSK, Aurinia. Member of speakers’ bureau; GSK, UCB, AstraZeneca. Grants/research support; GSK, Roche, Janssen.

P194 Bimekizumab is associated with improvement in quality of life in patients across the full spectrum of axial spondyloarthritis at week 16: results from two phase 3 studies

Abstract Background/Aims Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A and has demonstrated rapid and clinically meaningful improvements in disease activity (ASAS40, primary outcome measure) in patients across the full spectrum of axial spondyloarthritis (axSpA; active non-radiographic axSpA [nr-axSpA; BE MOBILE 1, NCT03928704] and ankylosing spondylitis [AS] / radiographic axSpA [r-axSpA; BE MOBILE 2, NCT03928743]). Here we report results related to HRQoL instruments (EQ-5D-3L, ASQoL and SF-36) from the two ongoing phase 3 studies at week (wk) 16. Methods BE MOBILE 1 and 2 were conducted in parallel with similar study designs: 16-wk double-blind placebo-controlled period followed by a 36-wk maintenance period. Patients were randomised (1:1 in BE MOBILE 1 and 2:1 in BE MOBILE 2) to BKZ 160 mg Q4W or placebo (PBO). All patients received BKZ 160 mg Q4W from wk16. We report change from baseline (CfB) in the overall EQ-5D-3L utility index, ASQoL and SF-36 Physical component Summary (PCS) scores at wk16 compared to PBO. Missing data is imputed using multiple imputation. Results Overall, 240/254 (94.5%; nr-axSpA) and 313/332 (94.3%; r-axSpA) patients completed the studies up to wk24. Both studies met their primary and all ranked secondary endpoints at wk16. In both studies, BKZ treatment resulted in improved health status as measured with the EQ-5D-3L utility score versus PBO. This improvement at wk16 was consistent across both tumour necrosis factor inhibitor (TNFi)-naive and TNFi-inadequate responders (IR) patients. Significantly greater improvements were also observed with BKZ compared to PBO in ASQoL and SF-36 PCS in both studies (p < 0.001, all comparisons) at wk16 (Table). At wk16, a higher proportion of BKZ- versus PBO-treated patients achieved ≥5-point improvement in SF-36 PCS (nr-axSpA: 64.8% vs 41.3% and r-axSpA: 63.8% vs 49.5%) and ≥4-point improvement in ASQoL (nr-axSpA: 58.6% vs 33.3% and r-axSpA: 57.5% vs 45.0%), respectively. Conclusion Dual inhibition of IL-17A and IL-17F with BKZ improved quality of life measured by EQ-5D-3L, ASQoL and SF-36 PCS scores compared with PBO in patients across the full spectrum of axSpA. Disclosure N. McKay: Member of speakers’ bureau; NM has received Speaker' bureau from Gilead. Other; NM has received travel fees from UCB Pharma and Gilead. A. Bennett: Honoraria; AB has received teaching honorarium from Abbvie Ltd, Pfizer, UCB Pharma, Novartis and Biogen. Grants/research support; AB has received research grants from Pfizer. Other; AB has received advisory board fees from Abbvie Ltd, Pfizer, UCB Pharma, MSD, Novartis and Eli Lilly. N. Goodson: Honoraria; NG has received honoraria from UCB Pharma and Novartis. C. Fleurinck: Other; CF is an employee of UCB Pharma. C. de la Loge: Consultancies; CdlL is a consultant to UCB Pharma, Brussels, Belgium. U. Massow: Other; UM is an employee of UCB Pharma. V. Taieb: Other; VT is employee of UCB Pharma. H. Marzo-Ortega: Grants/research support; HMO has received grants/research support from Janssen, Novartis and UCB Pharma. Other; HMO has received honoraria and/or consultancy and/or speaker fees from Abbvie, Biogen, Celgene, Janssen, Eli-Lilly, Moonlake, Novartis, Pfizer and UCB Pharma. K. Gaffney: Consultancies; KG has received honoraria or consultancy fees from Novartis, AbbVie, UCB Pharma, Eli Lilly and Pfizer. Shareholder/stock ownership; KG is a shareholder of Rheumatology Events. Member of speakers’ bureau; KG has paticipated in speaker's bureau for Novartis, UCB Pharma, AbbVie and Eli Lilly. Grants/research support; KG has received grants/research support from NASS, Versus Arthritis, AbbVie, Pfizer, UCB Pharma, Norvartis, Eli Lilly, Cellgene, Celltrion, Janssen, Gilead and Biogen. Other; KG has received meeting expenses from AbbVie, Eli Lilly, Roche, Novartis, Pfizer and UCB Pharma.

