Plaque psoriasis: extension study confirms tofacitinib long-term safety, efficacy

  • Valenzuela F & al.
  • Br J Dermatol
  • 21 May 2018

  • curated by Brian Richardson, PhD
  • Clinical Essentials
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • An open-label extension study of tofacitinib in patients with moderate-to-severe chronic plaque psoriasis suggests that most patients experience long-term clinical benefit, although adverse event (AE) rates were significant.

Why this matters

  • Patients with plaque psoriasis often require long-term maintenance treatment.

Key results

  • 82.5% of patients experienced AEs:
    • 13.7% of patients experienced serious AEs;
    • 13.9% of patients discontinued as a result of AEs;
    • 1% of patients died (n=29; 9 considered potentially related to study drug);
    • The most common AEs were nasopharyngitis, blood creatine phosphokinase increase, upper respiratory tract infection, and hypertension.
  • Incidence rates were 1.16/100 patient-years for serious infections, 2.51/100 patient-years for herpes zoster, 0.67/100 patient-years for malignancies, and 0.26/100 patient-years for major adverse cardiovascular events.
  • 52%-62% of patients achieved Physician’s Global Assessment clear/almost clear status through month 54.
  • 56%-74% of patients achieved ≥75% improvement in Psoriasis Area and Severity Index through month 54.

Study design

  • 2867 patients with moderate-to-severe chronic plaque psoriasis who received tofacitinib for a median of 35.6 months were analyzed for safety up to month 66 and efficacy up to month 54.
  • Funding: Pfizer.

Limitations

  • Open-label study with no placebo or active control comparator arms.

Please confirm your acceptance

To gain full access to GPnotebook please confirm:

By submitting here you confirm that you have accepted Terms of Use and Privacy Policy of GPnotebook.

Submit