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SAT0267 Safety of Ustekinumab from the Placebo-Controlled Periods of Psoriatic Arthritis and Psoriasis Clinical Developmental Programs
  1. I. McInnes1,
  2. K. Papp2,
  3. L. Puig3,
  4. K. Reich4,
  5. C. Ritchlin5,
  6. B. Strober6,
  7. P. Rahman7,
  8. A. Kavanaugh8,
  9. A. Mendelsohn9,
  10. M. Song9,
  11. D. Chan9,
  12. Y. K. Shen9,
  13. S. Li9,
  14. A. B. Gottlieb10
  1. 1U Glasgow, Glasgow, United Kingdom
  2. 2Probity Med Res, Waterloo, Canada
  3. 3U Automoma de Barcelona, Barcelona, Spain
  4. 4Dermatologikum Hamburg, Hamburg, Germany
  5. 5U Rochester, New York
  6. 6U Conn Sch of Med, Farmington, United States
  7. 7St.Clare’s Mercy Hosp, St John’s, Canada
  8. 8UCSD, La Jolla
  9. 9Janssen R&D, LLC, Spring House
  10. 10Tufts Med Ctr, Boston, United States

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.

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

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