MHRA approves Rinvoq for moderate to severe Crohn’s disease

13th February 2023

Upadacitinib (brand name Rinvoq) was previously been approved for ulcerative colitis and is now licensed in moderate to severe Crohn’s disease.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has now approved upadacitinib for use in patients with moderate to severely active Crohn’s disease and who have had either an inadequate response or were intolerant to, conventional therapy or a biological agent.

Crohn’s disease is a form of inflammatory bowel disease that affects any part of the gastrointestinal tract and which is thought to affect around 10 million people worldwide and has a major impact on health-related quality of life.

Patients with Crohn’s will often receive oral corticosteroids to manage a disease flare, although those with more severe disease receive biologics either with or without immunomodulators to induce and maintain remission.

Upadacitinib is a Janus kinase inhibitor and a Phase II trial, evaluating the efficacy of 3 mg, 6 mg, 12 mg 24 mg twice daily or 24 mg daily, concluded that the drug induced endoscopic remission in a significant proportion of patients in comparison to placebo.

The MHRA decision was based on the findings of three other clinical studies and are reported in the press release.

In the first, U-EXCEED, a significantly higher proportion of patients treated with upadacitinib 45 mg daily achieved clinical remission per SF/AP at week 12 compared to placebo (40% vs 14%, p<0.001) and an endoscopic response compared to placebo (35% vs 4%, p<0.001).

In the second trial, U-EXCEL, again more patients given a 12-week induction regimen of upadacitinib 45 mg daily achieved clinical remission (51% vs 22%, p < 0.001) and endoscopic response (46% vs 13%, p < 0.001) compared to placebo.

In the third study, U-ENDURE which was a maintenance trial, patients who had responded to 12 weeks of upadacitinib 45 mg, were re-randomised to 15 mg, 30 mg or placebo and assessed at week 52.

The results showed that clinical remission occurred in 36 and 46% respectively (i.e., for 15 and 30 mg) compared to 14% for placebo (p < 0.001).

Similarly, endoscopic response occurred in 28 and 40% compared to 7% in the placebo group (p < 0.001).

Interestingly, a recently published real-world study of upadacitinib in patients with Crohn’s disease has shown that the drug induced subjective and objective responses in 25% and 42% of patients, respectively.

Updated information on the indications for rinvoq can be found in the summary of product characteristics.