Secukinumab 75mg/0.5ml solution for injection pre-filled syringes

BACKGROUND Head-to-head trials in psoriatic arthritis are helpful in guiding clinical decision making. The EXCEED study evaluated the efficacy and safety of secukinumab versus adalimumab as first-line biological monotherapy for 52 weeks in patients with active psoriatic arthritis, with a musculoskeletal primary endpoint of American College of Rheumatology (ACR) 20 response. METHODS This parallel-group, double-blind, active-controlled, phase-3b, multicentre (168 sites in 26 countries) trial enrolled patients aged at least 18 years with active psoriatic arthritis. Eligible patients were randomly assigned (1:1) by means of interactive response technology to receive secukinumab or adalimumab. Patients, investigators, site personnel, and those doing the assessments (except independent study drug administrators) were masked to study assignment. 300 mg secukinumab was administered subcutaneously at baseline, weeks 1, 2, 3, and 4, and then every 4 weeks until week 48 as a pre-filled syringe. Adalimumab was administered every 2 weeks from baseline until week 50 as 40 mg per 0·4 mL citrate free subcutaneous injection. The primary outcome was the proportion of patients with at least 20% improvement in the ACR response criteria (ACR20) at week 52. Patients were analysed according to the treatment to which they were randomly assigned. Safety analyses included all safety data reported up to and including the week 52 visit for each patient who received at least one dose of study drug. The trial is registered at ClinicalTrials.gov, NCT02745080. FINDINGS Between April 3, 2017 and Aug 23, 2018, we randomly assigned 853 patients to receive secukinumab (n=426) or adalimumab (n=427). 709 (83%) of 853 patients completed week 52 of the study, of whom 691 (81%) received the last study treatment at week 50. 61 (14%) of 426 patients in the secukinumab group discontinued treatment by week 52 versus 101 (24%) of 427 patients in the adalimumab group. The primary endpoint of superiority of secukinumab versus adalimumab for ACR20 response at week 52 was not met. 67% of patients in the secukinumab group achieved an ACR20 response at week 52 versus 62% of patients in the adalimumab group (OR 1·30, 95% CI 0·98-1·72; p=0·0719). The safety profiles of secukinumab and adalimumab were consistent with previous reports. Seven (2%) of 426 patients in the secukinumab group and six (1%) of 427 patients in the adalimumab group had serious infections. One death was reported in the secukinumab group due to colon cancer and was assessed as not related to the study drug by the investigator. INTERPRETATION Secukinumab did not meet statistical significance for superiority versus adalimumab in the primary endpoint of ACR20 response at week 52. However, secukinumab was associated with a higher treatment retention rate than adalimumab. This study provides comparative data on two biological agents with different mechanisms of action, which could help guide clinical decision making in the management of patients with psoriatic arthritis. FUNDING Novartis Pharma.

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Background and objectivesEvidence for secukinumab and bimekizumab in hidradenitis suppurativa (HS) primarily comes from randomized clinical trials with selected patient populations. Conversely, real-world evidence (RWE) studies reflect broader patient demographics and clinical practice. This study aims to summarize RWE on the safety and efficacy profile of secukinumab and bimekizumab for HS through a systematic review and meta-analysis.MethodsWe conducted a comprehensive search using the Medline and Scopus databases. Eligible studies reported RWE on secukinumab or bimekizumab in HS. Furthermore, we conducted a meta-analysis to estimate the proportion of patients achieving HiSCR with secukinumab.ResultsA total of 13 studies were included, with 347 HS patients. The meta-analysis showed that 50.31% (95%CI, 37.41-63.18%) of patients on secukinumab achieved HiSCR at the longest follow-up available. While HiSCR was not reported for bimekizumab studies, significant improvements in IHS4 and pain-NRS were observed. Both drugs were well-tolerated, with adverse event rates of 8.22% for secukinumab and 5.45% for bimekizumab, most being mild and manageable.ConclusionsIL-17 inhibitors provide moderate response rates and are valuable options for patients refractory to other therapies, with low incidences of mild adverse events. More RWE studies are essential to better understand their safety and efficacy profile.

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IntroductionSystemic lupus erythematosus (SLE) is a disease with few licensed drugs when compared to rheumatoid arthritis, axial spondyloarthropathies, and psoriatic arthritis. We report on results of a systematic literature review of IL-17i in SLE with appraisal of published cases of both efficacy of treatment and the risk of developing new SLE following treatment with IL-17i through investigation of adverse events in the setting of clinical trials of IL-17i in non-SLE indications.MethodsWe performed a PubMed, EMBASE, and MEDLINE search from inception till 30 June 2025 for case reports of IL-17i-induced SLE. The four EMA-licensed IL-17 inhibitors secukinumab, bimekizumab, brodalumab, and ixekizumab were included for analysis. All four monoclonal antibodies block IL-17A, with bimekizumab having the dual functionality of blocking IL-17A/F. Furthermore, the clinical trial data for secukinumab in psoriasis, psoriatic arthritis, and axial spondylarthritis from inception till 2024 was reviewed for adverse event reporting of new cases of SLE. Both systemic and cutaneous SLE were reported on. We also reported on secukinumab case reports for treating SLE.ResultsClinical efficacy of IL-17i in case reports of active SLE: in the case of patients treated with secukinumab for known active SLE outside of the clinical trial setting (n = 4), the commonest indications for the use of secukinumab were active cutaneous disease and inflammatory arthritis (75%, n = 3), with 25% [n = 1] having lupus nephritis. All four patients had positive serology for ANA and dsDNA. New-onset SLE following IL-17i in the literature: amongst 56 clinical trials for secukinumab, there have been no reports of drug-induced or paradoxical/new-onset SLE following treatment in the reporting periods for each respective trial (n = 13,000). To date, there are no case reports of bimekizumab- or ixekizumab-induced SLE, although there are two case reports for ixekizumab-induced lupus tumidus, which were excluded from the analysis. One case report exists for new-onset SLE in a patient undergoing treatment with brodalumab for psoriasis, and six cases of SLE following initiation of secukinumab were identified. We identified four of the uses of secukinumab in the treatment of SLE.ConclusionDespite a handful of case reports for paradoxical reactions with IL-17i, they remain a potential therapeutic option in SLE. All patients recovered upon cessation of the offending IL-17i, and generally patients with drug-induced lupus only require symptomatic management and withdrawal of the offending agent. The efficacy of IL-17i for use in SLE remains unclear due to the limited data from case reports. Among the case reports there was heterogeneity in the reporting of disease activity with no standardization or the use of classic disease metrics such as the SLEDAI or DORIS, which can provide its own challenge in appreciating the results and validating the findings. In conclusion, this is an area that deserves further investigation. Translational research is needed to better understand the role of IL-17 in the pathogenesis of SLE. Dedicated studies and trials of clinical efficacy are needed.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier 1338317.

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