A 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.