Long-term efficacy and safety data presented at AAD 2013 encourage first-line use of Stelara in psoriasis.
By Rachel Chizkov, Analyst
8 March 2013
I am an Analyst for Datamonitor Healthcare based in our New York office. Prior to joining Datamonitor, I worked as a r...
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Interest in interleukin (IL) targeting therapies in the dermatology community is prominent, with general agreement that these agents offer a dramatic treatment that is both effective and durable. Janssen’s Stelara (ustekinumab), a fully human monoclonal antibody that targets the p40 subunit of cytokines interleukin (IL)-12 and IL-23 proteins, was the first drug in its class to be approved for moderate to severe plaque psoriasis, and has subsequently garnered increasing market share at both first and second line. Indeed, at this year’s American Academy of Dermatology annual meeting (AAD 2013), a key opinion leader in the dermatology community commented that Stelara is the “new kid on the biologic block.”
Stelara was first approved for psoriasis treatment in January 2009 in the EU; US and Japanese approvals followed in September 2009 and March 2011, respectively. Prior to its launch onto the market, the gold-standard class for this indication were the tumor necrosis factor (TNF) inhibitors, with Enbrel (etanercept; Amgen/Pfizer/Stiefel/Takeda) dominating at first line. However, Stelara is catching up to TNF therapies, and at a rapid pace.
The drug’s superior efficacy to Enbrel has already been demonstrated in a head-to-head clinical trial (as part of the ACCEPT program). The new data presented at the recent AAD 2013 conference examining Stelara’s long-term safety showcased the drug’s positive long-term clinical profile. Reich et al. presented an analysis of 5 years of follow-up data that had been pooled across 117 patients treated with Stelara from the ACCEPT, PHOENIX 1, and PHOENIX 2 trials. The results suggested no additional safety concerns with long-term use of Stelara and revealed that rates of major adverse cardiovascular events remained stable over time, with a very low cumulative rate of less than 2% over 5 years. Furthermore, analysis by Strober et al. on the same dataset demonstrated that rates of overall infections and infections that required treatment in patients receiving Stelara were stable over time, with a slight decreasing trend. No new patterns of infections were observed through 5 years, thus confirming the drug’s long-term safety profile in psoriasis.
The results presented at AAD 2013 were preceded by the positive data shown by Janssen from the Phase III PHOENIX 1 trial at the annual European Academy of Dermatology and Venereology (EADV) conference in June 2012. These data demonstrated consistent, significantly clinical responses in patients randomized to continue maintenance therapy on Stelara for 5 years following their original participation in the PHOENIX 1 trial.
Several pipeline agents threaten Janssen’s position in the market; multiple therapies that target IL-17 are in development, with data from their Phase III trials eagerly anticipated by key opinion leaders. Currently, Novartis’s secukinumab emerges as the most clinically advanced, having completed extensive Phase III trials with results expected in 2013. However, Stelara’s first-to-market status will prove to be beneficial, likely insulating the drug from competition in the pipeline. Furthermore, with the withdrawal of Abbott’s US and EU regulatory filings for Ozespa (briakinumab), and other pipeline IL-23 drugs only in the early stages of development, Stelara is free to continue its ascendance as the only IL-23 inhibitor currently on the market.
Datamonitor believes that there is immense opportunity in the psoriasis market for products with IL selectivity, particularly Stelara. Although Stelara still sits predominantly as a second-line biologic, this is likely due to the fact that it has been on the market for less time than the standard TNF inhibitors, causing physicians to be more concerned with its long-term safety in comparison to the already well-established drugs. However, additional experience prescribing the drug over time, coupled with long-term data such as those presented at EADV 2012 and AAD 2013, will aid in quelling any trepidation regarding Stelara’s safety. If Stelara continues to demonstrate a strong efficacy and safety profile in the long term, it will become the go-to first-line biologic treatment ahead of the anti-TNF therapies in psoriasis.