Latest news with #ulcerative colitis
Medscape
4 days ago
- Health
- Medscape
Cyclosporin: A Viable Option for Severe Ulcerative Colitis
TOPLINE: Cyclosporin was effective in achieving clinical response and remission in adults with severe steroid-refractory ulcerative colitis (UC), enabling more than half of the patients to avoid colectomy. METHODOLOGY: Researchers conducted a retrospective cohort study of 92 patients (mean age, 55 years; 54.4% men) with severe steroid-refractory UC between January 2001 and February 2024 to evaluate the short- and long-term effectiveness and safety of cyclosporin therapy. All patients received intravenous (IV) methylprednisolone (1 mg/kg/d) for 3-7 days as first-line therapy, and owing to unsuccessful treatment, they received IV cyclosporin (median, 3 mg/kg/d) for 5-7 days as second- or third-line rescue treatment. Clinical and endoscopic disease activity was assessed using the Mayo endoscopic subscore and the partial Mayo score (pMayo). The primary outcome was the rate of clinical response and remission to IV cyclosporin therapy. Clinical response was defined as any reduction in the pMayo score from baseline, and clinical remission was defined as a pMayo score of ≤ 2, with a rectal bleeding subscore of zero. In case of clinical response, IV cyclosporin was followed by oral cyclosporin treatment. Other assessments included colectomy-free survival rates and adverse events associated with cyclosporin therapy, with a median follow-up duration of 14 years. TAKEAWAY: Overall, 88% of patients achieved a clinical response, with 23.9% reaching remission after the IV phase of cyclosporin therapy. Among those on oral cyclosporin, 41.9% showed relapse, whereas 40.7% achieved or maintained remission. Cyclosporin therapy was discontinued in 12% of patients owing to insufficient response to IV therapy and in 14.1% due to adverse events. Adverse events associated with cyclosporin were reported in 53.3% of patients. Moreover, 51.9% of patients who showed response to cyclosporin avoided colectomy. At 1, 3, 5, and 14 years after initiating cyclosporin therapy, the probabilities of colectomy-free survival were 74.7%, 62.6%, 57.1%, and 45.6%, respectively. Concomitant immunomodulator use was the sole predictor of clinical remission after treatment with oral cyclosporin (odds ratio [OR], 6.41; P = .002), and hypoalbuminaemia (serum albumin levels < 35 g/L) at the start of therapy was the sole predictor of adverse events (OR, 0.36; P = .03). IN PRACTICE: "[The study] findings suggest that the effectiveness of CsA [cyclosporin] may be enhanced by the concomitant use of IMT [immunomodulator therapy] in active, severe, steroid-refractory UC, without compromising safety," the authors of the study concluded. SOURCE: This study was led by Bernadett Farkas, MD, Department of Internal Medicine, SZTE SZAKK Center for Gastroenterology, University of Szeged, Szeged, Hungary. It was published online on August 08, 2025, in Therapeutic Advances in Gastroenterology. LIMITATIONS: The study's retrospective design may have introduced confounding due to inherent differences in assessments. The sample size was small, and thus, the minimum effective dosage and duration of concomitant immunomodulator therapy were not identified. DISCLOSURES: This study received funding through a grant from the EU's Horizon 2020 research and innovation program, with additional support being received through grants from the National Research, Development and Innovation Office; the János Bolyai Research Grant; and the Géza Hetényi Research Grant from Albert Szent-Györgyi Medical School, University of Szeged to the authors. Two authors reported receiving speakers' honoraria from various pharmaceutical companies. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Yahoo
4 days ago
- Business
- Yahoo
Vendanta's culls UC microbiome therapy on Phase II fail
Vendanta Biosciences will be stopping development of its oral microbiome therapy, VE202, which failed to meet its primary endpoint in a Phase II trial in mild-to-moderate ulcerative colitis (UC). VE202 failed to show improvement in endoscopic response in UC patients in the randomised, double-blind, placebo-controlled COLLECTiVE202 study (NCT05370885), with Vendanta CEO Dr Bernat Olle confirming on LinkedIn that the drug will not be moving forward. In the press release confirming the trial failure, Olle said: 'We are very disappointed that our study did not meet its efficacy endpoints, and our greatest regret is that people living with inflammatory bowel disease will not, for now, have the opportunity to benefit from a new treatment option. 'The gut microbiome is a well-recognised driver of IBD [inflammatory bowel disease], yet remains a facet of the disease untouched by current treatments. As a field, we have not yet succeeded in making a meaningful impact for people with IBD through microbiome-based approaches, but every study moves us closer to that goal.' Vendanta will be sharing further analyses of the UC trial at upcoming scientific meetings. Due to the Phase II failure, Vendanta will be reducing its workforce by 20%, Olle also confirmed in his social media post. Amid the failure, the company said it is now focusing efforts on other pipeline assets, primarily VE303, which is in a Phase III registrational study for the prevention of recurrent C. difficile infection (rCDI). A Phase II trial of the drug demonstrated potentially best-in-disease efficacy with a 30.5% absolute risk reduction and a greater than 80% reduction in the possibility of CDI recurrence. Olle added: 'Our priority at Vedanta remains the successful execution of our ongoing global pivotal study of VE303 for the prevention of recurrent C. difficile infection, with the goal of potentially delivering the first approved live biotherapeutic product in any indication — and, in doing so, addressing a serious health condition with a significant unmet medical need.' The company's other clinical asset, VE707, will be investigated for its ability to prevent infections by multi-drug-resistant organisms that affect a wide range of vulnerable populations in areas such as oncology, urology, transplantation, and critical care. The investigational new drug (IND) submission for VE707 is planned for H1 2026. UC market remains competitive A large number of biologics have also been approved in UC, with the first being Janssen's Remicade (infliximab), which gained US Food and Drug Administration (FDA) approval in 2005. Since then, AbbVie's Humira (adalimumab), Takeda's Entyvio (vedolizumab), and Johnson & Johnson's Stelara (ustekinumab) have also all gained approval in the UC sector. As biosimilars for Humira began to enter the market in 2023, AbbVie is hoping to regain some control in the UC market with Skyrizi (risankizumab-rzaa) after it was approved in June 2024. It recently culled an IL-1 asset as a monotherapy for UC after it failed to show benefit in a Phase II trial. A company that could be set to make its mark in UC is Abivax, with the company's stock surging more than 500% after its first-in-class miRNA regulator, obefazimod, showed an average 16.4% placebo-adjusted clinical remission rate across two Phase III trials. According to GlobalData, the UC market across the eight major markets (the US, France, Germany, Italy, Spain, the UK, Japan, and Canada) will reach $10bn in 2031. GlobalData is the parent company of Clinical Trials Arena. "Vendanta's culls UC microbiome therapy on Phase II fail" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
