Omvoh (mirikizumab-mrkz)
/ Eli Lilly
- LARVOL DELTA
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September 25, 2026
Mirikizumab Induction Therapy Achieves Early Clinical, Endoscopic, and Biomarker Improvement in Children and Adolescents with Moderately to Severely Active Ulcerative Colitis: Week 12 Results From the SHINE-2 Study (Late-Breaking Abstract)
(ACG 2026)
- "Abstract text will be released on Sunday, October 11, 2026, at 12:00 pm CT (1:00 pm ET) when the ACG 2026 embargo lifts."
Biomarker • Clinical • Late-breaking abstract • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis
August 29, 2026
Updated Network Meta-Analysis of IL-23 Pathway Agents in Moderate-to-Severe Crohn's Disease Incorporating Full GALAXI-2/3 Data
(ACG 2026)
- "Serious adverse events (SAEs) were analyzed as exposure-adjusted incidence-rate ratios (IRRs per 100 patient-years) restricted to treat-through trials with a shared ustekinumab comparator; risankizumab safety phases were reported separately. All active agents outperformed placebo for clinical remission. Guselkumab 200 mg IV ranked highest (OR 3.77, 95% CI 2.39-5.96; P-score 0.96), followed by risankizumab 600 mg IV (OR 2.70, 1.99-3.66), risankizumab 1200 mg IV (OR 2.41, 1.78-3.27), and mirikizumab (OR 1.80, 1.25-2.58). For endoscopic response, guselkumab (OR 4.20, 2.29-7.73) and risankizumab 600 mg IV (OR 4.06, 2.50-6.61) were statistically comparable and most favorable."
Retrospective data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • IL23A
August 29, 2026
Advanced Therapy Exposure Is Associated With Increased Disease-Related Surgery but Not Cancer Risk in PSC-IBD: A Real-World Analysis
(ACG 2026)
- "Patients receiving advanced IBD therapies (anti-TNF agents, vedolizumab, ustekinumab, tofacitinib, upadacitinib, risankizumab, mirikizumab, or guselkumab) were compared with PSC-IBD patients without advanced therapy exposure. Among 4,116 eligible PSC-IBD patients, 723 advanced-therapy patients were matched to 723 non-advanced therapy patients. Advanced therapy exposure was associated with a significantly increased risk of IBD-related surgery (12.7% vs 5.3%; RR 2.42, 95% CI 1.68â3.48; p< 0.001) and higher corticosteroid utilization (59.3% vs 47.9%; RR 1.24, 95% CI 1.13â1.37; p< 0.001). Advanced therapy patients also demonstrated shorter surgery-free survival (HR 2.43, 95% CI 1.67â3.55; p< 0.001)."
Clinical • Metastases • Real-world • Real-world evidence • Surgery • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Crohn's disease • Gallbladder Cancer • Gastroenterology • Gastrointestinal Disorder • Hepatocellular Cancer • Hepatology • Immunology • Inflammatory Bowel Disease • Oncology • Primary Sclerosing Cholangitis • Solid Tumor • Ulcerative Colitis
August 29, 2026
Clinical and Safety Outcomes of Refractory Crohn's Disease Patients on Dual Advanced Therapy With IL-23 and Jak Inhibitor
(ACG 2026)
- "IL-23 inhibitors (Guselkumab, Mirikizumab, Risankizumab-rzaa) and Jak inhibitors (Upadacitinib) have become the most utilized in refractory Crohnâs patients, but their clinical outcomes remain less than ideal . Eighteen Crohn's patients on DAT were identified. On average, patients failed five different biologics prior to DAT and were on DAT for approximately 8 months. Seventy-two percent of Crohnâs patients on DAT reported clinical improvement."
Clinical • Metastases • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Inflammatory Bowel Disease • IL23A
August 29, 2026
Mirikizumab in Ulcerative Colitis: A Systematic Review of Real-World Outcomes in Patients With Prior Advanced Therapy
(ACG 2026)
- "Nine of eleven studies assessing outcomes after ustekinumab (UST) reported comparable clinical remission regardless of prior exposure . Twenty-eight studies ( Fig 1 ), comprising 3605 patients across 11 countries were included. The percentage of AT experienced patients ranged from 60-100%, with 6 studies reporting ~100% AT experienced patients; most studies included â¥30% patients exposed to â¥3 AT. Persistence to treatment was 91.7% (range: 80-100%) at 3 mo, 84.4% (66.7-96.7%) at 6 mo; 2 studies reported 62% and 67% persistence at 1 year."
