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Two-Year Data Show Long-Term Benefits of Mirikizumab in Crohn Disease - eMPR.com
Long-term data matter because they show whether benefits and safety of a new biologic hold up beyond the initial trial period. For people with Crohn’s disease, sustained clinical remission and endoscopic healing are meaningful outcomes that can reduce symptoms and complications.
Adults with moderately to severely active Crohn’s disease (including those with prior biologic failure), clinicians who treat IBD, patients on biologic therapies, and researchers following long-term outcomes of IL-23 inhibitors.
What To Know
Continuous treatment with mirikizumab (Omvoh) in the open-label VIVID-2 extension study was associated with sustained clinical remission and endoscopic response at 2 years among patients who had responded at 1 year.
The article summarizes key outcome rates (proportion maintaining clinical remission, endoscopic response, and endoscopic remission) and reports that the safety profile over 2 years was consistent with prior data, listing common adverse reactions and rates of serious adverse events and discontinuation.
This is a report of 2-year results from the VIVID-2 open-label extension of prior randomized trials; most participants who were in remission at 1 year remained in remission at 2 years. The measures cited include CDAI for clinical remission and SES-CD changes for endoscopic response and remission.
The article references the VIVID-1 randomized phase 3 study as the basis for initial approval and notes additional VIVID-2 data will be presented at a professional congress.
Safety note: The article states the 2-year safety findings were consistent with earlier reports and lists commonly reported adverse reactions; it also gives brief rates for serious adverse events and discontinuations during the extension phase.
Limitations: The reported numbers come from an open-label extension population of patients who had already achieved response at 1 year, which can overrepresent those who do well on continued therapy.
These results are from an open-label extension (VIVID-2) of prior phase 3 work; the figures describe the subset of patients who were in remission at 1 year and continued on treatment. Open-label extensions often enroll responders and lack a placebo control, so they are useful for durability and safety signals but not for assessing comparative efficacy.
Full trial details and additional data will be presented at the Crohn’s and Colitis Congress.
