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Psoriasis Club › HealthHealth Boards › Psoriasis In The News v
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Cosentyx gets psoriatic arthritis approval in Europe.

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Cosentyx gets psoriatic arthritis approval in Europe.
Fred Offline
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#1
News  Mon-26-10-2015, 10:32 AM
Cosentyx has been given European approval for the treatment of Psoriatic Arthritis (PsA) by the Committee for Medicinal Products for Human Use (CHMP) the approval is applicable to all European Union and European Economic Area countries.

Quote:
Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Cosentyx™ (secukinumab) in Europe to treat ankylosing spondylitis (AS) and psoriatic arthritis (PsA) patients. Following two separate regulatory submissions, Cosentyx is now recommended for the treatment of active AS in adults who have responded inadequately to conventional therapy, such as non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of active PsA in adult patients alone or in combination with methotrexate (MTX) when the response to previous disease modifying anti-rheumatic drug (DMARD) therapy has been inadequate.

Cosentyx is the first of a new class of medicines called interleukin-17A (IL-17A) inhibitors to be recommended for AS and PsA - conditions that affect around five million people in Europe. Both are life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine. If not treated effectively, both conditions can lead to irreversible joint and/or spinal damage caused by years of inflammation.

"Novartis is pleased to be so close to bringing this life-changing medicine to people living with ankylosing spondylitis and psoriatic arthritis who are struggling to find the right treatment to control their symptoms," said David Epstein, Division Head, Novartis Pharmaceuticals. "With Cosentyx, we have seen major and rapid reductions in the signs and symptoms of disease, including pain, disease progression and joint damage, paving the way for a potential new standard of care."

New treatment options with an alternative way of working are needed for both conditions as many patients do not achieve an adequate response from standard treatments, such as DMARDs, NSAIDs or anti-TNF therapies. For example, with the current biologic standard of care - anti-TNFs - up to 45% of PsA patients and up to 40% of AS patients are dissatisfied with, do not respond to or do not tolerate their treatment.

Cosentyx Phase III studies have consistently demonstrated significant improvements in the signs and symptoms of AS and PsA. Clinical improvements were seen as early as Week 3 and through to Week 52, with benefits reported across the spectrum of patients who have either never taken or who have had prior treatment with anti-TNF therapies.

The safety profile of Cosentyx was shown to be consistent to that reported in clinical trials across multiple indications involving more than 9,600 patients.

The European Commission reviews the recommendations of the CHMP who then provide their final decision on approval, usually two months or earlier, following CHMP opinion. This is applicable to all European Union and European Economic Area countries. Cosentyx has been approved for the treatment of PsA in Japan since December 2014 and has received approval in 49 countries worldwide for the treatment of moderate-to-severe plaque psoriasis.

About the CHMP recommendation
For patients with AS and PsA, the recommended dose is Cosentyx 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at Week 4. For PsA patients with concomitant moderate-to-severe plaque psoriasis, or who are anti-TNF inadequate responders, the recommended dose is Cosentyx 300 mg.

Source: novartis.com
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jiml Offline
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#2
Mon-26-10-2015, 11:01 AM
Great news Fred thanks for keeping us informed
It's nice to know that there's another treatment available if the other biological drugs stop working
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Fred Offline Author
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#3
Mon-26-10-2015, 11:12 AM
(Mon-26-10-2015, 11:01 AM)jiml Wrote: Great news Fred thanks for keeping us informed
It's nice to know that there's another treatment available if the other biological drugs stop working

You're welcome Jim.

Yes it is good news as this is something I could always go onto if needed. My rheumatologist only recently told me it will not be available for psoriatic arthritis. She didn't like it when I said you said the same thing about Stelara and here we are 5 years on with me using Stelara and you still only want to offer Methotrexate. Tongue
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jiml Offline
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#4
Mon-26-10-2015, 11:35 AM
(Mon-26-10-2015, 11:12 AM)Fred Wrote:
(Mon-26-10-2015, 11:01 AM)jiml Wrote: Great news Fred thanks for keeping us informed
It's nice to know that there's another treatment available if the other biological drugs stop working

You're welcome Jim.

Yes it is good news as this is something I could always go onto if needed. My rheumatologist only recently told me it will not be available for psoriatic arthritis. She didn't like it when I said you said the same thing about Stelara and here we are 5 years on with me using Stelara and you still only want to offer Methotrexate.  Tongue

It's what I was hinting in my reply Smile .it will give a lot of people hope who are struggling with current drugs Thumb
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#5
Mon-26-10-2015, 22:07 PM
(Mon-26-10-2015, 11:12 AM)Fred Wrote:
(Mon-26-10-2015, 11:01 AM)jiml Wrote: Great news Fred thanks for keeping us informed
It's nice to know that there's another treatment available if the other biological drugs stop working

You're welcome Jim.

