Real Life Efficacy and Safety of Secukinumab in Biologic-Experienced Patients With Psoriatic Arthritis

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.

Association of Gender, Diagnosis, and Obesity With Retention Rate of Secukinumab in Spondyloarthropathies: Results Form a Multicenter Real-World Study

“…In the multivariate Cox regression analysis model, the backward stepwise method (Wald) selected diagnosis, obesity, and gender as relevant variables, excluding age, time of disease progression, line of treatment, and initial secukinumab dose. Although a lower secukinumab retention rate has been reported in SpA patients previously treated with biologics ( 13 , 14 ), other real-life studies have shown that the secukinumab retention rate at 12 months was not influenced by the line of treatment in patients with AxSpa ( 15 , 30 ) or PsA ( 15 , 31 ), nor by the dose used ( 30 ), which is consistent with our own study. In our study, retention of secukinumab was not associated with time, diagnosis or patient age, results that have similarly been reported by other studies ( 13 , 14 ).…”

Multicenter Study of Secukinumab Survival and Safety in Spondyloarthritis and Psoriatic Arthritis: SEcukinumab in Cantabria and ASTURias Study

“…In line with our study, the retention rate of SEC at 12 months was lower in the group previously treated with biologics (81.5 vs. 90.9%) (26). Other reallife studies both in patients with PsA and AxSpA, had shown similar results with an ever decreasing SEC survival rate in patients who had previously received biological therapy (11,(26)(27)(28). We found only one study in real-life in which the survival rate of SEC was not related to the number of previous biologics.…”

“…Some severe cases and exacerbations of Crohn's disease have also been described (8), so caution is recommended with its use. In terms of routine clinical practice, studies show a safety profile similar to that previously reported in RCTs and their long-term extension studies (9)(10)(11)(12), but information from real-world evidence studies is still scarce. Data on survival of biological therapy in PsA from the DANBIO registry showed a median survival of the first TNF inhibitor (TNFi) being 2.2 years and the second and third TNFi being 1.3 and 1.1 years, respectively.…”

Effectiveness and safety of secukinumab in 608 patients with psoriatic arthritis in real life: a 24-month prospective, multicentre study

“…Until now, few prospective studies presented real-life data on the treatment of PsA with SEC. [27][28][29][30][31] In fact, the evidence of the effectiveness and safety of SEC in the real-world setting has been mainly generated from independent and company-sponsored registries and postmarketing phase IV studies. [32][33][34] The current prospective observational study aimed to: (i) evaluate the long-term effectiveness of SEC in the management of PsA manifestations, including joint and skin symptoms, in a real-life clinical setting for a 24-month follow-up period; (ii) identify the differences in the outcome measures of effectiveness according to the biological treatment line; (iii) analyse MDA according to dosage administered (150 or 300 mg/injection), biological treatment line, gender, body mass index (BMI); (iv) identify predictors of MDA and treatment discontinuation at 6 months; (v) describe any comorbidities; (vi) report any adverse events or infections and (vii) evaluate drug survival at 24 months.…”