Omvoh (mirikizumab-mrkz) / Eli Lilly - LARVOL DELTA

Practical Considerations for the use of IL-23p19 Inhibitors in Inflammatory Bowel Disease: How to Choose Between Them and Why it Matters? (PubMed, J Crohns Colitis) - "Three such agents, Risankizumab, Mirikizumab and Guselkumab, have now been approved in CD and UC. Its use in combination with other advanced therapies in selected patients is being explored to enhance therapeutic efficacy and improve long-term outcomes. Further real-world studies are needed to assess its effectiveness and benefits in complex disease phenotypes, including perianal fistulizing Crohn's disease."

Journal • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis • IL23A

Network Meta-Analysis: Comparative Efficacy of Biologics and Small Molecules in the Induction and Maintenance of Remission in Crohn's Disease. (PubMed, Aliment Pharmacol Ther) - "Novel IL-23 inhibitors (such as mirikizumab, risankizumab and guselkumab) and anti-TNFs (such as infliximab and adalimumab) ranked high in the induction of clinical and endoscopic remission. This highlights the potential of novel advanced therapies for CD."

Journal • Retrospective data • Review • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • IL23A

Mirikizumab Eases Bowel Urgency in Crohn’s Disease (Medscape) - P3 | N=1158 | VIVID-1 (NCT03926130) | Sponsor: Eli Lilly and Company | "Of 778 patients analyzed, 579 received mirikizumab (mean age, 36 years; 42.7% women) and 199 received placebo (mean age, 36.3 years; 40.7% women). At baseline, 94.2% had an Urgency NRS ≥ 3 and 65.9% ≥ 6; Crohn’s disease activity index and abdominal pain positively correlated with bowel urgency. Mirikizumab significantly improved bowel urgency compared with placebo, with effects noted as early as week 6 (P < .05) and sustained through week 52. Among those with Urgency NRS ≥ 3 at baseline, mirikizumab significantly increased rates of both clinically meaningful improvement and remission at weeks 12 and 52 compared with placebo. However, differences were not significant for those with baseline Urgency NRS ≥ 6."

P3 data • Crohn's disease

What is the optimal biological therapy for moderate to severe ulcerative colitis: a systematic review and network meta-analysis. (PubMed, Front Pharmacol) - "No significant differences between active interventions were observed when assessing safety outcomes, except for visilizumab...Regarding safety ranking, golimumab 100 mg was the lowest. In this network meta-analysis, infliximab and vedolizumab emerged as the most effective biologics for inducing and maintaining efficacy outcomes for patients with UC. Most drugs were found to be safe and well-tolerated, with ustekinumab and mirikizumab exhibiting particularly favorable safety profiles."

Journal • Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Advanced therapies targeting IL-23: clinical outcomes in ulcerative colitis. (PubMed, Expert Opin Biol Ther) - "It discusses both ustekinumab, a nonselective IL-12/23p40 blocker, and selective IL-23p19 inhibitors (i.e. mirikizumab, guselkumab, and risankizumab), covering their mechanisms of action, clinical efficacy, and safety profiles from registrative and post-marketing studies. Oral agents represent an exciting frontier, potentially improving patient adherence and accessibility. Direct comparative trials are needed to refine therapeutic positioning in personalized treatment algorithms."

Clinical data • Journal • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL12A • IL23A • TYK2

Mirikizumab Efficacy in Ulcerative Colitis: Association With Pretreatment Geboes Score Features in a Case Series. (PubMed, Inflamm Bowel Dis) - No abstract available

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Bowel Urgency in Crohn's Disease: Effects of Mirikizumab in a Randomized Controlled Phase 3 Trial. (PubMed, Clin Gastroenterol Hepatol) - P3 | "Mirikizumab-treated participants achieved significantly higher rates of BU CMI and remission at W12 and W52, which was associated with better short- and longer-term clinical outcomes. VIVID-1 was registered on ClinicalTrials.gov, NCT03926130."

Journal • P3 data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pain • Ulcerative Colitis

Health Canada Approves Lilly’s Omvoh (mirikizumab) for Crohn’s Disease; New Citrate-Free Formulation (Canada Newswire) - "Eli Lilly Canada Inc. (Lilly Canada) announced today that Health Canada has approved Omvoh (mirikizumab) for CD, which will soon be available to patients in Canada. Omvoh is an interleukin-23p19 antagonist for the treatment of adult patients with moderately to severely active CD who have had an inadequate response, loss of response, or were intolerant to either conventional therapy or a biologic treatment. Health Canada has also approved a new citrate-free formulation of Omvoh for subcutaneous injection, for the existing UC indication, as well as the new CD indication....The authorization of Omvoh for CD was based on results from the VIVID-1 clinical study, which included over 1,000 adults."

