Change In DAS28 Research Articles

Association between body weight and tocilizumab effectiveness in rheumatoid arthritis: results from the BSRBR-RA.

Tocilizumab is an IL-6 receptor humanised monoclonal antibody for the treatment of rheumatoid arthritis (RA) with intravenous (IV) and subcutaneous (SC) preparations available. Only IV tocilizumab is dosed adjusting for weight. Therefore, we aimed to study the association between body weight and the effectiveness of tocilizumab by the route of administration. Patients with RA administered tocilizumab in the BSRBR-RA were included in the analysis and stratified by route of administration. Outcomes included the 6 month change in DAS28, the proportion of patients achieving DAS28 remission, 6-month EULAR response and persistence of the first route of tocilizumab administration. The exposure was every increase in 10 kg of body weight. Adjusted regression models appropriate to outcome were used to study the associations between body weight and outcomes. Multiple imputations accounted for missing data. 2612 patients were included. Body weight was associated with reduced response to SC tocilizumab measured by change in DAS28: adjusted regression coefficient (95% CI) all patients 0.01 (-0.04, 0.07); IV: -0.03, (-0.1, 0.5); SC: 0.1 (0.02, 0.2) but not odds in achieving DAS28 remission or EULAR response. There was no significant association between body weight and the persistence of IV or SC tocilizumab. Body weight was associated with the initial response to SC tocilizumab, although the difference in response was small, but not drug persistence. Physicians should monitor the body weight of patients and consider interventions to promote maintenance of a healthy weight.

Correlation between Serum Levels of Factor I, CD59, Interferon-gamma, and Interleukin-6 with the Response to Rituximab in Iraqi Patients with Rheumatoid Arthritis

Background: Rituximab is a chimeric IgG1 kappa immunoglobulin that has been genetically modified to incorporate human constant region sequences together with murine light- and heavy-chain variable region sequences. People use it to treat rheumatoid arthritis and certain malignancies. Objective: The study aimed to assess the potential association between the serum levels of Factor I, CD59, interleukins (IL)-6, and interferon-gamma (IFN)-γ and the response to Rituximab treatment in Iraqi rheumatoid arthritis patients. Methods: A cross-sectional study was conducted at the rheumatology center at Baghdad Teaching Hospital. Ninety adult patients who have been diagnosed with rheumatoid arthritis and are receiving Rituximab intravenous infusions were included. The enrolled patients were divided into a responder group (45 patients) and a non-responder group (45 patients). The response to Rituximab was assessed according to the 28-joint Disease Activity Score (DAS28). Results: The serum levels of Factor I and CD59 were significantly higher in the non-responders group in comparison to the responders group. In addition, the serum IL-6 and IFN-γ levels were significantly elevated in the non-responders group in comparison to the responders group. The estimated marker serum levels showed a strong, significant correlation with the 6-month change in DAS28. Conclusions: In Rituximab nonresponder RA patients, serum levels of Factor I, CD59, Factor H, IL-6, and IFN-γ are higher, and they have good potential to be used in the assessment of the response to Rituximab therapy.

P046 The influence of deprivation in the outcomes of Psoriatic Arthritis within the UK - utilising Outcomes of Treatment in Psoriatic Arthritis Study Syndicate data

