Photo Credit: ALIOUI Mohammed Elamine

The following is a summary of “Efficacy and Safety of the Anti-mucosal Addressin Cell Adhesion Molecule-1 Antibody Ontamalimab in Patients with Moderate-to-Severe Ulcerative Colitis or Crohn’s Disease,” published in the December 2023 issue of Gastroenterology by Vermeire et al.

Ontamalimab, a fully human monoclonal antibody, targets mucosal address cell adhesion molecule-1 and was developed to treat inflammatory bowel disease (IBD).

Researchers conducted a prospective study evaluating the effectiveness of ontamalimab, a human monoclonal antibody, in treating IBD .

They performed six phase 3, multicentre, randomized, controlled clinical trials of ontamalimab (25 mg and 75 mg every 4 weeks) against a placebo in patients with moderate-to-severe ulcerative colitis or Crohn’s disease. The trial ended in 2020, not concerning safety or effectiveness, but the findings of Crohn’s disease are in the Supplementary data.

The results showed 12-week induction studies with 659 patients and 52-week maintenance studies with 366 patients, where more patients achieved clinical remission with ontamalimab compared to placebo (25 mg: 18.5% vs. 15.8%, P= 0.617; 27.0% vs. 12.5%, P= 0.027; 75 mg: 29.8% vs 15.8%, P= 0.018; 29.5% vs 12.5% P= 0.014). Patients who received ontamalimab induction than placebo achieved clinical remission at week 12 (25 mg: 18.5% vs. 15.8%, P= 0.617; 27.0% vs. 12.5%, P= 0.027; 75 mg: 29.8% vs. 15.8%, P= 0.018; 29.5% vs. 12.5% P= 0.014). Endoscopic improvement was higher with ontamalimab (25 mg: 27.8% vs. 21.1%, P= 0.253; 35.1% vs. 12.5%, P= 0.001; 75 mg: 41.1% vs. 21.1%, P= 0.002; 33.9% vs. 12.5%, P= 0.003). Ontamalimab maintenance therapy showed better clinical remission rates (25 mg: 53.5% vs. 8.2%, P<0.001; 75 mg: 40.2% vs. 12.8%, P<0.001) and endoscopic improvement (25 mg: 56.3% vs 9.6%, P<0.001; 75 mg: 48.8% vs. 15.1%, P<0.001) than placebo. Adverse events were similar between groups.

Investigators concluded that Ontamalimab 75 mg was effective and safe as both induction and maintenance therapy for patients with moderate-to-severe ulcerative colitis across multiple clinical trials.

Source: academic.oup.com/ecco-jcc/advance-article/doi/10.1093/ecco-jcc/jjad199/7473342