Gargiulo Luigi, Narcisi Alessandra, Ibba Luciano, Balato Anna, Bianchi Luca, Brianti Pina, Buononato Dario, Burlando Martina, Caldarola Giacomo, Campanati Anna, Campione Elena, Carrera Carlo G, Carugno Andrea, Cristaudo Antonio, Cusano Francesco, Dapavo Paolo, Dattola Annunziata, De Simone Clara, Gaiani Francesca M, Gisondi Paolo, Giunta Alessandro, Loconsole Francesco, Maione Vincenzo, Mortato Edoardo, Marzano Angelo V, Maurelli Martina, Megna Matteo, Mercuri Santo R, Offidani Annamaria, Orsini Diego, Parodi Aurora, Pellacani Giovanni, Potestio Luca, Quaglino Pietro, Richetta Antonio G, Romano Francesca, Sena Paolo, Venturini Marina, Malagoli Piergiorgio, Costanzo Antonio
Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Milan, Italy.
Front Med (Lausanne). 2023 Aug 8;10:1243843. doi: 10.3389/fmed.2023.1243843. eCollection 2023.
Bimekizumab is a monoclonal antibody that targets Interleukin-17 A and F, approved for the treatment of moderate-to-severe plaque psoriasis. While bimekizumab has been evaluated in several phase-III clinical trials, real-world evidence is still very limited.
This multicenter retrospective study included patients affected by plaque psoriasis treated with bimekizumab from May 1, 2022 to April 30, 2023, at 19 Italian referral hospitals. Patients affected by moderate-to-severe plaque psoriasis eligible for systemic treatments were included. The effectiveness of bimekizumab was evaluated in terms of reduction in psoriasis area and severity index (PASI) compared with baseline at weeks 4 and 16. The main outcomes were the percentages of patients achieving an improvement of at least 75% (PASI75), 90% (PASI90) and 100% (PASI100) in PASI score.
The study included 237 patients who received at least one injection of bimekizumab. One hundred and seventy-one patients and 114 reached four and 16 weeks of follow-up, respectively. Complete skin clearance was achieved by 43.3% and 75.4% of patients at weeks 4 and 16, respectively. At week 16, 86.8% of patients reported no impact on their quality of life. At week 16, there were no significant differences between bio-naïve and bio-experienced patients in terms of PASI75, PASI90 and PASI100. The most commonly reported adverse events (AEs) were oral candidiasis (10.1%). No severe AEs or AEs leading to discontinuation were observed throughout the study.
Our experience supports the effectiveness and tolerability of bimekizumab in a real-world setting with similar results compared with phase-III clinical trials.
比美吉珠单抗是一种靶向白细胞介素-17A和F的单克隆抗体，已被批准用于治疗中度至重度斑块状银屑病。虽然比美吉珠单抗已在多项III期临床试验中进行了评估，但真实世界证据仍然非常有限。
这项多中心回顾性研究纳入了2022年5月1日至2023年4月30日期间在19家意大利转诊医院接受比美吉珠单抗治疗的斑块状银屑病患者。纳入了符合全身治疗条件的中度至重度斑块状银屑病患者。在第4周和第16周时，对比美吉珠单抗的有效性根据银屑病面积和严重程度指数（PASI）相对于基线的降低情况进行评估。主要结局是PASI评分改善至少75%（PASI75）、90%（PASI90）和100%（PASI100）的患者百分比。
该研究纳入了237例接受至少一剂比美吉珠单抗治疗的患者。分别有171例和114例患者完成了4周和16周的随访。在第4周和第16周时，分别有43.3%和75.4%的患者实现了皮肤完全清除。在第16周时，86.8%的患者报告其生活质量未受影响。在第16周时，初用生物制剂患者和有生物制剂使用经验的患者在PASI75、PASI90和PASI100方面无显著差异。最常报告的不良事件（AE）为口腔念珠菌病（10.1%）。在整个研究过程中未观察到严重不良事件或导致停药的不良事件。
我们的经验支持比美吉珠单抗在真实世界环境中的有效性和耐受性，其结果与III期临床试验相似。