Abstract Background/Aims Psoriatic arthritis (PsA) is a chronic inflammatory arthropathy, which affects approximately 30% of patients with psoriasis and is associated with a high degree of morbidity. The introduction of biological disease-modifying antirheumatic drugs (bDMARDs) revolutionised treatment strategies for patients with PsA, however response is not universal. Deprivation and its associated risk factors may impact the initiation of and response to treatment with bDMARDs. There is limited data exploring the effect of deprivation on disease response to biologics in PsA. Psoriasis patients with a higher socioeconomic status have been shown to be more likely to respond to biologics, to our knowledge this has not been investigated in PsA. This study aimed to assess the impact of deprivation on initiation of and clinical response to biologic DMARDs. Methods Patients commencing a bDMARD were recruited to the UK prospective observational study Outcome of Treatment in Psoriatic Arthritis Studies Syndicate (OUTPASS REC ref:13/NW/0068). Index of Multiple Deprivation (IMD), the official measure of relative deprivation in England, was the exposure of interest. Subjects were ranked based on their IMD and split into the 20% most deprived (deciles 1-2), middle 40% (deciles 3-6) and 40% least deprived (deciles 7-10). This was done to aid analysis as IMD weightings provide greater differentiation among the least advantaged areas with fewer distinctions for less deprived areas. Treatment response was measured using changes in DAS28/PsARC, analysed using multivariate linear regression and multivariate logistic regression, respectively. Response was measured at three months as NICE guidance advises review of biological therapies at this time. Results There was no difference in the distribution of patients between the three groups (most deprived=138, middle deprived=207, least deprived=193). There were no statistically significant differences in the time from diagnosis to starting biologics in the most deprived group compared to the middle (p = 0.62) or least deprived p = 0.42) groups. There was no statistically significant difference in treatment responses between the groups. DAS28 change and PsARC improvement at three months remained similar between the most deprived, the middle deprived (p = 0.71, p = 0.08) and least deprived groups (p = 0.81, p = 0.22). Conclusion There was no difference in the distribution of IMD in patients recruited to OUTPASS, suggesting that the study is inclusive in recruiting across IMD subgroups. There was no difference in time from diagnosis to starting bDMARD therapy or response to treatment across the deprivation spectrum. These findings suggest that the NHS in England is performing its role of providing care according to need and regardless of circumstance. The study assesses deprivation in the context of free healthcare and may not be applicable to fee-paying healthcare systems. Further research is required to determine the relationship between deprivation and other outcomes, including work instability, in PsA. Disclosure M. Lyon: None. S. Zhao: None. A. Barton: Member of speakers’ bureau; speaker fees from Chugai-Roche and Galapagos. Grants/research support; grant funding from BMS, Pfizer, all unrelated to the work presented. H. Chinoy: Corporate appointments; Advisory Board member for Astra Zeneca, Pfizer, Argenx, Galapagos; Data and Science Monitoring Board chair for Horizon Therapeutics.. Consultancies; Consulting for PTC Therapeutics. Member of speakers’ bureau; fees as a speaker for GSK, UCB. M. Jani: None. J. Bluett: Grants/research support; research grant award from Pfizer and travel/conference fees from UCB, Fresenius Kabi, Pfizer and Eli Lilly.

Efficacy of montelukast as an adjuvant therapy in rheumatoid arthritis patients: A randomized controlled study

ObjectiveThis study aimed to evaluate the efficacy of montelukast in conjunction with non-biologic disease modifying anti-rheumatic drugs (nDMARDs) in rheumatoid arthritis (RA) patients. MethodsThis study was a single-center randomized double-blinded placebo-controlled study. Adult RA patients were included if they had moderate to severe disease activity and were receiving monotherapy or combination of nDMARDs. Eligible patients were randomized, in 1:1 ratio, to receive either 10 mg montelukast or placebo, once daily for 16 weeks. The primary endpoint was the change in the 28-joints disease activity score (DAS28) 16 weeks after treatment. The patients’ quality of life (QoL) was assessed by the Arabic version of the Health Assessment Questionnaire-Disability Index. Moreover, serum levels of vascular adhesion molecule-1 (VCAM-1) were measured. ResultsA total of 87 patients completed the study; 44 in the montelukast arm and 43 in the control arm. After 16 weeks of treatment, disease activity decreased significantly in the montelukast arm with mean change in DAS28 (95% CIs) of −1.5 (−1.7, −1.2) while the control arm showed no improvement (0.2 (0.0, 0.4), p < 0.01). The QoL of the patients improved significantly from baseline in the montelukast arm (p < 0.01) but not in the control arm (p = 0.08). The median (IQR) serum levels of VCAM-1 were significantly lower in the montelukast arm (22.8 (15.0–32.7)) than in the control arm (28.9 (15.4–42.8), p = 0.004). ConclusionThe co-administration of montelukast with nDMARDs in RA patients enhanced the anti-rheumatic effect which was reflected clinically by decreased disease activity.

The efficacy of statins in the treatment of rheumatoid arthritis: A systematic review and meta-analysis.

