Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission

Официальное название

Cessation of Biologic Treatment in Patients With Takayasu Arteritis in Sustained Remission

Обзор

Takayasu arteritis is a chronic large-vessel vasculitis affecting the aorta and its major branches. Biologic therapies such as tumor necrosis factor inhibitors and tocilizumab are commonly used in patients with refractory or relapsing disease. However, there is limited evidence regarding the optimal duration of biologic therapy and the safety of treatment discontinuation in patients who achieve sustained remission. This prospective study aims to evaluate the outcomes of planned biologic treatment withdrawal in patients with Takayasu arteritis who have been in long-standing clinical and radiologic remission and have received biologic therapy for at least three years. Eligible patients will undergo a predefined 3-month dose tapering protocol. Patients who remain relapse-free during this period will discontinue biologic therapy and will be followed for 12 months. The primary objective of the study is to determine the proportion of patients who maintain remission after biologic treatment withdrawal. Secondary objectives include evaluating the rate and timing of disease relapse during the tapering phase and the post-withdrawal follow-up period.

Подробное описание

Takayasu arteritis (TAK) is a chronic granulomatous large-vessel vasculitis that primarily affects the aorta and its major branches. Despite advances in treatment, many patients require long-term immunosuppressive therapy to maintain disease control. Biologic agents, particularly tumor necrosis factor inhibitors and interleukin-6 receptor inhibitors such as tocilizumab, have demonstrated efficacy in refractory or relapsing disease. However, there is limited evidence regarding the optimal duration of biologic therapy and the safety of treatment discontinuation in patients who achieve sustained remission.

This prospective interventional study is designed to evaluate the outcomes of planned biologic treatment withdrawal in patients with Takayasu arteritis who have achieved long-standing clinical and radiologic remission and have received biologic therapy for at least three years. Eligible patients will undergo a predefined dose tapering protocol over a 3-month period. Patients who do not experience relapse during this phase will discontinue biologic therapy completely at the end of the tapering period.

Following treatment discontinuation, patients will be followed for 12 months. Clinical and laboratory evaluations will be performed at 1 month after discontinuation and every 3 months thereafter. Imaging studies will be performed as clinically indicated.

The primary outcome of the study is the proportion of patients maintaining remission at 12 months after biologic treatment withdrawal. Secondary outcomes include the rate and timing of major and minor relapses during the tapering phase and the post-withdrawal follow-up period. Additional analyses will explore potential predictors of relapse and differences according to biologic agent type and concomitant therapies.

Вмешательства

• Препарат Tociliuzumab
  Dose tapering of tocilizumab followed by complete treatment discontinuation after a 3-month tapering period in patients with Takayasu arteritis in sustained clinical and radiologic remission.
• Препарат Infliximab
  Dose tapering of infliximab followed by treatment discontinuation after a predefined 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.
• Препарат Adalimumab
  Dose tapering of adalimumab followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.
• Препарат Certolizumab Pegol
  Dose tapering of certolizumab pegol followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.

Первичные конечные точки

• Proportion of Patients Maintaining Remission After Biologic Treatment Withdrawal [Срок оценки: 12 months after treatment discontinuation]

Вторичные конечные точки (2)

• Rate of Disease Relapse [Срок оценки: Up to 15 months]
• Time to Disease Relapse [Срок оценки: Up to 15 months]

Критерии участия

Критерии включения

• Diagnosis of Takayasu arteritis according to the 2022 American College of Rheumatology/EULAR classification criteria
• Treatment with biologic therapy (TNF inhibitors or tocilizumab) for at least 3 years
• Sustained clinical, laboratory, and radiologic remission
• No change in treatment during the previous 12 months
• No glucocorticoid use within the previous 6 months
• Ability and willingness to provide written informed consent

Критерии исключения

• Presence of other active inflammatory diseases requiring biologic therapy (e.g., inflammatory bowel disease, ankylosing spondylitis)
• Inability to attend scheduled follow-up visits after treatment tapering and discontinuation
• Pregnancy or planning pregnancy during the study period

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Marmara University Pendik Training and Research Hospital — Istanbul

Идентификаторы

NCT: NCT07491913 · 09.2024.1469

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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