Examining the Evidence That Led to the FDAs Approval of Upadacitinib for Crohns Disease

What is Upadacitinib (Rinvoq) and How Does it Treat Crohn’s Disease?

Upadacitinib (Rinvoq) is a selective Janus kinase (JAK) inhibitor developed as a potential treatment for Crohn’s disease. JAK is involved in cytokine signaling pathways associated with inflammation, so blocking its activity can help reduce the inflammation caused by Crohn’s. In clinical trials, the drug was found to improve clinical remission and endoscopic response rates compared to placebo in patients with moderate-to-severe forms of the disease.

The Efficacy of Upadacitinib in Crohn’s Disease

The efficacy of upadacitinib in treating Crohn’s disease was evaluated in two induction trials and one maintenance trial. The induction trials, U-STORM and U-BILD, included 412 and 503 patients respectively. They found that 30 and 45 mg doses of upadacitinib led to significantly higher proportions of clinical remission and endoscopic response than placebo at week 12. The maintenance trial, U-ENDURE, had 502 patients and showed that patients taking 30 or 45 mg doses of upadacitinib had a significantly higher rate of clinical remission at week 52 than those taking placebo.

Safety and Side Effects of Upadacitinib

Although upadacitinib was generally well tolerated in these studies, there were some side effects associated with the drug, with the most common being herpes zoster infections. In the U-ENDURE trial, the incidence of herpes zoster infections was 3.9%, 4.9%, and 1.4% in the 15-mg, 30-mg, and placebo groups respectively.

The Bottom Line

Upadacitinib (Rinvoq) has shown promise in treating moderate-to-severe Crohn’s disease, with clinical trials demonstrating improved clinical remission and endoscopic response rates compared with placebo. However, there are potential side effects to consider, such as herpes zoster infections, which occurred more frequently in the groups receiving the 45-mg and 30-mg doses of upadacitinib compared with placebo. If you have Crohn’s disease and are considering this treatment option, talk to your doctor about the potential benefits and risks of upadacitinib.