Efficacy and Safety of Vedolizumab in Ulcerative Colitis and Crohn’s Disease Patients Stratified by Age

Yajnik, Vijay; Khan, Nabeel; Dubinsky, Marla C.; Axler, Jeffrey; James, Alexandra; Abhyankar, Brihad; Lasch, Karen

doi:10.1007/s12325-016-0467-6

Cited by 83 publications

(97 citation statements)

References 29 publications

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“…In total, 15 studies (13 full‐text articles and two abstracts) met the eligibility criteria and reported the occurrence of infections or malignancies in IBD patients ≥60 years old. Nine were cohort studies, five were case‐control studies and one was the post hoc analysis of a randomised controlled trial (RCT) . All studies reported at least one relevant outcome for IBD patients, and two of them also reported data regarding CD and UC patients, separately.…”

Section: Resultsmentioning

confidence: 99%

Systematic review with meta‐analysis: biologics and risk of infection or cancer in elderly patients with inflammatory bowel disease

Piovani

Danese

Peyrin–Biroulet

et al. 2020

Aliment Pharmacol Ther

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Background: Uncertainty exists concerning the risk of infection and cancer associated with biologic therapies in elderly patients with inflammatory bowel disease (IBD). Aims:To identify, synthesise and critically appraise the available evidence on the topic. Methods:We systematically searched Medline/PubMed, Embase and Scopus, through October 2019, and recent conference proceedings, to identify studies investigating the risk of serious infections, opportunistic infections, any infection and cancer in elderly IBD patients (>60 years) exposed to biologics as compared to those unexposed to biologics. Two reviewers independently extracted study data and assessed each study's risk of bias. We examined heterogeneity, and calculated summary effect estimates using fixed-and random effects models. Quality of evidence was determined with GRADE. Results:We included 15 studies (one post hoc analysis of a randomised trial, nine cohort and five case-control studies). Elderly IBD patients treated with biologics were at increased risk of developing serious infections (random effects summary relative risk: 2.70, 95% CI: 1.56-4.66; seven studies; I 2 = 57%) and opportunistic infections (3.16, 1.09-9.20; four studies; I 2 = 73%). The occurrence of any infection (1.67, 0.51-5.43; five studies; I 2 = 75%) and cancer (0.90, 0.64-1.26; nine studies; I 2 = 0%) was not significantly affected. Nevertheless, our confidence in the effect estimates is rather limited; the quality of evidence is low to very low. Conclusions:Biologics are likely to increase the risk of serious and opportunistic infections in old IBD patients. Large prospective studies are needed to further assess the biologic treatments' long-term safety profile in this population. | 821PIOVANI et Al.

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Section: Resultsmentioning

confidence: 99%

Systematic review with meta‐analysis: biologics and risk of infection or cancer in elderly patients with inflammatory bowel disease

Piovani

Danese

Peyrin–Biroulet

et al. 2020

Aliment Pharmacol Ther

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“…32 This targeted approach is novel in the Japanese context, as the therapies recommended in guidelines for IBD treatment (mesalamine, sulfasalazine, corticosteroids, and immunomodulators) may need to be applied topically via an enema to achieve optimal results. 1,33 In addition, immunomodulators such as 6-mercaptopurine and cyclosporine may be associated with some serious side effects, such as bone marrow suppression, development of nonmelanomatous skin cancers, and hepatosplenic T-cell lymphoma. 1,8 Because vedolizumab has been shown to be effective in patients with moderately to severely active ulcerative colitis previously treated with corticosteroids, purine antimetabolites, and/or TNFα inhibitors, 14 this humanized monoclonal antibody has the potential to provide a new line of therapy for patients with ulcerative colitis that is resistant to treatments currently available in Japan.…”

Section: Discussionmentioning

confidence: 99%

A Phase 1, Multiple‐Dose Study of Vedolizumab in Japanese Patients With Ulcerative Colitis

