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Randomized Controlled Trial
. 2017 Apr;69(4):846-853.
doi: 10.1002/art.40037. Epub 2017 Mar 8.

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

Carol A Langford  1 , David Cuthbertson  2 , Steven R Ytterberg  3 , Nader Khalidi  4 , Paul A Monach  5 , Simon Carette  6 , Philip Seo  7 , Larry W Moreland  8 , Michael Weisman  9 , Curry L Koening  10 , Antoine G Sreih  11 , Robert Spiera  12 , Carol A McAlear  11 , Kenneth J Warrington  3 , Christian Pagnoux  6 , Kathleen McKinnon  8 , Lindsy J Forbess  9 , Gary S Hoffman  1 , Renée Borchin  2 , Jeffrey P Krischer  2 , Peter A Merkel  11 ; Vasculitis Clinical Research Consortium
Collaborators, Affiliations
Randomized Controlled Trial

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

Carol A Langford et al. Arthritis Rheumatol. 2017 Apr.

Abstract

Objective: To compare the efficacy of abatacept to that of placebo for the treatment of Takayasu arteritis (TAK).

Methods: In this multicenter trial, patients with newly diagnosed or relapsing TAK 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, reaching a dosage of 20 mg daily at week 12, 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).

Results: Thirty-four eligible patients with TAK were enrolled and treated with prednisone and abatacept; of these, 26 reached the week 12 randomization and underwent a blinded randomization to receive either abatacept or placebo. The relapse-free survival rate at 12 months was 22% for those receiving abatacept and 40% for those receiving placebo (P = 0.853). Treatment with abatacept in patients with TAK enrolled in this study was not associated with a longer median duration of remission (median duration 5.5 months for abatacept versus 5.7 months for placebo). There was no difference in the frequency or severity of adverse events, including infection, between the treatment arms.

Conclusion: In patients with TAK, the addition of abatacept to a treatment regimen with prednisone did not reduce the risk of relapse.

Trial registration: ClinicalTrials.gov NCT00556439.

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Figures

Figure 1
Figure 1
A randomized trial of abatacept in Takayasu’s arteritis – study diagram.
Figure 2
Figure 2
Randomization assignment at week 12. All patients were initially treated with abatacept and prednisone. At week 12, those in remission underwent a blinded randomization at a 1:1 ratio to receive placebo or to continue abatacept. All randomized patients were included in the intent-to-treat analysis.
Figure 3
Figure 3
Relapse-free survival following randomization.
See this image and copyright information in PMC

Comment in

  • Reply.
    Langford CA, Krischer JP, Merkel PA; Vasculitis Clinical Research Consortium. Langford CA, et al. Arthritis Rheumatol. 2017 Jul;69(7):1505-1506. doi: 10.1002/art.40107. Epub 2017 May 10. Arthritis Rheumatol. 2017. PMID: 28324914 No abstract available.
  • Personalized Biologic Therapy for Large Vessel Vasculitis: Comment on the Articles by Langford et al.
    Moiseev S, Novikov P, Smitienko I. Moiseev S, et al. Arthritis Rheumatol. 2017 Jul;69(7):1504-1505. doi: 10.1002/art.40106. Epub 2017 May 10. Arthritis Rheumatol. 2017. PMID: 28324916 No abstract available.

References

    1. Kerr GS, Hallahan CW, Giordano J, Leavitt RY, Fauci AS, Rottem M, et al. Takayasu arteritis. Ann Intern Med. 1994;120(11):919–929. - PubMed
    1. Hall S, Barr W, Lie JT, Stanson AW, Kazmier FJ, Hunder GG. Takayasu arteritis. A study of 32 North American patients. Medicine. 1985;64(2):89–99. - PubMed
    1. Vanoli M, Daina E, Salvarani C, Sabbadini MG, Rossi C, Bacchiani G, et al. Takayasu's arteritis: A study of 104 Italian patients. Arthritis Rheum. 2005;53(1):100–107. - PubMed
    1. Koide K. Takayasu arteritis in Japan. Heart Vessels Suppl. 1992;7:48–54. - PubMed
    1. Zheng D, Fan D, Liu L. Takayasu arteritis in China: a report of 530 cases. Heart Vessels Suppl. 1992;7:32–36. - PubMed

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