High adalimumab induction poses no added benefit over standard regimens for CD patients

Higher induction regimens (HIR) are not superior to standard induction regimens (SIR) for the use of adalimumab in patients with Crohn’s disease (CD), reports a new study. Similarly, clinically-adjusted (CA) and therapeutic drug monitoring (TDM) maintenance strategies yield similar efficacies.

Researchers conducted a phase III, randomized, double-blind, multicentre trial including adult CD patients with moderately to severely active disease. Participants were randomly assigned to HIR (n=308; 160-g adalimumab at weeks 0, 1, 2, and 3) or SIR (n=206; 160-g adalimumab at week 0, 80-g dose at week 2), followed by 40-g doses from week 4 onward.

At week 12, patients were then re-randomized to receive maintenance therapy optimized through either CA (n=92) or TDM (n=92).

Clinical remission at week 4, one of the study’s primary outcomes, occurred at comparable rates in the HIR and SIR arms (44 percent for both; p=0.939). Similarly, endoscopic response at week 12, another primary outcome, did not differ between groups (43 percent vs 39 percent, respectively; p=0.462).

The researchers then conducted an exploratory efficacy analysis at week 56 to compare TDM vs CA. They found that both maintenance strategies yielded comparable rates of remission (66.3 percent vs 70.7 percent; p=0.497). Deep remission, defined as both clinical and endoscopic remission, was achieved by a similar proportion of patients in the respective subgroups (26.1 percent vs 29.3 percent; p=0.507).