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

Abstract

to evaluate over a 48-month follow-up period the: 1) long-term effectiveness and safety; 2) drug retention rate (DRR); 3) impact of comorbidities and bDMARDs line on MDA and DAPSA remission/low disease activity (LDA) of secukinumab in a multicenter Italian cohort of PsA patients. Consecutive PsA patients receiving secukinumab were followed prospectively in Italian centers between 2016 and 2023. Disease characteristics, previous/ongoing treatments, comorbidities and follow-up duration were recorded. Treatment response was evaluated at 6 and 12 months after initiation, and every year up to 48 months (T48). DRR was assessed according to clinical and demographic features, comorbidities and bDMARDs line. Adverse events (AE) were recorded. Six hundred eighty-five patients [42.5% male] were enrolled; 32.9% naïve received secukinumab; 74.2% had ≥ 1 comorbidity. Overall, secukinumab yielded improved outcomes at T48: naïve maintained lower disease activity vs. non-naïve [DAPSA 4.0 (1.4–8.1) vs. 6.0 (2.2–10.4);p = 0.04]; 76.9% naïve and 66.2% non-naïve achieved MDA; MDA no comorbidities vs. 1–3 comorbidities 78.8% vs. 73.3% (p < 0.05), and MDA no comorbidities vs. > 3 comorbidities 78.8% vs. 48.7% (p < 0.001). DAPSA-REM and DAPSA-LDA rates were higher in naïve patients, albeit similar between those without comorbidities vs. 1–3 comorbidities, and slightly lower in those with > 3 comorbidities. Treatment was discontinued in 233 patients due to loss of effectiveness, and in 41 due to AE. The overall DRR at T48 was 66%, with differences according to bDMARDs line (p < 0.001), use of combined csDMARDs (p = 0.016), BMI (p = 0.037) and mono/oligoarthritis vs. polyarthritis (p = 0.012). Secukinumab proved safe and effective, and patients achieved sustained remission with a notable drug retention rate at 4 years. What is already known on this topic? • Secukinumab is a novel drug for psoriatic arthritis (PsA), but real-life long-term safety and effectiveness data are lacking. What this study adds? • Our findings confirmed the safety and notable effectiveness on all PsA domains (arthritis, enthesitis, dactylitis, spinal symptoms, psoriasis, PROs and inflammatory markers), over a 48-month follow-up period. • The drug retention rate (DRR) is considerably high at 48 months. The main clinical disease pattern (peripheral/axial involvement), male gender, age, and the presence of comorbidities do not influence the DRR of secukinumab over time. • The first line of bDMARDs seems to favor MDA and remission/low disease activity DAPSA achievement and drug retention, while fewer than 3 comorbidities have no impact on these outcomes. How this study might affect research, practice or policy • This study supports the effectiveness of secukinumab, which also seems to be a valid option for multi-drug failure patients; the safety of secukinumab means it can be used in patients with comorbidities, older age, higher BMI, and in particular cardiovascular conditions and metabolic syndrome.