Velsipity (etrasimod) / Everest Medicines, Pfizer - LARVOL DELTA

Etrasimod in Treatment of Ulcerative Colitis: A Comprehensive Review. (PubMed, Turk J Gastroenterol) - "The backbone of disease management in UC is 5-aminosalicylic acid (5-ASA), but patients unresponsive to 5-ASA or with severe disease require advanced therapies including tumor necrosis factor-alpha inhibitors (TNFi), anti-integrins, anti-interleukins and small molecule therapy, Janus kinase (JAK) inhibitors, and S1PR modulators. This review will briefly overview the current state of medical therapeutic options in UC, with further detailing the molecular and clinical aspects of Etrasimod, a sphingosine-1-phosphate receptor (S1PR) modulator."

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

Sphingosine-1-Phosphate Receptor Modulators for the Treatment of Ulcerative Colitis: A Narrative Review Focusing on Safety. (PubMed, United European Gastroenterol J) - "Safety data from the field of multiple sclerosis (MS) will be discussed because the first S1PR modulator to reach the market, fingolimod, was used extensively for relapsing-remitting MS. Indications for the safe use of ozanimod and etrasimod in ulcerative colitis patients will be provided."

Journal • Review • CNS Disorders • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Multiple Sclerosis • Oncology • Solid Tumor • Ulcerative Colitis

Comparative Efficacy of Different Targeted Therapies in Patients With Moderate-to-Severe Ulcerative Colitis: Systematic Review/Network Meta-Analysis and Mechanistic Overview. (PubMed, Pharmacol Res Perspect) - "Cobitolimod 250 mg was the first-ranked treatment (SUCRA, 92.67%) in Endoscopic remission. Vedolizumab 108 mg was the best dosage in reducing Adverse Events (AEs). The optimal dosage for reducing Serious Adverse Events (SAEs) was found to be Tulisokibart 1000/500 mg. During the maintenance phase, Etrasimod 2 mg/kg ranked first in clinical remission (OR 9.58; 95% CI, 2.82-32.59), and Upadacitinib 45 mg was superior in endoscopic remission. Additionally, the most effective medication for raising quality of life was Guselkumab 200 mg (OR 3.04; 95% CI, 1.70-5.40). Consequently, there is a need for further high-quality research to conclusively determine the best therapeutic option."

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

The Current Sphingosine 1 Phosphate Receptor Modulators in the Management of Ulcerative Colitis. (PubMed, J Clin Med) - "This narrative review aims to distil the key trial data on the efficacy and safety of ozanimod and etrasimod, the two S1PR modulators currently licensed for use in UC. We summarise their safety profiles, taking into consideration open label extension data. Finally, we consider where this class of drugs may be best placed in the treatment landscape and also provide a practical guide for their use in clinical practice."

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

New Therapeutic Challenges in Pediatric Gastroenterology: A Narrative Review. (PubMed, Healthcare (Basel)) - "For CeD, therapies like gluten-degrading enzymes (latiglutenase, Kuma030) and zonulin inhibitors (larazotide acetate) show promise, though clinical outcomes are inconsistent...Transglutaminase 2 inhibitors like ZED-1227 could help prevent gluten-induced damage. Monoclonal antibodies targeting immune pathways, such as AMG 714 and larazotide acetate, require further validation in pediatric populations. In EoE, biologics like dupilumab, cendakimab, dectrekumab (IL-13 inhibitors), and mepolizumab, reslizumab, and benralizumab (IL-5/IL-5R inhibitors) show varying efficacy, while thymic stromal lymphopoietin (TSLP) inhibitors like tezepelumab are also being investigated...For IBD, biologics like vedolizumab, ustekinumab, and risankizumab, as well as small molecules like tofacitinib, etrasimod, and upadacitinib, are emerging treatments...Personalized therapy, integrating precision medicine, therapeutic drug monitoring, and lifestyle changes, is increasingly guiding pediatric..."

