Upadacitinib for treating moderately to severely active ulcerative colitis (UC)

Upadacitinib for treating moderately to severely active ulcerative colitis (UC)

Upadacitinib is a selective small molecule that inhibits Janus kinase (JAK) type 1.

• data from two induction and two maintenance Phase III randomized controlled trials (RCTs) proved the efficacy of upadacitinib in achieving clinical and endoscopic remission in patients with moderate-to-severe UC, regardless of previous inadequate response to other biologic therapies (1)
• most often reported adverse effects in the induction trials associated with upadacitinib were:
  • acne,
  • raised creatine phosphokinase,
  • nasopharyngitis,
  • headache, and
  • anemia
• adverse effects reported in maintenance studies included:
  • nasopharyngitis, elevation of creatine phosphokinase, UC exacerbation, upper respiratory tract infection, arthralgia, and anemia

NICE state:

• Upadacitinib is recommended, within its marketing authorisation, as an option for treating moderately to severely active ulcerative colitis in adults:
  • when conventional or biological treatment cannot be tolerated, or
  • if the condition has not responded well enough or has stopped responding to these treatments, and
  • if the company provides upadacitinib according to the commercial arrangement

The NICE committee stated that "..Clinical trial evidence shows that upadacitinib is more effective than placebo for treating moderately to severely active ulcerative colitis. There is no direct evidence comparing upadacitinib with treatments that are offered after conventional treatment..."

Reference:

• Napolitano M, D'Amico F, Ragaini E, Peyrin-Biroulet L, Danese S. Evaluating Upadacitinib in the Treatment of Moderate-to-Severe Active Ulcerative Colitis: Design, Development, and Potential Position in Therapy. Drug Des Devel Ther. 2022 Jun 17;16:1897-1913.
• NICE (January 2023).Upadacitinib for treating moderately to severely active ulcerative colitis