Work Productivity Improvements in Adalimumab-treated Patients with Moderate to Severe Ileocolonic Crohnʼs Disease: The EXTEND Trial

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Purpose: The ability of anti-tumor necrosis factor (anti-TNF) therapy to restore work capacity in Crohn's disease (CD) has not been fully defined. We assessed the impact of adalimumab on work productivity in EXTEND, a 52-week, placebo-controlled study of the effect of adalimumab on mucosal healing in patients with moderate to severe ileocolonic CD. Methods: All patients received open-label adalimumab 160-/80-mg induction therapy at Weeks 0/2 and were randomized to adalimumab 40 mg every other week (eow) or placebo at Week 4. From Week 8, patients with flares or nonresponse could receive open-label adalimumab. The Work Productivity and Activity Impairment Questionnaire (WPAI) is a validated, self-administered tool that assesses impact of disease on productivity. The WPAI measures CD-related impairment in work productivity and daily activity via 4 component scores: absenteeism (CD-related absence from work), presenteeism (CD-related impairment of productivity during work), total work productivity impairment (TWPI; absenteeism and presenteeism combined), and total activity impairment (TAI; CD-related daily activity impairment). Differences in productivity between the continuous adalimumab group and the inductiononly placebo group were analyzed for the double-blind period via last-observation-carried-forward (LOCF) imputation. Only evaluations after Week 4 of double-blind treatment were carried forward; data after first open-label dose were excluded. Results: Of 129 patients randomized in EXTEND, 63% were women, 92% were white, mean age was 37 years, mean Crohn's Disease Activity Index was 320, mean CD duration was 10 years, and 61% were anti-TNF experienced. Concomitant steroids were used by 26% and immunosuppressants, by 41%. At Week 4, following treatment with the loading dose, all components of WPAI improved significantly (absenteeism: -18; presenteeism: -25; TWPI: -28; TAI: -25). At Week 52, the continuous adalimumab group experienced significant improvements in missed work time, daily activity impairment, and overall work impairment vs. the induction-only placebo group (Table). Conclusion: Adalimumab maintenance therapy was associated with significant and sustained improvements in work productivity and daily activity compared with the induction-only placebo therapy in patients with moderate to severe ileocolonic CD. Disclosure: Dr Binion - Speaker's bureau: Abbott Laboratories, Centocor, Elan Pharmaceuticals, Procter & Gamble Pharmaceuticals, Prometheus, Salix, Shire, and UCB Grants: the National Institute of Health, Centocor, Elan Biogen and Procter & Gamble Pharmaceuticals. Dr Rutgeerts - Served as study investigator and consultant for Abbott Laboratories and has participated in continuing medical education events supported by unrestricted educational grants from Abbott (research support, consultant fees, speaker's fees) Dr Chen - Employee - Abbott Dr Chao - Employee, stocks - Abbott Dr Mulani - Employee, stocks - Abbott. This research was funded by Abbott Laboratories, Abbott Park, IL.Table: WPAI change from baseline to week 52: LOCF