Spondyloarthritis & psoriatic arthritis
Methotrexate plus ustekinumab versus ustekinumab monotherapy in patients with active psoriatic arthritis (MUST): a randomised, multicentre, placebo-controlled, phase 3b, non-inferiority trial
Authors' conclusion
Interleukin (IL)-12 and IL-23 inhibition with ustekinumab is an effective treatment for psoriatic arthritis independent of methotrexate use; concomitant methotrexate did not increase efficacy of ustekinumab (based on DAS28).
Study context
- Population
- Patients with active PsA, 22 centres in Germany166 analysed at week 24
- Participants
- 173 patients
- Comparison
- Ustekinumab plus placebo vs ustekinumab plus MTX
- Ustekinumab plus placebon = 85
- Ustekinumab plus methotrexaten = 88reference
- Primary endpoint
- Non-inferiority of mean DAS28 for ustekinumab monotherapy vs combination therapy, stratified by previous MTX treatment
- Follow-up
- Week 24
Methodological detailsinvestigator-initiated, multicentre, placebo-controlled, phase 3b, non-inferiority
- Investigator-initiated
- Multicentre
- Placebo-controlled
- Phase 3b
- Non-inferiority
Primary result
DAS28
Stratified Mann-Whitney estimator
0.5426
95% CI 0.4545–0.6307
By group
Ustekinumab plus placebo
2.9
SD 1.31
Ustekinumab plus methotrexate
3.1
SD 1.42
As reported in the abstract
Further findings
DAS28 (key secondary) · week 52
- Non-inferiority for ustekinumab plus placebo also observed
Deaths
- No deaths
Safety
Serious adverse events
Serious adverse events
- No specific serious adverse event affected more than one patient
Original publication
Methotrexate plus ustekinumab versus ustekinumab monotherapy in patients with active psoriatic arthritis (MUST): a randomised, multicentre, placebo-controlled, phase 3b, non-inferiority trial. Lancet Rheumatol. Published January 2023. doi:10.
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