Omvoh (mirikizumab) / Eli Lilly - LARVOL DELTA

Safety of Rotavirus Vaccination in Infants That Were Exposed to Biologics In Utero: A Systematic Review. (PubMed, Inflamm Bowel Dis) - "Administration of the live rotavirus vaccine appears to be safe in biologic-exposed infants. As such, with careful examination of the risks and benefits, there may be a role for rotavirus vaccination in this population."

Journal • Review • Gastroenterology • Oncology • Rotavirus Infections

MIRIKIZUMAB EFFECT ON BOWEL URGENCY RESOLUTION IN A RANDOMISED CONTROLLED PHASE 3 TRIAL OF PARTICIPANTS WITH CROHN’S DISEASE (UEGW 2024) - P3 | "VIVID-1 co-primary and gated endpoints, including comparison with ustekinumab, are already reported2. BU is one of the most unrecognised symptoms in patients with CD. Patients enrolled in VIVID-1 had high BU scores at BL. Compared to PBO-treated pts, miri-treated pts achieved nominally significantly higher rates of BU CMI and remission at W12 and W52."

Clinical • P3 data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Pain • IL23A

REAL-WORLD DATA ON THE TREATMENT WITH MIRIKIZUMAB IN A MOSTLY BIOLOGICAL-EXPERIENCED ULCERATIVE COLITIS COHORT (UEGW 2024) - "Eight patients were treated with Ustekinumab prior to the therapy with Mirikizumab. We report preliminary real-world data on the treatment with Mirikizumab. In our interim analysis Mirikizumab proves to be an effective and safe treatment in biological-experienced UC patients."

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

IMPROVEMENT IN FATIGUE WITH MIRIKIZUMAB THERAPY AND ASSOCIATIONS WITH CLINICAL OUTCOMES IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: RESULTS FROM THE PHASE 3 VIVID-1 STUDY (UEGW 2024) - "Co primary and gated secondary outcomes, including comparisons with ustekinumab, have been presented elsewhere4,5Adult patients (N=1065) with moderately to severely active CD were randomized 6:3:2 to MIRI, ustekinumab or placebo. In patients with moderately to severely active CD treated with MIRI, improvements in clinical, endoscopic, and selected patient-reported outcomes were associated with clinically meaningful improvements in fatigue at W52."

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

NOVEL AI-ENABLED ASSESSMENT OF HISTOLOGIC REMISSION AND EARLY RESPONSE TO THERAPY IN A PHASE 2 CLINICAL TRIAL UC COHORT (UEGW 2024) - "Aims & Thus, our study aimed to develop a novel AI model for assessing histologic disease activity and predicting early therapy response in a Phase 2 Clinical trial UC cohort.We used 302 whole slide images (WSIs) from moderate-to-severe active UC patients enrolled in a phase 2 mirikizumab (anti-IL23 mAb) clinical trial to train a novel deep neural network (DNN) model for WSIs... Our study shows the remarkable ability of this novel AI histology model to distinguish histologic remission and activity in a clinical trial cohort. Notably, the model accurately predicted response to therapy at weeks 12 and 52. This AI model represents a promising tool in clinical trials and potentially in practice, offering objective guidance for personalized management in UC patients."

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

GUSELKUMAB BINDING TO CD64+ IL-23–PRODUCING MYELOID CELLS ENHANCES POTENCY FOR NEUTRALIZING IL-23 SIGNALING (UEGW 2024) - "Guselkumab (GUS), risankizumab (RZB), and mirikizumab (MIRI) are monoclonal antibodies (mAbs) specifically directed against the IL-23p19 subunit. Our transcriptomic analysis supported previous observations of CD64+ myeloid cells as a key source of IL-23 production in inflamed IBD gut tissue. GUS binding to CD64 on IL-23–producing cells likely contributed to the enhanced functional potency of GUS compared to RZB and MIRI for inhibition of IL-23 signaling in the co-culture assay. These in vitro data support a hypothesis for optimal localization of GUS in inflamed tissues where CD64+ IL-23–producing myeloid cells are increased and in proximity to IL-23–responsive lymphoid cells, enabling GUS to more potently neutralize IL-23 at its source of production."

Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • FCGR1A • IL12B • IL23A

IS 15 Early & Sustained Control in UC: from trials to clinical practice with mirikizumab (Eli Lilly and Company) (UEGW 2024) - "Sponsored By Eli Lilly and Company"

Clinical • Ulcerative Colitis

CORTICOSTEROID-SPARING EFFECT OF MIRIKIZUMAB FOR THE TREATMENT OF MODERATELY-TO-SEVERELY ACTIVE ULCERATIVE COLITIS: EXTENDED INDUCTION SUBGROUP ANALYSIS FROM PHASE 3 TRIAL (UEGW 2024) - P3 | "Patients receiving mirikizumab on CS at baseline (n=351) remained on their stable baseline dose (prednisone ≤20 mg/day or equivalent, budesonide MMX 9 mg/day, or beclomethasone 5 mg/day) during induction (W0 to W12). Nearly 70% of extended induction responders discontinued CS by W52. CS-sparing effect of mirikizumab in patients with moderately-to-severely active UC is clinically meaningful and aligns with the treatment goal of CS discontinuation."

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

THE URGENCY NUMERIC RATING SCALE: PSYCHOMETRIC EVALUATION IN ADULTS WITH CROHN’S DISEASE (UEGW 2024) - P3 | "Pooled data from VIVID-1 (NCT03926130), a Phase 3, multicentre, randomised, placebo- and active-controlled study of mirikizumab in adults with moderately to severely active CD were analyzed... These results support the reliability, validity, responsiveness of the Urgency NRS and provide definitions of clinically meaningful improvement (reduction of 3–5 points in the Urgency NRS score) and remission of bowel urgency (Urgency NRS score of ≤2) in adults with moderately to severely active CD. These findings confirm the Urgency NRS as suitable for assessing treatment benefits in patients with CD during clinical trials."

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

EFFECTIVENESS AND SAFETY OF MONOCLONAL ANTIBODIES AGAINST IL23 SUBUNIT P19 FOR TREATING PATIENTS WITH ULCERATIVE COLITIS: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS (UEGW 2024) - "A total of 1,227 patients (70.9%) received IL23 p19 monoclonal antibodies (Mirikizumab, 1019 patients [59.4%]; Guselkumab, 208 patients [12.1%]) and 489 patients (28.5%) received placebo. This analysis supports the use of IL-23 p19 monoclonal antibodies as a safe and effective option for induction therapy in patients with moderate to severely active UC who had failure to conventional treatment. However, new large RCTs are required to confirm these findings."

Retrospective data • Review • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis • IL23A

HISTOLOGICAL AND HISTO-ENDOSCOPIC OUTCOMES WITH ADVANCED TREATMENTS (BIOLOGICS AND SMALL MOLECULES) IN ULCERATIVE COLITIS - A NETWORK METANALYSIS (UEGW 2024) - "We found that etrasimod 2 mg/day ranked highest in achieving histologic response (P-score 0.98) and remission (P-score 0.90) following induction, while guselkumab ranked first for histoendoscopic improvement...Etrasimod 2 mg/day ranked second for histologic remission (P-score 0.70) and histo-endoscopic improvement (P-score 0.73), while mirikizumab 200 mg/month ranked second for histologic response. Our findings underscore the importance of small molecules in treating moderate-to-severe UC, particularly etrasimod and upadacitinib. Nonetheless, additional head-to-head RCTs are imperative to better inform clinical practice and to address unanswered questions."