Clinical • Metastases • Real-world • Real-world evidence • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis
August 29, 2026
Sex Differences in GI Treatment Response Hidden by a Reporting Vacuum: A Disease Burden-Adjusted Analysis of Sex Representation, Outcome Reporting, and Sex-Specific Effects in 2,328 GI Trials
(ACG 2026)
- P3 | "Among 9 trials with sex-stratified estimates, F/M effect ratios diverged: sorafenib + SBRT for HCC (F/M = 0.63 OS); adjuvant chemotherapy for pancreatic cancer (0.77); mirikizumab in pediatric IBD growth velocity (0.36); and HBV vaccine response (OR = 1.90). A total of 2,328 studies, including 574,244 patients, were analyzed. Females comprised 47.2% (95% CI: 47.1%-47.4%; PPR 0.93). The proportion of females participating varied significantly by disease category; females were underrepresented in Barrett's esophagus (PPR 0.79) and overrepresented in MASLD/MASH (PPR 1.39), pancreatitis (PPR 1.34), and eosinophilic esophagitis (PPR 1.26)."
Barrett Esophagus • Eosinophilic Esophagitis • Gastrointestinal Disorder • Hepatology • Immunology • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Pancreatic Cancer • Pancreatitis • Solid Tumor
August 29, 2026
Real-World Effectiveness and Safety of Mirikizumab in Ulcerative Colitis: A Systematic Review and Meta-Analysis
(ACG 2026)
- "Six studies (283-315 patients) met inclusion; all enrolled predominantly biologic-experienced patients (â¥3 prior advanced therapies in 32.7%-81.2%) . At week 12, biochemical remission was 58.69% (95% CI: 42.43-73.25%, I²=73.9%, n=264), clinical response was 54.36% (95% CI: 31.46-75.56%, I²=88.1%, n=205), clinical remission was 45.55% (95% CI: 23.28-69.75%, I²=91.0%, n=309), and steroid-free remission was 41.17% (95% CI: 18.09-68.92%, I²=91.7%, n=221). At weeks 50-52, clinical remission was 35.79% (95% CI: 9.07-75.69%, I²=82.1%, n=158); steroid-free remission being 49.50% (95% CI: 32.60-66.52%, I²=79.9%, n=167)."
Real-world • Real-world effectiveness • Real-world evidence • Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A
August 29, 2026
Comparative Efficacy of Interleukin Inhibitors as Induction Treatment Among Advanced Therapy-Naive Patients in Moderate to Severe Crohn's Disease: A Network Meta-Analysis
(ACG 2026)
- P3 | "Top-line results of AFFIRM (NCT06063967), a randomized placebo-controlled trial assessing risankizumab (RZB) 720 mg subcutaneous injection (SC) at weeks 0, 2, 4, and 8 (RZB720) as induction treatment, have recently become available...Indirect efficacy was estimated for RZB720, RZB 600 mg intravenous infusion (IV) at weeks 0, 4, and 8 (RZB600), guselkumab (GUS) 200 mg IV at weeks 0, 4, and 8 (GUS200), GUS 400 mg SC at weeks 0, 4, and 8 (GUS400), mirikizumab (MIR) 900 mg IV at weeks 0, 4, and 8 (MIR900), and ustekinumab (UST) 6 mg/kg IV (UST6) at week 0... RZB720 had the highest RD relative to placebo across all outcomes, followed by RZB600 for endoscopic outcomes and GUS200 for clinical remission. For clinical remission, both RZB720 and GUS200 had significant RDs relative to MIR900 and UST. For endoscopic response, RZB720 and RZB600 had significant RDs relative to MIR900 while all IL-23 inhibitors, with the exception of GUS400, had significant RDs relative to UST."
