Exploring the use of adalimumab for patients with moderate Crohn's disease: Subanalyses from induction and maintenance trials |
| |
| Affiliation: | 1. Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA;2. Hepatogastroenterology, Centre Hospitalier Universitaire de Lille, Lille, France;3. Department of Gastroenterology, Hospital Clinic of Barcelona, CIBERehd, Barcelona, Spain;4. AbbVie, North Chicago, IL, USA;1. Colorectal Surgery Unit, Cajuru University Hospital, Catholic University of Parana, Curitiba, PR, Brazil;2. Inflammatory Bowel Disease Center, Yokkaichi Social Insurance Hospital, Yokkaichi, Japan;1. Hepato-Gastroenterology and Digestive Oncology Department, Liège University Hospital, CHU and GIGA-R, University of Liège, Liège, Belgium;2. Department of Gastroenterology, Université Lille Nord de France and CHRU Lille, 59000 Lille, France;3. Service de Gastro-Entérologie Hôpital Nord et Faculté de Médecine de Marseille, 13915 Cedex 20, Marseille, France;4. Gastroenterology and IBD Department, Hôpital Beaujon-APHP-Paris-Diderot University, 92110 Clichy, France;5. CHU de Bordeaux, Hôpital Haut-Lévêque, Service d''Hépato-Gastroentérologie, Université de Bordeaux, Laboratoire de Bactériologie, 33000 Bordeaux, France;6. CHRU Tours Biochimie et Biologie Moleculaire, INSERM U966, Université François Rabelais de Tours, Faculté de Médecine, 10 Bd. Tonnellé, 37000 Tours, France;7. Medical Informatics and Biostatistics, University of Liège, Belgium;8. Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1069 New York, NY 10029, USA |
| |
| Abstract: | BackgroundAnti-TNF agents are often reserved for patients with severe Crohn's disease (CD).AimsWe explored the predictive value of baseline disease activity and C-reactive protein (CRP) for disease course, adalimumab efficacy for remission (induction and maintenance) in patients with moderate and severe CD, and adalimumab efficacy in moderate CD by CRP category.MethodsPost hoc analyses of remission data were performed for all randomized patients from induction (CLASSIC I) and maintenance (CHARM, EXTEND) adalimumab trials in patients with moderate (CDAI ≤ 300) or severe (CDAI > 300) CD, and in high (≥ 10 mg/L) or low (< 10 mg/L) CRP moderate CD subgroups. Placebo-treated CHARM patients were evaluated for disease activity over time and time to CD-related hospitalization, by baseline disease severity and CRP.ResultsModerate CD patients had the highest clinical remission rate and largest treatment effect size compared with placebo at week 4 after 160/80 mg induction (46.3% adalimumab, 17.4% placebo; versus 22.9%, 3.6% for severe patients). Moderate-CD/high-CRP patients had the most pronounced efficacy (57.1% adalimumab, 6.7% placebo; versus 40.7%, 20.0% for lower CRP group). Adalimumab maintenance treatment (40 mg every-other-week) achieved superior remission versus placebo at one year in moderate (32.9% versus 13.7%) and severe (27.2% versus 7.5%) cohorts. Among moderate patients, efficacy was similar by CRP category. Moderate-CD/high-CRP placebo-treated patients experienced disease activity and hospitalization rates at week 56 of CHARM approaching those of severe CD patients.ConclusionsThis analysis suggests that moderate CD patients can be treated effectively with adalimumab, and supports using CRP to identify moderate CD patients at greatest risk of disease progression. |
| |
| Keywords: | |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