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

IMPACT OF MIRIKIZUMAB ON CLINICALLY MEANINGFUL IMPROVEMENTS IN FATIGUE AS MEASURED BY FACIT-F IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE (UEGW 2024) - "Introduction: Fatigue is a debilitating multifactorial symptom experienced by many patients with Crohn's disease (CD).1 Topline efficacy data of mirikizumab (MIRI), an anti-interleukin-23p19 antibody, vs. placebo (PBO) and ustekinumab (UST) in patients with moderately to severely active Crohn’s disease in the Phase 3 VIVID-1 study were previously reported.2-4 Aims & This analysis assesses the impact of MIRI vs. PBO in improving fatigue and the correlation of patient variables with fatigue severity at baseline (BL) in the VIVID-1 study. MIRI showed a nominally clinically significant improvement in fatigue vs. PBO at W12 and a nominally statistically higher improvement in composite endpoints vs. PBO at W52."

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

PSYCHOMETRIC EVALUATION OF THE FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY–FATIGUE IN ADULTS WITH MODERATE-TO-SEVERE CROHN’S DISEASE (UEGW 2024) - P3 | "Pooled data from VIVID-1 (NCT03926130), a Phase 3, multicentre, randomised, placebo- and active-controlled study of mirikizumab in adults with moderately to severely active CD were analysed... These findings expand on previous research supporting the internal consistency, reliability, construct validity, and responsiveness of the FACIT-Fatigue. Analyses suggest an improvement range of 6–9 points for FACIT-Fatigue as clinically meaningful in the VIVID-1 trial population of adults with moderately to severely active CD."

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

EARLY SYMPTOMATIC IMPROVEMENT WITH MIRIKIZUMAB INDUCTION THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: RESULTS FROM THE PHASE 3 VIVID-1 STUDY (UEGW 2024) - 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). In patients with moderately to severely active CD, miri induction was associated with higher rates of clinical response and greater improvement in AP as early as W4, and higher rates of clinical remission and greater improvement in SF as early as W6 versus 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 • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease • Oncology • Pain

BROADENED REPRESENTATION OF PATIENTS WITH ULCERATIVE COLITIS, BUT NOT CROHN’S DISEASE, IN CONTEMPORARY RANDOMISED CONTROLLED TRIALS (UEGW 2024) - "Their characteristics were compared against inclusion and exclusion criteria of recently completed or ongoing RCTs: ozanimod, upadacitinib, risankizumab, golimumab-guselkumab, guselkumab (Crohn’s disease [CD] only), filgotinib, mirikizumab, and etrasimod (ulcerative colitis [UC] only for the latter three drugs). Only a minority of patients with IBD from routine practice would be eligible for participation in contemporary RCTs, although the percentage has increased for patients with UC compared to past studies."

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

A PATIENT-REPORTED OUTCOME MEASURE COMPRISING THE STOOL FREQUENCY AND ABDOMINAL PAIN ITEMS FROM THE CROHN’S DISEASE ACTIVITY INDEX: PSYCHOMETRIC EVALUATION IN ADULTS WITH CROHN’S DISEASE (UEGW 2024) - P3 | "Pooled data from VIVID-1 (NCT03926130), a Phase 3, multicentre, randomized, placebo- and active-controlled study of mirikizumab in adults with moderately to severely active Crohn’s Disease (CD) were analysed... These psychometric evaluation results support the reliability, construct-validity, and responsiveness of the PRO items when administered to adults with moderately to severely active CD. A combination of an SF score of ≤3 and an AP score of ≤1 could represent clinical remission by PRO."

Clinical • Patient reported outcomes • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pain

Positioning mirikizumab in the treatment landscape for Ulcerative Colitis (UEGW 2024) - "Sponsored By Eli Lilly and Company"

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

EXIT INTERVIEWS EXPLORING PATIENTS’ EXPERIENCE OF CHANGES IN THEIR FATIGUE DURING THE PHASE 3 CLINICAL TRIAL OF MIRIKIZUMAB FOR TREATMENT OF MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE (UEGW 2024) - P3 | "A sub-set of participants from either mirikizumab, ustekinumab or placebo arms were asked open-ended questions to explore changes in fatigue (N=31). Exit interview results showed that irrespective of the treatment received, most interviewed participants with moderately to severely active CD experienced an improvement in fatigue by end of the trial, resulting in better energy levels, physical function, daily functioning, and emotional well-being."

