The co-primary endpoints of endoscopic response (visible reduction of intestinal lining damage) and clinical remission were achieved by significantly more patients treated with Rinvoq (upadacitinib) at week 12 and week 52 versus placebo
US-based pharmaceutical company AbbVie has received the US Food and Drug Administration (FDA) approval for Rinvoq (upadacitinib) to treat a type of active Crohn’s disease in adults.
Rinvoq is a selective JAK inhibitor, previously approved in the US for several indications across rheumatology, dermatology, and gastroenterology.
The FDA approval expands its indication to include adults with moderate to severe active Crohn’s disease, who are intolerant to tumour necrosis factor blockers (TNF-blockers).
Rinvoq is currently being evaluated in Phase 3 studies in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis, and Takayasu arteritis.
AbbVie chief scientific officer and research and development senior vice president Thomas Hudson said: “AbbVie recognises the need for more treatment options for Crohn’s disease that can help address both rapid relief of symptoms along with the visible reduction of intestinal lining damage.”
The FDA approval is supported by data from two induction studies, U-EXCEED and U-EXCEL, along with the U-ENDURE maintenance study.
The two induction studies met the co-primary endpoints and key secondary endpoints.
In the two studies, 34% and 46% of patients treated with Rinvoq 45mg achieved endoscopic response, respectively at week 12, compared to 3% and 13% of patients receiving placebo.
Endoscopic response is defined as a decrease in more than 50% Simplified Endoscopic Score for SES-CD or, at least a two points reduction from baseline.
In the maintenance study, patients treated with Rinvoq 15mg and 30mg showed endoscopic responses of 28% and 41%, at week 52, compared to 7% in patients receiving placebo.
The drug showed clinical remission in 36% and 46% of patients in the two induction studies, compared to 18% and 23% of patients receiving placebo, at 12 weeks.
In addition, 42% and 55% of patients treated with Rinvoq 15mg and 30mg in the maintenance trial achieved clinical remission at 52 weeks, respectively, compared to 14% of patients receiving placebo.
Rinvoq showed an overall safety profile in patients with Crohn’s disease, that was consistent with the known safety profile for the drug in other indications.
Furthermore, the drug may cause serious side effects, including serious infections, risk of death in older population, cancer and immune system problems, and allergic reactions, said AbbVie.
U-EXCEL study investigator Edward V Loftus, Jr. said: “Symptoms of moderately to severely active Crohn’s disease can be disruptive and uncomfortable for patients, so relief as early as possible is key.
“Given the progressive nature of the disease, endoscopic response is just as important.
“Based on the clinical trial results, treatment with Rinvoq shows both early and long-term symptom relief along with evidence of a visible reduction of damage to the intestinal lining caused by excess inflammation.”