MUST
Trial question
Is ustekinumab monotherapy noninferior to ustekinumab plus methotrexate in patients with active psoriatic arthritis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 166
166 patients (69 female, 97 male).
Inclusion criteria: adult patients with active psoriatic arthritis.
Key exclusion criteria: previous use of ustekinumab or any other anti-IL-23 agent; inadequate response to prior methotrexate treatment for psoriatic arthritis; previous B-cell depleting therapy; active tuberculosis.
Interventions
N=79 ustekinumab monotherapy (open-label ustekinumab over a treatment period of 52 weeks plus methotrexate placebo 3 capsules once weekly).
N=87 ustekinumab combination therapy (open-label ustekinumab over a treatment period of 52 weeks plus methotrexate 15 mg once weekly, 3 capsules).
Primary outcome
Mean disease activity score-28 at week 24
2.9 points
3.1 points
3.1 points
2.3 points
1.6 points
0.8 points
0.0 points
Ustekinumab
monotherapy
Ustekinumab combination
therapy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in mean disease activity score-28 at week 24 (2.9 points vs. 3.1 points; AD -0.2 points, 95% CI -0.61 to 0.21).
Secondary outcomes
Borderline significant decrease in mean disease activity score-28 at week 52 (2.8 points vs. 3.1 points; AD -0.3 points, 95% CI -0.6 to 0).
No significant difference in disease activity score-28 remission at week 28 (46% vs. 44%; AD 2%, 95% CI -16.15 to 20.15).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients with active psoriatic arthritis, ustekinumab monotherapy was noninferior to ustekinumab combination therapy with respect to mean disease activity score-28 at week 24.
Reference
Michaela Koehm, Tanja Rossmanith, Ann C Foldenauer et al. 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. 2023 Jan;5(1):e14-e23.
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