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

New Interleukin-23 Antagonists' Use in Crohn's Disease. (PubMed, Pharmaceuticals (Basel)) - "Selective new IL-23 inhibitors, including risankizumab, guselkumab, and mirikizumab, block the IL-23p19 subunit to inhibit the Il-23 action and alleviate inflammation in CD. Selective new IL-23 inhibitors represent a targeted and effective therapeutic class for moderately to severely active CD, offering high clinical and endoscopic remission rates, and favorable safety outcomes. Continued research, particularly on long-term efficacy and the selection of patients based on inflammatory biomarkers, will help optimize their role in personalized treatment strategies for refractory CD."

Journal • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Oncology • IL23A

Efficacy and Safety of Mirikizumab in the Treatment of Moderately to Severely Active Ulcerative Colitis Regardless of Baseline Modified Mayo Score: Results From the Phase 3 LUCENT Trials. (PubMed, Crohns Colitis 360) - P3 | "No new safety signals were identified during the 2-year follow-up. Mirikizumab delivered significant clinical benefit for patients with baseline mMS of 5-9 and demonstrated a favorable safety profile."

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

COMMIT-CD: Mirikizumab and Tirzepatide Concomitantly Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight: Phase 3b Study (clinicaltrials.gov) - P3 | N=290 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P3 trial • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Obesity

COMMIT-UC: Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study (clinicaltrials.gov) - P3 | N=350 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P3 trial • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Obesity • Ulcerative Colitis

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Jul 2030 ➔ Dec 2030 | Trial primary completion date: Jul 2030 ➔ Dec 2030

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis

SHINE-2: A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis (clinicaltrials.gov) - P3 | N=60 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Mar 2027 ➔ Aug 2026

Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis

Mirikizumab for Ulcerative Colitis: A Game-Changer or Just Another Incremental Advance? (PubMed, Dig Dis Sci) - No abstract available

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

AMAY: A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease (clinicaltrials.gov) - P3 | N=90 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Oct 2027 ➔ Apr 2028 | Trial primary completion date: Jul 2027 ➔ Dec 2027

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Pediatrics

Real-World Effectiveness and Safety of Mirikizumab Induction Therapy in Patients With Ulcerative Colitis: A Multicentre Retrospective Observational Study. (PubMed, Aliment Pharmacol Ther) - "This real-world study demonstrated the short-term effectiveness and safety of mirikizumab in patients with UC."

Journal • Observational data • Real-world evidence • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

Efficacy of Mirikizumab in Patients with Prior Ustekinumab Exposure: A Case Series. (PubMed, Inflamm Bowel Dis) - No abstract available

Journal

IL23p19 therapies for moderately-to-severely active ulcerative colitis. (PubMed, Expert Opin Biol Ther) - "In this review, we summarize and discuss phase 2 and pivotal phase 3 clinical trials informing the efficacy and safety of mirikizumab (AMAC, LUCENT, SHINE), risankizumab (INSPIRE, COMMAND), and guselkumab (QUASAR, VEGA)...These well-tolerated agents are effective in both advanced treatment-naïve and experienced patients. Accordingly, IL23p19 antagonists have potential to be used in a diverse population of patients with UC, and as potential platform therapies for future combinations with other targeted immunomodulatory agents."

Journal • Review • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis • IL23A

Pharmacokinetic Comparability and Safety Between Original and Citrate-Free Mirikizumab Formulations for Subcutaneous Injections: Results from Three Clinical Trials. (PubMed, Adv Ther) - P1 | "Mirikizumab CF and original formulations were bioequivalent. The CF formulation was associated with less pain and fewer ISRs, with no other notable differences in safety profiles."

Journal • PK/PD data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pain • Ulcerative Colitis • IL23A

Paradigm Shift in Inflammatory Bowel Disease Management: Precision Medicine, Artificial Intelligence, and Emerging Therapies. (PubMed, J Clin Med) - "Recent approvals of etrasimod, upadacitinib, mirikizumab, and risankizumab have introduced novel mechanisms of action, offering renewed hope for IBD patients. Emerging therapies, precision medicine, and ongoing research into novel targets promise to reshape the IBD treatment landscape. As these advances continue to unfold, IBD patients can anticipate a brighter future, one marked by more effective, personalized, and accessible treatments."

