Mucosal Healing at 14 Weeks Predicts better Outcome in Low-dose Infliximab Treatment for Chinese Patients with Active Intestinal Behcet's Disease.

AIMS: To compare the efficacy and the safety of low-dose (3.5 mg/kg) or standard-dose (5 mg/kg) of infliximab (IFX) for induction and maintenance treatment in Chinese patients with intestinal Behcet's disease (BD), and to identify potential predictors to corticosteroid-free clinical remission at week 30.

METHODS: A prospective trial was conducted in 20 patients with moderate-to-severe active intestinal BD, followed up for 30 weeks. Ileocolonoscopic examinations were done at baseline and week 14. A logistic regression model was used to assess the predictors of corticosteroid-free remission at week 30.

RESULTS: As the primary end point, steroid-free remission at week 30 was observed in 40% and 60% of patients who received low and standard doses of IFX, respectively ( P >0.371). As the secondary end point, the mucosal healing (MH) rates at week 14 were found to be 60% for both low and standard doses of IFX. The clinical response rates at week 14 and 30 were also similar in both groups. Only MH at week 14 predicted steroid-free clinical remission at week 30.

CONCLUSIONS: Low-dose of IFX is effective and safe for induction and maintenance therapy in patients with active intestinal BD. MH at week 14 predicted clinical remission at week 30.