Latest news with #inflammatory bowel disease
Medscape
a day ago
- Health
- Medscape
Biologic Dose Adjustments May Benefit Patients With IBD
TOPLINE: The dose escalation of biologic therapy was effective in achieving remission in up to approximately half of patients with inflammatory bowel disease (IBD), with a probability of sustaining the escalated dose ranging from 71% to 88% at 24 months across different biologics. Dose de-escalation was proved to be feasible in selected patients, with 89%-100% maintaining clinical remission at 12 months. METHODOLOGY: In this cross-sectional study, researchers analysed patients with IBD enrolled in a Spanish registry (January 2012 to December 2022) from 72 Spanish centres to assess the frequency, persistence, and effectiveness of the dose escalation of biologics or their discontinuation. Adult patients with a diagnosis of Crohn's disease or ulcerative colitis (UC) who received standard maintenance doses of infliximab (5 mg/kg every 8 weeks), adalimumab (40 mg every other week), golimumab (50 and 100 mg monthly for those with weight ≤ 80 kg and > 80 kg, respectively), vedolizumab (300 mg every 8 weeks), or ustekinumab (90 mg every 8 or 12 weeks) were identified. Overall, 5096 patients underwent dose escalation, defined as any increase in the dose and/or shortening of the dosing interval from the standard schedule's doses. Conversely, dose de-escalation was defined as the reduction in the dose and/or lengthening of the dosing interval following an escalation regimen, occurring in 669 patients. The effectiveness of dose escalation or de-escalation was assessed on the basis of clinical remission with or without corticosteroids, response, and non-response. Factors associated with drug discontinuation after dose escalation were also assessed, with a median follow-up duration ranging from 9 to 24 months across different biologics. TAKEAWAY: Among patients on various biologics, the incidence rate of dose escalation per patient-year of follow-up was 5% for those on infliximab, 7% for those on adalimumab, 7% for those on golimumab, 10% for those on vedolizumab, and 12% for those on ustekinumab. Remission was achieved in 32%-49% of patients after dose escalation, with a probability of maintaining the escalated dose ranging from 71% to 88% at 24 months across different biologics. Incidence rates of dose de-escalation per patient-year of follow-up ranged from 3% to 9% across various biologics. Factors associated with drug discontinuation after dose escalation were previous biologic exposure and the duration of IBD (for infliximab), monotherapy (for adalimumab), and the presence of UC (for ustekinumab). Clinical remission was observed in 89%-100% of patients who underwent dose de-escalation, with a probability of maintaining the de-escalated dose ranging from 82% to 90% at 12 months across different biologics. Factors linked to relapses after dose de-escalation were previous biologic exposure (for infliximab) and age at dose de-escalation (for adalimumab). IN PRACTICE: "While dose escalation offers a clear benefit in cases of LOR [loss of response], with a high proportion of patients achieving response (and remission) over time, dose de-escalation seems feasible for long-term management in selected patients, although it must be approached with caution," the authors of the study wrote. SOURCE: This study was led by Cristina Rubín de Célix, MD, PhD, Department of Gastroenterology, Hospital Universitario de Fuenlabrada, Madrid, Spain. It was published online on August 08, 2025, in Alimentary Pharmacology and Therapeutics. LIMITATIONS: Drug trough levels and antidrug antibodies were not routinely measured prior to dose escalation and de-escalation. The small number of patients undergoing vedolizumab or ustekinumab dose de-escalation precluded definitive conclusions about these regimens. Response after dose escalation and outcomes following dose de-escalation were determined solely by clinician judgement as endoscopic confirmation was unavailable. DISCLOSURES: This study received support from Eli Lilly and Company for the statistical analysis, medical writing, and publication fees alone. Several authors reported receiving education funding, support for congress and conference attendance or travelling, speaker fees, research support, and consulting fees and serving as speakers, consultants, and advisory members for 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
14-08-2025
- 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
