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Vienna – A single intra-articular injection of JTA-004 can safely and effectively relieve symptoms of knee osteoarthritis. As the results of the KOA-2 study show, this applies to patients who are most severely affected by osteoarthritis and to those with high systemic inflammation parameters.

Yves Henrotin, University of Liège, presented the results at the European Congress of Rheumatology (EULAR 2024) in Vienna (Abstract OP0305; DOI: 10.1136/annrheumdis-2024-eular.1910). They need to be confirmed in further studies, focusing on patients with inflammatory and painful knee osteoarthritis.

More than 500 million people worldwide suffer from osteoarthritis. Despite this high prevalence, there are currently no disease-modifying drugs. According to the results of the KOA-2 study, the intra-articular injection of JTA-004 appears to provide relief for those suffering from severe knee osteoarthritis. The drug consists of hyaluronic acid, plasma proteins and clonidine.

Comparison with saline solution and hyaluronic acid

In the prospective, randomized, double-blind Phase 3 study, participants received a single injection of JTA-004 or hyaluronic acid (consisting of hylan A and hylan B polymers) or saline solution.

Patients aged 40 years and older (median 62.4 years) with primary knee osteoarthritis who had not responded adequately to analgesics and/or non-steroidal anti-inflammatory drugs were included. The primary endpoint was the mean change in the WOMAC VA3.1 pain score during treatment with JTA-004 compared to saline solution.

674 subjects were included in the analysis of the KOA-2 study, including 335 in the JTA-004 arm, 170 in the hyaluronic acid arm, and 169 in the saline arm. The mean VAS pain score in the target knee was 65.5, with a mean WOMAC pain subscore of 57.75.

According to the study authors, participants tolerated JTA-004 therapy well. There were no differences between JTA-004 and saline with regard to the primary endpoint.

In the post-hoc analysis, however, things looked different: JTA-004 proved to be more effective than the saline solution in terms of pain reduction in the group of patients with the most severe pain (highest quartile); however, the researchers observed no differences when comparing it with the hyaluronic acid injection.

Other subgroups benefit

Furthermore, the magnitude of the effect of JTA-004 on functional status was superior to that of hyaluronic acid in patients with the most severe knee osteoarthritis and with the highest baseline C-reactive protein levels.

The VAS pain score also decreased more significantly with JTA-004 in the group with the most severe knee osteoarthritis at baseline compared to the group with the least severe osteoarthritis. No significant differences were observed in this regard with either the saline solution or hyaluronic acid.

During JTA-004, WOMAC function scores decreased to a greater extent in individuals with the highest baseline C-reactive protein levels compared to those with the lowest levels. A similar trend was observed for WOMAC stiffness during JTA-004. © son/aerzteblatt.de