AbbVie has reported that its drug, upadacitinib, met the primary goal and all secondary endpoints at one year in the Phase III maintenance study in ulcerative colitis patients.
Upadacitinib is a selective and reversible JAK inhibitor being analysed as oral treatment in various immune-mediated inflammatory diseases.
The multi-centre, randomised, double-blind, placebo-controlled Phase III maintenance trial assessed the efficacy and safety of 15mg and 30mg once-daily doses of upadacitinib as maintenance treatment in moderate to severe ulcerative colitis patients.
Clinical remission according to the Adapted Mayo Score at one year was the trial’s primary goal. Endoscopic improvement, histologic-endoscopic mucosal improvement (HEMI) and corticosteroid-free clinical remission at one year were some of the secondary goals.
Data showed that 42% and 52% of subjects respectively receiving 15mg and 30mg of upadacitinib had clinical remission at one year versus 12% in the placebo arm.
Furthermore, 49% of the subjects in the upadacitinib 15mg arm and 62% in the 30mg arm experienced endoscopic improvement at one year as against 14% in the placebo arm.
The safety data of both tested doses of the drug is in line with the Phase III induction studies in ulcerative colitis and already known safety profile.
No new safety risks were detected while the most common adverse events in the trial were nasopharyngitis, disease exacerbation and surge in blood creatine phosphokinase.
AbbVie vice-chairman and president Michael Severino said: “Ulcerative colitis is a disease with unpredictable symptoms and frequent flares, which can make daily life challenging.
“We are encouraged by these results that demonstrate upadacitinib’s potential as a treatment option for patients with moderate to severe ulcerative colitis.”
Rinvoq (upadacitinib) obtained approval from the US Food and Drug Administration in August 2019 to treat adults with moderate to severe-rheumatoid arthritis.