HIGH WYCOMBE, England, June 6, 2012 -- Findings from a psoriasis clinical development program for a biologic following patients continuously for five years provide insights on the long-term response and safety profile of ustekinumab.
New efficacy and safety data from the Phase 3 PHOENIX 1 study, one of two pivotal registration trials, showed that maintenance treatment with STELARABlack Triangle Drug (ustekinumab) for up to five years of follow up resulted in consistent, significant clinical response in adults with moderate to severe plaque psoriasis. The data are presented today at the 9th Annual European Academy of Dermatology and Venereology (EADV) Spring Symposium in Verona, Italy.
In the PHOENIX 1 trial, patients receiving ustekinumab 45 mg or 90 mg from baseline and who experienced at least a 75 per cent improvement from baseline in their Psoriasis Area and Severity Index score (PASI 75 responders) at week 28 and 40, were re-randomised to either placebo or continued to receive ustekinumab every 12 weeks at their original dose. Of the patients who received continued maintenance therapy over five years, 79 per cent receiving ustekinumab 45 mg and 81 per cent receiving ustekinumab 90 mg were PASI 75 responders at the end of the treatment period. Investigators also observed treatment with the biologic therapy to be generally well-tolerated with rates of adverse events (AEs), including serious infections, malignancies and investigator-reported major adverse cardiovascular events, including myocardial infarction, stroke, and cardiovascular death, remaining stable over time.
"This study represents a significant milestone, as it describes five years of continuous biologic treatment for over 500 psoriasis patients," said Professor Christopher Griffiths, University of Manchester. "Moderate to severe plaque psoriasis can have a huge impact on quality of life and biologic treatments continue to be an important option for patients living with the condition. These findings are reassuring for healthcare professionals who may want to consider biologic therapy for suitable patients in their care."
Helen McAteer, Chief Executive of The Psoriasis Association said, "The advent of biologics has not only increased our knowledge and understanding of psoriasis, but also given a new treatment option and optimism for those living with the most severe form of the condition. Understandably, people can be cautious when trying new medications and so the Psoriasis Association welcomes the knowledge and reassurance that longer-term safety data provides."
In the PHOENIX 1 study, patients were randomised to receive placebo or ustekinumab 45 mg or 90 mg at weeks 0 and 4 with subsequent crossover to ustekinumab at week 12. Patients who were initially randomised to receive ustekinumab at week 0 who achieved long-term response (at least PASI 75 at weeks 28 and 40) were re-randomised at week 40 to maintenance ustekinumab or withdrawal from treatment until loss of response. Among the PASI 75 responders at week 28 and 40 who continued treatment from week 40 to the end of the study, 48 and 59 per cent achieved PASI 90 in the ustekinumab 45 mg and 90 mg groups, respectively, with up to five years of treatment. Efficacy was similarly maintained in the overall population, with 63 and 72 per cent of patients achieving PASI 75, and 40 and 49 per cent achieving PASI 90, in both the ustekinumab 45 mg and 90 mg groups, respectively.
Adverse events (AEs) were evaluated in up to 753 ustekinumab-treated patients with a total 3,104 patient-years (PY) of follow-up. Rates of AEs (220.9 and 209.0 per 100 PY), serious AEs (5.3 and 5.4 per 100 PY) and infections (83.7 and 81.6 per 100 PY) in the ustekinumab 45 mg and 90 mg treatment groups respectively remained stable over time. Rates of serious infection (1.03 per 100 PY), non-melanoma skin cancer (0.45 per 100 PY), other malignancies (0.48 per 100 PY), and major adverse cardiovascular events (0.35 per 100 PY) in combined ustekinumab groups were similarly consistent over the five-year period. No new safety signals were reported with the increased duration of exposure.