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VIVID-2: Omvoh demonstrates ‘continued durability,’ safety in Crohn’s disease at 2 years
Longer-term data help patients and clinicians understand whether an initial response to a new biologic (mirikizumab) is likely to last and whether safety findings remain acceptable over two years.
Durability and safety in both biologic-naive patients and those with prior biologic failure are relevant when considering treatment options.
Patients with Crohn’s disease considering or receiving mirikizumab, clinicians who treat IBD, and IBD researchers tracking long-term biologic outcomes.
What To Know
VIVID-2 is an open-label extension reporting 104-week (2-year) durability and safety data for Omvoh (mirikizumab-mrkz) in patients with moderately to severely active Crohn’s disease who continued subcutaneous mirikizumab after initial response in the VIVID-1 trial.
The article summarizes maintenance of endoscopic response and remission rates, clinical remission rates, and key safety outcomes presented at Crohn’s & Colitis Congress.
Among patients who had endoscopic response at week 52, the majority maintained response through week 104; a substantial proportion also maintained or achieved endoscopic and clinical remission by week 104.
Safety findings reported included low percentages of severe treatment-emergent adverse events, serious adverse events, and very few discontinuations due to adverse events.
The report is based on an open-label extension presented at a conference; it describes outcome definitions (SES-CD thresholds and CDAI <150) and uses a modified nonresponder imputation for some analyses. The article cites a presentation (Barnes et al.) and includes author disclosures.
These are results from an open-label extension (VIVID-2) following a phase 3 randomized study; open-label designs and imputation methods can affect interpretation. The article summarizes a conference presentation—read the full study report or peer-reviewed publication for complete methods, detailed safety data, and subgroup analyses.
