Ustekinumab well tolerated, effective in PHOENIX 1
MedWire News: Extended results from the PHOENIX 1 study suggest that ustekinumab is an effective and well-tolerated therapy for moderate-to-severe psoriasis for up to 3 years.
Many systemic therapies developed for treatment of psoriasis can have hazardous side effects, such as hepatotoxicity, if taken long term.
The recently US Food and Drug Administration (FDA) approved biologic ustekinumab is a human monoclonal antibody that binds to interleukin (IL)-12 and IL-23, which has shown significant therapeutic efficacy against moderate-to-severe psoriasis. However, the long-term effects of ustekinumab are unknown.
Alexa Kimball (Harvard Medical School, Boston, Massachusetts, USA) and colleagues report results from the extension phase of the phase III PHOENIX 1 study.
PHOENIX 1 included 766 psoriasis patients who were randomly assigned to placebo or ustekinumab 45 or 90 mg at baseline, week 4, and every 12 weeks thereafter.
Results from 76 weeks of follow-up have previously been reported. For the extended follow-up phase of the study, participants randomly assigned to receive ustekinumab at baseline (79.8% of original ustekinumab group) were re-randomized to continue receiving the drug every 12 weeks for 3 years or to withdraw from treatment at week 40. Those in the placebo group joined the withdrawn from therapy group and were also followed-up for 3 years.
If patients had a recurrence of psoriatic symptoms (loss of Psoriasis Area and Severity Index (PASI) improvement gained at 40 weeks of 50% or more) they were restarted on ustekinumab therapy at an initial 4 week and then 12 week intervals.
Kimball and colleagues found that PASI 75 scores at 76 weeks of 61.2% (45 mg) and 72.4% (90 mg) were maintained at 3 years at 62.7% and 72.2%, respectively.
They note that Physician's Global Assessment scores were similarly maintained over the follow-up period.
Serious adverse events (death, life-threatening condition, hospitalization, disability, or birth defect/congenital anomaly) were rare and reported in 9% of ustekinumab patients overall compared with 0.8% of placebo-treated patients, with no significant dose response reported between those given ustekinumab 45 mg versus 90 mg.
Milder adverse events were more common, with the most common being nasopharyngitis (29.6-30.1% in ustekinumab- vs 8.6% in placebo-treated patients at 3 years).
Writing in the British Journal of Dermatology, the team says: "These results continue to support the favourable benefit-risk profile of ustekinumab in the treatment of moderate-to severe psoriasis with continuous, stable, maintenance dosing for up to 3 years of therapy."
They conclude: "Additional data from PHOENIX 1 with 5 years of follow-up will continue to be evaluated for durability of the response of ustekinumab."
MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2012
By Helen Albert