A large body of research has investigated the use of statins in rheumatoid arthritis (RA); however, the therapeutic effects of statins remain uncertain. Thus, we designed a systematic review and meta-analysis to evaluate the role of statins in patients with RA. Databases searched to detect clinical randomized controlled trials or clinical controlled trials on the interaction between statins and RA before January 2020 included PubMed, Web of Sciences, Embase, Cochrane Library, CNKI, Wan Fang Database. Efficacy was measured by Disease Activity Score in 28 Joints (DAS28), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), tenderness of the joint (TJ), swelling of the joint (SJ), and interleukin-6. The level of blood lipid was also evaluated. STATA 12.0 was used for the meta-analysis. The Cochrane method was used for quality assessment. Heterogeneity was considered to determine fixed effects or random effects models. Nineteen clinical trials with a total of 22,906 subjects were included in the meta-analysis. Sixteen studies reported a change in DAS28 after statin treatment. The pooled analysis showed that statins reduced DAS28 in RA patients. Change in ESR after statin treatment was reported in 9 studies. The summary analysis showed that statins lowered ESR in RA patients. Twelve studies reported a change in CRP after statin treatment. The results of the entire analysis showed that statins lowered CRP in RA patients. Seven studies reported a change in TJ after statin treatment. The combined analysis showed that statins reduced TJ at RA patients. Six studies reported changes in IL6 after statin therapy. The results showed that statins failed to reduce IL6 in RA patients. Seven studies reported changes in SJ after statin therapy, which showed that statins failed to reduce SJ in RA patients. We also found that statins can reduce blood lipid levels in RA patients. In conclusion, statins were able to reduce DAS28, ESR, CRP, TJ, and blood lipids. It indicated that stains can benefit patients with RA by inhibiting the expression of inflammatory factors and reducing the levels of lipids in the blood. Our study may offer a new perspective on the treatment of RA and provide research ideas for future larger multi-center clinical trials.

Outcomes following switching from etanercept originator to etanercept biosimilar in 1024 patients with RA: a matched-analysis of the BSRBR-RA.

Adults with RA are being switched from etanercept originator to biosimilar in non-medical/cost-saving switching. This analysis aims to investigate outcomes in these patients, including (i) drug survival and (ii) disease activity at 6 months and 12 months, compared with those who remain on the originator. Using BSRBR-RA, those who switched directly from etanercept originator to biosimilar were identified and matched to patients receiving the originator, based on gender, age, disease duration and originator start year. Drug survival was calculated; Cox-proportional hazard models assessed differences in drug persistence between those who switched vs remaining on originator. Change in DAS28 after 6months and 12months was compared between cohorts. Multiple imputation was used. A total of 1024 adults with RA switching from etanercept originator to biosimilar were included, with a matched cohort of patients remaining on the originator. Patients who switched onto a biosimilar product were no more likely to discontinue etanercept treatment vs those who remained on the originator; hazard ratio 1.06 (95%CI 0.89-1.26), with 65% of patients remaining on treatment at three years. Ninety-five (9%) patients switched back to the originator within the first year. After 6months and 12months, biosimilar patients were no more likely to have a worsening of DAS28 (>0.6units) compared with those who remained on the originator. This is the largest matched comparative effectiveness analysis showing patients switching from etanercept originator to biosimilar appearing to do just as well with regard to disease activity and drug persistence compared with those who remained on the originator. These data will be reassuring to clinicians and patients regarding non-medical switching.

Three-month tapering and discontinuation of long- term, low-dose glucocorticoids in senior patients with rheumatoid arthritis is feasible and safe: placebo-controlled double blind tapering after the GLORIA trial

ObjectiveThe randomised placebo-controlled GLORIA (Glucocorticoid LOw-dose in RheumatoId Arthritis) trial evaluated the benefits and harms of prednisolone 5 mg/day added to standard care for 2 years in patients aged 65+...

The Cost-Effectiveness of and Adherence to Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Rheumatoid Arthritis Patients in a Tertiary Care Teaching Hospital in Uttarakhand, India.

Objective This study was conducted with the aim ofevaluating the cost-effectiveness of and adherence to treatment in patients on disease-modifying antirheumatic drug (DMARD) therapy for rheumatoid arthritis (RA) in a tertiary care teaching hospital in Uttarakhand, India. Methodology This prospective observational study was conducted on 150 rheumatoid arthritis patients presenting to the Rheumatology Outpatient Department (OPD) receiving DMARD therapy (approval number AIIMS/IEC/18/160). The patients were followed up for an average of 10.7 weeks and received drugs in four regimens with methotrexate (MTX) (Regimen 1) having the least contribution with a mean of 46.05 Rs, methotrexate + hydroxychloroquine(MTX + HCQ) (Regimen 2) with 174.15 Rs, methotrexate + hydroxychloroquine + leflunomide (MTX + HCQ + Lef) (Regimen 3) with Rs 371.70, and methotrexate + hydroxychloroquine + leflunomide + biological DMARD adalimumab(MTX + HCQ + Lef + bDMARD adalimumab) (Regimen 4) with 17,349.4 Rs.The cost of drug therapy was assessed by calculating the cost of therapy per month for each patient, and adherence was assessed using the Morisky-Green-Levine Scale (MGLS) at the follow-up visit. Results The overall mean cost of DMARD treatment was 205.81 Rs. The overall DMARD therapy cost-effectiveness was Rs 878.14 for a unit change of Disease Activity Score (DAS28). The most cost-effective treatment came out to be Regimen 1 with the least cost of 290.9Rs for a unit change of DAS28, and the least cost-effective was Regimen 4 with 65,661.8 Rs for a unit change of DAS28. At follow-up, among all subjects of the study, 49 (32.7%) subjects showed high adherence, 71 (47.3%) subjects showed medium adherence, and 30 (20%) subjects showed low adherence. Accordingly, the maximum number of participants fell in the category of medium adherence, i.e., 71 (47.4%). Conclusion Our study concluded that the cost burden varied according to the number of DMARDs being given to the patient. The double-drug therapy of methotrexate + hydroxychloroquine had a maximum "high adherence." On a whole, the majority of patients had "medium adherence" to therapy.

