Efficacy And Safety Of Bimekizumab For Adults With Moderate To Severe Plaque Psoriasis:A Meta-analysis Of Randomized Controlled Trials

Objective To evaluate the efficacy and safety of Bimekizumab in the treatment of moderate and severe plaque psoriasis with evidence-based medicine.Methods A comprehensive search was conducted in foreign language databases,including Pubmed,Clinical trials,and Cochrane Library,from January 2017 to December 2021.According to the inclusion and exclusion criteria,the qualified randomized controlled trials(RCTs)were selected from the search results,and the quality of the included RCTs was evaluated using the deviation risk assessment tool 2.0(ROB-2)recommended by Cochrane collaboration network.Extract the relevant data required for meta-analysis,among which the efficacy indicators include the Psoriasis Lesion Area and Severity Index(PASI),the Investigator’s Overall Assessment(IGA),the Scalp Investigator’s Overall Assessment(s IGA),the Dermatology Quality of Life Index(DLQI),the Psoriasis Symptoms and Effects Scale(P-SIM);Safety evaluation indicators include total adverse reaction events(TEAEs),serious adverse reaction events(SAEs),withdrawal from the trial due to adverse reaction events,upper respiratory tract infection,nasopharyngitis,oral candidiasis,and liver events.The Cochrane Review Manager(Revman)version 5.4.1 was used for meta-analysis.Results A total of 5 studies were included in the analysis.The treatment group was Bimekizumab,and the control group was placebo or other positive drugs,including 1726 patients and 903 patients respectively.The Meta-analysis showed that: compared to the placebo group,the PASI reduction of75% compared with the baseline in the Bimekizumab group was significantly improved(OR=195.17,95%CI=83.46-456.44,P<0.00001),the PASI reduction of 90% compared with the baseline in the Bimekizumab group was significantly improved(OR=228.00,95%CI:96.72-537.48,P<0.00001),the PASI reduction of 100% compared with the baseline in the Bimekizumab group was significantly improved(OR=182.91,95%CI:43.83-763.32,P<0.00001),the proportion of patients with IGA score of 0/1 in the Bimekizumab group was significantly improved(OR=195.78,95%CI:53.54-715.96,P<0.00001),the proportion of patients with IGA score of 0 in the Bimekizumab group was significantly improved(OR=211.35,95%CI:41.06-1087.95,P<0.00001),the proportion of patients with s IGA in the Bimekizumab group was significantly improved(OR=54.68,95%CI:6.73-444.06,P=0.0002),the proportion of patients with DLQI score of 0/1 in the Bimekizumab group was significantly improved(OR=195.78,95%CI:53.54-715.96,P<0.00001),and the proportion of patients with P-SIM in the Bimekizumab group was significantly improved [pain(OR=26.21,95%CI:7.87-87.26,P<0.00001),itch(OR=19.05,95%CI:5.22-69.46,P<0.00001),scaling(OR=27.41,95%CI:6.84-109.88,P<0.00001)],there were significant statistical differences(P<0.01);Compared with the positive drug group,the PASI reduction of 75%compared with the baseline in the Bimekizumab group was significantly improved(OR=7.00,95%CI:2.35-20.82,P=0.0005),the PASI reduction of 90% compared with the baseline in the Bimekizumab group was significantly improved(OR=4.32,95%CI:1.97-9.47,P=0.0003),the PASI reduction of 100% compared with the baseline in the Bimekizumab group was significantly improved(OR=3.50,95%CI:1.55-7.87,P=0.002),and the proportion of patients with IGA score of 0/1 in the Bimekizumab group was significantly improved(OR=3.18,95%CI:1.57-6.47,P=0.001),there were significant statistical differences(P<0.01).For safety,the incidence of TEAEs for Bimekizumab increased(RR=1.15,95%CI=1.02,1.28,P=0.02)with statistically significant differences(P<0.05).Among these,the incidence of oral candidiasis increased significantly(RR=9.52,95%CI=5.35,16.93,P <0.00001),with a significant statistical difference(P <0.01).However,SAEs,upper respiratory tract infection,nasopharyngitis,and liver events were not significantly different between the two groups(P> 0.05).Conclusion By analyzing all the test results,the short-term efficacy of Bimekizumab in the treatment of moderate and severe plaque psoriasis is significantly better than that of placebo and positive control drugs.In terms of safety,the incidence of adverse events of Bimekizumab is low,and there is no significant difference between Bimekizumab and placebo and positive control drugs.However,since Bimekizumab has just come into the market and there is no long-term clinical trial report,further research is urgently needed to verify whether Bimekizumab can be used as a new option for the treatment of moderate and severe plaque psoriasis.