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Recently,Johnson & JohnsonAnnounced the submission of a supplemental Biologics License Application (sBLA) to the U.S. FDA, seeking approval for itsAnti-IL-23 Antibody Tremfya (Guselkumab) for the Treatment of Moderate to Severe Active Ulcerative ColitisAdult patients with ulcerative colitis (UC). This sBLA submission is based on the results of the Phase 3 clinical trial QUASAR. The data shows,The patient is inStatistically and clinically significant improvements in symptoms, patient-reported outcomes (such as fatigue), and disease activity measures (including endpoints like endoscopic and histologic remission).Safety Results withTremfyaConsistent with the known safety profile in the approved indications.
QUASAR Phase 3 Induction Study is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study designed to evaluate the efficacy and safety of guselkumab as an induction therapy for patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to or cannot tolerate conventional therapies (i.e., thiopurines or corticosteroids) and/or advanced therapies (i.e., TNF-α antagonists, vedolizumab, or tofacitinib).The trial results published this time show,Single intravenous (IV) induction doseguselkumabSymptom relief was observed one week later, along with improvements in patient-reported rectal bleeding and the absolute number of bowel movements.。▲ Early symptom relief data from Week 1 to Week 12 (Image source: Reference [1])
To the 1stAt 2 weeks,With ComfortCompared with the placebo group, a significantly higher proportion of patients receiving guselkumab achieved clinical remission, with 61.5% (259/421) versus 27.9% (78/280).At Week 12, there was still no clinical remission in response to IV induction therapy.Among patients who subsequently received an additional 12 weeks of subcutaneous guselkumab treatment, 55% (66/120) achieved clinical remission at week 24.Aggregate the data from weeks 12 and 24,Among patients randomly assigned to the guselkumab treatment group at baseline, a cumulative 77.2%（325/421）Patients achieved clinical remission.Patients, regardless of their history of inadequate response or intolerance to biologics and JAK inhibitors, can benefit from continuous subcutaneous guselkumab treatment up to Week 24.In terms of safety, no new safety signals were identified. The most common adverse events in patients receiving guselkumab were COVID-19 (7.2%), anemia (5.1%), and UC exacerbation (4.6%).GuselkuMab is a humanized monoclonal antibody that selectively inhibits IL-23 signaling by binding to the p19 subunit of the IL-23 receptor.Currently, guselkumab has been approved in the United States, Canada, Japan, and many other countries/regions for the treatment of moderate to severe plaque psoriasis, as well as psoriatic arthritis.
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[1] New Phase 3 TREMFYA® (guselkumab) Results in Ulcerative Colitis Show a 77 Percent Overall Clinical Response Rate and Early Symptom Improvement. Retrieved October 24, 2023, from https://www.jnj.com/new-phase-3-tremfya-guselkumab-results-in-ulcerative-colitis-show-a-77-percent-overall-clinical-response-rate-and-early-symptom-improvement[2] Johnson & Johnson submits supplemental
Biologics License Application to U.S. FDA seeking approval of TREMFYA®
(guselkumab) for the treatment of adults with moderately to severely active
ulcerative colitis. Retrieved March 12, 2024, from https://www.prnewswire.com/news-releases/johnson--johnson-submits-supplemental-biologics-license-application-to-us-fda-seeking-approval-of-tremfya-guselkumab-for-the-treatment-of-adults-with-moderately-to-severely-active-ulcerative-colitis-302085776.html
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