TY - JOUR
T1 - Higher vs Standard Adalimumab Induction and Maintenance Dosing Regimens for Treatment of Ulcerative Colitis
T2 - SERENE UC Trial Results
AU - Panés, Julián
AU - Colombel, Jean Frederic
AU - D'Haens, Geert R.
AU - Schreiber, Stefan
AU - Panaccione, Remo
AU - Peyrin-Biroulet, Laurent
AU - Loftus, Edward V.
AU - Danese, Silvio
AU - Tanida, Satoshi
AU - Okuyama, Yusuke
AU - Louis, Edouard
AU - Armuzzi, Alessandro
AU - Ferrante, Marc
AU - Vogelsang, Harald
AU - Hibi, Toshifumi
AU - Watanabe, Mamoru
AU - Lefebvre, Jessica
AU - Finney-Hayward, Tricia
AU - Sanchez Gonzalez, Yuri
AU - Doan, Thao T.
AU - Mostafa, Nael M.
AU - Ikeda, Kimitoshi
AU - Xie, Wangang
AU - Huang, Bidan
AU - Petersson, Joel
AU - Kalabic, Jasmina
AU - Robinson, Anne M.
AU - Sandborn, William J.
N1 - Publisher Copyright:
© 2022 The Authors
PY - 2022/6
Y1 - 2022/6
N2 - Background & 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 rerandomized 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% vs 10.9% of patients receiving the higher induction regimen vs standard induction regimen achieved clinical remission (full Mayo score ≤2 with no subscore >1) at week 8 (induction primary end point; P = .265); among week-8 responders, 39.5% vs 29.0% receiving 40 mg ew vs 40 mg eow achieved clinical remission at week 52 (maintenance primary end point; P = .069). In the integrated (main + Japan) population, 41.1% vs 30.1% of week-8 responders receiving 40 mg ew vs 40 mg eow achieved clinical remission at week 52 (nominal P = .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. ClinicalTrials.gov, Number: NCT002209456.
AB - Background & 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 rerandomized 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% vs 10.9% of patients receiving the higher induction regimen vs standard induction regimen achieved clinical remission (full Mayo score ≤2 with no subscore >1) at week 8 (induction primary end point; P = .265); among week-8 responders, 39.5% vs 29.0% receiving 40 mg ew vs 40 mg eow achieved clinical remission at week 52 (maintenance primary end point; P = .069). In the integrated (main + Japan) population, 41.1% vs 30.1% of week-8 responders receiving 40 mg ew vs 40 mg eow achieved clinical remission at week 52 (nominal P = .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. ClinicalTrials.gov, Number: NCT002209456.
KW - Adalimumab
KW - Clinical Trial Result
KW - Inflammatory Bowel Disease
KW - Moderately to Severely Active Ulcerative Colitis
KW - Monoclonal Antibody
UR - http://www.scopus.com/inward/record.url?scp=85127544553&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85127544553&partnerID=8YFLogxK
U2 - 10.1053/j.gastro.2022.02.033
DO - 10.1053/j.gastro.2022.02.033
M3 - Article
C2 - 35227777
AN - SCOPUS:85127544553
SN - 0016-5085
VL - 162
SP - 1891
EP - 1910
JO - Gastroenterology
JF - Gastroenterology
IS - 7
ER -