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 steroidfree 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.