Janssen Biotech, Inc. and Janssen Biologics BV have submitted supplemental Biologics License Application (sBLA) to the United States Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) requesting approval of Stelara(ustekinumab) for the treatment of adult patients with active psoriatic arthritis. Stelara, a human interleukin (IL)-12 and IL-23 antagonist, is currently approved in 69 countries for the treatment of moderate to severe plaque psoriasis.
IL-12 and IL-23 are naturally occurring proteins that are believed to play a role in immune-mediated inflammatory diseases, including psoriasis and psoriatic arthritis.
It is estimated that more than two million people in the US and approximately 4.2 million people across Europe are living with psoriatic arthritis, a chronic autoimmune disease characterised by both joint inflammation and psoriasis skin lesions, for which there is no cure.
“We are pleased to present applications to health authorities in the US and Europe seeking approval of Stelarafor the treatment of active psoriatic arthritis, a chronic, debilitating immune-mediated inflammatory disease,” said Jerome A Boscia, MD, vice president, Head of Immunology Development, Janssen Research & Development, LLC. “The efficacy and safety of Stelara, an anti–interleukin-12/23 antibody, have been evaluated in a large Phase 3 clinical development programme for the treatment of active psoriatic arthritis, a disease for which tumor necrosis factor inhibitors are currently the only approved biologic therapies, and additional therapeutic options are needed.”
The applications are supported by findings from phase III multi-centre, randomised, double-blind, placebo-controlled trials of Ustekinumab, a Fully Human anti–IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis (PSUMMIT I and PSUMMIT II), which evaluated the efficacy and safety of subcutaneously administered 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 and five swollen joints and C-reactive protein (CRP) levels of at least 0.3 mg/dL in spite of previous treatment with conventional therapy. PSUMMIT II also included patients with previous exposure to tumor necrosis factor (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.
Data from the Janssen Research & Development–sponsored PSUMMIT I and PSUMMIT II studies were recently presented at the 2012 Annual Meeting of the American College of Rheumatology.
Psoriatic arthritis is a chronic immune-mediated inflammatory disease characterized by both joint inflammation and the skin lesions associated with psoriasis affects millions of people worldwide.
While estimates of the prevalence of psoriatic arthritis among people living with psoriasis vary, up to 30 percent may develop inflammatory arthritis. Though the exact cause of psoriatic arthritis is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease.
In addition to the phase III clinical development program in psoriatic arthritis, Stelara is in phase III development for the treatment of moderately to severely active Crohn’s disease.