A chinese medicine formula (kunbixiao granule) for female rheumatoid arthritis: Study protocol for a double-blind, randomized, placebo-controlled trial.

Introduction: Rheumatoid arthritis (RA) is a chronic autoimmune disease affecting females more than males. Clinical symptoms, disease activity and comorbidities are more severe in females. Moreover, the choice of treatment for females is limited during childbearing age due to the side effects of current drugs. Therefore, developing novel and safer drugs for females is urgently needed. Kunbixiao granules (KBXG), a Chinese medicine formula, has been applied to treat female RA patients in our center as a complementary therapy. However, there is insufficient evidence for its effect. Therefore, we aim to conduct a randomized, controlled, double-blind clinical trial to confirm the efficacy and safety of KBXG for the treatment of female RA. Methods: This study is a single-center, double-blind, randomized, parallel group, placebo-controlled clinical trial. A total of 90 female RA patients with Disease Activity Score for 28 joints (DAS28) > 3.2 will be enrolled. They will be randomly assigned to receive either KBXG or placebo for 12 weeks. The change in DAS28 based on C-reactive protein (DAS28-CRP) and the Clinical Disease Activity Index (CDAI) are the primary outcomes. The secondary outcomes include a rate of achieving 20%, 50% and 70% improvement in the American College Rheumatology criteria (ACR20, ACR50, ACR70), TCM syndrome score, visual analogue scale (VAS), average hands grip strength, the consumption of concomitant medication, Hospital Anxiety and Depression Scale (HADS), lumbar spine bone mineral density (L-BMD) and 7-joint ultrasound score (US7). Any adverse events will also be recorded. Discussion: This trial will provide evidence of KBXG in reducing disease activity, and improving clinical symptoms and quality of life of female RA patients. The long-term effects of KBXG on female RA patients still needs a further follow-up.

Machine learning predicts response to TNF inhibitors in rheumatoid arthritis: results on the ESPOIR and ABIRISK cohorts

ObjectivesAround 30% of patients with rheumatoid arthritis (RA) do not respond to tumour necrosis factor inhibitors (TNFi). We aimed to predict patient response to TNFi using machine learning on simple...

Quality of life and disease activity of patients with rheumatoid arthritis on tofacitinib and biologic disease-modifying antirheumatic drug therapies.

The aim of this study was to analyze the therapeutic results of rheumatoid arthritis (RA) therapy with different biologic disease-modifying antirheumatic drugs (bDMARDs) and the first Janus-activated kinase (JAK) inhibitor in real-life clinical settings. This is a prospective, observational, longitudinal study at the largest rheumatology clinic in Bulgaria conducted during the period 2012-2020. One hundred seventy-four patients were followed up for a period of one year. Patients naïve to biological therapy were consecutively assigned on the available at the time bDMARDs (infliximab, etanercept, adalimumab, rituximab, golimumab, cetrolizumab, tocilizumab) or tofacitinib. We evaluated the disease activity score (DAS28-CRP), Health assessment questionnaires (HAQ) and short form 36 (SF-36) were applied at the initiation of biological therapy, after 6, and 12months of follow-up. We analyze the changes in the two major subgroups of SF36-physical (MCS) and mental health (PCS). The age and gender distribution were similar between the groups on bDMARDs and tsDMARD. All observed indicators for disease control and QoL improve after the initiation of the biological or JAK inhibitor therapy. We also analyze the effect of therapies on DAS28-CRP, HAQ, SF-36 (PCS, MCS). Dispersion analysis for the effect of therapy measured through DAS28 between 1st and 3rd measurement shows a statically significant difference in between the average effect of therapies (p = 0.005). According to the average change in DAS28 between the first and third measurement the most effective is the golimumab (Median difference = 2.745), followed by rituximab (median = 2.305) and etanercept (median = 2.070). According to the average change in HAQ between first and third the most effective is tofacitinib (median 0.563), followed rituximab and infliximab (median 0.500 for both). Less effective in term of HAQ changes between the first and third measurement appears to be etanercept (median difference 0.250). All differences are statistically significant (p < 0.05). Regarding the changes in the QoL measured with SF-36 MCS and PCS there is no statistically significant differences in the average effect of different therapeutic agents. Tofacitinib is non-inferior in comparison to bDMARDs and improve both-disease activity and QoL in patients with RA.

