Adalimumab Improves and Maintains Health-Related Quality of Life in Patients With Crohn's Disease: Presented at ACG

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Title: Adalimumab Improves and Maintains Health-Related Quality of Life in Patients With Crohn's Disease: Presented at ACG
URL: http://www.pslgroup.com/dg/22E682.htm
Doctor's Guide
October 8, 2008

By Ed Susman

KISSIMMEE, Fla -- October 8, 2008 -- Patients with Crohn's disease treated with the biological agent adalimumab achieve statistically significant improvements in all aspects of health-related quality of life (HRQOL) when compared with placebo-treated patients, according to a phase 3, randomised, double-blind, placebo-controlled, 56-week study.

In addition, the study results show that adalimumab maintenance therapy provided substantial improvements in HRQOL over 56 weeks of treatment in patients with Crohn's disease who had not received previous treatment with tumour necrosis factor-antagonist therapy.

David T. Rubin, MD, University of Chicago Medical School, Chicago, Illinois, presented the findings here on October 7 at the American College of Gastroenterology (ACG) 73rd Annual Scientific Meeting.

Dr. Rubin and colleagues analysed outcomes on quality of life among Crohn's disease patients enrolled in the Crohn's Trial of the Fully Human Antibody Adalimumab for Remission Maintenance (CHARM).

Researchers assessed HRQOL at weeks 0, 4, 12, 26, and 56 using the Zung Self-Rating Depression Scale, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, Inflammatory Bowel Disease Questionnaire (IBDQ), and a visual analogue scale for pain.

A total of 388 patients were evaluated for HRQOL: about 41% of participants were men; the average age of the cohort was 37 years; and about 91% were white. Patients had been diagnosed with Crohn's disease for an average of 6.7 years.

Results show that the patient-rated Zung depression score decreased after patients received induction adalimumab therapy and continued to decrease significantly at the week-56 evaluation compared with placebo (P < .05).

Compared with placebo, adalimumab therapy also resulted in a significant improvement at week 56 on the visual analogue pain score (P < .05), the FACIT-F score (P < .05), and the IBDQ score (P < .05).

"Compared with placebo-treated patients, patients who continued adalimumab maintenance therapy following open-label induction therapy reported significantly less depression, less pain, and fewer fatigue symptoms from week 12 to week 56," Dr. Rubin said in his poster presentation.

[Presentation title: Health-Related Quality of Life in TNF-Antagonist-Naïve Patients With Crohn's Disease During Short- and Long-Term Adalimumab Treatment. Abstract P1012]

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