PROGRAMM JAHRESTAGUNG 2012 30. Nov. – 2. Dez ... - ÖGDV

Poster Psoriasis
P 32
Long-term safety of ustekinumab in patients with moderate to severe psoriasis
through up to 5 years of continuous follow-up
K. Papp 1
C.E.M. Griffiths 2
K. Gordon 3
M. Lebwohl 4
P.O. Szapary 5
Y. Wasfi 5
D. Chan 5
M.C. Hsu 5
V. Ho 6
P.D. Ghislain 7
B. Strober 8
K. Reich 9
1 Probity Medical Research, Waterloo, ON, Canada
2 Dermatology Centre, University of Manchester, Manchester Academic Health Science
Centre, Manchester, UK
3 Northwestern University, Feinberg School of Medicine, Chicago, IL, USA
4 Mount Sinai School of Medicine, New York, NY, USA
5 Janssen Research & Development, LLC., Spring House, PA, USA
6 University of British of Columbia, Vancouver, BC, Canada
7 Cliniques Universitaires Saint-Luc. Université Catholique de Louvain, Bruxelles
8 University of Connecticut School of Medicine, Department of Dermatology, Farmington,
CT, USA
9 Dermatologikum Hamburg, Hamburg, Germany
Objective: We report cumulative safety experience from the ustekinumab (UST)
psoriasis clinical development program with up to 5yrs of follow-up.
Methods: Pooled safety data across a Phase 2 (n=320) and Phase 3 [PHOENIX 1 (n=766),
PHOENIX 2 (n=1230), ACCEPT (n=903)] clinical trials were analyzed. Patients received
UST 45mg or 90mg sc 12wkly. The rates of overall AEs, serious AEs, infections and AEs
leading to discontinuation were analyzed by yr of follow-up (yr1 to yr5). Rates of AEs of
interest (serious infections, malignancies, investigator-reported major adverse CV
events [MACE]) were analyzed by UST dose grp (45mg or 90mg) and by yr of follow-up.
Results are expressed as rates per 100 patient-years of follow-up (PY) and 95% CI.
Results: The analysis included 3117 patients (8998 PY); with 1482 (47.5%) patients
treated continuously for >4yrs (including 838 [26.9%] for >5yrs). Rates of overall AEs
and infections consistently decreased over time from yrs1 to 5 while the rates of serious
AEs and AEs leading to discontinuation were stable over time. Cumulative rates of
serious infections per 100PY for UST45mg and UST90mg grps were 0.98 (0.69, 1.35) and
81