Bimekizumab 160mg/1ml solution for injection pre-filled disposable devices

BackgroundPsoriatic arthritis (PsA) is a chronic inflammatory disease that impacts both the skin and joints. Currently, interleukin (IL)-17, IL-12/23, and IL-23 inhibitors have become integral components of PsA treatment regimens. Nevertheless, the comparative effectiveness of these IL-targeted therapies remains a subject of ongoing debate. This study employs a network meta-analysis (NMA) approach to systematically evaluate the therapeutic efficacy and safety profiles of various IL-17, IL-12/23, and IL-23 inhibitors.MethodsWe searched PubMed, Web of Science, and Embase for randomized controlled trials (RCTs) to identify eligible research articles. This NMA was implemented by Stata 14.0 software, with odds ratios (ORs) and 95% confidence intervals (CIs) serving as effect and safety measures to evaluate clinical efficacy and safety profiles. Drugs were ranked based on their efficacy and safety profiles using the surface under the cumulative ranking curve values, enabling a comprehensive comparative assessment of interventional strategies. The CINeMA (Confidence in Network Meta-Analysis) online tool was utilized to evaluate the confidence level of the NMA results.ResultsThis NMA included 22 RCTs and 9,241 patients. All intervention groups demonstrated superior efficacy to the placebo group. Based on efficacy endpoints and subgroup analyses, bimekizumab, secukinumab, and ixekizumab exhibited superior short-term efficacy. Notably, subgroup analyses suggested that tildrakizumab may represent a promising therapeutic option for PsA. Regarding safety and the risk of adverse events, all treatments demonstrated no significant differences compared to placebo, except bimekizumab 160 mg every 4 weeks (Q4W) (OR = 1.37, 95% CI: 1.08-1.74). There were no significant differences in terms of serious adverse events and upper respiratory tract infection. Bimekizumab 160 mg Q4W showed heightened risk of nasopharyngitis (OR = 2.30, 95% CI: 1.26-4.22).ConclusionsThis NMA showed that IL-17, IL-12/23, and IL-23 inhibitors demonstrated remarkable efficacy in attaining ACR20, ACR50, ACR70, and MDA after 12, 16, or 24 weeks of treatment. Among these, IL-17 inhibitors-particularly bimekizumab, secukinumab, and ixekizumab-exhibited notably pronounced therapeutic effects. However, bimekizumab showed a less favorable clinical safety profile compared to other biological agents. In contrast, secukinumab and ixekizumab demonstrated a favorable balance of relatively high efficacy and low risk when considering safety profiles.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD420251023787, identifier CRD420251023787.

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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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BackgroundHidradenitis suppurativa (HS) is a chronic inflammatory dermatosis with limited treatment options. This systematic review and meta-analysis aimed to evaluate the evidence regarding the use of bimekizumab for treating moderate-to-severe HS, focusing on its clinical efficacy, safety, and outcomes across different clinical parameters.MethodsWe followed the "preferred reporting items for systematic reviews and meta-analyses" (PRISMA) guidelines and performed a systematic search for trials that compared bimekizumab with a placebo in patients with moderate-to-severe HS. A comprehensive search of PubMed, Web of Science, Cochrane CENTRAL, and Embase was conducted up to April 2025. The primary outcome of efficacy was the percentage of patients who reached "HS Clinical Response 50" (HiSCR50), with secondary outcomes including HiSCR75, reduction in skin pain, and safety (evaluated by serious adverse events). Two reviewers independently assessed the risk of bias using the Cochrane risk-of-bias 2 tool. A fixed-effects model was used for meta-analysis. The study protocol was preregistered in PROSPERO (CRD420251025763).ResultsThree RCTs, encompassing 1218 participants, were included. Bimekizumab made it substantially more probable that the HiSCR50 would be reached (RR: 1.64; 95% CI [1.37-1.97]; P ConclusionThe evidence, although derived from a limited number of trials, demonstrates the superiority of bimekizumab over placebo. For patients with moderate-to-severe HS, bimekizumab showed significantly improved outcomes compared to placebo in terms of enhancing clinical response and lessening skin pain. Although no statistically significant increase in serious adverse events was observed, a potential risk cannot be definitively ruled out given the numerical imbalance.

