Radiographic and clinical outcomes following etanercept monotherapy in Japanese methotrexate-naïve patients with active rheumatoid arthritis

Tsutomu Takeuchi, Nobuyuki Miyasaka, Ron Pedersen, Noriko Sugiyama, Tomohiro Hirose

Research output: Contribution to journalArticle

Abstract

Objectives: Compare outcomes with methotrexate (MTX) or etanercept (ETN) monotherapy in Japanese patients with active rheumatoid arthritis (RA) who were MTX-naïve or with intolerance or inadequate response to prior MTX (MTX-IR). Methods:Post hoc analysis of a phase 3 study comparing MTX, ETN 10 mg twice weekly, and ETN 25 mg twice weekly in Japanese patients with RA. Disease activity was evaluated using American College of Rheumatology (ACR) scores and 28-joint Disease Activity Score (DAS28), radiographic progression evaluated using van der Heijde’s modified Total Sharp Score (mTSS), and functional status evaluated using Health Assessment Questionnaire Disability Index (HAQ-DI). Results: Among MTX-naïve and MTX-IR patients, greater proportions of those randomized to either ETN group achieved ACR20, ACR50, ACR70, DAS28 ≤3.2 or <2.6, clinically relevant inhibition of mTSS changes, and reductions in HAQ-DI compared with MTX at the majority of time points. There were very few clinically meaningful differences between ETN groups for any of the variables evaluated. Conclusion: ETN monotherapy was more effective than MTX in both MTX-naïve and MTX-IR patients, with very few clinically meaningful differences between ETN 10 mg and ETN 25 mg when given twice weekly. The relative benefits of ETN were greater in MTX-naïve patients than MTX-IR patients. ClinicalTrials.gov identifier NCT00445770.

Original languageEnglish
JournalModern Rheumatology
DOIs
Publication statusPublished - 2019 Jan 1

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Methotrexate
Rheumatoid Arthritis
Etanercept
Joint Diseases
Health

Keywords

  • Etanercept
  • Japan
  • methotrexate
  • randomized controlled trial
  • rheumatoid arthritis

ASJC Scopus subject areas

  • Rheumatology

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Radiographic and clinical outcomes following etanercept monotherapy in Japanese methotrexate-naïve patients with active rheumatoid arthritis. / Takeuchi, Tsutomu; Miyasaka, Nobuyuki; Pedersen, Ron; Sugiyama, Noriko; Hirose, Tomohiro.

In: Modern Rheumatology, 01.01.2019.

Research output: Contribution to journalArticle

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abstract = "Objectives: Compare outcomes with methotrexate (MTX) or etanercept (ETN) monotherapy in Japanese patients with active rheumatoid arthritis (RA) who were MTX-na{\"i}ve or with intolerance or inadequate response to prior MTX (MTX-IR). Methods:Post hoc analysis of a phase 3 study comparing MTX, ETN 10 mg twice weekly, and ETN 25 mg twice weekly in Japanese patients with RA. Disease activity was evaluated using American College of Rheumatology (ACR) scores and 28-joint Disease Activity Score (DAS28), radiographic progression evaluated using van der Heijde’s modified Total Sharp Score (mTSS), and functional status evaluated using Health Assessment Questionnaire Disability Index (HAQ-DI). Results: Among MTX-na{\"i}ve and MTX-IR patients, greater proportions of those randomized to either ETN group achieved ACR20, ACR50, ACR70, DAS28 ≤3.2 or <2.6, clinically relevant inhibition of mTSS changes, and reductions in HAQ-DI compared with MTX at the majority of time points. There were very few clinically meaningful differences between ETN groups for any of the variables evaluated. Conclusion: ETN monotherapy was more effective than MTX in both MTX-na{\"i}ve and MTX-IR patients, with very few clinically meaningful differences between ETN 10 mg and ETN 25 mg when given twice weekly. The relative benefits of ETN were greater in MTX-na{\"i}ve patients than MTX-IR patients. ClinicalTrials.gov identifier NCT00445770.",
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AU - Hirose, Tomohiro

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