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Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-Naive Patients With Moderately-to-Severely Active Rheumatoid Arthritis (SELECT-EARLY): A Multicenter, Multi-Country, Randomized, Double-Blind, Active Comparator-Controlled Trial.
Arthritis Rheumatol. 2020 10; 72(10):1607-1620.AR

Abstract

OBJECTIVE

The SELECT-EARLY trial was undertaken to study the effect of upadacitinib, an oral, reversible Janus kinase 1-selective inhibitor, as monotherapy in patients with predominantly early rheumatoid arthritis who were naive for or had limited exposure to methotrexate (MTX).

METHODS

Patients (n = 947) were randomized 1:1:1 to receive once-daily doses of upadacitinib 15 mg or 30 mg or weekly MTX (7.5-20 mg/week) for 24 weeks. The primary end points were the proportion of patients who met the American College of Rheumatology 50% (ACR50) improvement criteria at week 12, and the proportion in whom a Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP) of <2.6 was achieved at week 24. Data are presented through week 24.

RESULTS

At baseline, the median disease duration was 0.5 years (range 0-44 years). A total of 840 patients (89%) completed 24 weeks of treatment. The study met both primary end points for upadacitinib 15 mg and 30 mg versus MTX (ACR50 was achieved at week 12 in 52% and 56% of patients, respectively, versus 28% [P < 0.001], and DAS28-CRP <2.6 was achieved at week 24 in 48% and 50% of patients, respectively, versus 19% [P < 0.001]). Statistically significant and clinically meaningful improvements in multiple patient-reported outcomes (PROs) were recorded for both upadacitinib doses versus MTX. Overall, 88% of patients receiving upadacitinib 15 mg and 89% of patients receiving 30 mg, respectively, had no radiographic progression (modified total Sharp score ≤0) compared to 78% of those receiving MTX (P < 0.01). Through week 24, the frequency of treatment-emergent adverse events was similar between the MTX arm (65%) and upadacitinib 15 mg arm (64%), but was slightly higher in the upadacitinib 30 mg arm (71%). Six deaths were reported (2 in the upadacitinib 15 mg arm, 3 in the upadacitinib 30 mg arm, and 1 in the MTX arm).

CONCLUSION

Our findings indicate that patients receiving either dose of upadacitinib monotherapy experienced significant improvements in clinical, radiographic, and PROs compared to patients receiving MTX.

Authors+Show Affiliations

Amsterdam University Medical Center, Amsterdam, The Netherlands.Keio University School of Medicine, Tokyo, Japan.AbbVie, Inc., North Chicago, Illinois, USA.AbbVie, Inc., North Chicago, Illinois, USA.AbbVie, Inc., North Chicago, Illinois, USA.AbbVie, Inc., North Chicago, Illinois, USA.The Queen Elizabeth Hospital and University of Adelaide, Adelaide, South Australia, Australia.Hospital Universitario Marques de Valdecilla and IDIVAL, Santander, Spain.Universidade Federal do Rio Grande do Sul Porto Alegre, Rio Grande do Sul, Brazil.Stanford University, Palo Alto, California, USA.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32638504