Metastases • Retrospective data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • IL23A
August 29, 2026
Herpes Zoster Infection as an Adverse Reaction to Treatments for Ulcerative Colitis: A Review of Reports to the FDA Adverse Events Reporting System (FAERS)
(ACG 2026)
- "Reports of ADRs of all FDA approved UC therapies including mesalamine, sulfasalazine, balsalazide, olsalazine, methotrexate, azathioprine, 6-mercaptopurine, infliximab, adalimumab, certolizumab, golimumab, vedolizumab, ustekinumab, mirikizumab, risankizumab, guselkumab, ozanimod, etrasimod, tofacitinib, and upadacitinib along with combination infliximab with methotrexate, infliximab with azathioprine, adalimumab with azathioprine, and golimumab with azathioprine were reviewed. Table 1 displays the total FAERS reports of ADRs and reported HZ infection in patients treated for UC. The JAK inhibitor tofacitinib showed increased risk of HZ with 58 total reports (ROR 2.79). In addition, methotrexate (ROR 1.83), azathioprine (ROR 1.74), 6-mercaptopurine (ROR 2.4), infliximab (ROR 2.49), and combination therapies of infliximab with methotrexate (ROR 2.61) and infliximab with azathioprine (ROR 2.91) demonstrated increased risk."
Adverse events • Review • Gastroenterology • Gastrointestinal Disorder • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Bowel Disease • Ulcerative Colitis • Varicella Zoster • ROR1
August 29, 2026
Prevalence and Outcomes of Hormone Therapy Use Among Menopausal Women With Inflammatory Bowel Disease
(ACG 2026)
- "However, patients with CD prescribed systemic HT had higher oral prednisone use, while osteoporosis/fracture outcomes were lower among patients receiving systemic HT. Figure: 1-Systemic non-transdermal HRT included oral estradiol, conjugated estrogens, esterified estrogens, synthetic conjugated estrogens A and B, oral progesterone, oral medroxyprogesterone, conjugated estrogens/bazedoxifene (Duavee), estradiol acetate vaginal ring (Femring), and norethindrone acetate/ethinyl estradiol (Femhrt). 2-Systemic transdermal HRT included estradiol/norethindrone acetate transdermal patch (CombiPatch), estradiol/levonorgestrel transdermal patch (Climara Pro), estradiol transdermal patches (Alora, Climara, Dotti, Estraderm, Lyllana, Minivelle, Vivelle-Dot), estradiol transdermal gel (EstroGel, Divigel), and estradiol transdermal spray (Evamist). 3-Local estrogen therapy included low-dose vaginal estradiol formulations (Estring, Imvexxy, Vagifem, and Yuvafem) and vaginal conjugated..."
Clinical • Cardiovascular • Coronary Artery Disease • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Pulmonary Embolism • Respiratory Diseases • Ulcerative Colitis
August 29, 2026
Previous Response-Insufficient Ustekinumab: Outcomes from a Retrospective Cohort Analysis in Patients Sith Ulcerative Colitis on Selective IL-23 (Prior-23 UC Study)
(ACG 2026)
- "Patients initiated Risankizumab (RZA), guselkumab (GUS), or mirikizumab (MIRI) and were followed via clinical visits, laboratory monitoring, and endoscopic assessment...Patients were variably pre-treated: 68% were non-biologic naïve, 57% had anti-TNF exposure, and 46% had used vedolizumab... Twenty-eight patients with UC and prior UST failure were included (Table 1). Mean age was 44.8 ± 17.2 years, 53.6% were female, and the mean disease duration was 9.96 ± 7.1 years. Extensive colitis (E3) was present in 72% of the cases."
Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A
August 29, 2026
Risk of Herpes Zoster in Patients With Inflammatory Bowel Disease Treated With Janus Kinase Inhibitors Compared With Anti-TNF Therapy: A Retrospective Cohort Study
(ACG 2026)
- "2 Advanced therapy was defined infliximab, adalimumab, certolizumab pegol, golimumab, vedolizumab, ustekinumab, tofacitinib, upadacitinib, risankizumab, etrasimod, ozanimod, guselkumab, and mirikizumab. Among 8,293 patients with IBD, 3,164 received JAKi and 5,129 received anti-TNF therapy (Table 1). JAKi-treated patients had higher HZ incidence rates than anti-TNF patients (32.81 vs. 14.58 per 1,000 person-years; p< 0.001)."
