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Tuesday 18 December 2018
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Topic: Gastroenterology

December 13, 2018
There is growing evidence that the composition of the microbiome is a promising predictive tool for disease and for patient response to therapy in conditions such as IBD, cancer and liver disease
BiomX Ltd, a microbiome company developing customised phage therapies,  has entered into a collaboration with Janssen Research & Development to utilise BiomX’s XMarker microbiome-based biomarker discovery platform. The XMarker platform will be used to stratify responders and non-responders to inflammatory bowel disease (IBD) therapeutics.
 
The collaboration was facilitated by Johnson & Johnson Innovation Limited.
 
December 10, 2018
Men with inflamed guts are four to five times at risk for prostate cancer and are in need of more careful screening
Men with inflammatory bowel disease have four to five times higher risk of being diagnosed with prostate cancer, reports a 20-year study from Northwestern Medicine.
 
This is the first report to show men with inflammatory bowel disease have higher than average PSA (prostate-specific antigen) values, and this group also has a significantly higher risk of potentially dangerous prostate cancer.
 
December 7, 2018
Researchers at the Karolinska Institutet in Sweden have published results showing that online cognitive behavioural therapy can be useful in treating gastrointestinal disorders in children when no physical cause can be found

Cognitive behavioural therapy (CBT) online can be useful in treating gastrointestinal disorders in children when no physical cause can be found.

This is the viewpoint of researchers at Karolinska Institutet in Sweden that is described in a new study published in the journal Clinical Gastroenterology and Hepatology.1

December 6, 2018
Nexvax2 is currently the only disease-modifying therapeutic in clinical development for patients with coeliac disease
December 6, 2018
One-year open-label extension study ongoing, with patients already well treated with ABX464 for a total of 5 to 12 months (induction and maintenance study)
Abivax, a biotechnology company harnessing the immune system to develop treatments for inflammatory/autoimmune diseases, infectious diseases and cancer, has announced that the Data Safety Monitoring Board (DSMB) has recommended continuation of its ongoing 12-month open-label maintenance extension study, ABX464-102, continuing its completed randomised, placebo-controlled Phase IIa induction trial, ABX464-101.
 
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.

December 3, 2018
Faecal calprotectin has a prognostic role for disease course in Crohn's disease and studies have suggested a revision of guidelines to incorporate it as a treatment target
The diagnosis of Crohn’s disease (CD) does not rely on a single gold standard but requires the integration of clinical data with endoscopic, histologic, radiological and biochemical investigations.1
 
December 3, 2018
An international research team from Italy and France has now uncovered a new molecular player in the development of gluten intolerance
Coeliac disease is a severe autoimmune disorder of the intestine. It occurs when people develop sensitivity to gluten, a substance found in wheat, rye, and barley. An international research team from Italy and France has now uncovered a new molecular player in the development of gluten intolerance.
 
Their discovery, published in The EMBO Journal, suggests potential targets for the development of therapeutic approaches for the disease.
 
November 20, 2018
1 in 100 people in the UK has coeliac disease but half a million people in the UK are undiagnosed

Refractory coeliac disease, a deadly form of the autoimmune condition coeliac disease, receives its first dedicated support from NHS England with the setting up of a Rare Disease Collaborative Network (RDCN) to accelerate research and treatment into this life threatening condition.

October 26, 2018
The study, by Erasmus University Medical Centre (EUMC), looked at data from 20 European countries, including the United Kingdom, France and the Netherlands.

The number of patients diagnosed with bowel cancer in Europe has been steadily increasing over the past 25 years, according to new research.
 
Between 2008 and 2016, diagnosis rates for bowel cancer, which is also known as colorectal cancer, increased by 6% every year in adults aged 20 to 39 years old.
 
For colon cancer, rates increased by 1.5% a year between 1990 and 2008, and an even greater 7.4% annually between 2008 and 2016, whereas rectal cancer was slightly slower at 1.8% per year from 1990 to 2016.
 

October 26, 2018
The study, by Erasmus University Medical Centre (EUMC), looked at data from 20 European countries, including the United Kingdom, France and the Netherlands.

The number of patients diagnosed with bowel cancer in Europe has been steadily increasing over the past 25 years, according to new research.
 
Between 2008 and 2016, diagnosis rates for bowel cancer, which is also known as colorectal cancer, increased by 6% every year in adults aged 20 to 39 years old.
 
For colon cancer, rates increased by 1.5% a year between 1990 and 2008, and an even greater 7.4% annually between 2008 and 2016, whereas rectal cancer was slightly slower at 1.8% per year from 1990 to 2016.
 

October 26, 2018
Researchers have said the next step is to explore the potential anti-inflammatory properties of cannabis to treat inflammatory bowel disease

Cannabis oil significantly improves symptoms of Crohn’s disease despite having no effect on gut inflammation, according to new research.
 
The study, revealed at UEG Week conference in Vienna this week, found that cannabis produced clinical remission in up to 65% of individuals after eight weeks of treatment. However, it also found that it did this despite having no effect on gut inflammation, contrary to previous medical thinking.
 

