New STELARA® (ustekinumab) five year data show consistent efficacy and safety profile in treatment of moderate to severe plaque psoriasis

New efficacy and safety data from the Phase 3 PHOENIX 1 study, one of two pivotal registration trials, showed that maintenance treatment with STELARA® (ustekinumab) for up to five years of follow up resulted in consistent, significant clinical response in adults with moderate to severe plaque psoriasis.1 The data were 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 STELARA 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 STELARA every 12 weeks at their original dose. Of the patients who received continued maintenance therapy over five years, 79.1 per cent receiving STELARA 45 mg and 80.8 per cent receiving STELARA 90 mg were PASI 75 responders at the end of the treatment period.1 Investigators also reported a consistent benefit-to-risk profile for STELARA over five years of follow up and 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.1

“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.”

In the PHOENIX 1 study, patients were randomised to receive placebo or STELARA 45 mg or 90 mg at weeks 0 and 4 with subsequent crossover to STELARA at week 12. Patients who were initially randomised to receive STELARA 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 STELARA or withdrawal from treatment until loss of response.2Among the PASI 75 responders at week 28 and 40 and who continued treatment from week 40 to the end of the study, 47.8 and 58.9 per cent achieved PASI 90 in the STELARA 45 mg and 90 mg groups, respectively, with up to five years of treatment. Efficacy was similarly maintained in the overall population* with 63.4 and 72.0 per cent of patients achieving PASI 75, and 39.7 and 49.0 per cent achieving PASI 90, in both the STELARA 45 mg and 90 mg groups, respectively.1

Adverse events were evaluated in up to 753 STELARA-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 STELARA 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 STELARA groups were similarly consistent over the five-year period. No new safety signals were reported with the increased duration of exposure.1

*PHOENIX 1 study design involved a revised dosing schedule for partial responders which is not included in the approved EMA Summary of Product Characteristics for STELARA®

References

1. Kimball A, et al. Long Term Efficacy and Safety of Ustekinumab in Patients with Moderate to Severe Psoriasis Through 5 Years of Follow-up: Results from the PHOENIX 1 Long-Term Extension. Poster presented at the European Association of Dermatology & Venereology (EADV) Annual Meeting, Verona, 6 June 2012. Poster P582
2. Leonardi et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet2008; 371: p1665–1674
3. The Psoriasis Association. Available at: http://www.psoriasis-association.org.uk/pages/view/about-psoriasis. Last accessed May 2012
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6. World Health Organisation. Available at: http://www.who.int/choice/demography/pop_death_rates/en/index.htmlLast accessed May 2012
7. National Psoriasis Foundation. Related Health concerns: Psoriasis comorbidities. Available at: http://www.psoriasis.org/about-psoriasis/related-conditionsLast accessed May 2012
8. Ustekinumab European Summary of Product Characteristics. Date: March 2012