Upadacitinib は従来型抗リウマチ薬が効果不十分な関節 リウマチ患者の患者報告アウトカムを改善する: SELECT-NEXT 試験結果

In SELECT-NEXT, UPA demonstrated clinically meaningful improvements in patient reported outcomes compared to PBO in patients with RA who had an inadequate response to csDMARDs. In this post hoc analysis, the effect of UPA 15 or 30 mg on patient reported outcomes were assessed and compared to PBO.Eligible patients (661) with an inadequate response to csDMARDs were randomly assigned 2:2:1:1 to receive background csDMARD therapy with either UPA 15 mg, UPA 30 mg or PBO. PROs collected at Wk4 and Wk12 included patient global assessment of disease activity, HAQ DI, pain, fatigue, morning stiffness, work instability and SF-36. The percentage of patients with improvements in PROs greater than the minimum clinically important difference or scores greater than normative values were compared between UPA and PBO groups.UPA 15 and 30 mg resulted in significant improvements compared to PBO in; patient global assessment of disease activity, pain, HAQ-DI, fatigue, SF-36 physical component summary, work instability and morning stiffness.The authors concluded that UPA 15 or 30 mg once daily resulted in significant and clinically meaningful improvements in multiple aspects of QoL among csDMARD-IR patients with RA compared to PBO, through 12 weeks.