DOP52 Guselkumab improves symptoms of fatigue in patients with moderately to severely active Ulcerative Colitis: Phase 3 QUASAR induction study results at Week 12

Abstract Background Fatigue is a common symptom in patients with ulcerative colitis (UC) that impairs health-related quality of life. The Phase 3 QUASAR Induction Study (NCT04033445) was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study of guselkumab (GUS), an interleukin-23 p19 subunit antagonist, in patients with moderately to severely active UC. The impact of GUS IV induction on patient-reported symptoms of fatigue is reported here. Methods Patients were randomized 3:2 to receive GUS 200 mg IV or placebo IV at Weeks 0, 4, and 8. At baseline and Week 12, patients completed the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 7a (SF7a) which includes 7 items to evaluate symptoms of fatigue (ie, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (ie, activity limitations related to work, self-care, and exercise). PROMIS-Fatigue-SF7a raw scores were converted to a standard T-score based on a general US population of mean=50 and SD=10. Higher scores indicate more severe fatigue symptoms. PROMIS-Fatigue SF7a outcomes were evaluated at Week 12 based on the improvements of ≥3, ≥5 and ≥7 points from baseline in PROMIS-Fatigue SF7a T-score. A ≥7-point improvement was defined as fatigue response (multiplicity-controlled secondary endpoint). A cumulative distribution function (CDF) curve and a probability density function (PDF) plot were used to demonstrate consistency of fatigue response. Results Seven hundred one patients were randomized and treated in the primary analysis population (mean UC duration, 7.5yrs, Mayo endoscopy subscore=3 [severe disease], 67.9%, and mean modified Mayo score, 6.9, at baseline). The mean (SD) PROMIS-Fatigue SF7a T-scores at baseline were similar between the treatment groups: 56.0 (8.77) for GUS 200 mg IV and 56.4 (8.90) for placebo IV. At Week 12, the mean change from baseline in PROMIS-Fatigue SF7a T-score was -5.7 for GUS and -2.1 for placebo (nominal p<0.001). Compared with placebo at Week 12, a higher proportion of GUS-treated patients achieved fatigue response (Table 1) and clinically meaningful ≥3-point and ≥5-point improvements in PROMIS-Fatigue SF7a T-scores (56.8% and 49.4% vs 34.6% and 26.4%, respectively, both nominal p<0.001). Both the CDF curve and PDF plot demonstrated consistency of greater treatment effect of GUS on fatigue vs placebo (Figure 1). Conclusion Moderately to severely active UC patients who received GUS induction treatment showed greater improvement in patient-reported symptoms of fatigue at Week 12 compared with placebo-treated patients.

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