P135 Efficacy and safety of upadacitinib in TNFi inadequate responders with rheumatoid arthritis from three Phase 3 clinical trials

Abstract Background/Aims For patients with RA who are refractory to biologic disease-modifying antirheumatic drugs (bDMARDs), such as tumor necrosis factor inhibitors (TNFis), optimal disease control is less likely to be achieved with subsequent therapy. In line with recommendations from EULAR and ACR, switching to a treatment with a different mechanism of action is appropriate for these patients. Objectives To describe the efficacy and safety of upadacitinib (UPA) 15 mg once daily in patients with RA and an inadequate response or intolerance to TNFis (TNFi-IR). Methods A post hoc subgroup analysis was conducted in TNFi-IR patients who were treated with UPA 15 mg once daily in three Phase 3 clinical trials: SELECT-BEYOND, -CHOICE, and -COMPARE. For COMPARE, only patients treated with adalimumab and switched to UPA as rescue therapy were included. ≥20/50/70% improvement in ACR criteria, DAS28-CRP, Clinical Disease Activity Index, and Simple Disease Activity Index, as well as change from baseline in HAQ-DI and other patient-reported outcomes (PROs) were reported through 24 weeks. Non-responder imputation was used for all missing categorical outcomes; as observed (COMPARE) or multiple imputation (CHOICE, BEYOND) were used for missing continuous outcomes. Pooled safety results were presented as exposure-adjusted event rates (EAERs) with a cut-off of June 30, 2021. Results 568 TNFi-IR patients were included: 146 from BEYOND, 263 from CHOICE, and 159 from COMPARE. Mean duration since RA diagnosis was longer for BEYOND and CHOICE versus COMPARE; CV risk factors were common among this refractory population. ACR20/50/70 and disease activity outcomes observed in the TNFi-IR population were generally consistent with the overall BEYOND and CHOICE bDMARD-IR populations, and consistent across the three studies in the TNFi-IR subgroups. Improvements in PROs including HAQ-DI, fatigue, pain, and morning stiffness over 24 weeks were observed (data not shown). Pooled safety results reporting 1574.8 PY of exposure in the TNFi-IR subgroup showed similar results to the overall BEYOND and CHOICE bDMARD-IR study populations, with EAERs of 3.1 events/100 PY for herpes zoster and 0.8 events/100 PY for adjudicated major adverse CV events and venous thromboembolism, and malignancy excluding non-melanoma skin cancer. The EAER of any AE leading to death was 1.4 events/100 PY. Conclusion In this post hoc subgroup analysis, TNFi-IR patients treated with UPA 15 mg achieved clinically meaningful efficacy responses over 24 weeks, with safety consistent with the overall bDMARD-IR patient population in the Phase 3 program. Disclosure R. Fleischmann: Consultancies; Consultant for AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Galvani, Gilead, GSK, Janssen, Novartis, Pfizer Inc, and UCB. Grants/research support; Grant/research support from AbbVie, Amgen, Biosplice, Bristol-Myers Squibb, Flexion, Gilead, Horizon, Eli Lilly, Galvani, Janssen, Novartis, Pfizer Inc, Sanofi-Aventis, Selecta, Teva, UCB, Viela, and. L. Bessette: Consultancies; AbbVie, Amgen, Bristol-Meyers Squibb, Celgene, Eli Lilly, Fresenius Kabi, Gilead, Janssen, Merck, Novartis, and Pfizer, Roche, Sanofi-Aventis, Teva, and UCB. Member of speakers’ bureau; AbbVie, Amgen, Bristol-Meyers Squibb, Celgene, Eli Lilly, Fresenius Kabi, Gilead, Janssen, Merck, Novartis, and Pfizer, Roche, Sanofi-Aventis, Teva, and UCB. Grants/research support; AbbVie, Amgen, Bristol-Meyers Squibb, Celgene, Eli Lilly, Fresenius Kabi, Gilead, Janssen, Merck, Novartis, and Pfizer, Roche, Sanofi-Aventis, Teva, and UCB. S. Hall: Consultancies; AbbVie, Amgen, Bristol-Meyers Sqibb, Eli Lilly, Gilead, Janssen, Merck, Novartis, and UCB. Grants/research support; AbbVie, Amgen, Bristol-Meyers Sqibb, Eli Lilly, Gilead, Janssen, Merck, Novartis, and UCB. J. Sparks: Consultancies; Consulted for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer. M. Jain: Consultancies; Amgen, Abbvie, Eli Lilly, Pfizer, and Novartis. Grants/research support; Amgen, Abbvie, Eli Lilly, Pfizer, and Novartis. A. Kakehasi: Consultancies; Amgen, Janssen, UCB, AbbVie, Pfizer, Eli Lilly, Novartis, Sandoz, Fresenius Kabi. Member of speakers’ bureau; Amgen, Janssen, UCB, AbbVie, Pfizer, Eli Lilly, Novartis, Sandoz, Fresenius Kabi. Grants/research support; Amgen, Janssen, UCB, AbbVie, Pfizer, Eli Lilly, Novartis, Sandoz, Fresenius Kabi. Y. Song: Shareholder/stock ownership; full-time employees of AbbVie and may own stock or options. S. Meerwein: Shareholder/stock ownership; full-time employees of AbbVie and may own stock or options. R. DeMasi: Shareholder/stock ownership; full-time employees of AbbVie and may own stock or options. J. Suboticki: Shareholder/stock ownership; full-time employees of AbbVie and may own stock or options. A. Rubbert-Roth: Consultancies; AbbVie, AbbVie Deutschland, Amgen, Bristol-Myers Squibb, Chugai Pharmaceuticals, Eli Lilly, F. Hoffman-La Roche, Gilead Sciences, Janssen Global Services, Novartis, and Sanofi Pasteur.