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BackgroundThere is a lack of direct comparative studies evaluating the long-term efficacy of the approved biologic therapies bimekizumab, secukinumab and adalimumab for moderate-to-severe hidradenitis suppurativa (HS) beyond Week 16. To address this evidence gap, this study uses matching-adjusted indirect comparisons (MAIC) to assess and compare their sustained efficacy.ObjectiveTo assess the long-term relative efficacy of bimekizumab 320 mg every 2 weeks/every 4 weeks (Q2W/Q4W) in moderate-to-severe HS compared with biologic therapies (secukinumab 300 mg Q2W and Q4W and adalimumab 40 mg every week [QW]) at Week 48-52.MethodsRelevant trials were identified as part of a systematic literature review. Individual patient data for bimekizumab trials (BE HEARD I/II; Week 48) were combined and subsequently weighted to match aggregate baseline characteristics of trials for secukinumab (SUNRISE/SUNSHINE; Week 52) and adalimumab (PIONEER I/II; Week 48). Weights for patients receiving bimekizumab were determined using a propensity score model. Unanchored comparisons of reweighted bimekizumab and comparator data for key HS efficacy outcomes were analysed.ResultsBimekizumab Q2W/Q4W demonstrated significantly higher odds of response for all HS Clinical Response (HiSCR) and HS Severity Score System (IHS4) outcomes compared with secukinumab Q4W, including HiSCR50 (odds ratio [OR]: 2.68; 95% confidence interval [CI]: 1.71, 4.19), HiSCR75 (OR: 2.20; 95% CI: 1.48, 3.26) and IHS4-55 (OR: 2.27; 95% CI: 1.48, 3.48); and for HiSCR50/75 compared with adalimumab QW (OR: 2.57; 95% CI: 1.48, 4.44/OR: 1.84; 95% CI: 1.08, 3.13, respectively).ConclusionCompared with other approved biologics, bimekizumab showed favourable efficacy across the majority of outcomes assessed at Week 48-52, indicating its potential as a durable long-term therapeutic option for patients with moderate-to-severe HS.

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IntroductionRecent trials with withdrawal arms in patients with psoriasis have highlighted the need for updated clinical guidance. The aim of this investigation was to compare the effects and safety of planned limited-time withdrawal versus continuous maintenance of interleukin (IL) inhibitors in patients with psoriasis.MethodsOn August 5, 2025, the following platforms were systematically searched: PubMed, Embase, Clarivate (Web of Science), Scopus, and Ovid. Titles and abstracts, followed by full-text articles, were independently screened by two reviewers, with any disagreements being resolved by a third reviewer. Certainty of evidence was evaluated via the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Network meta-analyses for the Psoriasis Area and Severity Index (PASI) 90 and PASI100 outcomes were performed. The risk ratio (RR) of relapse was ranked using the surface under the cumulative ranking curve (SUCRA) metric.ResultsA total of 7444 records were retrieved, 54 of which included data from 18 different trials. The data revealed a total of 2995 patients who were subjected to anti-IL withdrawal regimens that were eligible for comparison with anti-IL maintenance. For the PASI90 outcome, the network meta-regression, adjusted for a post-withdrawal follow-up duration of 40-48 weeks, indicated that bimekizumab demonstrated a RR for relapse (RR 5.36; 95% confidence interval (CI) 3.45-8.34; SUCRA 0.685) comparable to that of guselkumab (RR 7.45; 95% CI 4.97-11.19; SUCRA 0.412) and lower than that of ixekizumab (RR 17.45; 95% CI 10.22-29.80; SUCRA 0.006). No significant difference in adverse event rates was observed between the anti-IL withdrawal and maintenance groups.ConclusionsCompared with continued treatment, planned withdrawal of anti-IL therapy is associated with a largely superior risk of relapse, without any reduction in the incidence of adverse events. Moreover, bimekizumab withdrawal demonstrated better outcomes than ixekizumab withdrawal did according to the PASI90 outcome.Study registrationThis study was prospectively registered on PROSPERO (identification number CRD420251118724).

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