Citation
Takeuchi, Tsutomu, et al. "Upadacitinib Monotherapy Versus Methotrexate Monotherapy in Methotrexate-naïve Japanese Patients With Rheumatoid Arthritis: a Sub-analysis of the Phase 3 SELECT-EARLY Study." Modern Rheumatology, 2021, pp. 1-16.
Takeuchi T, Rischmueller M, Blanco R, et al. Upadacitinib monotherapy versus methotrexate monotherapy in methotrexate-naïve Japanese patients with rheumatoid arthritis: a sub-analysis of the Phase 3 SELECT-EARLY study. Mod Rheumatol. 2021.
Takeuchi, T., Rischmueller, M., Blanco, R., Xavier, R. M., Ueki, Y., Atsumi, T., Chen, S., Friedman, A., Pangan, A. L., Strand, V., & van Vollenhoven, R. F. (2021). Upadacitinib monotherapy versus methotrexate monotherapy in methotrexate-naïve Japanese patients with rheumatoid arthritis: a sub-analysis of the Phase 3 SELECT-EARLY study. Modern Rheumatology, 1-16. https://doi.org/10.1080/14397595.2020.1847776
Takeuchi T, et al. Upadacitinib Monotherapy Versus Methotrexate Monotherapy in Methotrexate-naïve Japanese Patients With Rheumatoid Arthritis: a Sub-analysis of the Phase 3 SELECT-EARLY Study. Mod Rheumatol. 2021 Jan 26;1-16. PubMed PMID: 33164611.
TY - JOUR
T1 - Upadacitinib monotherapy versus methotrexate monotherapy in methotrexate-naïve Japanese patients with rheumatoid arthritis: a sub-analysis of the Phase 3 SELECT-EARLY study.
AU - Takeuchi,Tsutomu,
AU - Rischmueller,Maureen,
AU - Blanco,Ricardo,
AU - Xavier,Ricardo M,
AU - Ueki,Yukitaka,
AU - Atsumi,Tatsuya,
AU - Chen,Su,
AU - Friedman,Alan,
AU - Pangan,Aileen L,
AU - Strand,Vibeke,
AU - van Vollenhoven,Ronald F,
Y1 - 2021/01/26/
PY - 2020/11/10/pubmed
PY - 2020/11/10/medline
PY - 2020/11/9/entrez
KW - DMARD
KW - Japan
KW - methotrexate
KW - rheumatoid arthritis
KW - upadacitinib
SP - 1
EP - 16
JF - Modern rheumatology
JO - Mod Rheumatol
N2 - 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.
SN - 1439-7609
UR - https://www.unboundmedicine.com/medline/citation/33164611/Upadacitinib_monotherapy_versus_methotrexate_monotherapy_in_methotrexate_naïve_Japanese_patients_with_rheumatoid_arthritis:_A_sub_analysis_of_the_Phase_3_SELECT_EARLY_study_
L2 - https://www.tandfonline.com/doi/full/10.1080/14397595.2020.1847776
DB - PRIME
DP - Unbound Medicine
ER -
