New Data Demonstrate Stelra® (Ustekinumab) Is Effective, Well-Tolerated And Improved QOL In Patients With Moderate To Severe Plaque Psoriasis

Date: Oct-02-2012A series of data presentations released at the 21st European Academy of Dermatology and Venereology (EADV) congress, in Prague, Czech Republic, demonstrate that STELARA® (ustekinumab) is effective, well tolerated and improved quality of life in patients with moderate to severe plaque psoriasis.

Specifically, efficacy results from the 52-week TRANSIT study showed that ustekinumab is highly effective
and well-tolerated in patients inadequately responsive to methotrexate,1 and that ustekinumab
substantially improved quality of life outcomes in patients transitioned from methotrexate regardless of
transition strategy.2 Additionally, results from the PHOENIX 2 study demonstrated that high levels of
clinical responses were achieved and maintained through up to five years of ustekinumab treatment.3

In terms of safety, an integrated analysis of safety data from four randomised-controlled studies
representing approximately 9,000 patient-years (PY) of follow-up showed that in general, there was no
dose-response or cumulative effect of increasing duration of exposure to ustekinumab on the rates of
overall and targeted adverse events after up to five years of treatment.4 In addition, data from the PSOLAR
Registry's annual database extract (last conducted in August 2011, representing a total of 13,733 PY)
described malignancy (excluding non-melanoma skin cancers), infection and major adverse cardiovascular
event (MACE) rates in patients eligible for systemic therapies, including ustekinumab and infliximab.5 No
new safety signals for ustekinumab and infliximab were detected in this analysis.6,7

Ustekinumab targets interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are
important in regulating immune responses and are thought to be associated with immune-mediated
inflammatory diseases such as plaque psoriasis.

Professor Jörg Prinz, University of Munich, Germany, said "The findings from these studies are promising
and support a favourable benefit-to-risk profile for ustekinumab with up to five years of treatment.
Importantly results demonstrated in clinical trials are consistent with the real-world experience to date.
These findings further advance our understanding of biologics, not just in terms of efficacy, safety and
tolerability, but also health-related quality of life."

Psoriasis is a chronic, immune-mediated inflammatory disease, which is highly visible on the patient but
incurable. It is often very painful and associated with multiple physical and psychological burdens such as
depression.8 There is now a recognised need for improved standards of care for each and every person
living with psoriasis in Europe today, and to address this need the European Expert Working Group for
Healthcare in Psoriasis recently launched a Europe-wide framework9 (White Paper) to improve standards
of care for patients, especially in terms of access to the right targeted treatment appropriate for their
disease severity.

View drug information on Stelara.
Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.