Academic Journal
DOP52 Guselkumab improves symptoms of fatigue in patients with moderately to severely active Ulcerative Colitis: Phase 3 QUASAR induction study results at Week 12
| العنوان: | DOP52 Guselkumab improves symptoms of fatigue in patients with moderately to severely active Ulcerative Colitis: Phase 3 QUASAR induction study results at Week 12 |
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| المؤلفون: | Dignass, A, Panés, J, Rubin, D T, Huang, K H G, Germinaro, M, Pandya, D, Han, C, Miao, Y, Zhang, H, Gu, F, Rowbotham, D, Mihaly, E, Bressler, B, Lichtenstein, G R, Allegretti, J R |
| المصدر: | Journal of Crohn's and Colitis ; volume 18, issue Supplement_1, page i166-i167 ; ISSN 1873-9946 1876-4479 |
| بيانات النشر: | Oxford University Press (OUP) |
| سنة النشر: | 2024 |
| مصطلحات موضوعية: | Gastroenterology, General Medicine |
| الوصف: | 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). ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1093/ecco-jcc/jjad212.0092 |
| الاتاحة: | http://dx.doi.org/10.1093/ecco-jcc/jjad212.0092 https://academic.oup.com/ecco-jcc/article-pdf/18/Supplement_1/i166/56347873/jjad212.0092.pdf |
| Rights: | https://academic.oup.com/pages/standard-publication-reuse-rights |
| رقم الانضمام: | edsbas.FFFE96C7 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1093/ecco-jcc/jjad212.0092 |
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