Ustekinumab and Marked Clinical Responses in Patients with Moderate to Severe Psoriasis

Abstract

Background

Ustekinumab has demonstrated significant efficacy and favorable safety in patients with moderate to severe psoriasis.

Objective

Characterization of patients achieving marked clinical responses (Psoriasis Area and Severity Index [PASI] 90 or Physician's Global Assessment [PGA] of cleared) in two double-blind, placebo-controlled, phase III studies.

Methods

PHOENIX 1 (n=766) and PHOENIX 2 (n=1,230) patients were randomized to receive placebo or ustekinumab 45 or 90 mg at weeks 0 and 4, then every 12 weeks. At week 12, placebo patients crossed over to ustekinumab. Marked responses, defined as PASI 90 or PGA of cleared, are reported.

Results

A significantly higher proportion of ustekinumab-treated patients in PHOENIX 1 (39.9%) and PHOENIX 2 (47.0%) achieved marked responses at week 12, compared with placebo-treated patients (p<0.001 each). At week 28, approximately 50% of ustekinumab-treated patients achieved marked responses.

Conclusion

Significant proportions of ustekinumab-treated patients with moderate to severe psoriasis achieved marked clinical responses through week 28. Ustekinumab had a favorable risk-benefit profile through up to 18 months of follow-up.