By Jenny Powers
PARIS -- September 25, 2008 -- Treatment with ustekinumab is safe and effective in patients with moderate to severe psoriasis, whether or not they have a history of previous treatment and independent of the type of previous therapy, according to data presented here at the 17th European Academy of Dermatology and Venereology (EADV) Congress.
Overall, 2,006 patients from the phase 3, double-blind, placebo-controlled Psoriasis Followed by Long-Term Extension (PHOENIX)-1 and PHOENIX-2 studies were randomised 1:1 to receive subcutaneous injections of either placebo or ustekinumab 45 or 90 mg 2 times at week 0 and 45, or 90 mg 2 times every 12 weeks, noted lead investigator Kim A. Papp, MD, PhD, Probity Medical Research, Waterloo, Ontario.
Dr. Papp described an analysis of data pooled from both trials in a poster presentation here on September 19. Subjects in this analysis who reported a treatment history had previously received the following: conventional systemic therapies, including methotrexate, acitretin, or cyclosporine (55.7%); biologics, including etanercept, alefacept, efalizumab, infliximab, or adalimumab (43%); and phototherapy, which comprised long-wave ultraviolet B or psoralen + long-wave ultraviolet A (66.2%).
All patients had moderate to severe psoriasis.
Patients in the placebo group crossed over at week 12 to receive ustekinumab 45 or 90 mg twice weekly at weeks 12 and 16.
The primary measurement tool was the Psoriasis Area and Severity Index (PASI), which describes a decrease of ≥50%, ≥75%, and ≥90% in patients' psoriasis involvement change from baseline. The primary endpoint of the pooled analysis was the number of patients who achieved PASI ≥75% at week 12.
The PASI response for patients in the initial ustekinumab treatment group was comparable between subjects who were treatment-naïve and those with a history of conventional therapy (71.8% vs 67.7%, respectively). Similarly, PASI ≥75% was achieved by 70.4% and 67.7%, respectively, of the patients who had received phototherapy versus those who were treatment-naive.
A different profile was observed in patients who had received prior treatment with biologics: 74.3% of these previously treated patients achieved PASI ≥75% versus 63.0% of the treatment-na´ve patients.
In the placebo group, PASI ≥75% rates were low, regardless of patient treatment history, (range: 1.4% to 5.7%; P < .001) for comparison between each ustekinumab-treated group and placebo.
Ustekinumab was well tolerated, the researchers noted, and the rates of adverse events experienced by ustekinumab-treated patients with treatment histories versus those who were treatment-naïve was as follows: conventional (53% vs 49.8%, respectively), phototherapy (51.3% vs 52.9%, respectively), and biologics (48.4% vs 54.3%, respectively).
Funding for this study was provided by Centocor Research & Development, Inc.
[Presentation title: Comparable Efficacy and Safety of Ustekinumab in Moderate to Severe Psoriasis Patients Previously Treated With Systemic Therapies and Treatment Naïve Patients. Abstract FP1388]
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