Long Term Improvements In Physical Function Are Associated With Improvements In Dactylitis, Enthesitis, Tender And Swollen Joint Counts, And Psoriasis Skin Involvement: Results From A Phase 3 Study Of Ustekinumab In Psoriatic Arthritis Patients

Objectives To evaluate the association of improvements in tender and swollen joint counts (TJC, SJC), psoriasis skin involvement, and dactylitis/enthesitis (in patients affected at baseline) with improvement in physical function using data from the ustekinumab (UST) PSUMMIT 1 trial in psoriatic arthritis (PsA) pts. Methods Adult PsA pts (n=615) with active disease (≥5 SJC and ≥5 TJC; CRP ≥0.3 mg/dL) despite DMARD and/or NSAIDs were randomized to UST45mg, 90mg, or PBO at wks 0, 4, and q12wks. Pts treated with prior anti-TNF agents were excluded. Stable concomitant MTX was permitted but not mandated. At wk16, pts with Results At baseline, mean (median) TJC and SJC values were 23.5 (20.0) and 13.5 (10.0), respectively. 441 (71.7%) and 296 (48.1%) patients had enthesitis or dactylits at baseline, respectively; 440 (71.7%) patients had u003e3% BSA psoriasis skin involvement. Improvements in TJC, SJC, dactylitis and enthesitis, and PASI scores were generally greater in HAQ responders compared with HAQ non-responders at both wk52 and wk100 (Table). Significant correlations were demonstrated between the HAQ change from baseline with percent change in outcomes parameters for all outcomes (Table) at wk52 and wk100. In addition, associations were observed at earlier time points at wk24/wk28 [TJC -0.39/-0.36; SJC -0.27/-0.20; enthesitis 0.30/0.28 (all p Conclusions Based on this post-hoc analysis of the PSUMMIT 1 population, improvements in physical function as measured by HAQ were associated with improvements in TJC, SJC, dactylitis and enthesitis, and these correlations were observed as early as week 24 and continued through week100. Improvement in skin disease was also associated with improvements in HAQ. Disclosure of Interest A. Kavanaugh Grant/research support from: AbbVie, Amgen, Janssen, and UCB., L. Puig Grant/research support from: AbbVie, Amgen, Boehringer, Celgene, Eli Lilly, Janssen, Leo-Pharma, Merck/Schering-Plough, Merck-Serono, Novartis, Pfizer, Sandoz, and VBL, A. Gottlieb Grant/research support from: Amgen, AbbVie, Celgene, Coronado, Eli Lilly, Janssen, Levia, Merck, and Pfizer., Consultant for: AbbVie, Actelion, Akros, Amgen, Astellas, Bristol Myers Squibb, Canfite, Catabasis, Celegene, CSL Behring Biotherapies for Life, Coronado, Dermipsor, Eli Lilly, GlaxoSmithKline, Incyte, Janssen, Karyopharm, Novartis, Novo Nordisk, Pfizer, Sanofi Aventix, UCB, Vertex, and Xenoport., C. Ritchlin Grant/research support from: Amgen, Janssen, and UCB, Consultant for: AbbVie, Amgen, Janssen, Regeneron, Roche, and UCB., S. Li Employee of: Janssen Ru0026D, LLC., Y. You Employee of: Janssen Ru0026D, LLC., A. Mendelsohn Employee of: Janssen Ru0026D, LLC., M. Song Employee of: Janssen Ru0026D, LLC., P. Rahman Grant/research support from: AbbVie, Amgen, Janssen, Pfizer, and Novartis., I. McInnes Grant/research support from: AbbVie, BMS, Janssen, Pfizer, Roche, Merck/Schering-Plough, and UCB