It’s today been announced that the National Institute for Health and Care Excellence (NICE) has issued positive Final Draft Guidance (FDG) recommending the biological drug for RINVOQ® (upadacitinib) as an option for treating moderately to severely active Crohn’s disease (CD) in adults. The drug will be an option when the condition has not responded well enough or has lost response to a previous biological treatment, or when a previous biological treatment was not tolerated, or when tumour necrosis factor [TNF]-alpha inhibitors are contraindicated.
It is estimated that over 155,000 adults are living with the condition in the UK and almost half have moderate or severe CD;a chronic, progressive condition of the digestive system, associated with inflammation and mucosal ulceration. Alongside ulcerative colitis, CD is a type of inflammatory bowel disease.
Uncontrolled CD leads to inflammation of the digestive system and results in over 20% of people with the condition undergoing surgery within five years of diagnosis. It is most commonly first diagnosed in those aged 20 to 30 and the number of people diagnosed is set to rise in the UK.
“The pain, physical symptoms, and complications of Crohn’s disease should not be underestimated.
Often starting at a pivotal time during young adulthood, it can lead to low quality of life and have a
significant impact on people’s daily activities and work, as well as having mental health consequences
including depression and anxiety”, said Sarah Sleet, Chief Executive Officer, Crohn’s and Colitis UK. “It
can be difficult for people with Crohn’s disease to find a suitable treatment that works for them or
continues to work for them, so new options are of vital importance.”
“As a progressive disease, it is imperative that we help people with Crohn’s disease to achieve disease
control and improve their quality of life.” said Dr. Alexandra Kent, Consultant Gastroenterologist at
King’s College Hospital NHS Trust says “There has been a lack of new advanced therapies made available on the NHS to treat Crohn’s disease for over half a decade. Being able to offer eligible people an
an additional treatment option that is available as a once-daily pill is a positive step forward.”
The NICE recommendation is based on data from three Phase 3 clinical trials, which demonstrated that
significantly more patients treated with the drug achieved the endpoints of clinical
remission and endoscopic response, with clinical remission measured by the patient-reported
symptoms of stool frequency/abdominal pain.
“We are pleased that NICE has recommended upadacitinib for eligible people with Crohn’s disease on
the NHS in England and Wales. This is another important milestone for the inflammatory bowel disease
community, as it follows NICE’s recommendation for upadacitinib in ulcerative colitis last year,” said
Belinda Byrne, Medical Director, AbbVie UK. “We are committed to using our extensive immunology
experience and working tirelessly to ensure as many people as possible with this debilitating condition
can find a treatment that has the potential to have a significant impact on their life.”