SAT0267 Safety of Ustekinumab from the Placebo-Controlled Periods of Psoriatic Arthritis and Psoriasis Clinical Developmental Programs
Authors: I. McInnes, K. Papp, L. Puig, K. Reich, C. Ritchlin, B. Strober, P. Rahman, A. Kavanaugh, A. Mendelsohn, M. Song, D. Chan, Y. K. Shen, S. Li, A. B. Gottlieb
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Objectives</h3> To describe safety of UST during double-blind, PBO-controlled portion of the PsA &amp; PsO programs. <h3>Methods</h3> Safety for PsA were pooled from a Ph2(n=146)&amp; 2 Ph3(PSUMMIT I[n=615], PSUMMIT II[n=312]) studies in pts with active PsA. Safety for PsO were pooled from 1 Ph2(n=320) &amp; 2 Ph3(PHOENIX1[n=766] &amp; PHOENIX2[n=1230]) studies of UST in mod-to-sev PsO, including sub-grp of pts with PsA (hx/current) at baseline(BL) [n=628]. Pts were rand to PBO, UST45mg or 90mg. PBO-controlled period was 16wks for PsA studies, 20wks for Ph2 PsO study, &amp; 12wks for Ph3 PsO studies. Concomitant therapy(stable doses of MTX/oral corticosteroids/NSAIDs) were permitted in PsA studies;no concurrent therapies for PsO/PsA were permitted in PsO studies. Overall safety rates were compared between PBO&amp;UST grps within each population. UST dose grps were analyzed as combined grp. Pts who received ≥1dose were included. Results reported as # of events/100 pt-yrs of follow-up(PY). <h3>Results</h3> 1071 treated pts (379 PBO, 692 UST) were included in PsA population &amp; 2314 treated pts (732 PBO, 1582 UST) were included in PsO population (including 207 PBO, 421 UST in PsA sub-grp). BL demographics &amp; medical history were generally comparable between PsA &amp; PsO populations with similar proportions reporting relevant comorbidities, including diabetes, hyperlipidemia, hypertension &amp; family history of CHD. In PsA, median duration of PsA at BL was ≥4yrs &amp;&gt;75% had PsO with ≥3% BSA skin involvement. In PsO, median BSA involvement was 21%;median PASI score was 17&amp;27% had PsA. Safety observed during the PBO-controlled period are detailed(Table). Within each population, rates of overall AEs, infections, &amp; SAEs in pts receiving PBO or UST were generally comparable. Slightly higher rates of AEs leading to d/c were observed across all PBO grps &amp; slightly higher rate of SAEs was observed in the PBO grp in the PsA population. Rates of AEs of interest were generally comparable, with overlapping confidence intervals, between PBO &amp; UST grps within the PsA &amp; PsO populations. <h3>Image/graph</h3> <h3>Conclusions</h3> During the PBO-controlled portion, UST was well-tolerated. Overall safety were consistent between populations &amp; safety event rates were generally comparable between pts receiving PBO &amp; UST within each population. <h3>Disclosure of Interest</h3> I. McInnes Grant/research support from: Janssen R&amp;D, LLC, K. Papp Grant/research support from: Janssen R&amp;D, LLC, L. Puig Grant/research support from: Janssen R&amp;D, LLC, K. Reich Grant/research support from: Janssen R&amp;D, LLC, C. Ritchlin Grant/research support from: Janssen R&amp;D, LLC, B. Strober Grant/research support from: Janssen R&amp;D, LLC, P. Rahman Grant/research support from: Janssen R&amp;D, LLC, A. Kavanaugh Grant/research support from: Janssen R&amp;D, LLC, A. Mendelsohn Employee of: Janssen R&amp;D, LLC, M. Song Employee of: Janssen R&amp;D, LLC, D. Chan Employee of: Janssen R&amp;D, LLC, Y. K. Shen Employee of: Janssen R&amp;D, LLC, S. Li Employee of: Janssen R&amp;D, LLC, A. B. Gottlieb Grant/research support from: Janssen R&amp;D, LLC