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

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

Keywords:

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

Acknowledgments

This study was sponsored by Pfizer. Medical writing support was provided by Sabrina Giavara, PhD, and David Wateridge, PhD, of Engage Scientific Solutions (Horsham, UK) and funded by Pfizer.

Conflict of interest

TT declares research grants from Abbott Japan Co, Ltd; Astellas Pharma; Bristol-Myers KK; Chugai Pharmaceutical Co, Ltd; Daiichi Sankyo Co, Ltd; Eisai Co, Ltd; Janssen Pharmaceutical KK; Mitsubishi Tanabe Pharma Co; Nippon Shinyaku Co, Ltd; Otsuka Pharmaceutical; Pfizer Japan Inc; Sanofi-Aventis KK; Santen Pharmaceutical Co, Ltd; Takeda Pharmaceutical Co, Ltd; and Teijin Pharma Ltd. TT declares acting as a consultant for AstraZeneca KK; Eli Lilly Japan KK; Novartis Pharma KK; Mitsubishi Tanabe Pharma Co; and Asahi Kasei Medical KK. NM declares no conflict of interest. RP, NS, and TH are employees of Pfizer and hold stock in Pfizer.

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Additional information

Funding

This study was sponsored by Pfizer.