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

DUAL MODULATION OF GPBAR1/RORΓT ATTENUATES CHOLESTATIC INFLAMMATION VIA IL-23/IL-17 PATHWAY REGULATION IN MURINE MODEL OF PSC (UEGW 2025) - "Recent clinical studies have demonstrated that IL-23 inhibitors, such as risankizumab [6] and mirikizumab [7], are effective in treating IBD, highlighting the significance of the IL-23/IL-17 axis. PBT002 exerts potent immunomodulatory effects in experimental PSC by rebalancing M1/M2 and Th17/Treg homeostasis through dual GPBAR1 activation and RORγt inhibition. These effects correlate with restoration of bile acid and microbiota profiles, confirming the key role of the microbiota–bile acid–immune axis in PSC and supporting PBT002's clinical development for immune-mediated cholangiopathies, particularly in PSC-IBD overlap."

IO biomarker • Preclinical • Cholestasis • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatology • Inflammation • Inflammatory Bowel Disease • Liver Cirrhosis • Liver Failure • Ulcerative Colitis • ABCB4 • CD4 • IL17A • IL17RA • IL22 • IL23A • PD-L1

EFFICACY OF BIOLOGIC AGENTS AND SMALL MOLECULES FOR ENDOSCOPIC IMPROVEMENT AND MUCOSAL HEALING IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS: A SYSTEMATIC REVIEW AND META-ANALYSIS (UEGW 2025) - "In biologic-naïve patients or those without prior biologic failure, all interventions—except filgotinib 100 mg and vedolizumab—were significantly superior to placebo, with etrasimod showing the highest efficacy (RR 3.12, 95% CI: 1.79–5.43). Among biologic-exposed patients or those with prior biologic failure, upadacitinib, mirikizumab, ustekinumab, etrasimod, tofacitinib, and risankizumab 180 mg were significantly superior to placebo...In biologic-naïve patients or those without prior biologic failure, only etrasimod, mirikizumab, upadacitinib 30 mg and subcutaneous infliximab were significantly superior to placebo, with upadacitinib showing the highest efficacy (RR 3.02, 95% CI: 1.18–7.71)... Biologic and small-molecule therapies demonstrated substantial efficacy in achieving key endoscopic and histologic endpoints in moderate to severe UC. Upadacitinib consistently showed the highest efficacy across both induction and maintenance phases. Stratified analyses..."

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

JAK INHIBITORS EXHIBIT SUPERIOR CLINICAL EFFICACY COMPARED TO ANTI-IL-23 BIOLOGICS IN REFRACTORY ULCERATIVE COLITIS (UEGW 2025) - "Vedolizumab has also demonstrated effectiveness when introduced early in the disease course with a greater 52-week treatment persistence and reduced hospitalisation rates compared to anti-TNFα agents as second-line therapy (2)...Notably, Guselkumab is not yet approved for UC treatment in the UK...Within the anti-IL-23 group, 5 patients received Mirikizumab and 8 Ustekinumab; Risankizumab was not used in this cohort. In the JAK group, 3 patients were treated with Upadacitinib, 4 with Filgotinib, and 4 with Tofacitinib...Subtotal colectomy was performed in one patient in the Mirikizumab group following completion of induction therapy, and in two additional patients within three months of initiating the same agent (Table 1).BiologicPatients (N)Colectomy(N)Drug persistenceMirikizumab533/5Ustekinumab815/8Upadacitinib303/3Filgotinib403/4Tofacitinib404/4Table 1... JAK inhibitors showed an improvement in SCCAI at 6 months compared to anti-IL-23 agents. No significant differences..."

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

Examine mirikizumab's efficacy in achieving current and future endpoints (UEGW 2025) - "Sponsored By Eli Lilly and Company."

Clinical

Review how mirikizumab provides symptomatic relief: from trials to clinical practice (UEGW 2025) - "Sponsored By Eli Lilly and Company."

Clinical • Review

Delve into how mirikizumab meets emerging goals: from trials to practice (UEGW 2025) - "Sponsored By Eli Lilly and Company."

Ulcerative Colitis

Explore mirikizumab's efficacy across early and intermediate endpoints with real-world insights (UEGW 2025) - "Sponsored By Eli Lilly and Company."

