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

Poster Psoriasis
2). UST was administered according to label: 45mg in patients less than or equal to
100kg or 90mg if >100kg. UST 45mg recipients not achieving a PASI decrease from
baseline greater than or equal to 75% (PASI 75) at Week 28 or 40 were dose escalated
to 90mg. Primary endpoint was treatment-emergent adverse events (AEs) by Week 12
in each arm. Secondary endpoints included safety and efficacy to Week 52 and in
dose-escalated patients.
Results: 244 patients entered Arm 1 and 245 Arm 2, with 8% (Arm 1) and 10% (Arm 2)
discontinuing before Week 52. 61% and 65% of patients in Arms 1 and 2, respectively,
experienced AEs at Week 12; 80% and 85% at Week 52. Most frequent AEs at Week 52
were headache, nasopharyngitis and arthralgia (similar rates in each arm). By Week 52,
8% of each arm experienced a serious AE; 4 patients had malignancies (2 per arm), 4
serious infections (1 in Arm 1; 3 in Arm 2), and 3 major adverse cardiac events (all Arm
2). No active tuberculosis was observed. 1 death occurred but was considered
doubtfully related to UST. Median PASI scores (interquartile range) for Arms 1 and 2,
respectively, decreased from 15.2 (12.3-20.4) and 15.4 (12.2-19.2) at baseline to 2.9 (0.8-
6.3) and 2.8 (1.1-5.8) at Week 12, and to 1.8 (0.1-4.2) and 1.6 (0.4-3.5) at Week 52. At Week
52 in Arms 1 and 2, respectively, 70% and 72% of patients reached PASI less than or
equal to 3, and 82% and 84% reached PASI less than or equal to 5; 76% and 77%
achieved PASI 75. 391 patients weighed less than or equal to 100kg, of whom 84 were
dose escalated at Week 28 and 31 at Week 40. PASI 75 was achieved at Week 52 in Arms
1 and 2, respectively, by 45% and 40% of Week 28 dose escalators, and 50% and 48%
of Week 40 dose escalators.
Conclusions: In patients with moderate to severe psoriasis and inadequate MTX
response who transitioned to UST, immediate cessation of MTX showed similar safety
and efficacy as gradual reduction of MTX. To Week 52, UST was well tolerated and associated
with sustained efficacy. Treatment discontinuation was low, with similar AE
profiles between treatment arms. Dose escalation, in patients