QUASAR maintenance study: Guselkumab effective and safe for UC

The efficacy of guselkumab was maintained in participants with moderately to severely active ulcerative colitis (UC) who responded to intravenous (IV) guselkumab induction, as shown in the QUASAR maintenance study.

The QUASAR study (NCT04033445) demonstrated that guselkumab maintenance therapy outperformed placebo, according to Dr David Rubin (University of Chicago, IL, USA) [1]. The study included 568 participants who responded to induction therapy; namely, week 12 guselkumab responders and week 24 placebo-to-guselkumab responders. Participants were randomised 1:1:1 to receive subcutaneous guselkumab at 200 mg every 4 weeks, 100 mg every 8 weeks, or a placebo. The primary endpoint was clinical remission at week 44.

After 44 weeks of treatment, clinical remission rates were significantly higher in the 100 mg arm (45.2%; 95% CI 16.4–33.9; P<0.001) and 200 mg arm (50%; 95% CI 20.9–38.1; P<0.001) compared with placebo (18.9%). Notably, 69% of guselkumab-treated participants in clinical remission also achieved endoscopic remission (Mayo endoscopic subscore=0). Both guselkumab regimens met all 9 major secondary endpoints with statistical significance versus placebo, including corticosteroid-free clinical remission (D25.7 and D29.0), maintenance of clinical remission (D25.9 and D38.4), clinical response (D33.6 and D30.7), symptomatic remission (D31.9 and D30.5), endoscopic improvement (D29.5 and D31.1), histo-endoscopic mucosal improvement (D25.7 and D29.6), endoscopic remission (D18.5 and D16.8), IBDQ remission (D26.3 and D25.9), and fatigue response (D20.1 and D12.6).

The safety profile was consistent with previous studies. The most common adverse events were COVID-19, UC flares, and arthralgia. No deaths were reported, although there was 1 case of malignancy, 1 major adverse cardiovascular event, and 1 venous thromboembolism among guselkumab-treated participants.

“Guselkumab was statistically superior to placebo for the primary endpoint of clinical remission at week 44. All 9 major secondary endpoints were also met. Both guselkumab maintenance doses were efficacious. Safety results through week 44 were consistent with the known and favourable safety profile of guselkumab in approved indications,” Dr Rubin concluded.

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   1. Rubin D, et al. The efficacy and safety of guselkumab as maintenance therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 Quasar maintenance study. 759, DDW 2024, 18–21 May, Washington DC, USA.

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Posted on 11 July 202411 July 2024