Comparison of Infliximab and Adalimumab in Biologic-Naive Patients With Ulcerative Colitis: A Nationwide Danish Cohort Study

BACKGROUND & AIMS: We compared the effectiveness and safety of infliximab and adalimumab in biologic-naïve patients with ulcerative colitis (UC), in a nationwide register-based propensity score-matched study of patients in Denmark.

METHODS: We collected data from 1719 adults with UC, 15-75 years old, in Denmark who were treated with either infliximab or adalimumab as their first biologic agent. We compared rates of all-cause hospitalization, UC-related hospitalization, major abdominal surgery, and serious infections after a variable 2:1 propensity score matching, accounting for baseline clinical characteristics, disease severity, healthcare use, and use of UC-related medications.

RESULTS: Compared to patients treated with infliximab, patients treated with adalimumab had a higher risk for all-cause hospitalization (hazard ratio [HR], 1.84; 95% CI, 1.18-2.85), with a trend towards higher risk of UC-related hospitalization (HR, 1.71; 95% CI, 0.95-3.07)-particularly for patients on concomitant immune modulator therapy. However, risk of abdominal surgery (HR, 1.35; 95% CI, 0.62-2.94) did not differ between patients given adalimumab vs infliximab. Risk of serious infection requiring hospitalization was significantly higher among patients treated with adalimumab (HR, 5.11; 95% CI, 1.20-21.80).

CONCLUSION: In a nationwide propensity score matched-cohort study of biologic-naïve adults with UC in Denmark, use of adalimumab as first-line biologic vs infliximab was associated with higher risk of hospitalization and serious infections, though risk of surgery was not different. In the absence of trials to directly compare these drugs, these findings could assist patients, healthcare providers, purchasers, and policy makers in making decisions that might improve care for patients with UC.