Citation

van Vollenhoven, Ronald, et al. "Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-Naive Patients With Moderately-to-Severely Active Rheumatoid Arthritis (SELECT-EARLY): a Multicenter, Multi-Country, Randomized, Double-Blind, Active Comparator-Controlled Trial." Arthritis & Rheumatology (Hoboken, N.J.), vol. 72, no. 10, 2020, pp. 1607-1620.
van Vollenhoven R, Takeuchi T, Pangan AL, et al. Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-Naive Patients With Moderately-to-Severely Active Rheumatoid Arthritis (SELECT-EARLY): A Multicenter, Multi-Country, Randomized, Double-Blind, Active Comparator-Controlled Trial. Arthritis Rheumatol. 2020;72(10):1607-1620.
van Vollenhoven, R., Takeuchi, T., Pangan, A. L., Friedman, A., Mohamed, M. F., Chen, S., Rischmueller, M., Blanco, R., Xavier, R. M., & Strand, V. (2020). Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-Naive Patients With Moderately-to-Severely Active Rheumatoid Arthritis (SELECT-EARLY): A Multicenter, Multi-Country, Randomized, Double-Blind, Active Comparator-Controlled Trial. Arthritis & Rheumatology (Hoboken, N.J.), 72(10), 1607-1620. https://doi.org/10.1002/art.41384
van Vollenhoven R, et al. Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-Naive Patients With Moderately-to-Severely Active Rheumatoid Arthritis (SELECT-EARLY): a Multicenter, Multi-Country, Randomized, Double-Blind, Active Comparator-Controlled Trial. Arthritis Rheumatol. 2020;72(10):1607-1620. PubMed PMID: 32638504.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-Naive Patients With Moderately-to-Severely Active Rheumatoid Arthritis (SELECT-EARLY): A Multicenter, Multi-Country, Randomized, Double-Blind, Active Comparator-Controlled Trial. AU - van Vollenhoven,Ronald, AU - Takeuchi,Tsutomu, AU - Pangan,Aileen L, AU - Friedman,Alan, AU - Mohamed,Mohamed-Eslam F, AU - Chen,Su, AU - Rischmueller,Maureen, AU - Blanco,Ricardo, AU - Xavier,Ricardo M, AU - Strand,Vibeke, Y1 - 2020/09/08/ PY - 2019/12/19/received PY - 2020/04/03/revised PY - 2020/05/01/accepted PY - 2020/7/9/pubmed PY - 2021/1/7/medline PY - 2020/7/9/entrez SP - 1607 EP - 1620 JF - Arthritis & rheumatology (Hoboken, N.J.) JO - Arthritis Rheumatol VL - 72 IS - 10 N2 - OBJECTIVE: The SELECT-EARLY trial was undertaken to study the effect of upadacitinib, an oral, reversible Janus kinase 1-selective inhibitor, as monotherapy in patients with predominantly early rheumatoid arthritis who were naive for or had limited exposure to methotrexate (MTX). METHODS: Patients (n = 947) were randomized 1:1:1 to receive once-daily doses of upadacitinib 15 mg or 30 mg or weekly MTX (7.5-20 mg/week) for 24 weeks. The primary end points were the proportion of patients who met the American College of Rheumatology 50% (ACR50) improvement criteria at week 12, and the proportion in whom a Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP) of <2.6 was achieved at week 24. Data are presented through week 24. RESULTS: At baseline, the median disease duration was 0.5 years (range 0-44 years). A total of 840 patients (89%) completed 24 weeks of treatment. The study met both primary end points for upadacitinib 15 mg and 30 mg versus MTX (ACR50 was achieved at week 12 in 52% and 56% of patients, respectively, versus 28% [P < 0.001], and DAS28-CRP <2.6 was achieved at week 24 in 48% and 50% of patients, respectively, versus 19% [P < 0.001]). Statistically significant and clinically meaningful improvements in multiple patient-reported outcomes (PROs) were recorded for both upadacitinib doses versus MTX. Overall, 88% of patients receiving upadacitinib 15 mg and 89% of patients receiving 30 mg, respectively, had no radiographic progression (modified total Sharp score ≤0) compared to 78% of those receiving MTX (P < 0.01). Through week 24, the frequency of treatment-emergent adverse events was similar between the MTX arm (65%) and upadacitinib 15 mg arm (64%), but was slightly higher in the upadacitinib 30 mg arm (71%). Six deaths were reported (2 in the upadacitinib 15 mg arm, 3 in the upadacitinib 30 mg arm, and 1 in the MTX arm). CONCLUSION: Our findings indicate that patients receiving either dose of upadacitinib monotherapy experienced significant improvements in clinical, radiographic, and PROs compared to patients receiving MTX. SN - 2326-5205 UR - https://www.unboundmedicine.com/medline/citation/32638504/Efficacy_and_Safety_of_Upadacitinib_Monotherapy_in_Methotrexate_naïve_Patients_with_Moderately_to_Severely_Active_Rheumatoid_Arthritis__SELECT_EARLY_:_A_Randomized_Double_blind_Active_comparator_Multi_center_Multi_country_Trial_ L2 - https://doi.org/10.1002/art.41384 DB - PRIME DP - Unbound Medicine ER -