High Adalimumab Dose at Beginning Maintenance Therapy in Crohn’s disease Patients

Abstract

Abstract Introduction: Adalimumab is used to treat Crohn's disease, but the high dosage is controversial. Methods In this retrospective study we compared patients with Crohn's disease who had not previously received or had received infliximab treatment with high doses (subcutaneously injected with 80mg of adalimumab every other week) and standard doses (subcutaneously injected with 40mg of adalimumab every other week). The primary outcome was 12th -week clinical remission rate with two different dosage regimens, while the secondary outcome included the time to treatment failure and the incidence of adverse events. Results 144 patients had not used infliximab before and 86 patients had used infliximab before. In the infliximab-naïve group, there were no significant differences in the 12th-week clinical remission rate (78.0% vs 73.8%, OR 1.36, 95%CI 0.56–3.54, P = 0.509), and treatment failure for two regimens were similar (HR 0.49,95%CI [0.19,1.22], P = 0.123). However, in the infliximab-exposed group, the high dose of adalimumab provided a significantly higher clinical remission rate (72.7% vs. 47.6%, OR 3.31, 95%CI 1.28–8.57, P = 0.035,) and lower risk of treatment failure (HR 0.33, 95%CI [0.13, 0.85], P = 0.019), The incidence of adverse events was comparable between two regimens (34.1% vs. 29.7%, P = 0.556). Conclusions The high dosage of adalimumab doesn’t provide additional clinical benefits to infliximab-naïve CD patients with the standard dosage. However, it can increase the clinical remission rate and reduce the risk of treatment failure in infliximab-exposed CD patients, without increasing the incidence of adverse events.