In the SERENE UC clinical trial, researchers found that a higher maintenance dose of adalimumab induced a more than 10% absolute difference in clinical remission in a cohort of patients with ulcerative colitis compared with standard maintenance. The findings were reported in Gastroenterology.
The phase 3 study enrolled patients from 120 research centers across 19 countries and also included a sub-study, which enrolled patients from 22 centers in Japan. Both studies were arranged as part of US Food and Drug Administration and Japanese Pharmaceuticals and Medical Devices Agency approvals, respectively.
Participants were randomized between a standard adalimumab induction regimen of 160 mg at week 0 and 80 mg at week 2, or a heightened regimen of 160 mg at weeks 0, 1, 2, and 3, after which both groups received adalimumab 40 mg at weeks 4 and 6. Patients were subsequently reassigned to maintenance groups of 40 mg every week or every other week.
In the primary study, 13.3% of patients on the higher induction dose achieved clinical remission at week 8 compared with 10.9% of those on the standard regimen (P=.265). At week 52, 39.5% of patients in the 40 mg every week group who responded at week 8 achieved the clinical remission maintenance end point compared with 29.0% of patients in the 40 mg every other week group (P=.069). The safety signals were similar between the groups, the authors added.
While the researchers noted that the primary end points were not met, they reported that higher adalimumab maintenance dosing appeared to improve clinical remission compared with standard dosing, and the higher dosing was typically well tolerated.
Reference: Panés J, Colombel JF, D’Haens GR, et al. Higher vs Standard Adalimumab Induction and Maintenance Dosing Regimens for Treatment of Ulcerative Colitis: SERENE UC Trial Results. Gastroenterology. 2022;162(7):1891-1910. doi:10.1053/j.gastro.2022.02.033
