抄録
Ruxolitinib, a potent JAK1/JAK2 inhibitor, was found to be superior to the best available therapy (BAT) in controlling hematocrit, reducing splenomegaly, and improving symptoms in the phase 3 RESPONSE study of patients with polycythemia vera with splenomegaly who experienced an inadequate response to or adverse effects from hydroxyurea. We report findings from a subgroup analysis of Japanese patients in RESPONSE (n = 18). The composite response rate (hematocrit control and spleen response) was higher in patients receiving ruxolitinib (50.0%) than in those receiving BAT (8.3%). A total of 50.0% of patients randomized to ruxolitinib achieved a spleen response vs 8.3% of those receiving BAT; 100 and 33.3% of patients in the respective groups achieved hematocrit control, with mean hematocrit in ruxolitinib-treated patients remaining stable at < 45% throughout the study. Similarly, a higher proportion of ruxolitinib-treated patients achieved complete hematologic remission (33.3 vs 16.7%). Ruxolitinib also led to rapid improvements in pruritus. All responses with ruxolitinib were durable to week 80, and its safety profile was consistent with that in the overall study. These findings suggest that ruxolitinib is an effective and well-tolerated treatment option for Japanese patients with polycythemia vera with an inadequate response to or adverse effects from hydroxyurea.
| 元の言語 | English |
|---|---|
| ページ（範囲） | 1-12 |
| ページ数 | 12 |
| ジャーナル | International Journal of Hematology |
| DOI | |
| 出版物ステータス | Accepted/In press - 2017 9 27 |
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ASJC Scopus subject areas
- Hematology
これを引用
Ruxolitinib is effective and safe in Japanese patients with hydroxyurea-resistant or hydroxyurea-intolerant polycythemia vera with splenomegaly. / Kirito, Keita; Suzuki, Kenshi; Miyamura, Koichi; Takeuchi, Masahiro; Handa, Hiroshi; Okamoto, Shinichiro; Gadbaw, Brian; Yamauchi, Kyosuke; Amagasaki, Taro; Ito, Kazuo; Hino, Masayuki.
：: International Journal of Hematology, 27.09.2017, p. 1-12.研究成果: Article
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TY - JOUR
T1 - Ruxolitinib is effective and safe in Japanese patients with hydroxyurea-resistant or hydroxyurea-intolerant polycythemia vera with splenomegaly
AU - Kirito, Keita
AU - Suzuki, Kenshi
AU - Miyamura, Koichi
AU - Takeuchi, Masahiro
AU - Handa, Hiroshi
AU - Okamoto, Shinichiro
AU - Gadbaw, Brian
AU - Yamauchi, Kyosuke
AU - Amagasaki, Taro
AU - Ito, Kazuo
AU - Hino, Masayuki
PY - 2017/9/27
Y1 - 2017/9/27
N2 - Ruxolitinib, a potent JAK1/JAK2 inhibitor, was found to be superior to the best available therapy (BAT) in controlling hematocrit, reducing splenomegaly, and improving symptoms in the phase 3 RESPONSE study of patients with polycythemia vera with splenomegaly who experienced an inadequate response to or adverse effects from hydroxyurea. We report findings from a subgroup analysis of Japanese patients in RESPONSE (n = 18). The composite response rate (hematocrit control and spleen response) was higher in patients receiving ruxolitinib (50.0%) than in those receiving BAT (8.3%). A total of 50.0% of patients randomized to ruxolitinib achieved a spleen response vs 8.3% of those receiving BAT; 100 and 33.3% of patients in the respective groups achieved hematocrit control, with mean hematocrit in ruxolitinib-treated patients remaining stable at < 45% throughout the study. Similarly, a higher proportion of ruxolitinib-treated patients achieved complete hematologic remission (33.3 vs 16.7%). Ruxolitinib also led to rapid improvements in pruritus. All responses with ruxolitinib were durable to week 80, and its safety profile was consistent with that in the overall study. These findings suggest that ruxolitinib is an effective and well-tolerated treatment option for Japanese patients with polycythemia vera with an inadequate response to or adverse effects from hydroxyurea.
AB - Ruxolitinib, a potent JAK1/JAK2 inhibitor, was found to be superior to the best available therapy (BAT) in controlling hematocrit, reducing splenomegaly, and improving symptoms in the phase 3 RESPONSE study of patients with polycythemia vera with splenomegaly who experienced an inadequate response to or adverse effects from hydroxyurea. We report findings from a subgroup analysis of Japanese patients in RESPONSE (n = 18). The composite response rate (hematocrit control and spleen response) was higher in patients receiving ruxolitinib (50.0%) than in those receiving BAT (8.3%). A total of 50.0% of patients randomized to ruxolitinib achieved a spleen response vs 8.3% of those receiving BAT; 100 and 33.3% of patients in the respective groups achieved hematocrit control, with mean hematocrit in ruxolitinib-treated patients remaining stable at < 45% throughout the study. Similarly, a higher proportion of ruxolitinib-treated patients achieved complete hematologic remission (33.3 vs 16.7%). Ruxolitinib also led to rapid improvements in pruritus. All responses with ruxolitinib were durable to week 80, and its safety profile was consistent with that in the overall study. These findings suggest that ruxolitinib is an effective and well-tolerated treatment option for Japanese patients with polycythemia vera with an inadequate response to or adverse effects from hydroxyurea.
KW - Hematocrit
KW - JAK inhibitor
KW - Japan
KW - Polycythemia vera
KW - Ruxolitinib
UR - http://www.scopus.com/inward/record.url?scp=85030113722&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85030113722&partnerID=8YFLogxK
U2 - 10.1007/s12185-017-2333-y
DO - 10.1007/s12185-017-2333-y
M3 - Article
C2 - 28956263
AN - SCOPUS:85030113722
SP - 1
EP - 12
JO - International Journal of Hematology
JF - International Journal of Hematology
SN - 0925-5710
ER -