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Press Release

New treatment option, Kineret (anakinra), launches in UK for patients with rare inflammatory diseases

SOBI (Swedish Orphan Biovitrum Ltd)
Posted on: 10 Jul 18
New treatment option, Kineret (anakinra), launches in UK for patients with rare inflammatory diseases

PRESS RELEASE

For UK medical and professional media only

Cambridge, UK, 09 July 2018
 

Today, following European Medicines Agency (EMA) authorisation, Sobi™ UK and Republic of Ireland (RoI) 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.(1) However, SJIA begins before 16 years of age,(2) 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).(3)

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.(4,5)

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,(6) 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.(6)

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, says: “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.”

 

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).(6) IL-1 activity is associated with the typical SJIA and AOSD symptoms of arthritis in multiple joints, spiking fever, skin rash, hepatosplenomegaly, and serositis.(6) It is the only IL-1 receptor antagonist indicated for AOSD and SJIA that blocks both IL-1α and IL-1β activity.(6)

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, including that remission is possible.”

 

The burden and the unmet need

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.(7)

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.(7)

SJIA is also rare, and makes up approximately 10% of juvenile idiopathic arthritis (JIA) diagnoses.(7) The estimated UK incidence of SJIA is 0.1 per 10,000 children per year, the equivalent to 100 children diagnosed each year and prevalence of 1 per 10,000 children, the equivalent to 1000 children affected by it at any time.(7)

Treatments for AOSD may include non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids as first-line treatments, methotrexate or other DMARDs as second line treatments, or biologic treatments such as anakinra or tocilizumab as third line treatments.(3)

Treatments used for SJIA include systemic corticosteroids, DMARDs such as methotrexate and biologic therapies such as anakinra or tocilizumab.(4,5)

There are several life-threatening complications which can cause distress, disability and mortality. Patients with Still’s disease have an increased risk of spontaneous development of Macrophage Activation Syndrome (MAS), a life-threatening disorder that is characterised by an uncontrolled activation and proliferation of T lymphocytes and macrophages. A causal relationship between Kineret® and MAS has not been established.(6,8)

 

Further information about Kineret® (anakinra) and its licensed indications can be viewed in the Summary of Product Characteristics - https://www.medicines.org.uk/emc/product/559

 

For more information please contact:

 

Neil Dugdale, General Manager, UK and RoI

T: +44 (0) 1223 891854

E: neil.dugdale@sobi.com

 

Anne-Marie Drummond,

Sales and Marketing Manager

T: +44 (0) 7789 178 070

E: Anne-Marie.Drummond@sobi.com

 

Notes to Editor:

 

About Sobi™

Sobi™ is an international speciality healthcare company dedicated to rare diseases. Our vision is to be recognised as a global leader in providing access to innovative treatments that make a significant difference for individuals with rare diseases.

The product portfolio is primarily focused on treatments in Haemophilia and Speciality Care. Partnering in the development and commercialisation of products in specialty care is a key element of our strategy. Sobi has pioneered in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2017, Sobi had total revenues of SEK 6.5 billion and approximately 850 employees. The share (STO:SOBI) is listed on Nasdaq Stockholm. More information is available at www.sobi.com

 

About Adult Onset Stills Disease (AOSD)

Adult-Onset Still’s Disease (AOSD) is a rare multisystemic autoinflammatory disorder which usually affects young adults between 16 and 35 years of age.(9,10)  Its precise aetiology is unknown; however, the pathogenesis is associated with the activity of proinflammatory cytokines IL-1β and IL-18.9 Mortality rates have been reported to range from 3% in Western countries, and up to 9.8% in chinese populations.(11,12)

AOSD is a diagnosis of exclusion as it has a similar manifestation to several other diseases, which often causes delays in diagnosis.(9) It occurs in either a systemic or an articular form,(9) and may be self-limiting, intermittent or chronic.(3) Symptoms include fever, salmon-pink rash, joint pain, sore throat, enlarged lymph nodes, swelling of the liver and spleen and abdominal pain.(9) Treatments for AOSD may include non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids as first-line treatments, methotrexate or other disease modifying anti-rheumatic drugs (DMARDs) as second line treatments, or biologic treatments such as anakinra or tocilizumab as third line treatments.(3)

 

About Systemic-Onset Juvenile Idiopathic Arthritis (SJIA)

Systemic-Onset Juvenile Idiopathic Arthritis (SJIA) is one of the seven subtypes of Juvenile Idiopathic Arthritis (JIA), accounting for approximately 10% of JIA cases in Europe and the US.2 Onset may occur at any time before the age of 16, but peaks between 1 and 5 years of age.(2)

