メトトレキサート未治療日本人関節リウマチ患者におけるウパダシチニブ単剤対メトトレキサート単剤: �フェーズ3 SELECT-EARLY 試験のサブ解析
In this sub-analysis of the Phase 3 SELECT-EARLY study, UPA demonstrated clinical efficacy superior to placebo in the Japanese subpopulation. Along with a favourable efficacy observed with the Japan-specific 7.5 mg dose of UPA for all secondary endpoints.
SELECT-EARLY was designed to study the safety and efficacy of UPA 15 and 30mg as monotherapy, but it also included a subset of 138 Japanese patients, 40% of whom were randomised to receive UPA 7.5mg. This was designed to meet the requirements of the Pharmaceuticals and Medical Devices Agency, Japan. The primary endpoints were proportion of patients with ACR20 responses at week 12 and changes from baseline in mTSS at week 24.
At Week 12, ACR20 was reported by significantly more patients receiving UPA 7.5mg and
15mg compared with MTX, but significance was not met for the co-primary endpoint of mTSS change from baseline at Week 24 for the 7.5 mg dose. Although there were improvements versus MTX for all secondary endpoints, responses based on more stringent measures such as ACR50/70, LDA, and clinical remission, were lower with 7.5 mg compared with higher doses. Overall, like the global population – and despite the small sample size – UPA improved clinical, radiographic, and patient-reported endpoints compared with MTX over 24 weeks in Japanese patients, with no new safety signals observed.