Upadacitinib Demonstrates Superiority vs Adalimumab, Placebo in Treatment-Resistant RA

The following article is part of conference coverage from the 2018 American College of Rheumatology and Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, Illinois. Rheumatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in rheumatology. Check back for the latest news from ACR/ARHP 2018 .

CHICAGO – Once-daily upadacitinib 15 mg resulted in greater improvements in rheumatoid arthritis (RA) signs and symptoms compared with placebo and adalimumab among patients with inadequate response to methotrexate, according to data presented at the 2018 ACR/ARHP Annual Meeting, held from October 19 to 24 in Chicago, Illinois.

Researchers conducted the SELECT-COMPARE study to assess the efficacy and safety of upadacitinib vs placebo and adalimumab in patients with active RA. A total of 1629 patients were randomly assigned to receive once-daily upadacitinib 15 mg, adalimumab 40 mg every other week, or placebo while continuing background methotrexate. The primary end points of the study were the 20% improvement in ACR criteria (ACR20) and the proportion of patients achieving a 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP) <2.6 at 12 weeks.

At 12 weeks, a significantly greater proportion of patients receiving upadacitinib achieved ACR20 compared with placebo (70.5% vs 36.4%), as well as DAS28-CRP <2.6 (28.7% vs 6.1%). Upadacitinib also showed superiority compared with adalimumab at 12 weeks for ACR50 (45.2% vs 29.1%), DAS28-CRP ≤3.2 (45.0% vs 28.7%), change from baseline in pain, and the Health Assessment Questionnaire Disability Index. Differences were maintained through 26 weeks.

Researchers also found that at 26 weeks, patients receiving upadacitinib had significantly less radiographic progression compared with those placebo, and significantly more patients receiving upadacitinib had no radiographic progression (83.5% vs 76.0%). More patients receiving upadacitinib also achieved low disease activity or remission compared with placebo or adalimumab.

Results showed that at 26 weeks, the proportion of patients with adverse events and serious infections was higher among patients who received upadacitinib compared with placebo, but was similar compared with patients receiving adalimumab. The investigators noted that safety events were consistent with phase 2 and phase 3 studies in RA to date.

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Reference

Fleischmann R, Mangan AL, Mysler E, et al. A phase 3, randomized, double-blind study comparing upadacitinib to placebo and to adalimumab, in patients with active rheumatoid arthritis with inadequate response to methotrexate. Presented at: ACR/ARHP 2018 Annual Meeting; October 19-24, 2018; Chicago, IL. Abstract 890.

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