Original articleOral p38 Mitogen-Activated Protein Kinase Inhibition With BIRB 796 for Active Crohn’s Disease: A Randomized, Double-Blind, Placebo-Controlled Trial
Section snippets
Patients and Concomitant Medications
Screened patients were 18–65 years old with documented chronic active CD for at least 6 months and moderate to severe activity (Crohn’s disease activity index [CDAI] ≥220 to ≤450) at baseline. The following concomitant therapies were allowed if administered in a stable dose and for at least the following time intervals before baseline: prednisone or other systemic corticosteroids (12 weeks and stable oral dosage ≤25 mg/day or equivalent for the past 2 weeks), budesonide (stable dose ≤9 mg/day
Study Population and Patient Characteristics
A total of 354 patients (108 in Russia) were screened for inclusion at 47 sites (7 in Russia), which led to randomization of 284 patients. One patient randomized to 60-mg BIRB 796 was excluded from the efficacy analysis populations because no postbaseline efficacy data were available for this patient.
Patients who were randomized to the 7 Russian centers (n = 96) showed different demographic and baseline disease characteristics than patients (n = 188) from the other countries, indicating less
Discussion
Preclinical data suggest that p38 MAPK plays an important role in the regulation of inflammatory mediators in CD.15, 17 Furthermore, in a recent pilot study, administration of the Janus kinase (JNK)/p38 inhibitor CNI-1493 (Cytokine Pharma Sciences, King of Prussia, PA) resulted in a significant decrease in CDAI scores and mucosal healing.23 Therefore, the use of the highly selective p38 MAPK inhibitor BIRB 79618 seemed to be a promising approach in patients suffering from CD.
However, none of
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Cited by (0)
Supported by Boehringer Ingelheim (trial 1175.12) in accordance with the principles laid out in the International Convention of Helsinki and Good Clinical Practice. Also supported in part by the publicly funded competence network for inflammatory bowel disease in Germany through Bundesministerium fur Bildung und Forschung (BMBF).
Drs C. Yong, Ulrich Meier, and J. Steffgen are employees of Boehringer Ingelheim. Dr Colombel has served as a consultant for Boehringer Ingelheim.
Present address for T.W.: Division of Digestive Diseases and Nutrition, University of Kentucky, Lexington, Kentucky.