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

Langford, Carol A. ; Cuthbertson, David ; Ytterberg, Steven R. ; Khalidi, Nader ; Monach, Paul A. ; Carette, Simon ; Seo, Philip ; Moreland, Larry W. ; Weisman, Michael ; Koening, Curry L. ; Sreih, Antoine G. ; Spiera, Robert ; McAlear, Carol A. ; Warrington, Kenneth J. ; Pagnoux, Christian ; McKinnon, Kathleen ; Forbess, Lindsy J. ; Hoffman, Gary S. ; Borchin, Renée ; Krischer, Jeffrey P. ; Merkel, Peter A. ; Hajj‐Ali, Rula ; Tuthill, Katherine ; Gartner, Kathleen ; Madden, Leah ; Matteson, Eric L. ; Kermani, Tanaz ; Jaquith, Jane ; Amudala, Naomi ; Clark‐Cotton, Manuella ; Messier, Sandra ; Farquharson, Julia ; Jagadeesh, Samyukta ; McBride, Dawn ; Venuturupalli, Swamy ; Wallace, Daniel ; Phan, Richard ; Verde, Nadia ; Salinas, Denise ; Godina, Jennifer ; Davids, Morgana ; Udeh, Uzunma ; Sejismundo, Lourdes ; Harris, Jennifer

Arthritis & rheumatology (Hoboken, N.J.), 2017-04, Vol.69 (4), p.837-845 [Periódico revisado por pares]

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Título:
A Randomized, Double‐Blind Trial of Abatacept (CTLA‐4Ig) for the Treatment of Giant Cell Arteritis
Autor: Langford, Carol A. ; Cuthbertson, David ; Ytterberg, Steven R. ; Khalidi, Nader ; Monach, Paul A. ; Carette, Simon ; Seo, Philip ; Moreland, Larry W. ; Weisman, Michael ; Koening, Curry L. ; Sreih, Antoine G. ; Spiera, Robert ; McAlear, Carol A. ; Warrington, Kenneth J. ; Pagnoux, Christian ; McKinnon, Kathleen ; Forbess, Lindsy J. ; Hoffman, Gary S. ; Borchin, Renée ; Krischer, Jeffrey P. ; Merkel, Peter A. ; Hajj‐Ali, Rula ; Tuthill, Katherine ; Gartner, Kathleen ; Madden, Leah ; Matteson, Eric L. ; Kermani, Tanaz ; Jaquith, Jane ; Amudala, Naomi ; Clark‐Cotton, Manuella ; Messier, Sandra ; Farquharson, Julia ; Jagadeesh, Samyukta ; McBride, Dawn ; Venuturupalli, Swamy ; Wallace, Daniel ; Phan, Richard ; Verde, Nadia ; Salinas, Denise ; Godina, Jennifer ; Davids, Morgana ; Udeh, Uzunma ; Sejismundo, Lourdes ; Harris, Jennifer
Assuntos: Abatacept - therapeutic use ; Aged ; Aged, 80 and over ; Arteritis ; Autoimmune diseases ; Double-Blind Method ; Female ; Giant Cell Arteritis - drug therapy ; Humans ; Male ; Middle Aged ; Prednisone ; Randomization ; Remission ; Schedules ; Survival ; Toxicity ; Vein & artery diseases
É parte de: Arthritis & rheumatology (Hoboken, N.J.), 2017-04, Vol.69 (4), p.837-845
Notas: identifier: NCT00556439.
ClinicalTrials.gov
This project has been funded in whole or in part with federal funds from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health, Department of Health and Human Services, under Contract HHSN‐2682007000036C. The Vasculitis Clinical Research Consortium (VCRC) is part of the Rare Diseases Clinical Research Network (RDCRN), an initiative of the Office of Rare Diseases Research (ORDR), National Center for Advancing Translational Science (NCATS). The VCRC is funded through a collaboration between NCATS and NIAMS (U54‐AR‐057319), and has received funding from the National Center for Research Resources (U54‐RR‐019497).
Dr. Langford has received research grants from Bristol‐Myers Squibb, Genentech, and GlaxoSmithKline. Dr. Ytterberg has received consulting fees from Sanofi (less than $10,000). Dr. Monach has received research grants from Bristol‐Myers Squibb. Dr. Weisman has received consulting fees from UCB, Ionis Pharmaceuticals, and Ampel Biosolutions, LLC (less than $10,000 each), has served as an expert witness on behalf of Paul Hastings, LLC, and has received research grants from Human Genome Sciences, UCB, Eli Lilly and Company, Genentech, DOD/Immunomedics, and EMD Serono. Dr. Pagnoux has received consulting fees from Hoffman‐LaRoche (less than $10,000). Dr. Hoffman has received consulting fees, speaking fees, and/or honoraria from Genentech/Roche (less than $10,000). Dr. Krischer has received research grants from Bristol‐Myers Squibb.
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Descrição: 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.
Editor: United States: Wiley Subscription Services, Inc
Idioma: Inglês

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

United States: Wiley Subscription Services, Inc

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