Yes it is good news as this is something I could always go onto if needed. My rheumatologist only recently told me it will not be available for psoriatic arthritis. She didn't like it when I said you said the same thing about Stelara and here we are 5 years on with me using Stelara and you still only want to offer Methotrexate.  Tongue

Sounds strange that the opinions of the dermatologist and the rheumatologist differ in such a way. This while one even should guess that the rheumatologist should know more of internal diseases like arthritis.
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Fred Offline Author
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#6
Tue-27-10-2015, 12:10 PM
(Mon-26-10-2015, 22:07 PM)Caroline Wrote: Sounds strange that the opinions of the dermatologist and the rheumatologist differ in such a way. This while one even should guess that the rheumatologist should know more of internal diseases like arthritis.

They don't differ that much, they both said methotrexate, stay on Stelara, or hard luck.  Big Grin

It's just that the rheumatologist has said before that Stelara doesn't work for psoriatic arthritis even though it did and still does, and now is saying Cosentyx will only be approved for psoriasis. I think it's about different departments wanting to prescribe certain things. Because dermatology got Stelara and will get Cosyntex first they will be prescribing it. So this means that rheumatology are not treating psoriatic arthritis.
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mataribot Offline
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#7
Tue-27-10-2015, 13:01 PM
Good luck to fat people at 150 dose.
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Caroline Online
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#8
Tue-27-10-2015, 17:06 PM
(Tue-27-10-2015, 12:10 PM)Fred Wrote:
(Mon-26-10-2015, 22:07 PM)Caroline Wrote: Sounds strange that the opinions of the dermatologist and the rheumatologist differ in such a way. This while one even should guess that the rheumatologist should know more of internal diseases like arthritis.

They don't differ that much, they both said methotrexate, stay on Stelara, or hard luck.  Big Grin

It's just that the rheumatologist has said before that Stelara doesn't work for psoriatic arthritis even though it did and still does, and now is saying Cosentyx will only be approved for psoriasis. I think it's about different departments wanting to prescribe certain things. Because dermatology got Stelara and will get Cosyntex first they will be prescribing it. So this means that rheumatology are not treating psoriatic arthritis.

I'm lost on so much stupidity. Wall
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Fred Offline Author
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#9
Tue-27-10-2015, 20:25 PM
(Tue-27-10-2015, 17:06 PM)Caroline Wrote:
(Tue-27-10-2015, 12:10 PM)Fred Wrote:
(Mon-26-10-2015, 22:07 PM)Caroline Wrote: Sounds strange that the opinions of the dermatologist and the rheumatologist differ in such a way. This while one even should guess that the rheumatologist should know more of internal diseases like arthritis.

They don't differ that much, they both said methotrexate, stay on Stelara, or hard luck.  Big Grin

It's just that the rheumatologist has said before that Stelara doesn't work for psoriatic arthritis even though it did and still does, and now is saying Cosentyx will only be approved for psoriasis. I think it's about different departments wanting to prescribe certain things. Because dermatology got Stelara and will get Cosyntex first they will be prescribing it. So this means that rheumatology are not treating psoriatic arthritis.

I'm lost on so much stupidity.  Wall

But we are just people living with the problem, how can we possibly know as much as people in white coats 85
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Caroline Online
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#10
Tue-27-10-2015, 21:08 PM
(Tue-27-10-2015, 20:25 PM)Fred Wrote:
(Tue-27-10-2015, 17:06 PM)Caroline Wrote:
(Tue-27-10-2015, 12:10 PM)Fred Wrote:
(Mon-26-10-2015, 22:07 PM)Caroline Wrote: Sounds strange that the opinions of the dermatologist and the rheumatologist differ in such a way. This while one even should guess that the rheumatologist should know more of internal diseases like arthritis.

They don't differ that much, they both said methotrexate, stay on Stelara, or hard luck.  Big Grin

It's just that the rheumatologist has said before that Stelara doesn't work for psoriatic arthritis even though it did and still does, and now is saying Cosentyx will only be approved for psoriasis. I think it's about different departments wanting to prescribe certain things. Because dermatology got Stelara and will get Cosyntex first they will be prescribing it. So this means that rheumatology are not treating psoriatic arthritis.

I'm lost on so much stupidity.  Wall

But we are just people living with the problem, how can we possibly know as much as people in white coats 85

You have a point there.. Tongue
But.... Butchers also have white coats. Rolleyes Surely they know a lot of course.
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