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 (naive/ non-naive), gender (male/female), subtype of axSpA [radiographic axSpA (r-axSpA)/nonradiographic 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% naive and in 71.1% non-naive 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, naive patients showed better physical functioning and lower disease activity than non-naive. After 24 months of treatment, 90.7% of naive and 75.3% of non-naive 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 naive-patients, with a notable drug retention rate. no differences were observed between r-axSpA and nr-axSpA.

Ramonda, R., Lorenzin, M., Chimenti, M.s., D’Angelo, S., Marchesoni, A., Salvarani, C., et al. (2022). Effectiveness and safety of secukinumab in axial spondyloarthritis: a 24-month prospective, multicenter real-life study. THERAPEUTIC ADVANCES IN MUSCULOSKELETAL DISEASE, 14 [10.1177/1759720X221090310].

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

Maria Sole Chimenti;Mario Ferraioli;Alberto Bergamini;
2022-01-01

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 (naive/ non-naive), gender (male/female), subtype of axSpA [radiographic axSpA (r-axSpA)/nonradiographic 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% naive and in 71.1% non-naive 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, naive patients showed better physical functioning and lower disease activity than non-naive. After 24 months of treatment, 90.7% of naive and 75.3% of non-naive 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 naive-patients, with a notable drug retention rate. no differences were observed between r-axSpA and nr-axSpA.
2022
Pubblicato
Rilevanza internazionale
Articolo
Esperti anonimi
Settore MED/16
English
anti-IL-17A
antirheumatic agents
axial spondyloarthritis
biological therapy
drug retention rate
effectiveness
safety
Ramonda, R., Lorenzin, M., Chimenti, M.s., D’Angelo, S., Marchesoni, A., Salvarani, C., et al. (2022). Effectiveness and safety of secukinumab in axial spondyloarthritis: a 24-month prospective, multicenter real-life study. THERAPEUTIC ADVANCES IN MUSCULOSKELETAL DISEASE, 14 [10.1177/1759720X221090310].
Ramonda, R; Lorenzin, M; Chimenti, Ms; D’Angelo, S; Marchesoni, A; Salvarani, C; Lubrano, E; Costa, L; Dal Bosco, Y; Fracassi, E; Ortolan, A; Ferraiol...espandi
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/346984
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