NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) announced new long-term results from the QUASAR long-term extension (LTE) study, showing that TREMFYA (guselkumab) sustained clinical, endoscopic, and histologic outcomes through Week 140 in adults with moderately to severely active ulcerative colitis (UC).
At Week 140, 80.8% of patients receiving TREMFYA were in clinical remission. Additionally, 78.6% achieved histo-endoscopic mucosal improvement (HEMI), while 53.6% reached endoscopic remission. Approximately 89% of eligible participants completed treatment through Week 140, and nearly all patients in clinical remission at this timepoint were corticosteroid-free for at least eight weeks.
Durability of response was also demonstrated. Among those in clinical remission at Week 44, 87.5% maintained remission through Week 140. Importantly, efficacy was consistent regardless of prior biologic or JAK inhibitor treatment history, and no new safety concerns were identified during the study period.
TREMFYA received U.S. Food and Drug Administration and European Commission approval for both SC and IV induction options for the treatment of adults with moderately to severely active Crohn's disease and U.S. FDA approval for both SC and IV induction options for the treatment of adults with moderately to severely active ulcerative colitis. TREMFYA is approved by the EC for the treatment of adult patients with moderately to severely active ulcerative colitis and is currently administered via an IV induction regimen, followed by a SC maintenance regimen.
Johnson & Johnson closed on February 20 at $242.49, reflecting a decline of $4.42 or 1.79%. In after-hours trading, the stock inched up slightly to $242.51, a modest increase of $0.02 or 0.01%.
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