Guideline review: Tofacitinib for adults with moderately to severely active ulcerative colitis - NICE guidance.
Akudo NwaoguAshley BondPhilip J SmithPublished in: Frontline gastroenterology (2020)
Tofacitinib is an oral, Janus kinase (JAK) molecule, which selectively inhibits Janus-associated tyrosine kinases JAK1 and JAK3. It has already shown efficacy in the treatment of rheumatoid arthritis and the prevention of organ allograft rejection in kidney transplantation. Two separate phase III placebo-controlled trials, assessing 8-week efficacy of tofacitinib induction for ulcerative colitis (UC), demonstrated superiority when compared with placebo. Tofacitinib also demonstrated robust efficacy versus placebo in the 52-week maintenance component of the same study. Tofacitinib has been recommended by the National Institute for Health and Care Excellence as an effective treatment option for adult patients with moderate to severe UC when conventional therapy or a biological agent cannot be tolerated or the disease has responded inadequately or lost response to treatment. We review the guidelines and provide brief commentary on the post hoc analysis related to lipid increases and thromboembolism risk, which have lead to changes in current therapeutic guidance.
Keyphrases
- ulcerative colitis
- rheumatoid arthritis
- phase iii
- placebo controlled
- kidney transplantation
- double blind
- healthcare
- clinical trial
- public health
- randomized controlled trial
- squamous cell carcinoma
- palliative care
- mental health
- risk assessment
- mesenchymal stem cells
- systemic lupus erythematosus
- study protocol
- climate change
- fatty acid
- early onset
- rectal cancer
- social media
- replacement therapy
- high intensity
- human health