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

for the Vasculitis Clinical Research Consortium

Research output: Contribution to journalArticle

52 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)846-853
Number of pages8
JournalArthritis and Rheumatology
Volume69
Issue number4
DOIs
StatePublished - Apr 1 2017

Fingerprint

Takayasu Arteritis
Prednisone
Placebos
Random Allocation
Therapeutics
Recurrence
Abatacept
Multicenter Studies
Survival Rate
Survival

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology

Cite this

A Randomized, Double-Blind Trial of Abatacept (CTLA-4Ig) for the Treatment of Takayasu Arteritis. / for the Vasculitis Clinical Research Consortium.

In: Arthritis and Rheumatology, Vol. 69, No. 4, 01.04.2017, p. 846-853.

Research output: Contribution to journalArticle

for the Vasculitis Clinical Research Consortium. / A Randomized, Double-Blind Trial of Abatacept (CTLA-4Ig) for the Treatment of Takayasu Arteritis. In: Arthritis and Rheumatology. 2017 ; Vol. 69, No. 4. pp. 846-853.
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title = "A Randomized, Double-Blind Trial of Abatacept (CTLA-4Ig) for the Treatment of Takayasu Arteritis",
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.",
author = "{for the Vasculitis Clinical Research Consortium} and Langford, {Carol A.} and David Cuthbertson and Ytterberg, {Steven R} and Nader Khalidi and Monach, {Paul A.} and Simon Carette and Philip Seo and Moreland, {Larry W.} and Michael Weisman and Koening, {Curry L.} and Sreih, {Antoine G.} and Robert Spiera and McAlear, {Carol A.} and Warrington, {Kenneth J} and Christian Pagnoux and Kathleen McKinnon and Forbess, {Lindsy J.} and Hoffman, {Gary S.} and Ren{\'e}e Borchin and Krischer, {Jeffrey P.} and Merkel, {Peter A.} and Rula Hajj-Ali and Katherine Tuthill and Kathleen Gartner and Leah Madden and Brian Rice and Matteson, {Eric L.} and Matteson, {Eric Lawrence} and Jane Jaquith and Naomi Amudala and Manuella Clark-Cotton and Sandra Messier and Julia Farquharson and Samyukta Jagadeesh and Dawn McBride and Swamy Venuturupalli and Daniel Wallace and Richard Phan and Nadia Verde and Denise Salinas and Jennifer Godina and Morgana Davids and Uzunma Udeh and Lourdes Sejismundo and Jennifer Harris",
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AU - Langford, Carol A.

AU - Cuthbertson, David

AU - Ytterberg, Steven R

AU - Khalidi, Nader

AU - Monach, Paul A.

AU - Carette, Simon

AU - Seo, Philip

AU - Moreland, Larry W.

AU - Weisman, Michael

AU - Koening, Curry L.

AU - Sreih, Antoine G.

AU - Spiera, Robert

AU - McAlear, Carol A.

AU - Warrington, Kenneth J

AU - Pagnoux, Christian

AU - McKinnon, Kathleen

AU - Forbess, Lindsy J.

AU - Hoffman, Gary S.

AU - Borchin, Renée

AU - Krischer, Jeffrey P.

AU - Merkel, Peter A.

AU - Hajj-Ali, Rula

AU - Tuthill, Katherine

AU - Gartner, Kathleen

AU - Madden, Leah

AU - Rice, Brian

AU - Matteson, Eric L.

AU - Matteson, Eric Lawrence

AU - Jaquith, Jane

AU - Amudala, Naomi

AU - Clark-Cotton, Manuella

AU - Messier, Sandra

AU - Farquharson, Julia

AU - Jagadeesh, Samyukta

AU - McBride, Dawn

AU - Venuturupalli, Swamy

AU - Wallace, Daniel

AU - Phan, Richard

AU - Verde, Nadia

AU - Salinas, Denise

AU - Godina, Jennifer

AU - Davids, Morgana

AU - Udeh, Uzunma

AU - Sejismundo, Lourdes

AU - Harris, Jennifer

PY - 2017/4/1

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N2 - 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.

AB - 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.

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DO - 10.1002/art.40037

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VL - 69

SP - 846

EP - 853

JO - Arthritis and Rheumatology

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