Zeposia (ozanimod) / BMS - LARVOL DELTA

Novel Agents on the Therapeutic Horizon For Paediatric Inflammatory Bowel Diseases: An Analysis of Clinical Trials Registries. (PubMed, Paediatr Drugs) - "Efforts to expedite approval of new agents in pIBD are warranted to ensure timely access to effective medications. Consideration for novel trial designs alongside continued engagement with regulatory bodies, sponsors, and the academic pIBD community is essential to advance drug approvals for pIBD."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics

EFFECTIVENESS AND SAFETY OF OZANIMOD AND NATALIZUMAB IN PATIENTS WITH COEXISTING INFLAMMATORY BOWEL DISEASE AND MULTIPLE SCLEROSIS: A EUROPEAN MULTICENTRE RETROSPECTIVE STUDY (UEGW 2026) - "OZA and NAT demonstrated effectiveness across IBD and MS outcomes with an acceptable safety profile. These preliminary real-world findings support their use in coexisting IBD-MS."

Retrospective data • CNS Disorders • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Multiple Sclerosis • Rare Diseases • Ulcerative Colitis

S1PR MODULATORS ATTENUATE INTESTINAL MUCOSAL INFLAMMATION AND LYMPHOCYTE ACTIVATION IN PATIENTS WITH IBD: AN EX VIVO ANALYSIS (UEGW 2026) - "The S1PR modulators (S1PRms), including etrasimod and ozanimod, are used in ulcerative colitis (UC). S1PRms exert multi-compartment immunomodulatory effects, including suppression of T-cell activation, reduction of mucosal inflammatory signaling, and direct epithelial responses. The observed variability in specific patient response highlights the potential of ex vivo platforms to capture differential drug responsiveness. Correlating ex vivo responses with in vivo outcomes, may support the development of the platforms for precision intervention in IBD."

Preclinical • Crohn's disease • Inflammation • Inflammatory Bowel Disease • Mucositis • Ulcerative Colitis • CXCL1 • CXCL8 • IL17A • IL6 • S1PR1 • S1PR5

HEAD-TO-HEAD POST-MARKETING SAFETY OF JAK INHIBITORS AND S1P RECEPTOR MODULATORS FOR ULCERATIVE COLITIS: A COMPARATIVE DISPROPORTIONALITY ANALYSIS OF THE FAERS DATABASE (UEGW 2026) - "Introduction: Oral small-molecule therapies for ulcerative colitis (UC) include Janus kinase inhibitors (JAKi; tofacitinib, upadacitinib) and sphingosine-1-phosphate receptor modulators (S1PRM; ozanimod, etrasimod). JAKi and S1PRM showed distinct mechanistic safety fingerprints: thromboembolic and herpes zoster signals for JAKi; cardiac-conduction, ophthalmic, and lymphoid signals for S1PRM. Notably, MACE did not signal for either JAK inhibitor despite adequate cell counts, and herpes zoster did not differentiate the classes — class choice should therefore be guided by cardiovascular-conduction and ophthalmologic risk rather than zoster concern. Findings are hypothesis-generating and require prospective confirmation."

Clinical • Head-to-Head • P4 data • Acne Vulgaris • Cardiovascular • Gastroenterology • Gastrointestinal Disorder • Herpes Zoster • Immunology • Inflammatory Bowel Disease • Macular Edema • Ophthalmology • Pulmonary Embolism • Respiratory Diseases • Ulcerative Colitis • Varicella Zoster

Functional antagonism of the S1P - S1PR1 signaling axis decreases trigeminocervical sensitization and migraine like neuronal activation in stress-induced rats. (Neuroscience 2026) - "Functional S1PR1 antagonists, such as ozanimod, have shown efficacy in preclinical models of chronic pain...These data demonstrate that a functional S1PR1 antagonist attenuates dural-TCC pathway activity in a migraine model, highlighting the role of the S1P-S1PR1 pathway in activating and sensitizing dural trigeminovascular neurons associated with migraine. Further, S1PR1 emerges as a promising new target for migraine therapy."

