Dosage adjustment during long‐term adalimumab treatment for Crohn's disease: Clinical efficacy and pharmacoeconomics

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)...

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Bibliographic Details
Published in:Inflammatory bowel diseases 2011-01, Vol.17 (1), p.141-151
Main Authors: Sandborn, William J., Colombel, Jean‐Frédéric, Schreiber, Stefan, Plevy, Scott E., Pollack, Paul F., Robinson, Anne M., Chao, Jingdong, Mulani, Parvez
Format: Article
Language:English
Subjects:
Adalimumab
Adult
Anti-Inflammatory Agents - administration & dosage
Anti-Inflammatory Agents - economics
Antibodies, Monoclonal - administration & dosage
Antibodies, Monoclonal - economics
Antibodies, Monoclonal, Humanized
Clinical trials
Crohn Disease - drug therapy
Crohn Disease - economics
Crohn's disease
Data processing
dosage adjustment
Dose-Response Relationship, Drug
Double-Blind Method
Economics
Economics, Pharmaceutical
Female
Humans
Inflammatory bowel diseases
Intestine
Long-Term Care
Male
Monoclonal antibodies
Pharmacology
Placebos
Remission
Treatment Outcome
Tumor Necrosis Factor-alpha - antagonists & inhibitors
Tumor Necrosis Factor-alpha - immunology
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Summary: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]
ISSN:1078-0998
1536-4844
1536-4844
DOI:10.1002/ibd.21328