Retrospective data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Herpes Zoster • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • Varicella Zoster
August 29, 2026
Real-World Cardiovascular Outcomes Following Janus Kinase and IL-23p19 Inhibitor Therapy in Inflammatory Bowel Disease
(ACG 2026)
- "Adults with Crohnâs disease or ulcerative colitis who initiated a JAK inhibitor (tofacitinib, upadacitinib, or filgotinib) or an IL-23p19 inhibitor (risankizumab, mirikizumab, or guselkumab) within three years of IBD diagnosis were identified. Before matching, 11,998 patients received JAK inhibitors and 13,239 received IL-23p19 inhibitors. After matching, 11,206 patients remained in each cohort with balanced baseline characteristics. Compared with IL-23p19 inhibitors, JAK inhibitor therapy was associated with a higher risk of all-cause mortality (0.6% vs 0.4%; RR 1.75, 95% CI 1.19â2.58; p=0.004), MACE (1.2% vs 0.9%; RR 1.33, 95% CI 1.03â1.73; p=0.029), MI (0.6% vs 0.4%; RR 1.51, 95% CI 1.02â2.24; p=0.038), and VTE (1.9% vs 1.5%; RR 1.27, 95% CI 1.04â1.56; p=0.019)."
Clinical • Real-world • Real-world evidence • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Immunology • Inflammation • Inflammatory Bowel Disease • Myocardial Infarction • Ulcerative Colitis • Venous Thromboembolism
August 29, 2026
Twelve-Month Outcomes of Treatment With Mirikizumab in Ulcerative Colitis in a Large United States Community Gastroenterology Practice
(ACG 2026)
- "Introduction: Mirikizumab (MIRI), an anti-interleukin-23p19 humanized IgG4 monoclonal antibody, demonstrated efficacy in the treatment of patients with ulcerative colitis (UC) in the LUCENT clinical trials. Inclusion criteria were met by 98 patients with mean (SD) age of 45.2 (16.2) years and mean (SD) disease duration of 4.4 (2.5) years. Pre-index use of advanced UC therapy was reported in 81.6% of patients; 29.6% were exposed to =3 advanced therapies including Janus kinase inhibitors (35.7%) and ustekinumab (24.5%). Of 78 patients with evidence of subcutaneous (maintenance) MIRI dosing, 54/78 (69.2%) persisted on treatment at 12 months; of these, 48/54 (88.9%) were corticosteroid-free at 12 months."
Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis
August 29, 2026
Rethinking First-Line Therapy: IL-23 Inhibitors vs Anti-TNF Agents in Biologic-Naive UC
(ACG 2026)
- "Eligible patients had a diagnosis of UC (ICD-10: K51.x) and were biologic naive at the time of cohort entry and initiated on anti-TNF agents (infliximab, adalimumab, or golimumab) or an IL-23 inhibitor (mirikizumab or risankizumab). After matching, 2,419 patients remained in each cohort. In fixed-time analysis excluding patients with prior outcome events, the composite outcome occurred in 39.35% of anti-TNF initiators versus 40.41% of IL-23 inhibitor initiators, with no significant risk difference (RR 0.974, 95% CI 0.789-1.201; OR 0.957, 95% CI 0.674-1.358; p=0.807). Kaplan-Meier analysis showed higher 1-year event-free survival among anti-TNF initiators (58.06% vs 47.42%; log-rank p=0.0048)."
Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A
August 29, 2026
Real-World Treatment Sequencing in Inflammatory Bowel Disease: An Epic Cosmos Analysis of Patients Transitioning From IL-23 p19 to IL-12/23p40 Inhibitors
(ACG 2026)
- "From this cohort, we selected patients initially treated with a p19 inhibitor (guselkumab, risankizumab, or mirikizumab) who were switched to ustekinumab during the study period. Of almost 2 million IBD patients identified, 76,449 were treated with a p19 inhibitor. Of these, 4,539 patients switched from a p19 inhibitor to ustekinumab within the 46-month study period, of whom 1,912 (42.1%) did not receive a subsequent IBD biologic, immune therapy, or systemic corticosteroid, suggesting a potential durable response, figure 1. Minimal differences were noted between patients with potential durable response vs."
Clinical • HEOR • Real-world • Real-world evidence • Crohn's disease • Dermatopathology • Gastroenterology • Gastrointestinal Disorder • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Seronegative Spondyloarthropathies • Ulcerative Colitis • IL12A • IL23A
August 29, 2026
Early Experience With Etrasimod in Ulcerative Colitis Patients: A Claims Database Study in the United States
(ACG 2026)
- "(e)Advanced treatments: adalimumab, golimumab, infliximab, vedolizumab, ustekinumab, mirikizumab, risankizumab, guselkumab, tofacitinib, upadacitinib, and ozanimod. A total of 297 patients were included (mean age, 47.3 years [SD, 17.5]; 52.2% male), and 127 comprised the follow-up population. In the follow-up population, most patients were AT-naïve (67.7%), and 48.0% had used steroids within 24 weeks prior to index date (Table 1). Through week 24, median adherence was 89.8% (quartile 1: 53.9%; quartile 3: 98.8%), and 59.1% of patients had PDC â¥0.80."
