TY - JOUR
T1 - Effect of ruxolitinib therapy on the quality-of-life of Japanese patients with myelofibrosis
AU - Oritani, Kenji
AU - Ohishi, Kohshi
AU - Okamoto, Shinichiro
AU - Kirito, Keita
AU - Komatsu, Norio
AU - Tauchi, Tetsuzo
AU - Handa, Hiroshi
AU - Saito, Shigeki
AU - Takenaka, Katsuto
AU - Shimoda, Kazuya
AU - Okada, Hikaru
AU - Amagasaki, Taro
AU - Wakase, Shiho
AU - Shimozuma, Kojiro
AU - Akashi, Koichi
N1 - Funding Information:
Both studies were designed by Novartis and conducted in compliance with Good Clinical Practice and in accordance with the principles of the Declaration of Helsinki. The study designs were approved by the independent ethics committee or institutional review board for each center. Written informed consent was obtained for all patients. Data were analyzed by the sponsor’s clinical and statistical teams and interpreted in collaboration with the study investigators. The first author prepared the first draft of the manuscript with the assistance of a medical writer funded by the sponsor. All authors reviewed the manuscript and attested to the integrity of the data.
Funding Information:
Merck Serono, Chugai Pharmaceutical Co, Bristol-Myers Squibb, and GlaxoSmithKline. S. Wakase, H. Okada, and T. Amagasaki are employees of Novartis Pharma KK. K. Ohishi, S. Saito, and K. Takenaka have nothing to disclose. A CMRO reviewer on this manuscript declares receiving research funding from Novartis and Incyte. They have also received consultancy payments from Novartis. All other CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Publisher Copyright:
© 2017 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2018/1/4
Y1 - 2018/1/4
N2 - Objectives: Myelofibrosis (MF) is associated with a significant symptom burden that severely impacts patient quality-of-life (QoL). Ruxolitinib, a potent Janus kinase 1 (JAK1)/JAK2 inhibitor, led to substantial improvements in splenomegaly, MF-associated symptoms, and QoL in the phase 3 COMFORT studies, proving superior to placebo and best available therapy. This study evaluated the effect of ruxolitinib on symptoms and QoL in Japanese patients with MF. Methods: A pooled analysis of studies A2202 (NCT01392443) and AJP01 (NCT02087059) of ruxolitinib in Japanese patients with MF (n=81) was conducted. Changes in total symptom score (TSS) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 were summarized. Results: Most patients received a starting dose of 15 or 20mg twice daily (BID) and had a final titrated dose of ≥10mg BID. Overall, 67.7% (44/65) achieved a ≥50% reduction from baseline in TSS at week 24. Reductions in TSS were seen in every dose group; the greatest reductions occurred in patients with a final titrated dose of 20 or 25mg BID. Improvements in QoL were seen in patients who achieved a ≥50% reduction in TSS. Generally, improvements in TSS and individual symptoms correlated with reductions in spleen size, with those having a ≥35% reduction in spleen volume having the greatest improvements. Conclusions: Consistent with COMFORT-I, ruxolitinib provided substantial improvements in symptoms and QoL in Japanese patients with MF, with higher doses of ruxolitinib associated with better responses.
AB - Objectives: Myelofibrosis (MF) is associated with a significant symptom burden that severely impacts patient quality-of-life (QoL). Ruxolitinib, a potent Janus kinase 1 (JAK1)/JAK2 inhibitor, led to substantial improvements in splenomegaly, MF-associated symptoms, and QoL in the phase 3 COMFORT studies, proving superior to placebo and best available therapy. This study evaluated the effect of ruxolitinib on symptoms and QoL in Japanese patients with MF. Methods: A pooled analysis of studies A2202 (NCT01392443) and AJP01 (NCT02087059) of ruxolitinib in Japanese patients with MF (n=81) was conducted. Changes in total symptom score (TSS) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 were summarized. Results: Most patients received a starting dose of 15 or 20mg twice daily (BID) and had a final titrated dose of ≥10mg BID. Overall, 67.7% (44/65) achieved a ≥50% reduction from baseline in TSS at week 24. Reductions in TSS were seen in every dose group; the greatest reductions occurred in patients with a final titrated dose of 20 or 25mg BID. Improvements in QoL were seen in patients who achieved a ≥50% reduction in TSS. Generally, improvements in TSS and individual symptoms correlated with reductions in spleen size, with those having a ≥35% reduction in spleen volume having the greatest improvements. Conclusions: Consistent with COMFORT-I, ruxolitinib provided substantial improvements in symptoms and QoL in Japanese patients with MF, with higher doses of ruxolitinib associated with better responses.
KW - Japanese
KW - Myelofibrosis
KW - Quality-of-life
KW - Ruxolitinib
UR - http://www.scopus.com/inward/record.url?scp=85041140370&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85041140370&partnerID=8YFLogxK
U2 - 10.1080/03007995.2017.1415874
DO - 10.1080/03007995.2017.1415874
M3 - Article
C2 - 29224367
AN - SCOPUS:85041140370
SN - 0300-7995
VL - 34
SP - 531
EP - 537
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
IS - 3
ER -
