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

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.

• Authors: Eric D Shah, Corey A Siegel, Kelly Chong, Gil Y Melmed
• Journal: Digestive diseases and sciences (Dig Dis Sci) Vol. 60 Issue 8 Pg. 2408-18 (Aug 2015) ISSN: 1573-2568 [Electronic] United States
• PMID: 25772778 (Publication Type: Journal Article, Meta-Analysis)

Chemical References

• Biological Products
• Immunologic Factors
• Immunosuppressive Agents
• Methotrexate

Topics

• Biological Products (therapeutic use)
• Comparative Effectiveness Research
• Crohn Disease (drug therapy)
• Humans
• Immunologic Factors (therapeutic use)
• Immunosuppressive Agents (adverse effects)
• Medication Adherence (statistics & numerical data)
• Methotrexate (adverse effects)
• Numbers Needed To Treat
• Treatment Outcome