6/28/23, 11:19 PM MUST Pathway Feedback Search Clinical Topics Home Studies MUST MUST Disease Psoriatic arthritis 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 N = 166 58.0% male 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) https://web.pathway.md/studies/rechktv2VQOP9AEHA 1/2 6/28/23, 11:19 PM MUST Pathway Primary outcome Mean disease activity score-28 at week 24 3.1 3.1 2.9 2.3 1.6 Difference not exceeding nonferiority margin 0.8 0.0 Ustekinumab monotherapy Ustekinumab combination therapy Difference not exceeding nonferiority margin in mean disease activity score-28 at week 24 (2.9 vs. 3.1; AD -0.2, 95% CI -0.61 to 0.21) Secondary outcomes No significant difference in mean disease activity score-28 at week 52 (2.8 vs. 3.1; AD -0.3, 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;3(1):E14-E23. Open reference URL https://web.pathway.md/studies/rechktv2VQOP9AEHA 2/2