Patients with ulcerative colitis (UC) who received higher induction or maintenance dosing of adalimumab had comparable outcomes with patients who received standard induction or maintenance dosing, according to a study published in Gastroenterology.
The international, double-blinded, phase 3 clinical trial, called SERENE UC (ClinicalTrials.gov Identifier: NCT02065622), included adult patients with a full Mayo score (FMS) of 6 to 12 points despite treatment, indicating moderate to severe disease. All patients on corticosteroids upon enrollment were required to wean off steroid treatment by week 4 of the study.
For the induction phase, patients were randomly assigned 3:2 to receive a higher induction regimen (HIR) of adalimumab 160 mg at weeks 0, 1, 2, and 3, followed by 40 mg at weeks 4 and 6 or to receive the standard induction regimen (SIR) of adalimumab 160 mg at week 0, 80 mg at week 2, and 40 mg at weeks 4 and 6. After 8 weeks, patients were randomly assigned again 2:2:1 to receive higher maintenance dosing of adalimumab 40 mg weekly, standard maintenance dosing of adalimumab 40 mg every other week, or a therapeutic drug monitoring regimen.
The primary outcome of the induction phase was clinical remission at week 8. The primary outcome of the maintenance phase was the rate of clinical remission at week 52 among patients who had responded to treatment at week 8. For both study components, clinical remission was defined as FMS of 2 or lower, with no subscore above 1.
Patients who received HIR had similar rates of clinical remission compared with patients who received SIR, at 13.3% and 10.9%, respectively (95% CI: -1.9 to 7.1; P =.265). In the maintenance study, patients who received weekly adalimumab had a higher rate of clinical remission compared with patients who received adalimumab every other week (39.5% vs 29.0%, absolute difference 10.5%; 95% CI, -0.8 to 20.6; P =.069). The subset of patients who had more severe disease, as indicated by disease duration, elevated C-reactive protein, or extensive UC, were more likely to obtain clinical remission when treated with adalimumab 40 mg weekly.
Due to reassignment at week 8, the results of the maintenance phase may have been affected by patients having received HIR or SIR. It is unknown if HIR and SIR are evenly represented in the weekly or every other week maintenance groups.
“The safety profile of higher adalimumab induction and maintenance dosing regimens was comparable with that of the standard dosing regimens, indicating no additional risk,” the study authors noted. “The benefit-risk profile of the adalimumab standard induction and maintenance dosing regimen as approved for patients with moderately to severely active UC remains unchanged.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Pleases see the original reference for a full list of authors’ disclosures.
Panés J, Colombel J-F, D’Haens GR, et al. Higher vs standard adalimumab induction and maintenance dosing regimens for treatment of ulcerative colitis: SERENE UC trial results. Gastroenterology. Published February 24, 2022. doi:10.1053/j.gastro.2022.02.033