Pain Reduction With Oral Methotrexate in Knee Osteoarthritis : A Randomized, Placebo-Controlled Clinical Trial
Authors' conclusion
Oral methotrexate added to usual medications demonstrated statistically significant reduction in KOA pain, stiffness, and function at 6 months.
Study context
- Population
- Symptomatic, radiographic knee osteoarthritis (OA) with knee pain (≥4/10) most days in past 3 months and inadequate response to current medication; 15 secondary care musculoskeletal clinics, UK134 followed up at 6 months
- Participants
- 155 participants
- Comparison
- Oral MTX once weekly (6-week escalation 10 to 25 mg) vs matched placebo over 12 months, with usual analgesia
- Methotrexaten = 77
- Placebon = 78reference
- Primary endpoint
- Average knee pain (NRS 0 to 10)
- Follow-up
- 6 months
Methodological detailsmulticentre, double-blind, placebo-controlled, Conducted 13 June 2014 to 13 October 2017
- Multicentre
- Double-blind
- Placebo-controlled
- Conducted 13 June 2014 to 13 October 2017
Primary result
Mean knee pain (NRS 0-10)
Pain reduction
0.79 NRS points
95% CI 0.08–1.51
P = 0.030
By group
Methotrexate
5.1
mean · SD 2.32
Placebo
6.2
mean · SD 2.30
As reported in the abstract
Secondary outcomes
| Outcome | Treatment group difference (points) (CI) | P value | |
|---|---|---|---|
| WOMAC stiffness · 6 monthsIn favor of methotrexate | 0.60 (0.01–1.18) | P = 0.045 | |
| WOMAC function · 6 monthsIn favor of methotrexate | 5.01 (1.29–8.74) | P = 0.008 | |
| −50510Difference, points (linear scale) |
Treatment adherence analysis
- Supported a dose-response effect
Safety
Events
| Outcome | Methotrexate | Placebo |
|---|---|---|
| Serious AEs (unrelated)Four unrelated serious AEs in total | 2 | 2 |
Original publication
Pain Reduction With Oral Methotrexate in Knee Osteoarthritis : A Randomized, Placebo-Controlled Clinical Trial. Ann Intern Med. Published 30 July 2024. doi:10.
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