Colon to Rectum

Gastroenterology. 2022;162(7):1891–910

Panés J, Colombel JF, D’Haens GR, Schreiber S, Panaccione R, Peyrin-Biroulet L, Loftus EV, Jr., Danese S, Tanida S, Okuyama Y, Louis E, Armuzzi A, Ferrante M, Vogelsang H, Hibi T, Watanabe M, Lefebvre J, Finney-Hayward T, Sanchez Gonzalez Y, Doan TT, Mostafa NM, Ikeda K, Xie W, Huang B, Petersson J, Kalabic J, Robinson AM, Sandborn WJ

Higher versus standard adalimumab induction and maintenance dosing regimens for treatment of ulcerative colitis: SERENE UC trial results

Background and aims: SERENE UC (Study of a Novel Approach to Induction and Maintenance Dosing With Adalimumab in Patients With Moderate to Severe Ulcerative Colitis) evaluated the efficacy of higher adalimumab induction and maintenance dose regimens in patients with ulcerative colitis.
Methods: This phase 3, double-blind, randomized trial included induction and maintenance studies, with a main study (ex-Japan) and Japan substudy. Eligible patients (18–75 years, full Mayo score 6–12, centrally read endoscopy subscore 2–3) were randomized 3:2 to higher induction regimen (adalimumab 160 mg at weeks 0, 1, 2, and 3) or standard induction regimen (160 mg at week 0 and 80 mg at week 2); all received 40 mg at weeks 4 and 6. At week 8, all patients were re-randomized 2:2:1 (main study) to 40 mg every week (ew), 40 mg every other week (eow), or exploratory therapeutic drug monitoring; or 1:1 (Japan substudy) to 40 mg ew or 40 mg eow maintenance regimens.
Results: In the main study, 13.3% versus 10.9% of patients receiving the higher induction regimen versus standard induction regimen achieved clinical remission (full Mayo score ≤ 2 with no subscore > 1) at week 8 (induction primary end point; p = 0.265); among week-8 responders, 39.5% versus 29.0% receiving 40 mg ew versus 40 mg eow achieved clinical remission at week 52 (maintenance primary end point; p = 0.069). In the integrated (main + Japan) population, 41.1% versus 30.1% of week-8 responders receiving 40 mg ew versus 40 mg eow achieved clinical remission at week 52 (nominal p = 0.045). Safety profiles were comparable between dosing regimens.

Conclusion: Although primary end points were not met, a > 10% absolute difference in clinical remission was demonstrated with higher adalimumab maintenance dosing. Higher dosing regimens were generally well tolerated and consistent with the known safety profile of adalimumab in ulcerative colitis.

Prof. Dr. J. Panés, Hospital Clínic i Provincial de Barcelona, August Pi i Sunyer Biomedical Research Institute, Biomedical Research Networking Center in Hepatic and Digestive Diseases, Barcelona, Spain,

DOI: DOI: 10.1053/j.gastro.2022.02.033

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