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

Impact of Mirikizumab Treatment on Fatigue in Patients with Moderately to Severely Active Crohn's Disease: Results from the Phase 3 VIVID-1 Study. (PubMed, J Crohns Colitis) - P3 | "Mirikizumab-treated patients with Crohn's disease achieved higher rates of clinically meaningful improvement in fatigue versus placebo at Weeks 12 and 52, which correlated with improvement in clinical and patient-reported outcomes. Baseline fatigue severity was strongly associated with depressive symptoms in VIVID-1 (NCT03926130)."

Journal • P3 data • CNS Disorders • Crohn's disease • Fatigue • Gastroenterology • Immunology • Inflammation • Inflammatory Bowel Disease

Interleukin-23 Inhibitors for Inflammatory Bowel Disease: Pivotal Trials and Practical Considerations. (PubMed, Curr Gastroenterol Rep) - "IL-23 inhibitors are safe and effective for treatment of moderate-to-severe inflammatory bowel disease and appear more effective than ustekinumab for Crohn's disease. The currently available IL-23 inhibitors likely have similar efficacy, but practical considerations may influence preferences."

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

Guselkumab (Tremfya) - an IL-23 antagonist for Crohn's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

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

IL-17A inhibitor-induced ulcerative colitis treated with an anti-IL-23 antibody. (PubMed, Clin J Gastroenterol) - "We present a case of ulcerative colitis caused by secukinumab, an anti-IL-17 receptor A monoclonal antibody, that was treated with mirikizumab, a p19-directed antibody against IL-23. In this case, an anti-IL-23 antibody was effective against ulcerative colitis induced by an Il-17A antibody agent. Although IL-23 exists upstream of the Th17 system, mirikizumab, an anti-IL-23 antibody preparation, has been shown to have the potential to alleviate UC."

Journal • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis • IL17A • IL17RA • IL23A

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.

New P4 trial • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

NICE recommends mirikizumab (Omvoh) for previously treated moderately to severely active Crohn’s disease (Pharmafile) - "Today, Eli Lilly and Company (Lilly) announced that the National Institute for Health and Care Excellence (NICE) has published final draft 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."

NICE • Crohn's disease

Omvoh: “Extension application to add a new strength of 200 mg grouped with an extension of indication to include treatment of adult patients with moderately to severely active Crohn's disease…based mainly on final results from study I6T-MC-AMAM…as a consequence, sections 1, 2, 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2, 5.3, 6.1, 6.5, 6.6 and 8 of the SmPC are updated.” (European Medicines Agency) - CHMP Final Minutes of the meeting on 9- 12 Dec 2024: “The committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable”

CHMP • Crohn's disease • Immunology

First Documented Case of Successful Dual Therapy With Upadacitinib and Mirikizumab for Multi-Refractory Ulcerative Proctitis. (PubMed, Inflamm Bowel Dis) - No abstract available

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

CD64 BINDING IS UNLIKELY TO CONTRIBUTE TO THE CLINICAL EFFICACY OF IL-23 INHIBITORS IN IBD (DDW 2025) - "Background: Risankizumab (RZB), guselkumab (GUS), mirikizumab (MIR) and ustekinumab (UST) are monoclonal antibodies that inhibit IL-23 and have been approved for IBD. The lack of significant binding of RZB, GUS and UST to CD64 in the presence of plasma indicates that under physiological conditions RZB, GUS and UST binding to CD64 is negligible and is unlikely to contribute to the mechanism of action and clinical efficacy of anti-IL23 antibodies."

Clinical • Inflammatory Bowel Disease • IL23A

With guselkumab, does the dual mechanisms to inhibit IL-23, help in ulcerative colitis? (PubMed, Expert Opin Biol Ther) - "Indirectly comparing trials suggests the clinical remission rates at the end of the trials was higher with guselkumab than with the other approved IL-23, inhibitors, mirikizumab or risankizumab (17 or 15% points, respectively). Thus, guselkumab may be more efficacious than the other 1 L-23 antagonists, possibly due to its additional action to block the CD64 receptor. However, this needs to be tested in a direct comparison trial."

