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Effect of adalimumab on clinical laboratory parameters in patients with Crohn's disease: Results from the CHARM trial

Authors


  • The CHARM study and this post-hoc analysis were fully funded by Abbott. Medical writing support was funded by Abbott.

  • Conflicts of interest: David Rubin has served as a consultant for Abbott, Centocor, Elan, Procter & Gamble, Prometheus, Salix, Shire, and UCB; has served on the advisory board for Abbott, Centocor, Elan, Shire, and UCB; and has received research support from Procter & Gamble, Prometheus, and Salix. Subrata Ghosh has served on ad-hoc advisory boards for Abbott, Centocor, Merck, Pfizer, and Shire; has received honorarium for lecturing in educational events from Abbott, Merck, and Shire; and has received research support from Abbott and Merck. Arielle Bensimon and Andrew Yu are employees of Analysis Group, Inc., and performed work under contract with Abbott. Paul Pollack, Parvez Mulani, and Jingdong Chao are employees of Abbott and hold stock in Abbott.

Abstract

Background:

Nutritional deficiencies and anemia are common in Crohn's disease (CD).

Methods:

We evaluated the effect of adalimumab on changes in laboratory values using data from CHARM, in which patients were randomized to adalimumab 40 mg every other week (eow), adalimumab 40 mg weekly, or placebo for 56 weeks. Mean changes in laboratory values from baseline to Weeks 26 and 56 were compared between adalimumab and placebo using analysis of covariance models. Percentages of patients with suboptimal laboratory values at Weeks 26 and 56 were compared between treatment groups using Cochran–Mantel–Haenszel (CMH) tests. Pearson correlation coefficients for associations between changes in Crohn's Disease Activity Index (CDAI) score and changes in laboratory values were estimated at Weeks 4, 26, and 56.

Results:

The intention-to-treat analysis included 778 patients randomized to adalimumab eow (N = 260), adalimumab weekly (N = 257), or placebo (N = 261). Baseline abnormalities in laboratory values were common across treatment groups. CMH tests revealed significantly lesser rates of suboptimal laboratory values with adalimumab vs. placebo at Week 26, including hypoalbuminemia, calcium deficiency, low hemoglobin, low hematocrit, low red blood cell count, elevated platelet count, and elevated C-reactive protein concentration (all P < 0.05). These improvements persisted at Week 56. Improvements in CDAI from baseline to Weeks 4, 26, and 56 were significantly correlated with changes from baseline for albumin, hemoglobin, and C-reactive protein (all P < 0.001).

Conclusions:

Adalimumab therapy for moderately to severely active CD was associated with significant improvements in nutritional, hematologic, and inflammatory markers. (Inflamm Bowel Dis 2011;)

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