P127 Baricitinib Efficacy in Moderate Rheumatoid Arthritis - A Post-hoc Analysis from two Phase III Trials

Abstract Background/Aims Baricitinib, an oral selective JAK 1/2 inhibitor, is approved for treating adults with moderate-to-severe active rheumatoid arthritis (RA). This analysis aims to report the efficacy of baricitinib in patients with moderate RA at weeks (W)12 and 24 from two phase III studies, RA-BEAM (NCT01710358) and RA-BUILD (NCT01721057). Methods This post-hoc analysis included patients from RA-BEAM (inadequate responders to methotrexate) and RA-BUILD (inadequate responders to conventional synthetic DMARDs) with moderate RA at baseline (defined as Disease Activity Score (DAS)-28 with C-reactive protein (CRP) of > 3.2 and ≤5.1). This analysis reports treatment response as low disease activity (LDA) defined by DAS28-CRP ≤3.2 and >2.6 or remission defined by < 2.6 and presents descriptive data at W12 and W24, including pain (visual analogue scale [VAS]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]), physical functioning (Health Assessment Questionnaire-Disability Index [HAQ-DI]), Work Productivity and Activity Impairment (WPAI), duration and severity of morning stiffness, joint pain, and fatigue using daily diaries. Continuous variables are presented as median with interquartile range and categorical variables as frequencies and percentages. Results At baseline, moderate RA was observed in 117 patients on baricitinib 4-mg, 80 on adalimumab, and 133 on placebo in RA-BEAM; and 80 on baricitinib 2-mg, 63 on baricitinib 4-mg, and 73 on placebo in RA-BUILD. In RA-BEAM at W12, 46.2%, 37.5%, and 9.0% of patients on baricitinib 4-mg, adalimumab, and placebo, respectively, achieved remission. In RA-BUILD at W12, 38.8%, 44.4%, and 13.7% of patients on baricitinib 2-mg, baricitinib 4-mg, and placebo, respectively, achieved remission. At W24, a further increase in the percentage of patients achieving remission was reported in both trials (Table). Improvement in pain (VAS), FACIT-F, and HAQ-DI was similar across RA-BEAM and RA-BUILD with baricitinib treatment (Table). In both trials, patients reported improvement in duration and severity of morning stiffness, worst tiredness, and worst joint pain with baricitinib treatment (Table). Additionally, baricitinib treatment yielded numerical improvement in impairment of daily activity and work productivity in RA-BEAM (Table). Conclusion In patients with moderate RA, baricitinib markedly improved signs and symptoms of RA and patient-reported outcomes (PROs) at W12 and W24. Disclosure B.W. Kirkham: Member of speakers’ bureau; B.K. has received speaker’s payments from AbbVie, Eli Lilly and Company, Galapagos, Janssen, Novartis, Pfizer, and UCB. Grants/research support; B. K. has received research support from Eli Lilly and Company and Novartis. Other; B. K. has been an adviser for AbbVie, Eli Lilly and Company, Galapagos, Janssen, Novartis, Pfizer, and UCB. B. W. has received meeting support payments from Eli Lilly and Company. E. Nikiphorou: Honoraria; E.N. received speaker honoraria from Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Eli Lilly and Company, and Fresenius. Grants/research support; E.N. holds grants from Pfizer and Eli Lilly and Company. Other; E.N. participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Eli Lilly and Company, and Fresenius. E. N. received travel payments from Eli Lilly and Company. C.J. Edwards: Honoraria; C.E received honoraria from Eli Lilly and Company. Grants/research support; C.E. received grant payments from Abbvie, Pfizer, Roche, Biogen, and Eli Lilly and Company. Other; C.E. received personal fees from Abbvie, Astra-Zeneca, BMS, Celltrion, Fresenius, Galapagos, Gilead, GSK, Janssen, Roche, Pfizer, and Sanofi and travel and meeting payments from Eli Lilly and Company. M. Sheesh: Corporate appointments; M. S. is a full-time employee at Eli Lilly and Company. Shareholder/stock ownership; M. S. is a minor shareholder at Eli Lilly and Company. E. Haladyj: Corporate appointments; E. H. is a full-time employee at Eli Lilly and Company. Shareholder/stock ownership; E. H. is a minor shareholder at Eli Lilly and Company. J. Gerwien: Corporate appointments; J. G. is a full-time employee at Eli Lilly and Company. Shareholder/stock ownership; J. G. is a minor shareholder at Eli Lilly and Company. L. Zaremba-Pechmann: Corporate appointments; L. Z-P is a contractor at HaaPACS gmbH. P.C. Taylor: Consultancies; P. T. has been a consultant for AbbVie, Biogen, Galapagos, Gilead, GlaxoSmithKline, Janssen, Eli Lilly and Company, BMS, Pfizer, Roche, Celltrion, Sanofi, Nordic Pharma, Fresenius, and UCB. Grants/research support; P. T. received grant/research support from Galapagos. Other; P. T. has received meeting support payments from Eli Lilly and Company.

