In Palace-1, 38 per cent of patients treated with Otezla 30 mg twice daily achieved an ACR 20
response at week 16 versus 19 per cent of patients on placebo.
The primary outcome was ACR 20
, which was consistently greater at each time point for MTX plus leflunomide compared with MTX monotherapy.
By the end of the first week, 36% of twice-daily patients had an ACR 20
response, compared with 23% in the once-daily R788 group and 14% in the placebo group (P less than .
Of 28 patients treated with this interleukin 1 receptor antagonist after failing a TNF blocker, only 8% achieved an ACR 20
response, and no patients achieved an ACR 50 or ACR 70 response, she said.
19) In the latter study, which involved 615 patients who had not previously been exposed to anti-TNF therapy, the ACR 20
, 50, and 70 and PASI75 responses in the 90 mg vs.
Thirty-six percent of patients achieved an ACR 20
response after just one week.
The primary end point in all five studies was the ACR 20
at 6 months.
The primary efficacy endpoint of this study is to determine the percent of patients with ACR 20
response at the end of 12 weeks.
The approval was based on results from two randomized, double-blind, placebo-controlled studies (Studies PSA-I and PSA-II) in which a higher proportion of patients achieved an ACR 20
response, the primary endpoint, after treatment with ORENCIA 10 mg/kg intravenous (IV) or 125 mg subcutaneous injection (SC) compared to placebo at Week 24: 47.