Kobayashi

Suzuki

Watanabe

et al. 2018

The Journal of Clinical Pharma

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Although previous studies have shown that patients with ulcerative colitis may benefit from treatment with vedolizumab, a humanized monoclonal antibody targeting the α β integrin heterodimer, no data exist in Japanese populations. The aim of this phase 1, open-label, multicenter study was to assess the pharmacokinetics, pharmacodynamics, efficacy, and safety of vedolizumab in Japanese patients with ulcerative colitis. Adult patients with confirmed ulcerative colitis received either 150 mg (step 1) or 300 mg (step 2) of intravenous (IV) vedolizumab on days 1, 15, and 43 of the study protocol. Pharmacokinetic, pharmacodynamic, safety, and efficacy parameters were all assessed through study end (day 239). Nine patients were enrolled in this study (150 mg, n = 3; 300 mg, n = 6). Patients who received vedolizumab IV 300 mg had approximately twice the drug exposure of those receiving vedolizumab IV 150 mg (day 1 AUC 744 vs 408 μg·d/mL) and a longer-lasting maximal saturation of α β integrin (155 vs 99 days). The number of treatment-emergent adverse events, all of which were mild or moderate in intensity, was similar between the 150-mg (15 events) and 300-mg (20 events) groups. The 2 patients (150 mg group) not in clinical remission by partial Mayo score at the start of the study met the criteria for clinical remission on days 15 and 155 of the study, respectively. In conclusion, in Japanese patients with ulcerative colitis, vedolizumab showed similar pharmacokinetic and pharmacodynamic results to those seen in non-Japanese patients. Vedolizumab was well tolerated and demonstrated clinical activity consistent with previous studies.

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“…A descriptive retrospective analysis of pivotal studies in UC and CD demonstrated that the safety profiles of vedolizumab and placebo were similar in patients aged <35 years, 35 to 55 years, and ≥55 years. (18) Vedolizumab-treated UC and CD patients in the oldest subgroup (n = 147) had fewest serious infections (<1%) and adverse events leading to hospitalization (11%) compared with patients in younger subgroups. Early experience in clinical practice (N = 66 IBD patients aged ≥18 years) has shown that older age may correlate with a higher likelihood of vedolizumab response.…”

Section: Medical Management In Elderly Ibd Patientsmentioning

confidence: 94%

“…Although recent literature has documented the efficacy and safety of IBD treatments in the elderly,(13–18) there are substantial gaps in our understanding of the special needs and challenges of this patient population. Most clinical trials have excluded or enrolled insufficient numbers of elderly patients, significantly limiting insights into the safety and efficacy of IBD therapy as a function of age.…”

Section: Introductionmentioning

confidence: 99%

Management of Inflammatory Bowel Disease in the Elderly Patient

Ananthakrishnan

Donaldson

Lasch

et al. 2017

Inflammatory Bowel Diseases

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The population of older patients with inflammatory bowel disease (IBD) continues to grow, partly reflecting the aging global population in general. The debilitating effects of IBD compound age-related decrements in health and functional capacity, and make the medical management of older patients with Crohn’s disease and ulcerative colitis distinctly challenging to clinicians. Here, we review the recent literature describing the pharmacologic management of IBD in this population, with focus on the safety, tolerability, and efficacy of common treatment options, such as steroids, immunomodulators, tumor necrosis factor-α antagonists, and integrin antagonists; surgical interventions in older patients are also discussed. Few studies have systematically and prospectively evaluated the clinical challenges in the medical management of IBD in this patient population, leaving a limited evidence base to which clinicians can turn to for guidance. Treatment patterns may thus be suboptimal. For example, prolonged steroid use in the elderly was found to be common, causing significant morbidity from side effects in a particularly vulnerable population. Finally, within the context of a limited evidence base, we discuss common treatment scenarios to define the parameters within which physicians can individualize care for older patients with IBD. Overall, older IBD patients are at higher risk of adverse events and less treatment responsiveness compared with younger patients, underscoring the need for future studies to fully characterize appropriate treatment courses for this population.

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Efficacy and Safety of Vedolizumab in Ulcerative Colitis and Crohn’s Disease Patients Stratified by Age

Cited by 83 publications

References 29 publications

Systematic review with meta‐analysis: biologics and risk of infection or cancer in elderly patients with inflammatory bowel disease

Systematic review with meta‐analysis: biologics and risk of infection or cancer in elderly patients with inflammatory bowel disease

A Phase 1, Multiple‐Dose Study of Vedolizumab in Japanese Patients With Ulcerative Colitis

Management of Inflammatory Bowel Disease in the Elderly Patient

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