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Introduction <p>This post hoc analysis assessed tofacitinib and adalimumab efficacy and safety, stratified by baseline methotrexate (MTX) dose, in patients with rheumatoid arthritis (RA) in the Oral Rheumatoid Arthritis triaL (ORAL) Strategy study.</p> Methods <p>ORAL Strategy (NCT02187055) was a global, 1-year, phase 3b/4 study. Patients with RA and an inadequate response to MTX were randomized to tofacitinib 5&#xa0;mg twice daily (BID), tofacitinib 5&#xa0;mg BID plus MTX, or adalimumab 40&#xa0;mg once every 2&#xa0;weeks plus MTX, with MTX dosed per the last weekly dose pre-randomization. This post hoc analysis stratified patients by MTX dose in tertiles normalized by body mass index (BMI) and weight at baseline. Efficacy was assessed using American College of Rheumatology (ACR) 50 response rates at month 6 (primary endpoint); safety was assessed throughout. Efficacy and safety were analyzed descriptively.</p> Results <p>Of 1146 patients, 97 received MTX &lt; 15&#xa0;mg/week at baseline, 712 received 15–17.5&#xa0;mg/week, and 337 received &gt; 17.5&#xa0;mg/week. In the tofacitinib and adalimumab combination therapy groups, similar ACR50 response rates at month 6 were observed across the baseline BMI-normalized MTX dose tertiles. This trend was also observed in the tofacitinib monotherapy group; however, the ACR50 response rates at month 6 were numerically higher with combination versus tofacitinib monotherapy, regardless of baseline BMI-normalized MTX dose tertile. Generally similar results were observed for the baseline weight-normalized MTX data. No clear trends across baseline BMI-normalized MTX dose tertiles were observed for safety outcomes.</p> Conclusions <p>In ORAL Strategy, tofacitinib efficacy was generally similar, and there were no clear safety trends regardless of baseline BMI-normalized MTX dose.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT02187055.</p>

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Efficacy and Safety of Tofacitinib and Adalimumab in Rheumatoid Arthritis by Body Mass Index-Normalized Methotrexate Dose: A Post Hoc Analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月22日

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  • Tsutomu Takeuchi,
  • Yoshiya Tanaka,
  • Hisashi Yamanaka,
  • Kunihiro Yamaoka,
  • Naonobu Sugiyama,
  • Noriko Iikuni,
  • Shigeyuki Toyoizumi,
  • Kenneth Kwok,
  • Wen-Chan Tsai,
  • Eduardo Mysler,
  • Robert J. Moots,
  • Josef S. Smolen,
  • Roy Fleischmann

摘要

Introduction

This post hoc analysis assessed tofacitinib and adalimumab efficacy and safety, stratified by baseline methotrexate (MTX) dose, in patients with rheumatoid arthritis (RA) in the Oral Rheumatoid Arthritis triaL (ORAL) Strategy study.

Methods

ORAL Strategy (NCT02187055) was a global, 1-year, phase 3b/4 study. Patients with RA and an inadequate response to MTX were randomized to tofacitinib 5 mg twice daily (BID), tofacitinib 5 mg BID plus MTX, or adalimumab 40 mg once every 2 weeks plus MTX, with MTX dosed per the last weekly dose pre-randomization. This post hoc analysis stratified patients by MTX dose in tertiles normalized by body mass index (BMI) and weight at baseline. Efficacy was assessed using American College of Rheumatology (ACR) 50 response rates at month 6 (primary endpoint); safety was assessed throughout. Efficacy and safety were analyzed descriptively.

Results

Of 1146 patients, 97 received MTX < 15 mg/week at baseline, 712 received 15–17.5 mg/week, and 337 received > 17.5 mg/week. In the tofacitinib and adalimumab combination therapy groups, similar ACR50 response rates at month 6 were observed across the baseline BMI-normalized MTX dose tertiles. This trend was also observed in the tofacitinib monotherapy group; however, the ACR50 response rates at month 6 were numerically higher with combination versus tofacitinib monotherapy, regardless of baseline BMI-normalized MTX dose tertile. Generally similar results were observed for the baseline weight-normalized MTX data. No clear trends across baseline BMI-normalized MTX dose tertiles were observed for safety outcomes.

Conclusions

In ORAL Strategy, tofacitinib efficacy was generally similar, and there were no clear safety trends regardless of baseline BMI-normalized MTX dose.

Trial Registration

ClinicalTrials.gov identifier, NCT02187055.