A Systematic Review on Long-Term Efficacy Outcome Measures in Crohn’s Disease Patients

Author:

Janssen Laura M12ORCID,Creemers Rob H13ORCID,van Bodegraven Adriaan A3,Pierik Marie J12ORCID

Affiliation:

1. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Centre+ , Maastricht , The Netherlands

2. School for Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+ , Maastricht , The Netherlands

3. Department of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine (Co-MIK), Zuyderland Medical Centre , Heerlen-Sittard-Geleen , The Netherlands

Abstract

Abstract Background The traditional long-term treatment goal of Crohn’s disease [CD] is maintenance of corticosteroid-free clinical remission. Additional treatment targets, such as biochemical, endoscopic and patient-reported remission, are advocated. The relapsing–remitting nature of CD provides a challenge to the timing of target assessment. Cross-sectional assessment at predetermined moments disregards the health state in between measurements. In this systematic review, we provide an overview of outcomes used to assess long-term efficacy in clinical trials in CD. Methods A systematic search of the PubMed and EMBASE databases was performed to identify clinical trials in luminal CD reporting on maintenance treatment [strategies] since 1995. Two independent reviewers selected eligible articles for full text retrieval, and assessed if long-term corticosteroid-free clinical, biochemical, endoscopic or patient-reported efficacy outcomes were used. Results The search resulted in 2452 hits and 82 articles were included. Clinical activity was used in 80 studies [98%] as the long-term efficacy outcome, and in 21 [26%] of these concomitant corticosteroid use was taken into account. C-reactive protein was used in 32 studies [41%], faecal calprotectin in 15 studies [18%], endoscopic activity in 34 studies [41%] and patient-reported outcome in 32 studies [39%]. In seven studies, clinical, biochemical, endoscopic activity and the patient’s perspective were measured. In most studies cross-sectional measures or multiple measurements over time were used. Conclusion In none of the published clinical trials in CD was sustained remission on all treatment targets reported. Cross-sectional outcomes at predetermined times were widely applied, leading to lack of information regarding sustained corticosteroid-free remission for this relapsing–remitting chronic disease.

Publisher

Oxford University Press (OUP)

Subject

Gastroenterology,General Medicine

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