TY - JOUR
T1 - Determinants of Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity in patients with rheumatoid arthritis
T2 - A post hoc analysis of overall and Japanese results from phase 3 clinical trials
AU - Kaneko, Yuko
AU - Takeuchi, Tsutomu
AU - Cai, Zhihong
AU - Sato, Masayo
AU - Awakura, Kenta
AU - Gaich, Carol
AU - Zhu, Baojin
AU - Guo, Jiaying
AU - Tanaka, Yoshiya
N1 - Funding Information:
ZC, MS, KA, CG, BZ, and JG are employees of Eli Lilly and Company. MS, CG and BZ own shares in Eli Lilly and Company. YK has received consulting fees, speaking fees, and/or honoraria from AbbVie, Astellas Pharma, Ayumi Pharmaceutical, Bristol-Myers K.K., Chugai Pharmaceutical, EA Pharma, Eisai, Eli Lilly and Company, Janssen, Mitsubishi Tanabe Pharma, Pfizer Japan, Taisho-Toyama, Takeda Pharmaceutical, and UCB. TT has received grants, consulting fees, and speaking fees from AbbVie, Asahikasei Pharma, Astellas Pharma, Astra Zeneca K.K., Ayumi Pharmaceutical, Bristol–Myers K.K., Chugai Pharmaceutical, Daiichi Sankyo, Eisai, Eli Lilly Japan K.K., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma K.K., Pfizer Japan, Taiho Pharmaceutical, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. YT has received consulting fees, speaking fees, honoraria, and/or research grants from AbbVie, Astellas Pharma, Bristol-Myers Squibb, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Eli Lilly and Company, Janssen, Kyowa-Kirin, Mitsubishi Tanabe Pharma, MSD, Ono, Pfizer, Sanofi, Takeda, UCB, and YL Biologics.
Funding Information:
RA-BEAM and RA-BEGIN were supported by Eli Lilly and Company and Incyte Corporation. Eli Lilly and Company was involved in the data collection, data analysis, and preparation of the manuscript. The study was designed by Eli Lilly and Company in consultation with an academic advisory board and Incyte Corporation.
Funding Information:
Studies RA-BEAM and RA-BEGIN were sponsored by Eli Lilly and Company. Medical writing assistance was provided by Thao Le, MD, PhD, and Luke Carey, PhD of ProScribe?Envision Pharma Group, and was funded by Eli Lilly Japan K.K. ProScribe?s services complied with international guidelines for Good Publication Practice (GPP3). RA-BEAM and RA-BEGIN were supported by Eli Lilly and Company and Incyte Corporation. Eli Lilly and Company was involved in the data collection, data analysis, and preparation of the manuscript. The study was designed by Eli Lilly and Company in consultation with an academic advisory board and Incyte Corporation.
Funding Information:
Medical writing assistance was provided by Thao Le, MD, PhD, and Luke Carey, PhD of ProScribe – Envision Pharma Group, and was funded by Eli Lilly Japan K.K. ProScribe’s services complied with international guidelines for Good Publication Practice (GPP3).
Publisher Copyright:
© 2018, © 2018 Japan College of Rheumatology. Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2018/11/2
Y1 - 2018/11/2
N2 - Objectives: To assess the determinants of Patient’s Global Assessment of Disease Activity (PtGA) and Physician’s Global Assessment of Disease Activity (PhGA) in overall and Japanese patients with rheumatoid arthritis (RA) from two large randomized controlled trials. Methods:Post hoc analysis of overall and Japanese RA patients who had previous inadequate responses to methotrexate or who had no/minimal previous disease-modifying antirheumatic drug treatment. We examined correlations between PtGA/PhGA and tender joint count in 28 joints (TJC28), swollen joint count in 28 joints (SJC28), inflammatory markers, pain visual analog scale (VAS), and other patient-reported outcomes at baseline, Week 12, and Week 24. Determinants of PtGA/PhGA were identified. Results: In overall populations, pain VAS was the main determinant of PtGA, whereas TJC28 was the main determinant of PhGA in both studies. In Japanese populations, consistent with overall populations, pain VAS was the main determinant of PtGA in both studies; in contrast to overall populations, pain VAS and SJC28/TJC28 played an important role in PhGA. Conclusion: Pain was the most important determinant of PtGA, whereas determinants of PhGA varied between populations/studies and were mostly explained by pain/joint counts. Physicians should be aware of patients’ perceptions of disease activity when performing assessments/prescribing treatments.
AB - Objectives: To assess the determinants of Patient’s Global Assessment of Disease Activity (PtGA) and Physician’s Global Assessment of Disease Activity (PhGA) in overall and Japanese patients with rheumatoid arthritis (RA) from two large randomized controlled trials. Methods:Post hoc analysis of overall and Japanese RA patients who had previous inadequate responses to methotrexate or who had no/minimal previous disease-modifying antirheumatic drug treatment. We examined correlations between PtGA/PhGA and tender joint count in 28 joints (TJC28), swollen joint count in 28 joints (SJC28), inflammatory markers, pain visual analog scale (VAS), and other patient-reported outcomes at baseline, Week 12, and Week 24. Determinants of PtGA/PhGA were identified. Results: In overall populations, pain VAS was the main determinant of PtGA, whereas TJC28 was the main determinant of PhGA in both studies. In Japanese populations, consistent with overall populations, pain VAS was the main determinant of PtGA in both studies; in contrast to overall populations, pain VAS and SJC28/TJC28 played an important role in PhGA. Conclusion: Pain was the most important determinant of PtGA, whereas determinants of PhGA varied between populations/studies and were mostly explained by pain/joint counts. Physicians should be aware of patients’ perceptions of disease activity when performing assessments/prescribing treatments.
KW - Clinician-reported outcomes
KW - Japan
KW - discordance
KW - patient-reported outcomes
KW - rheumatoid arthritis
UR - http://www.scopus.com/inward/record.url?scp=85041578218&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85041578218&partnerID=8YFLogxK
U2 - 10.1080/14397595.2017.1422304
DO - 10.1080/14397595.2017.1422304
M3 - Article
C2 - 29278339
AN - SCOPUS:85041578218
VL - 28
SP - 960
EP - 967
JO - Japanese Journal of Rheumatology
JF - Japanese Journal of Rheumatology
SN - 1439-7595
IS - 6
ER -