Real-world evidence on methotrexate-free subcutaneous tocilizumab therapy in patients with rheumatoid arthritis: 24-week data from the SIMPACT study.

ObjectivesThe aim of the SIMPACT study was to evaluate the efficacy and safety of MTX-free s.c. tocilizumab (TCZ) therapy in RA patients.MethodsSIMPACT was an open-label, non-controlled, non-randomized, non-interventional study, in which RA patients for whom the treating physicians ordered s.c. TCZ were observed during a 24-week treatment period in Hungarian centres. Although the use of MTX was avoided during the study period, other conventional synthetic DMARDs, oral CSs and NSAIDs were allowed. Study endpoints included the change in DAS28 and clinical activity index (CDAI) scores, the proportion of patients achieving remission in the whole population and in subgroups defined based on prior RA treatment history, and age, weight or biological sex post hoc. The extent of supplementary medication use was monitored.ResultsThree hundred and thirty-seven RA patients were enrolled in 18 study centres. TCZ therapy significantly decreased the disease activity measured by both DAS28 (P = 0.0001) and CDAI (P = 0.0001). Clinical response was more pronounced in biologic-naïve patients and was lower in patients >75 years of age. In the whole population, DAS28 ESR or CRP and CDAI remission rates were 70.10%, 78.95% and 33.59%, respectively. In patients <45 years of age, the CDAI remission rate doubled (67.86%). A significant decrease in the frequency of co-administered medication was reported, including oral CSs and DMARDs.ConclusionReal-world clinical evidence on s.c. TCZ reported here is in line with the efficacy outcomes of randomized clinical trials. Subgroup analysis revealed that TCZ was more effective in biologic-naïve patients and in those <75 years old.Trial registrationClinicalTrials.gov, http://www.clinicaltrials.gov, NCT02402686.

Does periodontal treatment improve rheumatoid arthritis disease activity? A systematic review.

ObjectivesThe association of periodontal disease in people diagnosed with RA is emerging as an important driver of the RA autoimmune response. Screening for and treating periodontal disease might benefit people with RA. We performed a systematic literature review to investigate the effect of periodontal treatment on RA disease activity.MethodsMedline/PubMed, Embase and Cochrane databases were searched. Studies investigating the effect of periodontal treatment on various RA disease activity measures were included. The quality of included studies was assessed. Data were grouped and analysed according to RA disease outcome measures, and a narrative synthesis was performed.ResultsWe identified a total of 21 studies, of which 11 were of non-randomized experimental design trials and 10 were randomized controlled trials. The quality of the studies ranged from low to serious/critical levels of bias. RA DAS-28 was the primary outcome for most studies. A total of 9 out of 17 studies reported a significant intra-group change in DAS-28. Three studies demonstrated a significant intra-group improvement in ACPA level after non-surgical periodontal treatment. Other RA biomarkers showed high levels of variability at baseline and after periodontal treatment.ConclusionThere is some evidence to suggest that periodontal treatment improves RA disease activity in the short term, as measured by DAS-28. Further high-quality studies with longer durations of follow-up are needed. The selection of the study population, periodontal interventions, biomarkers and outcome measures should all be considered when designing future studies. There is a need for well-balanced subject groups with prespecified disease characteristics.

Tofacitinib monotherapy and erectile dysfunction in rheumatoid arthritis: a pilot observational study.

