Gastric Emptying Before and After Endoscopic Submucosal Dissection in Patients With Gastric Cancer

Aim: Adalimumab is efficacious in inducing and maintain deep remission, defined as clinical remission (CDAI <150) and mucosal healing (absence of mucosal ulceration), in EXTEND.We identified patient subgroups (hyper-responders) for whom adalimumab treatment provided a high probability of achieving deep remission.Methods: EXTEND was a randomized, placebocontrolled study of patients with moderate to severe ileocolonic Crohn's disease .Patients received open-label adalimumab 160-/80-mg induction therapy at Weeks 0/ 2 and were randomized at Week 4 to maintenance therapy with adalimumab 40 mg every other week or placebo.Hyper-responders were identified through a novel method that generated an incremental benefit index score (IBIS) for each patient.IBIS was generated as the differences in predicted values of deep remission rates through the regression models from adalimumab and placebo arms.The association between IBIS and the probability of achieving deep remission and the 95% confidence intervals were evaluated using nonparametric methods.Hyper-responders among patients using adalimumab were identified as patients with an IBIS threshold of more than a certain value, which corresponded to a ≥34% probability of achieving deep remission at Week 12.This rate is double the average deep remission rate (17%) of all adalimumab-treated patients in EXTEND.Validation of the IBIS model based on Week-52 deep remission data was conducted using ROC curves and C statistics.Results: Deep remission hyper-responders at Week 12 (N=7) were identified as patients with an IBIS threshold ≥0.32, which corresponds to a 34% probability of achieving deep remission.The hyper-responders tended to be younger and with shorter disease duration than non-hyper-responders (N=57); hyper-responders were also more likely to have greater baseline IBDQ scores and to be naïve to anti-TNF therapy (table).ROC curves indicated excellent predictive value of IBIS with a C statistic of 0.92.Conclusion: Using the novel method of IBIS, we were able to identify a subgroup of the EXTEND population who were deep remission hyper-responders at Week 12 if treated with adalimumab maintenance therapy.These patients tended to be younger with shorter disease duration, greater IBDQ scores, and no history of anti-TNF therapy. Week-12 Hyper-Responders Receiving Adalimumab Treatment Sa1055