Secukinumab gets one step closer to approval in Europe for treating psoriasis.

[Caroline]

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Psoriasis-clearing trial drug helps psoriatic arthritis, too
By Melissa Leavitt
A new drug that’s making headlines for psoriasis could improve your psoriatic arthritis, too.
Secukinumab, a drug being developed by Novartis, was able to effectively treat psoriatic arthritis in two Phase III clinical trials, according to results presented at the American College of Rheumatology meeting earlier this month.
The randomized, placebo-controlled trials, called FUTURE 1 and FUTURE 2, together involved about 1,000 patients with psoriatic arthritis. FUTURE 1 tested 75 milligram- (mg) and 150-mg doses of secukinumab, while FUTURE 2 tested these doses as well as a 300 mg dose.
According to the results, after six months on the drug, about half of the patients in FUTURE 1 taking secukinumab achieved at least a 20 percent improvement in their psoriatic arthritis as measured by the American College of Rheumatology (ACR) response criteria. The criteria evaluate tender and swollen joints, physical function and pain, among other factors.
More than half of the patients in the FUTURE 2 trial taking 150 mg or 300 mg doses of the drug also achieved 20 percent improvement, known as ACR 20. Researchers reported that 51 percent of patients in the 150 mg group and 54 percent of patients in the 300 mg group experienced ACR 20, along with 29.3 percent of patients in the 75 mg group.
Only 17.3 percent of patients on the placebo in FUTURE 1, and 15.3 percent of placebo patients in FUTURE 2, achieved ACR20, according to the data.
Secukinumab also effectively treated skin psoriasis in the trials, with up to approximately 64 percent of patients taking secukinumab in both trials experiencing a 75 percent improvement in their psoriasis after six months, according to the results. Earlier this year, results from a Phase III trial testing secukinumab for psoriasis showed that the drug delivered dramatic skin improvements to large numbers of patients.
Serious side effects were experienced by 8.6 percent of patients in FUTURE 1 taking the 75 mg dose and 12.9 percent of patients in the 150 mg dose, as well as about 3 percent of the patients taking secukinumab in the FUTURE 2 trial, according to the results. A separate trial found that the most common side effects experienced by secukinumab patients included the common cold and headache.
Secukinumab targets interleukin-17A, which is a protein, or cytokine, that triggers inflammation. Two other drugs currently in development, brodalumab and ixekizumab, also target IL-17.

Source: psoriasis.org

[jiml]

More great news for psoriasis sufferers targeting specific cytokines seems to be the way to reduce serious side effects

[Caroline]

More great news for psoriasis sufferers targeting specific cytokines seems to be the way to reduce serious side effects

Well still there is 8.6 percent having serious side effects. It is not clear what they are from this article.

[jiml]

More great news for psoriasis sufferers targeting specific cytokines seems to be the way to reduce serious side effects

Well still there is 8.6 percent having serious side effects. It is not clear what they are from this article.

Yes I misread that and assumed the 8.6%were cold and headache side effects . Yes although that's not to high a percentage depending on what they call serious

[Fred]

It is not clear what they are from this article.

Maybe you should think about where you got the information from and how it is reported.

[Fred]

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:

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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.