UNITED KINGDOM — The National Institute for Health and Care Excellence (NICE) has given AbbVie positive Final Draft Guidance, recommending Rinvoq (upadacitinib) as a once-daily pill treatment for people with moderate-to-severely active ulcerative colitis (UC).
The recommendation is specifically for adults with immune-mediated inflammatory bowel disease, for whom conventional or biologic treatments cannot be tolerated, or for those who have found that the condition has not responded well enough or have stopped responding to treatments.
NICE’s decision is based on data taken from the induction studies, U-ACHIEVE and U-ACCOMPLISH, as well as the phase 3 U-ACHIEVE maintenance study and covers treatment access for patients in England and Wales.
The three studies showed the efficacy of Rinvoq compared to placebo in its ability to achieve clinical remission at the eighth and fifty-second week.
The recommendation allows for further access for UC patients across the UK, as the decision closely follows the Scottish Medicines Consortium’s acceptance of Rinvoq in October 2022.
In the UK, UC affects approximately 300,000 people and the burden of the disease is considerable because of the severity of the symptoms and uncertainty surrounding flares.
Per year, the financial cost of treating a flare, or relapse, may be up to six times greater than for treating a person in remission.
Although there are a number of treatments available for UC, a significant number of patients do not respond well to therapy still remain, while others can experience a loss of treatment efficacy.
Evaluations of the efficacy and safety profile of Rinvoq have been conducted in adults with moderately-to-severely active UC, while safety results have proved to be consistent with the known safety profile of Rinvoq in other licensed indications.
Rinvoq is used to treat adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis, moderate to severe ulcerative colitis, active ankylosing spondylitis, and active non-radiographic axial spondyloarthritis.
Meanwhile, in an effort to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended updates to the dosage regimen, special warnings, and precautions for JAK inhibitors.
The indications include chronic inflammatory disorders, such as rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, ulcerative colitis, atopic dermatitis, and alopecia areata.
The recommendations are based, in particular, on the final results from a clinical trial of the JAK inhibitor tofacitinib (Xeljanz), compared with a tumor necrosis factor (TNF) inhibitor, and on preliminary findings from an observational study involving baricitinib (Olumiant), another JAK inhibitor.
If the European Commission adopts the EMA’s opinion at the end of the year, the product information for JAK inhibitors used to treat chronic inflammatory disorders will be updated with new recommendations and warnings.
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