The study results were presented here at the European League Against Rheumatism Congress 2016.
In their placebo-controlled double-blind study, Dr van der Heijde and her colleagues evaluated dose-response to tofacitinib in patients with active ankylosing spondylitis and assessed safety and efficacy.
Patients were randomized to one of three doses of tofacitinib — 2 mg, 5 mg, or 10 mg, all administered twice a day — or to placebo for 12 weeks. Patients were then followed for an additional 4 weeks. The analysis involved 52 patients in the tofacitinib groups and 51 patients in the placebo group.
Patients were assessed with MRI at baseline and after 12 weeks of treatment.
At baseline, mean disease duration was 6.3 years and mean Bath Anklyosing Spondylitis Disease Activity Score (BASDAI) score was 6.7. “As expected, over 85% of patients were HLA-B27 positive,” Dr van der Heijde pointed out.