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.
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