Dataset Information

Assessing the Short-Term Efficacy and Safety of Guselkumab for Moderate-to-Severe Plaque Psoriasis: Meta-Analysis of Randomized Controlled Trials.

ABSTRACT: Background:To investigate the efficacy and safety of guselkumab in the treatment of moderate-to-severe plaque psoriasis. Methods:A systematic review was undertaken to identify double-blind randomized controlled trials (RCTs). PubMed, Web of Science, Cochrane Library, EMBASE, and Google Scholar databases were searched before 1 March 2020. The odds ratios (ORs) with 95% confidence interval (CI) were calculated. All analyses were conducted with intention-to-treat basis. A range of sensitivity analyses was undertaken. Results:A total of 7 articles contained 1206 plaque psoriasis patients with guselkumab, 585 patients with placebo, and 1250 patients with adalimumab were included. The results indicated that guselkumab had better efficacy than placebo or adalimumab for Psoriasis Area and Severity Index score reductions from baseline of 75% (PASI 75) (OR = 61.37, 95% CI = 31.15 to 120.91; OR = 3.08, 95% CI = 2.35 to 4.06), Investigator's Global Assessment scores of 0 or 1 (IGA 0/1) (OR = 65.75, 95% CI = 45.54 to 94.95; OR = 2.79, 95% CI = 2.17 to 3.59), and Dermatology Life Quality Index scores of 0 or 1 (DLQI 0/1) (OR = 29.64, 95% CI = 18.80 to 46.73; OR = 1.86, 95% CI = 1.50 to 2.31). The guselkumab had similar safety with placebo or adalimumab about the incidence of adverse events (AEs) (OR = 1.05, 95% CI = 0.86 to 1.29; OR = 0.97, 95% CI = 0.79 to 1.19) and serious adverse events (SAEs) (OR = 1.03, 95% CI = 0.47 to 2.27; OR = 0.91, 95% CI = 0.44 to 1.87). Meanwhile, there was no statistically significant association of infections and serious infections compared with the placebo or adalimumab group. The guselkumab was more effective and had the similar tolerance. Conclusion:The guselkumab had excellent efficacy and great safety in moderate-to-severe plaque psoriasis, but long-term safety remained to be determined.

SUBMITTER: Yang J

PROVIDER: S-EPMC7382754 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Assessing the Short-Term Efficacy and Safety of Guselkumab for Moderate-to-Severe Plaque Psoriasis: Meta-Analysis of Randomized Controlled Trials.

Yang Jing J Wang Zongming Z Zhang Xilin X

Journal of immunology research 20200717

<h4>Background</h4>To investigate the efficacy and safety of guselkumab in the treatment of moderate-to-severe plaque psoriasis.<h4>Methods</h4>A systematic review was undertaken to identify double-blind randomized controlled trials (RCTs). PubMed, Web of Science, Cochrane Library, EMBASE, and Google Scholar databases were searched before 1 March 2020. The odds ratios (ORs) with 95% confidence interval (CI) were calculated. All analyses were conducted with intention-to-treat basis. A range of se ...[more]

PMID: 32724829

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Project description:BackgroundThe role of interleukin-12 (IL-12), interleukin-23 (IL-23), and interleukin-17 (IL-17) has been recognized in psoriasis pathogenesis, and new drugs targeting this axis have already been developed which may provide a new therapeutic approach for patients with moderate to severe psoriasis.ObjectiveTo compare the direct and indirect evidences of the efficacy and safety of brodalumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tildrakizumab, and risankizumab in the short-term treatment of moderate to severe plaque psoriasis using network meta-analysis (NMA).MethodsA comprehensive literature search was performed in PubMed, EMBASE, and Cochrane Central Register of Controlled Trials for the available relevant studies. NMA was conducted by Stata 15.0 software using relative risks (RR) with 95% confidence interval to assess the clinical effectiveness and safety. Ranked the efficacy and safety for each drug accordance with the surface under the cumulative ranking curve (SUCRA).ResultsThis meta-analysis included 28 studies. All the interventions performed better than placebo in short-term achievement. Based on the result of SUCRA, ixekizumab 80 mg every 2 weeks ranked the highest in short-term achievement of PASI 75 (SUCRA = 93.0%). Brodalumab 210 mg ranked the highest in short-term achievement of PASI 100 (SUCRA = 85.0%). Secukinumab 300 mg ranked the highest in short-term achievement of sPGA 0/1 or IGA 0/1 or PGA 0/1 (SUCRA = 98.1%). In terms of having a risk of adverse events, the rates were higher in brodalumab, secukinumab, ixekizumab, and ustekinumab 45 mg compared with placebo. Ixekizumab 80 mg every 4 weeks ranked the highest in the risk of adverse events during short-term treatment (SUCRA = 4.5%). Guselkumab 50 mg ranked the highest in the risk of serious adverse events during short-term treatment (SUCRA = 25.9%). Ixekizumab 80 mg every 4 weeks ranked the highest in the risk of discontinuations due to adverse events during short-ter treatment (SUCRA = 10.7%).ConclusionsIL-17, IL-12/23, and IL-23 inhibitors had high efficacy in the achievement of PASI 75, PASI 100, and sPGA 0/1 or IGA 0/1 or PGA 0/1 in moderate to severe plaque psoriasis after 12 or 16 weeks of treatment. IL-17 inhibitors showed superior efficacy. However, its clinical safety was poor. Risankizumab appeared to have relatively high efficacy and low risk. The clinical tolerance of other biological agents needs to be further observed.

