Safety of a single intra-articular injection of LBSA0103 hyaluronic acid in patients with osteoarthritis of the knee: a multicenter, single-arm, prospective, cohort study

Abstract

Objective

LBSA0103 is a recently developed high-molecular-weight, cross-linked, non-animal hyaluronic acid (HA). The safety of LBSA0103 has been investigated only in a limited number of patients, therefore this prospective study was designed. This study sought to assess the safety including injection-site reactions and adverse drug reactions after a single intra-articular injection of LBSA0103 in patients with osteoarthritis (OA) of the knee joint.

Methods

This study was a multicenter, single-arm, prospective cohort study. After screening, eligible patients with OA of the knee joint (Kellgren–Lawrence grades I–III) were enrolled, received a single intra-articular HA (LBSA0103) injection, and were followed up for two weeks. Any adverse events including injection-site reactions and adverse drug reactions were evaluated by the investigators.

Results

A total of 1949 subjects (2976 knee joints) was enrolled, all of whom received a single intra-articular injection of LBSA0103. Injection-site reactions occurred in 5.59% of enrolled subjects (109/1949), and the most frequently reported injection-site reaction was pain (4.87%), followed by swelling (1.03%). Most of the injection-site reactions were transient and resolved within 14 days without additional treatment. The incidence of adverse drug reactions other than injection-site reactions was 0.67% (13/1949). Most adverse events were of mild severity. No serious adverse events related to the study drug were reported.

Conclusions

A single intra-articular injection of LBSA0103 in patients with OA of the knee joint was safe, and no significant safety concerns were observed. As such, LBSA0103 could be safely applied as an intra-articular injection for the management of knee OA.

Trial Registration

The study was registered at ClinicalTrials.gov (identifier: NCT04369261).

Keywords:

• Safety
• intra-articular injection
• hyaluronic acid
• osteoarthritis
• knee

Transparency

Declaration of Funding

This work was supported financially by LG Chem, Ltd. The sponsor (LG Chem, Ltd.) participated in the study design, data analysis, data interpretation, and writing of the report but had no role in the data collection.

Declaration of financial/other relationships

This study was funded by LG Chem, Ltd. YE is an employee of LG Chem, Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

K-MJ, Y-GP, WKC, YYC, KKK, JWL, SJL, and J-HY conducted the study and contributed toward the acquisition of data. K-MJ and J-HY interpreted the data and wrote the manuscript. YE contributed to the study design and developed the study protocol. All authors read and approved the final manuscript.

Acknowledgements

The authors acknowledge the efforts of all the investigators and site staff who devoted their time and energy to this study.

Data availability statement

The data that support the findings of this study are available on request from the corresponding author.