Scholarlink

Introduction <p>Upadacitinib (UPA) is approved for moderate-to-severe rheumatoid arthritis (RA) based on SELECT trials, but data on real-world effectiveness are limited. UPHOLD is a multicountry study of patients with RA receiving UPA 15&#xa0;mg.</p> Methods <p>The present interim analysis was based on the Italian cohort performed across 28 centers. Co-primary endpoints were (i) the proportion of patients receiving UPA who achieved DAS28(CRP) remission (&lt; 2.6) at 6&#xa0;months and (ii) the proportion of patients achieving DAS28(CRP) remission at 6&#xa0;months who continued to receive UPA and maintained remission (or had no more than a 0.6-point increase in DAS28[CRP]) at 12&#xa0;months, analyzed by modified non-responder imputation (mNRI) and as observed (AO). Modified full analysis sets (mFAS1 and mFAS2) included patients completing 6 and 12&#xa0;months, respectively. Safety analysis included reporting of adverse events and treatment-emergent adverse events (TEAEs), as exposure-adjusted event rates (EAERs; events per 100 patient-years [E/100PY]).</p> Results <p>Among 270 patients, 74 (27.4%) discontinued by 12&#xa0;months because of lack of efficacy (13.7%) or adverse events (8.1%). In mFAS1 (<i>N</i> = 168), 50.6% (mNRI) and 62% (AO) achieved DAS28(CRP) remission at 6&#xa0;months. In mFAS2 (<i>N</i> = 55), 80% (mNRI) and 91.7% (AO) maintained DAS28(CRP) remission at 12&#xa0;months. CDAI and SDAI remission rates at 12&#xa0;months were 31.3%. Patients on UPA monotherapy at 12&#xa0;months showed remission rates of 49.5% (DAS28[CRP]), 27.2% (CDAI), and 27.4% (SDAI). Significant improvements in patient-reported pain and physical function were also observed. A total of 278 TEAEs were reported (80.8&#xa0;E/100PY), including herpes zoster, liver disorders, and serious infections with EAERs of 2.0, 1.5, and 1.2&#xa0;E/100PY, respectively.</p> Conclusion <p>UPA 15&#xa0;mg was observed to effectively treat moderate-to-severe RA in the real-world setting, with ≥ 80% maintaining DAS28(CRP) remission at 12&#xa0;months, showing a favorable benefit–risk profile.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT04497597.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Achievement and Maintenance of Remission with Upadacitinib in Patients with Moderate-to-Severe Rheumatoid Arthritis in Italy: 1-Year Data from UPHOLD, a Prospective Real-World Observational Study

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年4月12日

查看全文
  • Caterina Baldi,
  • Eleonora Celletti,
  • Serena Bugatti,
  • Marcello Govoni,
  • Massimiliano Cazzato,
  • Andrea Picchianti Diamanti,
  • Marco Fornaro,
  • Giuliana Guggino,
  • Luca Navarini,
  • Maria Antonietta D’Agostino,
  • Luca Quartuccio,
  • Francesco Ciccia,
  • Lorenzo Dagna,
  • Paolo Stobbione,
  • Massimo Triggiani,
  • Ombretta Viapiana,
  • Annarita Giardina,
  • Gianluca Moroncini,
  • Roberto Caporali,
  • Chiara Bazzani,
  • Enrico Tirri,
  • Claudia Lomater,
  • Sara Di Fino,
  • Francesca Morello,
  • Carlo Selmi

摘要

Introduction

Upadacitinib (UPA) is approved for moderate-to-severe rheumatoid arthritis (RA) based on SELECT trials, but data on real-world effectiveness are limited. UPHOLD is a multicountry study of patients with RA receiving UPA 15 mg.

Methods

The present interim analysis was based on the Italian cohort performed across 28 centers. Co-primary endpoints were (i) the proportion of patients receiving UPA who achieved DAS28(CRP) remission (< 2.6) at 6 months and (ii) the proportion of patients achieving DAS28(CRP) remission at 6 months who continued to receive UPA and maintained remission (or had no more than a 0.6-point increase in DAS28[CRP]) at 12 months, analyzed by modified non-responder imputation (mNRI) and as observed (AO). Modified full analysis sets (mFAS1 and mFAS2) included patients completing 6 and 12 months, respectively. Safety analysis included reporting of adverse events and treatment-emergent adverse events (TEAEs), as exposure-adjusted event rates (EAERs; events per 100 patient-years [E/100PY]).

Results

Among 270 patients, 74 (27.4%) discontinued by 12 months because of lack of efficacy (13.7%) or adverse events (8.1%). In mFAS1 (N = 168), 50.6% (mNRI) and 62% (AO) achieved DAS28(CRP) remission at 6 months. In mFAS2 (N = 55), 80% (mNRI) and 91.7% (AO) maintained DAS28(CRP) remission at 12 months. CDAI and SDAI remission rates at 12 months were 31.3%. Patients on UPA monotherapy at 12 months showed remission rates of 49.5% (DAS28[CRP]), 27.2% (CDAI), and 27.4% (SDAI). Significant improvements in patient-reported pain and physical function were also observed. A total of 278 TEAEs were reported (80.8 E/100PY), including herpes zoster, liver disorders, and serious infections with EAERs of 2.0, 1.5, and 1.2 E/100PY, respectively.

Conclusion

UPA 15 mg was observed to effectively treat moderate-to-severe RA in the real-world setting, with ≥ 80% maintaining DAS28(CRP) remission at 12 months, showing a favorable benefit–risk profile.

Trial Registration

ClinicalTrials.gov identifier, NCT04497597.