"Alefacept has been tested in phase I, II, and III clinical trials. In a phase III trial of
intravenous alefacept in more than 1,000 patients for 12 weeks, 28% of patients had 75% or
greater clearance of psoriasis after one course of treatment, and 56% of patients had 50%
improvement. After a second 12-week course of treatment, 40% of patients had a 75% or
greater improvement in their psoriasis, and 71% had 50% improvement. Adverse effects
including headache, itching, and flu-like symptoms were reported by a small number of
patients. Remission was long — a median of 10 months and for some patients, 18 months.
Patients were equally responsive during extended treatment.
Efaluzimab (Raptiva) is also a T-cell inhibitor, targeting three key processes in the cascade
of events leading to psoriasis. "Given that psoriasis is a chronic disease, it's important that
An open-label, long-term trial with Raptiva presented by Leonardi at the meeting involved 339
patients receiving a three-month course of therapy, including weekly subcutaneous doses of 2
mg/kg of the study drug. Eighty-five percent of patients achieved a PASI of 50 or an Overall
Lesion Severity Score (OLS) of "mild." Of the 215 patients continuing with a one-year course,
79.1% maintained a PASI of 50 and 61% had a PASI of 75. Safety data from the first 12
weeks of therapy showed that mild, adverse effects occurred in only 10% of patients."
Let's see Amevive 28%, using anytime measure, after 12 weeks of treatment, not at the selected endpoint time, reached 75% PASI.
Raptiva 61% had 75% clearing after 12 weeks of treatment.
Got up to 40% clearance, anytime basis, after second round of treatment.
Amevive 50% had 50% Pasi.
Raptiva after 12 weeks 79.1% had 50% clearance.
Amevive touts the 18 month duration figure but the FDA has no idea of how BGEN arrived at it's duration numbers. FDA believes 50 day and 90 day duration fir I.V. and I.M. are closer to the truth.
30% of those in treatment arms of Amevive used non authorized treatments in addition to Amevive.
We don't yet know to what extent Raptiva subjects used non authorized treatments but it should be a lot less since Raptiva works quickly.
However Amevive could enjoy a huge price advantage should BGEN choose to compete on price. In adddition even the FDA duration figures for duration are very good.
Some raise the T-Cell depletion issue, for Amevive, but not sure this is as big a deal as some claim.
On balance big advantage to Raptiva over Amevive, but there are other things that may beat both.
Amevive should be first to market and should gain some advantage there. As Cacait points out, in real life the derms will use combinations of treatments. This may make the fact that Amevive is slow to show results less significant. |
