학술논문
Effectiveness and safety of polyacrylamide hydrogel injection for knee osteoarthritis: results from a 12-month follow up of an open-label study.
Document Type
Academic Journal
Author
Bliddal H; The Parker Institute, Bispebjerg Frederiksberg Hospital, University of Copenhagen, Ndr. Fasanvej 57, 2000, Copenhagen, Frederiksberg, Denmark. henning.bliddal@regionh.dk.; Beier J; Rheumatolog i Odense, Odense, Denmark.; Hartkopp A; A2 Rheumatology and Sports Medicine, Holte, Denmark.; Conaghan PG; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds & NIHR Leeds Biomedical Research Centre, Leeds, UK.; Henriksen M; The Parker Institute, Bispebjerg Frederiksberg Hospital, University of Copenhagen, Ndr. Fasanvej 57, 2000, Copenhagen, Frederiksberg, Denmark.
Source
Publisher: BioMed Central Country of Publication: England NLM ID: 101265112 Publication Model: Electronic Cited Medium: Internet ISSN: 1749-799X (Electronic) Linking ISSN: 1749799X NLM ISO Abbreviation: J Orthop Surg Res Subsets: MEDLINE
Subject
Language
English
Abstract
Objective: There are few effective osteoarthritis (OA) therapies. A novel injectable polyacrylamide hydrogel (iPAAG) previously demonstrated efficacy and safety up to week 26 in an open-label study of knee OA. Here we report longer-term effectiveness and safety data.
Methods: This multi-centre, open-label study included patients with symptomatic and radiographic knee OA. Primary outcome was WOMAC pain (0-100 scale) at 13 weeks, and patients continued to 26 weeks before entering a further 26-week extension phase. Secondary efficacy outcomes included WOMAC stiffness and function subscales, Patient Global Assessment (PGA) and proportion of OMERACT-OARSI responders. Safety outcomes were adverse events (AEs).
Results: 49 participants (31 women, mean age 70) received an ultrasound-guided, intra-articular injection of 6 ml iPAAG; 46 completed the extension phase to 52 weeks. There was a significant reduction in the WOMAC pain score from baseline to 52 weeks (- 17.7 points (95% CI - 23.1; - 12.4); p < 0.0001). Similar sustained improvements were observed for WOMAC stiffness (11.0 points; 95% CI - 17.0; - 4.9), physical function (18.0 points; 95% CI - 19.1; - 10.6), and PGA (16.3 points; 95% CI - 23.1; - 9.4). At 52 weeks 62.2% of patients were OMERACT-OARSI responders. From 26 to 52 weeks, 8 adverse effects (AE), including 1 serious AE (cerebrovascular accident) were reported in 5 subjects. None of the new adverse events were thought to be device related.
Conclusion: This open-label study suggests persistent benefits and safety of iPAAG through 52 weeks after a single injection.
Trial Registration: Clinicaltrials.gov NCT04179552.
(© 2024. The Author(s).)
Methods: This multi-centre, open-label study included patients with symptomatic and radiographic knee OA. Primary outcome was WOMAC pain (0-100 scale) at 13 weeks, and patients continued to 26 weeks before entering a further 26-week extension phase. Secondary efficacy outcomes included WOMAC stiffness and function subscales, Patient Global Assessment (PGA) and proportion of OMERACT-OARSI responders. Safety outcomes were adverse events (AEs).
Results: 49 participants (31 women, mean age 70) received an ultrasound-guided, intra-articular injection of 6 ml iPAAG; 46 completed the extension phase to 52 weeks. There was a significant reduction in the WOMAC pain score from baseline to 52 weeks (- 17.7 points (95% CI - 23.1; - 12.4); p < 0.0001). Similar sustained improvements were observed for WOMAC stiffness (11.0 points; 95% CI - 17.0; - 4.9), physical function (18.0 points; 95% CI - 19.1; - 10.6), and PGA (16.3 points; 95% CI - 23.1; - 9.4). At 52 weeks 62.2% of patients were OMERACT-OARSI responders. From 26 to 52 weeks, 8 adverse effects (AE), including 1 serious AE (cerebrovascular accident) were reported in 5 subjects. None of the new adverse events were thought to be device related.
Conclusion: This open-label study suggests persistent benefits and safety of iPAAG through 52 weeks after a single injection.
Trial Registration: Clinicaltrials.gov NCT04179552.
(© 2024. The Author(s).)