Brodalumab 210mg/1.5ml solution for injection pre-filled syringes

Objective: To systematically analyze the efficacy and safety of interleukin (IL)-12/23, IL-17, and selective IL-23 inhibitors in moderate to severe plaque psoriasis. Methods and results: Twenty-four randomized placebo-controlled trials were included. Compared to placebo, risk ratios (RR) of achieving PASI-75 and PGA/IGA 0/1 respectively were 20.20 (95% CI 13.82–29.54, p p p p p p p p p p p p p p p p p p p p p p  Conclusion: Ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab, and tildrakizumab were highly efficacious and generally well-tolerated when used as treatments for moderate to severe plaque psoriasis.</p

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Current guidelines recommend psoriatic patients with latent tuberculosis infection undergo chemoprophylaxis prior to initiating any biologic. However, clinical studies indicate that interleukin (IL) inhibitors may not increase the risk of tuberculosis reactivation. This review evaluates the safety in psoriatic patients with latent tuberculosis infection using IL inhibitors without chemoprophylaxis. PubMed and EMBASE were searched up to 1 November 2024 in accordance with PRISMA. Fifteen studies, including one safety analysis of a clinical trial, 2 case series, and 12 retrospective studies were analysed. The included studies reported a total of 837 cases: 179 patients were treated with secukinumab, 69 with ixekizumab, 8 with brodalumab, 539 with risankizumab, 22 with guselkumab, and 20 with tildrakizumab. Psoriatic patients with latent tuberculosis infection using an IL-12/23 inhibitor without chemoprophylaxis were not found in this review. Three of the 837 cases exhibited reactivation of tuberculosis. The reactivation rate is 0.78% among psoriatic patients with latent tuberculosis infection using IL-17 inhibitors, and 0.17% among those using IL-23 inhibitors. Our analysis shows that IL-17 and IL-23 inhibitors do not increase the risk of tuberculosis activation in psoriatic patients with latent tuberculosis infection. The impact of IL-12/23 inhibitors on tuberculosis reactivation among psoriatic patients with latent tuberculosis infection remains uncertain and requires further investigation.

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BackgroundInterleukin inhibitors represent a standard therapeutic approach for psoriasis. However, there is still debate about the risk of new-onset inflammatory bowel disease (IBD) in psoriasis patients following interleukin inhibitor treatment. This systematic review and meta-analysis aims to evaluate the risk of new-onset IBD in psoriasis patients treated with five interleukin inhibitors (Bimekizumab, Ixekizumab, Secukinumab, Brodalumab, and Ustekinumab), providing insights to inform clinical decision-making.MethodThis study was registered in the PROSPERO with registration number of CRD42024608423. The databases PubMed, Embase, Cochrane Library, and Web of Science were comprehensively searched for observational studies published as full-length papers in English. The Mantel-Haenszel method with a fixed-effects model and risk difference was used to compare the risk of new-onset IBD between experimental groups (using interleukin inhibitors) and the control groups (using placebo or non-interleukin inhibitors). Sensitivity analysis was performed using the leave-one-out method for the meta-analysis. Additionally, considering the potential for underdiagnosis of IBD, a meta-analysis of the risk of diarrhea was conducted.ResultThis study included 17 articles covering 21 Randomized Controlled Trials(RCTs). A total of 22 new-onset IBD cases were reported in the experimental groups, with 3, 14, 4, 1, and 0 cases in the Bimekizumab, Ixekizumab, Secukinumab, Brodalumab, and Ustekinumab group, respectively. The control group only reported 1 case of new-onset IBD. No significant difference in the risk of new-onset IBD was found between these experimental groups and control groups. Based on the fixed-effects model, the pooled risk difference for Ixekizumab group was MH RD 0.0027 (95% CI 0.0001-0.0054, I² = 0%, P = 0.04). Sensitivity analysis indicated that the data was stable. Regarding diarrhea, a total of 95 cases were reported in the experimental groups, compared to 50 cases in the control groups. The experimental groups of Bimekizumab, Secukinumab, and Brodalumab reported 49, 45, and 1 case of diarrhea, respectively, while their control groups reported 11, 39, and 0 cases, respectively. Based on the fixed-effects model, compared to the control groups, there were no significant differences in the risk of diarrhea among psoriasis patients treated with these three interleukin inhibitors, and sensitivity analysis demonstrated good data robustness. Additionally, no cases of diarrhea were reported in the Ixekizumab group and Ustekinumab group.ConclusionsThere is insufficient evidence to confirm that Ustekinumab, Bimekizumab, Secukinumab, and Brodalumab significantly increase the risk of new-onset IBD. However, compared to the control group, Ixekizumab was significantly associated with an increased risk of new-onset IBD in psoriasis patients. Psoriasis patients receiving Ixekizumab treatment should remain vigilant for gastrointestinal symptoms, particularly in high-risk patients, to identify and manage potential IBD early. Additionally, compared to the control group, no significant difference was observed in the risk of diarrhea as an adverse event among patients treated with Bimekizumab, Secukinumab, and Brodalumab.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD42024608423, identifier CRD42024608423.

