Celltrion Healthcare announced today that it presented new global Phase 3 results from its U.S. marketing authorization study of RAMSIMA SC (infliximab, subcutaneous) at the 2023 European Crohn's and Colitis Organization (ECCO) Congress in Copenhagen, Denmark, March 1-4 (local time).
The first study, which analyzed the efficacy and safety of RAMSIMA SC versus placebo in maintenance therapy following treatment with RAMSIMA in patients with Crohn's Disease (CD), was presented online as a digital oral presentation.
The study included 343 patients with moderate to severe CD who were randomized 2:1 to receive RAMSIMA SC at week 10 and placebo at week 54.
The primary endpoint of clinical remission was 62.3% with RAMSIMA SC and 32.1% with placebo, and endoscopic response was 51.1% with RAMSIMA SC and 17.9% with placebo, demonstrating statistically significant efficacy results. No new safety concerns were identified with maintenance treatment with RAMSIMA SC.
The second study was presented in a poster presentation, which analyzed whether maintenance treatment with RAMSIMA® SC demonstrated a statistically significant advantage over placebo in a Phase 3 study in patients with ulcerative colitis (UC).
438 patients with UC were treated with RAMSIMA through week 10 and then randomized in a 2:1 ratio to receive RAMSIMA SC or placebo, with data analyzed at week 54. Results showed that the primary endpoint of clinical remission was 43.2% in the RAMSIMA SC arm, compared to 20.8% in the placebo arm, and no new safety concerns were identified in the study.
"These trials further confirm the strength of RAMSIMA SC's high therapeutic efficacy in patients with inflammatory bowel disease (IBD)," said Dr. Jean-Frederic Colombel, Professor of Medicine at the Icahn School of Medicine at Mount Sinai in New York City, who participated in both trials. "The ease of self-administration at home with RAMSIMA SC maintenance treatment, as well as the strong benefits seen in the treatment of CD and UC, will likely increase physician and patient interest."
Celltrion Healthcare also presented posters such as "An Analysis of the Comparative Efficacy of Vedolizumab IV and SC Versus Infliximab IV in the Maintenance Treatment of Patients with Crohn's Disease and Ulcerative Colitis.
In addition, Celltrion Healthcare actively promoted its products at the booth, including various events to celebrate the 10th anniversary of the European sales of Ramsima, and received great response from attendees.
"At this year's ECCO, a number of studies demonstrating high efficacy and safety as well as ease of treatment for patients were presented, which attracted the attention of physicians attending the event," said a representative from Celltrion Healthcare. "These data are expected to further increase physician and patient prescribing preferences for Lamicta SC, and we will do our best to actively communicate them to the market and expand prescribing of Lamicta SC to more IBD patients."
