Abstract
IntroductionThe efficacy and safety of vedolizumab, a gut-selective α4β7 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.MethodsSafety 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.ResultsAt 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.ConclusionsThe 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.FundingMillennium Pharmaceuticals, Inc. (d/b/a Takeda Pharmaceuticals International Co.).Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-016-0467-6) contains supplementary material, which is available to authorized users.
Highlights
The efficacy and safety of vedolizumab, a gut-selective a4b7 integrin antibody, were demonstrated in the GEMINI 1 and GEMINI 2 clinical trials of adults aged 18–80 years
Vedolizumab-treated patients aged C55 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)
The safety and efficacy of vedolizumab in patients with ulcerative colitis (UC) or Crohn’s disease (CD) were similar for all age groups
Summary
The efficacy and safety of vedolizumab, a gut-selective a4b7 integrin antibody, were demonstrated in the GEMINI 1 and GEMINI 2 clinical trials of adults aged 18–80 years. The therapeutic management of IBD in aging populations is an active area of research, and numerous studies have demonstrated marked deficiencies and risks associated with the use of several IBD treatments [6, 8,9,10,11,12,13,14]. Anti-tumor necrosis factor (anti-TNF) therapies, corticosteroids, and thiopurines—as individual treatment regimens or in combination—are associated with higher risks of malignancy and opportunistic infections in elderly IBD patients than their younger counterparts [8, 9, 11, 15,16,17]. Increased infection rates with anti-TNF therapy in elderly IBD patients have, in turn, been proposed as an underlying reason for high rates of IBD treatment discontinuation [10] and increased risk of mortality related to hospitalizations [8]. Rates of non-melanoma skin cancer and risk of lymphoma associated with thiopurine use were found to increase with increasing age [17] or with successive years of therapy [16], making long-term use undesirable
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