Pfizer aims to differentiate Xeljanz from upcoming JAK inhibitors and address outstanding concerns.
By Christina Vasiliou, Senior Analyst
21 June 2016
I joined Datamonitor Healthcare in early 2014, having completed an MPhil in Bioscience Enterprise at the University of C...
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Posters and oral presentations sponsored by Pfizer at the 2016 annual meeting of the European League Against Rheumatism (EULAR 2016) aimed to address outstanding concerns regarding Xeljanz’s long-term risk-to-benefit profile, and differentiate the drug from upcoming Janus kinase (JAK) inhibitors. Data presented focused on the drug’s long-term safety and efficacy in rheumatoid arthritis (RA), highlighting that both 5mg and 10mg doses of Xeljanz administered orally twice-daily had a consistent safety profile up to 96 months, while American College of Rheumatology (ACR) 20/50/70 response rates were sustained from month 1 to month 84.
Additional data from long-term extension studies highlighted persistence to treatment with Xeljanz in RA, with a median drug survival of 5.2 years for all Xeljanz-treated patients. Aside from providing comfort to physicians regarding the long-term efficacy and tolerability of Xeljanz, the favorable persistence data also signal positive patient compliance, which is particularly important due to Xeljanz’s oral formulation. With patient reported outcomes increasingly influencing physician decision making, it was not surprising that Pfizer also presented positive data highlighting long-term radiographic and patient reported outcomes for Xeljanz, which further bolster its clinical attractiveness. Datamonitor Healthcare believes that the data shared by Pfizer at EULAR will support the company’s efforts to receive EU approval for Xeljanz in RA, following initial rejection in 2013 due to safety concerns. In addition, the data presented will also provide Xeljanz with a key differentiation from the numerous JAK inhibitors moving through the RA pipeline, including Lilly’s baricitinib and AbbVie’s ABT-494, since at launch, they will not be able to match its relatively large-scale, long-term data.
|Table 3: Response rates for all tofacitinib-treated patients (%)|
|Month 1||Month 84|
|ACR = American College of Rheumatology|
|Source: EULAR, 2016|
Datamonitor Healthcare attended EULAR 2016, which explored the current rheumatology landscape, and had a strong focus on the development programs of novel oral small molecules, interleukin inhibitors, and biosimilar versions of leading anti-TNF biologics.
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