Kineret (anakinra) has been made available for use in the UK for the treatment of 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.
In addition, 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, and therefore requiring further treatment to control their disease.
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.
It is difficult to diagnose SJIA and AOSD as there are no specific clinical tests to differentiate them from similar disorders, therefore diagnosis is usually based on clinical evaluation, patient history, identification of characteristic findings, and exclusion of other possible disorders.
AOSD has an estimated incidence of 1-2 per 1,000,000 and incidence of 55-110 cases each year in England. Prevalence is estimated at 400-800 patients in England.
Commenting on the launch and the publication of the NHS England policy Dr Sinisa Savic, Consultant in Clinical Immunology and Allergy at St James’s University Hospital in Leeds, said: “This is an important step in providing additional therapeutic options for the UK Still’s patients, especially for those who have not responded to previous treatments. 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. 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.”