Abstract: Infliximab (IFX) is an effective treatment for Crohn's disease (CD) and ulcerative colitis (UC) not responding to standard therapy. Thirty percent to forty percent of patients however do not improve and the response is often incomplete. We identified mucosal gene signatures predictive of response to EFX using high-density oligonucleotide arrays. Eight UC patients and twelve CD patients showed healing. In UC, only one probe set was differentially expressed in responders compared with non-responders, i.e., IL-13R(alpha)2. At PAM analysis, two probe sets, representing IL-13Ralpha2 and IL-I 1, separated IBD responders from non-responders with an overall misclassification error rate of 0.046 (2/43), with 100% sensitivity and 91.3% specificity. The IL-13R(alpha)2 probe set was a top-ranked probe set in all our analyses using both LIMMA and PAM strategies. Our gene array studies of mucosal biopsies identified IL-13R(alpha)2 in IBD as a predictor of response or non-response to IFX.

Abstract: The invention provides methods, uses and compositions for the treatment of Crohn's disease. The invention describes methods and uses for treating Crohn's disease, wherein a TNF? inhibitor, such as a human TNF? antibody, or antigen-binding portion thereof, is used to induce and maintain remission of Crohn's disease in a subject. Also described are methods for determining the efficacy of a TNF? inhibitor for treatment of Crohn's disease in a subject.