Mean BASDAI Research Articles

Sex-specific disparities in disease activity scores among patients with axial spondyloarthritis and their implications for evaluating the response to tumor necrosis factor alpha inhibitor therapy

BackgroundWe aimed to investigate whether there are sex differences in disease activity measures among patients with axial spondyloarthritis (axSpA) and to determine any potential impact on the assessment of treatment responses to tumor necrosis factor alpha inhibitors (TNFi).MethodsUsing the Korean College of Rheumatology Biologics and Targeted Therapy (KOBIO) registry data, we compared sex differences in changes in the Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) levels at baseline and one year after TNFi initiation in patients with axSpA.ResultsThis study included 1,753 patients with axSpA who started or changed TNFi, of whom 1,343 (76.6%) were male. At baseline, the mean BASDAI and ASDAS scores of all patients were 5.98 and 3.6, respectively. The BASDAI changes between baseline and the one-year follow-up were independently associated with sex (\U0001d6fd = 0.343, p = 0.011), whereas ASDAS was not (\U0001d6fd = 0.079, p = 0.235). When judging the effect of TNFi at one-year of treatment, male patients were more likely to be assessed as effective by the BASDAI-based criterion (ΔBASDAI ≥ 50% or ≥ 2; OR 1.700, 95% CI 1.200–2.406), while the ASDAS-based criterion (ΔASDAS ≥ 1.1) showed no significant difference between sexes (OR 0.993, 95% CI 0.678–1.455), after adjusting for other baseline characteristics.ConclusionsThe changes in disease activity before and after TNFi use were significantly different between sexes when measured by BASDAI, but not ASDAS. TNFi treatment effects may be interpreted differently between sexes depending on the disease activity measure used.

Clinical and structural damage outcomes in axial spondyloarthritis patients receiving NSAIDs or advanced therapies: a description of a real-life cohort.

This study aims to describe the clinical characteristics, disease activity, and structural damage in patients with axial spondyloarthritis (axSpA) who receive chronic treatment with nonsteroideal anti-inflammatory drugs (NSAIDs) or advanced therapies in a clinical setting. Cross-sectional study on axSpA patients consecutively recruited from the outpatient clinic of a tertiary hospital. We collected data on clinical and demographic characteristics, as well as treatment patterns involving NSAIDs and advanced therapies. Structural damage was assessed using mSASSS. Overall, data from 193 axSpA patients (83% ankylosing spondylitis) were gathered, with a mean disease duration of 21.4 years. Of these, 85 patients (44%) were exclusively taking NSAIDs, while 108 (56%) were receiving advanced therapies, with TNF inhibitors being the predominant choice (93 out of 108, 86.1%). Among patients using NSAIDs, 64.7% followed an on-demand dosing regimen, while only 17.6% used full doses. Disease activity was low, with a mean BASDAI of 3.1 and a mean ASDAS-CRP of 1.8. In comparison to patients under chronic NSAID treatment, those taking advanced therapies were primarily male (69.4% versus 51.8%, p = 0.025) and significantly younger (mean age of 49 versus 53.9 years, p = 0.033). Additionally, patients on advanced therapies exhibited lower ASDAS-CRP (p = 0.046), although CRP serum levels and BASDAI scores did not differ between the two groups. In the multivariable analysis, therapy (NSAID versus biological treatment) was not independently associated with ASDAS-CRP, BASDAI or mSASSS. This cross-sectional analysis of a real-world cohort of axSpA patients shows positive clinical and radiological outcomes for both NSAIDs and advanced therapies.

The Taiwanese Map of Axial Spondyloarthritis: Living with the Condition.

Background and Objective: The International Map of Axial Spondyloarthritis (IMAS) explores the physical, psychological, and social experiences of patients with axial spondyloarthritis (axSpA). This initiative is now being expanded to Taiwan as the Taiwanese Map of Axial Spondyloarthritis (TMAS). We aim to provide rheumatologists with insights into the perspectives of Taiwanese patients, enabling physicians to better understand the unmet needs of these patients and optimize their management. Materials and Methods: The TMAS is a cross-sectional study gathering data through an online survey of axSpA patients, promoted by the Ankylosing Spondylitis Caring Society of R.O.C. (ASCARES), conducted from July 2017 to March 2018 by Ipsos, and analyzed by the Health & Territory Research (HTR) group of the University of Seville. The questionnaire includes 99 questions that cover domains such as patient profile, diagnosis, habits/lifestyle, employment status, physical/psychological health status, social support, use of healthcare services, and treatments. Results: A total of 112 axSpA patients were included in this survey. The mean age was 38.6 years and 75.0% were male. The average diagnostic delay was 3 years, and 19.6% reported extra-articular manifestations. Out of the 49 respondents who reported HLA-B27 information, 35 were HLA-B27-positive. The disease burden was high, with a mean BASDAI score of 4.9 and 75.9% having a mild to moderate degree of spinal stiffness. Furthermore, they were socially and psychologically burdened, with 88.4% experiencing work-related issues and 25.9% suffering from anxiety. Conclusions: The TMAS sheds light on the overall perspective of axSpA patients in Taiwan. The TMAS shows shorter diagnostic delay compared to patients from the EMAS. However, high disease activity and significant psychological distress still trouble the patients, causing functional impairments and even leading to career failures. Understanding the perspective of axSpA patients can help rheumatologists adjust treatment strategies to their unmet needs and improve their disease outcomes.

Efficacy of Guselkumab on Axial-Related Symptoms Through up to 2 Years in Adults with Active Psoriatic Arthritis in the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Study.