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

Mirikizumab Improves Quality of Life and Work Productivity in Patients with Moderately to Severely Active Crohn's Disease: Results from the Phase 3 VIVID-1 study. (PubMed, Am J Gastroenterol) - "Patients with moderately to severely active CD treated with mirikizumab reported clinically meaningful improvements in HRQoL and work productivity versus placebo at Week 12 which were maintained at Week 52."

HEOR • Journal • P3 data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Long-Term Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis: An Integrated 2-Year Safety Analysis. (PubMed, Am J Gastroenterol) - P3 | "The mirikizumab 2-year integrated safety profile in patients with moderately to severely active UC was consistent across subgroups and with previous findings, without new significant safety concerns."

Journal • Cardiovascular • Gastroenterology • Gastrointestinal Disorder • Hypertension • Immunology • Infectious Disease • Inflammatory Bowel Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Oncology • Pain • Ulcerative Colitis

Guselkumab (Tremfya) for ulcerative colitis. (PubMed, Med Lett Drugs Ther) - No abstract available

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

EARLY HISTOLOGIC RESPONSE AND REMISSION ARE STRONGLY ASSOCIATED WITH OBJECTIVE CONTROL OF INFLAMMATION AFTER ONE YEAR OF TREATMENT WITH MIRIKIZUMAB IN MODERATELY-TO-SEVERELY ACTIVE CROHN'S DISEASE (DDW 2025) - No abstract available

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

IMPACT OF MIRIKIZUMAB ON EXTRAINTESTINAL MANIFESTATIONS OF CROHN'S DISEASE IN THE VIVID-1 STUDY (DDW 2025) - No abstract available

Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

LACK OF SIGNIFICANCE OF TREATMENT-EMERGENT ANTI-DRUG ANTIBODIES ON EFFICACY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY-TO-SEVERELY ACTIVE CROHN'S DISEASE: RESULTS FROM THE VIVID-1 STUDY (DDW 2025) - No abstract available

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

EFFECTIVENESS AND SAFETY OF MIRIKIZUMAB AFTER SWITCHING FROM USTEKINUMAB IN PATIENTS WITH MODERATE TO SEVERE CROHN'S DISEASE: RESULTS FROM A LONG-TERM EXTENSION STUDY (DDW 2025) - No abstract available

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

PHARMACOKINETIC COMPARABILITY AND SAFETY BETWEEN ORIGINAL AND CITRATE-FREE MIRIKIZUMAB FORMULATIONS FOR SUBCUTANEOUS INJECTIONS: RESULTS FROM THREE CLINICAL TRIALS IN HEALTHY PARTICIPANTS (DDW 2025) - No abstract available

Clinical • PK/PD data • Inflammatory Bowel Disease

MIRIKIZUMAB IS EQUALLY EFFECTIVE IN USTEKINUMAB-EXPOSED AND USTEKINUMAB-NAÏVE PATIENTS WITH UC: A MULTICENTRE REAL-WORLD COHORT. (DDW 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Ulcerative Colitis

TRAJECTORIES OF RESPONSE IN PATIENTS WITH MODERATELY-TO-SEVERELY ACTIVE CROHN'S DISEASE TREATED WITH MIRIKIZUMAB OR USTEKINUMAB: POST HOC RESULTS FROM THE VIVID-1 STUDY (DDW 2025) - No abstract available

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

MATCHING-ADJUSTED INDIRECT COMPARISON ON CLINICAL REMISSION FOR MIRIKIZUMAB AND RISANKIZUMAB MAINTENANCE IN THE TREATMENT OF ADULTS WITH MODERATELY-TO-SEVERELY ACTIVE ULCERATIVE COLITIS (DDW 2025) - No abstract available

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

TRAJECTORIES OF RESPONSE IN PATIENTS WITH MODERATELY-TO-SEVERELY ACTIVE CROHN'S DISEASE TREATED WITH MIRIKIZUMAB BASED ON BIOFAILED STATUS: POST HOC RESULTS FROM THE VIVID-1 STUDY (DDW 2025) - No abstract available

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