Claims database • Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis
August 29, 2026
Efficacy of Risankizumab Versus Other Advanced Therapies for Moderate to Severe Ulcerative Colitis in Advanced Therapy Naïve Populations: A Bayesian Network Meta-Analysis
(ACG 2026)
- " This NMA utilized published data from phase 3 randomized controlled trials of the following FDA-approved first-line ATs for moderate to severe UC: RZB, guselkumab (GUS), mirikizumab (MIR), ustekinumab (UST), vedolizumab (VDZ), golimumab (GOL), infliximab (IFX), adalimumab (ADA), etrasimod (ETR), and ozanimod (OZA). ITT efficacy rates of clinical remission and endoscopic improvement were highest for RZB (1200 mg x 360 mg) ( Figure ). GUS, MIR, and RZB (1200 mg x 180 mg) had the highest ITT rates for clinical response. In the Induction NMA, RZB demonstrated the highest odds ratio (OR [95% credible interval]) vs PBO for clinical response (5.12 [3.29-7.94]) and endoscopic improvement (5.32 [3.03-9.68])."
Metastases • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Mucositis • Ulcerative Colitis
August 29, 2026
S1P Receptor Modulation in J-Pouch Complications: Ozanimod Salvage Therapy for Refractory Cuffitis
(ACG 2026)
- "Case Description/ A 41-year-old female with a 20-year history of highly refractory UC sequentially treated with multiple advanced therapies (mesalamine, budesonide, infliximab, adalimumab, vedolizumab, azathioprine, ustekinumab, upadacitinib, and mirikizumab) without adequate response, necessitating a three-step IPAA. Figure: Figure 1: Pre-treatment pouchoscopy showing severe, ulcerated cuffitis. Figure: Figure 2: Post-treatment pouchoscopy showing complete mucosal healing after 5 months of ozanimod therapy, where random biopsies unmasked p16-positive AIN-3."
Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis
August 29, 2026
Efficacy and Safety of IL-23 Inhibitors in IBD: A Comprehensive Systemic Review and Network Meta-analysis of Emerging Targeted Therapies
(ACG 2026)
- "A total of 33 studies involving 19,668 patients were included, comprising 7,069 CD induction, 5,770 CD maintenance, 3,580 UC induction, and 3,249 UC maintenance participants. Mirikizumab demonstrated the highest efficacy for CD induction remission (OR 5.19; 95% CrI 1.75â16.7), followed by guselkumab (OR 3.07; 1.35â5.98) and risankizumab (OR 2.38; 1.42â3.98), with ustekinumab showing modest benefit (OR 1.67; 1.20â2.39). For UC induction remission, guselkumab ranked highest (OR 3.80; 1.10â13.3), followed by risankizumab (OR 3.96; 0.685â23.0), while mirikizumab showed smaller effects (OR 1.50; 0.497â6.63)."
Retrospective data • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A
August 29, 2026
Comparative Pancreatic Adverse Event Reporting of Non-TNF Biologics in Inflammatory Bowel Disease: A Layered FAERS Disproportionality Analysis, 2020-2025
(ACG 2026)
- "IBD-indicated primary-suspect reports for vedolizumab, ustekinumab, risankizumab, mirikizumab, and guselkumab were compared across IBD-restricted, all-FAERS, withinânon-TNF, and anti-TNF comparator layers...Comparator choice altered estimates: against all FAERS, vedolizumab (ROR 1.56; A=252), risankizumab (1.16; A=244), and mirikizumab (2.73; A=5) were above unity, whereas active-comparator analysis highlighted the anti-TNF class (1.22, 1.07â1.39; A=586) and infliximab (1.60, 1.40â1.83; A=336). Among 1,624 valid onset pairs, Weibull shapes were < 1 for infliximab, vedolizumab, adalimumab, and ustekinumab... Of 8,439,854 deduplicated reports, 241,416 carried an IBD indication. There were 88,061 non-TNF and 116,292 anti-TNF primary-suspect IBD reports; 422 non-TNF IBD reports had a narrow pancreatic event. In the primary IBD-restricted analysis, no individual non-TNF biologic or class met the primary or conservative signal definition."