Project description:ImportancePsoriasis is a chronic disease requiring long-term management; understanding the long-term safety profiles of psoriasis treatments, such as bimekizumab, is important.ObjectiveTo evaluate the 2-year safety profile of bimekizumab in patients with moderate to severe plaque psoriasis.Design, setting, and participantsSafety data were pooled from a cohort of patients from 4 phase 2 randomized clinical trials (BE ABLE 1, BE ABLE 2, PS0016, and PS0018) and 4 phase 3 randomized clinical trials (BE VIVID, BE READY, BE SURE, and BE BRIGHT) to include 2 years of study treatment. Data were obtained on adults with moderate to severe plaque psoriasis (Psoriasis Area and Severity Index level ≥12, ≥10% body surface area affected by psoriasis, and an Investigator's Global Assessment score ≥3 on a 5-point scale) who were eligible for systemic psoriasis therapy and/or phototherapy.InterventionsIncluded patients received 1 or more doses of bimekizumab during the phase 2 or phase 3 trials.Main outcomes and measuresTreatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs leading to treatment discontinuation are reported using exposure-adjusted incidence rates (EAIRs) per 100 person-years.ResultsA total of 1789 patients (1252 [70.0%] men; mean [SD] age, 45.2 [13.5] years) were treated with 1 or more doses of bimekizumab across the phase 2/3 trials and were included in these analyses; total bimekizumab exposure was 3109.7 person-years. TEAEs occurred at an EAIR of 202.4 per 100 person-years and did not increase with longer duration of bimekizumab exposure. The 3 most frequently reported TEAEs were nasopharyngitis (19.1 per 100 person-years; 95% CI, 17.4-20.9 per 100 person-years), oral candidiasis (12.6 per 100 person-years; 95% CI, 11.3-14.0 per 100 person-years), and upper respiratory tract infection (8.9 per 100 person-years; 95% CI, 7.8-10.1 per 100 person-years). Most oral candidiasis events were mild or moderate; 3 events led to discontinuation. The EAIRs of inflammatory bowel disease (0.1 per 100 person-years; 95% CI, 0.0-0.3 per 100 person-years), adjudicated suicidal ideation and behavior (0.0 per 100 person-years; 95% CI, 0.0-0.2 per 100 person-years), and adjudicated major adverse cardiac events (0.5 per 100 person-years; 95% CI, 0.3-0.8 per 100 person-years) were low.Conclusions and relevanceIn these pooled analyses of data from a cohort of patients from 8 randomized clinical trials, bimekizumab was well tolerated aside from an increased incidence of mild to moderate oral candidiasis. No safety signals were observed compared with previous reports, and there was no increased risk of AEs with longer duration of bimekizumab exposure.

Project description:BackgroundSignificantly more patients with moderate-to-severe plaque psoriasis treated with the interleukin (IL)-17A inhibitor ixekizumab vs. the IL-23p19 inhibitor guselkumab in the IXORA-R head-to-head trial achieved 100% improvement in Psoriasis Area and Severity Index (PASI 100) at week 12.ObjectivesTo compare skin and nail clearance and patient-reported outcomes for ixekizumab vs. guselkumab, up to week 24.MethodsIXORA-R enrolled adults with moderate-to-severe plaque psoriasis, defined as static Physician's Global Assessment ≥ 3, PASI ≥ 12 and involved body surface area ≥ 10%. Statistical comparisons were performed using the Cochran-Mantel-Haenszel test stratified by pooled site. Time-to-first-event comparisons were performed using Kaplan-Meier analysis, and P-values were generated using adjusted log-rank tests stratified by treatment group. Cumulative days at clinical and patient-reported responses were compared by ancova. The trial was registered with ClinicalTrials.gov (NCT03573323).ResultsOf the 1027 patients randomly assigned, 90% completed the trial (465 of 520 ixekizumab and 459 of 507 guselkumab). As early as week 2 and through week 16, more patients on ixekizumab achieved PASI 100 (P < 0·01). At week 24, ixekizumab was noninferior to guselkumab (50% vs. 52%, difference -2·3%), with no statistically significant difference in PASI 100 (P = 0·41). More patients receiving ixekizumab showed completely clear nails at week 24 (52% vs. 31%, P = 0·007). The median time to first PASI 50/75/90 and PASI 100 were 2 and 7·5 weeks shorter, respectively, for patients on ixekizumab vs. guselkumab (P < 0·001). Patients on ixekizumab also had a greater cumulative benefit, with more days at PASI 90 and 100, with Dermatology Life Quality Index of 0 or 1, and itch free (P < 0·05). The frequency of serious adverse events was 3% for each group, with no new safety signals.ConclusionsIxekizumab was noninferior to guselkumab in complete skin clearance and superior in clearing nails at week 24. Ixekizumab cleared skin more rapidly in patients with moderate-to-severe plaque psoriasis, with a greater cumulative benefit, than guselkumab. Overall, the safety findings were consistent with the known safety profile for ixekizumab.

Dataset Information

Assessing the Short-Term Efficacy and Safety of Guselkumab for Moderate-to-Severe Plaque Psoriasis: Meta-Analysis of Randomized Controlled Trials.

Publications

Assessing the Short-Term Efficacy and Safety of Guselkumab for Moderate-to-Severe Plaque Psoriasis: Meta-Analysis of Randomized Controlled Trials.

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