Adalimumab Induction Therapy Improves Health-Related Quality of Life in Patients with Moderately to Severely Active Ulcerative Colitis (2010)

Purpose: To investigate the effects of adalimumab induction therapy on health-related quality of life (HRQOL) in patients with ulcerative colitis (UC). Methods: Anti-tumor necrosis factor (anti-TNF)-naive patients with moderately to severely active UC (Mayo score ≥6 points and endoscopic subscore ≥2 points) despite treatment with corticosteroids and/or immunosuppressants were enrolled in an 8-week, randomized, placebo-controlled induction trial. Patients (N=186) were randomized 1:1 to subcutaneous adalimumab (160 mg at Week 0, 80 mg at Week 2, and 40 mg at Weeks 4 and 6) or placebo. Patients being treated with corticosteroids and/or immunosuppressants remained on stable dosages. Subsequent to approval of the Crohn's disease indication in Europe, in which the recommended induction dose was 80/40 mg (or 160/80 mg if a more rapid response was needed), the protocol was amended to prespecify enrollment of 390 additional patients who were randomized 1:1:1 to the original adalimumab 160-/80-mg regimen; adalimumab 80 mg at Week 0 and 40 mg at Weeks 2, 4, and 6; or placebo. HRQOL was measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) and Mental and Physical Component Summary (MCS and PCS) scores of the Short Form 36 Health Survey (SF-36). The intention-to-treat population enrolled after the protocol amendment was analyzed. Changes from baseline were compared using 1-way ANCOVA with treatment as a factor and baseline value as a covariate. Results: Patients treated with the 160-/80-mg induction regimen had significant improvements in IBDQ and SF-36 PCS scores vs. placebo at Week 4 that were maintained at Week 8 (table). With the 80-/40-mg induction regimen, only SF-36 scores at Week 4 were significantly better than placebo. SF-36 MCS scores were not significantly improved in either adalimumab group. Conclusion: Anti-TNF-naive patients with moderate to severe UC who failed conventional therapy experienced significant improvements in IBDQ and SF-36 PCS scores through Week 8 with adalimumab 160-/80-mg induction therapy vs. placebo. HRQOL improvements with the 80-/40-mg induction were inconsistent. Disclosure: W Reinisch: Consultant/Advisory Committee: Abbott, Aesca, Centocor, Genentech, Novartis, Schering-Plough, UCB. Consultant/Speaker: Ferring. WJ Sandborn: Financial Support for Research: Abbott Laboratories, Bristol Meyers Squibb, CentocorOrthoBiotech, Genentech, Millennium Pharmaceuticals, Novartis, Pfizer, Shire Pharmaceuticals, UCB Pharma, Warner Chilcott (previously Procter & Gamble).Lecture Fees: None. Consultancy: ActoGenix, Abbott Laboratories (fees paid to Mayo), AGI Therapeutics, Albireo, Alfa Wassermann, AM-Pharma, Amgen, Anaphore, Astellas Pharma, Athersys, Atlantic Healthcare Limited, Axcan Pharma, BioBalance Corporation, Celegene, Bristol Meyers Squibb (fees paid to Mayo), Celek Pharmaceuticals, Cellerix, CentocorOrthoBiotech (fees paid to Mayo), Chemocentryix, CoMentis, Cosmo Technologies, Cytokine Pharmasciences, Eagle Pharmaceuticals, Eisai Medical Research, Elan Pharmaceuticals (fees paid to Mayo), Eli Lilly, Enteromedics, Ferring Pharmaceuticals, Flexion Therapeutics, Funxional Therapeutics Limited, Genentech (fees paid to Mayo), Given Imaging, GlaxoSmithKline, KaloBios Pharmaceuticals, Merck Research Laboratories, Merck Serono, Novo Nordisk, Pfizer (fees paid to Mayo), Procter & Gamble (fees paid to Mayo), Purgenesis Technologies, Regeneron Pharmaceuticals, Salient Pharmaceuticals, Salix Pharmaceuticals, Santarus, Schering Plough Corporation, Shire Pharmaceuticals (fees paid to Mayo), Sigmoid Pharma, Sitrtis Pharmaceuticals, SLA Pharma, Takeda (fees paid to Mayo), Tillotts Pharma, UCB Pharma (fees paid to Mayo), Vascular Biogenics, Viamet Pharmaceuticals, Wyeth. Shareholder: None. Directorships: None. Other: None. R Thakkar: Employee/Stock: Abbott. A Lazar: Employee/Stock: Abbott. B Huang: Employee/Stock: Abbott. PM Mulani: Employee/Stock: Abbott. J Chao: Employee/Stock: Abbott.Table: [1207] Mean HRQOL scores over time (last observation carried forward)