Stelara could soon be used for PsA

[Fred]

I've been saying all along that Stelara is helping with my Psoriatic Arthritis, though maybe not as good as Enbrel or Humira this is good news for people with PsA.

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Janssen-Cilag International NV ("Janssen") announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending 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.

Based on the CHMP's positive opinion, a final decision from the European Commission is expected during the third quarter of 2013. If approved, STELARA will become available for patients living with active psoriatic arthritis, a chronic autoimmune disease characterized by both joint and 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"), and psoriasis skin lesions. The disease affects approximately 4.2 million people across Europe,1-5 and there is currently no cure.

"We are pleased that the CHMP has issued a positive opinion for STELARA in the treatment of psoriatic arthritis as we look to bring this new therapeutic option to patients living with active psoriatic arthritis," 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-tumor necrosis factor (TNF)-alpha naïve and experienced patients. We believe STELARA has the potential to play a critically important role in the treatment of this chronic disease and look forward to the European Commission's decision."

The CHMP adopted the opinion 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), which 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 included in the submissions 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 at baseline. The studies also captured improvements in enthesitis and dactylitis scores for patients with enthesitis and/or dactylitis at baseline.

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