Effectiveness and safety of secukinumab in 608 patients with psoriatic arthritis in real life: a 24-month prospective, multicentre study

• Published in: Rheumatic & musculoskeletal diseases open Vol. 7; no. 1; p. e001519
• Main Authors: Ramonda, Roberta, Lorenzin, Mariagrazia, Carriero, Antonio, Chimenti, Maria Sole, Scarpa, Raffaele, Marchesoni, Antonio, Lubrano, Ennio, Salvarani, Carlo, Cauli, Alberto, Semeraro, Angelo, Santo, Leonardo, Ortolan, Augusta, Doria, Andrea, Fracassi, Elena, Virelli, Giulia, Masia, Marco, Fanizzi, Rosalinda, Visalli, Elisa, Amato, Giorgio, Carletto, Antonio, Foti, Rosario, d’Angelo, Salvatore, Costa, Luisa, Francesca, Desiati, Fonti, Giulia Lavinia, Girolimetto, Nicolò, Perrotta, Fabio Massimo, Praino, Emanuela
• Format: Journal Article
• Language: English
• Published: England EULAR 01.02.2021; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Original research
• Subjects: antirheumatic agents; Arthritis; biological therapy; Body mass index; Cytokines; Disease; Drug dosages; Gender; Laboratories; Monoclonal antibodies; Patients; Psoriasis; psoriatic; Psoriatic Arthritis; Rheumatology; Skin; Tuberculosis; psoriatic; arthritis; antirheumatic agents; biological therapy
• ISSN: 2056-5933; 2056-5933
• DOI: 10.1136/rmdopen-2020-001519

ObjectivesTo evaluate in a multicentric Italian cohort of patients with psoriatic arthritis (PsA) on secukinumab followed for 24 months: (1) the long-term effectiveness and safety of secukinumab, (2) the drug retention rate and minimal disease activity (MDA), (3) differences in the outcomes according to the biological treatment line: biologic-naïve patients (group A) versus multifailure (group B) patients.MethodsConsecutive patients with PsA receiving secukinumab 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 overtime with descriptive statistics; multivariate Cox and logistic regression models were used to evaluate predictors of drug-discontinuation and MDA at T6. Infections and adverse events were recorded.Results608 patients (41.28% men; mean (SD) age 52.78 (11.33)) were enrolled; secukinumab was prescribed as first-line biological treatment in 227 (37.34%) patients, as second (or more)-line biological treatment in 381 (62.66%). Effectiveness of secukinumab was shown with an improvement in several outcomes, such as Ankylosing Spondylitis Disease Activity Score (T0=3.26 (0.88) vs T24=1.60 (0.69) ;p=0.02) and Disease Activity Index for Psoriatic Arthritis (T0=25.29 (11.14) vs T24=7.69 (4.51); p<0.01). At T24, group A showed lower Psoriasis Area Severity Index (p=0.04), erythrocyte sedimentation rate and C reactive protein (p=0.03 ;p=0.05) and joint count (p=0.03) compared with group B. At T24, MDA was achieved in 75.71% of group A and 70.37% of group B. Treatment was discontinued in 123 (20.23%) patients, mainly due to primary/secondary loss of effectiveness, and in 22 due to adverse events. Retention rate at T24 was 71% in the whole population, with some difference depending on secukinumab dosage (p=0.004) and gender (p=0.05).ConclusionsIn a real-life clinical setting, secukimumab proved safe and effective in all PsA domains, with notable drug retention rate.