Preclinical • CNS Disorders • Migraine • S1PR1

Efficacy and Safety of Ozanimod in Ulcerative Colitis: A Real-World Pan-Hellenic Study. (PubMed, Medicina (Kaunas)) - "Treatment persistence did not differ significantly according to overall prior biologic exposure, whereas previous vedolizumab exposure was associated with lower treatment persistence over the week 48 follow-up (log-rank p = 0.037). Adverse events were reported in 13.9% of patients. Ozanimod demonstrated good efficacy and a favorable safety profile in patients with moderate UC."

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

Efficacy and Safety of Upadacitinib in Moderate-to-Severe IBD: A Systematic Review of RCTs in Biologic-Naïve and Biologic-Experienced Populations (ACG 2026) - "Introduction: Upadacitinib (UPA),an oral selective Janus kinase 1 (JAK-1) inhibitor,has emerged as an important therapy for inflammatory bowel disease (IBD).There is a lack of evidence synthesizing its comparative efficacy in biologic-naiÌve versus biologic- experienced (Bio-IR) patients across both Ulcerative Colitis (UC) and Crohnâs Disease (CD).This systematic review evaluates the efficacy, safety, and dose-response relationship of UPA in moderate-to-severe IBD. Five RCTs were included.UPA 45 mg induction therapy showed superior clinical and endoscopic remission rates compared to placebo. In maintenance phases, biologic-naiÌve patients attained the highest remission rates (up to 64.0% in UC and 58.5% in CD at week 52).UPA showed a clinically significant rate of remission of 42% in Bio-IR patients, indicating it may overcome the âceiling effectâ of traditional biologics.The safety analysis demonstrated a dose-dependent increase of adverse..."

Clinical • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Herpes Zoster • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • Varicella Zoster • IL23A • JAK1

Drug-Induced Pancreatitis Across UC Therapeutics: A Real-World Pharmacovigilance Study (ACG 2026) - " FAERS was queried for reports of pancreatitis associated with UC treatments including immunomodulators (azathioprine, mercaptopurine, methotrexate, tacrolimus), 5-aminosalicylates (mesalamine, balsalazide, olsalazine, sulfasalazine), anti-TNF agents (adalimumab, infliximab, golimumab, certolizumab pegol), integrin inhibitors (vedolizumab, natalizumab), IL-12/23 inhibitors (ustekinumab, risankizumab, guselkumab), JAK inhibitors (tofacitinib, upadacitinib), and S1P modulators (ozanimod, etrasimod). 83,046 reports with 612 pancreatitis cases were analyzed. Significantly elevated risk was observed with azathioprine (ROR 4.38, 95% CI 3.56-5.38), mesalamine (ROR 2.32, 95% CI 1.87-2.89), and infliximab (ROR 1.47, 95% CI 1.21-1.80; all p< 0.0001). Reduced risk was identified with adalimumab (ROR 0.60, 95% CI 0.49-0.74), vedolizumab (ROR 0.69, 95% CI 0.51-0.93), and ustekinumab (ROR 0.13, 95% CI 0.02-0.94)."

Adverse events • Clinical • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pancreatitis • Ulcerative Colitis • IL12A • ROR1

Inducing Remission in UC/PSC Refractory to Four Advanced Therapies With Adjunctive Oral Vancomycin (ACG 2026) - "At diagnosis of PSC-UC, she was initiated on prednisone and vedolizumab which failed to control disease. She was transitioned to ozanimod which also failed. Infliximab 5mg/kg every 8 weeks resulted in clinical and endoscopic improvement, but was limited by neutralizing antibody formation...She was continued on vedolizumab and guselkumab, and OV was added. Clinical and endoscopic remission was achieved at 6 months. Further research is needed, but this case suggests OV can be used to induce remission even in refractory cases of PSC-UC."

