Oral Methotrexate Reduces Knee Osteoarthritis Pain and Stiffness Significantly in 6-Month Study

UK: A randomized, double-blind trial demonstrates that oral methotrexate, when combined with standard treatments, showed a statistically significant reduction in knee osteoarthritis (KOA) pain, stiffness, and functional impairment at the 6-month mark. The findings were published online in the Annals of Internal Medicine on 30 July 2024.

Osteoarthritis is classified as a degenerative disease that causes subchondral sclerosis, subchondral cysts, bone remodeling (osteophyte production), and loss of articular cartilage. The illness is typified by joint discomfort, functional disability, and a marked decline in life quality. Conservative (non-operative) and surgical (operative) approaches are typically used in KOA management. Pain, stiffness, restricted joint mobility, and muscle weakness are common KOA symptoms that severely hinder day-to-day activities and job performance. Considering this, Sarah R. Kingsbury, from Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and National Institute for Health and Care Research (NIHR) Leeds Biomedical Research Centre, Leeds, United Kingdom, et.al conducted a study to assess the symptomatic benefits of methotrexate in Knee Osteoarthritis.

For this purpose, the research team conducted a randomized, multicenter, double-blind, placebo-controlled trial involving 207 participants from the United Kingdom. The trial was conducted from 13 June 2014 to 13 October 2017 in the 15 secondary care musculoskeletal clinics in the United Kingdom.

The study included 207 individuals who had radiographic KOA and knee pain (severity ≥4 out of 10) on most days during the previous three months and were not responding well to their existing treatment were contacted. Over 12 months, they were randomized 1:1 to receive oral methotrexate once weekly (6-week escalation: 10 to 25 mg) or a matched placebo, while continuing with their regular analgesic regimen. Average knee pain (numerical rating scale [NRS] 0 to 10) at six months was the main outcome, and a 12-month follow-up was conducted to evaluate the longer-term response. Adverse events (AEs) and outcomes related to knee stiffness and function were included as secondary end goals.