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

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) - "Randomization was stratified by biologic agent/tofacitinib failed status, induction remission status and baseline corticosteroid (CS) use.The primary objective was to test the hypothesis that Miri was superior to PBO in achieving clinical remission at Week 40. In Chinese patients who responded to miri induction therapy, miri's maintenance treatment provided positive efficacy and safety profiles consistent with LUCENT-2 overall population, supporting benefits of miri treatment in the Chinese ulcerative colitis patients.Table 1: Primary and key secondary endpoints of LUCENT-2 at Week 40 in Chinese population (Miri Induction Respondersa)Placebo SCN=24Miri 200 mg SCN=56Clinical Remissionb, n (%)Common risk difference vs placebo3 (12.5)28 (50.0)40.4Alternate Clinical Remission c, n (%)Common risk difference vs placebo3 (12.5)31 (55.4)45.4Corticosteroid-free Clinical Remissiond, n (%)Common risk difference vs placebo2 (8.3)26 (46.4)40.2Endoscopic Remissione, n (%)Common..."

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

EFFICACY AND SAFETY OF MIRIKIZUMAB AS INDUCTION THERAPY FOR CHINESE PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: A SUBGROUP ANALYSIS OF THE PHASE 3 LUCENT-1 STUDY (UEGW 2025) - P3 | "Aims & In this Phase 3, multi-center, randomized, parallel-arm, double-blind, placebo-controlled trial, conventional-failed or biologic/tofacitinib-failed Chinese adult patients (N=184) with moderately to severely active ulcerative colitis (UC, Modified Mayo Score 4-9, endoscopic subscore ≧2) were randomized in a 3:1 ratio to 300 mg mirikizumab (intravenous) or placebo every 4 weeks for 12 weeks. Efficacy and safety profiles were consistent with LUCENT-1 overall population, supporting benefits of mirikizumab treatment in the Chinese UC patients."

Clinical • P3 data • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Solid Tumor • Ulcerative Colitis

EFFECTIVENESS AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS: REAL WORLD PRELIMINARY DATA FROM LATIUM NET (UEGW 2025) - "In a large cohort of refractory UC patients with multiple prior drug failures, including frequent failures with Ustekinumab and infliximab, nearly 55% achieved steroid-free clinical remission following mirikizumab induction. The safety profile of mirikizumab was consistent with existing literature."

Clinical • Real-world • Real-world evidence • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Psoriasis • Rheumatology • Ulcerative Colitis • CRP • IL23A

VALIDATING CALIBRATION OF AN ARTIFICIAL INTELLIGENCE ASSESSMENT OF ENDOSCOPIC SEVERITY IN ULCERATIVE COLITIS (UEGW 2025) - P3 | "We assessed calibration on a holdout test set of 639 videos (~25%) from the Phase 3 induction trial for mirikizumab in UC (NCT03518086)... Whereas data on the certainty of human readers in endoscopy subscore assessments are elusive, AI-ES is calibrated across all endoscopy subscore classes, providing reliable data on score probabilities. This novel measurement of certainty by AI-ES added to the score assessment may enable novel AI-based multi-reader or consensus workflows in trials, potentially improving the reliability of UC endpoint assessments."

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

WEEK 12 EFFECTIVENESS AND SAFETY OF MIRIKIZUMAB IN DIFFICULT-TO-TREAT ULCERATIVE COLITIS - PROSPECTIVE REAL-WORLD EVIDENCE FROM THE INITIATIVE ON CROHN AND COLITIS REGISTRY (UEGW 2025) - "Twelve patients (54.5%) had used at least four different advanced therapies; 19 (86.4%) patients have previously used ustekinumab (IL-12/23 inhibitor). We found that 7/16 patients with difficult-to-treat UC were in either clinical, biochemical or endoscopic remission at W12. Moreover, all patients in clinical remission at W12 were not using other medications. Mirikizumab was well tolerated, although the follow-up period was relatively short."

