Rheumatoid arthritis: add-on upadacitinib outperforms adalimumab

  • Fleischmann R & al.
  • Arthritis Rheumatol
  • 9 Jul 2019

  • International Clinical Digest
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Takeaway

  • 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.

Key results

  • 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 design

  • 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.

Limitations

  • No assessment of upadacitinib monotherapy vs adalimumab+methotrexate.
  • Severe RA in this population.