Guselkumab previously showed greater improvements versus placebo in axial symptoms in patients with psoriatic arthritis (PsA) (assessed by Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] and Ankylosing Spondylitis Disease Activity Score [ASDAS]), in post hoc analyses of the phase 3, placebo-controlled, randomized DISCOVER-1 and DISCOVER-2 studies. We now evaluate durability of response in axial-related outcomes through 2 years of DISCOVER-2. DISCOVER-2 biologic-naive adults with active PsA (≥ 5 tender/ ≥ 5 swollen joints, C-reactive protein ≥ 0.6 mg/dl) were randomized to guselkumab 100 mg every 4 weeks (Q4W) or at week0, week4, then Q8W, or placebo → guselkumab Q4W at week 24. Among patients with imaging-confirmed sacroiliitis (investigator-identified), axial symptoms were assessed through 2years utilizing BASDAI, BASDAI Question #2 (spinal pain), modified BASDAI (mBASDAI; excludes Question #3 [peripheral joint pain]), and ASDAS. Mean changes in scores and proportions of patients achieving ≥ 50% improvement in BASDAI (BASDAI 50) and ASDAS responses, including major improvement (decrease ≥ 2.0), were determined through week 100. Treatment failure rules (through week 24) and nonresponder imputation of missing data (post-week 24) were utilized. Mean BASDAI component scores were assessed through week 100 (observed data). Exploratory analyses evaluated efficacy by sex and HLA-B*27 status. Among 246 patients with PsA and imaging-confirmed sacroiliitis, guselkumab-treated patients had greater mean improvements in BASDAI, mBASDAI, spinal pain, and ASDAS scores, lower mean BASDAI component scores, and greater response rates in achieving BASDAI 50 and ASDAS major improvement vs. placebo at week 24. Differences from placebo were observed for guselkumab-treated patients in selected endpoints regardless of sex or HLA-B*27 status. At week 100, mean improvements were ~ 3 points for all BASDAI scores and 1.6-1.7 for ASDAS; 49-54% achieved BASDAI50 and 39% achieved ASDAS major improvement at week 100. Guselkumab treatment provided durable and meaningful improvements in axial symptoms and disease activity in substantial proportions of patients with active PsA and imaging-confirmed sacroiliitis. Clinicaltrials.gov NCT03158285.

Efficacy and safety of early treatment of patients with skin psoriasis and axial arthritis with IL-17 inhibitors

BACKGROUND: On average, within 7 years from the debut of skin psoriasis, patients may develop psoriatic arthritis, characterized by a chronic, relapsing progressive course. Early manifestations of psoriatic arthritis may be axial lesions presenting with inflammatory back pain. Currently, many experts are raising the topic of early prescription of genetically engineered biological drugs for axial lesions in order to prevent disability. Members of the GRAPPA expert group (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) currently do not provide specific recommendations for the treatment of axial lesions in psoriatic arthritis. The most commonly used regimens are those for axial spondyloarthritis and ankylosing spondylitis. There are also no treatment regimens for early manifestations of axial lesions in patients with smooth skin psoriasis without an established diagnosis of psoriatic arthritis. All regimens consider axial lesions in patients who have already been diagnosed with psoriatic arthritis. Thus, it is necessary to form interdisciplinary standardized protocols for the management of such patients.
 AIM: to investigate the efficacy and safety of IL-17 inhibitors in axial lesions in patients with skin psoriasis.
 MATERIALS AND METHODS: A prospective non-interventional comparative multicenter study was conducted in parallel groups of patients with smooth skin psoriasis (n=87). To study the effectiveness of the developed method of therapy, the formation of comparison groups is provided. 3 variants of therapy were analyzed: IL-17A inhibitors (n=21; group 1, main); methotrexate (n=35; group 2, comparison); standard desensitizing therapy was used in group 3 (n=31; control). The distribution into groups was carried out taking into account the severity, prevalence of the skin process (according to PASI, BSA), the quality of life of the patient (according to DLQI), the patient's wishes and the patient's ability to purchase genetically engineered biological drugs.
 RESULTS: According to our results, the use of IL-17A inhibitors shows high efficiency: by week 52, 100% of patients reached the level of PASI 75, 90.5% ― PASI 90 and 85.7% ― PASI 100, NAPSI 100 (Nail Psoriasis Severity Index) was observed in 71.4% patients. All patients reported a reduction of pain at 12, 24 and 52 weeks with a mean BASDAI of 5.9 (SD=2.3), 4.1 (SD=1.3), and 2.7 (SD=0.9), respectively. It was found that 90.5% of patients achieved ACR 20 by the end of the study at week 52. The majority of patients (85.7%) achieved remission or low DAPSA disease activity after 24 weeks of therapy. The mean ASDAS at 12, 24, 52 weeks was 3.07 (0.9), 2.2 (1.0), and 2.3 (0.9), respectively.
 CONCLUSIONS: Thus, in patients with skin psoriasis and axial lesions, it is recommended to make the earlier prescription of biologic treatment from the group of IL-17 inhibitors in order to prevent the development of severe forms of psoriatic arthritis and human disability.

Functional Outcome of McKenzie Exercise in Patients with Ankylosing Spondylitis- A Single Center Study in Bangladesh

Background: Ankylosing spondylitis (AS) is a common inflammatory rheumatic disease that affects the axial skeleton, causing inflammatory back pain and can lead to structural and functional impairments. On average, ankylosing spondylitis (AS) incidence rates range from 0.2% to 1% of the adult population. McKenzie exercise seems to be beneficial for those affected by AS, in particular when it is planned according to the needs of the individual aiming to maintain or improve the level of physical fitness. The prevalence of AS is generally believed to be between 0.1% and 1.4% globally. Aim of the study: The aim of this study was to evaluate the functional outcome of McKenzie exercise in patients with ankylosing spondylitis. Methods: This was a comparative experimental study which was conducted in the Department of Physical Medicine and Rehabilitation, BSMMU, Dhaka, Bangladesh from October 2019 September 2020. The study was approved by Institutional Review Board (IRB) of BSMMU on. A total of 112 patients with ankylosing spondylitis were selected who were divided into two groups. 56 patients were allotted in group A (NSAID group) and another 56 patients were allotted in group B (NSAID with McKenzie exercise). Collected data were processed, analyzed and disseminated by using MS Excel and SPSS version 23.0 program as per necessity. Results: The mean VAS score at baseline was 34.44 ±2.78 in group A and 34.03±2.23 in group B, at 4 weeks 28.89±3.67 in group A and 21.23 ±3.57 in group B, at 8 weeks 30.59 ±3.69 in group A and 16.95±3.62 in group B and at 12 weeks 28.08±3.34 in group A and 15.04 ±3.77 in group B. The mean BASFI at baseline was 3.19±0.15 in group A and 3.51±0.18 in group B, at 4 weeks 2.99±0.15 in group A and 2.15±0.05 in group B, at 8 weeks 1.99±0.09 in group A and 1.26±0.22 in group B and at 12 weeks 2.01±0.09 in group A and 1.25±0.2 in group B. The mean BASDAI at baseline was 5.01±0.39 in group A and 4.95±0.4 in group B, at 4 weeks 3.99±0.07 in group A and 3.43±0.09 in group B, at 8 weeks 3.97±0.09 in group A and 3.02±0.07 in group B and at 12 weeks 3.49±0.06 in group A and 1.98±0.09 in group B. The differences of VAS score, BASFI and BASDAI at 4, 8 and 12 weeks were statistically significant (p<0.05) between two groups. Conclusion: Ankylosing spondylitis (AS) causes pain and stiffness to affected joints and the spine and if the disease progresses, it can cause fusion of the joints, which can limit a person’s mobility and flexibility. In analyzing the outcomes of McKenzie exercise in patients with ankylosing spondylitis the differences of VAS score, BASFI and BASDAI at 4, 8 and 12 weeks were found as statistically significant (p<0.05) between NSAID group and NSAID with McKenzie exercise patient groups.