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

PREVALENCE OF EXTRAINTESTINAL CUTANEOUS MANIFESTATIONS OF INFLAMMATORY BOWEL DISEASE IN NON-WHITE PATIENTS: A RETROSPECTIVE COHORT ANALYSIS (DDW 2025) - " In this retrospective cohort study, we used TriNetX, a healthcare database comprising over 119 million patients, to identify both White and non-White patients with a diagnosis of IBD who were prescribed at least one IBD-specific medication or advanced therapy including: Mesalamine, sulfasalazine, balsalazide, budesonide, azathioprine, methotrexate, 6-mercatopurine, infliximab, certolizumab, golimumab, adalimumab, vedolizumab, ustekinumab, tofacitinib, upadacitinib, risankizumab, mirikizumab, guselkumab, etrasimod, and ozanimod. With the rise of IBD in non-White populations, the representation of CM of IBD in this population is significantly limited, underrecognized, and thus undertreated. Our results reveal increased prevalence of several CM in the non-White IBD patient population. Notably, hidradenitis suppurativa has been shown to be associated with IBD, however our study is one of the first to highlight that it is significantly increased in IBD patients who are..."

Retrospective data • Cognitive Disorders • Dermatology • Dermatopathology • Gastroenterology • Gastrointestinal Disorder • Herpes Zoster • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Varicella Zoster • Vasculitis • Vitiligo

RISK FOR RECURRENT VTE IN IBD PATIENTS ON ANTICOAGULATION FOR JAK INHIBITORS COMPARED TO OTHER THERAPIES (DDW 2025) - "This population was then divided into patients who were prescribed a JAKi (tofacitinib for ulcerative colitis (UC) or upadacitinib for either UC or Crohn's disease) or other IBD-specific medications including: Mesalamine, sulfasalazine, balsalazide, budesonide, azathioprine, methotrexate, 6-mercatopurine, infliximab, certolizumab, golimumab, adalimumab, vedolizumab, ustekinumab, and risankizumab, mirikizumab, guselkumab, etrasimod, and ozanimod. IBD is associated with an increased risk of VTE. The evidence of recurrent VTE for patients with JAKi use is limited. Current disclaimers for JAKi emphasize risks of use in patients with history of VTE."

Clinical • Cardiovascular • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Inflammatory Bowel Disease • Respiratory Diseases • Ulcerative Colitis • Venous Thromboembolism

NET REMISSION RATES WITH ADVANCED THERAPIES IN ULCERATIVE COLITIS: AN ANALYSIS OF PHASE 3 RANDOMIZED CONTROLLED TRIALS (DDW 2025) - " Advanced therapies evaluated were (in order of FDA approval) infliximab (ACT), adalimumab (ULTRA), golimumab (PURSUIT), vedolizumab (GEMINI), tofacitinib (OCTAVE), ustekinumab (UNIFI), ozanimod (TRUE NORTH), upadacitinib (U-ACHIEVE), etrasimod (ELEVATE UC), mirikizumab (LUCENT), risankizumab (INSPIRE; COMMAND), and guselkumab (QUASAR). This exploratory analysis helps to contextualize the efficacy of advanced therapies for UC assessed with different trial designs among different populations and highlights the persistent treatment gap that remains in UC. Further head-to-head studies would allow for further understanding of differences across treatments. Reference: 1."

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

Mirikizumab (Omvoh) - an IL-23 antagonist for Crohn's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Cost per remission for mirikizumab versus ustekinumab for moderately to severely active ulcerative colitis treatment from the United States commercial payer perspective. (PubMed, J Med Econ) - No abstract available

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

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) - "The results from VIVID-2 showed clinical and endoscopic efficacy of Miri up to 1 year in patients with moderately-to-severely active CD previously exposed to Ust. Over 40% of Ust endoscopic non-responders in VIVID-1 achieved endoscopic response at W52 of Miri treatment. Safety data were consistent with the known Miri safety profile."

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

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) - P3 | "Week (W) 52 data comparing mirikizumab (Miri) vs placebo (PBO) and ustekinumab in the randomized, double-blind, placebo- and active-controlled, treat-through Phase 3 VIVID-1 trial in patients with moderately-to-severely active CD (NCT03926130) were reported previously. Histologic response seems to be an early objective sign of anti-inflammatory response and was significantly associated with one-year endoscopic and histologic outcomes, as well as biomarker normalisation."

