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

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2024年9月28日

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Roberta Ramonda,
Mariagrazia Lorenzin,
Maria Sole Chimenti,
Fabiola Atzeni,
Angelo Semeraro,
Salvatore D’Angelo,
Carlo Selmi,
Augusta Ortolan,
Antonio Marchesoni,
Maria Manara,
Michele Maria Luchetti Gentiloni,
Leonardo Santo,
Carlo Salvarani,
Alberto Cauli,
Maurizio Rossini,
Giorgio Amato,
Giacomo Cozzi,
Laura Scagnellato,
Mario Ferraioli,
Antonio Carriero,
Elena Fracassi,
Francesco Giorgio,
Andrea Doria,
Rosario Foti,
Antonio Carletto,
Roberta Foti,
Elisa Visalli,
Ylenia Dal Bosco,
De Lucia Francesco,
Cesaro Siracusano,
Sergio Collela,
Nicoletta Luciano,
Valentino Paci,
Giulia Marchionni,
Nicolò Girolimetto,
Alberto Floris,
Giorgia Citriniti,
Giovanni Striani,
Antonio Carriero,
Roberta Foti,
Elisa Visalli,
Ylenia Dal Bosco,
De Lucia Francesco,
Cesaro Siracusano,
Sergio Collela,
Giacomo M. Guidelli,
Nicoletta Luciano,
Valentino Paci,
Giulia Marchionni,
Nicolò Girolimetto,
Alberto Floris,
Giorgia Citriniti,
Giovanni Striani

摘要

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.