Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission

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

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.

Study Overview

• Status: Recruiting
• Conditions: Takayasu Arteritis
• Intervention / Treatment: Drug: Tociliuzumab; Drug: Infliximab; Drug: Adalimumab; Drug: Certolizumab Pegol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatma Alibaz-Oner, MD; Phone Number: 05326368554; Email: falibaz@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • Marmara University Pendik Training and Research Hospital
    • Contact: Fatma Alibaz-Oner, MD; Email: falibaz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Biologic Treatment Withdrawal; Patients with Takayasu arteritis in sustained clinical and radiologic remission who have received biologic therapy for at least 3 years will undergo a predefined 3-month biologic dose tapering protocol followed by complete treatment discontinuation and a 12-month follow-up period to evaluate remission maintenance and relapse rates.

Drug: 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.; Drug: Infliximab; Dose tapering of infliximab followed by treatment discontinuation after a predefined 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.; Drug: Adalimumab; Dose tapering of adalimumab followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Maintaining Remission After Biologic Treatment Withdrawal	The proportion of patients with Takayasu arteritis who maintain clinical and laboratory remission without relapse following biologic treatment withdrawal after a predefined tapering protocol.	12 months after treatment discontinuation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Disease Relapse	Proportion of patients experiencing major or minor relapse during the 3-month tapering phase and the 12-month follow-up period after biologic treatment withdrawal.	Up to 15 months
Time to Disease Relapse	Time from biologic treatment discontinuation to the occurrence of the first major or minor relapse in patients with Takayasu arteritis.	Up to 15 months

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Fatma Alibaz-Oner, MD, Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Tocilizumab; Takayasu arteritis; TNF inhibitors; Large vessel vasculitis; Biologic therapy withdrawal; Treatment discontinuation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Diseases, Vascular; Aortic Diseases; Vasculitis; Arteritis; Skin and Connective Tissue Diseases; Aortic Arch Syndromes; Takayasu Arteritis; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Polymers; Macromolecular Substances; Immunoglobulin Fragments; Peptide Fragments; Polyethylene Glycols; Immunoglobulin Fab Fragments; Adalimumab; Infliximab; Certolizumab Pegol; tocilizumab
• Other Study ID Numbers: 09.2024.1469

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be available upon reasonable request and subject to approval by the principal investigator and the ethics committee, in accordance with institutional and ethical regulations.
• IPD Sharing Time Frame: Data will be available after publication of the study results and will be accessible for 5 years.
• IPD Sharing Access Criteria: Data will be available upon reasonable request to the principal investigator. Requests will be evaluated based on scientific merit, and data will be shared in anonymized form in accordance with institutional and ethical guidelines.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No