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

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. 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. 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). Secukinumab proved safe and effective, and patients achieved sustained remission with a notable drug retention rate at 4 years.

Ramonda R ，Lorenzin M ，Chimenti MS ，Atzeni F ，Semeraro A ，D'Angelo S ，Selmi C ，Ortolan A ，Marchesoni A ，Manara M ，Luchetti Gentiloni MM ，Santo L ，Salvarani C ，Cauli A ，Rossini M ，Amato G ，Cozzi G ，Scagnellato L ，Ferraioli M ，Carriero A ，Fracassi E ，Giorgio F ，Doria A ，Foti R ，Carletto A ，on behalf Spondyloarthritis and Psoriatic Arthritis SIR Study Group “Antonio Spadaro” ... -  《-》

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” ... -  《-》

The assessment of the drug retention rate of secukinumab in patients with psoriatic arthritis in a real-life multicentre cohort.

Ruscitti P ，Pantano I ，Perrotta FM ，Celletti E ，Volpe P ，Ciliento MS ，Marino V ，Raimondi M ，Gaggiano E ，Mauro D ，Cataldi G ，Italiano N ，Di Muzio C ，Navarini L ，Zicolella R ，Gabini M ，Cipollone F ，Lubrano E ，Giacomelli R ，Ciccia F ，Cipriani P ... -  《CLINICAL AND EXPERIMENTAL RHEUMATOLOGY》

Comparison of remission and low disease activity states with DAPSA, MDA and VLDA in a clinical trial setting in psoriatic arthritis patients: 2-year results from the FUTURE 2 study.

Remission (REM) or low disease activity (LDA) states were compared in a clinical trial setting of the FUTURE 2 study (NCT01752634) using Disease Activity Index for Psoriatic Arthritis (DAPSA) and Minimal Disease Activity (MDA) composite indices in secukinumab treated PsA patients. The proportion of patients reaching DAPSA-REM (cut-off ≤4) or REM+LDA (≤14), and very low disease activity (VLDA; achieving 7/7 criteria) or MDA (≥5/7), were compared in the overall population, by prior use of anti-TNF therapy, and by time since diagnosis using as observed data. The proportion of patients who met individual core component and other variables of interest were also computed to assess residual disease activity in DAPSA-REM/REM+LDA states and VLDA/MDA responses. The relationship between DAPSA/MDA and patient reported outcomes (PROs), including health-related quality of life, physical function, and fatigue were assessed using mixed model for repeated measures. More patients could achieve DAPSA-REM or DAPSA-REM+LDA status than VLDA or MDA responses, respectively, at all the time points in the overall population, irrespective of anti‒TNF status and time since diagnosis. Higher proportion of patients reaching DAPSA-REM or VLDA achieved more thresholds of core components (joints, pain, patient and physician global assessments, and function) than DAPSA-REM+LDA or MDA over Week 104. There were differences with numerically higher proportion of patients achieving patient global assessment ≤10 mm and ≤20 mm, and physician global assessment ≤10 mm with MDA than with DAPSA-REM+LDA, and patient pain VAS ≤15 mm, PASI ≤1, HAQ ≤0.5 with VLDA or MDA than with DAPSA-REM or DAPSA-REM+LDA, respectively, through 104 weeks. Improvements in PROs were significantly better for patients in DAPSA-REM+LDA versus DAPSA-moderate+high disease activity status, and for MDA responders versus non-responders. These analysis add to the evidence that both DAPSA and MDA composite index measures can be used for evaluation of the status and treatment response utilizing a treat to target approach in PsA patients in a clinical trial setting and improve patient health related outcomes. The study and analysis was funded by Novartis Pharma AG, Basel, Switzerland.

Coates LC ，Nash P ，Kvien TK ，Gossec L ，Mease PJ ，Rasouliyan L ，Pricop L ，Jugl SM ，Gandhi KK ，Gaillez C ，Smolen JS ... -  《-》