Achilles enthesitis on physical examination leads to worse outcomes after 2 years of follow up in patients with ankylosing spondylitis from REGISPONSER-AS registry

BackgroundEnthesitis represents one of the most important peripheral musculoskeletal manifestations in patients with axial spondyloarthritis (axSpA). However, studies specifically evaluating Achilles tendon enthesitis and its impact over time are scarce. The objectives of this study were to evaluate the impact of Achilles’ tendon enthesitis found at baseline during physical examination on the outcome measures after 2 years of follow-up in patients with ankylosing spondylitis (AS).MethodsThis was an observational and prospective study conducted during 2 years of follow-up in the REGISPONSER-AS registry. Linear regression models adjusted for age, body mass index (BMI), and anti-TNF intake were conducted to evaluate the association between the presence of Achilles enthesitis at baseline and the patient-reported outcome (PRO) scores at baseline. The impact of this feature on PROs over 2 years of follow-up was evaluated using mixed models for repeated measures adjusted for age, BMI, and anti-TNF intake.ResultsAmong the 749 patients included, 46 patients (6.1%) showed Achilles’ tendon enthesitis during physical examination at the baseline study visit. Patients with Achilles enthesitis had an increase in the global VAS score, BASDAI, mBASDAI, ASDAS-CRP, and BASFI scores in comparison with patients without this feature. In addition, the mean global VAS, BASDAI, and ASDAS-CRP scores were significantly higher among patients with Achilles enthesitis over the 2 years of follow-up after adjusting for age, BMI, and current anti-TNF intake. The percentage of patients achieving ASDAS low disease activity (ASDAS < 2.1) after 2 years of follow-up was 15.9% and 31.5% for patients with and without Achilles enthesitis, respectively (p = 0.030).ConclusionsIn patients with AS, the presence of Achilles’ tendon enthesitis was associated with worse scores on the outcome measures after 2 years of follow-up, leading to a lower probability of achieving low disease activity.

Disease activity indexes might not capture the same disease aspects in males and females with ankylosing spondylitis: A real-world nationwide analysis.

To evaluate gender differences in disease activity and health status (HS) in patients with radiographic axial spondyloarthritis (r-axSpA)/ankylosing spondylitis (AS). Ancillary analysis of the MIDAS study, an observational, non-interventional, cross-sectional and retrospective multicenter nationwide study to assess disease activity and its relationship with HS in clinical practice. Adult patients with AS diagnosis, fulfilling ASAS and modified New York criteria, treated for ≥3 months upon study inclusion according to clinical practice were included. The primary outcome was "disease control" assessed by the percentage of patients in remission and low disease activity (BASDAI and ASDAS-CRP scores). HS was evaluated using the ASAS health index (ASAS-HI). Patients' responses and characteristics were analyzed by gender. We analyzed 313 patients with AS, 237 (75.7%) males and 76 (24.3%) females. A total of 202 (64.5%) patients had adequate disease control (BASDAI < 4); 69.2% of males [mean (SD) BASDAI 2.9 (2.1)] and 50.0% of females [mean (SD) BASDAI 3.8 (2.4); p = 0.01]. According to ASDAS-CRP, 57.5% of patients were adequately controlled (ASDAS-ID +ASDAS-LDA); 138 (58.2%) males and 42 (55.3%) females. The mean (SD) ASDAS-CRP was 1.9 (1.1); being 1.9 (1.0) in males and 2.0 (1.1) in females. Overall, the impact of AS on HS was low to moderate [mean (SD) ASAS-HI 5.8 (4.4)]; being 5.5 (4.4) for males and 6.8 (4.2) for females (p = 0.02). This study showed a higher proportion of females with AS and active disease using the BASDAI definition. When using the ASDAS-CRP definition these differences by gender were less pronounced. The impact of disease activity on HS appears to be higher in females than males.

Absence of overexpression of KIR3DL2 on CD4+ T cells and NK cells in patients with axial spondyloarthritis.