We aimed to explore the effect of tofacitinib on erectile dysfunction (ED), as well as disease activity and health related quality of life in male patients with rheumatoid arthritis (RA). Forty eight male RA patients with ED were included. Demographic and clinical data at baseline and 6 month of treatment were recorded from patients' medical records. Disease activity was evaluated with the disease activity score on 28 joints (DAS28), quality of life with Health Assessment Questionnaire-Disability Index (HAQ-DI) and ED with International Index of Erectile Function-5 (IIEF-5). The patients were aged 45.58 [Formula: see text] 2.14years with a disease duration of 79.33 [Formula: see text] 25.31months. According to the IIEF-5, 17 (35.4%) patients had severe ED, 10 (20.8%) patients moderate ED, 10 (20.8%) patients mild to moderate ED and 11 (22.9%) patients mild ED. For the entire patient group, baseline median IIEF-5 score was significantly increased from 9.35 (5.30-19.40) to 9.90 (5.20-24.90), baseline median DAS28 was significantly decreased from 5.65 (4.80-6.70) to 5.00 (2.40-6.40), HAQ-DI from 1.70 (1.10-2.40) to 1.15 (0.40-2.20) at 6th month of treatment (all p value < 0.001). Also, quantitative change in IIEF-5 was significantly correlated with changes in DAS28 (r:-0.735, p < 0.001) and HAQ-DI (r: -0.700, p < 0.001). Tofacitinib monotherapy may improve ED severity and as well as disease activity and health related quality of life in male patients with RA complaining of ED.

P189 A longitudinal study of psychological predictors of response to adalimumab in patients with rheumatoid arthritis

Abstract Background/Aims The treatment of rheumatoid arthritis (RA) has improved since the introduction of targeted biological disease-modifying antirheumatic drugs (bDMARDs), such as adalimumab. However, no treatment options for RA are universally effective. Psychological factors may have an important role in treatment response. Published data reported that pre-treatment psychological variables such as an increased treatment necessity belief correlated with better adherence to adalimumab in RA patients. This current study aimed to investigate whether psychological factors correlate with change in 4V-DAS28-CRP as well as subcomponents of the score in adalimumab-treated RA patients. Methods Psychological, clinical and demographic data and DAS28 scores were collected pre-treatment, and at 3,6, and 12-months post-treatment, as part of a prospective national study, BRAGGSS. Sixteen pre-treatment clinical and psychological variables were tested for association with treatment response at 3 and 12 months. Multiple linear regression models were analysed and a Bonferroni corrected p-value of &amp;lt; 0.003 was applied at each interval to assess significance. Results Data was available for 501 patients at 3 months follow up. Pre-treatment Beliefs about Medicine Questionnaire (BMQ) scores with regards to treatment necessity (P = 0.001), and two domains of the Illness Perception Questionnaire (IPQ), which were treatment belief and treatment control (P = 0.0001), correlated with the change in DAS28 by 3 months (Table 1). At 12 months, data were available for 362 patients. The treatment belief domain of the pre-treatment Illness Perception Questionnaire correlated with the change in tender joint count (P = 0.001) (Table 1). At 12 months no other sub-components correlated with the psychological variables. Conclusion Pre-treatment scores with regards to Illness Perception and Beliefs about Medicine correlated with 4V-DAS28-CRP response at 3 months. Of the subcomponents of DAS28, the psychological variables showed the highest correlation with tender joint count; as the tender joint count receives the highest weighting in the 4 variable DAS28 score, this may confound the assessment of treatment response. It will be necessary to undertake further analyses to assess the predictive value of these potentially modifiable psychological variables identified, but to also understand factors contributing to these psychological scores, such as the role of severe disease itself on psychological beliefs. Disclosure N. Raza: None. N. Nair: None. D. Plant: None. K. Hyrich: None. A.W. Morgan: None. J. Isaacs: None. A.G. Wilson: None. A. Barton: None.

P031 Assessing the safety and efficacy of JAK inhibitors in inflammatory arthritis

Abstract Background/Aims JAK inhibitors were recently licensed in the UK and have been shown to be efficacious in refractory moderate to severe rheumatoid arthritis and psoriatic arthritis. We aim to assess their efficacy and safety in use in clinical practice in NHS Tayside. Additionally, there have been several emerging safety concerns, particularly regarding infections and venous thromboembolism risk. Methods This project was an observational retrospective case note review of 130 patients. We assessed JAK-inhibitor efficacy via mean change in DAS28 and number of tender and swollen joints at 6 months after initiating therapy. Additionally, 6-month and 2-year drug survival rates were calculated. The presence of adverse events was evaluated. Results At 6 months JAK inhibitor therapy produced a mean reduction in DAS28 of 2.04 (p = 0.096) and a mean reduction in number of swollen joints of 3.72 (p = 0.002). Drug survival was 81.42% at 6-months and 51.25% at 24-months. Non-smokers, those with BMI &amp;lt;30, biologic naïve patients and those prescribed a concomitant cDMARD all achieved a greater reduction in DAS28. 53 patients (40.77%) experienced an adverse event, including venous thromboembolism, acute diverticulitis and herpes zoster reactivation. In addition to these, 40.91% of patients experienced dyslipidaemia. Conclusion JAK-inhibitors are efficacious in controlling active disease in inflammatory arthritis, however, are better suited to some patients over others based on emergency concerns about side effect profiles. Longer follow up is needed to assess long term efficacy. Disclosure I. Smedley: None.

