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Saturday 19 January 2019
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Topic: Rheumatology

December 17, 2018
Early diagnosis is mandatory in order to start treatment before irreversible tissue damage takes place and this approach results in a better prognosis (that is, less organ damage) and in reduced costs of the disease

 

December 6, 2018
Harmonisation of the diagnostic performance of existing serological assays, finding novel markers to reduce the diagnostic limitation of seronegativity and exploring the predictive value of autoantibodies are the major goals of serodiagnostic research in rheumatoid arthritis

Rheumatoid arthritis (RA) is a prevalent chronic inflammatory autoimmune disease mainly characterised by joint swelling and pain, affecting approximately 0.5–1% of the population in industrialised countries.1

December 6, 2018
Observations from a recent Phase II trial support further development of ustekinumab as a new therapy for SLE, and results from Phase III trials are awaited

Development of new treatments for systemic lupus erythematosus (SLE) has been challenging.

Many components of the immune system have been identified as targets for novel therapies, but the majority of the clinical trials have failed. However, many trials are ongoing and some of them have reported promising preliminary results.

December 3, 2018
An opinion from the CHMP is expected in the second half of 2019

Celltrion has announced that the European Medicines Agency (EMA) has accepted for review of the Extension Marketing Authorisation Application for ‘Remsima SC’, the subcutaneous (SC) version of Remsima®, the autoimmune disease therapeutic antibody biosimilar of infliximab.

November 27, 2018
NHS on track to make £300m in savings after adalimumab deals

The NHS is on track to make record savings of £300m after negotiating deals on low cost versions of the health service’s most expensive drug.
 
Deals with five manufacturers have been made to on biosimilar versions of adalimumab. The drug is used to treat 46,000 patients with conditions including rheumatoid arthritis, inflammatory bowel disease and psoriasis.
 
The savings will mean hospitals will pay around a quarter of the amount they usually spend on adalimumab, which is over £400m each year.
 

November 27, 2018
NHS on track to make £300m in savings after adalimumab deals

The NHS is on track to make record savings of £300m after negotiating deals on low cost versions of the health service’s most expensive drug.
 
Deals with five manufacturers have been made to on biosimilar versions of adalimumab. The drug is used to treat 46,000 patients with conditions including rheumatoid arthritis, inflammatory bowel disease and psoriasis.
 
The savings will mean hospitals will pay around a quarter of the amount they usually spend on adalimumab, which is over £400m each year.
 

October 17, 2018
Imraldi is approved in Europe for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis and axial spondyloarthritis with radiographic evidence of AS

ImraldiTM is approved in the European Union (EU) for 13 of the same complex autoimmune conditions as its reference product and is now available in the UK via the NHS.

Imraldi is approved in Europe for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis; enthesitis-related arthritis), axial spondyloarthritis (ankylosing spondylitis (AS) and axial spondyloarthritis with radiographic evidence of AS).

October 2, 2018
Progress in treating rheumatoid arthritis has been achieved with Janus kinase inhibitors, orally available disease-modifying anti-rheumatic drugs targeting the intracellular kinase JAK and having similar efficacies to biologics
Rheumatoid arthritis (RA) is a systemic autoimmune disease characterised by inflammation, synovitis and progressive destruction of the articular cartilage and underlying bone, along with various extra-articular manifestations. Cytokines act as soluble mediators responsible for the inflammatory process, activating endothelial cells and attracting immune cells to accumulate within the synovial compartment.1
 
October 2, 2018
There is now a better understanding of autoimmunity in systemic lupus erythematosus, which has led to improved therapeutic strategies, but revolutionary treatments have yet to be discovered
Systemic lupus erythematosus (SLE) is a chronic inflammatory autoimmune disorder that predominantly affects women of child-bearing age with a ~9:1 female-to-male ratio. Patients with SLE suffer an impaired health-related quality of life (HRQoL), and experience fatigue and pain as major problems. 
 
October 2, 2018
Giant cell arteritis remains a clinical emergency, which can lead to irreversible sight loss. New ‘Fast Track Pathways’, diagnostics and treatments are improving the standard of care and outcomes
Giant cell arteritis (GCA) remains a rheumatology emergency. Critical ischaemia of the temporal arteries can lead to anterior ischaemic optic neuropathy and irreversible sight loss. This is a significant cause of morbidity among these patients, not least due to subsequent loss of independence and depression. If the symptoms of GCA are recognised promptly and treated appropriately, then the incidence of this catastrophic event could be reduced.
 
October 1, 2018
The ability to understand and manage psoriatic arthritis has progressed enormously over the past few years and we are thus approaching a more personalised approach
July 12, 2018
Patients with rare autoinflammatory diseases in the UK have a new treatment option with the launch of Kineret following approval from the European Medicines Agency earlier this year.

Patients with rare autoinflammatory diseases in the UK have a new treatment option with the launch of Sobi’s Kineret following approval from the European Medicines Agency (EMA) earlier this year.

