TY - JOUR
T1 - Efficacy and safety of mavrilimumab in Japanese subjects with rheumatoid arthritis
T2 - Findings from a phase iia study
AU - Takeuchi, Tsutomu
AU - Tanaka, Yoshiya
AU - Close, David
AU - Godwood, Alex
AU - Wu, Chi Yuan
AU - Saurigny, Didier
N1 - Funding Information:
This study was sponsored by MedImmune and in part by AstraZeneca K.K. Medical writing services were provided by Sarah Reynolds (BSc) from QXV Communications, Macclesfield, UK, funded by MedImmune.
Funding Information:
Tsutomu Takeuchi is an investigator on the EARTH study and has received service honoraria from Abbott Japan Co. Ltd, Bristol-Myers Squibb, Chu-gai Pharmaceutical Co. Ltd, Eisai Co. Ltd, Mitsubishi Tanabe Pharma Co. and Pfizer Japan Inc, and research grants from Abbott Japan Co. Ltd, Astellas Pharma Inc., Bristol-Myers Squibb, Chugai Pharmaceutical Co. Ltd, Daiichi Sankyo Co. Ltd, Eisai Co. Ltd, Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Nippon Shinyaku Co. Ltd, Novo Nordisk Pharma Ltd, Otsuka Pharmaceutical Co. Ltd, Pfizer Japan Inc., Sanofi K.K., Santen Pharmaceutical Co. Ltd, Takeda Pharmaceutical Co. Ltd and Teijin Pharma Ltd. Yoshiya Tanaka is an investigator on the EARTH study and has received consulting and speaking fees, and/or honoraria from Mitsubishi-Tanabe Pharma Co, Abbott Japan Co. Ltd., Eisai Co. Ltd, Chu-gai Pharmaceutical Co. Ltd, Janssen Pharmaceutical K.K., Santen Pharmaceutical Co. Ltd., Pfizer Japan Inc, Astellas Pharma Inc, Daiichi-Sankyo Co. Ltd, GlaxoSmithKline K.K., AstraZeneca, Otsuka Pharmaceutical Co. Ltd., Actelion Pharmaceuticals Japan Ltd, Eli Lilly Japan K.K., Nippon Kayaku Co. Ltd, UCB Japan Co. Ltd, Quintiles Transnational Japan Co. Ltd, Ono Pharmaceutical Co. Ltd., and Novartis Pharma K.K., and has received research grants from Bristol-Myers Squibb, MSD K.K., Chugai Pharmaceutical Co. Ltd, Mitsubishi-Tanabe Pharma Corporation, Astellas Pharma Inc, Abbott Japan Co. Ltd., Eisai Co. Ltd. and Janssen Pharmaceutical K.K. David Close, Alex Godwood, Chi-Yuan Wu, and Didier Saurigny are employees of MedImmune and own stocks/stock options in AstraZeneca.
Publisher Copyright:
© 2014 Japan College of Rheumatology.
PY - 2015
Y1 - 2015
N2 - Objective. A phase IIa study investigated efficacy and safety/tolerability of ascending doses of mavrilimumab (anti-granulocyte-macrophage colony-stimulating factor receptor [GM-CSFR] α monoclonal antibody) in adult subjects with moderate to severe rheumatoid arthritis from Japan and Europe. Findings from the Japanese population are presented. Methods. Fifty-one subjects received mavrilimumab (10-100 mg) or placebo subcutaneously every other week for 12 weeks, followed by a 12-week follow-up period. The primary endpoint was the proportion of subjects achieving a Disease Activity Score using 28 joints (DAS28)-Creactive protein (CRP) response (decrease > 1.2 from baseline). Secondary endpoints included DAS28-CRP remission, Health Assessment Questionnaire Disability Index (HAQ-DI) and American College of Rheumatology (ACR) response. Results. By Week 12, more mavrilimumab- versus placebo-treated subjects achieved a DAS28-CRP response (50.0% vs. 23.5%, p = 0.081); a signifi cant response was seen in the 30 mg and 100 mg dose groups (both 75.0% vs. 23.5%, p = 0.028). The 100 mg group also demonstrated statistically signifi cant HAQ-DI and ACR20 responses at Week 12. Results were generally consistent between Japanese and European populations. Overall, adverse events (AEs) were mild to moderate in intensity with one serious AE of pneumonia, considered possibly treatment-related. Conclusions. A rapid and clinically meaningful response was seen in subjects treated with GM-CSFR α blockade with mavrilimumab, supporting further investigation of mavrilimumab for the treatment of RA in Japanese subjects.
AB - Objective. A phase IIa study investigated efficacy and safety/tolerability of ascending doses of mavrilimumab (anti-granulocyte-macrophage colony-stimulating factor receptor [GM-CSFR] α monoclonal antibody) in adult subjects with moderate to severe rheumatoid arthritis from Japan and Europe. Findings from the Japanese population are presented. Methods. Fifty-one subjects received mavrilimumab (10-100 mg) or placebo subcutaneously every other week for 12 weeks, followed by a 12-week follow-up period. The primary endpoint was the proportion of subjects achieving a Disease Activity Score using 28 joints (DAS28)-Creactive protein (CRP) response (decrease > 1.2 from baseline). Secondary endpoints included DAS28-CRP remission, Health Assessment Questionnaire Disability Index (HAQ-DI) and American College of Rheumatology (ACR) response. Results. By Week 12, more mavrilimumab- versus placebo-treated subjects achieved a DAS28-CRP response (50.0% vs. 23.5%, p = 0.081); a signifi cant response was seen in the 30 mg and 100 mg dose groups (both 75.0% vs. 23.5%, p = 0.028). The 100 mg group also demonstrated statistically signifi cant HAQ-DI and ACR20 responses at Week 12. Results were generally consistent between Japanese and European populations. Overall, adverse events (AEs) were mild to moderate in intensity with one serious AE of pneumonia, considered possibly treatment-related. Conclusions. A rapid and clinically meaningful response was seen in subjects treated with GM-CSFR α blockade with mavrilimumab, supporting further investigation of mavrilimumab for the treatment of RA in Japanese subjects.
KW - Granulocyte-macrophage colony-stimulating factor
KW - Mavrilimumab
KW - Phase II
KW - Rheumatoid arthritis
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UR - http://www.scopus.com/inward/citedby.url?scp=84983421796&partnerID=8YFLogxK
U2 - 10.3109/14397595.2014.896448
DO - 10.3109/14397595.2014.896448
M3 - Article
C2 - 24720551
AN - SCOPUS:84983421796
VL - 25
SP - 21
EP - 30
JO - Japanese Journal of Rheumatology
JF - Japanese Journal of Rheumatology
SN - 1439-7595
IS - 1
ER -