P112 Patient Experience of Remote Healthcare during the Pandemic in Rheumatoid Arthritis and Adult Juvenile Idiopathic Arthritis

Abstract Background/Aims COVID-19 challenged traditional care models and necessitated introduction of remote consultations. We wanted to understand the experiences of people with rheumatoid arthritis (RA)/adult juvenile idiopathic arthritis (AJIA) on accessing healthcare remotely, and how well people understood their condition and treatment. Methods This collaborative work between the National Rheumatoid Arthritis Society (NRAS) and clinicians in Oxford led to the development of an electronic questionnaire that was disseminated in July 2021 for four weeks through e-newsletters and all NRAS social media platforms. Those living in the UK with RA and AJIA aged 18 and over were eligible. Analyses of data were performed in Microsoft Excel and IBM SPSSv28. Results We analysed 316 responses. There was a middle-aged (ages 46 to 54, 54.1%, n = 171), Caucasian (97.5%, n = 306), female (92.4%, n = 292) preponderance. Most had RA (93%, n = 294) followed by another inflammatory arthritis (4.1%, n = 13) and AJIA (2.8%, n = 9). The majority had their condition for >10 years (43.4%, n = 137) but some were diagnosed <12 months ago (3.2%, n = 10). Two thirds of participants (66.5%, n = 210) did not know their DAS28 score. Of the remaining third, the most commonly reported measure was moderate disease activity (12%, n = 38). Those with higher self-reported DAS28 scores were using analgesia more regularly (p < 0.01) but we found no difference in NSAID, DMARD or steroid use. Age did not influence steroid usage (p = 0.35), but those who had their condition for longer used more steroids and regular analgesia. Only 33.9% (n = 107) of responders felt their condition had been managed adequately in the pandemic, with more reporting poor status (40.8%, n = 129) rather than good (16.8%, n = 53). Those living in the South of England reported statistically better disease control than those from the North, despite having more virtual assessments (p = 0.02). Travelling and fear of Covid appeared more important than consultation skills. Just over a fifth (20.3%, n = 64) felt greater focus should be given to patient concerns. Of the 9.1% of patients (n = 29) with a new diagnosis made during the pandemic, 24.1% (n = 7) unable to book a GP appointment easily. Patients experienced a median symptom time of 4-10 weeks before consulting GPs. Once assessed, 31% (n = 9) were referred immediately while the median time was 4-8 weeks. We found 58.6% (n = 17) of patients received their diagnosis within their initial rheumatology consultation and 76.5% (n = 13) of these started a DMARD immediately. Conclusion Despite a greater emphasis on patient education and PROMs influencing clinical decision-making, it is staggering that two-thirds did not know their DAS28 score. Analgesia and steroid use were common in patients with well-established disease which remains a concern. Accessing appointments was a significant barrier to patients and delays in care were experienced at every step in the NHS management pathways. Remote consultations need greater emphasis on patient concerns. Disclosure R.S. Andev: Member of speakers’ bureau; RSA received speaker funds from Novartis. A. Bosworth: None. C. Jacklin: None. S. Dubey: None.

P180 Minimal disease activity response patterns in bio-naïve patients with psoriatic arthritis treated with guselkumab: a machine learning analysis

