QUASAR: Guselkumab improves QoL for patients with ulcerative colitis

In the phase 3 QUASAR trial, guselkumab induction therapy delivered clinically meaningful improvements across all measured domains of health-related quality-of-life (QoL) compared with placebo in patients with moderately to severely active ulcerative colitis (UC).

The phase 3 QUASAR induction study (NCT04033445) assessed the efficacy and safety of the IL-23p19 inhibitor guselkumab in patients with moderately to severely active UC who had displayed intolerance or an inadequate response to a prior conventional therapy, biologic, or JAK inhibitor. The participants (n=701) were randomised 3:2 to guselkumab i.v. every 4 weeks, or a placebo. Prof. Julian Panés (Hospital Clinic de Barcelona, Spain) shared findings of the health-related QoL assessment, as measured by the patient-reported outcomes measurement information system (PROMIS)-29 [1].

At week 12, significantly higher proportions of participants in the guselkumab arm achieved clinically meaningful improvements (i.e. ≥5 point improvement) in symptom scores and function scores. The effect was observed across all domains of measured symptoms: anxiety (44.9% vs 25.4%), depression (39.0% vs 21.8%), fatigue (51.5% vs 30.0%), pain interference (44.2% vs 28.2%), and sleep disturbance (38.5% vs 20.4%), as well as across the 2 measured function domains: physical function (30.9% vs 19.3%) and social participation (50.4% vs 31.1%). Finally, pain scores, as measured by a numeric rating scale, were reduced with an average 1.69 points in the guselkumab arm and an average 0.95 points in the placebo arm.

“Patients with UC treated with guselkumab induction therapy in the QUASAR trial experienced broad and clinically meaningful improvements in health-related QoL, compared with patients who received placebo,” concluded Prof. Panés.

1. Panés J, et al. Guselkumab improves health-related quality of life as measured by PROMIS-29 in patients with moderately to severely active ulcerative colitis: phase 3 QUASAR induction study. DOP49, 19^th Congress of ECCO, 21–24 February 2024, Stockholm, Sweden.

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Posted on 18 April 2024