Do Crohn's disease patients benefit from an optimized adalimumab therapy?

Abstract Background Adalimumab induction and maintenance therapy have been applied to patients with Crohn's disease (CD). This study aimed to analyze the efficacy and safety of an optimized dose versus a standard dose of adalimumab in the treatment of CD. Methods It was a retrospective study involving 192 CD patients treated with adalimumab. According to the maintenance therapy following an induction therapy, CD patients were assigned to receive a standard dose (subcutaneously injected with 40mg of adalimumab every other week) and an optimized dose (subcutaneously injected with 80mg of adalimumab every other week). The clinical remission rate, inflammatory and nutritional indicators, mucosal healing rate, endoscopic response rate at 12th week, risk of treatment failure and safety were compared between groups. Results There were 139 patients in the standard dose group and 53 in the optimized dose group. At 12 weeks, no significant difference was detected in the clinical remission rate (79.1% vs. 81.1%; RR, 0.97; 95% CI, 0.81–1.24; P = 0.842). In infliximab-exposed CD patients, the optimized dose of adalimumab provided a significantly higher clinical remission rate (76.9% vs. 44.4%; RR, 0.58; 95% CI, 0.37–0.88; P = 0.018) and lower risk of treatment failure (HR, 0.36; 95% CI, 0.14–0.97; P = 0.042), but not in infliximab-naïve CD patients. The incidence of adverse events was comparable between groups (32.1% vs. 30.9%, P = 0.864). Conclusions An optimized adalimumab dose does not provide additionally clinical benefits to infliximab-naïve CD patients, compared with a standard dose, but can increase the clinical remission rate and lower the risk of treatment failure in infliximab-exposed CD patients at 12 weeks, without increasing the incidence of adverse events.