Upadacitinib monotherapy results in improved outcomes versus methotrexate for patients with predominantly early rheumatoid arthritis, according to a study published online July 8 in Arthritis & Rheumatology.
Ronald van Vollenhoven, M.D., from the Amsterdam University Medical Centers, and colleagues randomly assigned 947 patients with predominantly early rheumatoid arthritis who were naive or had limited exposure to methotrexate to once-daily upadacitinib (15 or 30 mg) or weekly methotrexate in a 1:1:1 ratio for 24 weeks.
The researchers found that the study met both primary end points for upadacitinib 15 and 30 mg versus methotrexate (proportion of patients achieving ≥50 percent response in the American College of Rheumatology criteria at week 12: 52 and 56 percent versus 28 percent; proportion achieving a 28-joint Disease Activity Score including C-reactive protein of <2.6 at week 24: 48 and 50 percent versus 19 percent). With both doses of upadacitinib versus methotrexate, there were statistically significant and clinically meaningful improvements observed in multiple patient-reported outcomes. No radiographic progression was reported in 88 and 89 percent of patients receiving upadacitinib 15 and 30 mg, respectively, versus 78 percent with methotrexate.
"These head-to-head data provide consistent evidence of the efficacy of this JAK inhibitor versus the gold standard of initial rheumatoid arthritis therapy, supporting the potential of upadacitinib as a new therapeutic option for patients with rheumatoid arthritis," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including AbbVie, which manufactures upadacitinib and funded the study.