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New Five Year Data for STELARA,u- (Ustekinumab) Show Consistent Efficacy and Safety Profile in Treatment of Moderate to Severe Plaque Psoriasis.

HIGH WYCOMBE, England, June 6, 2012 /PRNewswire/ --

Findings from a psoriasis clinical development programme 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 STELARA ▼ (ustekinumab) for up to five years of follow up resulted in consistent, significant clinical response in adults with moderate to severe plaque psoriasis.[sup.[] [sup.1]] The data are presented today at the 9[sup.th] 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.[sup.[] [sup.1]] 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.[sup.[] [sup.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."

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.[sup.[] [sup.1,2]] 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.[sup.[] [sup.1]]

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.[sup.[] [sup.1]]

# ENDS #

About Psoriasis

Psoriasis is a chronic disease caused when the immune system mistakenly attacks healthy skin cells, speeding up skin cell production.[sup.[] [sup.3]] Plaque psoriasis, the most common type of psoriasis,[sup.[] [sup.4]] often results in patches of thick, red or inflamed skin covered with silvery scales (known as plaques). These plaques usually itch or feel sore, can crack and bleed, and can occur anywhere on the body.

Psoriasis affects up to 1.8 million people in the UK,[sup.[] [sup.3]] of whom 20-30 per cent are estimated to have moderate to severe disease.[sup.[] [sup.5,6]] As an incurable, highly visible and often painful disease, psoriasis is also associated with multiple physical and psychological burdens such as depression.[sup.[] [sup.7]]

About PHOENIX 1

The Phase 3, Multicentre, Randomised, Double-Blind, Placebo-Controlled Trial Evaluating in Subjects with Moderate to Severe Plaque-type Psoriasis Followed by Long-term Extension (PHOENIX 1) evaluated the efficacy and safety of ustekinumab in the treatment of 766 patients with chronic plaque psoriasis for up to five years. Patients were randomised to receive subcutaneously administered ustekinumab or placebo. Patients randomised to receive ustekinumab received 45 mg or 90 mg doses at weeks 0 and 4 followed by the same dose every 12 weeks with subsequent crossover to ustekinumab at week 12. The primary endpoint of the study was the proportion of patients achieving PASI 75 at week 12. Patients who were initially randomised to receive ustekinumab at week 0 who achieved long-term response (at least 75 per cent improvement in psoriasis area and severity index[PASI 75] at weeks 28 and 40) were re-randomised at week 40 to maintenance ustekinumab or withdrawal from treatment until loss of response.[sup.[] [sup.2]] After week 76, subjects continued on treatment in a long-term extension for up to five years.

About STELARA (Ustekinumab)

Ustekinumab is a human monoclonal antibody with a novel mechanism of action that targets the p40 sub-unit of two cytokines, interleukin-12 (IL-12) and interleukin-23 (IL-23) naturally occurring proteins that are important in regulating immune responses and that are thought to be associated with immune-mediated inflammatory disorders, including plaque psoriasis. Ustekinumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA.[sup.[] [sup.8]]

The recommended dosing regimen for adults and the elderly who with a body weight of 100 kg or less, is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose at week 4, and then every 12 weeks. For patients with a body weight of greater than 100 kg, the recommended dose is 90 mg administered subcutaneously, followed by a 90 mg dose at week 4, then every 12 weeks (45 mg was less effective in these patients).[sup.[] [sup.8]]

Janssen Biotech, Inc. discovered and developed ustekinumab and has exclusive marketing rights to the product in the United States. Janssen companies have exclusive marketing rights in all countries outside of the United States.

The Summary of Product Characteristics for STELARA, which includes safety information, can be found on the eMC website here. Janssen provides information on ustekinumab for healthcare professionals here.

About Janssen

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in immunology, oncology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world.

The legal entity for Janssen in the UK and Ireland is Janssen-Cilag Ltd. Please visit http://www.janssen.co.uk for more information.

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). Lancet 2008; 371: p1665-1674

3. The Psoriasis Association. Available at: http://www.psoriasis-association.org.uk/pages/view/about-psoriasis. Last accessed May 2012

4. National Psoriasis Foundation. Psoriasis types. Available at: http://www.psoriasis.org/netcommunity/learn/about-psoriasis/types. Last accessed May 2012

5. Smith CH, et al. British Association of Dermatologists guidelines for use of biological interventions in psoriasis 2005. Br J Dermatol. 2005;153(3):486-97.

6. National Psoriasis Foundation. About Psoriasis: Statistics. Available at: http://www.psoriasis.org/about/stats Last accessed May 2012

7. National Psoriasis Foundation. Related Health concerns: Psoriasis comorbidities. Available at: http://www.psoriasis.org/about-psoriasis/related-conditions Last accessed May 2012

8. Ustekinumab Summary of Product Characteristics. Date: March 2012

UK/UTK/2012/0204 May 2012
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