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IMPACT OF ADALIMUMAB THERAPY ON PATIENT-REPORTED OUTCOMES IN CROHN’S DISEASE
BG Feagan1, EV Loftus2, J Colombel3, EQ Wu4, A Yu4, PF Pollack5, J Chao5, P Mulani5
1Robarts Research Institute, London, Ontario; 2Mayo Clinic, Rochester, MN, USA; 3CHU Lille, Lille, France; 4Analysis Group, Inc., Boston, MA, USA; 5Abbott, Abbott Park, IL, USA
AIMS: To assess the effect of adalimumab (ADA) maintenance therapy on fatigue (F) and depressive (D) symptoms and traditional patient-reported outcomes (PROs) in patients (pts) with Crohn’s disease (CD) participating in the CHARM trial.1 ADA is approved for the treatment of adults with moderately to severely active CD. There are limited available data regarding the impact of anti-TNF therapy on D and F symptoms in pts with CD.
METHODS: We analyzed PROs in CHARM randomized responders (RRs) [pts with a decrease =>70 points from baseline (BL) CDAI score at Week (Wk) 4]. All pts received an induction regimen of open-label ADA 80 mg at BL (Wk 0) and 40 mg ADA at Wk 2. At Wk 4, pts were stratified by response and randomized to a maintenance regimen of ADA 40 mg every other week or weekly, or placebo. PROs [SF-36, IBDQ, FACIT-Fatigue (F), and Zung Depression scale (ZD)] collected at Wks 0, 4, 12, 26, and 56 were compared for RRs receiving ADA induction only (IO) and ADA maintenance (IM) therapy. Fatigue was measured by FACIT-F (scale range 0-52); a 3-4 point change was considered clinically meaningful. D symptoms were measured by ZD (scale range 20-80, with >50=D state).
RESULTS: At Wk 4, 499 responders were randomized (IO, n=170; IM, n=329). At Wk 0, PROs suggested an impaired health-related quality of life (HRQOL). The mean FACIT-F score at BL (23) was similar to cancer pts with anemia. The mean ZD score at BL (IO=55, IM=56) indicated depressed states among CD pts. Pts improved across all 4 PROs during the IO phase (Wk 4 vs. BL). Pts in the IM group showed significantly improved quality of life according to PRO measures from Wks 12-56 compared with pts in the IO group. FACIT-F scores indicated reduced F symptoms in the IM group (p<0.01 vs. IO). Improvements in D symptoms, shown by statistically significant reductions in ZD scores, were observed in the IM group (p<0.01 vs. IO). At Wks 26 and 56, SF-36 Physical Component (PCS) and Mental Component (MCS) Summary PROs were greater for the IM group (p<0.05 vs. IO). Highly significant and sustained improvements in disease-specific IBDQ scores were observed in the IM group (p<0.01 vs. IO) throughout the study.
CONCLUSIONS: CD pts receiving ADA IM therapy achieved substantial and sustained improvements in F and D outcomes. ADA IM therapy also was associated with significant and lasting improvements in CD-specific (IBDQ) and general (SF-36, PCS, and MCS) HRQOL measurements, compared with IO therapy.
REFERENCE: 1. Colombel JF, et al. Gastroenterology. 2007;132(1):52-65.
Funded by Abbott Laboratories