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

MIRIKIZUMAB IS EQUALLY EFFECTIVE IN USTEKINUMAB-EXPOSED AND USTEKINUMAB-NAÏVE PATIENTS WITH UC: A MULTICENTRE REAL-WORLD COHORT. (DDW 2025) - "No difference in outcome was seen between uste-naïve and uste-exposed patients. In addition, exposure to multiple previous AT was not associated with diminished response."

Clinical • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Ulcerative Colitis • CRP

TREATMENT DISCONTINUATION IN PATIENTS WITH ULCERATIVE COLITIS OR CROHN'S DISEASE RECEIVING BIOLOGIC THERAPIES THAT REQUIRE INTRAVENOUS INFUSIONS DURING INDUCTION AND SUBCUTANEOUS INJECTIONS DURING MAINTENANCE (DDW 2025) - "Eligible patients were ≥18 years old, had a diagnosis of UC or CD, had ≥1 claim indicating an IV infusion of ustekinumab (UST), risankizumab (RZB), or mirikizumab (MKZ) on or after the respective FDA approval date, and had continuous enrollment for 6 months prior to (baseline) and 30 weeks post (follow up) the first biologic IV infusion (index biologic)...At baseline, 58.4% of patients had prior exposure to advanced therapies, with vedolizumab (17.0%) and adalimumab (16.0%) being the most common (Table 1)... Among patients with UC or CD treated with UST or RZB, one in five to one in four patients discontinued treatment during the transition from induction to maintenance. These findings underscore an unmet need in biologic therapy options, e.g., one without a need for transitioning from IV to SC. Study limitations include the lack of information on reasons for discontinuation and receipt of free trial offers for biologics using claims data."

Clinical • Crohn's disease • 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 OR USTEKINUMAB: POST HOC RESULTS FROM THE VIVID-1 STUDY (DDW 2025) - "The overall response was 70.3% for MIRI and 55.1% for USTE. For the 4 MIRI symptom response trajectory groups – Super Responder, Responder, Delayed Responder, and Non/Incomplete Responder – the proportion of Super Responders plus Responders was greater for MIRI vs USTE and the proportion of Non/Incomplete Responders was less for MIRI vs USTE, while the proportion of patients achieving clinical endpoints for MIRI was generally numerically greater than USTE for Super Responders plus Responders."

Clinical • Retrospective data • 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) - P3 | "VIVID-1 co-primary and gated endpoints, including comparison with ustekinumab (uste), are already reported 1, 2 . The results from this study show that the overall immunogenicity of miri is low. TE ADA did not adversely impact the clinical efficacy of miri for patients with moderately-to-severely active CD. This was also true in the subgroup of patients with high-titer TE ADA."

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • IL23A

MIRROR: Mirikizumab Real World Protocol (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: University of North Carolina, Chapel Hill | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2025 ➔ May 2025

Enrollment open • Real-world evidence • Trial initiation date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

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) - P3 | "MAIC results further support the high efficacy profile of MIR for maintaining clinical remission, providing additional information for treatment decisions for UC within the interleukin-23p19 class. 1. Louis E. et al."

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

COMPARATIVE EFFICACY OF BIOLOGICS AND SMALL MOLECULES IN CROHN'S DISEASE: A SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS (DDW 2025) - "As for maintenance of clinical remission, combination of infliximab and azathioprine ranked highest (78%) followed by mirikizumab (70%) and guselkumab (69%)...Secondary outcome analysis showed that upadacitinib (87%) ranked highest in induction of endoscopic remission followed by risankizumab (70%) and guselkumab (69%). As for maintenance of endoscopic remission, guselkumab (74%) ranked highest, followed by adalimumab (66%) and mirikizumab (63%)...This network meta-analysis showed that novel biologics such as mirikizumab, risankizumab and guselkumab ranked high in inducing clinical and endoscopic remission. This study highlights the role of novel biologic therapies as effective alternatives in patients with CD."

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

IMPACT OF MIRIKIZUMAB ON EXTRAINTESTINAL MANIFESTATIONS OF CROHN'S DISEASE IN THE VIVID-1 STUDY (DDW 2025) - "Treatment with mirikizumab led to higher rates of EIM resolution at W52 compared to placebo. Response rates for clinical and endoscopic outcomes were similar between patients with EIMs at baseline and the overall population in VIVID-1. 1"

Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Musculoskeletal Pain • Rheumatology