New findings presented at the 20th Congress of ECCO, February 19–22, 2025, from the open-label extension study VIVID-2 (NCT04232553) provide evidence supporting the sustained efficacy of mirikizumab, an interleukin-23p19 inhibitor, over a one-year period in patients with moderate-to-severe active Crohn’s disease (CD) who were previously treated with ustekinumab.
The VIVID-2 study included patients who had completed the earlier phase III VIVID-1 trial (NCT03926130) and received ustekinumab (6 mg/kg intravenous [IV] at week 0, followed by 90 mg subcutaneous [SC] every 8 weeks). Upon enrolling in VIVID-2, these patients were switched to mirikizumab, with their dosing regimen determined by their endoscopic response status to ustekinumab at week 52 of VIVID-1.
Endoscopic responders (≥50% reduction from baseline in the Simple Endoscopic Score for Crohn’s Disease [SES-CD]) transitioned to SC mirikizumab 300 mg every four weeks (Q4W), while non-responders received an induction regimen of IV mirikizumab 900 mg at weeks 0, 4, and 8, followed by SC mirikizumab 300 mg Q4W. Efficacy was assessed at week 52 of VIVID-2, measuring endoscopic response, endoscopic remission (SES-CD ≤4 with ≥2-point reduction from baseline and no subscore >1 in any variable) and clinical remission (Crohn’s Disease Activity Index [CDAI] <150).
Of the 92 patients who had not achieved an endoscopic response to ustekinumab in the VIVID-1 trial and received mirikizumab IV-SC in VIVID-2, a total of 41.4% (Modified Non-Responder Imputation [mNRI]) and 46.2% (Observed Case [OC]) achieved endoscopic response, while 22.0% and 24.4% reached endoscopic remission. Notably, 75.0% and 84.8% of these patients achieved CDAI remission by week 52. Among the 122 patients who were considered endoscopic responders to ustekinumab in VIVID-1 and switched to mirikizumab SC in VIVIV-2, treatment efficacy was reported to be maintained across clinical and endoscopic endpoints. For those not in remission at the time of switching to mirikizumab, 57.2% and 60.0% achieved CDAI remission, while 26.5% and 28.3% reached endoscopic remission at one year.
Treatment-emergent adverse events (AEs) were reported in 64.7% of patients in the mirikizumab IV-SC group and 62.5% in the mirikizumab SC group. Serious AEs occurred in 6.9% and 7.0% of patients, respectively, while discontinuations due to AEs were 1% and 2.3%.
Concluding the results, the study investigators noted that in patients with moderately-to-severely active Crohn’s disease who had prior exposure to ustekinumab, mirikizumab can maintain clinical and endoscopic efficacy for up to one year. Among those patients who did not achieve an endoscopic response to ustekinumab in VIVID-1, more than 40% showed improvement by week 52 of switching to mirikizumab. In terms of safety, the findings were thought to be consistent with previously established data for mirikizumab.
The full abstract can be found here.
Further content in digestive disorders.
Disclosure: This article was created by the touchIMMUNOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
Support: No funding was received in the publication of this short article.
Cite: Mirikizumab maintains efficacy in patients with Crohn’s disease previously treated with ustekinumab: One-year results from VIVID-2. touchIMMUNOLOGY. February 26, 2025.
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