Dear Editor, Chan et al. described an overexpression of KIR3DL2, a receptor for HLA-B27 homodimer, on NK cells and CD4+ T cells in patients with axial SpA (axSpA) [1, 2]. HLA-B27:05 expressing cells have also been shown to promote KIR3DL2+ NK cells, with more NK cells and CD4+ T cells expressing KIR3DL2 in patients with axSpA [3]. However the overexpression of KIR3DL2 was not confirmed in another population of patients with active axSpA [4]. All these studies were conducted in patients carrying the HLA-B27 antigen. We aimed to assess the expression of KIR3DL2 in patients with axSpA, according to the presence or not of HLA B27. We included 20 patients with axSpA [16 with AS and 4 with non-radiographic axSpA (nr-axSpA)] fulfilling the Assessment of SpondyloArthritis international Society (ASAS) classification criteria [5] and 5 healthy controls. Stratification according to the presence or not of HLA-B27 was applied. The axSpA main characteristics were: 11 HLA-B27+, 9 HLA-B27-, 14 males, mean disease duration 15.2 years and mean BASDAI of 4.7/10; all were synthetic and biologic DMARD naïve. We analysed by flow cytometry whole blood and peripheral blood mononuclear cell samples using fluorescent antibodies against CD45, CD14, CD3, CD19, CD4, CD8, gamma-delta-TCR, CD56, CD16, CD45RA, CXCR3, CCR6, KIR3DL1, KIR3DL2, IL-17A, IL-22, IL-2 and IFN-gamma. Positivity thresholds were set using control isotypes. Overnight pharmacological stimulation was performed with PMA/Ionomycin. All statistical analyses were performed using Graph Pad Prism (GraphPad Software, San Diego, CA, USA). Paired data were analysed with Wilcoxon test, and unpaired data with Mann–Whitney test. P-values <0.05 were considered to be significant. The study was approved by local ethics committee and conducted in accordance with the Declaration of Helsinki.

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.

Serum granulocyte-macrophage colony-stimulating factor (GM-CSF) is increased in patients with active radiographic axial spondyloarthritis and persists despite anti-TNF treatment

BackgroundAccumulating evidence supports the role of monocytes and neutrophils in radiographic axSpA (r-axSpA). Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor for both leukocyte lineages and a pro-inflammatory cytokine activating myeloid cells and promoting osteoclastogenesis. It acts through the JAK-STAT pathway. We measured serum GM-CSF and markers of bone metabolism in patients with r-axSpA before and after anti-TNF treatment.MethodsPatients with active r-axSpA despite treatment with NSAIDs, all eligible for treatment with a biologic agent, were recruited. Healthy donors were sampled as controls. Serum was collected before (baseline) and after 4–6 months (follow-up) of anti-TNF treatment and the following molecules were measured with ELISA: GM-CSF, sclerostin (SOST), and dickkopf-1 (Dkk-1).ResultsTwelve r-axSpA patients (7 males, 5 females, median age 37 years) with a median disease duration of 1 year and 16 age- and sex-matched controls were included. At baseline, patients had mean BASDAI 6.3±2 and ASDAS 3.2±0.7, which decreased to 4.1±1.7 and 2.2±0.6 at follow-up, respectively. At baseline, r-axSpA patients had significantly higher mean serum levels of GM-CSF (150 vs 62pg/ml, p=0.049), significantly lower Dkk-1 (1228 vs 3052pg/ml, p=0.001), but similar levels of SOST (369 vs 544pg/ml, p=0.144) compared to controls. Anti-TNF treatment did not affect GM-CSF, Dkk-1, or SOST levels. Spearman correlation analysis showed that GM-CSF correlated positively with ASDAS at baseline (r=0.61, p=0.039), while no correlations were identified between bone markers (Dkk-1, SOST) on one hand and GM-CSF or disease activity indices on the other.ConclusionsGM-CSF is increased in patients with active AS and strongly correlates with disease activity. TNF inhibition does not affect GM-SCF levels, despite improving disease activity. GM-CSF may represent an important pathway responsible for residual inflammation during TNF blockade, but also a potential target of JAK inhibitors, explaining their efficacy in r-axSpA.

Role of serum calprotectin in diagnosis of inflammatory bowel diseases in patients with ankylosing spondylitis (preliminary results)

Background. Patients with inflammatory bowel diseases (IBD) often have lesions of the musculoskeletal system, which is an extra-intestinal manifestation and mainly belongs to the group of seronegative spondyloarthritis (SPA). Ankylosing spondylitis (AS) is one of the main forms of diseases from the group of spondyloarthritis, associated with IBD. The frequency of AS in patients with IBD is of interest for elucidating the general pathophysiology of diseases. Colonoscopy is required to diagnose intestinal pathology. Colonoscopy in patients with AS to detect IBD, especially in the absence of intestinal symptoms, is very diffcult. Mainly for the diagnosis of IBD, the defnition of fecal calprotectin is used. Recently, there has been an interest in serum calprotectin, an increase in which is associated with a higher activity of the disease and is a marker of the intensity of inflammation in the intestine. However, there is currently no consensus on the clinical signifcance for serum calprotectin.The aim. To evaluate the role of serum calprotectin in diagnosis of inflammatory bowel disease in patients with ankylosing spondylitis.Materials and methods. In the analysis were included 50 patients with AS, fulflling the modifed New York criteria, among them were 36 (72%) men and 14 (28%) women, the mean age of patients was 42.5 ± 9.9, mean disease duration was 13.4 ± 8.7 years. All patients were examined with ESR, CRP, FC (range: 100–1800 µg/g), esophagogastroduodenoscopy, colonoscopy and quantitative analysis of the SC level using ELISA (Buhlmann MRP8/14 ELISA, range: 0.4–3.9 µg/ml).Results. All patients had a high disease activity, mean BASDAI was 5.3 ± 1.8, mean ASDAS CRP was 3.7 ± 1.01, mean ASDAS ESR was 3.6 ± 1.01. 78% patients had high FC level (more than 100 µg/g), while only 18% patients had an increase of SC level. IBD were diagnosed in 11 cases: 6 (12%) patients with CD and 5 (10%) patients with UC, in the remaining cases (78%) was no intestinal pathology. Only two patients with IBD had a high SC level. SC level was more correlated with ESR (r = 0.5) and CRP (r = 0.5) (p &lt; 0.05) levels, than with FC level (r = 0.4) (p &lt; 0.05).Conclusion. The results have shown that there was currently insuffcient data to assess the possibility of using SC in the diagnosis of IBD in patients with AS. There was a signifcant association between the SC, CRP and ESR, but not fecal calprotectin. Potentially SC may be more representative for systemic inflammation than intestinal inflammation.

