Ustekinumab improves physical function, quality of life and work productivity of patients with active psoriatic arthritis who were naïve to MTX, despite MTX therapy or previously treated with anti-TNF: Results from psummit I and psummit II

Objectives To examine the impact of ustekinumab (UST) treatment on patient reported outcomes in patients with active psoriatic arthritis (PsA) using week 24 data from two Phase 3 clinical studies, PSUMMIT I and II. Methods Adult patients with active PsA despite DMARD and/or NSAID therapy (PSUMMIT I, n=617) or previously treated with anti-TNFα therapy (PSUMMIT II, n=312) were randomized to receive UST 45mg, 90mg, or placebo (PBO) at wks 0, 4, and q12wks, thereafter. Patient reported outcomes were measured using the Health Assessment Questionnaire (HAQ), Dermatology Quality Life Index (DLQI), SF-36health survey questionnaire (SF-36), Visual Analogue Scales (VAS) for impact of PsA on work productivity (0-10), patient assessment of pain (0-10), and disease activity (0-10). Sub-analyses were conducted by combining both studies into 3 mutually exclusive groups based on treatment history: MTX naïve, previously treated with MTX therapy, and previously treated with anti-TNF therapy. Results At baseline, patients in both studies had moderate to severe physical disability and impaired health related quality of life with a mean HAQ score of ≥1.25, mean DLQI score of ≥10 and mean SF-36 PCS and MCS below 50 (normal population score). In PSUMMIT I, UST-treated patients achieved statistically significantly greater improvements in HAQ (- 0.31 and -0.4 vs. -0.1), DLQI (-6.6 and -7.5 vs. -1.4), and SF-36 PCS (4.9 and 6.2 vs. 1.4), for the UST 45mg, 90mg, vs. PBO groups, respectively. When compared to PBO, greater proportions of UST-treated patients achieved clinical meaningful improvements in HAQ (≥0.3) (47.8% and 47.5% vs. 28.2%), DLQI (≥5) (58.6% and 63.1% vs. 32.9%), and SF-36 PCS (≥5) (45.5%, and 53.3% vs. 26.0%), for the UST 45mg, 90mg, vs. PBO groups, respectively. Similar results were observed in PSUMMIT II and in the sub-analyses by MTX naïve, prior MTX experienced, and prior anti-TNFα experienced patients. Similar results were also observed in SF-36 sub-scales, especially in bodily pain and physical health. In the anti-TNF naïve population, statistically significantly greater improvement in SF-36 MCS was observed in the combined UST 45mg and 90mg group vs PBO Additionally, UST-treated patients achieved statistically significantly greater improvements in patient assessment of pain, patient assessment of disease activity, and greater reduction in impact of disease on work productivity vs PBO-treated patients. Conclusions UST improves physical function, improves general, arthritis and skin-related quality of life, and reduces the impact of disease on work productivity in patients with active PsA regardless of current or prior MTX use or prior anti-TNF experience.