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

Louis, Edouard; Reinisch, Walter; Schwartz, David A.; Lofberg, Robert; Robinson, Anne M.; Berg, Sofie; Wang, Anthony W.; Maa, Jen-Fue; Huang, Bidan; Pappalardo, Brandee

doi:10.1007/s12325-018-0678-0

Article (Scientific journals)

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

Louis, Edouard; Reinisch, Walter; Schwartz, David A. et al.

2018 • In Advances in Therapy, 35 (4), p. 563-576

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https://hdl.handle.net/2268/229800

DOI
10.1007/s12325-018-0678-0

PubMed
29516410

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Keywords :

Adalimumab; Arthralgia; Arthritis; CDAI; Crohn's disease; Extraintestinal manifestation; Gastroenterology; Inflammatory bowel disease

Abstract :

[en] 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.

Disciplines :

Gastroenterology & hepatology

Author, co-author :

Louis, Edouard ; Université de Liège - ULiège > Département des sciences cliniques > Hépato-gastroentérologie

Reinisch, Walter

Schwartz, David A.

Lofberg, Robert

Robinson, Anne M.

Berg, Sofie

Wang, Anthony W.

Maa, Jen-Fue

Huang, Bidan

Pappalardo, Brandee

Language :

English

Title :

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

Publication date :

2018

Journal title :

Advances in Therapy

ISSN :

0741-238X

eISSN :

1865-8652

Publisher :

Springer, New York, United States - New York

Volume :

Issue :

Pages :

563-576

Additional URL :

https://academic.oup.com/ibdjournal/article/24/4/725/4934202

Available on ORBi :

since 02 December 2018

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