Johnson & Johnson (J&J) has reported new findings from the QUASAR long-term extension study of Tremfya (guselkumab) for ulcerative colitis (UC).
The results highlighted that the dual-acting monoclonal antibody Tremfya maintained endoscopic, histologic, and clinical remission through week 140 in adults with moderately to severely active UC.
The Phase IIb/III, double-blind, randomised, multi-centre, placebo-controlled trial is designed to assess the safety and efficacy of Tremfya in adults.
It involves patients who did not respond to or could not tolerate conventional therapies such as thiopurines or corticosteroids, prior biologics, including tumour necrosis factor (TNF) antagonists or vedolizumab, and/or janus kinase (JAK) inhibitors.
QUASAR included a Phase IIb dose-ranging induction trial, a confirmatory Phase III induction study, and a Phase III randomised withdrawal maintenance investigation.
In the Phase III induction portion, patients were given either 200mg guselkumab or a placebo by IV infusion at weeks 0, 4, and 8.
At week 140, 80.8% of those administered guselkumab achieved clinical remission. Histo-endoscopic mucosal improvement was recorded in 78.6% of patients, and 53.6% reached endoscopic remission.
Around 89% of eligible participants completed therapy through week 140. Nearly all individuals in clinical remission at this timepoint were corticosteroid-free for at least eight weeks.
Among those in remission at week 44, 87.5% sustained remission through week 140. Efficacy remained consistent regardless of previous biologic or JAK inhibitor use, with no new safety concerns identified.
J&J vice-president and immunology gastroenterology disease area lead Esi Lamousé-Smith said: “These findings highlight the endoscopic outcomes that can be achieved with Tremfya, raising expectations for what is possible for patients with ulcerative colitis. Patients who achieve endoscopic remission experience fewer flare-ups and are less likely to need steroids or require surgery over time.”
In January 2026, J&J’s Caplyta (lumateperone) combined with antidepressants nearly doubled the likelihood of remission after six weeks, and the benefit was maintained for more than six months in patients diagnosed with major depressive disorder (MDD).
