Warren Richard B, Donnelly Kerry, Kiri Sandeep, Taieb Vanessa, Slim Mahmoud, Fahrbach Kyle, Neupane Binod, Betts Marissa, Armstrong April
Dermatology Centre, Northern Care Alliance NHS Foundation Trust, Manchester, UK.
NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
Dermatol Ther (Heidelb). 2024 Nov;14(11):3133-3147. doi: 10.1007/s13555-024-01302-0. Epub 2024 Nov 1.
Biologic treatments have made complete skin clearance in moderate to severe plaque psoriasis a real possibility. Although clinical trials demonstrated the superiority of bimekizumab over secukinumab, adalimumab, and ustekinumab, direct comparisons with other biologics are not available. This systematic literature review (SLR) and network meta-analysis (NMA) aimed to evaluate the 1-year efficacy and safety of bimekizumab versus other biologic systemic therapies for moderate to severe plaque psoriasis.
We conducted an SLR to retrieve published randomised controlled trials (RCTs) in patients with moderate to severe plaque psoriasis. We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews and PsycINFO on 13 January 2022. Two NMA types were used to analyse the long-term achievement of 100% improvement from baseline in Psoriasis Area and Severity Index (PASI 100): (1) NMA of cumulative clinical benefits, based on the area under the curve, from week 0 to 52; (2) multinomial NMA at weeks 44‒60. Binomial NMA was used to evaluate long-term serious adverse events (SAEs).
The SLR identified 38 RCTs, of which 19 were included in the NMA. Bimekizumab 320 mg administered every 4 weeks to week 16 then every 8 weeks (Q4W/Q8W) showed a greater cumulative average number of days of PASI 100 response compared with all other biologics. These differences were statistically significant versus all biologics, except risankizumab 150 mg. The multinomial NMA demonstrated that interleukin (IL)-17 and IL-23 inhibitors were the most efficacious treatments. No significant differences were found in long-term occurrence of SAEs.
Bimekizumab 320 mg Q4W/Q8W was superior to most other treatments in maintaining complete skin clearance during the first year of treatment. It demonstrated a greater cumulative average number of days with completely clear skin while displaying a comparable safety profile compared with all other biologics.
生物治疗使中重度斑块状银屑病实现皮肤完全清除成为可能。尽管临床试验证明比美吉珠单抗优于司库奇尤单抗、阿达木单抗和乌司奴单抗，但缺乏与其他生物制剂的直接对比。本系统文献综述（SLR）和网状Meta分析（NMA）旨在评估比美吉珠单抗与其他生物系统疗法治疗中重度斑块状银屑病的1年疗效和安全性。
我们进行了一项SLR，以检索中重度斑块状银屑病患者已发表的随机对照试验（RCT）。于2022年1月13日检索了MEDLINE、Embase、Cochrane对照试验中央登记库、Cochrane系统评价数据库和PsycINFO。使用两种NMA类型分析银屑病面积和严重程度指数（PASI）从基线改善100%的长期实现情况：（1）基于第0周至52周曲线下面积的累积临床益处NMA；（2）第44至60周的多项NMA。使用二项式NMA评估长期严重不良事件（SAE）。
SLR共识别出38项RCT，其中19项纳入NMA。与所有其他生物制剂相比，每4周给药一次320mg比美吉珠单抗至第16周，然后每8周给药一次（Q4W/Q8W）显示PASI 100反应的累积平均天数更多。除150mg司库奇尤单抗外，与所有生物制剂相比，这些差异具有统计学意义。多项NMA表明，白细胞介素（IL）-17和IL-23抑制剂是最有效的治疗方法。在SAE的长期发生率方面未发现显著差异。
在治疗的第一年，每4周给药一次320mg比美吉珠单抗然后每8周给药一次（Q4W/Q8W）在维持皮肤完全清除方面优于大多数其他治疗方法。它显示出皮肤完全清除累积平均天数更多，同时与所有其他生物制剂相比具有相当的安全性。
