Published in:
01-04-2015 | Original Article
The International Immune Tolerance Induction Study and its follow-up study on Japanese hemophilia A patients with inhibitors
Authors:
Akira Yoshioka, Eizaburo Ishii, Tamaki Ueno, Ikuya Usami, Masao Kobayashi, Ryoji Kobayashi, Manabu Sotomatsu, Akira Shirahata, Takashi Suzuki, Masashi Taki, Yasushi Ishida, Tadashi Matsushita, Midori Shima, Keiji Nogami, Michio Sakai, Hisato Kigasawa, Katsuyuki Fukutake
Published in:
International Journal of Hematology
|
Issue 4/2015
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Abstract
The International Immune Tolerance Induction (I-ITI) Study in hemophilia A patients with inhibitors included 16 Japanese patients among a total of 115 test subjects. The results within this group of Japanese patients were 11 cases of I-ITI off-study, three cases of I-ITI on-study, and two cases of tolerance on prophylaxis. There was no significant difference in success rate between the low-dose and high-dose groups (Study I). Successively, independent follow-up survey in Japan was conducted in 14 cases, with consent (Study II). Ten cases were off-study at the end of the I-ITI Study. Of these 10 cases, seven of seven successful cases remained clinical successes at the end of the follow-up study, one partial success became a full success while a second relapsed, and one failure was subsequently evaluated as a partial success. Four cases that were on-study at the end of I-ITI Study were classified as three successes and one failure at the end of the follow-up study. As a result, the status at the end of follow-up study was: 11 ITI successes (78.6 %); one partial success; one failure; and one relapse. Thus, the ITI follow-up study was helpful in providing a long-term prognostic determination of inhibitors.