Sustained Clinical Remission of Ulcerative Colitis is Associated with Greater Improvements in Quality of Life, Work Productivity and Activity (2011)

Purpose: To investigate the associations between time in sustained clinical remission and quality of life, work productivity, and activity impairment in patients with moderate to severely active ulcerative colitis (UC). Methods: Patients were included from a Phase III randomized trial (M06-827) of adalimumab (160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week between Weeks 4 and 52) or placebo for the treatment of UC. At each study visit, achievement of clinical remission was defined as having a total Mayo score no greater than 2 and no individual subscore greater than 1. Outcomes included scores from the Inflammatory Bowel Disease Questionnaire (IBDQ), the Short Form 36 Health Survey (SF-36), and the Work Productivity and Activity Impairment Questionnaire (WPAI). The effects on these outcomes of current remission status and duration of sustained remission were estimated using longitudinal models with adjustment for baseline Mayo score, prior anti-TNF treatment, and randomized treatment. Results: Among the 494 enrolled patients, 260 (52.6%) were observed to have achieved clinical remission during at least 1 visit during the 52 week clinical trial. Achievement of clinical remission at any time was associated with increases from baseline of 35.8 (SE=1.7) in the total IBDQ score, 5.0 (SE=0.4) in the Physical Component Summary (PCS) score of the SF-36, and 6.4 (SE=0.5) in the Mental Component Summary (MCS) score of the SF-36 and with reductions of 20.7 (SE=1.9) in WPAI total work productivity impairment (TWPI) score and 19.3 (SE=1.3) in total activity impairment (TAI) score (all p<0.05). Including the effect of current remission status, patients who achieved and sustained clinical remission for 6 months are estimated to experience increases of 49.6 (SE=2.3) in total IBDQ score, 7.9 (SE=0.5) in the PCS, and 8.2 (SE=0.7) in the MCS and decreases of 31.9 (SE=2.4) in TWPI score and 28.4 (SE=1.8) in TAI score compared to similar patients who did not achieve clinical remission (all p<0.05). Conclusion: Patients with sustained remission experienced significantly greater improvements in UC-related quality of life, greater improvements in mental and physical components of quality of life and greater reductions in work productivity impairment and impairment of non-work activities. Disclosure: Dr. William J Sandborn - Financial Support for Research: Abbott, Bristol-Myers Squibb, CentocorOrthoBiotech, Genentech, Millennium, Novartis, Pfizer, Shire, UCB, Warner Chilcott (previously Procter & Gamble). Lecture Fees: None. Consultancy: ActoGenix, Abbott (fees paid to Mayo), AGI Therapeutics, Albireo, Alfa Wassermann, AM-Pharma, Amgen, Anaphore, Astellas, Athersys, Atlantic Healthcare, Axcan, BioBalance, Celegene, Bristol-Myers Squibb (fees paid to Mayo), Celek, Cellerix, CentocorOrthoBiotech (fees paid to Mayo), Chemocentryix, CoMentis, Cosmo Technologies, Cytokine Pharmasciences, Eagle, Eisai Medical Research, Elan (fees paid to Mayo), Eli Lilly, Enteromedics, Ferring, Flexion Therapeutics, Funxional Therapeutics, Genentech (fees paid to Mayo), Given Imaging, GlaxoSmithKline, KaloBios, Merck Research Laboratories, Merck Serono, Novo Nordisk, Pfizer (fees paid to Mayo), Procter & Gamble (fees paid to Mayo), Purgenesis Technologies, Regeneron, Salient, Salix, Santarus, Schering-Plough, Shire (fees paid to Mayo), Sigmoid, Sitrtis, SLA, Takeda (fees paid to Mayo), Tillotts, UCB (fees paid to Mayo), Vascular Biogenics, Viamet, Wyeth. Dr. Colombel - Consultant: Abbott, AstraZeneca, Berlex/Schering, Boehringer-Ingelheim, Bristol-Myers Squibb, Cellerix, Centocor, Cosmo, Danone, Elan, Grunenethal, Millenium, Ocerra, Otsuka, Pharmion, Protein Design Labs, Schering-Plough, Shire, Therakos, UCB/Celltech. Speaker's Bureau: Abbott, Centocor, Elan, Ferring, Schering-Plough, UCB. Grant Support: AstraZeneca, Ferring France, Giuliani, UCB. Drs. M Yang, RB Thakkar, J Chao, and PM Mulani: Employee/Stock: Abbott.