Inflammatory Bowel Disease
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TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years
Prnewswire· 2026-02-21 13:00
Core Insights - Johnson & Johnson announced long-term data from the QUASAR study showing that TREMFYA® (guselkumab) maintains clinical and endoscopic remission in ulcerative colitis patients over three years, with over 80% of patients in clinical remission and more than 50% in endoscopic remission at Week 140 [1][2]. Group 1: Clinical Efficacy - At Week 140, 80.8% of patients treated with TREMFYA® were in clinical remission, while 53.6% achieved endoscopic remission [1]. - 78.6% of patients experienced histo-endoscopic mucosal improvement (HEMI), indicating significant intestinal healing [1]. - Among those in clinical remission at Week 44, 87.5% maintained remission through Week 140, demonstrating sustained efficacy [1]. Group 2: Study Retention and Safety - Approximately 89% of eligible study participants completed treatment through Week 140, indicating high retention rates [1]. - No new safety concerns were reported during the study, reinforcing the long-term safety profile of TREMFYA® [1][2]. Group 3: Mechanism and Approval - TREMFYA® is the first and only approved dual-acting monoclonal antibody that blocks IL-23 and binds to CD64, targeting immune-mediated diseases [1][2]. - The drug has received FDA and European Commission approval for treating both moderately to severely active Crohn's disease and ulcerative colitis [1][2]. Group 4: Additional Research and Commitment - Johnson & Johnson presented 30 abstracts at the European Crohn's and Colitis Organisation (ECCO) 2026 conference, highlighting ongoing research and commitment to inflammatory bowel disease treatments [1]. - Two other abstracts from Johnson & Johnson were recognized as Top 10 oral abstracts, showcasing the company's dedication to advancing treatment options [1].
Abivax Presents First Evidence of Anti-Fibrotic Activity for Obefazimod Alongside New Clinical Efficacy and Safety Analyses in Inflammatory Bowel Disease at ECCO 2026
Globenewswire· 2026-02-21 11:00
Core Insights - Abivax has presented new preclinical and clinical data for obefazimod, demonstrating its anti-fibrotic potential and favorable safety profile for treating inflammatory bowel disease at ECCO 2026 [2][3] Group 1: Clinical Data and Efficacy - The data presented includes evidence of obefazimod's anti-fibrotic effects in both preclinical human fibroblast models and in vivo animal models, indicating its potential to address unmet needs in Crohn's disease [4] - A pooled analysis from the Phase 3 ABTECT induction trials shows that obefazimod leads to symptomatic response as early as week 1 and symptomatic remission by week 2, with a nominally significant p-value of <0.05 [4][5] - Obefazimod demonstrated a ~50% reduction in a biomarker of active fibrosis (Pro-C3) and a ~30% reduction in a fibroblast activation marker (⍺SMA) in preclinical models, both with p-values <0.0001 [5] Group 2: Safety Profile - The safety data from the ABTECT-1 and ABTECT-2 trials indicate that the rates of serious treatment emergent adverse events (TEAEs) were comparable across treatment groups, with Obe-50mg at 3.1%, Obe-25mg at 2.2%, and placebo at 3.2% [8] - TEAEs leading to study discontinuation were also similar across groups, with Obe-50mg at 4.7%, Obe-25mg at 1.9%, and placebo at 4.1% [8] Group 3: Mechanism of Action - Biomarker data from the trials indicate that obefazimod enhances the expression of miR-124 and reduces key inflammatory cytokines IL-17A and IL-6 towards homeostatic levels, supporting its mechanism of action in restoring immune balance [4][8] - The mechanism allows for partial reduction of inflammatory cytokines without completely blocking these pathways, which may be beneficial for long-term disease management [8]