P096 Analysis of frailty in rheumatoid arthritis and its relationship with disease activity, hospitalization and mortality: findings from the Scottish Early Rheumatoid Arthritis cohort and UK Biobank

Abstract Background/Aims Frailty is present in relatively young people with rheumatoid arthritis (RA) but its association with longitudinal outcomes is unclear. This study aimed to assess the prevalence of frailty in RA and its association with disease activity, all-cause mortality, and hospitalisation. Methods People with RA identified from Scottish Early Rheumatoid Arthritis cohort (recruited at diagnosis, mean age 58.2) and UK Biobank (identified using diagnostic codes occurring prior to baseline assessment, mean age 59). Frailty was quantified using the frailty index approach (a cumulative count of age-related deficits, assessed in both datasets) and the frailty phenotype (based on low grip strength, weight loss, low physical activity, exhaustion and slow walking speed, assessed in UK Biobank only). Disease activity was assessed using DAS28-score in SERA. Relationship between baseline frailty and all-cause mortality and unscheduled hospitalization was assessed adjusted for age, sex, socioeconomic status, smoking and alcohol (model 1), plus DAS28 in SERA (model 2). In SERA, changes in frailty index, DAS28, self-rated health and HAQ-DI were reassessed after 6 months. Results Using the frailty index, frailty was common in SERA (12% moderate, 0.3% severe) and UK Biobank (20% moderate, 3% severe). In UK Biobank 23% were frail using the frailty phenotype. Frailty index was associated with DAS28, age and female sex. Both the frailty index and frailty phenotype were associated with all-cause mortality and unscheduled hospitalisation. In SERA, the relationship with hospitalisation was attenuated after adjusting for DAS28 (table). In SERA, as DAS28 fell over time with treatment, 46% of moderately frail participants improved to mildly frail or robust states after 6 months. However, despite these improvements, participants with moderate or severe frailty at baseline had higher mean DAS28, greater functional impairment, poorer self-rated health, and still had higher mean frailty index than people who were robust or mildly frail at baseline. Conclusion Frailty is common in early and established RA and associated with hospitalisation and mortality. Frailty in RA is dynamic and, for some, may be ameliorated through controlling disease activity in early disease. Future work should explore how best to identify individuals likely to benefit from specific treatment strategies. Disclosure P. Hanlon: Grants/research support; Medical Research Council Clinical Research Training Fellowship (MR/S021949/1). F. Morton: None. S. Siebert: None. B. Jani: None. J. Lewsey: None. D. McAllister: None. F. Mair: None.

OA15 Drivers of change in four and two component disease activity scores after etanercept treatment, in a multi-centre cohort of patients with established rheumatoid arthritis

Abstract Background/Aims Treatment response in RA is measured by different disease activity scores (DAS28). The widely used 4 component (4C) DAS28 does not always correlate with synovitis, and a new 2 component version (2C) DAS28 has been developed to address this problem. Here, we use multivariable linear regression models to identify drives of change (Δ) in 4C and 2C DAS28 after 3 months on the anti-TNF drug etanercept (ETN). Methods Using data from the Biologics in RA Genetics and Genomics Study Syndicate (BRAGGSS), we identified patients treated with originator or biosimilar ETN (N = 773). Differences between the follow-up (FU) and baseline (BL) DAS28, adjusted for baseline, serve as outcome variables. Multiple imputation by chained equations was used to impute missing data, and models were internally validated via bootstrapping. Table 1 shows the baseline statistics, and model parameters for the included covariates. Results We found that 15.8% (95% CI: 11 - 20.6%) of the variance in Δ4C was explained by the baseline DAS28, compared to 26.3% (95% CI: 20.9 - 31.7%) for the Δ2C. Age of onset, HAQ score and concurrent DMARD treatment were significantly associated with both ΔDAS28 scores. Δ4C-DAS28 was additionally associated with first biologic use, seropositivity for either rheumatoid factor or anti-citrullinated peptide antibodies, and the Hospital Anxiety and Depression Scale-Anxiety score. The only additional predictor significantly associated with Δ2C-DAS28 was weight. After adjusting for baseline DAS28, the additional clinical covariates only explained 7.6% (IQR: 7.3 - 7.8%), and 2.3% (IQR: 2.0 - 2.6%) of the variance for the 4C- and 2C-DAS28, respectively. Conclusion ΔDAS28 is heavily influenced by the baseline DAS28, and additional clinical covariates explain little to none of the additional variance. Notably, known factors associated with treatment response, such as seropositivity and previous unsuccessful treatments, were only significant for the 4C-DAS28. This suggests that the 4C DAS and 2C DAS capture different aspects of RA disease progression. Further association studies are required to find other reliable predictors for ΔDAS28, which may include biological markers of response. Significant covariates identified here should be considered as potential confounding factors. Disclosure M. Stadler: None. S. Ling: None. N. Nair: None. J. Isaacs: None. K. Hyrich: None. A. Morgan: None. G. Wilson: None. D. Plant: None. J. Bowes: None. A. Barton: None.