Journal • Review • Autoimmune Hepatitis • Celiac Disease • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Hepatitis B • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics • Transplantation • IL13 • IL5 • TGM2 • TSLP

Etrasimod for alopecia areata: The scenario for a less extensive and moderate form. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Alopecia • Immunology

Network Meta-Analysis: Efficacy of Biological Therapies and Small Molecules as Maintenance Therapy in Ulcerative Colitis. (PubMed, Aliment Pharmacol Ther) - "In network meta-analysis, upadacitinib and etrasimod were consistently efficacious as maintenance therapy in UC."

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

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

SYMPTOM RESPONSE TRAJECTORY ANALYSIS IDENTIFIES DISTINCT SUBPOPULATIONS IN MODERATE-TO-SEVERE ULCERATIVE COLITIS LINKED TO MAINTENANCE OUTCOMES: A PATIENT LEVEL POST-HOC ANALYSIS OF 2,378 PARTICIPANTS ACROSS 6 RCT'S WITH 8 ADVANCED THERAPIES (DDW 2025) - "Posthoc analysis of the SELECTION trial (filgotinib) demonstrated that analysis of daily PRO2 scores (stool frequency/rectal bleeding) as time-series data reveals discrete subpopulations...Methods In a cross-industry/academia collaboration, data from 2,378 UC participants from RCTs of adalimumab, brepocitinib, etrasimod, etrolizumab, ozanimod, ritlecitinib, ustekinumab, and vedolizumab in UC were analyzed for PRO2-based treatment symptom response trajectories using group-based trajectory modeling (GBTM)...Symptom response trajectories may reflect underlying heterogeneity in individual disease biology in interaction with different MOA (i.e. endotypes). RNASeq analysis of transcriptome regulation in these patients aims to further explore this hypothesis."

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

Etrasimod in the treatment of eosinophilic oesophagitis: a promising match? (PubMed, Lancet Gastroenterol Hepatol) - No abstract available

Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Etrasimod as a treatment for eosinophilic oesophagitis (VOYAGE): a double-blind, placebo-controlled, randomised, phase 2 trial. (PubMed, Lancet Gastroenterol Hepatol) - P2 | "Etrasimod led to sustained histological and endoscopic improvements in eosinophilic oesophagitis over 52 weeks, symptom improvement in patients without dilation, and was well tolerated. This trial provides the first evidence that targeting the S1P pathway can improve disease activity in patients with eosinophilic oesophagitis and that S1P receptor modulation is a viable treatment target for this disease."

Journal • P2 data • Cardiovascular • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation

Etrasimod for Immune Checkpoint Inhibitor Diarrhea and Colitis (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Yale University | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Oncology

“Update of sections 4.4, and 4.6 of the SmPC in order to amend an existing warning and information on pregnancy regarding reduced the contraceptive washout period from 14 to 7 days based on the results of recently completed DDI studies; the Package Leaflet is updated accordingly. The RMP version 2.1 has also been submitted.” (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC)-Draft agenda for the meeting on 5 - 8 May 2025: “For adoption of PRAC RMP AR, PRAC RMP assessment overview and advice to CHMP”

PRAC • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

SYNERGISTIC REDUCTION OF INFLAMMATORY CYTOKINES WITH OBEFAZIMOD AND ETRASIMOD IN COMBINATION TREATMENT VS. EITHER MONOTHERAPY IN A MOUSE MODEL OF INFLAMMATORY BOWEL DISEASE (DDW 2025) - No abstract available

Monotherapy • Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

ETRASIMOD FOR THE TREATMENT OF ULCERATIVE COLITIS: UP TO 4 YEARS OF SAFETY DATA FROM THE GLOBAL CLINICAL PROGRAM (DDW 2025) - "Etrasimod remains well tolerated in patients with moderately to severely active UC, with a favourable safety profile that has not changed with longer-term treatment exposure for up to 4 years. Reference: 1. Vermeire S et al."

