PHILADELPHIA—The Phase 3 QUASAR study demonstrated efficacy of guselkumab as a maintenance therapy for patients with ulcerative colitis who initially did not respond to intravenous guselkumab induction therapy, according to results presented at ACG 2024.

Patients with moderately to severely active UC who initiated intravenous induction therapy with guselkumab (Tremfya, Janssen) were evaluated at week 12 (I-12). Those who did not achieve a clinical response (n=203) given subcutaneous guselkumab induction at weeks I-12, I-16, I-20, and were evaluated at week I-24. The responders at I-24 (n=123), initiated maintenance therapy of 200 mg of guselkumab every four weeks (abstract P0826).

 

The majority of these 123 patients had severe disease at the start of induction therapy (modified Mayo score of 7-9, 75%; Mayo endoscopy subscore of 3, 77%), and most had failed prior advanced treatments (inadequate response/intolerance to biologic or Janus kinase inhibitor, 59%).

When evaluated at week 44 of the maintenance phase, 67.5% and 30.1% of patients achieved the end points of clinical response maintenance and clinical remission, respectively. In addition, symptomatic remission generally was maintained, with a similar proportion of patients with symptomatic remission at the start (58.5%) and week 44 (56.9%) of maintenance therapy.

The investigators noted that the safety of guselkumab was as expected, based on use in its currently approved indications, with “no new safety concerns … identified” in this study. In total, 5.7% of maintenance patients experienced serious adverse events, 1.6% experienced serious infections, and there were no deaths.

—Natasha Albaneze, MPH

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