O001. Juvenile-onset spondyloarthritis: a study of 54 cases in Senegal

Abstract Background Juvenile onset spondyloarthritis (JoSpA), also known as enthesitis-related arthritis (ERA), accounts for approximately 10-20% of all juvenile idiopathic arthritis (JIA) and affects four times more boys than girls. It’s characterized by frequent arthritis of the lower limbs and strongly associated with presence of HLA-B27. In sub-Saharan Africa, SpA is considered as a rare disease where the frequency of HLA-B27 is &amp;lt; 1% in the population. However, an interesting exception is found in the Fula ethnic group of Gambia, where the prevalence of HLA-B27 was estimated at 6% to 7.8%. This ethnic group is also present in Senegal Aims: To determine the epidemiological, clinical, Para clinical, therapeutic and disease course aspects of JoSpA in Senegal. Methods A retrospective observational study, was conducted in rheumatology department of Aristide Le Dantec Hospital, between January 2012 and December 2020. Two hundred and fifteen JIA cases were collated, 54 were JoSpA fulfilling the ILAR classification criteria of ERA, with age of onset of symptoms ≤ 16 years. Exclusion criteria were: psoriasis or history of psoriasis, presence of rheumatoid factor and presence of systemic arthritis. Disease activity was assessed by activity indexes (BASDAI and ASDAS), functional impact by BASFI, and Quality of Life by Nottingham Health Profile (NHP). Results A total of 54 patients (29 males and 25 females with a sex ratio M/F of 1.16) were included in the study. The mean age at onset of symptoms was 12.4 years, mean age at diagnosis was 23.2 years. 34 (63%) patients were of Fula ethnicity. The inaugural symptomatology was exclusively peripheral in 33 cases (61.1%), axial and peripheral in 23 cases (42.6%). At the time of diagnosis, arthritis was located in the lower limbs in 92.1% of cases, where knee involvement was predominant in 30 (55.6%) cases, followed by hip involvement in 17 (31.5%) cases. Axial involvement was present in 46 cases (85.2%), dominated by sacroiliac pain/ buttock pain in 73.9%, followed by low back pain in 52.1%. Entheseal involvement was present in 30 cases, dominated by Achilles enthesitis and plantar fasciitis in 83.3%. Involvement of the anterior chest wall was found in 12 patients. Uveitis was present in 3 patients. Biological inflammatory syndrome was found in 55.5% of cases, with a mean CRP level of 17.1mg/l. Search for HLA-B27 was carried out in 34 patients, 25 were HLA-B27 positive (73.5%). Among HLA-B27 positive patients, 21 (84%) were of Fula ethnicity. On radiography, sacroiliitis was present in 29 patients, and 8 had coxitis. On admission, the mean BASDAI and ASDAS-CRP were 4.66/10 and 2.98 respectively, mean BASFI was 4.36/10. NHP showed impairment of all items, especially the concepts of energy, pain, sleep and physical mobility. Treatment was based on: NSAIDs (42 patients, 79.6%), methotrexate (30 patients, 55.5%), sulfasalazine (8 patients, 14.8%), oral steroids (15 patients, 27.7%), intra-articular joint steroid injections (6 patients), hip replacement surgery (2 patients), and functional rehabilitation (5 patients). The evolution was favorable, after 6 months of treatment, mean BASDAI and BASFI were 2.47/10 and 2.19/10 respectively. Conclusion In our study, JoSpA affects both girls and boys. The prevalence of HLA-B27 was 73.5% of cases, especially in the Fula ethnic group. The disease is considered as a source of significant functional impact and impairment of quality of life. The treatment was based mainly on conventional treatment. Evolution was globally favorable after treatment. Further epidemiological studies are needed to obtain reliable prevalence rates and to better understand our findings.

P057 Uveitis in enthesitis-related arthritis: what are the predictive factors?

Abstract Background Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease of childhood. Uveitis is its most common extra-articular manifestation [1]. It is a potentially sight-threatening condition with a considerable risk of morbidity. This study aimed to describe the prevalence and characteristics of JIA-related uveitis in enthesitis-related arthritis (ERA) patients. Methods We conducted a retrospective study including 40 patients with JIA according to the classification criteria of the International League of Associations for Rheumatology (ILAR). All selected patients presented with ERA. A screening of uveitis was conducted in all patients. Clinical, radiologic and, biologic features of JIA were collected. We evaluated the association between these features and the presence of uveitis. Results The mean age of our patients was 24 years, with a sex ratio of 3. The mean age at the onset of JIA was 11 years. Upon screening, fifteen percent of the patients had active uveitis. Nine percent of the patients presented with an acute onset of JIA. Forty-six percent had initial spinal symptoms, while 26% presented with peripheral onset. Upon examination, 4% of the patients presented with monoarthritis, 20.4% with oligoarthritis and 34.8% with polyarthritis. Thirteen percent had enthesitis. Fifty-seven percent of the patients had coxitis. Sixty-eight percent had sacroiliitis. The mean CRP and ESR levels were respectively 16 mg/l and 34. Human leucocyte antigen (HLA) B27 screening came back positive in 11% of the cases. The mean BASDAI and BASFI levels were both at 4.7. The mean MASES was 0.44. Twenty percent of the patients received NSAIDs. Eleven percent received methotrexate, 18% salazopyrine and, 5.6% biologics. A significant association was established between the presence of uveitis and a polyarticular onset of JIA (P = 0.036). However, no significant associations were established with the sex of patients (P = 0.457), age of onset (P = 0.828), activity of the disease as evaluated by BASDAI (P = 0.40) and MASES (P = 0.87), inflammatory markers (CRP P = 0.946, and ESR P = 0.662), the use of NSAIDS (P = 1), methotrexate (P = 0.318), salazopyrine (P = 0.170) and biologics (P = 1). Conclusion In conclusion, uveitis associated with JIA is a serious and sight-threatening disease. Several factors associated with a more severe disease development have been identified [2–4]. Our study showed a significant association between the polyarticular onset of JIA and the occurrence of uveitis. Also, our study showed no significant association with male gender and HLA-B27 in children, unlike previous studies of spondyloarthritis conducted in adults [5–6]. We conclude that the screening of uveitis should be performed in all JIA patients, especially those presenting initially with polyarthritis.

Poor work outcomes in patients with spondyloarthritis: causes, consequences, and solutions.