Effectiveness of SB4 Transition from Originator Etanercept in Rheumatoid Arthritis and Axial Spondyloarthritis: A Subgroup Analysis from the BENEFIT Study.

The pan-European BENEFIT study of patients with stable rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) who transitioned from reference etanercept to SB4 found no clinically meaningful changes in disease control after transition. The analysis aims to illustrate the peculiarities of the Italian cohort of patients compared with the whole population to provide a more real-life approach to the data for the Italian rheumatologists, ruling out possible local confounding factors. A prospective study for up to 6 months following transition was conducted. Outcome measures of interest include clinical characteristics at time of transition and disease activity scores (Disease Activity Score-28 [DAS28] for RA, Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] for axSpA) over time and safety. One-hundred and eleven subjects (out of the 557 in total enrolled in the study) were derived from 8 Italian sites, including 79 with RA and 32 with axSpA. In both cohorts, the efficacy was maintained at 3 months and 6 months from the transition to the biosimilar with no significant change in mean DAS28 and BASDAI scores: at the end of the 6 months of observation the mean DAS28 and BASDAI was similar to baseline (confidence interval [CI] -0.22, 0.22), while the mean variation of the BASDAI was -0.14. Of note, 100.0% (95% CI 89.1, 100.0) in the axSpA and 90.8% (95% CI 81.5, 95.5) in the RA cohort of patients continued to receive SB4 at month 6 (binary variable with 95% Clopper-Pearson CI). Italian patients with stable RA or axSpA who transitioned from originator Etanercept to SB4 maintained clinical response at 6 months post-transition. Both the cohorts are representative of typical patients with long-standing established diagnoses. Most of the patients transitioned to the same dose regimen of biosimilar as that received for the originator, and the regimen remained unchanged at 6 months, supporting the effectiveness of the transition.

Effectiveness of baricitinib and tofacitinib compared with bDMARDs in RA: results from a cohort study using nationwide Swedish register data.

ObjectivesTo describe the use of baricitinib and tofacitinib by Swedish RA patients and to compare their effectiveness with that of biologic DMARDs (bDMARDs).MethodsRA patients who initiated baricitinib (n = 1420), tofacitinib (n = 316), abatacept (n = 1050), IL-6 inhibitors (IL-6is; n = 849), rituximab (n = 1101) or TNF inhibitors (TNFis; n = 6036) between January 2017 and November 2019 were followed for a minimum of 1 year using data from several linked Swedish national registers. Proportions reaching a good EULAR 28-joint DAS (DAS28) response, HAQ Disability Index (HAQ-DI) improvement >0.2 units and Clinical Disease Activity Index (CDAI) remission were compared at 1 year, imputing discontinued treatments as ‘non-response’. Additionally, we compared drug retention and changes in DAS28, HAQ-DI and CDAI from baseline to 3 months after treatment initiation.ResultsOn average, baricitinib, and particularly tofacitinib, were initiated as later lines of therapy and more frequently as monotherapy compared with rituximab and TNFi. Adjusted 1 year response proportions were consistently lower on TNFi compared with baricitinib, with differences of −4.3 percentage points (95% CI −8.7, 0.1) for good EULAR response, −9.9 (−14.4 to −5.4) for HAQ-DI improvement and −6.0 (−9.8 to −2.2) for CDAI remission. Comparisons with non-TNFi bDMARDs also favoured baricitinib, but not consistently. Treatment responses for tofacitinib were only marginally lower than those for baricitinib and generally similar to those of bDMARDs, with precision limited by low power. Comparisons of drug retention and changes in disease activity from baseline to 3 months supported the 1 year findings. ConclusionsBaricitinib and tofacitinib showed at least equivalent effectiveness compared with bDMARDs after exploring several different effectiveness measures.