Real-World Effectiveness and Treatment Retention of Secukinumab in Patients with Psoriatic Arthritis and Axial Spondyloarthritis: A Descriptive Observational Analysis of the Spanish BIOBADASER Registry

Abstract

Rheumatic diseases are extensively managed with biological disease-modifying antirheumatic drugs (bDMARDs), but a notable proportion of patients withdraw in the long term because of lack of effectiveness, adverse events, or the patient’s decision. The present real-world analysis showed the effectiveness, retention, and safety data collected in the Spanish BIOBADASER registry for patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA, including ankylosing spondylitis (AS) and non-radiographic axSpA) treated with secukinumab, a human antibody against interleukin-17A (IL-17A), for more than 12 months. Six hundred and thirty-nine patients were analysed (350, 262, and 27 PsA, AS, and nr-axSpA patients, respectively). The results showed an improvement in the disease activity after 1 year of treatment, in terms of decreases of the mean Disease Activity Score 28 using C-reactive protein (DAS28-CRP), the mean Disease Activity Psoriatic Arthritis (DAPSA) score, swollen joint counts (SJC), and tender joint counts (TJC) in PsA patients and decreases in the mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the mean Ankylosing Spondylitis Disease Activity Score (ASDAS) in axSpA patients. This improvement was maintained or increased after 2 and 3 years of treatment, indicating that secukinumab is effective in both naïve and non-responder patients. Retention rates were higher when secukinumab was used as the first-line biological treatment, although they were also adequate in the second and third lines of treatment. Collected safety data were consistent with previous reports. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-022-00446-9.

Four-year effectiveness, safety and drug retention rate of secukinumab in psoriatic arthritis: a real-life Italian multicenter cohort

“…In our study population, the drug's safety pro le was good (only 41 cases leading to drug withdrawal due to adverse events). Although this low incidence of adverse events might be linked to the fact that minor side effects may not be reported in a real-life setting, this frequency was consistent with previous real-life reports [22,24,25,31,32,33,43]. A pooled safety analysis from a phase III RCT supports the favorable long-term safety of secukinumab in patients with psoriasis and PsA [15].…”

“…Furthermore, in our study MDA was achieved in 65.6% at T24, and this proportion increased to 70.9% at T48; similarly, 36.7% and 43.1% of patients achieved DAPSA-REM and DAPSA-LDA at T24, respectively, and this state was maintained or improved at T48 (DAPSA-REM in 50% and DAPSA-LDA in 39.6%). Higher MDA and DAPSA response rates were also observed in the naïve group vs. the non-naïve group, in line with RCT data [12,14,18] and real-life experiences [22,24,25,31,32,33,43]. In this sense, the results for the sustained effectiveness of secukinumab presented here, regardless of biologic treatment line, highlight that therapy with this drug is appropriate both in non-naïve patients with an inadequate response or intolerant to previous TNF inhibitors (TNFi), and in biologic-naïve patients.…”

Factors associated with the retention of secukinumab in patients with axial spondyloarthritis in real-world practice: results from a retrospective study (FORSYA)

“…It is well established that the retention rate of secukinumab is the highest when this therapy is used as the first biological agent in patients with axSpA or PsA compared with when it is used as second or third line of treatment,20 22 35 likewise with any b/tsDMARD. In alignment with other real-world studies, better retention of secukinumab in first-line treatment compared with ≥third-line treatment (70% vs 57%) was observed in this study and ≥third line of secukinumab was a significant predictor of secukinumab discontinuation at 1 year 17 35…”

“…16 Under real-world conditions, drug retention provides critical information on efficacy, safety, compliance and convenience of use. The retention of secukinumab has been evaluated in retrospective observational series and registries [17][18][19][20][21][22] including axSpA. 20 23 24 Although the factors influencing anti-TNF efficacy and retention in axSpAsuch as smoking status, young age, gender, human leucocyte antigen (HLA)-B27 positivity, radiographic status, objective signs of inflammation (OSI) and rank of drug administration-have been identified in various RCTs and RWE studies, [25][26][27] data on anti-IL17 agents are sparse.…”

“…The retention of secukinumab has been evaluated in retrospective observational series and registries17–22 including axSpA 20 23 24. Although the factors influencing anti-TNF efficacy and retention in axSpA—such as smoking status, young age, gender, human leucocyte antigen (HLA)-B27 positivity, radiographic status, objective signs of inflammation (OSI) and rank of drug administration—have been identified in various RCTs and RWE studies,25–27 data on anti-IL17 agents are sparse 20 22 23. The impact that patient characteristics, diagnosis or drug use (line of treatment or dosage) might have on secukinumab retention under real-life conditions in patients with axSpA is only partially understood.…”