SAT0267 Safety of Ustekinumab from the Placebo-Controlled Periods of Psoriatic Arthritis and Psoriasis Clinical Developmental Programs. (23rd January 2014)

• Record Type: Journal Article
• Authors: McInnes, I.; Papp, K.; Puig, L.; Reich, K.; Ritchlin, C.; Strober, B.; Rahman, P.; Kavanaugh, A.; Mendelsohn, A.; Song, M.; Chan, D.; Shen, Y. K.; Li, S.; Gottlieb, A. B.
• Is Part Of: Annals of the rheumatic diseases. Volume 72:Supplement 3(2013)
• Page Start: A673
• Page End: A673
• Publication Date: 2014-01-23
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2013-eular.1992
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Objectives: To describe safety of UST during double-blind, PBO-controlled portion of the PsA & PsO programs. Methods: Safety for PsA were pooled from a Ph2(n=146)& 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) & 2 Ph3(PHOENIX1[n=766] & 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, & 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&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). Results: 1071 treated pts (379 PBO, 692 UST) were included in PsA population & 2314 treated pts (732 PBO, 1582 UST) were included in PsO population (including 207 PBO, 421 UST in PsA sub-grp). BL demographics & medical history were generally comparable between PsA & PsO populations with similar proportions reporting relevant comorbidities, including diabetes, hyperlipidemia, hypertension & family history of CHD. In PsA, median duration of PsA at BL was ≥4yrs &>75% had PsO with ≥3% BSA skin involvement. In PsO, median BSA involvement was 21%;median PASI score was 17&27% had PsA. Safety observed during the PBO-controlled period are detailed(Table ). Within each population, rates of overall AEs, infections, & 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 & 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 & UST grps within the PsA & PsO populations. Image/graph: Conclusions: During the PBO-controlled portion, UST was well-tolerated. Overall safety were consistent between populations & safety event rates were generally comparable between pts receiving PBO & UST within each population. Disclosure of Interest: I. McInnes Grant/research support from: Janssen R&D, LLC, K. Papp Grant/research support from: Janssen R&D, LLC, L. Puig Grant/research support from: Janssen R&D, LLC, K. Reich Grant/research support from: Janssen R&D, LLC, C. Ritchlin Grant/research support from: Janssen R&D, LLC, B. Strober Grant/research support from: Janssen R&D, LLC, P. Rahman Grant/research support from: Janssen R&D, LLC, A. Kavanaugh Grant/research support from: Janssen R&D, LLC, A. Mendelsohn Employee of: Janssen R&D, LLC, M. Song Employee of: Janssen R&D, LLC, D. Chan Employee of: Janssen R&D, LLC, Y. K. Shen Employee of: Janssen R&D, LLC, S. Li Employee of: Janssen R&D, LLC, A. B. Gottlieb Grant/research support from: Janssen R&D, LLC