Kineret (anakinra), developed by Sobi, is now available as a treatment option in the United Kingdom for patients with systemic-onset juvenile idiopathic arthritis (SJIA) and adult-onset Still’s disease (AOSD).
This decision follows the authorization of Kineret by the European Medicines Agency (EMA) earlier this year for SJIA. In April 2018, the EMA extended the authorization to Still’s disease.
SJIA develops in children and affects about 10% of all JIA patients in the U.K. Adult-onset Still’s disease affects young adults from the ages of 16 to 35 and, like SJIA, its cause is not known.
The National Health Service (NHS) England — a subsidized, publicly funded healthcare system — has now published its Clinical Commissioning Policy for the treatment of Still’s disease.
After a review of data on the use of interleukin blockers such as Kineret (which blocks interleukin-1, or IL-1) and Actemra/RoActemra (tocilizumab, developed by Roche) in the treatment of rare inflammatory diseases, the NHS policy recommends that they may be used as a third-line treatment in patients who are intolerant to, or do not respond to, other treatments such as corticosteroids and disease-modifying anti-rheumatic drugs (DMARDs).
Interleukins are proteins that trigger inflammation and are responsible for the symptoms observed in patients with JIA. Kineret is an injectable immunosuppressant that works by blocking IL-1.
“We are very pleased that Kineret is now licensed for patients with SJIA and [adult-onset Still’s disease], particularly because it has been granted this new indication, partly as a result of clinicians publishing their case reports over many years, as well as running small trials, showing very positive results, including that remission is possible,” Neil Dugdale, general manager of Sobi for the U.K. and the Republic of Ireland, said in a press release.
The extension of Kineret’s use was based on data from scientific literature, an analysis of published results, and clinical trials that evaluated the effectiveness and safety of the therapy in over 400 patients.
“This is an important step in providing additional therapeutic options for the U.K. Still’s patients, especially for those who have not responded to previous treatments,” said Sinisa Savic, a consultant in clinical immunology and allergy at St James’s University Hospital, Leeds.
“Furthermore, the new NHS England policy for patients with AOSD is a positive step, providing clinicians with additional options to treat patients who do not respond to corticosteroids and DMARDs,” Savic said. “No therapy is consistently effective in all cases, so having additional treatments that can be given in combination with other disease-modifying antirheumatic drugs or as monotherapy will help to address this unmet need.”