PROGRAMM JAHRESTAGUNG 2012 30. Nov. – 2. Dez ... - ÖGDV
PROGRAMM JAHRESTAGUNG 2012 30. Nov. – 2. Dez ... - ÖGDV
PROGRAMM JAHRESTAGUNG 2012 30. Nov. – 2. Dez ... - ÖGDV
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Poster Psoriasis<br />
P 32<br />
Long-term safety of ustekinumab in patients with moderate to severe psoriasis<br />
through up to 5 years of continuous follow-up<br />
K. Papp 1<br />
C.E.M. Griffiths 2<br />
K. Gordon 3<br />
M. Lebwohl 4<br />
P.O. Szapary 5<br />
Y. Wasfi 5<br />
D. Chan 5<br />
M.C. Hsu 5<br />
V. Ho 6<br />
P.D. Ghislain 7<br />
B. Strober 8<br />
K. Reich 9<br />
1 Probity Medical Research, Waterloo, ON, Canada<br />
2 Dermatology Centre, University of Manchester, Manchester Academic Health Science<br />
Centre, Manchester, UK<br />
3 Northwestern University, Feinberg School of Medicine, Chicago, IL, USA<br />
4 Mount Sinai School of Medicine, New York, NY, USA<br />
5 Janssen Research & Development, LLC., Spring House, PA, USA<br />
6 University of British of Columbia, Vancouver, BC, Canada<br />
7 Cliniques Universitaires Saint-Luc. Université Catholique de Louvain, Bruxelles<br />
8 University of Connecticut School of Medicine, Department of Dermatology, Farmington,<br />
CT, USA<br />
9 Dermatologikum Hamburg, Hamburg, Germany<br />
Objective: We report cumulative safety experience from the ustekinumab (UST)<br />
psoriasis clinical development program with up to 5yrs of follow-up.<br />
Methods: Pooled safety data across a Phase 2 (n=320) and Phase 3 [PHOENIX 1 (n=766),<br />
PHOENIX 2 (n=1230), ACCEPT (n=903)] clinical trials were analyzed. Patients received<br />
UST 45mg or 90mg sc 12wkly. The rates of overall AEs, serious AEs, infections and AEs<br />
leading to discontinuation were analyzed by yr of follow-up (yr1 to yr5). Rates of AEs of<br />
interest (serious infections, malignancies, investigator-reported major adverse CV<br />
events [MACE]) were analyzed by UST dose grp (45mg or 90mg) and by yr of follow-up.<br />
Results are expressed as rates per 100 patient-years of follow-up (PY) and 95% CI.<br />
Results: The analysis included 3117 patients (8998 PY); with 1482 (47.5%) patients<br />
treated continuously for >4yrs (including 838 [26.9%] for >5yrs). Rates of overall AEs<br />
and infections consistently decreased over time from yrs1 to 5 while the rates of serious<br />
AEs and AEs leading to discontinuation were stable over time. Cumulative rates of<br />
serious infections per 100PY for UST45mg and UST90mg grps were 0.98 (0.69, 1.35) and<br />
81