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STELARA® (Ustekinumab) Is Effective, Well-Tolerated And Improves Quality Of Life In Patients With Moderate To Severe Plaque Psoriasis Inadequately Responsive To Methotrexate[1,2]
STELARA® (Ustekinumab) Is Effective, Well-Tolerated And Improves Quality Of Life In Patients With Moderate To Severe Plaque Psoriasis Inadequately Responsive To Methotrexate[1,2]
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NEW DATA PRESENTED AT EADV

Beerse, Belgium (October 21, 2011) – New findings from the TRANSIT study were presented today at the 20th European Academy of Dermatology and Venereology (EADV) congress, which showed treatment with STELARA® (ustekinumab) is well-tolerated and effective in patients with moderate to severe plaque psoriasis inadequately responsive to methotrexate therapy.1 Health-related quality of life was also significantly improved according to the study results reported.2

The TRANSIT study, a 52 week, open-label, phase IV study of 489 patients, was designed to compare two methods of transitioning patients from methotrexate to ustekinumab. The first was discontinuation of methotrexate with immediate initiation of ustekinumab and the second was initiation of ustekinumab with overlap and gradual dose reduction of methotrexate over four weeks. Results up to week 16 were presented today at the EADV congress.

The primary endpoint of the TRANSIT study was the proportion of patients experiencing at least 1 treatment-emergent adverse event through week 12 in arm 1 versus arm 2.  The number and types of adverse events were similar in the two treatment arms. Serious adverse events were infrequent regardless of the transition strategy: 2.9% of patients in the methotrexate immediate cessation arm versus 2.0% of patients in the methotrexate gradual withdrawal arm.1 Substantial improvement in efficacy was also observed above and beyond the results patients had achieved on methotrexate, which all patients had been receiving for at least 8 consecutive weeks prior to baseline, and which was considered to be inadequately effective.  Through week 12, the majority of patients in both arms achieved a Psoriasis Global Assessment (PGA) rating of ‘cleared’ or ‘minimal’ (65.3% in the methotrexate immediate cessation arm and 69.5% in the methotrexate gradual withdrawal arm).1 The median Psoriasis Area and Severity Index (PASI) score decreased from approximately 15 in both arms at baseline to 2.9 in the methotrexate immediate cessation arm versus 2.8 in the methotrexate gradual withdrawal arm.1

Improvements in health-related quality of life, as assessed by the Dermatology Life Quality Index (DLQI), were observed as early as week four in both arms of the study.2 Over the study period of 16 weeks, the mean improvement in DLQI was demonstrated by a reduction from 8.0 in the immediate cessation arm and 9.0 in the gradual withdrawal arm to a score of 1.0 in both arms, a clinically meaningful improvement in health-related quality of life.2 Substantial improvement in the EuroQOL-5D Visual Analogue Scale (EQ-5D VAS) was also observed in both arms.2

“Until now there has been very limited data on how to safely and effectively transition patients with moderate to severe plaque psoriasis from conventional systemic agents to biologics,” said Professor Carle Paul,* University of Toulouse, France and one of the lead investigators for the TRANSIT study. “Results from the TRANSIT study are important because they further advance our understanding of biologics, not just in terms of efficacy, safety and tolerability, but also health-related quality of life. The health-related quality of life improvements are particularly notable given that patients were already being treated with methotrexate when they entered the study, and over a quarter of patients included in the study had been previously treated with other biologic therapies.”

Also presented at EADV were findings from pooled analyses of the ongoing ustekinumab psoriasis clinical development programme (which includes the Phase 2 trial, and the Phase 3 PHOENIX 1, PHOENIX 2 and ACCEPT trials). Data showed that the safety profile of ustekinumab and rates of adverse events remained consistent and stable over time in adults with moderate to severe plaque psoriasis receiving up to four years of treatment.3,4,5 More than 1100 patients had been treated for at least three years with ustekinumab and more than 600 patients had been treated for at least four years, representing a total of nearly 6800 patient years (PY).3,4,5

“Biological therapies are a valuable advancement in the treatment of moderate to severe psoriasis. To support dermatologists in their decision-making about the most suitable treatment option for patients, it is important to have long-term data on available therapies. This pooled 4-year safety data provides a growing and significant body of evidence about the role ustekinumab can play in the management of this chronic, life-long condition”, said Professor Christopher Griffiths,** University of Manchester, UK, and lead trial investigator for the ACCEPT study.