Spondyloarthritis (SpA) affects patients in the prime of their economic productivity and can cause loss of work productivity and unemployment. We aim to identify factors associated with poor work outcomes in patients with SpA. A cross-sectional study was performed in 100 patients with SpA who were employed, retired, or off work because of SpA. Data on sociodemographic and professional characteristics were collected as well as specific indices: BASDAI, ASDAS-CRP, BASFI, and BASMI. Work productivity in employed patients was assessed by the Work Productivity and Activity Impairment scale (WPAI:SpA). Patients were divided into 73 men and 27 women; the mean age was 43.68 ± 10.3years. Fifty-nine percent of patients were employed and 26% were off work. The average disease duration was 12.24 ± 8.73years. The mean BASDAI score was 4.4 ± 2.4, the average BASFI score was 4.6 ± 2.7, and the average ASDAS-CRP score was 2.77 ± 1.18. The mean BASMI was 4.4 ± 2.8. Among employed patients, the mean of absenteeism, presenteeism, and work productivity loss was 21.8 ± 33.13%, 42 ± 32%, and 46.5 ± 35.31%, respectively. In multivariable analysis, absenteeism was associated with ASDAS ≥ 2.1 (β = 20.14), peripheral joint involvement (β = 15.6), manual work (β = 14.31), low level of education (β = 7.92), and BASFI ≥ 4 (β = 6.39). Presenteeism and work productivity loss were associated with manual work, BASFI ≥ , body mass index ≥ 25kg/m2, smoking, the use of symptomatic treatment, and ASDAS-CRP ≥ 2.1. Spondyloarthritis affects work productivity. Screening for predictive factors should be considered by the clinician in the overall management of the disease. Key Points • SpA occurs among young and active patients; it could affect their professional lives and thus lead to loss of work productivity and unemployment. • The management of patients with SpA must be multidisciplinary; this includes assessing contextual factors in order to act on modifiable factors such as smoking and BMI, optimal management of the disease to maintain at least a low disease activity, and to ensure workstation layout and elimination of professional constraints that can affect work outcomes in patients with SpA.

Real-life efficacy of guselkumab in patients with early psoriatic arthritis.

To assess the efficacy of the novel anti-IL-23 monoclonal antibody guselkumab in a real-life observational cohort of patients with early PsA. We conducted an observational study on patients with early PsA followed by the joint dermatology-rheumatology clinics of two Italian centres starting therapy with guselkumab for severe skin involvement. Each patient was evaluated at baseline and every 24 weeks for one year, recording Disease Activity Index for PsA (DAPSA), PASI, VAS Pain, VAS Prutitus, Patient's Global Assessment (PtGA) and assessing DAPSA response. Twenty-four patients were recruited (16 women). The mean duration of skin disease was 12.5 years (CI 8; 17), but all patients had a shorter articular disease duration, 21.29 months (CI 15.9; 26.68). At baseline, all patients displayed a moderate cutaneous disease with a mean PASI of 15.2 (CI 11.7-18.6) and high disease activity, characterized by mean DAPSA of 26.84 (CI 22.49-31.19). An inflammatory low back pain was reported by five patients (20%) with a mean BASDAI 5.1 (CI 4,38-5,85) at baseline. The majority of guselkumab-treated patients (n = 18; 75%) reached DAPSA remission or DAPSA low disease activity after six months. Seventeen out of 24 patients completed 12 months of treatment, 11 of them (65%) in low disease activity, six (35%) in remission. All patients with axial disease reported improvement of inflammatory low back pain at week 24 with a mean BASDAI 2.98 (CI 2,18- 3,77). No significant side effects were reported. Real-life data on a cohort of early PsA patients confirm the efficacy and safety of guselkumab on peripheral and axial manifestations.

OP0138 FEASIBILITY OF PROGRESSIVE ANTI-TNF TAPERING IN AXIAL SPONDYLOARTHRITIS PATIENTS IN LOW DISEASE ACTIVITY: RESULTS FROM THE MULTICENTER NON-INFERIORITY PROSPECTIVE RANDOMIZED CONTROLLED TRIAL SPACING

