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| Gastroenterology. 2022 Feb 25. pii: S0016-5085(22)00199-8. doi: 10.1053/j.gastro.2022.02.033 |
| Higher vs Standard Adalimumab Induction and Maintenance Dosing Regimens for Treatment of Ulcerative Colitis: SERENE UC Trial Results. |
| Panés J1, Colombel JF2, D'Haens GR3, Schreiber S4, Panaccione R5, Peyrin-Biroulet L6, Loftus EV7, Danese S8, Tanida S9, Okuyama Y10, Louis E11, Armuzzi A12, Ferrante M13, Vogelsang H14, Hibi T15, Watanabe M16, Lefebvre J17, Finney-Hayward T18, Gonzalez YS19, Doan TT20, Mostafa NM21, Ikeda K22, Xie W23, Huang B24, Petersson J25, Kalabic J26, Robinson AM27, Sandborn WJ28 |
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Abstract BACKGROUND & AIMS: SERENE UC evaluated the efficacy of higher adalimumab induction and maintenance dose regimens in patients with ulcerative colitis (UC). 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 [FMS] 6-12, centrally read endoscopy subscore 2-3) were randomized 3:2 to higher induction regimen (HIR; adalimumab 160mg at weeks 0, 1, 2, and 3) or standard induction regimen (SIR; 160mg at week 0, 80mg at week 2); all received 40mg at weeks 4 and 6. At week 8, all patients were rerandomized 2:2:1 (main study) to 40mg every week (ew), 40mg every other week (eow), or exploratory therapeutic drug monitoring; or 1:1 (Japan substudy) to 40mg ew or 40mg eow maintenance regimens. RESULTS: In the main study, 13.3% vs 10.9% of patients receiving HIR vs SIR achieved clinical remission (FMS ≤2 with no subscore >1) at week 8 (induction primary endpoint; P=.265); among week-8 responders, 39.5% vs 29.0% receiving 40mg ew vs 40mg eow achieved clinical remission at week 52 (maintenance primary endpoint; P=.069). In the integrated (main+Japan) population, 41.1% vs 30.1% of week-8 responders receiving 40mg ew vs 40mg eow achieved clinical remission at week 52 (nominal P=.045). Safety profiles were comparable between dosing regimens. CONCLUSION: Though primary endpoints 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 UC. ClinicalTrials.gov number, NCT002209456. |
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Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved. |
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KEYWORDS: Adalimumab, clinical trial result, inflammatory bowel disease, moderately to severely active ulcerative colitis, monoclonal antibody |
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Publikations ID: 35227777 Quelle: öffnen |
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