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

EFFECT OF MIRIKIZUMAB ON CLINICAL AND ENDOSCOPIC OUTCOMES AFTER 1 ANTI-TNF FAILURE IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (UEGW 2024) - P3 | "At the LUCENT-1 induction baseline, 41% of the population had experienced a biologic/tofacitinib failure, and 36.3% experienced at least one anti-TNF failure. Mirikizumab is efficacious for induction and maintenance therapy in patients with moderately to severely active UC who have failed one prior anti-TNF."

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

ASSOCIATION OF FAECAL CALPROTECTIN WITH SYMPTOMATIC, ENDOSCOPIC, AND CLINICAL REMISSION IN PATIENTS WITH MODERATELY-TO-SEVERELY ACTIVE ULCERATIVE COLITIS TREATED WITH MIRIKIZUMAB (UEGW 2024) - P3 | "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

LONG-TERM EFFICACY AND SAFETY OF MIRIKIZUMAB FOLLOWING 152 WEEKS OF CONTINUOUS TREATMENT: RESULTS FROM THE LUCENT-3 OPEN-LABEL EXTENSION STUDY (UEGW 2024) - P3 | "Symptomatic, clinical, endoscopic, histologic, and quality-of-life outcomes support the long-term sustained benefit of mirikizumab treatment up to 152 Wks in patients with UC, including biologic failed patients, with no new safety concerns."

Clinical • Atrial Fibrillation • Candidiasis • Cardiovascular • Endocrine Cancer • Gastroenterology • Gastrointestinal Disorder • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Bowel Disease • Oncology • Pain • Solid Tumor • Thyroid Gland Carcinoma • Ulcerative Colitis • Varicella Zoster • Ventricular Tachycardia

THE IMPACT OF MIRIKIZUMAB INDUCTION, MAINTENANCE, AND LONG-TERM TREATMENT ON DISEASE CLEARANCE IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: POST HOC ANALYSIS OF LUCENT TRIALS (UEGW 2024) - P3 | "Miri consistently demonstrated DC across induction, maintenance, and long-term studies. Over 36% of patients achieved DC after one year of miri treatment. The attainment of DC was associated with improvement in PROs in LUCENT-1 and -2."

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

MIRIKIZUMAB IMPROVED BOWEL URGENCY, ABDOMINAL PAIN, AND FATIGUE IN PEDIATRIC PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS: RESULTS FROM THE PHASE 2 SHINE-1 STUDY (UEGW 2024) - P2 | "Mirikizumab demonstrated improvements in abdominal pain, bowel urgency, and fatigue following induction and maintenance treatment. These results provide supporting evidence for the pivotal phase 3 pediatric study SHINE-2 and suggest important improvements in quality of life."

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

EFFICACY AND SAFETY OF MIRIKIZUMAB THERAPY IN PEDIATRIC PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS: RESULTS FROM THE PHASE 2 SHINE-1 STUDY (UEGW 2024) - P2 | "Mirikizumab demonstrated an acceptable safety profile, and similar clinical response, clinical remission, and endoscopic remission compared to LUCENT adults. These results are the foundation of the pivotal Phase 3 pediatric SHINE-2 study."

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

EFFECTS OF MIRIKIZUMAB AND USTEKINUMAB ON HISTOLOGIC INFLAMMATION EVALUATED BY COMPREHENSIVE ASSESSMENT IN 5 INTESTINAL SEGMENTS IN A RANDOMIZED CONTROLLED PHASE 3 TRIAL OF PARTICIPANTS WITH CROHN’S DISEASE (UEGW 2024) - P3 | "Using strict definitions, all histology-based endpoints were achieved by MIRI versus PBO. For comparison versus UST, MIRI also showed nominal statistical difference for H-Res, which was prespecified and is considered the most sensitive to change, particularly driven by BF pts. The implication of these results on clinical endpoints and long-term outcomes, including hospitalization rates and surgeries, requires further evaluation."

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