In:
PLOS ONE, Public Library of Science (PLoS), Vol. 18, No. 6 ( 2023-6-22), p. e0287222-
Abstract:
This study aimed to assess the safety and effectiveness of the highly cross-linked hyaluronic acid—LBSA0103—in patients with knee osteoarthritis (OA) as per the prescribing information (PI) in South Korea. A total of 3,140 subjects aged ≥19 years were enrolled in this post-marketing surveillance (PMS) study from 2013 to 2019. The subjects received one or two injections of LBSA0103. The median duration of follow-up was 308 days. Adverse events (AEs), adverse drug reactions (ADRs), and serious AEs (SAEs) were monitored. Effectiveness was evaluated based on an index of effectiveness in accordance with the guidelines established by the Ministry of Food and Drug Safety and using a 100-mm visual analog scale (VAS) for weight-bearing pain. Overall, 250 subjects (7.96%) experienced 292 AEs and of these, unexpected AEs occurred in 114 subjects (3.63% [95% CI: 3.00–4.35]). Injection site pain was the most frequent AE reported by 81 subjects (2.58% [95% confidence intervals (CI): 2.05–3.20] ). One hundred subjects experienced 108 ADRs (3.18% [95% CI: 2.60, 3.86]) and 15 unexpected ADRs were experienced by 13 subjects (0.41% [95% CI: 0.22–0.71] ). Seventeen subjects experienced 22 SAEs (0.54% [95% CI: 0.32–0.87]) during the entire PMS period, and all were considered “unlikely” related to the study drug. Most AEs were mild in terms of severity and resolved during the study period. LBSA0103 was also effective in relieving symptomatic pain in knee OA patients. The condition in more than 80% of the subjects was considered to be improved when assessed by the investigators. LBSA0103 resulted in a significant reduction in the mean VAS score at 12 weeks after the first and second injections (24.79 (± 20.55) mm and 17.63 (±12.31) mm, respectively; p 〈 0.0001). In conclusion, LBSA0103, used for the treatment of knee OA in a real-world setting, was well tolerated, with an acceptable safety profile and consistent therapeutic effect.
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0287222
DOI:
10.1371/journal.pone.0287222.g001
DOI:
10.1371/journal.pone.0287222.g002
DOI:
10.1371/journal.pone.0287222.g003
DOI:
10.1371/journal.pone.0287222.g004
DOI:
10.1371/journal.pone.0287222.t001
DOI:
10.1371/journal.pone.0287222.t002
DOI:
10.1371/journal.pone.0287222.t003
DOI:
10.1371/journal.pone.0287222.t004
DOI:
10.1371/journal.pone.0287222.t005
DOI:
10.1371/journal.pone.0287222.t006
DOI:
10.1371/journal.pone.0287222.t007
DOI:
10.1371/journal.pone.0287222.s001
DOI:
10.1371/journal.pone.0287222.s002
DOI:
10.1371/journal.pone.0287222.s003
DOI:
10.1371/journal.pone.0287222.s004
DOI:
10.1371/journal.pone.0287222.s005
DOI:
10.1371/journal.pone.0287222.s006
DOI:
10.1371/journal.pone.0287222.s007
DOI:
10.1371/journal.pone.0287222.s008
DOI:
10.1371/journal.pone.0287222.s009
DOI:
10.1371/journal.pone.0287222.s010
DOI:
10.1371/journal.pone.0287222.s011
DOI:
10.1371/journal.pone.0287222.s012
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2023
detail.hit.zdb_id:
2267670-3
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