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Upadacitinib monotherapy versus methotrexate monotherapy in methotrexate-naïve Japanese patients with rheumatoid arthritis: a sub-analysis of the Phase 3 SELECT-EARLY study
- Source :
- Repositório Institucional da UFRGS, Universidade Federal do Rio Grande do Sul (UFRGS), instacron:UFRGS, Modern rheumatology / the Japan Rheumatism Association, 31(3), 534-542. Taylor and Francis Ltd.
- Publication Year :
- 2021
- Publisher :
- Taylor & Francis, 2021.
-
Abstract
- Objective: To assess upadacitinib monotherapy versus methotrexate (MTX) in MTX-naïve Japanese patients with rheumatoid arthritis (RA) from the Phase 3 SELECT-EARLY study. Methods: Japanese patients were randomized 2:1:1:1 to upadacitinib 7.5, 15, or 30 mg daily or MTX 7.5 mg/week (titrated to ≤15 mg/week). Efficacy endpoints included the proportion of patients reporting 20% improvement in American College of Rheumatology criteria (ACR20) at week 12 and change from baseline in modified Total Sharp Score (mTSS) at week 24. Other efficacy outcomes were also assessed at weeks 12 and/or 24. Safety was assessed over 24 weeks. Results: Of 138 Japanese patients enrolled, significantly more patients treated with upadacitinib 7.5 and 15 mg, but not 30 mg, reported ACR20 responses versus MTX at week 12. Significantly smaller changes from baseline in mTSS were observed with upadacitinib 15 and 30 mg, but not 7.5 mg, versus MTX at week 24. Upadacitinib demonstrated an acceptable safety profile; herpes zoster occurred in 3.6%, 7.4%, and 7.1% of patients treated with upadacitinib 7.5, 15, and 30 mg, respectively. Conclusion: Similar to the global study population, upadacitinib demonstrated clinical efficacy superior to placebo in the Japanese subpopulation. Among upadacitinib-treated patients, herpes zoster was least common with 7.5 mg.
- Subjects :
- musculoskeletal diseases
rheumatoid arthritis
Adult
Male
medicine.medical_specialty
Artrite reumatóide
Gastroenterology
Metotrexato
Arthritis, Rheumatoid
Japão
Rheumatology
Double-Blind Method
Japan
Internal medicine
medicine
Humans
heterocyclic compounds
Rheumatoid arthritis
skin and connective tissue diseases
business.industry
Middle Aged
medicine.disease
upadacitinib
DMARD
Methotrexate
Treatment Outcome
Upadacitinib
Antirheumatic Agents
Female
business
Heterocyclic Compounds, 3-Ring
medicine.drug
Tratamento farmacológico
Subjects
Details
- ISSN :
- 14397595
- Database :
- OpenAIRE
- Journal :
- Repositório Institucional da UFRGS, Universidade Federal do Rio Grande do Sul (UFRGS), instacron:UFRGS, Modern rheumatology / the Japan Rheumatism Association, 31(3), 534-542. Taylor and Francis Ltd.
- Accession number :
- edsair.doi.dedup.....44b87bf402ee7acd8627b55bf6240c18
- Full Text :
- https://doi.org/10.6084/m9.figshare.13643841.v1