Clinical • Metastases • Autoimmune Hepatitis • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease • Primary Sclerosing Cholangitis • Ulcerative Colitis

Cutaneous Kaposi Sarcoma in a Patient With Ulcerative Colitis: Progression on Infliximab and Regression After Withdrawal (ACG 2026) - "If colitis relapses, non-TNF options require caution, as KS has also been reported with vedolizumab, tofacitinib, ozanimod, and upadacitinib. (D) Marked regression ~6 months after infliximab withdrawal, with residual hyperpigmented macules and scarring. (consented)"

Clinical • Dermatopathology • Epstein-Barr Virus Infections • Gastroenterology • Gastrointestinal Disorder • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammatory Bowel Disease • Kaposi Sarcoma • Sarcoma • Solid Tumor • Ulcerative Colitis • CD34 • TNFA

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

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

Sustained Clinical and Endoscopic Improvements With up to 3 Years of Risankizumab Maintenance Treatment in Patients With Moderate to Severe Ulcerative Colitis Regardless of the Number of Prior Advanced Therapy Exposures (ACG 2026) - "AT included approved biologics for UC (infliximab, adalimumab, golimumab, ustekinumab, and/or vedolizumab), approved Janus kinase inhibitors for UC (tofacitinib, filgotinib, upadacitinib), and/or ozanimod. At induction baseline, among the 1003 pts included in the AO analysis, 29.4% (N=295) were AT-naïve; 29.4% (N=295) and 41.2% (N=418) had previously experienced 1 and >1 AT, respectively. Among the RZB180 and RZB360 groups, rates of CR (per AMS or PAMS) generally remained stable at OLE W0 and 96, regardless of the number of prior AT exposures, per AO analysis. Rates of endoscopic improvement and remission were sustained, regardless of the number of prior AT exposures, per AO analysis."

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

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

Efficacy and Safety of Ozanimod 1 Mg for Induction Therapy in Ulcerative Colitis: A Systematic Review and Meta-analysis of Phase 2 to 3 Trials (ACG 2026) - "A total of 907 patients were included from 3 RCTâS. Ozanimod significantly improved clinical remission (risk ratio 3.50, 95 percent confidence interval 1.78 to 6.89), clinical response (risk ratio 1.78, 95 percent confidence interval 1.48 to 2.14), endoscopic improvement (risk ratio 2.59, 95 percent confidence interval 1.87 to 3.59), and histologic remission (risk ratio 2.49, 95 percent confidence interval 1.62 to 3.81). Safety outcomes were comparable to placebo, including overall adverse events (risk ratio 1.03, 95 percent confidence interval 0.87 to 1.21), serious adverse events (risk ratio 1.13, 95 percent confidence interval 0.56 to 2.27), and discontinuations due to adverse events (risk ratio 1.08, 95 percent confidence interval 0.50 to 2.33)."

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

Comparative Efficacy and Safety of Etrasimod Versus Ozanimod, JAK Inhibitors, and Placebo in Adults With Moderate to Severe Ulcerative Colitis (ACG 2026) - "Regarding safety, filgotinib 100 mg was the only treatment significantly reducing any-TEAE risk versus placebo (OR 0.82; 95% CrI 0.68-0.98), while ozanimod 1 mg was the only treatment significantly increasing TEAE risk (OR 1.71; 95% CrI 1.22-2.40). Up to 28 RCTs enrolling 8,377 participants were included. For induction clinical remission (18 RCTs; N=6,562), upadacitinib 45 mg ranked highest (OR 9.92, 95% CrI 5.81-18.11; SUCRA 90%), followed by ozanimod 1 mg (OR 4.37; SUCRA 63%), tofacitinib 10 mg induction (OR 4.23; SUCRA 60%), and etrasimod 2 mg (OR 3.61; SUCRA 52%). For induction clinical response, upadacitinib 45 mg again ranked first (OR 7.84; SUCRA 94%), with etrasimod 2 mg (OR 3.01; SUCRA 59%) and tofacitinib 10 mg (OR 2.96; SUCRA 58%) performing comparably."

