| Original Article |
Questions: In individuals with ulcerative colitis (CD), how effective are higher adalimumab induction and maintenance dosage regimens? 2) How do the combined populations of Japanese and Western patients compare in terms of consistency of efficacy?
Design/Method: A 3 phase, double-blind, randomized, multicenter study under the name SERENE UC was conducted in 19 countries, and a sub-study was conducted in Japan (ClinicalTrials.gov .Number: NCT02065622). Eligible patients were randomized to a higher induction regimen (adalimumab 160 mg at weeks 0, 1, 2, and 3) or a 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 (main study) to 40 mg every week, 40 mg every other week, or exploratory therapeutic drug monitoring or (Japan sub-study) to 40 mg every week or 40 mg every other week maintenance regimens
Setting: Austria, Belgium, Canada, The Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Slovakia, Spain, Switzerland, Ukraine, The United Kingdom, Japan, and The United States
Patient/Study community: 18-75 years old adults with moderately to severely active CD
Results: Higher and standard induction adalimumab dosing do not differ in efficacy. In the integrated (ex-Japan þ Japan) population, a higher maintenance adalimumab dosing regimen demonstrated superior efficacy compared with the standard maintenance regimen
| The details of study results | ||||
| Main study | ||||
| HIR | SIR | P value | ||
| Clinical remission (week 8) | 13.3% | 10.9% | .265 | |
| Clinical remission (week 52) | 39.5% | 29.0% | .069 | |
| Integrated population (Main + Japan) | ||||
| HIR | SIR | P value | ||
| Clinical remission (week 8) | 13.8 | 11.6 | .297 | |
| Clinical remission (week 52) | 41.1% | 30.1% | .045 | |
Commentary:
| Adalimumab is efficacious and well tolerated for producing and maintaining clinical remission in individuals with moderate to severe UC, according to the findings of the SERENE UC research. For some individuals, a weekly adalimumab maintenance dose, which is authorized in the European Union for loss of response, may be suitable. There is no increased risk because the safety profile of higher adalimumab induction and maintenance dose regimens was comparable to that of the normal dosing regimens. Adalimumab’s standard induction and maintenance dosage regimen, which is licensed for use in patients with moderately to highly active UC, continues to have an unaltered benefit-risk profile |
Citation: Julián Panés, Jean-Frederic Colombel, Geert R. D’Haens, and et all. Higher vs Standard Adalimumab Induction and Maintenance Dosing Regimens for Treatment of Ulcerative Colitis: SERENE UC Trial Results. Gastroenterology. 2022; 162(7):1891–1910
DOI: 10.1053/j.gastro.2022.02.033
Topics: Adalimumab, Monoclonal Antibody, Inflammatory Bowel Disease, Ulcerative Colitis
