The first patients have started receiving treatment in a Phase 3 trial evaluating the therapeutic potential of Kineret (anakinra) for adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA).
AOSD and SJIA are rare disorders with an auto-inflammatory nature. The anaSTILLs study (NCT03265132) is expected to enroll 81 adults or children with active disease. The patients will randomly receive once daily subcutaneous injections of 2 mg/kg or 4 mg/kg of Kineret, or a placebo for up to 12 weeks. The study is being conducted in the United States.
The main goal of the study is to determine the efficacy of the treatment in this population according to the guidelines of the American College of Rheumatology. Assessment of the global patient health, disease activity, number of joints with active arthritis and limited movement, and overall physical function will be performed during the 12 weeks of the study.
Biochemical analysis of biomarkers of the disease will also be evaluated.
The safety of the treatment will be evaluated during the 12 weeks of the study, and for an additional four weeks following treatment.
“We are very pleased with having initiated this confirmatory clinical study investigating the safety and efficacy of anakinra in people with Still’s disease. This is a disease affecting both young people and adults and is associated with a significant morbidity and with a large unmet medical need,” Milan Zdravkovic, senior vice president, chief medical officer, and head of research & development at the Swedish Orphan Biovitrum (Sobi), Kineret’s developer, said in a press release.
Anakinra, also known by its brand name Kineret, was developed by Sobi to inhibit the pro-inflammatory activity of the interleukin-1 receptor.
The therapy was approved in 2011 by the U.S. Food and Drug Administration (FDA) for the treatment of moderately to severely active rheumatoid arthritis in adult patients who have failed to respond to disease-modifying, anti-rheumatic drugs (DMARDs). Kineret was also the first FDA-approved therapy for the treatment of neonatal-onset multisystem inflammatory disease.
The European Commission has also approved Kineret for the treatment of adult patients with rheumatoid arthritis in combination with methotrexate, and for all patients older than 8 months of age who have cryopyrin-associated periodic syndromes.
Australia is the only country that has approved Kineret to treat active SJIA in patients age 2 or older who have not responded adequately to non-biological DMARDs.
Visit the anaSTILLs trial website for more information and to learn how to participate.