Background:Anti-TNF treatments (TNFi) have shown high efficacy in axial spondyloarthritis (ax-SpA) with inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). However their effect remains predominantly symptomatic, and their long-term tolerance as well as significant societal cost justify investigation about a potential reduction in drug dosage, or –most feasible and comfortable for the patient– increase in intervals between doses.Objectives:To assess if a progressive and monitored reduction of administered TNFi by increase of intervals between injections results in a comparable proportion of patients remaining after 12 months (m) in low disease activity state despite a decreased cumulative treatment dose received.Methods:Non-inferiority randomized controlled trial, having included adult patients with ax-SpA fulfilling ASAS criteria, already treated by anti-TNF, and in stable low disease activity for at least 6 m (current and at least 6 m old BASDAI&lt;4/10), who were randomized into 2 groups: either keeping on their usual treatment with stable doses (“unchanged” group), or progressive spacing of injections of their treatment (“spacing” group). Follow-up was done every 3 m during 12 m, with regular monitoring of disease activity and, in patients from the group “spacing”, modification of the rhythm of injections according to disease activity and predefined standardized protocol (either increase or decrease (step-back) of intervals between injections). The primary endpoint was the difference of proportions of patients having a low disease activity state (BASDAI&lt;4/10) after 12 m of follow-up between the 2 groups. It was estimated on the ITT population after multiple imputation. The 90% confidence interval associated was calculated using the Farrington-Manning method and the lower bound was compared to the non-inferiority margin of -20%. With an expected proportion of 85% patients remaining in low disease activity in the unchanged group, and α and β risks at respectively 5% and 90%, the required number of patients was calculated at 358, and thus 398 had to be included with a 10% expected proportion of patients with unavailable data.Results:398 patients were randomized in 23 French rheumatology units (197 and 201 in the spacing and unchanged groups respectively), and 389 included in analyses (9 did not receive the allocated treatment). Mean (SD) age was 44.3 (12.4) years, 71.2% were males. Mean (SD) BASDAI at inclusion was 1.45 (1.02). TNFi used were etanercept (35.7%), adalimumab (33.9%), infliximab (20.6%), golimumab (9.3%) and certolizumab (0.5%). For the 373 patients with complete follow-up (93.7%), 162/184 (88.0%) had a low disease activity in the “spacing” group vs. 173/189 (91.5%) in the “unchanged” group at 12 m. After multiple imputation for the 16 patients with missing data, the difference of proportion between the two groups was estimated to -4.18% [CI90% -10.0; 1.7], thus confirming the non-inferiority of the “spacing” procedure. In the “spacing” group at 12 m, 134/162 (82.7%) patients in low disease activity were still receiving a lowered TNFi dose.Conclusion:In ax-SpA patients with BASDAI&lt;4 for at least 6 months under TNFi, it is possible to increase intervals between injections while maintaining a low disease activity by adjusting treatment with quarterly monitoring of SpA activity.Disclosure of Interests:Cédric Lukas Speakers bureau: Abbvie, Amgen, Janssen, Lilly, MSD, Novartis, Pfizer, Roche-Chugai, UCB, Consultant of: Abbvie, Amgen, Janssen, Lilly, MSD, Novartis, Pfizer, Roche-Chugai, UCB, Grant/research support from: Pfizer, Novartis and Roche-Chugai, Anne Tournadre Speakers bureau: Abbvie, Fresenius, Janssen, MSD, Pfizer, Roche Chugai, Sanofi, Paid instructor for: Fresenius, Consultant of: Abbvie, Fresenius, Lilly, Novartis, Sanofi, Grant/research support from: Fresenius, Novartis, Pfizer, UCB, Marie Christine Picot: None declared, Erika Nogué: None declared, Emmanuelle Dernis Speakers bureau: Roche chugai, UCB, BMS, Novartis, Lilly, Mylan, Pfizer, Celgène, Consultant of: UCB, MSD, BMS, Lilly, Novartis, Philippe Goupille Speakers bureau: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Janssen, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Consultant of: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Janssen, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Grant/research support from: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Janssen, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Bernard Combe Speakers bureau: AbbVie; Bristol-Myers Squibb; Gilead; Janssen; Lilly; Merck; Novartis; Pfizer; Roche-Chugai; and Sanofi, Consultant of: AbbVie; Bristol-Myers Squibb; Gilead; Janssen; Lilly; Merck; Novartis; Pfizer; Roche-Chugai; and Sanofi, Grant/research support from: Novartis, Pfizer, and Roche-Chugai, Jacques Morel Speakers bureau: Abbvie, Biogen, BMS, Fresenius Kabi, Lilly, Mylan, Novartis, Pfizer, Sanofi, Consultant of: Abbvie, BMS, Boerhinger Ingelheim, Galpaagos, GSK, Lilly, Novartis, Sanofi

P179 Perpetual dilemma: international multicentre study correlating BASDAI and ASDAS (CRP) as a marker of disease activity in spondyloarthritis

Abstract Background/Aims While BASDAI is one of the most widely used tool it has limited face and construct validity. ASDAS on the other hand is considered more objective ,however in absence of blood investigations, it might not be an ideal measure. We aimed to study correlation and agreement between ASDAS-CRP with BASDAI score. We correlated these outcome measures with MRI activity Methods This was a multi-centre study, conducted at rheumatology department of two teaching hospitals in United Kingdom and India. Anonymised data of all consecutive patients with the clinical diagnosis of SpA were analysed. We compared outcome measure variables ASDAS-CRP with BASDAI at baseline and follow-up with subgroup analysis of BASDAI cutoff of 4. We also analysed radiological parameters and compared disease activity of patients with active changes of SpA in MRI versus those with inactive changes . SPSS software and Cohen’s kappa statistics used Results Total 250 patients with SpA were analysed with median age of 34 years and total duration of 5.9 +6 years. Mean BASDAI 4.9 +8.8, Mean ASDAS-CRP 3.04 + 3.5, Mean CRP 19.32 +12.8 mg/l. The Correlation between BASDAI and ASDAS-CRP (r) was 0.76 and the correlation coefficient of agreement between ASDAS-CRP and BASDAI &amp;gt;4 was 0.75.The cutoff point of ASDAS with the best agreement with BASDAI was 3.5 (global agreement 78%, kappa 0.55). Both BASDAI and ASDAS showed a higher correlation with patient’s global assessment (PtGA) (r = 0.82 and 0.74, respectively) than with physician’s global assessment(PhyGA) (r = 0.76 and 0.7) The discriminant validity analysis showed that both ASDAS and BASDAI were able to discriminate patients above and below median PtGA (d = 1.15 &amp;d=1.3) and PhyGA (d = 0.75 and d = 0.9) respectively however BASDAI was better than ASDAS to discriminate patients above and below the median PhyGA (p = 0.05)60 patients were followed up with mean duration of follow-up of 6.2 +1.6 months. Both ASDAS and BASDAI decrease significantly (p = 0.03 and 0.02 respectively) however effect size was greater for ASDAS(0.8) than BASDAI (0.6). There was no difference noted in the degree of spinal inflammation as evidenced by MRI when patients with BASDAI &amp;gt;4 were compared to &amp;lt; 4. (p = 0.43, OR 0.6). The correlation between ASDAS and BASDAI was much higher in patients with active MRI lesions (r = 0.84), without any difference in CRP or BASDAI (p = 0.8 and p = 0.66 respectively) Conclusion This is a first study involving India and UK, which systematically compares the disease activity and outcome measures. Although BASDAI and ASDAS correlate well, the agreement is better for patients with high disease activity. ASDAS is more sensitive to change and shows larger effect size on follow-up. The outcome measures correlated more with active MRI lesions. Thus the cutoff value of BASDAI &amp;gt;4 for active disease might need a revision in clinical practice Disclosure N. Jain: None. S. Pandya: None. P. Srivastava: None. D. Shukla: None. A. Moorthy: Honoraria; Speaker and Conference fee MSD, Novartis Abbvie.

