Development of rheumatoid arthritis after methotrexate in anticitrullinated protein antibody-negative people with clinically suspect arthralgia at risk of rheumatoid arthritis: 4-year data from the TREAT EARLIER trial
Authors' conclusion
Thus, after risk stratification, a 1-year course of methotrexate was associated with a reduced rate of development of ACPA-negative rheumatoid arthritis in participants with predicted increased risk of developing the disease.
Study context
- Population
- Adults aged ≥18 years with clinically suspect arthralgia and subclinical joint inflammation at risk of RA, southwest Netherlands; Anti-citrullinated protein antibody (ACPA)-negative participants stratified into low, increased and high predicted risk217 completed 4-year follow-up
- Participants
- 236 adults
- Comparison
- Single intramuscular GC injection (120 mg methylprednisolone) then 1-year course of MTX vs placebo injection and 1-year course of placebo tablets
- Treatmentn = 119
- Placebon = 117reference
- Primary endpoint
- Development of RA (clinically apparent inflammatory arthritis and clinical diagnosis of RA)
- Follow-up
- 4 years
Methodological detailsdouble-blind, placebo-controlled, proof-of-concept, 4-year follow-up, risk-stratified via prediction model
- Double-blind
- Placebo-controlled
- Proof-of-concept
- 4-year follow-up
- Risk-stratified via prediction model
Primary result
As reported in the abstract
Development of RA in ACPA-negative participants, by predicted risk subgroup
Treatment vs PlaceboHazard ratio (95% CI)P value
ACPA-negative, increased risk (n=66)
0.27(0.07–0.99)
P = 0.034ACPA-negative, low risk (n=116)
0.79(0.22–2.80)
P = 0.71Further findings
Development of RA, all participants · 4 years
Subclinical joint inflammation, physical functioning and grip strength in ACPA-negative participants · 2 years
- Persistently improved upon treatment in increased-risk participants, but not in low-risk participants
Original publication
Development of rheumatoid arthritis after methotrexate in anticitrullinated protein antibody-negative people with clinically suspect arthralgia at risk of rheumatoid arthritis: 4-year data from the TREAT EARLIER trial. Lancet Rheumatol. Published 17 September 2024. doi:10.
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