Canada approval • Crohn's disease

Efficacy and safety of mirikizumab (LY3074828) in chronic plaque psoriasis: a systematic review and meta-analysis of randomized controlled trials (Front Med) - "Mirikizumab significantly increased the rates of achieving PASI 100, PASI 90, and PASI 75 compared to placebo. Mirikizumab also demonstrated superior efficacy in various secondary outcomes compared to placebo. Safety analysis indicated no significant differences in overall treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs), although upper respiratory tract infections occurred more frequently in the mirikizumab group."

Retrospective data • Psoriasis

Interleukin 23: Pathogenetic Involvement and Therapeutic Target for Ulcerative Colitis. (PubMed, J Clin Med) - "In recent years, several drugs selectively targeting IL-23 have been developed and three of them (mirikizumab, risankizumab and guselkumab) were successfully investigated in clinical trials for ulcerative colitis (UC). A role for IL-23-inhibitors may also lie in combination with drugs with different mechanisms of action for complex, multi-refractory patients. This review, focusing on UC, summarizes all the clinical data available on IL-23 inhibitors and provides a perspective on the best clinical scenarios to maximize their effectiveness."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A

Efficacy and safety of long-term mirikizumab treatment in patients with moderate-to-severe Crohn's disease (BSG 2025) - P2, P3 | "Rates of TEAEs of special interest were any infection/infestation, 54.7% (n=58); opportunistic infections, 3.8% (n=4; 1 candidiasis; 3 herpes zoster [with concomitant azathioprine use in 2 of these cases]); malignancies, 0.9% (n=1 non-melanoma skin cancer [basal cell carcinoma]); and cerebro-cardiovascular events, 0.9% (n=1 bradycardia).Conclusion Miri demonstrated durable efficacy up to >6 years in patients with moderately-to-severely active CD. Rates of endoscopic and clinical remission were generally maintained from the end of the AMAG maintenance period at Week 52. No unexpected safety events were reported and there were few discontinuations due to adverse events."

Clinical • Basal Cell Carcinoma • Candidiasis • Crohn's disease • Gastroenterology • Genetic Disorders • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Bowel Disease • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor • Varicella Zoster

Efficacy and safety of mirikizumab as induction and maintenance treatment in ≥60-year-old adults with moderately-to-severely active ulcerative colitis (BSG 2025) - P3 | "The safety profile for MIRI in older patients was consistent with the overall study population. There were no deaths and no discontinuations due to adverse events among MIRI-treated older adults.Conclusion Mirikizumab induced and maintained clinical response and was well tolerated in patients 60 years of age and older with moderately-to-severely active UC."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy of mirikizumab by baseline disease location in moderately-to-severely active crohn's disease: results of the phase 3 VIVID-1 study (BSG 2025) - P3 | "Introduction Results from the phase 3 VIVID-1 study (NCT03926130) showed the efficacy of mirikizumab (miri), an anti-IL-23p19 monoclonal antibody, versus (vs) placebo (PBO), and ustekinumab (uste) in moderately-to-severely active Crohn's disease (CD)1. For ileal CD, miri response rates were numerically greater vs PBO for all reported endpoints except W12 CDAI clinical remission.Conclusion These results by BL CD location are consistent with the VIVID-1 primary results, which demonstrated effectiveness of miri in achieving and maintaining symptomatic and endoscopic improvements up to 1 year. Analyses of patients with ileal-only disease were limited by the small sample size."

Clinical • P3 data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Association of faecal calprotectin with symptomatic, endoscopic, and clinical remission in patients with moderately-to-severely active ulcerative colitis treated with mirikizumab (BSG 2025) - P3 | "W12 fCAL levels had 83.0% predictability for W12 endoscopic remission, 78.5% for clinical remission, and 67.4% for symptomatic remission. W52 fCAL levels had higher predictability for W52 endoscopic (76.6%) and clinical remission (72.7%) than for symptomatic remission (62.3%).Conclusion These results support the use of fCAL as an early predictor of clinical outcomes and as a non-invasive biomarker for predicting clinical outcomes."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A

Early symptomatic improvement with mirikizumab induction therapy in patients with moderately-to-severely active crohn's disease: phase 3 vivid-1 study results (BSG 2025) - P3 | "Patients were randomized in a 6:3:2 ratio to receive miri (a single 900mg intravenous (IV) dose at W0, W4, and W8 followed by a subcutaneous (SC) dose of 300mg at W12 and then every 4 weeks), ustekinumab (uste) (6mg/kg IV at W0 and SC dose of 90mg at W8 and then every 8 weeks), or placebo (PBO). Increasing treatment effect was observed through W12. The safety of miri induction therapy was consistent with its known favourable safety profile."

