Janssen-Cilag International NV has received the European Commission approval for 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 nonbiological therapy anti-rheumatic drug disease modifying drugs (DMARDs) has been inadequate.
The European Commission decision follows a positive opinion recommending the use of Stelara through the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July 2013. Stelara is the first of a new class of biological products already available to patients with active psoriatic arthritis, a chronic autoimmune disease characterized by inflammation and pain, periarticular tissue inflammation (enthesitis, inflammation of the site where ligaments or tendons inserted into the bone, and dactylitis, inflammation of a complete digit, for example, toe or finger, often called "finger sausage") and psoriatic lesions.
"The approval of Stelara by the European Union for the treatment of active psoriatic arthritis f has an important new therapeutic option to patients, and marks the first approved treatment for this devastating disease and complex since the introduction of agents factor of anti-tumor necrosis (TNF)-alpha," said Jerome A Boscia, MD, vice president of Development Immunology Janssen Research & Development, LLC. "Data from the phase III clinical programme, one of the largest conducted for a biological product to date in psoriatic arthritis have shown that Stelara effectively improves the signs and symptoms of active psoriatic arthritis in patients experienced not experts in anti-TNF-alpha. believe that Stelara develop a vital role in advancing the treatment of this chronic disease."
The EC has given approval based on data from two phase III pivotal trials multi-centre, randomized, double-blind, placebo-controlled ustekinumab, a monoclonal antibody of the fully human anti-interleukin (IL) -12/23, administered subcutaneously, in patients with active psoriatic arthritis (PSUMMIT PSUMMIT I and II). The trials evaluated the efficacy and safety of subcutaneous administration of Stelara45 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 joints and swollen joints and five levels of C-reactive protein (CRP) of at least 0.3 mg/ dL despite prior treatment with conventional therapies. PSUMMIT II also included patients who had previously undergone treatment with TNF inhibitors.
The primary endpoints for both studies were the proportion of patients showing at least a 20 per cent improvement in signs and symptoms of arthritis (American College of Rheumatology [ACR] 20) at week 24. Secondary endpoints at week 24 were: score improvements in Health Assessment Questionnaire Disability Index (HAQ-DI), an improvement of 50 per cent or 70 per cent in the signs and symptoms of arthritis (ACR 50 or ACR 70) and at least 75 per cent improvement in the psoriatic skin lesions evaluated according Psoriasis Area Severity Index (PASI 75) in patients with at least three per cent of body surface area involved in psoriasis as baseline. Studies also captured improvements in scores for entesitis and Dactylitis entesitis patients and/ or Dactylitis at baseline.
The safety of Stelara results observed in PSUMMIT studies were consistent with the known safety profile of Stelara in psoriasis indication of moderate to severe plaque with up to five years of security experience in clinical trials.
STELARA, an antagonist of human interleukin (IL-12/23) is currently approved in 74 countries for the treatment of plaque psoriasis moderate to severe. IL-12 and IL-23 are naturally occurring proteins that are believed to play a role in inflammatory diseases mediated immunity, including psoriasis and psoriatic arthritis.
In the EU, Stelara is approved for the treatment of plaque psoriasis moderate to severe in adults who have not responded, or in which it is contraindicated, or are intolerant to other systemic therapy including cyclosporine, methotrexate and PUVA (psoralen more UVA rays). Stelara is also approved alone or in combination with methotrexate for the treatment of active psoriatic arthritis in adults when the response to previous therapy nonbiological DMARDs has been inadequate.
Janssen Biotech, Inc. discovered and developed Stelara and has the exclusive marketing rights to the product in the United States. Janssen Pharmaceutical companies have the exclusive marketing rights to STELARA.
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