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Dosage adjustment during long-term adalimumab treatment for Crohn's disease: clinical efficacy and pharmacoeconomics.

Author(s): Sandborn WJ, Colombel JF, Schreiber S, Plevy SE, Pollack PF, Robinson AM, Chao J, Mulani P

Affiliation(s): Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA. sandborn.william@mayo.edu

Publication date & source: 2011-01, Inflamm Bowel Dis., 17(1):141-51.

Publication type: Clinical Trial, Phase III; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: Data from CHARM, a 56-week, randomized controlled trial of adalimumab for patients with moderately to severely active Crohn's disease (CD), were used to evaluate outcomes of adalimumab dosage adjustment. METHODS: Patients randomized to blinded adalimumab 40 mg every other week (EOW) in CHARM were the focus of the analysis. At >/=12 weeks, patients with flares or lack of response versus baseline (including patients who responded and then lost response) could move sequentially to open-label (OL) adalimumab EOW and then to OL adalimumab weekly. RESULTS: Of 260 patients randomized to adalimumab EOW, 140 (54%) continued blinded EOW therapy and 120 (46%) moved to OL therapy. Of patients on OL therapy, 49 (19%) continued EOW therapy and 71 (27%) moved to weekly therapy; 36 (14%) completed the trial on weekly therapy. Of 71 patients on weekly therapy, 37% achieved clinical remission (Crohn's Disease Activity Index [CDAI] <150), 58% achieved CR-100 (CDAI decreased >/=100 points), and 63% achieved CR-70 (CDAI decreased >/=70 points). Of the 49 patients who remained on OL EOW therapy, 39% achieved clinical remission, 59% achieved CR-100, and 63% achieved CR-70. In a logistic regression, greater baseline CDAI predicted changing to weekly therapy. A model of dosage-adjustment cost indicated a modest per-patient drug-acquisition cost increase ($574 over yearly EOW dosing cost [$22,518]). CONCLUSIONS: Of patients randomized to blinded EOW therapy, 19% moved to OL EOW therapy and 27% moved to OL weekly therapy for flares or lack of response versus baseline. Weekly therapy was associated with clear clinical benefits and a small cost increase. Copyright (c) 2010 Crohn's & Colitis Foundation of America, Inc.

Page last updated: 2011-12-09

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