Article Text
PDF
Abstract
Background PSUMMIT 1 and PSUMMIT 2 were Phase 3 trials of ustekinumab (UST) in adults with PsA.
Objectives Evaluate the efficacy of UST by prior treatment exposure and disease duration in PsA patients (pts) in PSUMMIT 1 and 2.
Methods Pts had active PsA (≥5 swollen, ≥5 tender joints, CRP ≥3.0mg/dL,) for ≥6 mos despite treatment with DMARDs and/or NSAIDs (PSUMMIT 1) or DMARDs, NSAIDs, and/or anti-tumor necrosis factor (TNF) agents (PSUMMIT 2). In both studies, pts were randomized to SC injections of placebo (PBO) or UST 45mg or 90mg at wks 0, 4 and every 12 wks. PBO pts crossed over to UST 45mg at wk 24. At wk 16, early escape (PBO –> UST45mg; UST45mg –> UST90mg; UST90mg –> UST90mg) was possible. Stable doses of MTX were allowed. Pooled data from both PSUMMIT 1 and 2 were analyzed. Efficacy assessments included ACR response, DAS28-CRP response, DAS28-CRP remission (score <2.6), changes in enthesitis (modified MASES index) and dactylitis scores, and total van der Heijde-Sharp (vdH-S) score for radiographic progression. Pts who were anti-TNF-naïve, MTX- and anti-TNF-naïve, all DMARD- and anti-TNF-naïve were evaluated. ACR response at wks 4 and 16 to assess for early efficacy was also evaluated for anti-TNF-naïve pts with PsA duration <1 year, ≥1 to <3 years, and ≥3 years.
Results In the pooled data, 747 pts were anti-TNF-naïve (53.8% were male; mean age=47 years); 179 pts were MTX- and anti-TNF-naïve (63.7% were male; mean age =47 years); 146 pts were all DMARD- and anti-TNF-naïve (61.0% male; mean age=46 years). In all three prior treatment populations significantly greater proportions of pts in the combined UST group vs PBO achieved an ACR20, ACR50, or ACR70 at wk 24. (Table). Similarly, greater proportions of pts in the combined UST group had DAS28-CRP response or remission vs PBO across all three prior treatment populations. In anti-TNF-naïve pts, improvements in enthesitis and dactylitis were significantly greater in the combined UST group vs PBO, and mean change in total vdH-S score was significantly greater for pts in the PBO group than the combined UST group; comparable trends were observed for the MTX- and anti-TNF-naïve pts and all DMARD- and anti-TNF-naïve pts, but did not reach statistical significance due to the smaller sample sizes in both subgroups. Among anti-TNF-naïve pts treated with UST, ACR20/50/70 response rates were similar across different PsA disease duration groups at early time-points (either wk4 or wk16).
Conclusions UST-treated patients had greater improvements in signs and symptoms of PsA regardless of prior treatment exposure and disease duration.
Disclosure of Interest I. McInnes Consultant for: Janssen Research & Development, LLC, S. Chakravarty Employee of: Janssen Scientific Affairs, LLC, G. Morgan Employee of: Janssen Scientific Affairs, LLC, I. Apaolaza Employee of: Janssen Biologics, BV, S. Kafka Employee of: Janssen Scientific Affairs, LLC, E. Hsia Employee of: Janssen Research & Development, LLC, M. Song Employee of: Janssen Research & Development, LLC, Y. You Employee of: Janssen Research & Development, LLC, A. Kavanaugh Consultant for: Janssen Research & Development, LLC