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      Respiratory Tract Infections in Patients With Inflammatory Bowel Disease: Safety Analyses From Vedolizumab Clinical Trials

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          Abstract

          Background and Aims

          Vedolizumab, a humanised monoclonal antibody for the treatment of inflammatory bowel disease, selectively blocks gut lymphocyte trafficking. This may reduce the risk of respiratory tract infections [RTIs] compared with systemic immunosuppressive therapies. To assess this possibility, we evaluated the rates of RTIs in clinical trials of vedolizumab.

          Methods

          Patient-level data from Phase 3 randomised controlled trials [RCTs] of vedolizumab in ulcerative colitis [UC; GEMINI 1] and Crohn’s disease [CD; GEMINI 2], and a long-term safety study [UC and CD] were pooled. Cox proportional hazards models were used to estimate the incidence of upper RTIs [URTIs] and lower RTIs [LRTIs] with adjustment for significant covariates.

          Results

          In the RCTs [ n = 1731 patients], the incidence of URTIs was numerically higher in patients receiving vedolizumab compared with those receiving placebo, although this difference was not statistically significant (38.7 vs 33.0 patients per 100 patient-years; hazard ratio [HR] 1.12; 95% confidence interval [CI]: 0.83–1.51; p = 0.463). The rate of LRTIs, including pneumonia, was numerically lower in the vedolizumab versus the placebo group: this difference was not statistically significant (7.7 vs 8.5 per 100 patient-years [HR 0.85; 95% CI: 0.48–1.52; p = 0.585]). Both URTIs and LRTIs were more frequent in patients with CD compared with UC. Most RTIs in patients receiving vedolizumab were not serious and did not require treatment discontinuation.

          Conclusions

          Vedolizumab therapy was not associated with an increased incidence of respiratory tract infection compared with placebo.

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          Most cited references21

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          Infliximab for induction and maintenance therapy for ulcerative colitis.

          Paul Rutgeerts, William J Sandborn, Brian Feagan … (2005)
          Infliximab, a chimeric monoclonal antibody directed against tumor necrosis factor alpha, is an established treatment for Crohn's disease but not ulcerative colitis. Two randomized, double-blind, placebo-controlled studies--the Active Ulcerative Colitis Trials 1 and 2 (ACT 1 and ACT 2, respectively)--evaluated the efficacy of infliximab for induction and maintenance therapy in adults with ulcerative colitis. In each study, 364 patients with moderate-to-severe active ulcerative colitis despite treatment with concurrent medications received placebo or infliximab (5 mg or 10 mg per kilogram of body weight) intravenously at weeks 0, 2, and 6 and then every eight weeks through week 46 (in ACT 1) or week 22 (in ACT 2). Patients were followed for 54 weeks in ACT 1 and 30 weeks in ACT 2. In ACT 1, 69 percent of patients who received 5 mg of infliximab and 61 percent of those who received 10 mg had a clinical response at week 8, as compared with 37 percent of those who received placebo (P<0.001 for both comparisons with placebo). A response was defined as a decrease in the Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute rectal-bleeding subscore of 0 or 1. In ACT 2, 64 percent of patients who received 5 mg of infliximab and 69 percent of those who received 10 mg had a clinical response at week 8, as compared with 29 percent of those who received placebo (P<0.001 for both comparisons with placebo). In both studies, patients who received infliximab were more likely to have a clinical response at week 30 (P< or =0.002 for all comparisons). In ACT 1, more patients who received 5 mg or 10 mg of infliximab had a clinical response at week 54 (45 percent and 44 percent, respectively) than did those who received placebo (20 percent, P<0.001 for both comparisons). Patients with moderate-to-severe active ulcerative colitis treated with infliximab at weeks 0, 2, and 6 and every eight weeks thereafter were more likely to have a clinical response at weeks 8, 30, and 54 than were those receiving placebo. (ClinicalTrials.gov numbers, NCT00036439 and NCT00096655.) Copyright 2005 Massachusetts Medical Society.
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            3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn's Disease 2016: Part 1: Diagnosis and Medical Management.

            Fernando Gomollon, Axel Dignass, Vito Annese … (2016)
            This paper is the first in a series of two publications relating to the European Crohn's and Colitis Organisation [ECCO] evidence-based consensus on the diagnosis and management of Crohn's disease and concerns the methodology of the consensus process, and the classification, diagnosis and medical management of active and quiescent Crohn's disease. Surgical management as well as special situations including management of perianal Crohn's disease of this ECCO Consensus are covered in a subsequent second paper [Gionchetti et al JCC 2016].
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              Infliximab for the treatment of fistulas in patients with Crohn's disease.

              D Present, P Rutgeerts, S Targan … (1999)
              Enterocutaneous fistulas are a serious complication of Crohn's disease and are difficult to treat. Infliximab, a chimeric monoclonal antibody to tumor necrosis factor alpha, has recently been developed as a treatment for Crohn's disease. We conducted a randomized, multicenter, double-blind, placebo-controlled trial of infliximab for the treatment of fistulas in patients with Crohn's disease. The study included 94 adult patients who had draining abdominal or perianal fistulas of at least three months' duration as a complication of Crohn's disease. Patients were randomly assigned to receive one of three treatments: placebo (31 patients), 5 mg of infliximab per kilogram of body weight (31 patients), or 10 mg of infliximab per kilogram (32 patients); all three were to be administered intravenously at weeks 0, 2, and 6. The primary end point was a reduction of 50 percent or more from base line in the number of draining fistulas observed at two or more consecutive study visits. A secondary end point was the closure of all fistulas. Sixty-eight percent of the patients who received 5 mg of infliximab per kilogram and 56 percent of those who received 10 mg per kilogram achieved the primary end point, as compared with 26 percent of the patients in the placebo group (P=0.002 and P=0.02, respectively). In addition, 55 percent of the patients assigned to receive 5 mg of infliximab per kilogram and 38 percent of those assigned to 10 mg per kilogram had closure of all fistulas, as compared with 13 percent of the patients assigned to placebo (P=0.001 and P=0.04, respectively). The median length of time during which the fistulas remained closed was three months. More than 60 percent of patients in all the groups had adverse events. For patients treated with infliximab, the most common were headache, abscess, upper respiratory tract infection, and fatigue. Infliximab is an efficacious treatment for fistulas in patients with Crohn's disease.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Crohns Colitis
                Journal ID (iso-abbrev): J Crohns Colitis
                Journal ID (publisher-id): eccojc
                Title: Journal of Crohn's & Colitis
                Publisher: Oxford University Press (UK )
                ISSN (Print): 1873-9946
                ISSN (Electronic): 1876-4479
                Publication date (Print): July 2018
                Publication date (Electronic): 17 May 2018
                Publication date PMC-release: 17 May 2018
                Volume: 12
                Issue: 8
                Pages: 905-919
                Affiliations
                [1 ]Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, ON, Canada
                [2 ]Global Patient Safety, Takeda Pharmaceuticals International Co., Cambridge, MA, USA
                [3 ]Evidence and Value generation, Takeda International – UK Branch, London, UK
                [4 ]Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, UK
                Author notes
                Corresponding author: Brian G. Feagan, MD, FRCPC, Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, 1151 Richmond St N., London, ON, N6A 5B7, Canada. Tel.: 1 [519] 931–5289 or 858–5087; fax: 1 [519] 931–5278; email: bfeagan@ 123456robarts.ca
                Article
                Publisher ID: jjy047
                DOI: 10.1093/ecco-jcc/jjy047
                PMC ID: 6065483
                PubMed ID: 29788248
                SO-VID: 48b9c0d7-3ad5-46e1-af36-05e01e26fb07
                Copyright © © The Author(s) 2018. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 14 December 2017
                Date accepted : 01 May 2018
                Date revision received : 16 March 2018
                Page count
                Pages: 15
                Funding
                Funded by: Takeda Pharmaceutical Company Ltd.
                Categories
                Subject: Original Articles

                Keywords: α4β7 integrin,adverse event,clinical trials,bronchopneumonia,crohn’s disease,gemini 1,gemini 2,gut lymphocyte trafficking,hospitalization,humanised monoclonal antibody,induction therapy,inflammatory bowel disease,lower respiratory tract infection,long-term safety,maintenance therapy,nasopharyngitis,placebo,pneumonia,post hoc analysis,respiratory tract infection,smoking status,systemic immunosuppressive therapy,tumour necrosis factor antagonist,ulcerative colitis; upper respiratory tract infectionl,vedolizumab
                Data availability:
                Keywords: α4β7 integrin, adverse event, clinical trials, bronchopneumonia, crohn’s disease, gemini 1, gemini 2, gut lymphocyte trafficking, hospitalization, humanised monoclonal antibody, induction therapy, inflammatory bowel disease, lower respiratory tract infection, long-term safety, maintenance therapy, nasopharyngitis, placebo, pneumonia, post hoc analysis, respiratory tract infection, smoking status, systemic immunosuppressive therapy, tumour necrosis factor antagonist, ulcerative colitis; upper respiratory tract infectionl, vedolizumab

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