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Wednesday 22 May 2019
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Topic: Rheumatology

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.

 

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.
 

March 1, 2018
Simplified administration and improved safety (needle protection) associated with greater treatment compliance

In January 2013, Medac, the market leader in parenteral methotrexate (MTX), introduced MTX in the pharmaceutical form of a pre-filled pen in Germany for the first time worldwide. This was a brand-new innovation for doctors, practice teams and patients who, until then, had been used to the established methotrexate pre-filled syringe metex®.1

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.

 

The opinion is now referred to the European Commission for a decision.
 

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 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®.

 

November 9, 2017
Ustekinumab showed significant improvements in various disease measures compared with placebo, including musculoskeletal, mucocutaneous, immunological markers and flares

Janssen has announced positive results from a randomised, placebo-controlled Phase II study investigating the anti-interleukin (IL)-12/23 monoclonal antibody Stelara® (ustekinumab) in the treatment of active systemic lupus erythematosus (SLE or lupus).

 

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 14, 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 14, 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

 

June 14, 2017
Only 6.6% of patients over the age of 50 started osteoporosis treatment within one year of first fracture according to Swedish Observational Study

UCB has announced results from a comprehensive real world database analysis that assessed the rates of osteoporosis treatment initiation within one year following a first fracture in patients in Sweden.

 

The data showed that only 6.6% of patients, who were treatment naive, were initiated on osteoporosis treatment.1 This analysis, performed by Quantify Research and funded by UCB, was presented today at the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid, Spain.
 

May 5, 2017
Kevzara is an investigational human monoclonal antibody directed against the IL-6 receptor

Sanofi and Regeneron Pharmaceuticals have announced that the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorisation of Kevzara® (sarilumab), recommending its approval for use in adult patients with moderately to severely active rheumatoid arthritis.

 

May 5, 2017
Alternatives to biologic medicines will shake up rheumatoid arthritis sufferers’ treatment regimes

The National Rheumatoid Arthritis Society (NRAS) launched an informative video at the British Society of Rheumatology (BSR) conference to help rheumatoid arthritis sufferers understand upcoming potential changes to their medication.

May 5, 2017
Sandoz receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases. Biosimilar rituximab also recommended to treat blood cancers

Sandoz has announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both the biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines.
 

August 4, 2016
Sanofi and Regeneron announce EMA Acceptance for review of marketing authorisation application for sarilumab

Sanofi and Regeneron Pharmaceuticals have announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) for sarilumab, an investigational human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).1

February 29, 2016
Eli Lilly and Company announced that ixekizumab [TALTZ®] has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use

Eli Lilly and Company announced that ixekizumab [TALTZ®] has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of moderate-to-severe plaque psoriasis in adults in the European Union (EU) who are candidates for systemic therapy,1 Ixekizumab is specifically designed to target the cytokine interleukin IL-17A, a protein that plays a key role in driving underlying inflammation in psoriasis.2

 

February 29, 2016
The National Ankylosing Spondylitis Society (NASS) has launched a new campaign aimed at ophthalmologists, dermatologists and gastroenterologists called Back Pain Plus

The National Ankylosing Spondylitis Society (NASS) has launched a new campaign aimed at ophthalmologists, dermatologists and gastroenterologists called Back Pain Plus. The initiative aims to encourage professionals in these fields to think about the link between axial spondyloarthritis including ankylosing spondylitis (AS) and acute anterior uveitis (AAU), psoriasis and inflammatory bowel disease (IBD).
 

As it stands:

September 30, 2015
Celgene working with NICE to ensure OTEZLA is made available to patients in England and Wales as soon as possible

The National Institute for Health Care and Excellence (NICE) has issued a Final Appraisal Determination (FAD) not recommending OTEZLA® (apremilast), a novel oral treatment for adults with moderate to severe plaque psoriasis, for use within NHS England and Wales. (1)

 

September 4, 2015
NICE recommends RoActemra® (tocilizumab) as monotherapy for treatment of severe rheumatoid arthritis

As many as 20,000 patients in England and Wales with severe rheumatoid arthritis (RA) could soon benefit from RoActemra monotherapy, after the National Institute for Health and Care Excellence (NICE) issued a positive Final Appraisal Determination (FAD), recommending the medicine for use on the NHS.

 

September 3, 2015
Pfizer welcomes the decision from the National Institute for Health and Care Excellence (NICE) to support continued access to biologic disease-modifying anti-rheumatic drugs

Pfizer welcomes the decision from the National Institute for Health and Care Excellence (NICE) to support continued access to biologic disease-modifying anti-rheumatic drugs (DMARDs) such as Enbrel® (etanercept) for patients with severe rheumatoid arthritis (RA) in England and Wales. (1)

The Final Appraisal Determination (FAD) issued by NICE follows a technology appraisal reviewing the most commonly prescribed biologic DMARDs for the treatment of the condition.
 

June 26, 2015
Adults with non-radiographic axial spondyloarthritis can be considered for once-monthly subcutaneous injection with SIMPONI® (golimumab)

MSD (Merck & Co., Inc., Kenilworth, New Jersey, USA) announced that on 22 June the European Commission approved SIMPONI® (golimumab) for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA). This follows CHMP positive opinion issued in May 2015, (1) based on the findings from the GO-AHEAD study, which demonstrated significant clinical improvement in patients with active nr-axial SpA treated with SIMPONI®, compared with patients treated with placebo, over 16 weeks. (2)

 

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