The study titled “Efficacy, Safety, Pharmacokinetics and Immunogenicity of Repeated Dosing of GSK3858279 in Patients with Knee Osteoarthritis” aimed to evaluate a new treatment for knee osteoarthritis (OA) pain. This treatment, GSK3858279, is a human monoclonal antibody that targets a specific protein involved in inflammatory pain.
Background and Purpose:
Chronic pain in osteoarthritis is challenging to manage with current treatments due to limited effectiveness and side effects. GSK3858279 aims to address this by blocking the protein CCL17, which is involved in causing pain and joint damage. The study’s goal was to assess the effectiveness, safety, pharmacokinetics (how the drug moves through the body), and immunogenicity (potential to trigger an immune response) of GSK3858279.
Methods:
Participants with knee OA were randomly assigned to receive either weekly injections of GSK3858279 or a placebo for 8 weeks. They were evaluated on changes in pain intensity from the start of the study to Week 8. Pain was measured using a numerical rating scale. Additional assessments included the WOMAC index, which measures pain and physical function. Blood samples were taken to analyze drug levels and immune response up to Week 20.
Results:
• All 48 participants completed the study, with 2 discontinuations in the placebo group.
• GSK3858279 was quickly absorbed, reaching steady levels by Week 8.
• Some participants developed antibodies against the drug, but this did not affect its performance.
• GSK3858279 significantly reduced both average and worst knee pain compared to placebo at all time points, with greater improvements noted in pain and function scores.
• Adverse events were more common in the treatment group (88%) compared to the placebo group (63%), but no serious adverse events or deaths occurred.
Conclusion:
The study found that weekly doses of GSK3858279 over 8 weeks effectively reduced knee pain in osteoarthritis patients and had a favorable safety profile. These promising results suggest further research is needed to confirm the drug’s effectiveness and safety for OA pain.