生物製剤未治療活動性乾癬性関節炎患者におけるビメキズマブ: 52週間のフェーズIII無作為化プラセボおよび実薬対照試験
Ann Rheum Dis. 2023;82(11):1404–1414 doi: 10.1136/ard-2023-224431
Data from this phase 3 RCT demonstrated that the efficacy of bimekizumab observed at 16 weeks remained consistent through to 52 weeks in the treatment of bDMARD-naïve patients with PsA. Patients who started the trial on placebo and switched to bimekizumab at week 16 showed similar improvements to those patients who were randomised to receive bimekizumab at the start of the trail. No new safety signals were identified.
Previous studies have demonstrated that, after 16 weeks, the monoclonal antibody bimekizumab is more effective than treatment with a placebo in bDMARD-naïve patients with PsA. The BE OPTIMAL study shows that this efficacy is maintained through to 52 weeks of treatment and supports the previously established safety profile of bimekizumab.