Ab0966 efficacy and safety of secukinumab in patients with axial spondyloarthritis: single center experience

Background Secukinumab (SCK), the first-in-class human monoclonal antibody against interleukin-17A, has been approved for the treatment of AS in many countries, including the US and EU. The efficacy of subcutaneous secukinumab in the treatment of Ax-SpA was primarily evaluated in five multicenter, phase III studies that included four randomized double-blind studies (MEASURE Studies). However, there are few studies evaluating long-term SCK efficacy in real-life data in patients with AxSpA [1,2]. Objectives Our aim in this study is to retrospectively evaluate the clinical findings and treatment response status of patients who were followed up with the diagnosis of Ax-SpA and using SCK. Methods A total of 60 patients who were followed up with the diagnosis of akSpA in our rheumatology clinic were included in the study. Demographic characteristics of the patients, comorbidities, duration of symptoms, delay in diagnosis, biologics and DMARDS were recorded. In the evaluation of the patients, BASDAI, BASFI, ASDAS, VAS pain, and VAS global scores were recorded as baseline, 3, 6, 12 and 24th months. The number and order of treatment before SEC in patients using bDMARDs were also examined, and SCK efficacy and drug retention characteristics were investigated between the biological treatment naive and resistant groups. Variables were analyzed at 95% confidence level, and p value less than 0.05 was considered significant. Results Follow-up data of 60 patients diagnosed with SpA (n=50 AS and n=10 nr-AxSpA) followed in a single center (inception cohort) were evaluated. Of these patients, 15 (25%) were bDMARD naive patients and 45 (75%) had used ≥1 bDMARD before SEC. The age and gender distribution was similar between the bDMARD naive and ≥1 bDMARD group. At 1-year follow-up, 1 and 7 patients discontinued their treatment in the ≥1 bDMARD group and the SCK group, respectively (p<0.001) (Table 1). The retention rate at 24 months was 80% and 49% in the naive and ≥1 bDMARD patients, respectively (p=0.026) (Figure 1). In our study, no significant drug-related serious adverse events or safety problems were encountered in the follow-up of secukinumab treatment for more than 36 months. Conclusion We found that SCK treatment in patients with Ax-SpA had better clinical response and higher drug survival rates in biologic naive patients, similar to TNFi treatment in real-life data. However, better drug retention rates were found in naive patients compared to patients using >1 bdmard, which is consistent with the results of previous studies. References [1]Williams T, et al. Clin Rheumatol. 2020 May 27;39(5):1501–4. [2]Ward MM, Deodhar A, et al. Arthritis Care Res (Hoboken). 2019;71(10):1285–99. Table 1. Demographic and clinical characteristics of patients using secukinumab treatment. Naive (n=15) ≥ 1bDMARD (n=45) Total (n=60) p value n (%) n (%) n (%) Gender male 9 (60) 24 (53.3) 33 (55) 0.263 Diagnosis nr-AxSpA 5 (33.3) 5 (11.1) 10 (16.7) 0.002 AS 10 (66.7) 40 (88.9) 50 (83.3) Smoking history (+) 7 (46.7) 31 (68.9) 38 (63.3) 0.341 HLA B27 (+) 8 (57.1) 29 (65.9) 37 (63.8) 0.284 Median (IQR ) Median (IQR ) Median (IQR ) Age (year ) 41 (33-65) 42 (20-75) 42 (20-75) 0.199 BMİ (kg/m 2 ) 25.1 (22.7-29.6) 26.8 (19.6-43.2) 26.7 (19.6-43.2) 0.350 Diagnosis Duration 72 (9-360) 84 (4-473) 84 (4-473) 0.130 Symptom duration (month ) 6 (5-16) 16 (5-50) 15.5 (5-50) <0.001 Symptom duration (year ) 6 (5-12) 16 (11-20) 15.5 (9-20) <0.001 Secukinumab treatment (month/total ) 12 (1-46) 13 (1-44) 12.5 (1-46) 0.010 BASDAI Baseline 5.7 (5.3-6.5) 4.8 (3.1-5.6) 5 (3.1-5.8) 0.018 6 th month 1.2 (1.1-3) 4.1 (1.9-5) 3.1 (1.4-4.7) <0.001 12 th month 2.4 (1.2-2.9) 3.2 (2.1-4.9) 3.1 (1.75-3.75) 0.325 VAS Pain Baseline 2.8 (2.6-3) 5.9 (4.6-6.5) 5.6 (4.2-6.5) <0.001 6 th month 1.6 (1-2.2) 5.2 (4-5.7) 4.8 (3.9-5.3) 0.046 12 th month 3 (0-6) 4.6 (4-6) 4.6 (4-6) 0.660 ASDAS-CRP Baseline 2.7 (2.6-2.7) 3.2 (2.7-4) 3.2 (2.6-4) 0.002 6 th month 1.6 (0.9-2.3) 3.2 (2.4-3.8) 3.1 (2.4-3.7) 0.246 12 th month 2.1 (1.8-2.4) 2.7 (2.3-3.3) 2.4 (2.3-3) 0.148 Figure 1. Secukinumab drug retention in naïve and ≥1bDMARD groups Acknowledgements: NIL. Disclosure of Interests None Declared.