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Open Access 01-04-2018 | Original Research

Adalimumab Reduces Extraintestinal Manifestations in Patients with Crohn’s Disease: A Pooled Analysis of 11 Clinical Studies

Authors: Edouard J. Louis, Walter Reinisch, David A. Schwartz, Robert Löfberg, Anne M. Robinson, Sofie Berg, Anthony W. Wang, Jen-fue Maa, Bidan Huang, Brandee Pappalardo

Published in: Advances in Therapy | Issue 4/2018

Abstract

Introduction

Extraintestinal manifestations (EIMs) in patients with Crohn’s disease (CD) are common and associated with additional morbidity. This study aimed to evaluate the effect of adalimumab therapy on EIM resolution and identify potential predictors of EIM resolution in adult and pediatric patients with moderate to severe CD.

Methods

EIM data were pooled from 11 induction, maintenance, and open-label extension studies of adalimumab. Resolution of EIMs was evaluated at approximately 6 months and 1 year. Median time to initial EIM resolution and first EIM recurrence (reflecting durable resolution) of any EIM and specific categories of EIMs (arthritis/arthralgia, ocular, cutaneous) were calculated. A Cox model was used to determine predictors of initial and durable EIM resolution.

Results

At baseline, 54% (1137/2094) of patients receiving adalimumab and 51% (297/586) receiving placebo had EIMs. EIM resolution occurred in a significantly greater proportion of adalimumab versus placebo patients at 6 months (54% vs 31%; P < .001) and 1 year (60% vs 42%; P = .008). Median time to initial resolution of any EIM, arthritis/arthralgia, and cutaneous EIMs was significantly shorter in patients receiving adalimumab versus placebo. Durable resolution of any EIM and arthritis/arthralgia was significantly longer for patients receiving adalimumab versus placebo. Clinically meaningful predictors of EIM resolution included adalimumab treatment, male sex, and moderate (versus severe) disease activity at baseline.

Conclusion

Adalimumab is effective for achieving initial and durable resolution of any EIM and, in particular, arthritis/arthralgia in patients with moderate to severe CD. Predictors of EIM resolution included adalimumab treatment and moderate disease severity.

Funding

AbbVie.

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Title: Adalimumab Reduces Extraintestinal Manifestations in Patients with Crohn’s Disease: A Pooled Analysis of 11 Clinical Studies
Authors: Edouard J. Louis
Walter Reinisch
David A. Schwartz
Robert Löfberg
Anne M. Robinson
Sofie Berg
Anthony W. Wang
Jen-fue Maa
Bidan Huang
Brandee Pappalardo
Publication date: 01-04-2018
Publisher: Springer Healthcare
Published in: Advances in Therapy / Issue 4/2018
Print ISSN: 0741-238X
Electronic ISSN: 1865-8652
DOI: https://doi.org/10.1007/s12325-018-0678-0

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Adalimumab Reduces Extraintestinal Manifestations in Patients with Crohn’s Disease: A Pooled Analysis of 11 Clinical Studies

Abstract

Introduction

Methods

Results

Conclusion

Funding

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Abstract

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Funding

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