Abstract Background/Aims Guselkumab, a human monoclonal antibody targeting the interleukin-23 p19 subunit, demonstrated joint and skin efficacy in patients with PsA in the Phase III DISCOVER-1/-2 trials. MDA, a multi-domain composite outcome, is a clinically relevant measure of therapeutic response in PsA. However, response dynamics and the effect of individual domains on achieving MDA are not well understood. This analysis aimed to characterise MDA response clusters according to domain changes over time and identify potential baseline predictors in patients with PsA receiving guselkumab. Methods Data from bio-naïve patients with active PsA receiving guselkumab 100 mg every 4 or 8 weeks were pooled across DISCOVER-1/-2. Unsupervised machine learning using the time-series K-means clustering algorithm was performed to identify clusters according to MDA domain responses over 52 weeks. Missing data were not imputed. Results This analysis included 571 of 669 patients receiving guselkumab and distinguished four response clusters (C1-4; Table 1). Mean age and body mass index were similar across clusters; C3 had a lower proportion of female patients vs. other clusters. Relative to C3, a high burden of baseline disease was observed in C4 across clinical measures and PROs, and across PROs only in C2. Through Week 52, mean values for all MDA domains showed continuous improvement across clusters (Table 1). MDA response rates were highest in C3, in which all individual domain thresholds were rapidly approached, and lowest in C4. In C1 and C2, improvement in clinical measures paralleled that of C3; both met the PASI threshold and showed substantial reduction in SJC. PROs appeared to take longer to improve but did so earlier in C1 than C2. Improvements were slowest in C4, though still substantial given the high baseline disease burden. Conclusion Machine learning differentiated four clusters of patients with PsA receiving guselkumab based on response patterns in individual MDA domains. Response may differ due to baseline disease burden, especially in patients with high pain, PtGA and functional disability scores. These results offer an innovative, complementary approach to identifying treatment response patterns across diverse clusters of bio-naïve patients with PsA, which may facilitate clinical decision-making. Disclosure A. Zabotti: Member of speakers’ bureau; AbbVie, Amgen, Janssen, Lilly, Novartis and UCB. Grants/research support; Novartis. S. Ohrndorf: Other; Speaker fees or travel expense reimbursements from AbbVie, BMS, Janssen, Novartis and Pfizer. W. Tillett: Other; Research funding, consulting, speaker fees and/or honoraria from AbbVie, Amgen, Celgene, GlaxoSmithKline, Janssen, Lilly, MSD, Novartis, Pfizer and UCB. M. Neuhold: Other; Former employee of Janssen and is now an employee of Takeda Pharmaceuticals International AG. M. van Speybroeck: Shareholder/stock ownership; Employee of Janssen and owns stocks in Johnson & Johnson. E. Theander: Other; Former employee of Janssen. C. Contré: Other; Former employee of Janssen and is now an employee of Chiesi. M. Sharaf: Shareholder/stock ownership; Employee of Janssen and owns stocks in Johnson & Johnson. M. Shawi: Shareholder/stock ownership; Employee of Janssen and owns stocks in Johnson & Johnson. M. Perate: Shareholder/stock ownership; Employee of Janssen and owns stocks in Johnson & Johnson. A. Kollmeier: Shareholder/stock ownership; Employee of Janssen and owns stocks in Johnson & Johnson. P. Richette: Other; Received fees from AbbVie, Amgen, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer and UCB.

P186 Long-term safety of ixekizumab in adult patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis

P186 Long-term safety of ixekizumab in adult patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis

OA19 Incidence and management of inflammatory arthritis in England before and during the COVID-19 pandemic: a population-level cohort study using OpenSAFELY

