Launch Of Stelara(R), Offers Psoriasis Patients Significant And Visible Results Maintained With Just Five Doses A Year

February 9, 2009 at 11:00 am Leave a comment


Janssen-Cilag announced the launch of STELARA (ustekinumab), the first in a new class of biologics, for the treatment of adults with moderate-to-severe plaque psoriasis. Ustekinumab has been authorised by the European Medicines Evaluation Agency (EMEA) for the treatment of moderate-to-severe plaque psoriasis in adults who failed to respond to, or have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (psoralen plus ultraviolet A light).



Psoriasis is a chronic skin disease that can be itchy, painful and debilitating. Around 1.5 million people in the UK1, 2 have psoriasis and it is estimated that 20-30% of those have severe disease.3 Psoriasis is often associated with potentially serious co-morbidities and substantial physical and emotional burdens.4,5



In Phase III clinical studies, treatment with ustekinumab demonstrated a significant, visible improvement in patients’ psoriasis with convenient 12 weekly maintenance dosing, as well as demonstrating improvements in quality of life.6,7 This means that patients need just 5 doses a year versus up to 104 injections with currently available biologic therapies. Furthermore, ustekinumab has been shown, in a head-to-head Phase III clinical study, to be more effective at 12 weeks than etanercept, a widely-used biologic treatment for psoriasis.8



“This is an important day for patients with psoriasis and for their doctors. Two-thirds of patients taking STELARA in placebo-controlled trials saw a significant, visible improvement in their psoriasis in just 12 weeks” said Chris Griffiths, Professor of Dermatology at the University of Manchester. “This improvement is sustained for up to a year-and-a-half with just 5 doses a year, allowing patients to get on with their lives.”



About Psoriasis




Psoriasis is a chronic, immune-mediated inflammatory disease resulting in the over-production of skin cells which accumulate on the surface of the skin, leading to raised, red, scaly plaques that may itch and bleed. It is estimated that 1.5 million people in the UK have psoriasis.1,2 Twenty to thirty percent of those with psoriasis have severe disease.3 In addition to the significant impact that psoriasis can have on quality of life,5 many patients report feeling dissatisfied and frustrated with some existing treatment options which can be inconvenient and time consuming to use.5



About Ustekinumab




Ustekinumab is a new, fully human monoclonal antibody with a novel mechanism of action that targets the p40 subunit of the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23). IL-12 and IL-23 are naturally occurring proteins that are important in regulating immune responses and are thought to be associated with some immune-mediated inflammatory disorders, including plaque psoriasis.



Clinical trials




The authorisation of ustekinumab is based on data from two large pivotal Phase III, multi-centre, randomised, double-blind, placebo controlled trials (PHOENIX 1 & 2). 6,7 These trials involved nearly 2,000 adult patients in whom the efficacy and tolerability of ustekinumab in the treatment of moderate-to-severe plaque psoriasis was evaluated.6,7 The primary endpoint of both trials was a reduction in psoriasis severity (measured using the Psoriasis Area and Severity Index, PASI) of at least 75% (PASI 75) by week 12. Just over two-thirds of patients achieved this outcome in both studies (after two doses at weeks 0 and 4).6,7 Improvement in skin quality was seen after just two weeks in PHOENIX 1. 6 Significant improvements in quality of life for patients suffering with psoriasis was seen as early as week 2 in PHOENIX 16, and was sustained with maintenance treatment in both studies.6,7



Both PHOENIX 1 and PHOENIX 2 are currently ongoing and will last five years, with data up to 76 weeks published so far. 6 The benefits of maintenance therapy were generally shown to last for up to a year-and-a-half in patients receiving ustekinumab every 12 weeks.6



Findings from an additional Phase III (head-to-head), randomised, multi-centre trial comparing ustekinumab and etanercept (Enbrel®) for the treatment of moderate-to-severe psoriasis showed ustekinumab was more effective than etanercept.8 The primary endpoint of the trial was a reduction in PASI of at least 75% by week 12. At week 12, after two subcutaneous injections at weeks 0 and 4, 68% and 74% of patients receiving ustekinumab 45 mg or ustekinumab 90 mg, respectively, achieved a PASI 75 compared with 57% of patients receiving etanercept 50 mg subcutaneous injections twice weekly.8



Tolerability profile




Ustekinumab therapy was generally well-tolerated during Phase III clinical trials.6,7 The most common side effects reported in Phase III clinical trials were arthralgia, cough, headache, injection site erythema, nasopharyngitis and upper respiratory tract infection. 6,7 In general, adverse events were mild and did not require treatment adjustment. No dose response was seen in the rates of adverse events, serious adverse events, or adverse events leading to study agent discontinuation. 6,7



Ustekinumab is a selective immunosuppressant and may have the potential to increase the risk of infections and reactivate latent infections. Patients should be evaluated for tuberculosis (TB) infection prior to initiating treatment with STELARA.



Ustekinumab is a selective immunosuppressant. Immunosuppressive agents have the potential to increase the risk of malignancy. Caution should be exercised when considering the use of STELARA in patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.



Centocor Ortho Biotech Inc. developed ustekinumab and has exclusive marketing rights to the product in the United States. Janssen-Cilag has exclusive marketing rights in all countries outside of the United States.



References




1. National Statistics Online. Population size. Available here. Accessed on November 27, 2008.




2. The Psoriasis Association. What is psoriasis? Available at: http://www.psoriasis-association.org.uk/what-is.html. Accessed November 25, 2008.




3. Smith CH, Anstey AV, Barker JN, et al. British Association of Dermatologists guidelines for use of biological interventions in psoriasis 2005. Br J Dermatol. 2005;153(3):486-497.




4. Henseler T, Christophers E. Disease concomitance in psoriasis. J Am Acad Dermatol. 1995;32(6):982-986.




5. Dubertret L, Mrowietz U, Ranki A, et al. European patient perspectives on the impact of psoriasis: the EUROPSO patient membership survey. Br J Dermatol. 2006;155(4):729-736.




6. Leonardi CL, Kimball AB, Papp KA, 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). The Lancet. 2008;371:1665-74




7. Papp K, Langley RG, Lebwohl M, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). The Lancet. 2008;371:1675-84.




8. Griffiths C, Strober B, van de Kerkhof PCM, et al. A Phase 3, Multicenter, Randomized Study Comparing Ustekinumab and Etanercept for the Treatment of Moderate to Severe Plaque Psoriasis. Poster presented at: 17th Congress of European Academy of Dermatology and Venereology; 2008 September 17-21; Paris, France. Poster FP1336.



Janssen-Cilag

[Via http://www.medicalnewstoday.com]

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