IMPACT OF TREATMENT RESPONSE ON HEALTH UTILITIES AND WORK PRODUCTIVITY AMONG PATIENTS WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION- POOLED RESULTS FROM PHASE III CLINICAL TRIALS

Author(s)

Huang H1, Taylor D2, Carson RT3, Sarocco P2, Menzin J11Boston Health Economics, Inc., Waltham, MA, USA, 2Ironwood Pharmaceuticals, Inc., Cambridge, MA, USA, 3Forest Research Institute, Jersey City, NJ, USA

OBJECTIVES: To assess the impact of treatment response on quality of life (QOL) and work productivity for patients with irritable bowel syndrome with constipation (IBS-C). METHODS: Irritable Bowel Syndrome - QOL (IBS-QOL) score, EQ-5D index score, work productivity, and IBS symptom relief were collected in two phase III randomized placebo-controlled clinical trials of linaclotide, an investigational treatment for IBS-C.  Treatment response for IBS-C was defined as (1) a ≥ 14-point increase at Week 12 from baseline on the overall IBS-QOL score or (2) moderately or significantly relieved on a seven-point Likert scale on global symptom relief for ≥ 2 out of 3 months.  Hours of work missed due to IBS-C were collected using the Work Productivity and Activity Impairment (WPAI) Questionnaire.  Data from the intent-to-treat populations were pooled for linaclotide and placebo across two trials.  EQ-5D index score and work productivity were evaluated among responders and non-responders. RESULTS: Patients were analyzed with available EQ-5D and IBS-QOL data (n=1,487) and available EQ-5D and IBS symptom relief data (n=1,558), with response rates of 46% and 14% respectively.  Patients were analyzed with available WPAI and IBS-QOL data (n=1,056) and WPAI and IBS symptom relief data (n=1,103), with response rates of 47% and 15%, respectively.  Responders had statistically significantly higher EQ-5D scores at Week 12 than non-responders, for both definitions (IBS-QOL: 0.85 vs. 0.81, IBS symptom relief: 0.91 vs. 0.81, both P<0.05).  Responders were statistically significantly less likely to miss ≥1 hour of work during 12 weeks for IBS-C (IBS-QOL: 16.0% vs. 21.7%, IBS symptom relief: 9.6% vs. 20.8%, both P<0.05). CONCLUSIONS: Improvements in disease-specific measures correlate with improvements in health utilities and reduced work absenteeism among patients with IBS-C.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PGI31

Topic

Patient-Centered Research

Topic Subcategory

Health State Utilities

Disease

Gastrointestinal Disorders

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