Abstract Background/Aims The impact of the pandemic on the incidence and management of inflammatory arthritis (IA) is not understood. Routinely-captured data in secure platforms, such as OpenSAFELY, offer unique opportunities to understand how IA was impacted upon by the pandemic. Our objective was to use OpenSAFELY to assess the effects of the pandemic on diagnostic incidence and care delivery for IA in England, and replicate key metrics from the National Early Inflammatory Arthritis Audit. Methods With the approval of NHS England, we used primary care and hospital data for 17 million adults registered with general practices using TPP health record software, to explore the following outcomes between 1 April 2019 and 31 March 2022: 1) incidence of IA diagnoses (rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, undifferentiated IA) recorded in primary care; 2) time to first rheumatology assessment; 3) time to first prescription of a conventional synthetic DMARD (csDMARD) in primary care, and choice of first csDMARD. Results From 17,683,500 adults (representing 40% of the English population), there were 31,280 incident IA diagnoses recorded between April 2019 and March 2022. New IA diagnoses decreased by 39.7% in the early months of the pandemic. Overall, a 20.3% decrease in IA diagnoses was seen in the year commencing April 2020, relative to the preceding year (5.1 vs. 6.4 diagnoses per 10,000 adults, respectively). Further decreases coincided with rising COVID-19 numbers, before returning to pre-pandemic levels by the end of the study period. No rebound increase in IA incidence was observed as of April 2022. The median time from referral to first rheumatology assessment was shorter during the pandemic (18 days; IQR 8-35 days) than before (21 days; 9-41 days). The proportion of patients prescribed csDMARDs in primary care was comparable to before the pandemic; however, fewer people were prescribed methotrexate or leflunomide, and more were prescribed sulfasalazine or hydroxychloroquine. Conclusion IA diagnoses decreased markedly during the early phase of the pandemic; however, the impact on rheumatology assessment times and DMARD prescribing was less marked than might have been anticipated. This study demonstrates the feasibility of using routinely-captured, near real-time data in the secure OpenSAFELY platform to benchmark care quality on a national scale, without the need for manual data collection. Disclosure M.D. Russell: Honoraria; Lilly, Menarini, Biogen. Other; Lilly, Pfizer, Janssen, UCB. J.B. Galloway: Honoraria; Abbvie, Biovitrum, BMS, Celgene, Chugai, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, Sobi, UCB. C.D. Andrews: None. B. MacKenna: None. B. Goldacre: Grants/research support; Laura and John Arnold Foundation, NIHR, Mohn-Westlake Foundation, Wellcome Trust, Good Thinking Foundation, Health Data Research UK, Health Foundation, World Health Organisation, UKRI, Asthma UK, British Lung Foundation, and National Core Studies programme. A. Mehrkar: Other; Former employee and interim CMO of NHS Digital, and RCGP representative on GP Data Professional Advisory Group to NHS Digital. H.J. Curtis: None. B. Butler-Cole: None. T. O'Dwyer: None. S. Qureshi: Grants/research support; BMS. J.M. Ledingham: Other; Clinical