Johnson & Johnson has announced that the Scottish Medicines Consortium (SMC) has accepted Tremfya® (guselkumab) for use in NHS Scotland for adult patients with moderately to severely active Crohn’s disease and ulcerative colitis.1,2
Guselkumab can be used as an option for Crohn’s disease for those who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.1
Guselkumab can be used for ulcerative colitis as an option for those who have had an inadequate response, lost response, or were intolerant to either conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.2
This acceptance is based on multiple phase 3 trials which evaluated the efficacy and safety of guselkumab in Crohn’s disease and ulcerative colitis.1,2,b For Crohn’s disease, both the GALAXI and GRAVITI studies found that patients treated with guselkumab demonstrated statistically significant higher rates of clinical remission and endoscopic response compared to placebo at week 12.5,11
In ulcerative colitis, the QUASAR studies reported statistically significant improvements in clinical remission for guselkumab recipients verus placebo, at both week 12 (induction) and week 44 (maintenance, QUASAR only).12
The safety results from the GALAXI, GRAVITI and QUASAR studies proved similar to the known safety profile of guselkumab in approved indications 5,11,12,c
The most prevalent forms of IBD are Crohn’s disease and ulcerative colitis. In Scotland, these conditions affect one in every 103 people, with the capital, Edinburgh, exhibiting some of the highest known rates of IBD in the world.
In Lothian, Edinburgh’s region, the prevalence of people living with either ulcerative colitis or Crohn’s disease is one in 125. This is predicted to rise to one in 98 by 2028.10,13,14,a
The SMC’s acceptance follows the August publication of Final Guidance from the National Institute for Health and Care Excellence (NICE) recommending the use of the treatment for adult patients with moderately to severely active Crohn’s disease and ulcerative colitis.3,4
In May this year, the Medicines and Healthcare products Regulatory Agency’s (MHRA) issued the marketing authorisation of guselkumab for moderately to severely active Crohn’s disease and ulcerative colitis.15
References were supplied.
