NEW YORK (Reuters Health) – A higher-than-standard maintenance (but not induction) dosing regimen of adalimumab may be beneficial for some patients with moderate to severe ulcerative colitis (UC), according to results of the SERENE UC study.
The study confirms that currently approved doses of adalimumab are effective and well tolerated in inducing and maintaining clinical remission in patients with moderately to severely active UC who fail to respond to conventional therapies, researchers report in Gastroenterology.
The findings also show that weekly adalimumab maintenance dosing “may be appropriate for some patients (eg, those with extensive colitis or low albumin levels, based on results from the subgroup analyses),” Dr. Julian Panes of the Hospital Clinic of Barcelona, Spain, and colleagues say.
Based on results from the eight-week, randomized, phase-3 ULTRA 1 study, an induction dosing regimen of adalimumab 160 mg at week 0, followed by 80 mg at week 2 and then 40 mg every other week (eow) starting at week 4 is approved for the treatment of adults with moderately to severely active UC, they explain in their paper.
However, data from the 52-week, randomized, phase-3 ULTRA 2 study suggest that a higher induction dose of adalimumab may provide greater efficacy in some patients with moderately to severely active UC.
According to the current European label for the drug, the recommended adalimumab maintenance dosing regimen is 40 mg eow. Weekly adalimumab maintenance dosing is approved for loss of response in Europe. Weekly adalimumab maintenance dosing is not approved for patients with UC in the United States or Japan.
The SERENE UC study tested the efficacy of higher adalimumab induction and maintenance dose regimens in patients with ulcerative colitis (UC).
The higher induction regimen (HIR) was adalimumab 160 mg at weeks 0, 1, 2, and 3 and the or standard induction regimen (SIR) was 160 mg at week 0 and 80 mg at week 2; all patients received 40 mg at weeks 4 and 6. At eight weeks, the maintenance regimens tested were 40 mg ew or 40 mg eow.
In the induction study with 952 patients, the higher induction regimen did not lead to superior clinical and/or endoscopic efficacy at week 8 compared with the approved standard dosing regimen, the investigators report.
At week 8 (induction primary endpoint), 13.3% receiving HIR achieved clinical remission, as did 10.9% of patients receiving SIR (P=0.265).
In the maintenance study with 412 patients, at week 52, a “clinically meaningful” difference in clinical remission was observed with weekly adalimumab dosing, as evidenced by a >10% absolute difference for clinical remission rates between groups (39.5% with ew dosing vs. 29.0% with eow dosing (P=0.069).
The higher dosing regimens were “generally well tolerated and consistent with the known safety profile of adalimumab in UC,” the study team says.
The study was funded by AbbVie. Dr. Panes disclosed relationships with AbbVie and other pharmaceutical companies.
SOURCE: https://bit.ly/3CrbDrG Gastroenterology, online February 24, 2022.
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