The approved drug has been developed to treat patients with moderate to severe Crohn’s disease
AbbVie has announced that the National Institute for Health and Care Excellence (NICE) has delivered a positive Final Draft Guidance (FDG) recommending its Rinvoq therapy for the treatment of moderately to severely active Crohn’s disease.
The therapy – also known as upadacitinib – will be used among patients whose condition has not responded well enough, or has lost response, to a previous biological treatment. It also involves individuals who have not tolerated a previous biological treatment.
The NICE recommendation is based on data emerging from three phase 3 studies, which have shown that many patients treated with upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response. Clinical remission was measured by patient-reported symptoms of stool frequency/abdominal pain.
Dr Alexandra Kent, consultant gastroenterologist at King's College Hospital NHS Trust, reflected: “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.”
She added: “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 additional treatment option that is available as a once daily pill is a positive step forward.”
Belinda Byrne, medical director at AbbVie UK, explained: “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.”
She added: “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.”
Sarah Sleet, chief executive officer at Crohn’s and Colitis UK, concluded: “The pain, physical symptoms and complications of Crohn’s disease should not be underestimated. Often starting at 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.”
Around 155,000 adults are living with Crohn’s condition in the UK. It is a chronic, progressive condition of the digestive system, associated with inflammation and mucosal ulceration.