- Add-on upadacitinib outperformed placebo and adalimumab for improving disease, symptoms, signs, and physical function in a phase 3 trial of patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX).
- Primary and secondary endpoints were met.
Why this matters
- The double-blind SELECT-COMPARE trial compared once-daily investigational upadacitinib vs placebo or adalimumab in combination with MTX for patients whose RA remained active on MTX alone.
- Upadacitinib met primary endpoints vs placebo at 12 weeks: 20% improvement in American College of Rheumatology (ACR) score (ACR20: 71% vs 36%) and disease activity score using C-reactive protein
- Upadacitinib bested adalimumab for ACR50 (45% vs 15%), pain scores, health assessment and disability index scores, and DAS28CRP ≤3.2 (45% vs 29%; all P≤.001).
- Discontinuations were highest with adalimumab, but upadacitinib was associated with higher rates of herpes zoster, elevated creatinine kinase.
- Study of 1629 patients with RA inadequately controlled on MTX alone, randomly assigned 2:2:1 to additional once-daily 15 mg upadacitinib, placebo, or 40 mg adalimumab.
- Funding: AbbVie.
- No assessment of upadacitinib monotherapy vs adalimumab+methotrexate.
- Severe RA in this population.