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

Authors
  • Louis, Edouard J.1
  • Reinisch, Walter2, 3
  • Schwartz, David A.4
  • Löfberg, Robert5
  • Robinson, Anne M.6
  • Berg, Sofie6
  • Wang, Anthony W.6
  • Maa, Jen-fue6
  • Huang, Bidan6
  • Pappalardo, Brandee6
  • 1 University Hospital CHU of Liège, Liège, Belgium , Liège (Belgium)
  • 2 McMaster University, Hamilton, ON, Canada , Hamilton (Canada)
  • 3 Medical University of Vienna, Vienna, Austria , Vienna (Austria)
  • 4 Vanderbilt University, Nashville, TN, USA , Nashville (United States)
  • 5 Karolinska Institutet, Sophiahemmet, Stockholm, Sweden , Stockholm (Sweden)
  • 6 AbbVie Inc., North Chicago, IL, USA , North Chicago (United States)
Type
Published Article
Journal
Advances in Therapy
Publisher
Springer Healthcare
Publication Date
Mar 07, 2018
Volume
35
Issue
4
Pages
563–576
Identifiers
DOI: 10.1007/s12325-018-0678-0
Source
Springer Nature
Keywords
License
Green

Abstract

IntroductionExtraintestinal 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.MethodsEIM 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.ResultsAt 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.ConclusionAdalimumab 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.FundingAbbVie.

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