Long-Term Efficacy and Safety of Mirikizumab Following 104 Weeks of Continuous Treatment for CD: Results From the VIVID-2 Open-Label Extension Study

Mirikizumab is an IL-23 p19 inhibitor that received FDA approval in January 2025 for the treatment of moderately to severely active ulcerative colitis.¹ The approval was based on results of the phase 3 VIVID-1 study, in which mirikizumab demonstrated a significant improvement over placebo in 2 composite endpoints: patient-reported outcome clinical response at week 12 and endoscopic response at week 52 (38.0% vs 9.0%; P<.0001), and patient-reported outcome clinical response at week 12 and CDAI clinical remission at week 52 (45.4% vs 19.6%; P<.0001).²

At DDW 2025, Edward L. Barnes, MD, MPH, and colleagues presented the long-term efficacy and safety of mirikizumab in 251 patients who were randomized to mirikizumab in VIVID-1 and continued on to the open-label extension study VIVID-2 (Table 6).³ Patients received induction therapy with mirikizumab 900 mg IV at weeks 0, 4, and 8 followed by mirikizumab SC q4w. Patients with endoscopic response at week 52 continued to receive the same dosage of mirikizumab in VIVID-2.

Table 6.

Long-Term Efficacy of Mirikizumab Following 104 Weeks of Continuous Treatment for CD

Parameter	Proportion of participants
	Modified nonresponder imputation approach	Observed-cases approach
Endoscopic responsea	81.8%	87.6%
Endoscopic remissionb	54.9%	58.7%
Clinical remissionc	79.0%	84.7%
Corticosteroid-free clinical remissiond	86.5%	92.6%

CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; SES-CD, Simple Endoscopic Score for Crohn’s Disease.

^aEndoscopic response: ≥50% improvement from baseline in SES-CD.

^bEndoscopic remission: SES-CD <4 and >2-point reduction from baseline, with no subscore >1 in any individual variable.

^cClinical remission: CDAI <150.

^dClinical remission by CDAI at week 52 and corticosteroid-free from week 40 to week 52.

Adapted from Barnes EL et al. Presented at: DDW 2025; May 3-6, 2025; San Diego, California, USA.

Abstract Tu1814.3

The VIVID-2 extension study highlights the long-term efficacy and safety of mirikizumab in moderate-to-severe CD. After 104 weeks, over 80% of patients maintained endoscopic response, and more than one-half achieved endoscopic remission. Impressively, clinical remission was sustained or newly achieved regardless of prior biologic failure. High persistence with therapy, low discontinuation, and favorable safety contrast with anti-TNF agents, possibly owing to low immunogenicity of this class. These findings underscore the importance of long-term data in guiding treatment decisions.

—Remo Panaccione, MD, FRCPC

At 104 weeks, endoscopic response was maintained in 81.8% of patients using a modified nonresponder imputation analysis or 87.6% in an observed-case analysis; endoscopic remission rates were 54.9% and 58.7% and clinical remission by CDAI was achieved in 79.0% and 84.7%, respectively. Endoscopic remission was maintained in 72.5% and 78.6% of patients who were in endoscopic remission at the end of VIVID-1 and was attained in an additional 33.3% and 35.4%, respectively. Clinical remission by CDAI was maintained by 86.9% and 92.9% of patients and was attained in an additional 55.8% and 60.8%, respectively.

Investigators reported that the efficacy of mirikizumab was generally similar regardless of prior biologic failure. During the first year of VIVID-2 (the second year of patients receiving mirikizumab), 64.3% of patients had at least 1 treatment-emergent AE, 6.8% developed a serious AE, and 2 patients (0.8%) discontinued mirikizumab owing to an AE.

The investigators concluded that the VIVID-2 extension study demonstrated the long-term efficacy of mirikizumab by clinical and endoscopic measures in patients with moderately to severely active CD, with many patients maintaining response and remission after 2 years and others gaining remission in the second year of treatment. Moreover, the safety outcomes were consistent with the known safety profile of mirikizumab.²

ABSTRACT SUMMARY Superior Clinical and Endoscopic Remission Rates With Vedolizumab in Early Versus Late CD: Data From the LOVE-CD Trial.

Oldenburg and colleagues presented results from the open-label, multi-center LOVE-CD trial comparing use of vedolizumab in early CD (<2 years and treatment-naive or treated with only corticosteroids and/or immuno-modulators) vs late CD (>2 years and treated with immunomodulators and anti-TNF agents plus corticosteroids) (Abstract Tu1893). Baseline CDAI and SES-CD were comparable between the early-CD cohort (n=86) and the late-CD cohort (n=174). At all timepoints between weeks 6 and 52, steroid-free clinical remission rates were higher in early CD vs late CD. The proportion of patients with steroid-free deep remissions (clinical [CDAI ≤150] and endoscopic [SES-CD ≤3] remission) at weeks 26 and 52 was significantly higher in the early-CD group vs the late-CD group (31.4% vs 8.6%; P<.001). Individual efficacy measures were also significantly better in the early-CD group. There was no benefit with dose intensification among patients with endoscopic nonresponse at week 26.