Rare Daily Staff
Swedish Orphan Biovitrum said that it has randomized the first patient in its late-stage study of Kineret in the treatment of Still’s disease, a rare systemic auto-inflammatory disorder.
The purpose of the study is to assess the efficacy and to evaluate the safety of Kineret in patients with newly diagnosed Still’s disease, including systemic juvenile idiopathic arthritis and adult onset Still’s disease. The study is a randomized, double-blind, multi-center study being conducted in North America studying two dose levels of anakinra, administrated subcutaneously, in comparison to placebo. A total of 81 individuals are expected to be randomized in the study.
“This is a disease affecting both young people and adults and is associated with a significant morbidity and with a large unmet medical need,” said Milan Zdravkovic, chief medical officer and head of research and development at Sobi.
Adult-onset Still’s disease and systemic juvenile idiopathic arthritis share common clinical manifestations, such as daily spiking fever, typical transient cutaneous rash, arthritis, lymphadenopathy, hepatosplenomegaly and serositis.
Kineret is an interleukin-1 receptor antagonist that in the United States is approved for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed one or more disease modifying antirheumatic drugs. It is also approved for the treatment of neonatal-onset multisystem inflammatory disease, a form of cryopyrin-associated periodic syndromes.
In Europe, Kineret is approved for use in adults for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, with an inadequate response to methotrexate alone, and for the treatment of cryopyrin-associated periodic syndromes. It is also approved in Australia for the treatment of active systemic juvenile idiopathic arthritis, rheumatoid arthritis, and for the treatment of cryopyrin-associated periodic syndromes.
November 16, 2017