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Psoriasis Club › HealthHealth Boards › Psoriasis In The News v
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Taltz (ixekizumab) gets FDA approval for Psoriasis

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Taltz (ixekizumab) gets FDA approval for Psoriasis
Fred Offline
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#1
News  Tue-22-03-2016, 22:29 PM
Taltz formerly known as (ixekizumab) has been given the green light for psoriasis by the FDA for the treatment of adults with moderate-to-severe plaque psoriasis.

Quote:
The U.S. Food and Drug Administration today approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis.

Psoriasis is a skin condition that causes patches of skin redness and flaking. Psoriasis is an autoimmune disorder that occurs more commonly in patients with a family history of the disease, and most often begins in people between the ages of 15 and 35. The most common form of psoriasis is plaque psoriasis, in which patients develop thick, red skin with flaky, silver-white scales.

“Today’s approval provides patients suffering from plaque psoriasis with another important treatment option to help relieve the skin irritation and discomfort from the condition,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

Taltz’s active ingredient is an antibody (ixekizumab) that binds to a protein (interleukin (IL)-17A) that causes inflammation. By binding to the protein, ixekizumab is able to inhibit the inflammatory response that plays a role in the development of plaque psoriasis.

Taltz is administered as an injection. It is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected), phototherapy (ultraviolet light treatment) or a combination of both.

Taltz’s safety and efficacy were established in three randomized, placebo-controlled clinical trials with a total of 3,866 participants with plaque psoriasis who were candidates for systemic or phototherapy therapy. The results showed that Taltz achieved greater clinical response than placebo, with skin that was clear or almost clear, as assessed by scoring of the extent, nature and severity of psoriatic changes of the skin.

Because Taltz is a medicine that affects the immune system, it is being approved with a Medication Guide to inform patients that they may have a greater risk of an infection, or an allergic or autoimmune condition. Serious allergic reactions and development or worsening of inflammatory bowel disease have been reported with the use of Taltz. Monitor patients closely for these conditions. The most common side effects include upper respiratory infections, injection site reactions and fungal (tinea) infections.

Source: fda.gov
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jiml Offline
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#2
Tue-22-03-2016, 22:53 PM
Another interesting IL17A inhibitor in the armoury of the US dermatologists

A bit concerning is the possible side effects, but like any drug that's affects the immune system there are bound to be risks,
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Fred Offline Author
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#3
Tue-22-03-2016, 23:00 PM
(Tue-22-03-2016, 22:53 PM)jiml Wrote: Another interesting IL17A inhibitor in the armoury of the US dermatologists

A bit concerning is the possible side effects, but like any  drug that's affects  the immune system there are bound to be risks,

The trouble is these days they have to warn us about everything. But at least it makes the dermatologists keep an eye on us.

I think if we looked at all treatments (even the natural ones) we could find some side effect. But we have to weigh up as individuals is the risk worth taking, and is it high enough to put us off.

The good thing about the Bio's is as soon as there is a problem spotted they will pull you, and the majority of side effects are reversible or will go away.
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jiml Offline
100 + Member I Just Cant Stop !

100 + Member I Just Cant Stop !
Posts: 47,972
Threads: 357
Joined: Oct 2013
Gender: Male
Location: Norwich England
Psoriasis Score: 3
Treatment: Skilarence 5x120mg a day
#4
Tue-22-03-2016, 23:10 PM
(Tue-22-03-2016, 23:00 PM)Fred Wrote:
(Tue-22-03-2016, 22:53 PM)jiml Wrote: Another interesting IL17A inhibitor in the armoury of the US dermatologists

A bit concerning is the possible side effects, but like any  drug that's affects  the immune system there are bound to be risks,

The trouble is these days they have to warn us about everything. But at least it makes the dermatologists keep an eye on us.

I think if we looked at all treatments (even the natural ones) we could find some side effect. But we have to weigh up as individuals is the risk worth taking, and is it high enough to put us off.

The good thing about the Bio's is as soon as there is a problem spotted they will pull you, and the majority of side effects are reversible or will go away.

I didn't know the side effects were reversible, if monitored .. I know the side effects are reversible with DMF if caught early enough ...the fact that bios are similar in that respect makes me more confident in case I ever need to change Thumb
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Fred Offline Author
I Wanted To Change the World But Got Up Far Too Late.
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#5
Tue-22-03-2016, 23:17 PM
(Tue-22-03-2016, 23:10 PM)jiml Wrote:
(Tue-22-03-2016, 23:00 PM)Fred Wrote:
(Tue-22-03-2016, 22:53 PM)jiml Wrote: Another interesting IL17A inhibitor in the armoury of the US dermatologists

A bit concerning is the possible side effects, but like any  drug that's affects  the immune system there are bound to be risks,

The trouble is these days they have to warn us about everything. But at least it makes the dermatologists keep an eye on us.

I think if we looked at all treatments (even the natural ones) we could find some side effect. But we have to weigh up as individuals is the risk worth taking, and is it high enough to put us off.

The good thing about the Bio's is as soon as there is a problem spotted they will pull you, and the majority of side effects are reversible or will go away.

I didn't know the side effects were reversible, if monitored .. I know the side effects are reversible with DMF if caught early enough ...the fact that bios are similar in that respect makes me more confident in case I ever need to change  Thumb

Well I'll stand corrected if not, but my understanding is that they don't cause long term damage say like Methotrexate can. But I suppose like you say it has to be caught early enough, and that will happen as they monitor you well. Unlike years ago when I was given Methotrexate, I only ever had one blood test and was never monitored, I just collected my repeat prescription of a jar of little pills.
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