Original Contribution

The American Journal of Gastroenterology (2008) 103, 3132–3141; doi:10.1111/j.1572-0241.2008.02175.x

Effects of Adalimumab Maintenance Therapy on Health-Related Quality of Life of Patients With Crohn's Disease: Patient-Reported Outcomes of the CHARM Trial

Edward V Loftus MD1, Brian G Feagan MD2, Jean-Frédéric Colombel MD3, David T Rubin MD4, Eric Q Wu PhD5, Andrew P Yu PhD5, Paul F Pollack MD6, Jingdong Chao PhD6 and Parvez Mulani Phd6

  1. 1Miles & Shirley Fiterman Center for Digestive Diseases, Mayo Clinic, Rochester, Minnesota
  2. 2Robarts Research Institute, University of Western Ontario, London, Ontario, Canada
  3. 3CHU Lille, Lille, France
  4. 4University of Chicago, Chicago, Illinois
  5. 5Analysis Group, Inc., Boston, Massachusetts
  6. 6Abbott Laboratories, Abbott Park, Illinois

Correspondence: Edward V Loftus, Jr, MD, Professor of Medicine, Director, Inflammatory Bowel Disease, Division of Gastroenterology & Hepatology, Mayo Clinic, 200 First Street, SW, Rochester, MN 55905.

Received 22 October 2007; Accepted 11 July 2008.

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Abstract

OBJECTIVES:

 

We evaluated the effects of adalimumab maintenance therapy on health-related quality of life (HRQOL) in patients with moderate to severe Crohn's disease.

METHODS:

 

In a Phase III, randomized, double-blind clinical trial (CHARM) of moderate to severe Crohn's disease patients, HRQOL outcomes were compared between the adalimumab maintenance treatment groups (every other week and weekly injection) and the adalimumab induction-only group. The Zung Self-Rating Depression Scale, functional assessment of chronic illness therapy (FACIT)-Fatigue, visual analog pain scales, Inflammatory Bowel Disease questionnaire (IBDQ), and Medical Outcomes Study 36-item Short Form Health Survey (SF-36) were analyzed for 499 randomized responders (a decrease of greater than or equal to70 points from baseline in the Crohn's Disease Activity Index [CDAI]) at baseline and weeks 4, 12, 26, and 56.

RESULTS:

 

CHARM patients' HRQOL was substantially impaired at baseline. Following a 4-week adalimumab induction therapy, patients experienced statistically significant improvements in all HRQOL measures (P < 0.0001). Compared with patients who were assigned to placebo after induction therapy, patients who continued adalimumab at 40 mg every other week maintenance therapy reported less depression (P < 0.01), fewer fatigue symptoms (P < 0.001), greater improvements in the IBDQ (P < 0.05), greater SF-36 physical component summary scores (P < 0.05), and less abdominal pain (P < 0.05) from weeks 12 to 56. They also had greater SF-36 mental component summary scores at week 56 (P < 0.05). Patients who continued adalimumab at 40-mg weekly maintenance therapy reported less depression and fewer fatigue symptoms at week 56, greater improvement in IBDQ, and less abdominal pain from weeks 12 to 56 (all P < 0.05 vs. placebo).

CONCLUSIONS:

 

Adalimumab maintenance therapy provided sustained improvements in HRQOL for patients with moderate to severe Crohn's disease through week 56.