Comparison of two hyaluronic acid formulations for safety and efficacy (CHASE)
study in knee osteoarthritis: a multicenter, randomized, double-blind, 26-week
non-inferiority trial comparing Durolane to Artz.
Author(s): Zhang H(1), Zhang K(2), Zhang X(3), Zhu Z(4), Yan S(5), Sun T(6), Guo A(7), Jones
J(8), Steen RG(9), Shan B(10), Zhang J(11), Lin J(12).
Affiliation(s): Author information:
(1)Arthritis Clinic & Research Center, Peking University People's Hospital, 11
Xizhimen South Street, Xicheng District, Beijing, 100044, China.
469325342@qq.com. (2)Department of Orthopedics, Peking University Third Hospital,
Beijing, China. zhangke60@medmail.com.cn. (3)Department of Orthopedics, Shanghai
6th People's Hospital, Shanghai, China. zxl40@vip.sina.com. (4)Department of
Orthopedics, Shanghai 9th People's Hospital, Shanghai, China.
zhuzhenan2006@126.com. (5)Department of Orthopedics, The Second Affiliated
Hospital of Zhejiang University School of Medicine, Zhejiang Province, China.
zrjwsj@zju.edu.cn. (6)Department of Orthopedics, Beijing Military General
Hospital, Beijing, China. suntiansheng_@163.com. (7)Department of Orthopedics,
Beijing Friendship Hospital, Beijing, China. guoaij@yahoo.com.cn. (8)Bioventus
LLC, Durham, NC, USA. John.Jones@bioventusglobal.com. (9)Bioventus LLC, Durham,
NC, USA. Grant.Steen@bioventusglobal.com. (10)TigerMed Consulting Co., Ltd,
Beijing, China. bin.shan@tigermed.net. (11)TigerMed Consulting Co., Ltd, Beijing,
China. jenny.zhang@tigermed.net. (12)Arthritis Clinic & Research Center, Peking
University People's Hospital, 11 Xizhimen South Street, Xicheng District,
Beijing, 100044, China. linjianhao@pkuph.edu.cn.
Publication date & source: 2015, Arthritis Res Ther. , 17:51
INTRODUCTION: Intra-articular injection of hyaluronic acid (HA) is often used as
therapy for knee osteoarthritis because it is less expensive and less aggressive
than total knee replacement. Therefore, it is important to document whether HA is
safe and efficacious. We tested whether single and multiple injection
viscosupplementation with HA is associated with clinically meaningful pain relief
in a new randomized clinical trial (RCT). Our objective was to compare safety and
efficacy of intra-articular HA in two formulations: one 3.0 ml injection of
Durolane versus five 2.5 ml injections of Artz for the treatment of knee
osteoarthritis pain.
METHODS: Patients (N=349) from the People's Republic of China were randomized to
treatment (Durolane=175, Artz=174). The Durolane group received a 3.0 ml
injection at week 0 (baseline), with sham skin punctures at weeks 1, 2, 3, and 4.
The Artz group received one 2.5 ml injection at each of the same time points. The
primary assessment tool was the Likert-type Western Ontario and McMaster
University (WOMAC) pain scale at weeks 0, 6, 10, 14, 18, and 26. Secondary
assessments were WOMAC physical function, knee stiffness, and global
self-assessment, at identical time points. Statistically-controlled analyses were
non-inferiority of Durolane over 18, then over 26 weeks, with a priori
non-inferiority defined as 8% of the relevant scale. Acetaminophen was permitted
as rescue analgesia and all adverse events (AEs) were recorded.
RESULTS: Overall study retention was excellent; 332 patients (95.1%) completed 18
weeks and 319 (91.4%) completed 26 weeks, with no significant retention
difference between treatment arms. All variables met non-inferiority criteria
over 18 and 26 weeks. Efficacy response in both arms was >90%. Treatment-related
AEs were 9.8% (17/174) for Artz and 13.1% (23/175) for Durolane.
CONCLUSIONS: A single injection of Durolane is non-inferior to 5 injections of
Artz over 18 and 26 weeks for pain, physical function, global self-assessment,
and knee stiffness. Both treatments were efficacious, safe, and well tolerated.
TRIAL REGISTRATION: ClinicalTrials.gov NCT01295580 . Registered 11 February 2011.
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