医学
乌斯特基努马
中止
加药
随机对照试验
临床终点
银屑病
随机化
维持疗法
银屑病面积及严重程度指数
内科学
置信区间
外科
胃肠病学
皮肤病科
化疗
疾病
英夫利昔单抗
作者
Andrew Blauvelt,Laura K. Ferris,Paul S. Yamauchi,Abrar A. Qureshi,Craig Leonardi,Kamyar Farahi,Steven Fakharzadeh,Ming-Chun Hsu,S. Li,Marc Chévrier,Kevin S. Smith,Kavitha Goyal,Yanqing Chen,Ernesto J. Muñoz‐Elías,Kristina Callis Duffin
摘要
Phase III studies showed that some patients maintained response for ≥ 6 months following ustekinumab discontinuation.To assess clinical responses with extended ustekinumab maintenance dosing intervals.Adults with moderate-to-severe plaque psoriasis received ustekinumab at weeks 0, 4 and 16 during open-label treatment. Patients achieving a week-28 Physician's Global Assessment (PGA) score of cleared/minimal (PGA = 0/1) were randomized 1 : 4 to group 1 [approved every 12 weeks (q12 wk) maintenance] or group 2 (q12-24 wk; response-based dosing determined by time to loss of PGA = 0/1). Key end points included the number of visits with PGA = 0/1 (primary end point) and ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) between weeks 88 and 112, and PGA/PASI responses between weeks 28 and 112.Overall, 378 patients achieved PGA = 0/1 at week 28 and were randomized to group 1 (n = 76) or group 2 (n = 302). Patients in group 1 had numerically greater mean numbers of visits with PGA = 0/1 than group 2 and also with PASI 75 from week 88 to 112. A higher proportion of patients in group 1 (55%) than group 2 (39%) had PGA = 0/1 at all seven visits from week 88 to 112. Maintenance of response was observed with dose-interval extension beyond q12 wk in a subset of patients. Extending the dosing interval did not affect antibody development or safety.Efficacy was better maintained among week-28 PGA responders randomized to continue q12 wk ustekinumab vs. extending maintenance dosing based on clinical response, although some patients maintained high levels of efficacy with up to q24 wk dosing.
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