Scholarlink

Introduction <p>This is an&#xa0;interim analysis of the long-term effectiveness and safety of canakinumab in the tumor necrosis factor receptor-associated periodic syndrome (TRAPS) cohort of the RELIANCE non-interventional study.</p> Methods <p>From June 2018, the RELIANCE non-interventional study enrolled paediatric (aged ≥ 2 – &lt; 18&#xa0;years) and adult patients (aged ≥ 18&#xa0;years) with TRAPS who were receiving canakinumab as part of their routine medical care. Physician- and patient-reported measures of disease activity, dosing patterns and safety were evaluated at baseline and every 6&#xa0;months until the end-of-study visit.</p> Results <p>A total of 21 patients with TRAPS were enrolled by the analysis cut-off date of December 2022, of which 61.9% (13/21) were paediatric patients (&lt; 18&#xa0;years) and 66.7% (14/21) were female. All patients were pre-treated with canakinumab prior to enrolment (median duration of canakinumab treatment prior to study inclusion: 1.2&#xa0;years). Disease activity, evaluated by physician-reported (physician’s global assessment, disease remission, C-reactive protein, serum amyloid A) and patient-reported (disease activity, fatigue, impact on social life, autoinflammatory disease activity index diary) measures, was generally well controlled throughout the study. At baseline, the majority of patients (71.4%) were receiving the recommended starting dose (SD) of canakinumab, with a more even distribution between the &lt; SD, SD, and &gt; SD dosing schedules observed from month 6. No serious adverse drug reactions were reported. Patients continued to receive vaccinations during long-term treatment with canakinumab. In total, 85.7% (18/21) of&#xa0;patients met the Eurofever/PRINTO classification criteria for TRAPS, 42.9% (9/21) with the presence of a confirmative <i>TNFRSF1A</i> genotype and 42.9% (9/21) without. In total, 14.3% (3/21)&#xa0;of patients did not meet the classification criteria.</p> Conclusions <p>Data from this interim analysis support the long-term effectiveness and safety of canakinumab for the treatment of TRAPS.</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

Long-term Effectiveness and Safety of Canakinumab in Patients with TRAPS: Analysis of the RELIANCE Non-Interventional Study

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年11月26日

查看全文
  • Norbert Blank,
  • Catharina Schuetz,
  • Markus Hufnagel,
  • Gerd Horneff,
  • Michael Borte,
  • Tilmann Kallinich,
  • Prasad T. Oommen,
  • Ales Janda,
  • Joerg Henes,
  • Julia Weber-Arden,
  • Michael Stock,
  • Jasmin B. Kuemmerle-Deschner

摘要

Introduction

This is an interim analysis of the long-term effectiveness and safety of canakinumab in the tumor necrosis factor receptor-associated periodic syndrome (TRAPS) cohort of the RELIANCE non-interventional study.

Methods

From June 2018, the RELIANCE non-interventional study enrolled paediatric (aged ≥ 2 – < 18 years) and adult patients (aged ≥ 18 years) with TRAPS who were receiving canakinumab as part of their routine medical care. Physician- and patient-reported measures of disease activity, dosing patterns and safety were evaluated at baseline and every 6 months until the end-of-study visit.

Results

A total of 21 patients with TRAPS were enrolled by the analysis cut-off date of December 2022, of which 61.9% (13/21) were paediatric patients (< 18 years) and 66.7% (14/21) were female. All patients were pre-treated with canakinumab prior to enrolment (median duration of canakinumab treatment prior to study inclusion: 1.2 years). Disease activity, evaluated by physician-reported (physician’s global assessment, disease remission, C-reactive protein, serum amyloid A) and patient-reported (disease activity, fatigue, impact on social life, autoinflammatory disease activity index diary) measures, was generally well controlled throughout the study. At baseline, the majority of patients (71.4%) were receiving the recommended starting dose (SD) of canakinumab, with a more even distribution between the < SD, SD, and > SD dosing schedules observed from month 6. No serious adverse drug reactions were reported. Patients continued to receive vaccinations during long-term treatment with canakinumab. In total, 85.7% (18/21) of patients met the Eurofever/PRINTO classification criteria for TRAPS, 42.9% (9/21) with the presence of a confirmative TNFRSF1A genotype and 42.9% (9/21) without. In total, 14.3% (3/21) of patients did not meet the classification criteria.

Conclusions

Data from this interim analysis support the long-term effectiveness and safety of canakinumab for the treatment of TRAPS.