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
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFRGS |
Texto Completo: | http://hdl.handle.net/10183/230694 |
Resumo: | 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 signicant 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 |
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Vollenhoven, Ronald F. vanTakeuchi, TsutomuPangan, Aileen L.Friedman, AlanMohamed, Mohamed-Eslam F.Chen, SuRischmueller, MaureenBlanco, RicardoXavier, Ricardo MachadoStrand, Vibeke2021-10-14T04:29:45Z20202326-5205http://hdl.handle.net/10183/230694001131598Objective. 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 signicant 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 MTXapplication/pdfengArthritis & rheumatology. Malden. Vol. 72, no. 10 (2020), p. 1607-1620.EficáciaSegurança do pacienteArtrite reumatóideTratamento farmacológicoEfficacy 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 trialEstrangeiroinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFRGSinstname:Universidade Federal do Rio Grande do Sul (UFRGS)instacron:UFRGSTEXT001131598.pdf.txt001131598.pdf.txtExtracted Texttext/plain65655http://www.lume.ufrgs.br/bitstream/10183/230694/2/001131598.pdf.txt2aeb9ca57e1b0cd0e596f661093cf1deMD52ORIGINAL001131598.pdfTexto completo (inglês)application/pdf980318http://www.lume.ufrgs.br/bitstream/10183/230694/1/001131598.pdf6e206788979e349ab0c88c3e07195ad0MD5110183/2306942021-11-20 05:43:03.189925oai:www.lume.ufrgs.br:10183/230694Repositório de PublicaçõesPUBhttps://lume.ufrgs.br/oai/requestopendoar:2021-11-20T07:43:03Repositório Institucional da UFRGS - Universidade Federal do Rio Grande do Sul (UFRGS)false |
dc.title.pt_BR.fl_str_mv |
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 |
title |
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 |
spellingShingle |
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 Vollenhoven, Ronald F. van Eficácia Segurança do paciente Artrite reumatóide Tratamento farmacológico |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
author |
Vollenhoven, Ronald F. van |
author_facet |
Vollenhoven, Ronald F. van Takeuchi, Tsutomu Pangan, Aileen L. Friedman, Alan Mohamed, Mohamed-Eslam F. Chen, Su Rischmueller, Maureen Blanco, Ricardo Xavier, Ricardo Machado Strand, Vibeke |
author_role |
author |
author2 |
Takeuchi, Tsutomu Pangan, Aileen L. Friedman, Alan Mohamed, Mohamed-Eslam F. Chen, Su Rischmueller, Maureen Blanco, Ricardo Xavier, Ricardo Machado Strand, Vibeke |
author2_role |
author author author author author author author author author |
dc.contributor.author.fl_str_mv |
Vollenhoven, Ronald F. van Takeuchi, Tsutomu Pangan, Aileen L. Friedman, Alan Mohamed, Mohamed-Eslam F. Chen, Su Rischmueller, Maureen Blanco, Ricardo Xavier, Ricardo Machado Strand, Vibeke |
dc.subject.por.fl_str_mv |
Eficácia Segurança do paciente Artrite reumatóide Tratamento farmacológico |
topic |
Eficácia Segurança do paciente Artrite reumatóide Tratamento farmacológico |
description |
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 signicant 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 |
publishDate |
2020 |
dc.date.issued.fl_str_mv |
2020 |
dc.date.accessioned.fl_str_mv |
2021-10-14T04:29:45Z |
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dc.relation.ispartof.pt_BR.fl_str_mv |
Arthritis & rheumatology. Malden. Vol. 72, no. 10 (2020), p. 1607-1620. |
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