Clinical • Basal Cell Carcinoma • Cardiovascular • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Herpes Zoster • Hypertension • Immunology • Infectious Disease • Inflammatory Bowel Disease • Macular Edema • Non-melanoma Skin Cancer • Oncology • Ophthalmology • Squamous Cell Carcinoma • Ulcerative Colitis • Varicella Zoster

DISCOVER VELSIPITY® (ETRASIMOD): AN RX TABLET TREATMENT OPTION FROM PFIZER (DDW 2025) - "Supported by: Pfizer"

4435: Immunology, Microbiology & Inflammatory Bowel Diseases (IMIBD) Section Distinguished Abstract Plenary (DDW 2025) - "Description: This session highlights the best of the best in basic and clinical science inflammatory bowel diseases research submitted to DDW 2025 and will cover novel genetic variants and gene expression patterns linked with disease, recent findings on the role of the gut microbiota on disease pathogenesis and the latest clinical trials controlled clinical trials in the field.Learning Objectives:• Examine the effect of a low-emulsifer diet on disease activity in Crohn's disease• Examine the efficacy of etrasimod for treatment of mild to moderately active UC• Learn about novel genetic variants and gene expression signatures in Inflammatory Bowel Disease; Understand host microbe interactions in Inflammatory Bowel Disease"

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

THE IMPACT OF ETRASIMOD ON NEUTROPHILS IN THE ELEVATE UC CLINICAL PROGRAM (DDW 2025) - P3 | "Our data support a relationship between decreased circulating and mucosal neutrophil levels and clinical and endoscopic improvement with etrasimod treatment in pts with UC, while showing a low likelihood of neutropenia."

Clinical • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Infectious Disease • Inflammatory Bowel Disease • Neutropenia • Ulcerative Colitis

S1PR4-dependent effects of Etrasimod on primary human myeloid immune cell activation. (PubMed, Front Pharmacol) - "Primary human macrophages, plasmacytoid dendritic cells and neutrophils were pretreated with S1P, Etrasimod (S1PR1/4/5), Ozanimod (S1PR1/5), Siponimod (S1PR1/5), CYM 50308 (S1PR4 agonist) and CYM 50358 (S1PR4 antagonist), and then stimulated with Zymosan A, ODN 2336 and PMA, respectively. Regarding receptor dynamics, we show that Etrasimod induces internalization of S1PR4. Taken together, our data show that S1PR4 takes on an essential role in the regulation of various immunological functions, and that Etrasimod can act as a superagonist/functional antagonist of S1PR4."

Journal • CNS Disorders • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Multiple Sclerosis • Ulcerative Colitis • CCL20 • CXCL5 • IFNA1 • S1PR1

13085: Discover VELSIPITY® (etrasimod): An Rx Tablet Treatment Option from Pfizer (DDW 2025) - "Join us for an overview of key efficacy and safety data, steps in getting patients started, and other clinical treatment considerations. PP-V1A-USA-0953."

ETRASIMOD EFFICACY IN PATIENTS WITH MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS (MODIFIED MAYO SCORE 4–6) IN THE PHASE 3 ELEVATE UC CLINICAL PROGRAM (DDW 2025) - P3 | "Etrasimod demonstrated robust efficacy in clinical, symptomatic, and endoscopic endpoints and safety consistent with the overall population in patients with mildly to moderately active UC, as defined by an MMS of 4–6."

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

EFFICACY OF ETRASIMOD AT WEEK 52 AMONG BIOLOGIC/JANUS KINASE INHIBITOR-NAÏVE PATIENTS WITH ULCERATIVE COLITIS WHO REACHED CLINICAL RESPONSE AT WEEK 12: POST HOC ANALYSIS OF THE PHASE 3 ELEVATE UC 52 RANDOMIZED TRIAL (DDW 2025) - P3 | "As a first-line advanced UC therapy, etrasimod demonstrated significant efficacy over placebo in all Week 52 efficacy outcomes in bio/JAKi-naïve induction treatment responders. These findings help contextualize data from the ELEVATE UC clinical program for patients receiving their first advanced UC therapy within a treat-through trial design. Pfizer's generative artificial intelligence tool MAIA was used to assist production of the abstract first draft."

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

THE EFFICACY AND SAFETY OF ETRASIMOD IN MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE GLADIATOR TRIAL (DDW 2025) - P2, P3 | No abstract available

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