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Low Frequency of Opportunistic Infections in Patients Receiving Vedolizumab in Clinical Trials and Post-Marketing Setting.

ABSTRACT: Background:Vedolizumab (ENTYVIO) is a humanized ?4?7 integrin antagonist approved for the treatment of inflammatory bowel disease, which selectively blocks gut-specific lymphocyte trafficking. We evaluated the risk of opportunistic infections of interest in patients treated with vedolizumab. Methods:We determined the frequency of opportunistic infections and tuberculosis in patients receiving vedolizumab in phase 3 clinical trials and post-marketing settings. We also evaluated adverse events reported in the post-marketing setting in patients with a history of or concurrent hepatitis B/C virus infection. Results:The incidence of opportunistic infections in patients receiving vedolizumab was 0.7 (GEMINI 1 and 2 clinical trials) and 1.0 (long-term safety study) per 100 patient-years, with 217 events reported in approximately 114,071 patient-years of exposure (post-marketing setting). Most opportunistic infections were nonserious and the majority of patients continued treatment with vedolizumab. Clostridium difficile was the most commonly reported infection, with an incidence rate of 0.5 per 100 patient-years (clinical trials). Tuberculosis was reported at 0.1 per 100 patient-years (clinical trials), with 7 events in the post-marketing setting. No tuberculosis-related deaths were reported in either setting. No cases of progressive multifocal leukoencephalopathy were reported. In 29 patients with a history of or concurrent hepatitis B/C infection in the post-marketing setting, no viral reactivation was observed. Conclusions:Clinical trials and post-marketing data showed that the rate of serious opportunistic infections in patients receiving vedolizumab was low and most patients could continue vedolizumab treatment. The frequency of tuberculosis infection was also low and no hepatitis B/C viral reactivation was reported.

SUBMITTER: Ng SC

PROVIDER: S-EPMC6185254 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Low Frequency of Opportunistic Infections in Patients Receiving Vedolizumab in Clinical Trials and Post-Marketing Setting.

Ng Siew C SC Hilmi Ida Normiha IN Blake Aimee A Bhayat Fatima F Adsul Shashi S Khan Qasim Rana QR Wu Deng-Chyang DC

Inflammatory bowel diseases 20181001 11

<h4>Background</h4>Vedolizumab (ENTYVIO) is a humanized α4β7 integrin antagonist approved for the treatment of inflammatory bowel disease, which selectively blocks gut-specific lymphocyte trafficking. We evaluated the risk of opportunistic infections of interest in patients treated with vedolizumab.<h4>Methods</h4>We determined the frequency of opportunistic infections and tuberculosis in patients receiving vedolizumab in phase 3 clinical trials and post-marketing settings. We also evaluated adv ...[more]

PMID: 30312414

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Project description:IntroductionSkin and soft tissue infections involve microbial invasion of the skin and underlying soft tissues and are estimated to affect 7-10% of hospitalized patients worldwide. Nadifloxacin, a topical fluoroquinolone, has been shown to be effective against aerobic Gram-negative, Gram-positive (including MRSA and coagulase-negative staphylococci), and anaerobic bacteria. However, there is paucity of data comparing efficacy and safety of 1% nadifloxacin with other anti-bacterials for skin infections in Indian patients.MethodsThis article presents the results of one post-marketing surveillance (PMS) and three randomized, open, non-blinded, multi-centric clinical studies that compared nadifloxacin with mupirocin and framycetin, and nadifloxacin with fusidic acid. Patients in India, aged from 1 to 65 years old, suffering from mild to moderate bacterial skin infections including impetigo, secondarily infected wounds, folliculitis, infected atopic dermatitis, and furunculosis were randomly allocated to three treatment groups within the studies. Efficacy was assessed by the evaluation of symptoms of erythema, exudation, swelling, pruritus, crusting, pain and tenderness in all the studies.ResultsA total of 272 subjects were enrolled in the study and subjects were randomly assigned to one of the three treatment groups; 92 in the nadifloxacin group, 90 in the mupirocin group, and 90 in the framycetin group. A significant reduction in the mean scores for bacterial infection symptoms in the nadifloxacin groups was observed when compared to mupirocin, framycetin and fusidic acid groups. Both physician and patients rated nadifloxacin as excellent (complete remission of symptoms) on a 4-point scale in the studies. No adverse events (AEs) were reported in the clinical studies. In the PMS, only two patients (of 329, 0.6%) reported AEs including burning and itching, one in each patient that had resolved at the time of reporting.ConclusionNadifloxacin, a fluoroquinolone, is a new alternative topical agent in the treatment of bacterial skin infection with minimal AEs.

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Low Frequency of Opportunistic Infections in Patients Receiving Vedolizumab in Clinical Trials and Post-Marketing Setting.

Publications

Low Frequency of Opportunistic Infections in Patients Receiving Vedolizumab in Clinical Trials and Post-Marketing Setting.

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