J&J's JNJ Janssen Biotech, Inc. and Janssen Biologics B.V. announced today the
submission of a 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. It is estimated that more than two million people in the U.S.[1]
and approximately 4.2 million people across Europe[2],[3],[4] are living with
psoriatic arthritis, a chronic autoimmune disease characterized 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 U.S. and
Europe seeking approval of STELARA for the treatment of active psoriatic
arthritis, a chronic, debilitating immune-mediated inflammatory disease," said
Jerome A. Boscia, M.D., 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 program 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 P hase 3 Multicenter, Randomi
s ed, Double-blind, Placebo-controlled trials of U stekinumab, a Fully Human
anti–IL-12/23p40 M onoclonal Antibody, Ad m inistered Subcutaneously, i n
Subjects with Active Psoriatic Ar t hritis (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
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.
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