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

Poster Psoriasis
1.19 (0.91, 1.52), respectively; rates for the dose grps combined from yrs1 to 5 were 1.33,
1.03, 0.66, 1.11, and 1.17, respectively. Cumulative rates of non-melanoma skin cancer
(NMSC) per 100PY for UST45mg and UST90mg grps were 0.64 (0.41, 0.95) and 0.44 (0.28,
0.66), respectively; rates for the dose grps combined from yr1 to 5 were 0.94, 0.49, 0.40,
0.42, and 0.16, respectively. Cumulative rates of other malignancies per 100PY for
UST45mg and UST90mg grps were 0.59 (0.37, 0.89) and 0.61 (0.42, 0.87), respectively;
rates for the dose grps combined from yr 1 to 5 were 0.39, 0.97, 0.40, 0.77, and 0.59,
respectively. Investigator-reported MACE rates per 100PY for UST 45mg and UST 90mg
grps were 0.45 (0.26, 0.72) and 0.31 (0.17, 0.50), respectively; rates for the dose grps
combined from yr 1 to 5 were 0.47, 0.24, 0.33, 0.35 and 0.37, respectively. No TB or
serious hypersensitivity reactions were reported. Rates of serious infections,
malignancies, and MACE were stable over time and were consistent with rates
previously described and with observations in the general and/or psoriasis population.
Conclusions: With continuous exposure for up to 5 yrs and approximately 9000 PY
exposure, the long-term safety profile of UST remained stable over time and consistent
with that previously reported after 4yrs of follow-up.
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