Adverse events • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pancreatic Cancer • Pancreatitis • Solid Tumor • IL12A • ROR1
August 29, 2026
Beyond the Label? Real-World Dosing Strategies for Newer Biologic Therapies in Ulcerative Colitis
(ACG 2026)
- "The following are considered unique advanced therapies: adalimumab, etrasimod, golimumab, guselkumab, infliximab, mirikizumab, risankizumab, ustekinumab (includes biosimilars), upadacitinib, vedolizumab, tofacitinib, ozanimod assessed 12-months prior to index date...on-label refers to FDA label maintenance dosing: Q2W (vedolizumab [subcutaneous]), Q4W (mirikizumab) and Q8W (ustekinumab, risankizumab, vedolizumab [intravenous])... The maintenance cohorts comprised patients receiving USTE (n=7641), MIRI (n=322), RISA (n=707), and VEDO (n=15167) ( Table 1 ). Patients with â¥2 unique advanced therapies within 12 mo prior to index drug were 13.4% in MIRI, 10.9% in RISA, 7.1% in USTE and 1.7% in VEDO cohorts. During the maintenance period, most fills occurred at the on-label dosing interval for each therapy."
Clinical • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL12A • IL23A
August 29, 2026
Perforated Cytomegalovirus Colitis in a Patient With Ulcerative Colitis on Mirikizumab Following Renal Transplant
(ACG 2026)
- "His post-transplant immunosuppression at the time of admission included Prednisone, Tacrolimus, and Mycophenolate...He was started on renally adjusted intravenous Ganciclovir 2.5mg/kg per 24 hours, before being transitioned to Valganciclovir 450mg orally daily...A recent review of use of immunomodulators and biologic therapies in these patients highlighted that anti-TNF, anti-integrin agents, and Ustekinumab appeared to be safe, regardless of transplant-related immunosuppression...Figure: High power photomicrograph showing many viral inclusion bodies in resected sigmoid colon (routine H&E stain). Figure: High power photomicrograph of resected sigmoid colon showing strongly positive nuclear staining by CMV immunohistochemistry."
Clinical • Cardiovascular • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Hypertension • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Nephrology • Renal Disease • Solid Organ Transplantation • Transplantation • Ulcerative Colitis
August 29, 2026
Identifying Safety Signals in Mirikizumab Therapy by Distinguishing True Drug Toxicity From Disease-Related Adverse Events: A Systematic Review and Meta-Analysis
(ACG 2026)
- "Five RCTs comprising 3,140 patients (mirikizumab: n=2,289; placebo: n=851) met inclusion criteria. Mirikizumab was associated with a significant reduction in serious adverse events (SAEs) (RR 0.54, 95% CI 0.43â0.67; p=0.0013; I²=0%) and discontinuations due to adverse events (RR 0.33, 95% CI 0.18â0.60; p=0.007; I²=37.5%). Endpoints reflecting mechanism-based toxicity showed no significant increase compared with placebo, including any infection (RR 1.12, 95% CI 0.92â1.37; p=0.165), serious infection (RR 0.65, 95% CI 0.28â1.48; p=0.198), opportunistic infection (RR 1.25, 95% CI 0.45â3.43; p=0.550), and herpes zoster (RR 1.05, 95% CI 0.38â2.87; p=0.880)."
Adverse events • Retrospective data • Review • Cardiovascular • Gastroenterology • Gastrointestinal Disorder • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Bowel Disease • Varicella Zoster
August 29, 2026
Drug Similarity Network Model for Personalized Biologic Sequencing in Inflammatory Bowel Disease - A Novel Undirected Weighted Similarity-Graph Framework
(ACG 2026)
- "Eight therapeutic classes were represented as network nodes: anti-TNF agents (infliximab, adalimumab), vedolizumab, ustekinumab, risankizumab, mirikizumab, ozanimod, and JAK inhibitors (tofacitinib, filgotinib), with similarity metrics derived from clinical remission, endoscopic healing, biomarker normalization, and safety outcomes. The calibrated network identified ustekinumab as a key bridging therapy after anti-TNF failure in Crohn's disease (CD). Key similarity scores included: vedolizumab-anti-TNF (0.68), ustekinumab-risankizumab (0.78), ustekinumab-vedolizumab (0.72), and anti-TNF-ozanimod (0.55). In anti-TNF-experienced CD, the model prioritized risankizumab over ustekinumab, consistent with SEQUENCE trial findings (endoscopic remission at week 48: 31.8% vs 16.2%, p< 0.0001)."
Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis
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