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

Efficacy and safety of Mirikizumab in the treatment of moderate to severe active ulcerative colitis: a systematic review. (PubMed, J Basic Clin Physiol Pharmacol) - "Mirikizumab improves clinical, endoscopic, and histological results in ulcerative colitis. This study highlights the clinical importance of Mirikizumab and its potential to change treatment standards for ulcerative colitis."

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

Mirikizumab: a landmark in IL-23-targeted therapy for ulcerative colitis. (PubMed, Ann Med Surg (Lond)) - No abstract available

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

Efficacy and safety of IL-23p19 and IL-12/23p40 inhibitors in moderate-to-severe Crohn's disease: a systematic review and network meta-analysis. (PubMed, Ann Med) - "Interleukin (IL)-23 inhibitors-including IL-23p19 inhibitors (guselkumab, mirikizumab, risankizumab) and the IL-12/23p40 inhibitor ustekinumab-are emerging treatments for Crohn's disease (CD), but comparative data among them remain limited. This is the first NMA comparing IL-23 inhibitors using contemporary evidence. The results offer practical insights for personalized CD treatment: guselkumab may be preferred for rapid response, mirikizumab for safety, and risankizumab for balanced efficacy."

Clinical • Journal • Retrospective data • Review • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • IL12A • IL23A

One Subcutaneous 2-ml Injection of Mirikizumab is Bioequivalent to Two 1-ml Subcutaneous Injections in Healthy Participants. (PubMed, Adv Ther) - P1 | "Mirikizumab 200 mg administered as one 2-ml SC injection was bioequivalent to two 1-ml injections, and most treatment-emergent adverse events were mild in both groups. In clinical practice, reducing the number of injections may improve treatment adherence."

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

TOPAZ-UC: LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis: (clinicaltrials.gov) - P2 | N=252 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Interleukin-23 (IL-23) inhibitor, mirikizumab in the treatment of ulcerative colitis (UC): a promising therapy? (PubMed, J Basic Clin Physiol Pharmacol) - "The trials data indicated that the treatment not only swiftly alleviated symptoms but also exhibited potential for sustaining remission over an extended period. This article seeks to offer a condensed overview of the noteworthy clinical trial outcomes that contributed to the development of mirikizumab, ultimately leading to its initial approval for the treatment of ulcerative colitis."

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

Serum and Histologic Eosinophilia as a Predictive Biomarker of Response to Mirikizumab in Ulcerative Colitis. (PubMed, Inflamm Bowel Dis) - P3 | "Baseline eosinophil levels may predict response to mirikizumab and guide early treatment decisions. These findings support a potential role for eosinophils as biomarkers in UC management."

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

AGA Living Clinical Practice Guideline on the Pharmacologic Management of Moderate-to-Severe Crohn's Disease. (PubMed, Gastroenterology) - "This guideline provides a comprehensive, patient-centered, evidence-based approach to the pharmacologic management of patients with moderate-to-severely active CD."

Clinical guideline • Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Advanced Drugs Should Be Used First In Crohn’s Disease, New Guidelines Suggest (SW Iowa News) - "In its new guideline, the AGA recommends infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab or upadacitinib as first-line treatments for moderate-to-severe Crohn’s disease...The guideline specifically suggests against using the class of immune-modulating drugs known as thiopurines to make Crohn’s symptoms go away."

Clinical guideline • Crohn's disease

Personalizing IL-23 Inhibitor Therapy in IBD: Current Evidence and Future Directions in Therapeutic Drug Monitoring and Dose Optimization. (PubMed, J Clin Med) - "Risankizumab, mirikizumab, and guselkumab share broadly similar pharmacokinetic and pharmacodynamic properties, including linear clearance, long half-lives, and low immunogenicity. However, this preliminary data is predominantly retrospective, often single-center, and involves a small number of patients. Until more robust evidence supporting the efficacy of TDM and dose optimization emerges, routine use of this clinical practice in IBD remains investigational."

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

Efficacy and safety of IL-23p19 antagonists versus placebo in inflammatory bowel disease: a systematic review and meta‑analysis of randomized controlled trials. (PubMed, Int J Clin Pharm) - "This meta-analysis confirms robust therapeutic benefits and acceptable safety of IL-23p19 inhibitors in IBD patients. Subgroup analyses showed IL-23p19 inhibitors maintained comparable efficacy regardless of prior biologic use, disease duration, or baseline C-reactive protein levels, indicating consistent efficacy across these clinical subgroups. Future longitudinal investigations should evaluate durability of treatment response and extended safety outcomes."

