Abstract
Background: Real world evidence data regarding secukinumab (SEC) use in biologic-experienced patients with psoriatic arthritis (PsA) are scarce.Objectives: To assess the real life survival, safety and efficacy of SEC in biologic-experienced patients with PsA.Methods: All biologic-experienced PsA patients treated with SEC in 2 University Rheumatology Units were included (3/2016-12/2018). Patients' and disease characteristics were recorded at baseline and during SEC therapy.Results: 75 patients were included; 76% were females with a mean age of 53.9 years, median disease duration of 6.7 years and median SEC treatment duration of 11.1 months. At baseline, 97% had peripheral arthritis, 42% axial involvement, 22% enthesitis, and 12% dactylitis. Regarding previous biologic exposure, 48 (64%) had been exposed to anti-tumor necrosis factor (TNF) agents only, 5 (7%) to the interleukin (IL)-12/23 inhibitor (Ustekinumab-UST) only while 22 (29%) both to anti-TNFs and UST. Fifty-three percent received SEC in combination with non-biologics and 35% with glucocorticoids, respectively. During follow-up, statistically significant improvement in different disease activity indices were noted (DAS28-CRP, DAPSA, BASDAI). SEC survival rate at the end of follow-up was 64% (48/75), without difference between patients exposed to anti-TNFs only (67%) vs. anti-TNFs and UST (68%) as well as to 1 vs. ≥2 anti-TNFs. The rate of serious adverse events and serious infections during follow-up was 4.8 and 1.2/100 patient-years, respectively.Discussion: In real life, in biologic-experienced patients with PsA, SEC displayed a high retention rate, regardless of the type, and number of previous biologics (anti-TNFs ± anti-IL12/23), without significant side effects.
Highlights
Secukinumab (SEC) is a recombinant human monoclonal antibody against interleukin-17A (IL17A) that has been approved since 2015 by the European Medicines Agency (EMA) and 2016 by the US Food and Drug Administration (FDA), for the treatment of psoriatic arthritis (PsA) [1, 2]
No specific baseline or on-treatment factors were associated with SEC discontinuation by uni- and multivariate Cox regression analysis (Table S1). This is one of the few real world studies assessing the usefulness of SEC in patients with PsA who had previously exposed to two different classes of biologics
In this treatment-resistant group, the drug survival of SEC at the end of the follow-up was 64% with an acceptable safety profile similar to what has been previously reported in randomized controlled trials (RCTs)
Summary
Secukinumab (SEC) is a recombinant human monoclonal antibody against interleukin-17A (IL17A) that has been approved since 2015 by the European Medicines Agency (EMA) and 2016 by the US Food and Drug Administration (FDA), for the treatment of psoriatic arthritis (PsA) [1, 2]. Three different classes of biologics had been approved for PsA: the anti-tumor necrosis factor (TNF), the anti-IL12/23 (Ustekinumab—UST) and the anti-IL17 (SEC, ixekizumab) agents [10, 11]. In RCTs, SEC has shown efficacy both in anti-TNF naïve as well as anti-TNF-experienced patients [3, 5, 6]. Real world evidence (RWE) data regarding survival as well as efficacy and safety of SEC in patients with PsA are scarce [12,13,14], especially for those who had been exposed to both classes of biologics (anti-TNF, anti-IL12/23). The aim of our study was to evaluate the use of SEC in biologic-experienced patients with PsA in daily clinical practice. Real world evidence data regarding secukinumab (SEC) use in biologic-experienced patients with psoriatic arthritis (PsA) are scarce
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