Clinical • HEOR • Real-world • Real-world evidence • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Ulcerative Colitis • IL12A

COMBINED ACHIEVEMENT OF SYMPTOMATIC AND BIOMARKER REMISSION WITH MIRIKIZUMAB IN PATIENTS WITH ULCERATIVE COLITIS IN THE PHASE 3 LUCENT STUDIES (UEGW 2025) - P3 | "At W12 and W24, 2.9% and 23.5% of the extended induction group achieved combined symptomatic response and biomarker remission endpoints, respectively, while 1.1% and 13.2% achieved the combined remission endpoints.WeekDoseSymptomatic responsea and FCP ≤250 μg/g, n (%) Common risk difference (CI)bP-ValueSymptomatic remissionc and FCP ≤250 μg/g, n (%) Common risk difference (CI)bP-ValueWeek 4Miri, N=868123 (14.2)5.7 (1.7, 9.6)0.011363 (7.3) 3.7 (0.9, 6.4) 0.0282 PBO, N =294 25 (8.5)11 (3.7) Week 12Miri, N=868288 (33.2)14.8 (9.4, 20.2)<0.0001206 (23.7) 12.7 (8.1, 17.3) <0.0001 PBO, N =294 55 (18.7)33 (11.2) Week 52Miri, N=365 198 (54.3)25.4 (17.3, 33.6)<0.0001177 (48.5) 25.0 (17.3, 32.6) <0.0001 PBO, N=179 49 (27.4)39 (21.8) Table 1: Proportion of patients with Ulcerative Colitis who achieved combined symptomatic and biomarker endpoints in LUCENT-1/-2 studiesaDefined as ≥30% decrease from baseline of the sum of stool frequency (SF) and rectal bleeding (RB)..."

Biomarker • Clinical • P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A

COMPARISON OF MIRIKIZUMAB VS. USTEKINUMAB EFFICACY FOR INDUCTION OF REMISSION IN ULCERATIVE COLITIS – A 1:2 MATCHED ANALYSIS (UEGW 2025) - "Mirikizumab is an effective induction treatment for patients with active ulcerative colitis, including those who previously did not respond adequately to Ustekinumab therapy."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL12A • IL23A

MIRIKIZUMAB DEMONSTRATES LONG-TERM EFFICACY ON HISTOLOGICAL RESOLUTION IN THE PHASE 3, MULTICENTER, OPEN-LABEL VIVID-2 EXTENSION STUDY (UEGW 2025) - "In VIVID-2, achievement of histologic response and remission after one year of miri treatment was strongly associated with longer term endoscopic outcomes. High rates of histologic and combined endo-histo endpoints were maintained after 2 years of miri treatment."

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

ONE SUBCUTANEOUS INJECTION OF MIRIKIZUMAB IS BIOEQUIVALENT TO TWO SUBCUTANEOUS INJECTIONS: RESULTS FROM A PHARMACOKINETIC COMPARABILITY STUDY IN HEALTHY PARTICIPANTS (UEGW 2025) - P1 | "Miri 200 mg administered as one 2-ml SC injection was bioequivalent to two 1-ml injections, and most TEAEs were mild. In clinical practice, reducing the number of injections may improve patient experience and treatment adherence."

Clinical • PK/PD data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Ulcerative Colitis

SUBCUTANEOUS MIRIKIZUMAB MAINTENANCE TREATMENT OVER 40 WEEKS LEADS TO INCREMENTAL IMPROVEMENTS IN RATES OF CLINICAL REMISSION AND ENDOSCOPIC RESPONSE: RESULTS FROM THE PHASE 3 VIVID-1 STUDY (UEGW 2025) - P3 | "Subcutaneous mirikizumab maintenance treatment over 40 weeks leads to incremental and sustained improvements in rates of clinical and endoscopic response regardless of PRO clinical response status after induction. A substantial proportion of clinical nonresponders at W12 improved early during maintenance treatment suggesting continued treatment with mirikizumab can be beneficial and lead to long-term response."

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

MIRIKIZUMAB-TREATED PATIENTS ARE ASSOCIATED WITH REDUCED RISK OF UC-RELATED HOSPITALIZATION AND SURGERY IN PATIENTS WITH ULCERATIVE COLITIS IN LUCENT TRIALS (UEGW 2025) - P3 | "Lower rates of UC-related hospitalizations and UC-related surgery were observed in patients treated with MIRI compared to those treated with PBO during the 12W induction LUCENT-1, and that impact continued through the 40W of maintenance LUCENT-2 with no UC-related hospitalizations or UC-related surgery reported in MIRI-treated patients."

