| Original Article |
Questions: 1) How effective and secure are higher adalimumab induction regimens compared to standard ones in adult patients with moderately to severely active Crohn’s disease (CD)? 2) In adult patients with moderately to severely active CD, how effective and safe are therapeutic drug monitoring (TDM) vs. clinically adjusted (CA) maintenance strategies?
Design/Method: A 3-phase, randomized, double-blind, multicenter, clinical trial study was conducted in 19 countries under the name SERENE CD (ClinicalTrials.gov, Number: NCT02065570). Eligible adults were randomized to a higher induction regimen (adalimumab 160 mg at weeks 0, 1, 2, and 3) or a standard induction regimen (adalimumab 160 mg at week 0 and 80 mg at week 2) followed by 40 mg every other week from week 4 onward. Co-primary endpoints included clinical remission at week 4 and endoscopic response at week 12. At week 12, patients were re-randomized to maintenance therapy optimized by Crohn’s Disease Activity Index and C-reactive protein or serum adalimumab concentrations and/or clinical criteria), exploratory endpoints were evaluated at week 56
Setting: Austria, Belgium, Canada, The Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Slovakia, Spain, Switzerland, Ukraine, The United Kingdom, and The United States
Patient/ Study community: 18-75 years old adults with moderately to severely active CD
Results: The recommended standard dose of adalimumab for individuals with moderately to severely active CD is suitable. HIR does not significantly outperform the approved SIR in terms of clinical or endoscopic efficacy. No new safety signals are found, and the safety profile of the increased adalimumab induction dose schedule is equivalent to the standard dosage regimen
| The details of the study results | |||||
| HIR | SIR | CA | TDM | P value | |
| Clinical remission (week 4) | 43.5% | 43.7% | – | – | .939 |
| Endoscopic response (week 12) | 42.9% | 39.3% | – | – | .462 |
| Clinical remission (week 56) | – | – | 70.7 | 66.3 | .497 |
| Endoscopic response (week 56) | – | – | 44.6 | 43.5 | .824 |
Commentary:
| Both CA and TDM maintenance techniques are equally effective, and higher induction regimens are similar to standard induction regimens in efficacy and safety. There are no unresolved safety concerns with adalimumab therapy |
Citation: Geert R. D’Haens, William J. Sandborn, Edward V. Loftus Jr, and et all. Higher vs Standard Adalimumab Induction Dosing Regimens and Two Maintenance Strategies: Randomized SERENE CD Trial Results. Gastroenterology. 2022; 162 (7):1876–1890
DOI: 10.1053/j.gastro.2022.01.044
https://pubmed.ncbi.nlm.nih.gov/35122766/
Topics: Biologic Agent, Monoclonal Antibody, Inflammatory Bowel Disease, TNF Inhibitor
