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dc.contributor.authorYajnik, Vijayen_US
dc.contributor.authorKhan, Nabeelen_US
dc.contributor.authorDubinsky, Marlaen_US
dc.contributor.authorAxler, Jeffreyen_US
dc.contributor.authorJames, Alexandraen_US
dc.contributor.authorAbhyankar, Brihaden_US
dc.contributor.authorLasch, Karenen_US
dc.date.accessioned2017-04-06T03:18:07Z
dc.date.issued2017en_US
dc.identifier.citationYajnik, Vijay, Nabeel Khan, Marla Dubinsky, Jeffrey Axler, Alexandra James, Brihad Abhyankar, and Karen Lasch. 2017. “Efficacy and Safety of Vedolizumab in Ulcerative Colitis and Crohn’s Disease Patients Stratified by Age.” Advances in Therapy 34 (2): 542-559. doi:10.1007/s12325-016-0467-6. http://dx.doi.org/10.1007/s12325-016-0467-6.en
dc.identifier.issnen
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:32071897
dc.description.abstractIntroduction: The 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. Methods: 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. Results: 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. Conclusions: 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. Funding Millennium Pharmaceuticals, Inc. (d/b/a Takeda Pharmaceuticals International Co.). Electronic supplementary material The online version of this article (doi:10.1007/s12325-016-0467-6) contains supplementary material, which is available to authorized users.en
dc.language.isoen_USen
dc.publisherSpringer Healthcareen
dc.relation.isversionofdoi:10.1007/s12325-016-0467-6en
dc.relation.hasversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC5331094/pdf/en
dash.licenseLAAen_US
dc.subjectCrohn’s diseaseen
dc.subjectUlcerative colitisen
dc.subjectVedolizumaben
dc.titleEfficacy and Safety of Vedolizumab in Ulcerative Colitis and Crohn’s Disease Patients Stratified by Ageen
dc.typeJournal Articleen_US
dc.description.versionVersion of Recorden
dc.relation.journalAdvances in Therapyen
dash.depositing.authorYajnik, Vijayen_US
dc.date.available2017-04-06T03:18:07Z
dc.identifier.doi10.1007/s12325-016-0467-6*
dash.contributor.affiliatedYajnik, Vijay


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