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A Randomized, Double-Blind Trial of Abatacept (CTLA-4Ig) for the Treatment of Takayasu Arteritis

Published on Apr 1, 2017in Arthritis & Rheumatism9.002
· DOI :10.1002/art.40044
Carol A. Langford40
Estimated H-index: 40
(Cleveland Clinic),
David Cuthbertson35
Estimated H-index: 35
(USF: University of South Florida)
+ 42 AuthorsJennifer Harris1
Estimated H-index: 1
Abstract
Objective To compare the efficacy of abatacept to that of placebo for the treatment of giant cell arteritis (GCA). Methods In this multicenter trial, patients with newly diagnosed or relapsing GCA were treated with abatacept 10 mg/kg intravenously on days 1, 15, and 29 and week 8, together with prednisone administered daily. At week 12, patients in remission underwent a double-blinded randomization to continue to receive abatacept monthly or switch to placebo. Patients in both study arms received a standardized prednisone taper, with discontinuation of prednisone at week 28. All patients remained on their randomized assignment until meeting criteria for early termination or until 12 months after enrollment of the last patient. The primary end point was duration of remission (relapse-free survival rate). Results Forty-nine eligible patients with GCA were enrolled and treated with prednisone and abatacept; of these, 41 reached the week 12 randomization and underwent a blinded randomization to receive abatacept or placebo. Prednisone was tapered using a standardized schedule, reaching a daily dosage of 20 mg at week 12 with discontinuation in all patients at week 28. The relapse-free survival rate at 12 months was 48% for those receiving abatacept and 31% for those receiving placebo (P = 0.049). A longer median duration of remission was seen in those receiving abatacept compared to those receiving placebo (median duration 9.9 months versus 3.9 months; P = 0.023). There was no difference in the frequency or severity of adverse events, including infection, between the treatment arms. Conclusion In patients with GCA, the addition of abatacept to a treatment regimen with prednisone reduced the risk of relapse and was not associated with a higher rate of toxicity compared to prednisone alone.
  • References (55)
  • Citations (109)
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References55
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Large vessel vasculitis (LVV) is characterized by immune-mediated injury of predominantly large vessels. Histopathologic features include mononuclear cell infiltration of the vessel wall that often includes granuloma formation. Within this group of diseases, Takayasu arteritis (TAK) affects younger individuals (younger than 50 years; mean age ~26 years at onset), whereas giant cell arteritis (GCA) is unique to older patients (older than 50 years; mean age ~74 years at onset) (1). Both predominan...
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Objective. To evaluate the frequency, timing, and clinical features of relapses in giant cell arteritis (GCA). Methods. Patients with GCA enrolled in a prospective, multicenter, longitudinal study were included in the analysis. Relapse was defined as either new disease activity after a period of remission or worsening disease activity. Results. The study included 128 subjects: 102 women (80%) and 26 men (20%). Mean ± SD age at diagnosis of GCA was 69.9 ± 8.6 years. Mean followup for the cohort w...
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