Following European Medicines Agency (EMA) authorisation, Sobi™ UK and Republic of Ireland have made Kineret® (anakinra) available to treat UK patients with Systemic-Onset Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD).
SJIA and AOSD belong to the autoinflammatory Still’s disease continuum, as both rare conditions share similar epidemiology, genetic features, clinical presentation and course. However, SJIA begins before 16 years of age, whereas AOSD begins in adulthood.
Kineret®, which is administered daily via subcutaneous injection, is a biologic immunosuppressive medicine which blocks the activity of a chemical messenger in the body called interleukin 1 (IL-1). IL-1 activity is associated with the typical SJIA and AOSD symptoms of arthritis in multiple joints, spiking fever, skin rash, hepatosplenomegaly, and serositis.
NHS England has now published its Clinical Commissioning Policy for the treatment of AOSD. Based on a review of the evidence, it has recommended that interleukin-blockers (IL-blockers), anakinra (IL-1) and tocilizumab (IL-6) can be used as a third line treatment for patients where the disease does not respond to corticosteroids and disease modifying anti-rheumatic drugs (DMARDs).
This follows on from NHS England’s Clinical Commissioning Policy on biologics for the treatment of JIA which states that anakinra may be considered for SJIA patients who are intolerant to or do not respond to treatment with methotrexate.
Kineret® is already licenced in the UK for Rheumatoid Arthritis (RA) and Cryopyrin-Associated Periodic Syndromes (CAPS). The new indication follows market authorisation by the European Commission in April 2018 for the use of Kineret® in SJIA and AOSD patients over 8 months old, presenting with active systemic features of moderate to high disease activity, or continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids.
The license authorisation is based on data from clinical trials as well as data from scientific literature and meta-analyses of published data. Overall, the evaluation of the medicine is based on pivotal data from more than 400 patients with Still’s disease, which has evaluated the efficacy and safety of Kineret® in patients with SJIA and AOSD.
Dr Sinisa Savic, Consultant in Clinical Immunology and Allergy at St James’s University Hospital in Leeds, says: “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. No therapy is consistently effective in all cases, so having additional treatments that can be given in a combination with other disease-modifying antirheumatic drugs or as a monotherapy will help to address this unmet need.”
Neil Dugdale, General Manager UK and RoI at Sobi™, states: “We are very pleased that Kineret is now licenced for patients with SJIA and AOSD, 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.”