VIVID-2: Militizumab shows 'sustained durability' and safety in Crohn's disease at 2 years

In theVIVID-1 study, more than 80% of milikizumab (Mirikizumab) responders maintained endoscopic response at VIVID-2 Week 104. Endoscopic and clinical response rates remained at 72.5% and 86.9%, respectively. The majority of patients with moderately to severely active Crohn's disease (CD) achieved endoscopic response and remission after 52 weeks of treatment with militizumab and maintained these results through 104 weeks, according to results from the VIVID-2 study.

Durability of response and response was a key outcome among patients with endoscopic response at week 52 of the pilot study. Endoscopic responses remained above 80% over the next 52 weeks and above 85% among patients in clinical response at week 104, which is key to understanding the durability of this therapy.

In the Phase 3 VIVID-1 study, patients with moderately to severely active CD who were randomly assigned to militizumab received 900 mg intravenously for induction at 0, 4, and 8 weeks, followed by 300 mg subcutaneously every 4 weeks. In the ongoing open-label VIVID-2 extension study, patients who achieved an endoscopic response (defined as at least a 50% decrease in Simple Endoscopic Score for CD (SES-CD) from baseline) at Week 52 continued to receive militizumab 300 mg subcutaneously.

VIVID-2 outcomes at 104 weeks included endoscopic response; endoscopic remission, defined as an SES-CD of 4 or less and a reduction of at least two points from baseline; and clinical remission, defined as a CD Activity Index score below 150. Researchers also evaluated safety from the first dose of VIVID-2 through August 2, 2024.

Using a modified no-think imputation method, the researchers found that among patients who achieved an endoscopic response at week 52, 81.8% maintained an endoscopic response at week 104, with 54.9% achieving endoscopic mid-remission and 79% achieving clinical remission. Among patients with endoscopic response at week 52, 72.5% remained in response.

Another key takeaway from the study was that one-third of patients who did not have endoscopic response at week 52 achieved endoscopic response at week 104. Additionally, 86.9% of patients maintained clinical remission at Week 104, and among patients who did not have clinical remission at Week 52, 55.8% achieved clinical remission at Week 104. Similar results were observed between patients with and without prior biological failure, the researchers noted.

Overall, 3.4% of patients experienced serious treatment-emergent adverse events, and 6.8% of patients experienced a serious adverse event. 0.8% of patients discontinued treatment due to adverse events.

In the absence of any new safety signals, the durability of treatment demonstrates the overall balance of efficacy and safety that we hope to achieve with Crohn's disease treatments in the current era. Particularly when considering outcomes in biologic-naïve and prior biologic failure patients, this demonstrates the potential efficacy of militizumab in multiple settings in patients with Crohn's disease and should also give those who achieve initial response/remission with militizumab confidence in the continued durability of treatment.

References:https://www.healio.com/news/gastroenterology/20250213/vivid2-omvoh-demonstrates-continued-durability-safety-in-crohns-disease-at-2-years