Effectiveness and safety of secukinumab in axial spondyloarthritis: a 24-month prospective, multicenter real-life study

Roberta Ramonda; Mariagrazia Lorenzin; Maria Sole Chimenti; Salvatore D'Angelo; Antonio Marchesoni; Carlo Salvarani; Ennio Lubrano; Luisa Costa; Ylenia Dal Bosco; Elena Fracassi; Augusta Ortolan; Mario Ferraioli; Antonio Carriero; Elisa Visalli; Riccardo Bixio; Francesca Desiati; Alberto Bergamini; Elisa Pedrollo; Andrea Doria; Rosario Foti; Antonio Carletto

doi:10.1177/1759720X221090310

Effectiveness and safety of secukinumab in axial spondyloarthritis: a 24-month prospective, multicenter real-life study

Ther Adv Musculoskelet Dis. 2022 Apr 29:14:1759720X221090310. doi: 10.1177/1759720X221090310. eCollection 2022.

Authors

Roberta Ramonda¹, Mariagrazia Lorenzin², Maria Sole Chimenti³, Salvatore D'Angelo⁴, Antonio Marchesoni⁵, Carlo Salvarani⁶, Ennio Lubrano⁷, Luisa Costa⁸, Ylenia Dal Bosco⁹, Elena Fracassi¹⁰, Augusta Ortolan², Mario Ferraioli³, Antonio Carriero⁴, Elisa Visalli⁹, Riccardo Bixio¹⁰, Francesca Desiati¹¹, Alberto Bergamini³, Elisa Pedrollo¹⁰, Andrea Doria², Rosario Foti⁹, Antonio Carletto¹⁰

Affiliations

¹ Rheumatology Unit, Department of Medicine (DIMED), University of Padova, Via Giustiniani, 2, 35128 Padova, Italy.
² Rheumatology Unit, Department of Medicine (DIMED), University of Padova, Padova, Italy.
³ Rheumatology, Allergology and Clinical Immunology, Department of 'Medicina dei Sistemi', University of Rome 'Tor Vergata', Rome, Italy.
⁴ Rheumatology Institute of Lucania (IReL), Rheumatology Department of Lucania, San Carlo Hospital of Potenza and Madonna delle Grazie Hospital of Matera, Potenza Local Health System, Potenza, Italy.
⁵ Rheumatology, Humanitas San Pio X, Milan, Italy.
⁶ Rheumatology Unit, Department of Internal Medicine, Azienda USL-IRCCS, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy.
⁷ Academic Rheumatology Unit, Dipartimento di Medicina e Scienze per la Salute 'Vincenzo Tiberio', University of Molise, Campobasso, Italy.
⁸ Rheumatology Research Unit, Department of Clinical Medicine and Surgery, School of Medicine and Surgery, University of Naples FEDERICO II, Naples, Italy.
⁹ Rheumatology Unit, A.O.U. Policlinico S. Marco, Catania, Italy.
¹⁰ Rheumatology Unit, Department of Medicine, AOUI University of Verona, Verona, Italy.
¹¹ Department of Rheumatology, ASST Gaetano Pini-CTO, Milan, Italy.

Abstract

Objectives: To evaluate, in a multicentric Italian cohort of axial spondyloarthritis (axSpA) patients on Secukinumab (SEC) followed for 24 months: (1) the long-term effectiveness and safety of SEC; (2) the drug retention rate and low disease activity (LDA) measured as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) < 4/Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1 and very low disease activity (VLDA) measured as BASDAI < 2/ASDAS < 1.3; (3) any differences in outcomes according to line of biological treatment (naïve/non-naïve), gender (male/female), subtype of axSpA [radiographic axSpA (r-axSpA)/non-radiographic axSpA (nr-axSpA)].

Methods: Consecutive axSpA patients treated with SEC were evaluated prospectively. Disease characteristics, previous/ongoing treatments, comorbidities, and follow-up duration were collected. Disease activity/functional/clinimetric scores and biochemical-values were recorded at baseline (T0), 6 (T6), 12 (T12), and 24 (T24) months. Effectiveness was evaluated over-time with descriptive statistics; multivariate Cox and logistic regression models were used to evaluate predictors of drug discontinuation and LDA at T6. Infections and adverse events were recorded.

Results: A total 249 patients (47.8% male; median age 51) were enrolled; 40.9% had HLA-B27; 53.8% had r-axSpA, and 46.2% nr-axSpA. SEC was prescribed in 28.9% naïve and in 71.1% non-naïve patients. SEC effectiveness was shown as an improvement in several outcomes, such as ASDAS [T0 = 3.5 (2.9-4.4) versus T24 = 1.9 (1.2-2.4); p = 0.02] and BASDAI [T0 = 6.5 (5.0-7.5) versus T24 = 2.8 (1.8-4.0); p = 0.03]. At T24, naïve patients showed better physical functioning and lower disease activity than non-naïve. After 24 months of treatment, 90.7% of naïve and 75.3% of non-naïve patients achieved LDA (BASDAI < 4). Treatment was discontinued in 24.5% patients, mainly due to primary/secondary loss of effectiveness, and in 6.8% due to adverse events. Retention rate at T24 was 75% in the whole population, with some difference depending on gender (p = 0.002).

Conclusion: In a real-life clinical setting, SEC proved to be safe and effective in axSpA, mainly in naïve-patients, with a notable drug retention rate. No differences were observed between r-axSpA and nr-axSpA.

Keywords: anti-IL-17A; antirheumatic agents; axial spondyloarthritis; biological therapy; drug retention rate; effectiveness; safety.