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BackgroundPyoderma gangrenosum (PG) is a rare disease causing painful skin ulcers, typically starting with tender pustules that quickly develop into painful ulcers. Traditional treatments like glucocorticoids and immunosuppressants often have adverse effects and limited efficacy, making them unsuitable for all patients. Recent evidence shows that biological agents are more effective and safer, leading to increased acceptance. However, selecting the most suitable biological agent from the many available options remains a significant challenge for both physicians and patients.ObjectiveTo systematically review the treatment outcomes of two biologics: TNF (tumour necrosis factors)-α inhibitors and IL (interleukin) inhibitors in pyoderma gangrenosum.MethodsA search of Pubmed was conducted on September 7, 2024. A total of 107 studies were included using Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines.ResultsA total of 139 patients were included. Ninety-two were treated with TNF-α inhibitors and 47 with IL inhibitors. The number of included cases and the efficacy are Infliximab (n=52, 88.4%), Adalimumab (n=23, 91.3%), Etanercept (n=13, 84.6%), Certolizumab (n=3, 66.6%), Golimumab (n=1, 100.0%), Anakinra (n=11, 100.0%), Canakinumab (n=7, 100.0%), Secukinumab (n=5, 40.0%), Brodalumab (n=3, 100.0%), Ixekizumab (n=1, 100.0%), Ustekinumab (n=12, 100.0%), Spesolimab (n=3, 100.0%), Guselkumab (n=2, 100.0%), Tildrakizumab (n=2, 100.0%), Risankizuma (n=1, 100.0%). Among them, 46.0% (n=64) achieved complete remission, including 47 (33.8%) who used TNF-α inhibitors and 17 (12.2%) with IL inhibitors. And the total effective rate of IL- inhibitors (93.6%) was higher than that of TNF-α inhibitors (88.0%), but had no statistical significance (p>0.05). However, it takes less time for IL inhibitors to reach partial remission or complete remission. Additionally, in infliximab group, the number of adverse events that occurred was large and varied.ConclusionDifference in effective rate shows no statistical significance between two kinds of agents. However, IL inhibitors demonstrate an advantage with shorter treatment cycles. Additionally, Infliximab has a wider range of side effects and should be used with caution.PROSPERO number: CRD42024608039.

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BackgroundPsoriasis is a long-lasting inflammatory condition of the skin associated with various comorbidities, including depression and suicidal ideation. Management strategies for psoriasis include symptom alleviation, quality-of-life enhancement, and prevention of disease progression. Psoriasis treatments include topical therapies, phototherapy, oral systemic medications, and biologics.ObjectivesIn this review, we evaluate the impact of psoriasis treatments on depression and suicidal ideation in affected patients.MethodsWe systematically searched multiple databases, including PubMed, Scopus, and Web of Science, until September 30, 2024, to identify relevant articles. Studies that examined the effects of psoriasis therapies on depression and suicidal thoughts were included. Data on treatment modalities, psychological health outcomes, and psoriasis severity was obtained. Quality evaluation instruments, such as JBI, consolidated standards of reporting trials (CONSORTs), Center for Evidence-Based Management (CEMBa), and appraisal tool for cross-sectional studies (AXIS), were used to appraise study quality.ResultsTen studies met inclusion criteria, predominantly focusing on biologic therapies. Biologics like guselkumab, brodalumab, and bimekizumab have shown notable reductions in depression symptoms, probably through the alleviation of psoriasis severity and the enhancement of quality-of-life. Suicidal ideation occurred in some cases, especially with brodalumab; however, a definitive causal relationship was not established.ConclusionsTreatments for psoriasis, especially biologics, have shown some advantages in reducing depression symptoms as well as relieving skin symptoms. However, cautious monitoring is required due to the possible hazards of suicidal thoughts with certain therapeutic options such as biologics. Addressing the complex issues of psoriasis requires comprehensive therapy that includes dermatologists and mental health specialists.

