Caldarola Giacomo, Dattola Annunziata, Bernardini Nicoletta, Blundo Veronica, Campione Elena, De Luca Eleonora, Giordano Domenico, Giunta Alessandro, Moretta Gaia, Orsini Diego, Pagnanelli Gianluca, Richetta Antonio, Picchianti Diamanti Andrea
UOC di Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy.
Dermatologia, Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy.
Int J Dermatol. 2025 Jun 27. doi: 10.1111/ijd.17927.
Bimekizumab, a monoclonal antibody targeting interleukin (IL)-17A and IL-17F, has shown efficacy in psoriatic arthritis (PsA) clinical trials, but real-world data on its effectiveness are limited. This study aimed to evaluate its real-world effectiveness in PsA patients treated in dermatologic settings.
We conducted a multicenter, prospective, observational study in dermatology units across Lazio, Italy, including 20 patients with psoriasis and PsA treated with bimekizumab. Rheumatologic assessments were performed at baseline and after 16 weeks, evaluating tender and swollen joint counts, the Visual Analog Scale (VAS) pain score, the Disease Activity in Psoriatic Arthritis (DAPSA) score, and the Leeds Enthesitis Index (LEI). Ultrasound evaluations (US) of joints and entheses were conducted at baseline and Week 16.
Twenty patients were enrolled, including 10 bio-experienced patients. At 16 weeks, significant improvements were observed in tender joint count (3.65 to 2.15, p = 0.004), swollen joint count (1.35 to 0.55, p = 0.028), VAS pain score (6.35 to 3.35, p < 0.001), DAPSA (22.71 to 8.67, p < 0.001), and LEI (0.85 to 0.25, p = 0.004). US revealed a decrease in the number of patients with power Doppler (PD) positive joints (45% to 25%) and a reduction in synovial PD score (2.26 to 0.81, p = 0.002). The number of patients with US-positive enthesitis decreased (50% to 30%), with a significant reduction in the enthesis PD score (1.00 to 0.25, p = 0.047). Four patients (20%) developed mild candidiasis, with no treatment discontinuation.
Bimekizumab demonstrated significant, rapid improvements in real-world PsA patients, including those with prior biologic failures. Its favorable safety profile and effectiveness highlight its potential as a valuable treatment option for PsA.
比美吉珠单抗是一种靶向白细胞介素（IL）-17A和IL-17F的单克隆抗体，在银屑病关节炎（PsA）临床试验中已显示出疗效，但关于其有效性的真实世界数据有限。本研究旨在评估其在皮肤科环境中治疗的PsA患者中的真实世界有效性。
我们在意大利拉齐奥的皮肤科单位进行了一项多中心、前瞻性、观察性研究，纳入了20例接受比美吉珠单抗治疗的银屑病和PsA患者。在基线和16周后进行了风湿病学评估，评估压痛和肿胀关节计数、视觉模拟量表（VAS）疼痛评分、银屑病关节炎疾病活动度（DAPSA）评分和利兹附着点炎指数（LEI）。在基线和第16周对关节和附着点进行了超声评估（US）。
共纳入20例患者，其中10例有生物制剂使用经验。在16周时，压痛关节计数（从3.65降至2.15，p = 0.004）、肿胀关节计数（从1.35降至0.55，p = 0.028）、VAS疼痛评分（从6.35降至3.35，p < 0.001）、DAPSA（从22.71降至8.67，p < 0.001）和LEI（从0.85降至0.25，p = 0.004）均有显著改善。超声显示能量多普勒（PD）阳性关节的患者数量减少（从45%降至25%），滑膜PD评分降低（从2.26降至0.81，p = 0.002）。超声阳性附着点炎的患者数量减少（从50%降至30%），附着点PD评分显著降低（从1.00降至0.25，p = 0.047）。4例患者（20%）发生轻度念珠菌病，均未停药。
比美吉珠单抗在真实世界的PsA患者中显示出显著、快速的改善，包括那些既往生物制剂治疗失败的患者。其良好的安全性和有效性突出了其作为PsA一种有价值治疗选择的潜力。
