Upadacitinib versus placebo or adalimumab with background methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate: a subgroup analysis of a phase III randomized controlled trial in Central and Eastern European patients

Drugs in Context

article

Roy Fleischmann¹  Karel Pavelka²  Zoltán Szekanecz³  Nemanja Damjanov⁴  Branimir Anić⁵  Matija Tomšič⁶  Vadim Mazurov⁷  Marija Maksimovic⁸  Orsolya Nagy⁹  Jerzy Świerkot^1,10  Tzvetanka Petranova^1,11  Tiina Veldi^1,12  Asta Baranauskaitė^1,13  Catalin Codreanu^1,14  Daina Andersone^1,15 

[1] University of Texas Southwestern Medical Center, Metroplex Clinical Research Center;Institute of Rheumatology and Department of Rheumatology, Charles University;Division of Rheumatology, Faculty of Medicine, University of Debrecen;University of Belgrade School of Medicine, Institute of Rheumatology;Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, University of Zagreb School of Medicine;Department of Rheumatology, University Medical Centre Ljubljana;North-Western State Medical University named after I.I. Mechnikov;AbbVie Biopharmaceuticals GmbH;AbbVie Global Medical Affairs;Department of Rheumatology and Internal Medicine, Wroclaw Medical University;Department of Rheumatology, UMHAT St.Iv.Rilsky, Medical University;East-Tallinn Central Hospital;Department of Rheumatology, Lithuanian University of Health Sciences;Center of Rheumatic Diseases, University of Medicine and Pharmacy;P. Stradins Clinical University Hospital

关键词: Eastern Europe;    rheumatoid arthritis;    safety;    treatment efficacy;    upadacitinib;   

DOI  :  10.7573/dic.2020-7-5

学科分类：社会科学、人文和艺术（综合）

来源: C S F Medical Communications Ltd.

【 摘 要 】

Background: In the randomized, phase III, global SELECTCOMPARE study, upadacitinib 15 mg demonstrated efficacy at week 12 versus placebo and adalimumab with methotrexate (MTX) in patients with rheumatoid arthritis and inadequate response to MTX, which was maintained over 48 weeks. This post hoc analysis of SELECT-COMPARE reports the efficacy and safety of upadacitinib in Central and Eastern European (CEE) patients. Methods: Patients were randomized 2:2:1 to upadacitinib 15 mg once daily, placebo, or adalimumab 40 mg every other week, and continued MTX. Efficacy and safety were assessed through 48 weeks. Primary endpoints were the achievement of ≥20% improvement in American College of Rheumatology response criteria and Disease Activity Score in 28 joints with C-reactive protein <2.6 responses at week 12 for upadacitinib versus placebo. No statistical comparisons were conducted. Results: A total of 596 patients from 12 CEE countries were randomized. At week 12, a numerically greater proportion of patients receiving upadacitinib versus placebo or adalimumab achieved ≥20% improvement in American College of Rheumatology response criteria (72% versus 33% and 59%), Disease Activity Score in 28 joints with C-reactive protein <2.6 (26% versus 4% and 11%), low disease activity and remission, and improved physical function, with results maintained over 48 weeks. Upadacitinib treatment numerically inhibited structural progression versus placebo at week 26. Serious infection and herpes zoster rates were numerically higher with upadacitinib versus adalimumab (2.7 versus 1.7 and 2.3 versus 1.1 events/100 patient-years, respectively) over 48 weeks. Conclusion: Consistent with the global population of patients with rheumatoid arthritis and an inadequate response to MTX, in CEE patients, upadacitinib 15 mg demonstrated clinical and functional improvements versus placebo and adalimumab, radiographic improvements versus placebo, and reasonable safety, over 48 weeks.

【 授权许可】

CC BY-NC-ND