Omvoh (mirikizumab) — A Lilly Medicine

For adults with moderately to severely active UC1

Nearly 2 in 3 patients taking Omvoh achieved clinical response at Week 121

63% of patients taking Omvoh achieved clinical response after 12 weeks of induction dosing, and nearly 1 in 4 achieved clinical remission.

Clinical Response (secondary endpoint) at Week 12: 63% Omvoh vs 42% placebo (p<0.001). Clinical Remission (primary endpoint) at Week 12: 24% Omvoh vs 13% placebo (p<0.001).
  1. a Clinical response was defined as a decrease in the modified Mayo Score (MMS) of ≥2 points and ≥30% from baseline, with either a decrease in rectal bleeding subscore of ≥1 or an absolute rectal bleeding subscore of 0 or 1.
  2. b Clinical remission was defined as an MMS subscore of stool frequency = 0 or 1 (with ≥1-point decrease from baseline), rectal bleeding = 0, and endoscopic = 0 or 1 (excluding friability).

IV=intravenous; MMS=modified Mayo Score; Q4W=every 4 weeks; UC= ulcerative colitis.

Among patients who achieved clinical response with Omvoh at Week 121

Omvoh demonstrated sustained clinical remission and mucosal healing at Week 521

Week 52 Endpoints: Clinical Remission (primary) 50% vs 25% placebo. Endoscopic Improvement (secondary) 59% vs 29% placebo. HEMR (secondary) 43% vs 22% placebo. All p<0.001. Omvoh 200 mg SC Q4W (N=365) vs Placebo (N=179).

Post Hoc Analysis2

98% of patients who achieved clinical remission at Week 52 with Omvoh were corticosteroid-free for at least 12 weeks (n=178/182).

12 weeks of continuous treatment includes the period of intermittent oral corticosteroid use during LUCENT-2.

  1. a Clinical remission was defined as an MMS subscore of stool frequency = 0 or 1 (with ≥1-point decrease from baseline), rectal bleeding = 0, and endoscopic = 0 or 1 (excluding friability).
  2. b Endoscopic improvement was defined as an MMS endoscopic subscore of 0 or 1 (excluding friability).
  3. c HEMR was defined as endoscopic remission plus histologic remission per Geboes scoring.

HEMR=histologic-endoscopic mucosal remission; MMS=modified Mayo Score; SC= subcutaneous; Q4W=every 4 weeks.

Among patients who achieved clinical response with Omvoh at Week 121

Omvoh demonstrated clinical remission regardless of biologic experience1

Bio-naïvea and Bio-failedb Patients Achieved Clinical Remission at Week 521

Bio-naïve and Bio-failed Patients Achieved Clinical Remission at Week 52: Omvoh 52% vs Placebo 31% in Bio-naïve (N=229 vs N=114). Omvoh 46% vs Placebo 16% in Bio-failed (N=128 vs N=64).
  1. a Bio-naïve includes patients who either had not been treated with biologics or were exposed to biologics but did not experience inadequate responses, loss of response, or intolerance.
  2. b Bio-failed includes prior biologic failures (inadequate response, intolerance to one or more biologic therapy).
  3. Prespecified subgroup analysis not controlled for multiplicity.

Bio-failed=biologic-failure; bio-naïve=biologic-naïve; SC= subcutaneous; Q4W=every 4 weeks.

For adults with moderately to severely active UC1

Omvoh achieved and sustained clinical remission up to 4 years1,2

78% achieved Clinical Remission at Year 4 (N=103). 100% of Omvoh-treated patients who maintained Clinical Remission up to 4 Years were FREE OF CORTICOSTEROIDS for at least 12 weeks prior to Week 160.
  1. Clinical remission was defined as an MMS subscore of stool frequency = 0 or 1 (with ≥1-point decrease from baseline), rectal bleeding = 0, and endoscopic = 0 or 1 (excluding friability).
  2. Observed case (OC) population: patients who completed Week 160 of continuous Omvoh treatment.

MMS=modified Mayo Score; OC= observed case.

For adults with moderately to severely active UC1

Patients achieved clinical, endoscopic and BU remission, along with HEMR up to 4 years1,2

4 in 5 patients achieved and sustained long-term Clinical Remission following 4 years of continuous treatment with Omvoh. Remission rates at Year 4: Clinical 78%, Endoscopic 81%, Histologic-Endoscopic Mucosal 66%, Bowel Urgency 74%.
  1. Efficacy at Week 212 — endoscopic remission, histologic-endoscopic mucosal remission (HEMR), and bowel urgency remission shown for Week 12 remitters.
  2. Observed case (OC) analysis. Prespecified secondary and exploratory endpoints not controlled for multiplicity.

BU=bowel urgency; HEMR= histologic-endoscopic mucosal remission; OC=observed case.

For adults with moderately to severely active UC1

Omvoh significantly improved bowel urgency as early as Week 2 vs placebo, sustained up to 4 years1–3

Analysis was completed for patients in the mITT population to estimate the mean change from induction baseline.

Urgency NRS Change From Baseline (LSM, MMRM) over 212 weeks of continuous treatment across LUCENT-1 (mITT Induction 0-12 weeks), LUCENT-2 (Omvoh Induction Responders Maintenance 0-52 weeks), and LUCENT-3 (Omvoh Maintenance Completers Extension 0-212 weeks). Omvoh led to early and sustained control of bowel urgency up to 4 years.
  1. MMRM was used for treatment comparison adjusting for baseline stratification factors. LSM were reported for each treatment group except for W0 of maintenance (W12 continuous treatment); no treatment comparisons in LUCENT-3.2
  2. Patients who were induction responders and who moved into LUCENT-3.2

CMI=clinically meaningful improvement; LSM=least squares mean; mITT= modified intent-to-treat; MMRM=mixed-effect model of repeated measures; NRS=numeric rating scale; PBO=placebo.

BU = bowel urgency; HEMR = histologic-endoscopic mucosal remission; IV = intravenous; LSM = least squares mean; mITT = modified intent-to-treat; MMRM = mixed-effect model of repeated measures; MMS = modified Mayo Score; NRS = numeric rating scale; OC = observed case; PBO = placebo; Q4W = every 4 weeks; RB = rectal bleeding; SC = subcutaneous; SF = stool frequency; UC = ulcerative colitis.

  1. Omvoh EUSPC FEB 2025.
  2. Sands BE, et al. Inflamm Bowel Dis. 2025;31(7):1876–1890.
  3. D'Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med.2023;388(26):2444–2455.