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