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

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)]. 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. 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). 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.

Ramonda R ，Lorenzin M ，Sole Chimenti M ，D'Angelo S ，Marchesoni A ，Salvarani C ，Lubrano E ，Costa L ，Dal Bosco Y ，Fracassi E ，Ortolan A ，Ferraioli M ，Carriero A ，Visalli E ，Bixio R ，Desiati F ，Bergamini A ，Pedrollo E ，Doria A ，Foti R ，Carletto A ... -  《-》

Four-year real-world experience of secukinumab in a large Italian cohort of axial spondyloarthritis.

This study aims to evaluate in a real-life Italian multicenter cohort of axial spondyloarthritis (axSpA) (1) the 4-year effectiveness and safety of secukinumab, (2) the drug retention rate (DRR), and (3) the impact of the line of bDMARDs treatment, subtype of axSpA, and sex on achieving low disease activity (LDA) and very low disease activity (VLDA). Consecutive axSpA patients receiving secukinumab between 2016 and 2023 were prospectively evaluated. Data on disease characteristics, previous/ongoing treatments, comorbidities, and follow-up duration were collected. Treatment response was evaluated at 6 and 12 months after initiation and yearly up to 48 months (T48). DRR and effectiveness outcomes were evaluated according to bDMARDs treatment, axSpA subtype, and sex. Infections and adverse events (AEs) were recorded. We enrolled 272 patients (48.2% male; median age, 51; 39.7% HLA-B27+; 40.4% nr-axSpA), of whom 30.9% were naïve to secukinumab. Overall, secukinumab yielded improvement in effectiveness outcomes; the naïve patients maintained lower disease activity vs. the non-naïve ones. At T48, the LDA and VLDA rates were higher in naïve patients and in male individuals. Treatment was discontinued in 104 patients due to primary/secondary loss of effectiveness and in 34 patients due to AEs. The DRR at T48 was 67.4% in the whole population, regardless of treatment line, axSpA subtype, and sex. Secukinumab was safe and effective in all axSpA patients irrespective of treatment line, disease subtype, and sex. The patients achieved sustained 4-year remission and DRR.

Ramonda R ，Lorenzin M ，Chimenti MS ，D'Angelo S ，Marchesoni A ，Selmi C ，Lubrano E ，Santo L ，Luchetti Gentiloni MM ，Atzeni F ，Cauli A ，Manara M ，Rossini M ，Foti R ，Cozzi G ，Scagnellato L ，Ferraioli M ，Carriero A ，Luciano N ，Ruzzon F ，Fatica M ，Fracassi E ，Doria A ，Foti R ，Carletto A ... -  《Frontiers in Immunology》

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

Ramonda R ，Lorenzin M ，Carriero A ，Chimenti MS ，Scarpa R ，Marchesoni A ，Lubrano di Scorpaniello E ，Salvarani C ，Cauli A ，Semeraro A ，Santo L ，Ortolan A ，Doria A ，Fracassi E ，Virelli G ，Masia M ，Fanizzi R ，Visalli E ，Amato G ，Carletto A ，Foti R ，on behalf Spondyloartritis and Psoriatic Arthritis SIR Study Group “Antonio Spadaro” ... -  《-》

Effectiveness of secukinumab in radiographic and non-radiographic axial spondyloarthritis: a European routine-care observational study.

To compare the treatment effectiveness of secukinumab in radiographic (r) versus non-radiographic (nr) axial spondyloarthritis (axSpA) patients treated in routine care across Europe. Prospectively collected data on secukinumab-treated axSpA patients with known radiographic status were pooled from nine countries.Remission rates based on patient-reported outcomes (PROs; Numeric Rating Scale (0-10), for example, pain ≤2/Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≤2 and Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (ID) <1.3 after 6/12/24 months of secukinumab treatment were calculated.Remission and drug retention rates in r-axSpA versus nr-axSpA patients were compared by logistic and Cox regression models (unadjusted/adjusted for age+sex/adjusted for multiple confounders). Overall, 1161 secukinumab-treated patients were included (r-axSpA/nr-axSpA: 922/239). At baseline, r-axSpA patients had longer disease duration and higher C reactive protein, were more often male and HLA-B27 positive and had received fewer prior biological or targeted synthetic disease-modifying antirheumatic drugs compared with nr-axSpA patients, whereas PROs were largely similar.During follow-up, crude PRO remission rates were significantly higher in r-axSpA compared with nr-axSpA patients (6 months: pain≤2: 40%/28%, OR=1.7; BASDAI≤2: 37%/25%, OR=1.8), as were drug retention rates (24 months: 66%/58%, HR 0.73 (ref: r-axSpA)). Proportions of patients achieving ASDAS ID were low for both groups, particularly nr-axSpA (6 months: 11%/8%).However, when adjusting for age+sex, these differences diminished, and after adjusting for multiple confounders, no significant between-group differences remained for either remission or drug retention rates. Crude remission/drug retention rates in European secukinumab-treated patients were higher in r-axSpA compared with nr-axSpA patients. In adjusted analyses, secukinumab effectiveness was similar in both groups, suggesting that observed differences were related to factors other than radiographic status.

Christiansen SN ，Horskjær Rasmussen S ，Ostergaard M ，Pons M ，Michelsen B ，Pavelka K ，Codreanu C ，Ciurea A ，Glintborg B ，Santos MJ ，Sari I ，Rotar Z ，Gudbjornsson B ，Macfarlane GJ ，Relas H ，Iannone F ，Laas K ，Wallman JK ，van de Sande M ，Provan SA ，Castrejon I ，Zavada J ，Mogosan C ，Nissen MJ ，Loft AG ，Barcelos A ，Erez Y ，Pirkmajer KP ，Grondal G ，Jones GT ，Hokkanen AM ，Chimenti MS ，Vorobjov S ，Di Giuseppe D ，Kvien TK ，Otero-Varela L ，van der Horst-Bruinsma I ，Hetland ML ，Ørnbjerg LM ... -  《-》

Different drug survival of first line tumour necrosis factor inhibitors in radiographic and non-radiographic axial spondyloarthritis: a multicentre retrospective survey.

Lopalco G ，Venerito V ，Cantarini L ，Emmi G ，Salaffi F ，Di Carlo M ，Tafuri S ，Gentileschi S ，Di Scala G ，Nivuori M ，Cacciapaglia F ，Galeazzi M ，Lapadula G ，Iannone F ... -  《CLINICAL AND EXPERIMENTAL RHEUMATOLOGY》