The drug is already licensed in the UK for treating rheumatoid arthritis and cryopyrin-associated periodic syndromes (CAPS). It will now be available to patients with adult onset Stills disease (AOSD) and systemic-onset juvenile idiopathic arthritis (SIJA), which impacts children under the age of 16 years.

July 12, 2018
Patients with rare autoinflammatory diseases in the UK have a new treatment option with the launch of Sobi’s Kineret following approval from the European Medicines Agency (EMA) earlier this year.

Patients with rare autoinflammatory diseases in the UK have a new treatment option with the launch of Sobi’s Kineret following approval from the European Medicines Agency (EMA) earlier this year.
 
The drug is already licensed in the UK for treating rheumatoid arthritis and cryopyrin-associated periodic syndromes (CAPS). It will now be available to patients with adult onset stills disease (AOSD) and systemic-onset juvenile idiopathic arthritis (SIJA), which impacts children under the age of 16 years.
 

February 27, 2018
Adult-onset Still’s disease and systemic juvenile idiopathic arthritis are rare systemic disorders of auto-inflammatory nature, which share common clinical manifestations such as daily spiking fever, typical transient cutaneous rash, arthritis and serositis

Sobi has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for anakinra for the treatment of Still’s disease.

February 22, 2018
Still’s disease is a serious orphan disease manifested by high fevers, skin and joint involvement, including paralysis, as well as damage to other organs such as the liver or spleen

In its adult form, Still’s disease affects about 1 in 100,000 people each year, with its infantile form being ten times more common. This rare condition can take different forms: monocyclic, polycyclic or chronic, leading to attacks on several organs that may threaten the quality of life - or even life - of those affected.

January 23, 2018
Ixekizumab is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor

Eli Lilly and Company has announced that the European Commission has granted marketing authorisation (MA) for Taltz® (ixekizumab), alone or in combination with methotrexate, for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drug (DMARD) therapies.1,2,3

November 17, 2017
Robust analytical, pharmacological, non–clinical and clinical data demonstrated the similarity of Cyltezo® to Humira®

Boehringer Ingelheim has announced that the European Commission has granted marketing authorisation for Cyltezo® a biosimilar to Humira® for the treatment of multiple chronic inflammatory diseases in adults and children.

November 16, 2017
Adult-onset Still’s disease and systemic juvenile idiopathic arthritis are rare systemic disorders of auto-inflammatory nature

Swedish Orphan Biovitrum AB has announced that the first patient has been randomised in the Phase III study anaSTILLs, to evaluate efficacy and safety of anakinra in the treatment of Still’s disease.

November 16, 2017
Adult-onset Still’s disease and systemic juvenile idiopathic arthritis are rare systemic disorders of auto-inflammatory nature

Swedish Orphan Biovitrum AB has announced that the first patient has been randomised in the Phase III study anaSTILLs, to evaluate efficacy and safety of anakinra in the treatment of Still’s disease.

November 9, 2017
48-week Phase III data showed Cyltezo® and Humira® have similar efficacy, safety and immunogenicity in people with rheumatoid arthritis

Boehringer Ingelheim has announced one-year data from Voltaire®-RA, a pivotal Phase III clinical trial comparing Cyltezo® (adalimumab-adbm) and reference product Humira®.

September 18, 2017
Positive opinion follows the recent FDA approval of Cyltezo

Boehringer Ingelheim has  announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorisation Application of Cyltezo® (adalimumab biosimilar), to treat multiple chronic inflammatory diseases in adults and children.

The decision of the European Commission on the approval is expected in the fourth quarter of 2017.

June 29, 2017
The EC approval is based upon receipt of a positive opinion by European Medicine Agency's Committee for Medicinal Products for Human Use, which evaluated results from seven Phase III trials in the global SARIL-RA clinical development program

Regeneron Pharmaceuticals and Sanofi have announced that the European Commission (EC) has granted marketing authorisation for Kevzara® (sarilumab) in combination with methotrexate (MTX) for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs), such as MTX.

June 15, 2017
­Sustained efficacy was shown over 48 weeks irrespective of BMI in a Phase III rheumatoid arthritis study that demonstrated equivalent efficacy between Truxima® and reference rituximab

New data presented at the International Conference on Malignant Lymphoma (ICML) and the European League Against Rheumatism (EULAR) congress 2017 demonstrate that CT-P10 is comparable to reference rituximab in terms of efficacy and safety in both oncology and autoimmune disease indications.

June 15, 2017
Sirukumab Phase III data presented at the Annual European Congress of Rheumatology (EULAR) 2017 also show significant improvement in quality of life measures

Janssen-Cilag International NV has announced long-term results from SIRROUND-T, a pivotal Phase III study that showed sirukumab improved the signs and symptoms of moderately to severely active rheumatoid arthritis (RA) through 52 weeks of treatment in adult patients with an inadequate response and/or intolerance to anti-tumour necrosis factor (TNF)-alpha treatments.1