ORIGINAL ARTICLE Response and Remission Are Associated with Improved Quality of Life, Employment and Disability Status, Hours Worked, and Productivity of Patients with Ulcerative Colitis Walter Reinisch, MD,* William J. Sandborn, MD, † Mohan Bala, PhD, ‡ Songkai Yan, MS, ‡ Brian G. Feagan, MD, § Paul Rutgeerts, MD, PhD, P Graham Radford-Smith, MD, ¶ Stephen Xu, MS, ‡ Debra Eisenberg, MS, ‡ Allan Olson, MD,** and Jean Fre ´de ´ric Colombel, MD †† Background: Impairment of health-related quality of life, employ- ment, and productivity has been documented in patients with mod- erate to severe ulcerative colitis. Methods: Using prospectively collected data from the Active Ulcerative Colitis Trials 1 and 2, we examined the impact of clinical response or remission, as defined using the Mayo score, on health- related quality of life, employment, disability, productivity, and hours worked per week. These analyses were based on observed data and included all 728 patients, regardless of their randomized treat- ment group (i.e., placebo and infliximab patients were grouped for analysis). Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) and Medical Outcomes Study 36-Item Short Form (SF-36) scores among nonresponders, responders, and patients in remission were compared. In addition, changes in employment, disability status, productivity, and hours worked per week of patients in clinical remission and patients not in clinical remission were com- pared. Results: Ulcerative colitis patients in clinical response or remission had significantly improved IBDQ and SF-36 scores at week 30 compared with those of nonresponders (P  0.001). Among those not employed at baseline, including those receiving disability com- pensation, greater percentages of patients in remission at week 30 were employed (20.6%) and not receiving disability compensation (58.8%) than were those not in remission (8.3% and 20.0%, respec- tively; P  0.05 for both comparisons). At week 30, improvements from baseline in productivity and both actual and fully productive hours worked per week were greater for patients in remission compared with those not in remission (P  0.05 for all three comparisons). Conclusions: These results confirm the validity of response and remission as defined using the Mayo score. (Inflamm Bowel Dis 2007;13:1135–1140) Key Words: health-related quality of life, employment, productiv- ity, ulcerative colitis, infliximab U lcerative colitis is a chronic inflammatory disease that affects the mucosa of the colon. The extent and severity of disease can range from mild proctitis to extensive fulmi- nant disease that may cause perforation and can lead to potentially fatal peritonitis and toxemia. The most common course of ulcerative colitis (UC) is recurrent attacks of bloody diarrhea interspersed with asymptomatic remissions. It is not uncommon for a patient with active ulcerative colitis to have as many as 15 to 20 liquid, bloody stools daily. Other symp- toms can include severe fecal urgency because of reduced rectal compliance, abdominal pain, irritability, incontinence, weight loss, and general malaise. Impairment of health-re- lated quality of life is well documented in patients with moderate to severe ulcerative colitis. 1–3 A negative associa- tion between health-related quality of life and unemployment, sick leave, and disability pension has recently been reported. 4 Over the past decade several new treatment options based on an increased understanding of the pathogenesis of UC have become available for patients with ulcerative colitis. One such class of agents includes antibodies directed against the proinflammatory cytokine tumor necrosis factor alpha (TNF). TNF in increased concentrations is found in the blood, colonic tissue, and stools of UC patients. 5–7 Infliximab (REMICADE; Centocor, Inc., Malvern, This article contains Supplementary Material available at http://www. interscience.wiley.com/jpages/1078-0998/suppmat Received for publication October 26, 2006; revised January 26, 2007; accepted March 21, 2007. From the *Univ Klinik Innere Medizin IV, AKH Wien, Vienna, Austria; † Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota; ‡ Outcomes Research, Centocor, Inc., Malvern, Pennsylvania; § Robarts Research Institute, University of Western Ontario, London, On- tario, Canada; P Division of Gastroenterology, Hospital Leuven, Leuven, Belgium; ¶ Royal Brisbane Hospital, Herston, Queensland, Australia; **Clin- ical Research and Development, Centocor, Inc., Malvern, Pennsylvania; and †† Hopital Huriez-CIC Inserm CH et U de Lille, Lille, France. Supported by Centocor, Inc., Malvern, PA and Shering Plough, Ken- ilworth, NJ. Reprints: Walter Reinisch MD, Univ Klinik Innere Medizin IV, Abteilung Gastroenterologie und Hepatologie, AKH Wien, Vienna, Austria (e-mail: walter.reinisch@meduniwien.ac.at) Copyright © 2007 Crohn’s & Colitis Foundation of America, Inc. DOI 10.1002/ibd.20165 Published online 2 May 2007 in Wiley InterScience (www.interscience. wiley.com). Inflamm Bowel Dis ● Volume 13, Number 9, September 2007 1135