Journal of Crohn's and Colitis (2013) 7, 154-160
Adalimumab dose escalation and dose de-escalation success rate and predictors in a large national cohort of Crohn\'s patients
Filip Baert, Elien Glorieus, CathÃ©rine Reenaers, Geert D'Haens, Harald Peeters, Dennis Franchimont, Olivier Dewit, Philippe Caenepeel, Edouard Louis, Gert Van Assche for BIRD (Belgian IBD Research and Development)Abstract
BACKGROUND AND AIMS: Adalimumab is efficacious in inducing and maintaining remission in Crohn\'s disease but dose escalation is needed in 30–40% after 1 year. Attempts for dose de-escalation have not been studied. This study aimed to assess the need for, predictors, and outcome of dose escalation and de-escalation in a large cohort of adalimumab treated Crohn\'s patients.
METHODS: All consecutive patients treated with open label adalimumab for active Crohn\'s disease from the participating centres were included in this cohort study. A detailed retrospective chart review was performed to look for possible factors predicting outcome.
RESULTS: Eighty four percent of 720 patients had a primary response and were followed up for a median of 14 months. Thirty four percent needed escalation after a median of 7 months (0–55 months). Multivariate predictors for dose escalation were the following: prior anti-TNF use (pb0.0001), no concomitant azathioprine or b3 m (pb0.02) and abnormal CRP at start (pb0.05).
Dose escalation re-induced response for at least 6 months in 67%. Only abnormal CRP at start correlated with failure of dose escalation (p=0.02). Dose de-escalation was attempted in 54% and was successful in 63%. After a median follow-up of 14 m adalimumab was discontinued in 29% of patients.
CONCLUSION: In this study real life nationwide cohort of Crohn\'s patients treated with adalimumab dose escalation was needed in 34% and was successful in 67%. Dose de-escalation was attempted in 54% and was successful in 63%. Overall 71% of patients maintained long term response on adalimumab.