At last the European Commission have approved Stelara for use with Psoriatic Arthritis. I have been following this for a while now as I have always said it works (maybe not as good as others), but it does work for Psoriatic Arthritis (PsA).

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Janssen-Cilag International NV ("Janssen") announced today that the European Commission has approved the use of STELARA (ustekinumab), alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.  

The decision from the European Commission follows a positive opinion recommending the use of STELARA from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July 2013. STELARA is the first in a new class of biologics now available for patients living with active psoriatic arthritis, a chronic autoimmune disease characterised by joint swelling and tenderness, periarticular tissue inflammation (enthesitis, inflammation of the site where ligaments or tendons insert into the bones, and dactylitis, inflammation of an entire digit, e.g., finger or toe, often called "sausage digit"), as well as psoriasis. The disease affects approximately 4.2 million people across Europe, and there is currently no cure.

"The European Commission approval of STELARA for the treatment of active psoriatic arthritis brings an important new therapeutic option to patients and marks the first treatment approved for this devastating and complex disease since the introduction of anti-tumor necrosis factor (TNF)-alpha agents," said Jerome A. Boscia, M.D., Vice President, Head of Immunology Development, Janssen Research & Development, LLC. "Data from the Phase 3 clinical program, one of the largest conducted for a biologic to date in psoriatic arthritis, showed STELARA effective in improving symptoms and signs of active psoriatic arthritis in anti-TNF-alpha naïve and experienced patients. We believe STELARA will play a critically important role in the treatment of this chronic disease moving forward."

The European Commission provided approval based on a review of data from two pivotal Phase 3 multicenter, randomised, double-blind, placebo-controlled trials of ustekinumab, a fully human anti-interleukin (IL)-12/23p40 monoclonal antibody, administered subcutaneously, in patients with active psoriatic arthritis (PSUMMIT I and PSUMMIT II). The trials evaluated the efficacy and safety of subcutaneously administered STELARA 45 mg or 90 mg at weeks 0, 4 and then every 12 weeks. The trials included patients diagnosed with active psoriatic arthritis who had at least five tender and five swollen joints and C-reactive protein (CRP) levels of at least 0.3 mg/dL despite previous treatment with conventional therapies. PSUMMIT II also included patients who had previously experienced treatment with TNF inhibitors. The primary endpoints for both studies were the proportion of patients demonstrating at least a 20 percent improvement in arthritis signs and symptoms (American College of Rheumatology [ACR] 20) at week 24. Secondary endpoints at week 24 were: improvements in Health Assessment Questionnaire Disability Index (HAQ-DI) scores, a 50 or 70 percent improvement in arthritis signs and symptoms (ACR 50 or ACR 70) and at least a 75 percent improvement in psoriatic skin lesions as measured by the Psoriasis Area Severity Index (PASI 75) in patients with at least three percent body surface area involvement with psoriasis at baseline. The studies also captured improvements in enthesitis and dactylitis scores for patients with enthesitis and/or dactylitis at baseline.

The safety results of STELARA observed in the PSUMMIT studies were consistent with the known safety profile of STELARA in the labelled moderate to severe plaque psoriasis indication with up to 5 years of safety experience in clinical trials.

Source: NO LINKS ALLOWED

You can see the progress of this in these other threads.
Stelara seeks approval for PsA
Stelara could soon be used for PsA
Stelara and Psoriatic Arhtritis Phase 3 data
Stelara Significantly Reduced Psoriatic Arhtritis

Stelara has been a great drug for my psoriasis - no side effects at all. I have had issues with both Enbrel and Humira. However, wish it did bit more for my PsA. Also, I wish I had a CRP that low!

(Wed-25-09-2013, 03:23 AM)mataribot Wrote: Stelara has been a great drug for my psoriasis - no side effects at all. I have had issues with both Enbrel and Humira. However, wish it did bit more for my PsA. Also, I wish I had a CRP that low!

Second that
I too had problems with Enbrel & Humira but Stelara has been great for me, I have found it has helped my PsA though not as much as Enbrel & Humira but it has helped, and I did wonder if it helped with PsA because my skin is clear.

My CRP is fine though my eosinophils are high

Stelara has been approved for PsA use in the USA too.

Quote:Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved STELARA® (ustekinumab) alone or in combination with methotrexate for the treatment of adult patients (18 years or older) with active psoriatic arthritis.

Source: NO LINKS ALLOWED

(Thu-26-09-2013, 11:45 AM)Fred Wrote: Stelara has been approved for PsA use in the USA too.

Quote:Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved STELARA® (ustekinumab) alone or in combination with methotrexate for the treatment of adult patients (18 years or older) with active psoriatic arthritis.

Source: NO LINKS ALLOWED

Funny (?) that they still want to combine with methotrexate, while investigations show that effects are limited, except for Krissie then.

The number one reason that biologics fail is not because of side effects; its because patients do not receive significant improvement in a short period of time. For psoriasis, adding 25 mg of MTX will more likely bring more immediate response. The goal then would be to tapper off. It's also worth noting that biologics do not have the best track record for the higher order psoriasis conditions. The biologic maybe uses for PsA and the MTX maybe used for PP.

Now Canada

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Janssen Inc. announced today that Health Canada approved STELARA® (ustekinumab) for the treatment of adult patients with active psoriatic arthritis, alone or in combination with methotrexate. It is estimated that approximately 30 per cent of Canadians living with psoriasis may develop psoriatic arthritis.

Interesting how they say 30% of Canadians may get PsA when the average I have found throughout the world is 20%. I wonder if it's due to the weather.

Still it's another plus for Stelara.

Nice article on this website about 12 famous people with psoriasis, one girl Carrie Dee English. Shows photos of before starting with Stelara and after treatment. Worth a look [web]https://www.health.com/health/gallery/0,,20446234,00.html[/web]

I don't know if this is the right place for this post

(Sat-25-01-2014, 01:14 AM)jiml Wrote: Nice article on this website about 12 famous people with psoriasis, one girl Carrie Dee English. Shows photos of before starting with Stelara and after treatment. Worth a look [web]https://www.health.com/health/gallery/0,,20446234,00.html[/web]

I don't know if this is the right place for this post

I could tell you the right place

Been there seen it: So called superstars and their psoriasis experience

*PC Statement: The views in the above thread are my own, and in no way intended as an opinion of Psoriasis Club.

Ooooooh Fred you can be harsh, and cynical you read things into articles I would not think of.
You are probably right but I like to believe there is good in everyone and anyone who is "famous" in popular culture "coming out" with their psoriasis just may help teenagers with psoriasis feel less worthless.
All opinions are valid