Patients with Crohn's Disease Are More Likely to Remain on Biologics Than Immunomodulators: A Meta-Analysis of Treatment Durability

Overview

Journal Dig Dis Sci

Specialty Gastroenterology

Date 2015 Mar 17

PMID 25772778

Citations 3

Authors

Eric D Shah

Corey A Siegel

Kelly Chong

Gil Y Melmed

Affiliations

Soon will be listed here.

Abstract

Background And Aim: The comparative effectiveness of treatments for moderate-to-severe Crohn's disease can be influenced by the likelihood of remaining on medication. We aimed to clarify this treatment durability by assessing subject discontinuations from clinical trials in the context of treatment efficacy.

Methods: We conducted a literature search for double-blind RCT of Crohn's disease therapies recommended in international guidelines or with recent positive phase III trial results. Durability was defined through study discontinuation due to adverse events or disease exacerbation represented by number needed to discontinue (NND). Efficacy was defined as clinical remission represented by number needed to treat (NNT). The primary endpoint was NND/NNT, with a higher value representing more durable and effective treatment.

Results: Treatment with azathioprine/6-mercaptopurine (AZA/6MP) was associated with more discontinuations than with clinical remission (NND/NNT = 0.92) in maintenance trials. For induction, methotrexate was associated with similar rates of discontinuations and remission (NND/NNT = 1.4). In one maintenance trial, the remission rate for methotrexate was greater than the study discontinuation rate (NND/NNT = 23.3). In contrast, anti-TNF trials revealed greater durability among induction (no excess discontinuation) and maintenance (NND/NNT = 37.9) trials. Trials of anti-trafficking agents had fewer discontinuations in the drug treatment arms than placebo resulting in most favorable NND/NNT ratios.

Conclusions: For patients with Crohn's disease, biologic therapies had higher durability than immunomodulators for induction and maintenance therapy. We also report the results of a novel NND/NNT ratio that should be validated in a prospective head-to-head placebo-controlled trial.

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