Journal • Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • CRP • IL12A • IL23A

Efficacy and safety of mirikizumab in paediatric participants with moderately-to-severely active ulcerative colitis (SHINE-1): a multicentre, open-label, non-randomised phase 2 trial. (PubMed, Lancet Gastroenterol Hepatol) - P2 | "Mirikizumab exhibited safety and efficacy in paediatric participants with moderately-to-severely active ulcerative colitis. These results support further evaluation of mirikizumab in the paediatric population."

Journal • P2 data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease • Osteoarthritis • Pain • Pediatrics • Respiratory Diseases • Ulcerative Colitis • IL23A

MIRACLE: Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed Moderate-to-severe Ulcerative Colitis (clinicaltrials.gov) - P4 | N=300 | Not yet recruiting | Sponsor: University Hospital Schleswig-Holstein

New P4 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Real-World Effectiveness of and Optimization Strategies for Mirikizumab in Pediatric Ulcerative Colitis: A Prospective, Observational Study. (PubMed, Inflamm Bowel Dis) - "MIRI can induce and sustain CR in pediatric UC, particularly when early optimization strategies are applied. These findings highlight IUS as a useful surrogate for mucosal healing and support MIRI as a promising, adaptable, and safe therapeutic option in pediatric UC."

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

Mirikizumab in ulcerative colitis: real-world evidence from an international two-center retrospective cohort study. (PubMed, Therap Adv Gastroenterol) - "Week-12 clinical response and clinical remission rates were comparable between exposed and naïve patients for anti-tumor necrosis factor agents, ustekinumab, vedolizumab, and Janus-kinase inhibitors. Mirikizumab was effective for inducing clinical response and well-tolerated in a substantial cohort of treatment-experienced patients with UC. This positions mirikizumab as a valuable option to the expanding therapeutic armamentarium for UC."

HEOR • Journal • Real-world evidence • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • TNFA

Requirements for Payer Recognition of Disease-Modifying Effect in New Drug Launches (ISPOR-EU 2025) - "The study examined recurring features cited by payers as value drivers, including clinical innovation, trial design, safety, and cost-effectiveness. All products achieving premium pricing addressed high unmet need, either by treating severe orphan diseases (e.g., Fintepla, Cablivi) or late-line settings (e.g., Omvoh)...Safety advantages and cost offsets (e.g., with Fintepla, Takhzyro, Tavneos) played a supportive role in reinforcing the perception of value. Achieving a disease-modifying profile and premium pricing is most viable when targeting high unmet need with compelling efficacy and clinical innovation... Achieving a disease-modifying profile and premium pricing is most viable when targeting high unmet need with compelling efficacy and clinical innovation. Novel mechanisms and clear differentiation enhance payer acceptance. While safety and economic benefits can reinforce value, they are insufficient without demonstrable clinical impact."

Cognitive Disorders

Baseline Characteristics and Treatment Persistence in UK Patients With Moderate-to-Severe UC Following 12-Week Mirikizumab Induction: Real-World Data From IBD BioResource (ISPOR-EU 2025) - "85.9% of patients had prior experience with advanced therapies, which included anti-tumour necrosis factor inhibitors (66.7%), vedolizumab (60.3%), Janus kinase inhibitors (28.2%) and ustekinumab (25.6%). Induction therapy with mirikizumab was successfully continued through 12 weeks in the majority of patients in a real-world UK cohort."

Clinical • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

VIVID-2: A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (clinicaltrials.gov) - P3 | N=996 | Active, not recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Dec 2026 ➔ Apr 2027

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

Meta-Analysis: Improvement of Bowel Urgency With Advanced Therapies for Inflammatory Bowel Disease. (PubMed, Aliment Pharmacol Ther) - "Advanced IBD therapies with different mechanisms of action produce rapid and sustained improvement in BU. The degree of BU improvement was similar among agents. Areas for future research include investigation of BU outcomes with other IBD therapies, exploration of underlying mechanisms of action, and greater standardisation for measuring BU through validated scores."