O11 Examining BASDAI by gender: differing scores, but similar patterns of disease

Abstract Background/Aims Research has shown that females with axial spondyloarthritis (axSpA) score worse on patient reported outcomes (PROs) than males. However, this does not always correlate to worse clinical findings. The purpose of this study was to understand why women with axSpA have worse BASDAI scores than men, by examining how both genders score across the components of the BASDAI. The Ankylosing Spondylitis Registry of Ireland (ARSI) is a national registry on patients with axSpA in Ireland and a source of epidemiological data. Methods Analysis of the ASRI was preformed using IBM SPSS version 26. Patients were analysed on the basis of gender. Comparison of baseline characteristics and mean BASMI, BASFI, HAQ and ASQoL were tested for significance using an independent two tailed t-test and a Mann Whitney U test. Mean total BASDAI score and mean score for each component of the BASDAI were compared and tested for significance with the same statistical tests. A chi-squared test for independence was used to determine significance in variation of HLA-B27 status and radiographic findings. Results A total of 857 patients were included in the analysis. Patient population was 24.9% (213) female and 75.1% (644) male with a mean age of 45.9 years and mean disease duration of 19.4 years (means: BASDAI 4.02, BASMI 4, BASFI 3.67, HAQ 0.53, ASQoL 6.48). Females had worse BASDAI(4.6 vs 3.83, p &amp;lt; 0.01), HAQ(0.6 vs 0.51, p = 0.03) and ASQoL scores (7.62 vs 6.12, p &amp;lt; 0.01) than males. BASFI scores were worse in females which did not reach significance (3.89 vs 3.63, p = 0.26). However, females had significantly better BASMI scores than males (3.51 vs 4.16, p &amp;lt; 0.01). Within the BASDAI, females scored significantly worse than males across all components (Fatigue: 5.56 vs 4.51, p &amp;lt; 0.01; Spinal pain: 5.51 vs 4.63, p &amp;lt; 0.01; Other pain: 3.82 vs 3.19, p = 0.01; Discomfort: 4.05 vs 3.29, p &amp;lt; 0.01; EMS: 4.55 vs 3.94, p = 0.01), however duration of EMS did not reach significance (3.54 vs 3.12, p = 0.07)(table 1). Within the BASDAI, females recorded highest mean scores for fatigue (5.56), while males recorded highest mean scores for spinal pain(4.63). Lowest mean scores for both genders was for EMS duration (3.54 vs 3.12). Ranking of the BASDAI components by mean scores show similarity in the ranking of discomfort, EMS, other pain and EMS duration. Conclusion AxSpA females have consistently worse PROs but have better spinal mobility than males. Despite females recording worse BASDAI scores than males, the pattern of disease activity manifestation is similar in 4 of the 6 components of the BASDAI. However, fatigue is the most problematic symptom in females with active axSpA while spinal pain is the most problematic symptom for males. This variation by gender should be kept in consideration when evaluating a patient with suspected active axSpA. Disclosure S. Maguire: None. P. Gallagher: None. F. O'Shea: None.

P198 Efficacy and safety of secukinumab in ankylosing spondylitis: real-world data from Midlands Ankylosing Spondylitis Collaboration (MASC)

Abstract Background/Aims Secukinumab is an interleukin-17 inhibitor has been found to be effective in the treatment of ankylosing spondylitis (AS) in studies, including phase 3 clinical trials, however these are conducted in highly selected patients and it is important to confirm the efficacy and safety in a real world data. Response to secukinumab should be assessed after 16-weeks and continued if there has been sufficient response to treatment according to the BASDAI and spinal VAS scores. Methods This was a multicentre cross-sectional observational study in collaboration with Midland Ankylosing Spondylitis Collaboration. Consecutive baseline and 16th week data of all AS patients on Secukinumab from 2017 to 2019 were collected and analysed to assess treatment response. All data were compiled in excel sheets and analysed using Medcalc calculator. Data were collected from collaborative efforts of the Royal Wolverhampton NHS trust, Queen’s Hospital (Burton on Trent), Leicester Royal Infirmary and Robert Jones and Agnes Hunt hospital. Results Total 92 patients with radiographic AS on standard dose of secukinumab were included at baseline and 88 were followed up till week 16. Mean age was 45.9(SD ± 15) (Median=44years) and 67% were male. Baseline Mean BASDAI was 7 (SD ± 1.7); Mean CRP was 16.6 (SD ± 11.2), Mean VAS was 7.6(SD ± 1.6). There was statistical significant change in BASDAI, VAS and CRP levels at week 16th. ΔBASDAI=2.2 (SD ± 2) (p = 0.002), ΔVAS=3.2 (SD ± 2.1) (p = 0.001), ΔCRP=6.9 (SD ± 17) (p = 0.03). At 16th week, 68% had clinical improvement while 4 patients discontinued therapy (2-colitis, 1-uveitis and 1-patient choice). 10% overall had some adverse effects with most common being upper respiratory tract infection. We also compared patients with previous anti-TNF exposure (TE) to Anti-TNF naïve (TN). 63% were in TE group vs 37% in TN. 69% of TE and 76% of TN showed clinical improvement at week 16.Mean ΔBASDAI was more in TN group vs TE (p = 0.01), however there was no difference in ΔVAS and ΔCRP levels. (p = 0.0 &amp; p = 0.2 respectively). Conclusion This multi-centre retrospective analysis found secukinumab to be clinically effective in 68% of patients with AS. There was significant improvement in BASDAI, VAS and CRP levels at week16. Compared to anti-TNF resistant patients, TNF-Naïve responded better to secukinumab, although both showed good clinical improvement. These findings support the use of secukinumab in the treatment of AS, as a first line therapy or for those who have failed anti-TNF therapy. Safety signals observed in the real-word data set were consistent with those seen in the clinical trials and the Summary of Product Characteristics. Disclosure N. Jain: None. R. Laxminarayan: Honoraria; Honorarium from Novartis, Lilly, Pfizer and Abvie. A. Moorthy: Honoraria; Speaker and conference fee MSD, Novartis, Abbvie. R. Amarasena: None. N. Cleaton: None. G. Kakade: None. A. Gunawardane: None. T. Khan: None. H. Sapkota: None. N. Barkham: Grants/research support; research funding from Novartis, Eli Lilly, UCB.