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BackgroundScalp, nail, and palmoplantar psoriasis are termed "difficult-to-treat sites" owing to their unique anatomical features and therapeutic resistance, substantially impairing patient quality of life. Although anti-IL-17 and anti-IL-23 biologics are widely used, head-to-head comparative evidence for achieving high-level lesion clearance at these specific sites remains limited.MethodsFollowing PRISMA-NMA guidelines, we systematically searched PubMed, Embase, and other databases from inception through November 2025 for randomized controlled trials (RCTs). Primary outcomes were defined as complete or near-complete clearance. Frequentist network meta-analysis was performed to calculate odds ratios (ORs), with treatment rankings derived from surface under the cumulative ranking curve (SUCRA) values.ResultsTwenty-four RCTs involving 5,946 patients and eight biologics plus placebo were included. For palmoplantar psoriasis, secukinumab ranked highest (SUCRA = 79.7%), followed by bimekizumab (72.2%) and ustekinumab (69.7%). For nail psoriasis, bimekizumab ranked first (78.9%), followed by ixekizumab (77.2%) and brodalumab (67.5%); however, local inconsistency for the ixekizumab-placebo comparison and low-certainty evidence warrant caution. For scalp psoriasis, brodalumab (87.7%) and ixekizumab (86.9%) ranked highest, followed by bimekizumab (69.0%) and guselkumab (65.1%); the brodalumab estimate relied on a single contributing study.ConclusionDuring induction-phase follow-up, IL-17 inhibitors tended to rank highly for complete or near-complete clearance at difficult-to-treat psoriasis sites. Bimekizumab and ixekizumab showed consistently favorable rankings across sites, but treatment selection should consider certainty of evidence, sensitivity analyses, long-term response, and patient-level factors.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO, identifier CRD420251271255.

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BackgroundPsoriasis is a relapsing inflammatory skin disease that significantly impacts patients' quality of life, particularly those with moderate-to-severe lesions, which also impose considerable psychological stress. Biologics have become a primary therapeutic approach for moderate-to-severe plaque psoriasis. This study aims to evaluate the clinical efficacy and safety of biologics, providing guidance for clinical application.MethodsWe searched PubMed, Cochrane Library, EMBASE, and Web of Science from inception to May 29, 2024, and conducted an updated supplementary search from May 30, 2024 to April 25, 2026 to identify randomized controlled trials (RCTs) assessing the efficacy and safety of IL-23/IL-17 inhibitors in treating moderate-to-severe plaque psoriasis. The quality of the included studies was evaluated using the Cochrane risk of bias tool, and a meta-analysis was performed using R software (version 4.3.1).ResultA total of 23 publications were included after screening, comprising 27 RCTs that were incorporated into the network meta-analysis. The meta-analysis results showed that several regimens, including Guselkumab 200 mg, Secukinumab 300 mg, and Brodalumab 210 mg, ranked highly for PASI 75 and PASI 90 at specific follow-up time points; however, ranking patterns varied across outcomes and follow-up durations. Additionally, Tildrakizumab 100 mg and Tildrakizumab 200 mg showed high SUCRA values for achieving cleared or almost cleared skin and reducing the Dermatology Life Quality Index (DLQI) score at most follow-up time points. In short-term safety analyses, some agents showed a higher incidence of adverse events compared to placebo, including Brodalumab 140 mg at 12 weeks [RR = 1.12, 95%CrI = (1.03, 1.23)] and Secukinumab 150 mg [RR = 1.22, 95% CrI = (1.09, 1.35)]. However, adverse-event reporting was not uniformly comprehensive across all included trials, and these findings should therefore be interpreted with caution.ConclusionThis network meta-analysis provides regimen-specific comparative evidence for short-term efficacy and safety of IL-23/IL-17 inhibitors. Treatment rankings should be interpreted within each outcome and follow-up time point, together with effect estimates, safety profiles, and the amount of supporting evidence.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO, identifier CRD42024584441.

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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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