# END #

About Psoriasis
Psoriasis is a chronic, immune-mediated disease that results from the overproduction of skin cells, which accumulate on the surface of the skin and cause red, scaly plaques that may crack and bleed. It is estimated that nearly three percent of the world’s population are living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.

Psoriasis affects 125 million people worldwide.6 As an incurable, highly visible and often painful disease, psoriasis is associated with multiple physical and psychological burdens such as depression.7   Plaque psoriasis 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.7

For more information about psoriasis, available treatment options and tools to assess the medical severity of psoriasis please visit www.psoriasis360.com

About STELARA
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.

The recommended dosing regimen for ustekinumab is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter.  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 4 weeks later, then every 12 weeks thereafter.

In patients weighing greater than 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these patients.

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.

Important Safety Information
Ustekinumab is a selective immunosuppressant and may have the potential to increase the risk of infections and reactivate latent infections. Serious infections have been observed in patients receiving ustekinumab in clinical trials. Do not start ustekinumab during an active infection.  If a serious infection develops, monitor patients carefully and stop ustekinumab until the infection resolves. Patients should be evaluated for tuberculosis (TB) infection prior to initiating treatment with ustekinumab.

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

Serious allergic reactions have been reported in the post-marketing setting, in some cases several days after treatment. Anaphylaxis and angioedema have occurred. If an anaphylactic or other serious allergic reaction occurs, administration of ustekinumab should be discontinued immediately and appropriate treatment instituted.

Special warnings and precautions for use
Concomitant immunosuppressive therapy: Caution should be exercised when considering concomitant use of other immunosuppressants and ustekinumab or when transitioning from other immunosuppressive biologics.

About Janssen
Janssen Pharmaceutical Companies are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes).

Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found at http://www.janssen-emea.com/.

For further information please contact:
Sue Silk
Janssen EMEA
Phone: 44 (0)1494 553 955
Email: ssilk@its.jnj.com

Liz Wyatt                                            
Publicis Life Brands Resolute                  
Phone: 44 (0) 207 397 7474
Email: liz.wyatt@publicislifebrandsresolute.com

Notes:
*Professor Carle Paul has been an investigator and paid consultant of Janssen.
**Professor Christopher Griffiths has at times been a paid consultant of Janssen.

References:

[1]Paul C et al. Ustekinumab is well-tolerated and effective in patients with moderate to severe plaque psoriasis inadequately responsive to methotrexate: Week 12 results from the TRANSIT study. Poster presented at the European Association of Dermatology & Venereology (EADV) Annual Meeting, Lisbon, October 2011. Poster P01121

[2]Reich K et al. Ustekinumab improves quality of life outcomes in psoriasis patients transitioned from methotrexate regardless of transition strategy: Week 16 results from the TRANSIT study. Poster presented at the European Association of Dermatology & Venereology (EADV) Annual Meeting, Lisbon, October 2011. Poster P01123                                                              

[3]Kimball AB et al. Infection rates in the ustekinumab psoriasis clinical trial program: Update with up to 4 years of follow-up. Poster presented at the European Association of Dermatology & Venereology (EADV) Annual Meeting, Lisbon, October 2011. Poster P01151

[4]Reich K et al. Update on the cardiovascular safety of ustekinumab in pooled phase 2 & 3 psoriasis clinical trials with up to 4 years of follow-up. Poster presented at the European Association of Dermatology & Venereology (EADV) Annual Meeting, Lisbon, October 2011. Poster P01153

[5]Papp KA et al. Malignancy rates in the ustekinumab psoriasis clinical trial program: Update with up to 4 years of follow-up and comparisons to the general United States population. Poster presented at the European Association of Dermatology & Venereology (EADV) Annual Meeting, Lisbon, October 2011. Poster P01158

[6]National Psoriasis Foundation. About Psoriasis: Statistics. Available at: www.psoriasis.org/about/stats. Accessed 14 September 2011

[7]National Institute of Arthritis and Musculoskeletal and Skin Disorders. Questions and Answers About Psoriasis. U.S. Department of Health and Human Services, National Institutes of Health; 2003. NIH Publication No. 03-5040. 

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