TY - JOUR
T1 - An open-label trial of abatacept (CTLA4-IG) in non-severe relapsing granulomatosis with polyangiitis (Wegener's)
AU - Langford, Carol A.
AU - Monach, Paul A.
AU - Specks, Ulrich
AU - Seo, Philip
AU - Cuthbertson, David
AU - McAlear, Carol A.
AU - Ytterberg, Steven R.
AU - Hoffman, Gary S.
AU - Krischer, Jeffrey P.
AU - Merkel, Peter A.
N1 - Copyright:
Copyright 2014 Elsevier B.V., All rights reserved.
PY - 2014/7
Y1 - 2014/7
N2 - Objectives To determine the safety and efficacy of abatacept in non-severe relapsing granulomatosis with polyangiitis (Wegener's)(GPA). Methods An open-label trial of intravenous abatacept was conducted in 20 patients with non-severe relapsing GPA. Prednisone up to 30 mg daily was permitted within the first 2 months, and patients on methotrexate, azathioprine, or mycophenolate mofetil continued these agents. Patients remained on study until common closing or early termination. Results Of the 20 patients, 18 (90%) had disease improvement, 16 (80%) achieved remission (BVAS/ WG=0) at a median of 1.9 months, and 14 (70%) reached common closing. Six patients (30%) met criteria for early termination due to increased disease activity; 3 of 6 achieved remission and relapsed at a median of 8.6 months. The median duration of remission before common closing was 14.4 months, with the median duration of time on study for all patients being 12.3 months (range 2-35 months). Eleven of the 15 (73%) patients on prednisone reached 0 mg. Nine severe adverse events occurred in 7 patients, including 7 infections that were successfully treated. Conclusions In this study of patients with non-severe relapsing GPA, abatacept was well tolerated and was associated with a high frequency of disease remission and prednisone discontinuation.
AB - Objectives To determine the safety and efficacy of abatacept in non-severe relapsing granulomatosis with polyangiitis (Wegener's)(GPA). Methods An open-label trial of intravenous abatacept was conducted in 20 patients with non-severe relapsing GPA. Prednisone up to 30 mg daily was permitted within the first 2 months, and patients on methotrexate, azathioprine, or mycophenolate mofetil continued these agents. Patients remained on study until common closing or early termination. Results Of the 20 patients, 18 (90%) had disease improvement, 16 (80%) achieved remission (BVAS/ WG=0) at a median of 1.9 months, and 14 (70%) reached common closing. Six patients (30%) met criteria for early termination due to increased disease activity; 3 of 6 achieved remission and relapsed at a median of 8.6 months. The median duration of remission before common closing was 14.4 months, with the median duration of time on study for all patients being 12.3 months (range 2-35 months). Eleven of the 15 (73%) patients on prednisone reached 0 mg. Nine severe adverse events occurred in 7 patients, including 7 infections that were successfully treated. Conclusions In this study of patients with non-severe relapsing GPA, abatacept was well tolerated and was associated with a high frequency of disease remission and prednisone discontinuation.
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U2 - 10.1136/annrheumdis-2013-204164
DO - 10.1136/annrheumdis-2013-204164
M3 - Article
C2 - 24323392
AN - SCOPUS:84902251458
SN - 0003-4967
VL - 73
SP - 1376
EP - 1379
JO - Annals of the rheumatic diseases
JF - Annals of the rheumatic diseases
IS - 7
ER -