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Introduction <p>Upadacitinib, an oral Janus kinase inhibitor, has shown a favorable benefit–risk profile in rheumatoid arthritis (RA) clinical trials. This analysis aimed to assess the long-term effectiveness and safety of upadacitinib through 24&#xa0;months in the UPHOLD real-world observational study.</p> Methods <p>The coprimary endpoints were: (1) proportion of patients achieving disease activity score in 28 joints using C-reactive protein (DAS28[CRP]) remission (&lt; 2.6) at 6&#xa0;months; and (2) proportion of those patients who maintained remission at 12&#xa0;months. Additional endpoints assessed through 24&#xa0;months included: achievement and maintenance of DAS28(CRP) low disease activity (LDA; ≤ 3.2); maintenance of response by treatment strategy and prior therapy; disease category by visit; improvements in patient-reported outcomes (PROs); and achievement of glucocorticoid (GC)-free remission. Endpoints were analyzed by modified nonresponder imputation (mNRI) and as observed (AO). Exposure-adjusted event rates (events/100 patient-years [E/100 PY]) for treatment-emergent adverse events (TEAEs) were reported through May 15, 2024.</p> Results <p>In total, 1029/1715 (60.0%) patients completed the 24-month follow-up. DAS28(CRP) responses at 6&#xa0;months were well maintained through 24&#xa0;months (mNRI/AO remission, 62.9%/83.9%; and LDA, 65.7%/90.1%, respectively). Remission rates at 24&#xa0;months were consistent between patients maintaining combination therapy and those maintaining monotherapy (81.1% and 87.4%, respectively; AO). Responses were also largely similar across prior therapy subgroups. Improvements in PROs achieved by 12&#xa0;months were maintained through 24&#xa0;months. Most patients receiving GCs at baseline who achieved GC-free remission maintained GC-free remission at 24&#xa0;months. Among selected TEAEs of interest, herpes zoster, serious infection, and hepatic disorder occurred at 3.5, 3.1, and 2.6 E/100 PY, respectively. No new safety signals were identified.</p> Conclusions <p>Upadacitinib was effective for the long-term treatment of RA in real-world practice, with responses achieved at 6&#xa0;months maintained through 2&#xa0;years, and no new safety findings.</p> Trial Registration <p>NCT04497597.</p>

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Achievement and Maintenance of Disease Targets with Upadacitinib in Rheumatoid Arthritis: 2-Year Outcomes from the UPHOLD Real-World Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月19日

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  • Andrew Östör,
  • Eugen Feist,
  • Prodromos Sidiropoulos,
  • Jérôme Avouac,
  • Martin Rebella,
  • Rajaie Namas,
  • Frank Buttgereit,
  • Philip G. Conaghan,
  • Ana B. Romero,
  • Erin L. McDearmon-Blondell,
  • Ivan Lagunes-Galindo,
  • Tianming Gao,
  • Aditi Kadakia,
  • Tim Shaw,
  • Suzan Attar

摘要

Introduction

Upadacitinib, an oral Janus kinase inhibitor, has shown a favorable benefit–risk profile in rheumatoid arthritis (RA) clinical trials. This analysis aimed to assess the long-term effectiveness and safety of upadacitinib through 24 months in the UPHOLD real-world observational study.

Methods

The coprimary endpoints were: (1) proportion of patients achieving disease activity score in 28 joints using C-reactive protein (DAS28[CRP]) remission (< 2.6) at 6 months; and (2) proportion of those patients who maintained remission at 12 months. Additional endpoints assessed through 24 months included: achievement and maintenance of DAS28(CRP) low disease activity (LDA; ≤ 3.2); maintenance of response by treatment strategy and prior therapy; disease category by visit; improvements in patient-reported outcomes (PROs); and achievement of glucocorticoid (GC)-free remission. Endpoints were analyzed by modified nonresponder imputation (mNRI) and as observed (AO). Exposure-adjusted event rates (events/100 patient-years [E/100 PY]) for treatment-emergent adverse events (TEAEs) were reported through May 15, 2024.

Results

In total, 1029/1715 (60.0%) patients completed the 24-month follow-up. DAS28(CRP) responses at 6 months were well maintained through 24 months (mNRI/AO remission, 62.9%/83.9%; and LDA, 65.7%/90.1%, respectively). Remission rates at 24 months were consistent between patients maintaining combination therapy and those maintaining monotherapy (81.1% and 87.4%, respectively; AO). Responses were also largely similar across prior therapy subgroups. Improvements in PROs achieved by 12 months were maintained through 24 months. Most patients receiving GCs at baseline who achieved GC-free remission maintained GC-free remission at 24 months. Among selected TEAEs of interest, herpes zoster, serious infection, and hepatic disorder occurred at 3.5, 3.1, and 2.6 E/100 PY, respectively. No new safety signals were identified.

Conclusions

Upadacitinib was effective for the long-term treatment of RA in real-world practice, with responses achieved at 6 months maintained through 2 years, and no new safety findings.

Trial Registration

NCT04497597.