Health Boards
Mon-24-11-2014, 12:32 PM
FUTURE 1 and FUTURE 2 enrolled a combined total of more than 1,000 patients and are randomized, placebo-controlled, multicenter studies designed to demonstrate efficacy of secukinumab in PsA compared to placebo and to assess safety and tolerability. The American College of Rheumatology response criteria (ACR20) was the primary endpoint in the studies.
They say on their website:
That was mostly the Phase II data Novartis AIN457 (secukinumab) data shows relief for 81% of psoriasis patients and on post two it says: "The most common adverse events (AEs) observed being infections."
And the Secukinumab V Enbrel thread says: "The observed safety profile was consistent with previously reported results from Phase II studies in moderate-to-severe plaque psoriasis and no new safety concerns were identified."
So I would assume the 8.6 percent having serious side effects would mean infections, I've been unable to find anything worse than that.
Source: novartis.com
*Interesting how Phase ll was more than 3,000 patients, and Phase lll it's nearly 4,000 patients. Technically the same thing, but the latter looks/sounds better perhaps.
They say on their website:
Quote:
FUTURE 1 and FUTURE 2 are randomized, placebo-controlled, multicenter studies designed to demonstrate efficacy of secukinumab in PsA compared to placebo and to assess safety and tolerability. The American College of Rheumatology response criteria (ACR20) was the primary endpoint in the studies. Secukinumab was well tolerated in both studies. The observed safety profile was consistent with previously reported results from the large psoriasis clinical trial program involving nearly 4,000 patients
That was mostly the Phase II data Novartis AIN457 (secukinumab) data shows relief for 81% of psoriasis patients and on post two it says: "The most common adverse events (AEs) observed being infections."
And the Secukinumab V Enbrel thread says: "The observed safety profile was consistent with previously reported results from Phase II studies in moderate-to-severe plaque psoriasis and no new safety concerns were identified."
So I would assume the 8.6 percent having serious side effects would mean infections, I've been unable to find anything worse than that.
Source: novartis.com
*Interesting how Phase ll was more than 3,000 patients, and Phase lll it's nearly 4,000 patients. Technically the same thing, but the latter looks/sounds better perhaps.
