AbbVie Inc.'s upadacitinib maintained its treatment response among patients with Crohn's disease in the 36-week extension period of a phase 2 study.
The phase 2 study, named Celest, evaluated upadacitinib for treating patients with moderately to severely active Crohn's disease, an inflammation of the digestive tract.
The patients in the study also had a history of inadequate response or intolerance to an immunomodulator, a drug that affects the body's immune response, or a tumor necrosis factor alpha inhibitor such as AbbVie's Humira and Johnson & Johnson's Remicade.
Upadacitinib, a JAK1 inhibitor, had achieved desired results when initially given in four different doses along with placebo in an earlier 16-week induction phase. JAK1 plays an important role in the pathophysiology of immune-mediated disorders.
Patients were randomized to double-blind induction therapy with placebo or immediate-release formulation of upadacitinib at 3, 6, 12 or 24 milligrams twice daily or 24 milligrams once daily for 16 weeks, followed by blinded extension therapy for 36 weeks. The 24-milligram, once-daily arm was later stopped and a 6-milligram, twice-daily arm was initiated.
All patients who completed the induction phase were re-randomized to receive three different doses of upadacitinib for 36 weeks as part of an extension phase.
The latest data showed that the patients maintained their response to upadacitinib treatment through the extension phase, with higher doses of 6 milligrams and 12 milligrams showing better response compared to 3 milligrams.
After taking upadacitinib doses of 3, 6 and 12 milligrams, respectively, 25%, 29% and 41% of patients achieved the secondary endpoint of clinical remission at 52 weeks. Meanwhile, 16%, 21% and 24% of patients achieved endoscopic remission after taking doses of 3, 6 and 12 milligrams, respectively.
Results also showed that a significantly greater percentage of patients receiving upadacitinib 24 milligrams twice daily were able to discontinue taking corticosteroids. Clinical remission was seen in 32% of patients in the 24-milligram, once-daily group.
The company noted that the overall safety profile of upadacitinib was consistent with those in other studies and that no new safety signals were detected.
Upadacitinib is undergoing phase 3 trials for treating Crohn's disease, with earliest study completion expected in December 2019.
The drug is also being tested to treat other conditions, such as skin disease, moderate to severe atopic dermatitis and rheumatoid arthritis.