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

NOSTRICTURE: Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD (clinicaltrials.gov) - P4 | N=60 | Not yet recruiting | Sponsor: Alimentiv Inc. | Initiation date: Oct 2025 ➔ Feb 2026

Trial initiation date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

Dual-Targeted Therapy of Upadacitinib and Mirikizumab in Clinically Complex Ulcerative Colitis (ACG 2025) - "We present a case of medically resistant ulcerative colitis successfully treated with the combination of upadacitinib and mirikizumab.Case Description/ A 40-year-old woman with a history of left-sided UC diagnosed in 2003 initially achieved clinical remission with mesalamine and then switched to balsalazide...In 2006, she was treated with both mesalamine and 6-mercaptopurine (6-MP) and achieved clinical remission which was sustained for 12 years. After a relapse in Feb 2018 she switched to vedolizumab and achieved deep remission. A subsequent relapse in Aug 2022 prompted a switch to infliximab and reintroduction of mesalamine, however, this was not effective...Combination IL23 inhibitor and JAK inhibitors has been previously reported by our group and others, but not with mirikizumab. We demonstrate efficacy and safety of this unique approach."

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

Efficacy of Advanced Therapies for Naïve and Experienced Patients for Moderately-to-Severely Active Ulcerative Colitis: A Bayesian Network Meta-Analysis (ACG 2025) - "ADA, adalimumab; CrI, credible interval; ETS, etrasimod; FIL, filgotinib; GOL, golimumab; GUS, guselkumab; IFX, infliximab; MIR, mirikizumab; OZN, ozanimod; PBO, placebo; RR, relative risk; RZB, risankizumab; TOF, tofacitinib; UPA, upadacitinib; UST, ustekinumab; VDZ, vedolizumab. Four additional studies each for induction and maintenance were included. Results of pairwise comparisons across agents from the 2022 NMA were consistent. For additional agents, most pairwise comparisons had no significant difference at the end of induction and maintenance (Figs 1 & 2).For AT-N induction clinical remission, MIR 300mg was significantly less effective vs RZB 1200mg (RR, 0.7; 95% CrI, 0.5-1.0) and GUS 200mg was favored vs MIR 300mg (1.6, 1.1-1.2)."

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

Mirikizumab Long-Term Impact on Bowel Urgency in Crohn's Disease and Its Association With Clinical and Other Efficacy Outcomes: Results From the VIVID-2 Open-Label Extension Study (ACG 2025) - "Over 50% of the MIRI total group, 56% MIRI W52 endoscopic responders, and 43% MIRI W52 endoscopic non-responders achieved W104 BU remission. In the MIRI total group, a significantly higher percentage of pts achieved clinical remission, endoscopic remission and IBDQ remission at W104 in the BU remission group vs those without BU remission. The improvement in fatigue by FACIT-Fatigue score was significantly more in the group with BU remission vs those without BU remission (p< 0.0001)."

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

Incremental Improvement in Bowel Urgency Was Associated With Improved Patient-Reported Outcomes: Post Hoc Results From LUCENT-1 and -2 Trials (ACG 2025) - "Significantly greater proportions of patients receiving MIRI achieved UNRS score reduction of ≥1 point through ≥7 points versus PBO at W12 and W52. The reduction of each single point of UNRS score was associated with improvement in patient's physical and mental health, fatigue, work productivity, and quality of life. At W12, fatigue and IBDQ showed greater percent improvements among all the PRO outcomes studied for each 1-point reduction of UNRS."

Clinical • Patient reported outcomes • Retrospective data • Fatigue • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A

Demographics and Clinical Characteristics of Patients With Ulcerative Colitis Receiving First-Line Advanced Therapies Categorized in AGA Guidelines as Lower, Intermediate, and Higher Efficacy (ACG 2025) - "Patients were categorized into the higher (etrasimod, infliximab, ozanimod, upadacitinib, and vedolizumab), intermediate (golimumab, mirikizumab, tofacitinib, and ustekinumab), and lower (adalimumab) efficacy groups. In total, 3,833 and 2,719 patients were included from the IQVIA and Optum databases, respectively, with a substantial proportion of patients in the lower efficacy group (lower: 34.9% and 23.8%; intermediate: 8.8% and 12.3%; higher: 56.4% and 64.0%; Figure 1). Within the higher efficacy group in IQVIA and Optum databases, respectively, 59.5% and 61.7% received vedolizumab, 39.7% and 34.8% received infliximab, and < 1% and 3.5% received other treatments. Age was significantly associated with higher vs."

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