director for NEIAA, Secretary for The Federation of Joint Royal Colleges of Physicians SCE Board, and trustee of the BSR. A. Mahto: Honoraria; Abbvie, Galapagos. Other; Lilly. A.I. Rutherford: Other; Lilly. M.A. Adas: None. E. Alveyn: None. S. Norton: None. A.P. Cope: Consultancies; BMS, Abbvie, GSK/Galvini. Member of speakers’ bureau; BMS, Abbvie. Grants/research support; BMS. Other; Executive committee of the EULAR research centre. K. Bechman: Grants/research support; Versus Arthritis and Pfizer Global Medical Grants.

P091 Outcomes following switching from originator to biosimilar product in children and young people with JIA

Abstract Background/Aims There are many biosimilar products available to use in children and young people with JIA. Due to competitive pricing, patients are being switched from biologic originator to biosimilar (non-medical switch). This analysis aims to describe characteristics of, and outcomes, following TNF-inhibitor originator to biosimilar switch in JIA. Methods All patients in the UK JIA Biologics Register switching from an originator to a biosimilar of the same product were identified. Patient characteristics are presented, including time on originator prior to switch. Patients were followed until their final follow-up form was returned. For those with >1 year of follow-up post-switch, treatment persistence and reasons for stopping are described. Results As of 28-Sept-2022, 202 children and young people had switched from originator to biosimilar; 125 adalimumab, 55 etanercept, and 22 infliximab (table). Switching was seen in all ILAR categories. Patients were predominantly female (63%), median age at JIA diagnosis six years, 11 years at originator start, 14 years at biosimilar start, median time on originator 2.2 years. Most patients had started originator as their first biologic (74%) and most started biosimilar with no significant treatment gaps. Five patients reported >1 year gap between originator stop and biosimilar start, suggesting a planned period off biologic therapy (two stopped for remission, one for adverse event, two unknown). Of the 134 patients with >1 year of follow-up available after switching (median 1.9 years per patient), 77 remained on biosimilar at their final follow-up, whilst 57 had stopped therapy. Of those who stopped, 10 had stopped for remission, 12 stopped for ineffectiveness, 18 for adverse event, and 17 other/missing reason. Thirty-nine patients then re-started biologic therapy (including four of the remission patients); 16 switched back to the originator mostly due to an adverse event on the biosimilar, and 23 started a different biologic therapy mostly due to inefficacy of the biosimilar. Conclusion Many children with JIA have now been switched from TNF-inhibitor originator to biosimilar product, with the majority still receiving their biosimilar after one year. Switching back to originator was uncommon, 12% overall after one year, suggesting good tolerance of non-medical switching in this patient population. Disclosure L. Kearsley-Fleet: None. E. Baildam: None. M.W. Beresford: None. S. Douglas: None. H.E. Foster: None. T.R. Southwood: None. K.L. Hyrich: Member of speakers’ bureau; non-personal speakers fees from Abbvie. Grants/research support; BMS, UCB, Pfizer.

