Oral methotrexate added to usual analgesia reduces pain, stiffness in knee osteoarthritis
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Key takeaways:
- Methotrexate plus usual analgesia significantly outperformed placebo in knee OA pain reduction at 6 months.
- The difference between treatments decreased over time and was similar at 12 months.
Oral methotrexate in combination with usual analgesics significantly reduced knee osteoarthritis pain and stiffness, and improved function, vs. placebo, according to data published in Annals of Internal Medicine.
“Current pharmacologic treatments for OA are limited by lack of efficacy,” Sarah R. Kingsbury, PhD, of the Leeds Institute of Rheumatic and Musculoskeletal Medicine at the University of Leeds, in the United Kingdom, and colleagues wrote.
“The disease-modifying anti-rheumatic drug methotrexate is the standard-of-care treatment of inflammatory arthritis,” she added. “Small clinical and experimental studies suggest that methotrexate could be a potential treatment for persons with [knee OA (KOA)] symptoms.”
To examine the effects of methotrexate on knee OA, Kingsbury and colleagues conducted a multicenter, randomized, double-blind, placebo-controlled trial. Across 15 U.K. secondary care musculoskeletal clinics, 207 adults with knee OA (mean age, 60.9 years) were randomly assigned to receive either oral methotrexate once weekly, with a 6-week escalation from 10 mg to 25 mg, or a matched placebo, while continuing their usual analgesia.
Eligible participants were those who demonstrated radiographic changes, reported knee pain on most days within the last 3 months, and had an inadequate response to their current medication. The primary endpoint was average past-week knee pain at 6 months, assessed with a zero-to-10 scale. The researchers assessed longer-term response at a 12-month follow-up visit.
According to the researchers, the methotrexate group demonstrated a statistically significant reduction in mean knee pain score at 6 months, from 6.4 (standard deviation [SD], 1.8) at baseline to 5.1 (SD, 2.32). Compared with placebo, methotrexate also yielded significantly better improvement in the Western Ontario and McMaster Universities Osteoarthritis Index stiffness (mean difference, 0.6 points; 95% CI, 0.01-1.18) and function (mean difference, 5.01; 95% CI, 1.29-8.74) scores at 6 months.
In terms of numerical pain score, methotrexate outperformed placebo at 6 months (mean difference, 0.79; 95% CI, 0.08-1.51). However, this difference decreased over time, and by 12 months the regimens appeared to perform similarly.
According to the researchers, the decreased benefit of methotrexate over time may be attributable to diminishing doses, higher loss to follow-up in the methotrexate group, or the confounding effect of background analgesic use.
“Oral methotrexate added to usual care showed statistically significant reduction in KOA pain, WOMAC stiffness and function, and a composite patient responder index,” Kingsbury and colleagues wrote. “Further work is required to understand adequate methotrexate dosing, whether benefits are greater in those with elevated systemic inflammation levels, and to consider cost effectiveness before introducing this therapy for a potentially large population.”
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