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

for the Vasculitis Clinical Research Consortium

Research output: Contribution to journalArticle

78 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)837-845
Number of pages9
JournalArthritis and Rheumatology
Volume69
Issue number4
DOIs
StatePublished - Apr 1 2017

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Giant Cell Arteritis
Prednisone
Placebos
Random Allocation
Therapeutics
Recurrence
Survival Rate
Abatacept
Multicenter Studies
Appointments and Schedules
Infection

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology

Cite this

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

In: Arthritis and Rheumatology, Vol. 69, No. 4, 01.04.2017, p. 837-845.

Research output: Contribution to journalArticle

for the Vasculitis Clinical Research Consortium. / A Randomized, Double-Blind Trial of Abatacept (CTLA-4Ig) for the Treatment of Giant Cell Arteritis. In: Arthritis and Rheumatology. 2017 ; Vol. 69, No. 4. pp. 837-845.
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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.",
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T1 - A Randomized, Double-Blind Trial of Abatacept (CTLA-4Ig) for the Treatment of Giant Cell Arteritis

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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 - 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 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.

AB - 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.

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