PROMOTE
Trial question
What is the role of oral methotrexate for pain reduction in patients with knee OA?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
64.0% female
36.0% male
N = 155
155 patients (99 female, 56 male).
Inclusion criteria: patients with knee OA.
Key exclusion criteria: inflammatory arthritis; use of intra-articular hyaluronic in the past 4 months; use of corticosteroids in the past 3 months; significant knee injury or knee surgery in the past 6 months.
Interventions
N=77 methotrexate (once-weekly oral dose, with a 6-week escalation from 10 to 25 mg, over 12 months and continued usual analgesia).
N=78 placebo (matching placebo over 12 months and continued usual analgesia).
Primary outcome
Mean pain reduction at 6 months
1.3 points
0.6 points
1.3 points
1.0 points
0.7 points
0.3 points
0.0 points
Methotrexate
Placebo
Significant
increase ▲
Significant increase in mean pain reduction at 6 months (1.3 points vs. 0.6 points; MD 0.79, 95% CI 0.08 to 1.51).
Conclusion
In patients with knee OA, methotrexate was superior to placebo with respect to mean pain reduction at 6 months.
Reference
Sarah R Kingsbury, Puvan Tharmanathan, Ada Keding et al. Pain Reduction With Oral Methotrexate in Knee Osteoarthritis : A Randomized, Placebo-Controlled Clinical Trial. Ann Intern Med. 2024 Jul 30.
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