Spondyloarthritis & psoriatic arthritis
Effect of a treatment strategy utilising golimumab, methotrexate and corticosteroids versus methotrexate and corticosteroids in early, untreated psoriatic arthritis (GOLMePsA): a single-centre, double-blind, parallel-group, randomised controlled trial
Primary result · PASDASResult — go to the resultAdjusted difference −0.55 95% CI −1.12 to 0.03Authors' conclusion
Both interventions led to improved disease activity in patients with early, untreated psoriatic arthritis, without a clinically or statistically significant difference in PASDAS between treatment groups at week 24.
Study context
- Population
- Adults with treatment-naïve active PsA diagnosed up to 24 months before enrolment, naïve to DMARDs or systemic treatmentsrandomly assigned
- Participants
- 84 adults
- Comparison
- Golimumab plus MTX plus corticosteroids vs placebo plus MTX plus corticosteroids
- GOLIMUMAB + MTXn = 43
- PLACEBO + MTXn = 41reference
- Primary endpoint
- Difference in mean PASDAS, ITT population, ANCOVA via multiple linear regression
- Follow-up
- Week 24
Methodological detailsdouble-blind, placebo-controlled, parallel-group, single-centre, stratified by number of involved peripheral joints at baseline, People with lived experience of PsA were involved in the design and conduct of the study
- Double-blind
- Placebo-controlled
- Parallel-group
- Single-centre
- Stratified by number of involved peripheral joints at baseline
- People with lived experience of PsA were involved in the design and conduct of the study
Primary result
PASDAS
Adjusted difference
−0.55
95% CI −1.12 to 0.03
P = 0.064
By group
Golimumab and MTX
2.70
unadjusted mean · SD 1.38
Placebo and MTX
3.09
unadjusted mean · SD 1.32
Golimumab and MTXvs Placebo and MTX
adjusted difference −0.55 (95% CI −1.12 to 0.03); P = 0.064
As reported in the abstract
Further findings
| Outcome | GOLIMUMAB + MTX | PLACEBO + MTX | OR (95% CI) | P value | |
|---|---|---|---|---|---|
| Additional corticosteroids before week 24 | 21% | 49% | 0.28 (0.11–0.72) | P = 0.009 | |
| 0.10.31310Odds ratio (log scale) |
Deaths, serious or unexpected adverse events
- None occurred
- 0
Safety
| Outcome | GOLIMUMAB + MTX | PLACEBO + MTX | Risk difference (95% CI) | |
|---|---|---|---|---|
| Adverse events | 95% | 93% | 0.03 (−0.09 to 0.15) | |
| −0.100.10.2Difference (linear scale) |
Adverse events
- Altered laboratory investigations and infections more frequent with golimumab and MTX
Original publication
Effect of a treatment strategy utilising golimumab, methotrexate and corticosteroids versus methotrexate and corticosteroids in early, untreated psoriatic arthritis (GOLMePsA): a single-centre, double-blind, parallel-group, randomised controlled trial. Lancet Rheumatol. Published 3 September 2025. doi:10.
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