Hepatology research : the official journal of the Japan Society of Hepatology · 2014
Multicenter validation study of anti-programmed cell death-1 antibody as a serological marker for type 1 autoimmune hepatitis.
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Miyake Yasuhiro, Yamamoto Kazuhide, Matsushita Hiroshi, Abe Masanori, Takahashi Atsushi, Umemura Takeji, Tanaka Atsushi, Nakamuta Makoto, Nakamoto Yasunari, Ueno Yoshiyuki, Saibara Toshiji, Takikawa Hajime, Yoshizawa Kaname, Ohira Hiromasa, Zeniya Mikio, Onji Morikazu, Tsubouchi Hirohito, Intractable Hepato-Biliary Disease Study Group of Japan
Аннотация
AIM: Recently, serum levels of anti-programmed cell death-1 (anti-PD-1) antibodies have been reported to be useful for the discrimination of type 1 autoimmune hepatitis (AIH) from drug-induced liver injury (DILI) and to be associated with clinical features of type 1 AIH. This multicenter study aimed to validate the usefulness of serum anti-PD-1 antibody as a serological marker for type 1 AIH.
METHODS: Serum samples before the initiation of corticosteroid treatment were obtained from 71 type 1 AIH patients and 37 DILI patients. Serum levels of anti-PD-1 antibodies were measured by indirect enzyme-linked immunosorbent assay.
RESULTS: Serum levels of anti-PD-1 antibodies were higher in type 1 AIH patients than in DILI patients (P < 0.001). The receiver-operator curve analysis showed that serum levels of anti-PD-1 antibodies were useful for the discrimination of type 1 AIH from DILI (area under the curve, 0.80). On the other hand, the multivariate Cox proportional hazard model showed that positivity for serum anti-PD-1 antibody, probable diagnosis based on the revised scoring system proposed by the International Autoimmune Hepatitis Group, and prothrombin activity of less than 60% were associated with the later normalization of serum transaminase levels. During the clinical course, the disease relapsed more frequently in patients positive for serum anti-PD-1 antibody (36% vs 11%).
CONCLUSION: This study suggests that serum anti-PD-1 antibody is useful for the diagnosis of type 1 AIH as an auxiliary diagnostic marker, and that serum levels of anti-PD-1 antibodies reflect clinical features of type 1 AIH.
METHODS: Serum samples before the initiation of corticosteroid treatment were obtained from 71 type 1 AIH patients and 37 DILI patients. Serum levels of anti-PD-1 antibodies were measured by indirect enzyme-linked immunosorbent assay.
RESULTS: Serum levels of anti-PD-1 antibodies were higher in type 1 AIH patients than in DILI patients (P < 0.001). The receiver-operator curve analysis showed that serum levels of anti-PD-1 antibodies were useful for the discrimination of type 1 AIH from DILI (area under the curve, 0.80). On the other hand, the multivariate Cox proportional hazard model showed that positivity for serum anti-PD-1 antibody, probable diagnosis based on the revised scoring system proposed by the International Autoimmune Hepatitis Group, and prothrombin activity of less than 60% were associated with the later normalization of serum transaminase levels. During the clinical course, the disease relapsed more frequently in patients positive for serum anti-PD-1 antibody (36% vs 11%).
CONCLUSION: This study suggests that serum anti-PD-1 antibody is useful for the diagnosis of type 1 AIH as an auxiliary diagnostic marker, and that serum levels of anti-PD-1 antibodies reflect clinical features of type 1 AIH.