Clinical • P3 data • Anemia • Crohn's disease • Gastroenterology • Immunology • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease • Oncology • Pain

Efficacy and safety of the mirikizumab extended induction cohort moderately-to-severely active ulcerative colitis: LUCENT-3 open-label extension study results (BSG 2025) - P3 | "In the safety population (N=150), 116 (77.3%) pts experienced TEAEs, with 9 (6.0%) experiencing severe TEAEs. There were 15 (10.0%) SAEs, with 1 (0.7%) death due to COVID-19 pneumonia, and 11 (7.3%) discontinuations due to AEs.Conclusion Mirikizumab demonstrates sustained efficacy up to W152 in patients with UC refractory to initial induction and who received extended induction, with no new safety concerns."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Ulcerative Colitis

Mirikizumab improves bowel urgency severity and frequency, and stool deferral time in ulcerative colitis patients: phase-3b LUCENT-URGE trial results (BSG 2025) - P3 | "Selecting patients with urgency and targeting BU improvement is a novel strategy to assess response to therapy for UC. Broader associations between BU and quality of life, UC symptoms, histopathologic findings, and gene expression data will be explored upon completion of the W28 LUCENT-URGE study."

Clinical • P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Long-term endoscopic and histological outcomes of mirikizumab in moderately-to-severely active ulcerative colitis with up to 3 years of treatment (BSG 2025) - P3 | "Greater than 90% of patients who maintained these outcomes at all timepoints during 3 years with MIRI achieved IBDQ remission.Conclusion MIRI maintained endoscopic and histologic outcomes through an additional 2 years of continuous treatment among clinical remitters at W52 (3 years in total). The achievement of LT durable and sustained endoscopic and histologic outcomes with MIRI was strongly associated with IBDQ remission."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Impact of mirikizumab induction, maintenance, and long-term treatment on disease clearance in ulcerative colitis: post HOC analysis of LUCENT trials (BSG 2025) - P3 | "The attainment of DC was associated with improvement in PROs in LUCENT-1 and -2. Early achievement of DC was associated with better."

Clinical • Retrospective data • Fatigue • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Mirikizumab versus placebo: histologic inflammation in 5 intestinal segments in randomized controlled phase 3 trial for crohn's disease participants (BSG 2025) - P3 | "For W52 composite H-Rem, nominally statistically significant differences between MIRI vs PBO were observed in all patients (p<.001), in non-BF patients (p<.05), and in BF patients (p<.001).Conclusions Based upon strict definitions that applied to all 5 intestinal segments, MIRI achieved nominally significantly higher rates of H-Res and H-Rem compared to PBO in all patients at W12 and W52. The statistical difference was more pronounced in the BF population after 1 year of treatment."

Clinical • P3 data • Crohn's disease • Gastroenterology • Immunology • Inflammation • Inflammatory Bowel Disease • Pain

Mirikizumab impact on disease clearance in patients with moderately to severely active ulcerative colitis: analysis of a pre-specified LUCENT trial endpoint. (PubMed, J Crohns Colitis) - P3 | "Mirikizumab consistently demonstrated disease clearance across induction, maintenance, and long-term studies. The attainment of disease clearance was associated with greater improvement in PROs, and early achievement of disease clearance was associated with better long-term outcomes, including clinical remission, corticosteroid-free remission, endoscopic and histological outcomes, reduced stool frequency, and rectal bleeding."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerative Colitis (clinicaltrials.gov) - P4 | N=150 | Not yet recruiting | Sponsor: Rubix LS

New P4 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Does Mirikizumab benefit patients with plaque psoriasis? a systematic review and meta-analysis. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Mirikizumab showed good responses in managing plaque psoriasis. However, additional clinical trials are required to verify its safety and evaluate its long-term efficacy."

Journal • Retrospective data • Dermatology • Immunology • Psoriasis

NICE recommends Eli Lilly’s treatment for Crohn’s disease (Pf Media) - "The National Institute for Health and Care Excellence (NICE) has published final guidance recommending mirikizumab (Omvoh) for use on the NHS in England and Wales as an option to treat moderately to severely active Crohn’s disease in adults only if: The disease has not responded well enough or stopped responding to a previous biological treatment, or A previous biological treatment was not tolerated, or Tumour necrosis factor (TNF)-alpha inhibitors are not suitable....Mirikizumab will now be available to eligible patients in England within 30 days, and within 60 days in Wales."

NICE • Crohn's disease

POSITIVE EFFICACY AND SAFETY OF MIRIKIZUMAB AS MAINTENANCE THERAPY IN CHINESE PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: SUBGROUP RESULTS FROM THE PHASE 3 LUCENT-2 STUDY (UEGW 2025) - No abstract available

Clinical • P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis