دورية أكاديمية
Efficacy, patient-reported outcomes, and safety of the anti-granulocyte macrophage colony-stimulating factor antibody otilimab (GSK3196165) in patients with rheumatoid arthritis: a randomised, phase 2b, dose-ranging study
| العنوان: | Efficacy, patient-reported outcomes, and safety of the anti-granulocyte macrophage colony-stimulating factor antibody otilimab (GSK3196165) in patients with rheumatoid arthritis: a randomised, phase 2b, dose-ranging study |
|---|---|
| المؤلفون: | Buckley, Christopher D., Simón-Campos, Jesus A., Zhdan, Vyacheslav, Becker, Brandon, Davy, Katherine, Fisheleva, Elena, Gupta, Anubha, Hawkes, Carol, Inman, David, Layton, Mark, Mitchell, Nina, Patel, Jatin, Saurigny, Didier, Williamson*, Russell, Tak, Paul P., Ждан, Вячеслав Миколайович |
| بيانات النشر: | Copyright© 2020 Elsevier Ltd. All rights reserved |
| سنة النشر: | 2020 |
| المجموعة: | eaUMSA electronic archive – repository of the UMSA / eaUMSA електронний архів – репозитарій ВДНЗУ «УМСА» (УКРАЇНСЬКА МЕДИЧНА СТОМАТОЛОГІЧНА АКАДЕМІЯ) |
| الوصف: | The human monoclonal antibody otilimab inhibits granulocyte-macrophage colony-stimulating factor (GM-CSF), a key driver in immune-mediated inflammatory conditions. We aimed to evaluate the efficacy, safety, and key patient-reported outcomes related to pain in patients with active rheumatoid arthritis receiving otilimab. Methods. This phase 2b, dose-ranging, multicentre, placebo-controlled study was done at 64 sites across 14 countries. Patients aged 18 years or older with rheumatoid arthritis who were receiving stable methotrexate were randomly assigned (1:1:1:1:1:1) to subcutaneous placebo or otilimab 22·5 mg, 45 mg, 90 mg, 135 mg, or 180 mg, plus methotrexate, once weekly for 5 weeks, then every other week until week 50. The randomisation schedule was generated by the sponsor, and patients were assigned to treatment by interactive response technology. Randomisation was blocked (block size of six) but was not stratified. Investigators, patients, and the sponsor were blinded to treatment. An unblinded administrator prepared and administered the study drug. The primary endpoint was the proportion of patients who achieved disease activity score for 28 joints with C-reactive protein (DAS28-CRP) <2·6 at week 24. Patients who were not in the otilimab 180 mg group, without a good or moderate European League Against Rheumatism response (week 12) or with DAS28-CRP >3·2 (week 24) escaped to otilimab 180 mg. Patients who escaped were treated as non-responders in their original assigned group. Safety endpoints were incidence of adverse events and serious adverse events, infections, and pulmonary events. Efficacy and safety outcomes were assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02504671. Findings.Between July 23, 2015, and Dec 29, 2017, 222 patients were randomly assigned (37 to each group). 86 (49%) of 175 escaped to otilimab 180 mg at week 12 and 57 (69%) of 83 at week 24. At week 24, the proportion of patients with DAS28-CRP <2·6 was two (5%) of 37 in ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | Efficacy, patient-reported outcomes, and safety of the anti-granulocyte macrophage colony-stimulating factor antibody otilimab (GSK3196165) in patients with rheumatoid arthritis: a randomised, phase 2b, dose-ranging study / C. D Buckley, J. A. Simón-Campos,V. Zhdan [et al.] // The Lancet Rheumatology. – 2020. – Vol. 2, № 11. – P. 677–688. – Режим доступу до журн. : https://doi.org/10.1016/S2665-9913Test(20)30229-0.; http://repository.pdmu.edu.ua/handle/123456789/14003Test; https://doi.org/10.1016/S2665-9913Test(20)30229-0 |
| DOI: | 10.1016/S2665-9913(20)30229-0 |
| الإتاحة: | https://doi.org/10.1016/S2665-9913Test(20)30229-0 http://repository.pdmu.edu.ua/handle/123456789/14003Test |
| رقم الانضمام: | edsbas.3BB1F22A |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/S2665-9913(20)30229-0 |
|---|