P164 An emerging role of interferon targeted therapy in mucocutaneous SLE: a prospective real-world evaluation of anifrolumab for refractory cutaneous lupus

Abstract Background/Aims Advances in rational drug design and recent clinical trials are leading to emergence of a range of novel therapies for SLE and therapeutic options in clinical practice are expected to broaden rapidly. The optimal real-world place of emerging and established agents will be guided by understanding their differential efficacy on specific SLE manifestations as well as efficacy for more resistant disease. Anifrolumab, a type-I interferon receptor blocking monoclonal antibody, showed efficacy in SLE in phase III trials with a notable effect on mucocutaneous disease although specific lesion subtypes and chroncicity were not explored. Severe refractory mucocutaneous SLE such as scarring discoid lesions are an important and common clinical challenge in current practice. We therefore prospectively evaluated the real-world efficacy and quality of life impact of anifolumab for active mucocutaneous SLE, recalcitrant to multiple biologic and immunosuppressant therapies. Methods Seven patients commenced anifrolumab (300 mg by monthly iv infusion) following application to the manufacturer’s early access programme (NCT 04750057). Prior biologic therapies were discontinued at least 5 half-lives in advance. Mucocutaneous disease activity was captured by Cutaneous Lupus Disease Area and Severity Index (CLASI) activity score and medical photography. Patient reported health-related quality of life comprising the Dermatology Life Quality Index (DLQI); Lupus-QoL and EQ5D-5L were evaluated at baseline, three and six months. Results Seven female patients with active mucocutaneous SLE (Discoid LE n = 5, chilblain LE n = 1, subacute cutaneous LE n = 1) and median disease duration of 17 years were evaluated. Median baseline CLASI activity score was 17 (range 10-26; higher scores indicating severe disease). Median number of previously failed therapies was 7 and included rituximab in 6/7, belimumab in 2/7 and thalidomide in 4/7. Rapid resolution of scale and erythema in DLE was established within 1 month of anifrolumab treatment. Improvements to chilblain lupus were evident by three months. CLASI activity score was improved ≥75% in all patients at 3 months. Clinical responses were associated with significant improvements in DLQI (p < 0.001) and EQ5D-VAS (p = 0.002) by three months. Lupus-QoL trended toward improvement across all domains but most strongly for fatigue (p = 0.01) and pain (p = 0.002) by 6 months. One patient discontinued treatment after 4 months due to polydermatomal shingles complicated by sensorineural hearing loss. Infection coincided with background prednisolone dose >15 mg daily, recent COVID-19 infection and new on-treatment hypogammaglobulinaemia (IgG <5 g/L). Prolonged aciclovir treatment was required for lesion resolution. Conclusion We report rapid real-world efficacy and quality of life impact of anifrolumab on highly refractory mucocutaneous SLE, which exceeded that anticipated from existing clinical trial data. Findings suggest a unique role for emerging interferon targeting therapies in management of mucocutaneous SLE but emphasize need for enhanced VZV precautions among higher risk patients. Disclosure L. Carter: Consultancies; UCB. Z. Wigston: None. P. Laws: Consultancies; Amgen, Celgene, Janssen, Leo, Lilly and Sanofi. Member of speakers’ bureau; AbbVie, Actelion and BMS. Grants/research support; UCB, Almirall, and Novartis. E.M. Vital: Consultancies; Roche, GSK, AstraZeneca, Aurinia Pharmaceuticals, Lilly and Novartis. Grants/research support; Roche, AstraZeneca and Sandoz.