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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.
Mod Rheumatol. 2021 Jan 26 [Online ahead of print]MR

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.

Authors+Show Affiliations

Keio University School of Medicine, Tokyo, Japan.The Queen Elizabeth Hospital and University of Adelaide, Adelaide, Australia.Hospital Universitario Marques de Valdecilla, Cantabria, Spain.Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.Rheumatic and Collagen Disease Center, Sasebo Chuo Hospital, Sasebo, Nagasaki, Japan.Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University, Sapporo, Japan.AbbVie Inc., North Chicago, IL, United States.AbbVie Inc., North Chicago, IL, United States.AbbVie Inc., North Chicago, IL, United States.Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, United States.Amsterdam University Medical Centers, Amsterdam, The Netherlands.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

33164611

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.
* Article titles in AMA citation format should be in sentence-case
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 -
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