BMJ: ‘Adding a sulfonylurea to metformin looks safer than switching to one’

BMJ: ‘Adding a sulfonylurea to metformin looks safer than switching to one’

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DOACs associated with reduced risk of major bleeding compared to warfarin

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Syphilis and gonorrhoea diagnoses see significant increase

Syphilis and gonorrhoea diagnoses see significant increase

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Anticholinergics linked to increased risk of dementia

Anticholinergics linked to increased risk of dementia

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    BMJ: ‘Adding a sulfonylurea to metformin looks safer than switching to one’

    Wednesday, 25 July 2018 13:55
  • DOACs associated with reduced risk of major bleeding compared to warfarin

    DOACs associated with reduced risk of major bleeding compared to warfarin

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  • Recorded penicillin allergy associated with increased risk of MRSA and C difficile

    Recorded penicillin allergy associated with increased risk of MRSA and C difficile

    Tuesday, 03 July 2018 16:42
  • Syphilis and gonorrhoea diagnoses see significant increase

    Syphilis and gonorrhoea diagnoses see significant increase

    Monday, 11 June 2018 14:16
  • Anticholinergics linked to increased risk of dementia

    Anticholinergics linked to increased risk of dementia

    Monday, 30 April 2018 12:08

Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
More inWhite Papers  

testtubes2December 7 2015

This milestone brings potentially efficacious treatment a step closer to people suffering with Crohn's disease in the United Kingdom.


 
Today Janssen announced that it has submitted a Grouped Type II Variation/Extension Application to the European Medicines Agency (EMA) seeking approval of STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active Crohn's disease.


 
Crohn’s disease is a chronic inflammatory bowel disease that affects the lining of the digestive tract. It affects approximately 115,000 people in the UK and is associated with abnormalities of the immune system that could be triggered by a genetic predisposition or diet and other environmental factors. The cause of Crohn’s disease is not known and there is currently no cure.
 
A recent study suggests the number of young people in England admitted to hospital with the disease has risen dramatically. According to the Health and Social Care Information Centre, 4,937 16 to 29-year-olds were admitted for treatment in England in 2003/4. In 2013, the figure nearly quadrupled to 19,405.
 
Data from the Phase 3 UNITI clinical development program, which includes three studies (UNITI-1, UNITI-2 and IM-UNITI) evaluating the efficacy and safety of ustekinumab induction and maintenance treatment in patients with moderately to severely active Crohn's disease, served as the basis for the application. Data from the UNITI-2 study were recently presented at the American College of Gastroenterology and United European Gastroenterology Week annual meetings, and results from the UNITI-1 and IM-UNITI studies will be presented at future medical congresses.
 
Dr Rozlyn Bekker, Medical Director at Janssen UK commented: “At Janssen, we are committed to ensuring that people living with Crohn’s disease can access and benefit from a variety of treatment options. We are pleased to submit the application seeking approval of ustekinumab for the treatment of moderately to severely active Crohn's disease in Europe. When the time comes, we look forward to working closely with NICE and others to ensure that this important treatment is made available to patients."
 
STELARA®, which is approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in the UK, is a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines. These cytokines are believed to play an important role in immune-mediated diseases, including Crohn's disease.

About Crohn's disease

More than five million people worldwide are living with Crohn's disease and ulcerative colitis—collectively known as inflammatory bowel disease (IBD).

Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract that affects approximately 700,000 Americans2 and nearly 250,000 Europeans.

Symptoms of Crohn's disease can vary but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss and fever. There is currently no cure for Crohn's disease.

About STELARA® (ustekinumab)

STELARA®, a human IL-12 and IL-23 antagonist, is approved in the UK for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, MTX or psoralen plus ultraviolet A (PUVA).

STELARA® is also indicated for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older who are inadequately controlled by or are intolerant to other systemic therapies or phototherapies.

In addition, STELARA® is approved alone or in combination with MTX for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.

Links:

Janssen

EU prescribing information

Crohn's disease

Clinical News

July 31 2018 General practices employing pharmacists are citing improved capacity to see patients and workload changes as the main benefits of the scheme.
July 25 2018 Switching to sulfonylureas in type 2 diabetes has been linked with an increased risk of complications compared with staying on metformin, a BMJ study has concluded. However, the study has...