Yajnik Vijay, Khan Nabeel, Dubinsky Marla, Axler Jeffrey, James Alexandra, Abhyankar Brihad, Lasch Karen
Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Adv Ther. 2017 Feb;34(2):542-559. doi: 10.1007/s12325-016-0467-6. Epub 2017 Jan 9.
The efficacy and safety of vedolizumab, a gut-selective αβ integrin antibody, were demonstrated in the GEMINI 1 and GEMINI 2 clinical trials of adults aged 18-80 years. We investigated the efficacy and safety of vedolizumab in patients stratified by age from the GEMINI trials.
Safety and efficacy, including clinical response, clinical remission, and corticosteroid-free remission, at week 6 and/or 52 were determined post hoc in patients aged <35, 35 to <55, and ≥55 years.
At baseline, 353, 412, and 130 ulcerative colitis (UC) and 582, 443, and 90 Crohn's disease (CD) patients were aged <35, 35 to <55, and ≥55. Of these patients, 56 were aged ≥65 years (UC: 33, CD: 23). Trends favoring vedolizumab over placebo were observed for most efficacy endpoints irrespective of patient age; some variability between subgroups was observed. Safety profiles of vedolizumab and placebo were similar in all age groups. Vedolizumab-treated patients aged ≥55 had the lowest incidence of serious infections (0.9 per 100 person-years) and adverse events leading to hospitalization (14.8 per 100 person-years). There were no age-related differences in the incidence of adverse hematological events, malignancy, or death.
The safety and efficacy of vedolizumab in patients with UC or CD were similar for all age groups. The number of patients in the oldest age group in these analyses was small; thus further studies of vedolizumab in larger cohorts of elderly patients are warranted.
Millennium Pharmaceuticals, Inc. (d/b/a Takeda Pharmaceuticals International Co.).
肠道选择性αβ整合素抗体维多珠单抗的疗效和安全性已在18 - 80岁成年人的GEMINI 1和GEMINI 2临床试验中得到证实。我们在GEMINI试验中按年龄分层研究了维多珠单抗在患者中的疗效和安全性。
在年龄小于35岁、35至小于55岁以及≥55岁的患者中，事后确定第6周和/或第52周时的安全性和疗效，包括临床反应、临床缓解和无皮质类固醇缓解。
基线时，年龄小于35岁、35至小于55岁以及≥55岁的溃疡性结肠炎（UC）患者分别为353例、412例和130例，克罗恩病（CD）患者分别为582例、443例和90例。其中，年龄≥65岁的患者有56例（UC：33例，CD：23例）。无论患者年龄如何，在大多数疗效终点上均观察到维多珠单抗优于安慰剂的趋势；亚组之间存在一些差异。维多珠单抗和安慰剂在所有年龄组中的安全性概况相似。年龄≥55岁接受维多珠单抗治疗的患者严重感染发生率最低（每100人年0.9例），导致住院的不良事件发生率最低（每100人年14.8例）。血液学不良事件、恶性肿瘤或死亡的发生率在各年龄组中无差异。
维多珠单抗在UC或CD患者中的安全性和疗效在所有年龄组中相似。这些分析中年龄最大组的患者数量较少；因此，有必要在更大规模的老年患者队列中对维多珠单抗进行进一步研究。
千禧制药公司（现称武田国际制药公司）。