October 25, 2018
New study data also confirm efficacy for Stelara (ustekinumab) in Crohn's disease patients who are naïve and refractory/intolerant to tumour necrosis factor antagonist treatment

Janssen has announced new three-year data from the IM-UNITI study, which demonstrates the continued efficacy of ustekinumab in improving clinical remission rates and shows ustekinumab to be generally well-tolerated in patients with Crohn’s disease.1

The data from the IM-UNITI trial, which will continue for a further two years, were presented today at the 26th United European Gastroenterology Week (UEGW) congress in Austria, Vienna.

August 28, 2018
In undiagnosed, untreated coeliac disease there is a greater risk of complications including anaemia, osteoporosis, and neurological conditions such as gluten ataxia and neuropathy
Coeliac UK, the largest independent charity for people who need to live gluten free, has announced recent research shows diagnosis of the autoimmune disease, coeliac disease, which affects 1 in 100 people, has risen in the UK from 24%1 in 2011 to 30%2 in 2015. 
 
July 11, 2018
The drug will be now available for dose optimisation in UC patients with a body weight of less than 80kg, who do not respond to induction therapy.

The European Commission (EC) has approved a label change for Simponi (golumumab) allowing early dose optimisation in patients with ulcerative colitis (UC).

 

The drug will be now available for dose optimisation in UC patients with a body weight of less than 80kg, who do not respond to induction therapy.

 

July 11, 2018
The drug will be now available for dose optimisation in UC patients with a body weight of less than 80kg, who do not respond to induction therapy.

The European Commission (EC) has approved a label change for Simponi (golumumab) allowing early dose optimisation in patients with ulcerative colitis (UC).

 

The drug will be now available for dose optimisation in UC patients with a body weight of less than 80kg, who do not respond to induction therapy.

 

April 11, 2018
The Scottish Medicines Consortium (SMC) has accepted Shire's Revestive® (teduglutide) for restricted use in children aged one and above with short bowel syndrome

Global biotechnology company Shire has announced that the Scottish Medicines Consortium (SMC) has accepted its Revestive® (teduglutide) 5mg and 1.25mg for restricted use in the treatment of children aged one year and above with short bowel syndrome (SBS).

February 19, 2018
PANTS study shows that CT-P13 is an efficacious therapy option when investigating personalised approaches to anti-TNF therapy

Twelve-month data from the Personalised Anti-TNF therapy in Crohn’s disease Study (PANTS) was presented at the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO).

The results indicate that the clinical effectiveness, safety and immunogenicity of Pfizer and Celltrion Healthcare’s CT-P13 (biosimilar infliximab) in patients with Crohn’s disease (CD) is comparable to those treated with reference infliximab as well as those treated with adalimumab.1

November 2, 2017
CT-P13 shown to be comparable in efficacy and safety to reference infliximab in switched inflammatory bowel disease patients

Celltrion Healthcare and Pfizer have jointly announced data from the Phase III, randomised controlled, switching trial comparing CT-P13 and reference infliximab.

The data showed comparable efficacy and safety between all treatment groups (maintained and switched) in patients with moderate to severe Crohn’s disease (CD) up to one year.1

November 2, 2017
Late-breaking data demonstrate rapid improvement in patient-reported symptoms in patients intolerant or refractory to anti-TNF treatment

Janssen has presented new late-breaking data from UNITI-1 assessing Crohn's disease symptom improvement in patients during the first 2 weeks after an intravenous (IV) infusion dose of Stelara®(ustekinumab).1

The data presented at the 25th United European Gastroenterology Week (UEGW 2017) showed that patient-reported symptom improvement began as early as day 1 post ustekinumab IV infusion and was observed consistently at day 8 and beyond when compared with placebo.1

August 31, 2017
Truberzi® now funded by the NHS, becomes the first IBS-D treatment reviewed and recommended by NICE in a Technology Appraisal Guidance

Allergan has announced that the National Institute of Health and Care Excellence (NICE) has published Final Guidance, with the positive recommendation that Truberzi® (eluxadoline) be made available on the National Health Service for adults living with Irritable Bowel Syndrome with Diarrhoea (IBS-D).1

May 8, 2017
The goals of treatment of short bowel syndrome in children are to promote intestinal adaptation, maintain growth and development, and prevent complications

 

Jaini Shah MPharm PG Dip GPP
Highly Specialist Pharmacist – Paediatric & Neonatal Nutrition, The Royal London Hospital, Barts Health NHS Trust, London, UK

May 5, 2017
NICE recommendations are in line with the licensed indication for ustekinumab, speeding up access for patients with moderately to severely active Crohn’s disease

Janssen has announced that the National Institute for Health and Care Excellence (NICE) has recommended Stelara® (ustekinumab) in its Final Appraisal Determination (FAD) as a treatment option for adult patients with moderately to severely active Crohn’s disease, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF alpha inhibitor or have medical contraindications to such therapies.1

March 1, 2017
With an ever-increasing incidence of IBD and a number of new agents in the pipeline, pharmacists are ideally placed to deal with the increased complexity in cost and treatment decisions in a disease where stratification is still in its infancy

Anja St Clair Jones Dip Pharm MSc