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

IS 11 Paving the way to comprehensive management in CD: Long-term remission with mirikizumab (Eli Lilly and Company) (UEGW 2025) - "Sponsored By Eli Lilly and Company."

Clinical

IS 06 Driving the evolution of treatment goals in UC management: Long-term remission with mirikizumab (Eli Lilly and Company) (UEGW 2025) - "Sponsored By Eli Lilly and Company."

Clinical • Ulcerative Colitis

EFFECTIVENESS AND SAFETY OF MIRIKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS: A REAL-LIFE MULTICENTER STUDY (UEGW 2025) - "Most patients (81, 81%) were already treated with at least one advanced therapy before starting mirikizumab (including 28 patients treated with ustekinumab, 28%). This is the largest study demonstrating the effectiveness and safety of mirikizumab in inducing clinical remission in patients with UC in a real-life setting. Patients treated with mirikizumab achieved a significant reduction in bowel urgency, FC and CRP levels. No statistically significant increase in liver toxicity was detected during the induction treatment."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Respiratory Diseases • Ulcerative Colitis • CRP

SHORT-TERM EFFECTIVENESS AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS: REAL-WORLD EVIDENCE FROM THE ENEIDA REGISTRY OF GETECCU (UEGW 2025) - "Prior advanced therapies exposure was: 89% Anti-TNF, 69% vedolizumab, 54% ustekinumab, and 40% JAK inhibitors, with 54% exposed to > 2 mechanisms of action (MoA). MIRI demonstrated its real-life effectiveness in the short-term, even in a highly-refractory cohort. Prior advanced therapy exposure to more than one MoA significantly impacts the effectiveness of MIRI during the induction. Safety was consistent with the known profile of this drug."

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

MIRIKIZUMAB DEMONSTRATES RAPID AND SUSTAINED IMPROVEMENTS IN BOWEL URGENCY MEASURES AND CLINICAL MEASURES IN PATIENTS WITH MODERATELY-TO-SEVERELY ACTIVE ULCERATIVE COLITIS: 28-WEEK RESULTS FROM THE PHASE 3B LUCENT-URGE TRIAL (UEGW 2025) - P3 | "MIRI showed an early and sustained improvement on BU severity, frequency and stool deferral time through W28 in LUCENT-URGE. MIRI consistently improved clinical outcomes in patients with moderately-to-severely active UC."

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

MIRIKIZUMAB PROVIDES SUSTAINED LONG-TERM EFFICACY UP TO 4 YEARS OF TREATMENT FOR ULCERATIVE COLITIS: FINAL RESULTS FROM THE LUCENT-3 OPEN-LABEL EXTENSION STUDY (UEGW 2025) - P3 | "Mirikizumab provides sustained long-term symptomatic, clinical, endoscopic, histologic, corticosteroid-free, and quality-of-life remission up to 4 years in patients with UC, including for biologic failed patients, with no new safety concerns."

Clinical • Atrial Fibrillation • Breast Cancer • Candidiasis • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder • Herpes Simplex • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Bowel Disease • Solid Tumor • Thyroid Gland Carcinoma • Ulcerative Colitis • Varicella Zoster • Ventricular Tachycardia

ENDO-HISTO FOUNDATIONAL FUSION MODEL: A NOVEL ARTIFICIAL INTELLIGENCE APPROACH FOR PREDICTING HISTOLOGIC REMISSION AND EARLY RESPONSE TO THERAPY IN A PHASE 2 ULCERATIVE COLITIS CLINICAL TRIAL (UEGW 2025) - P2 | "A novel multimodal AI fusion algorithm was developed by integrating paired endoscopic videos and histological whole-slide images (WSIs) from the phase 2 clinical trial of Mirikizumab in UC (NCT02589665)... This innovative multimodal fusion AI model enhances the assessment of histological remission and accurately predicts response to therapy. By potentially standardising central readouts and enabling automated disease assessment, this novel tool marks a significant advancement towards precision medicine in clinical trials."

Clinical • P2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis