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

Abstract

Objectives: 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.

Methods: 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.

Results: 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).

Conclusions: Secukinumab proved safe and effective, and patients achieved sustained remission with a notable drug retention rate at 4 years.

Keywords: Biologics; Drug retention rate; Psoriatic arthritis; Remission/Effectiveness; Safety; Secukinumab.

Fig. 1

A-B Minimal disease activity (MDA) (percentage, %) of overall population and after their subdivision in two groups, according to the DMARD treatment line (naïve patients vs non-naïve patients) (A) and after their subdivision in three groups, according to number of comorbidities (0 comorbidities, 1–3 comorbidities, > 3 comorbidities) (B). Legend: n, number of evaluated patients; naïve: naïve to bDMARDs; non-naïve: bDMARDs failure

Fig. 2

A-B Disease Activity for Psoriatic Arthritis (DAPSA) score (percentage, %) of overall population and after their subdivision in two groups, according to the DMARD treatment line (naïve patients vs non-naïve patients) (A) and after their subdivision in three groups, according to number of comorbidities (0 comorbidities, 1–3 comorbidities, > 3 comorbidities) (B). Legend: n, number of evaluated patients; naïve: naïve to bDMARDs; non-naïve: bDMARDs failure

Fig. 3

A-L Drug survival in the overall population and after their subdivision in two groups, according to the DMARD treatment line (naïve vs non-naïve patients) (A), use of combined csDMARDs (no csDMARDs vs. csDMARDs) (B), gender (male vs. female) (C), age (< 60 years patients vs < 60 years patients) (D), BMI (overweight vs. normal weight) (E), comorbidities (patients without comorbidities vs patients with comorbidities (F), disease phenotype (mono/oligoarthritis vs. polyarthritis (G), no axial disease vs. axial disease (H), no enthesitis vs. enthesitis (I), and no psoriasis vs. psoriasis (L)