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

Anchored Too Soon: Cholangiocarcinoma Masquerading as Drug-Induced Liver Injury (ACG 2026) - "Given recent exposure to ozanimod, a sphingosine-1-phosphate receptor modulator with known hepatotoxicity, the leading diagnosis on admission was ALF secondary to DILI. He was briefly treated with an infusion of N-acetylcysteine without significant improvement...However, the presence of ductal dilation on imaging eventually redirected the diagnostic workup, leading to the correct diagnosis of cholangiocarcinoma. In patients with suspected DILI, physicians should practice diagnostic flexibility and systematically reevaluate for competing etiologies."

Biliary Cancer • Cholangiocarcinoma • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Hepatic Encephalopathy • Hepatology • Immunology • Inflammatory Bowel Disease • Liver Failure • Oncology • Solid Tumor • Ulcerative Colitis

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

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

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

Autoimmune Hemolytic Anemia: A Rare Presentation in the Setting of Ozanimod Therapy for Ulcerative Pancolitis (ACG 2026) - "Case Description/ A 43-year-old female with long standing ulcerative pancolitis, previously treated with adalimumab before transitioning to ozanimod...She was treated with rituximab and prednisone; ozanimod was discontinued and replaced with risankizumab, resulting in clinical and biochemical improvement...Figure: Table 1. Laboratory trends demonstrating the development of autoimmune hemolytic anemia during ozanimod therapy and subsequent improvement following treatment."

Anemia • Autoimmune Hemolytic Anemia • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • HP

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

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

The Efficacy and Safety of Guselkumab in Patients With Moderate to Severe Ulcerative Colitis Through Two Years: ASTRO Week 96 Results (ACG 2026) - "ADT, advanced therapy; ADT-IR, inadequate response to or intolerance of advanced therapy (TNFa antagonists, vedolizumab, ozanimod, or approved JAK inhibitors); AE, adverse event; NRI, nonresponder imputation; Q, question; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous; UC, ulcerative colitis; UC-PRO/SS, Ulcerative Colitis-Patient-reported Outcome/Signs and Symptoms; W, week. A total of 235 pts who were randomized to GUS continued trt after W48. At W96, the proportion of pts in symptomatic remission was 81.9% and 82.8% (observed) and 64.2% and 71.3% (modified NRI) in the GUS 100 mg SC q8w and GUS 200 mg SC q4w trt arms, respectively (Table). A similar pattern was reported in the advanced therapy pt subgroups (Table)."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease • Ulcerative Colitis • CRP

Comparative Post-Marketing Safety Signals of Etrasimod Versus Ozanimod: A Head-to-Head Disproportionality Analysis of the FDA Adverse Event Reporting System (FAERS) (ACG 2026) - "After these interpretive exclusions, 42 clinically relevant PTs were identified with etrasimod and 16 with ozanimod. Etrasimod-preferred signals included bradycardia (ROR 4.90, 95% CI 2.58â9.31), macular edema ( 2.36, 95% CI 1.17â4.76), blurry vision( 2.23, 95% CI 1.49â3.33), LFTs increased (6.01, 2.11â17.17), rash (1.80, 1.22â2.67), and dizziness (1.62, 1.27â2.07). Ozanimod PTs included fatigue (0.51, 0.39â0.66), lymphopenia (0.22, 0.07â0.70), back pain (0.32, 0.17â0.58), and urinary tract infection (0.36, 0.17â0.78)."

Adverse events • Clinical • Head-to-Head • P4 data • Back Pain • Cardiovascular • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Macular Edema • Multiple Sclerosis • Musculoskeletal Diseases • Musculoskeletal Pain • Nephrology • Ophthalmology • Ulcerative Colitis