Whilst its aetiology is unclear, SJIA is thought to be an autoinflammatory disease, and is uniquely characterised by its systemic symptoms.(2) Symptoms of SJIA include joint pain, fever, salmon-pink rash, enlarged lymph nodes and swelling in the liver and spleen.(2) SJIA can manifest as a single flare followed by clinical remission (monocyclic), as multiple flares over a period of time (polycyclic), or as persistent disease.(2)

There is limited data on SJIA mortality, however it may be between 2% and 4%.(13) Approximately 10% of SJIA patients will develop Macrophage Activation Syndrome (MAS), which leads to impaired immune response.(2) The mortality rate due to MAS in SJIA has been reported at 22% to 30%.(14)

Treatments used for SJIA include systemic corticosteroids, disease modifying anti-rheumatic drugs such as methotrexate and biologic therapies such as anakinra or tocilizumab.(4,5)

 

References

  1. Jamilloux Y, et al. Pathogenesis of adult-onset Still’s disease: new insights from the juvenile counterpart. Immunol Res 2015;61:53-62
  2. Grevich S & Shenoi S. Update on the management of systemic juvenile idiopathic arthritis and role of IL-1 and IL-6 inhibition. Adolescent Health, Medicine and Therapeutics 2017; 8:125-135
  3. NHS England, Clinical Commissioning Policy: Anakinra/tocilizumab for the treatment of Adult-Onset Still’s Disease refractory to second-line therapy (adults). Available at: https://www.england.nhs.uk/wp-content/uploads/2018/07/1609-anakinra-and-tocilizumab-for-aosd.pdf Accessed July 2018
  4. NHS England. Clinical Commissioning Policy Statement: Biologic Therapies for the treatment of Juvenile Idiopathic Arthritis (JIA). 2015. Available at: https://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2015/10/e03pd-bio-therapies-jia-oct15.pdf Accessed May 2018
  5. NHS England. Appendix A: Suggested treatment flow-chart for JIA. Clinical Commissioning Policy Statement: Biologic Therapies for the treatment of Juvenile Idiopathic Arthritis (JIA). 2015 Available at: https://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2015/10/e03pd-bio-therapies-jia-oct15.pdf Accessed May 2018
  6. Kineret (anakinra) Summary of Product Characteristics. 2018 https://www.medicines.org.uk/emc/product/559
  7. NHS National Institute for Health Research. Innovation Observatory Evidence Briefing: April 2018 Anakinra for Still’s disease. Available at: http://www.io.nihr.ac.uk/wp-content/uploads/2018/05/13328-Anakinra-for-Stills-Disease-V01.0-APR2018-NON-CONF.pdf. Accessed May 2018
  8. Claudia Bracaglia, Giusi Prencipe, Fabrizio De Benedetti Macrophage Activation Syndrome: different mechanisms leading to a one clinical syndrome Pediatr Rheumatol Online J. 2017; 15: 5. Published online 2017 Jan 17. doi: 10.1186/s12969-016-0130-4 PMCID: PMC5240371
  9. Gerfaud-Valentin M et al. Adult-Onset Still’s disease. Autoimmunity Reviews 2014; 13: 708-722
  10. Al-Homood IA. Biologic treatments for adult-onset Still’s disease. Rheumatology 2014; 53: 32-38
  11. Pouchot J, Sampalis JS, Beaudet F, et al. Adult Still's disease: manifestations, disease course, and outcome in 62 patients. Medicine (Baltimore) 1991; 70:118-36.
  12. Zeng T, Zou YQ, Wu MF, Yang CD. Clinical features and prognosis of adult-onset Still's disease: 61 cases from China. J Rheumatol 2009; 36:1026-31.
  13. Roche – Background information on Systemic Juvenile Idiopathic Arthritis. 2001. Available at: http://partnerships.ifpma.org/uploads/documents/79_1403622897.pdf  Accessed: May 2018.
  14. Boom V, Anton J, Lahdenne P et al. Evidence-based diagnosis and treatment of macrophage activation syndrome in systemic juvenile idiopathic arthritis. Pediatr Rheumatol Online J 2015; 13:55. DOI: 10.1186/s12969-015-0055-3.

 

 

Job no NP-4377

Date of Preparation: May 2018

Swedish Orphan Biovitrum Ltd

Suite 2, Riverside 3, Granta Park,

Great Abington,

Cambridgeshire, CB21 6AD

Editor's Details

Richard Cable
Say Communications
02089716402
rcable@saycomms.co.uk

Last updated on: 10/07/2018

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