EXTON, Pa., April 29, 2020 /PRNewswire/ -- The recent approval of UCB's TNF inhibitor, Cimzia, for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) has reinvigorated a somewhat dull treatment landscape, while the IL-17 inhibitors continue to carve a niche for themselves in the treatment of ankylosing spondylitis (AS).
The latest semiannual report included in Spherix's RealTime Dynamix™ service captures the responses of 98 US rheumatologists surveyed in March 2020 and highlights differences in the management of patients with AS and those with nr-axSpA. According to the report, use of biologics and off-label biologic/small molecule agents tends to be higher in AS compared to nr-axSpA, though the incidence of biologic treatment in non-radiographic disease has increased over the past year.
Indeed, with Cimzia recently emerging as the only FDA-approved agent for the treatment of nr-axSpA, the majority of surveyed rheumatologists report having prescribed the TNF inhibitor in at least one patient with non-radiographic disease within the past six months. As a result, Cimzia now accounts for the greatest percentage of on- and off-label biologic/small molecule brand share in nr-axSpA. This is quite the coup for UCB, given the historic stronghold of two gold-standard TNF inhibitor agents, AbbVie's Humira and Amgen's Enbrel.
While insurance/cost issues (as opposed to a lack of efficacy or safety concerns) are reported by respondents as leading barriers to Cimzia use, the percent of rheumatologists who consider it a barrier at all has decreased significantly year over year – suggesting Cimzia is poised for continued success (given those issues can be resolved). Furthermore, and likely a halo effect of its initial success in nr-axSpA, user-base and brand share for UCB's agent have also increased in AS (though to a lesser extent), a market in which the agent has been approved since 2013 and has otherwise seen relatively stagnant growth over the past few years.
In AS, where rheumatologists have a much wider selection of FDA-approved biologic treatments, including agents with alternate mechanisms of action, the Spherix study reveals that TNF inhibitors still hold a deep-seated preference. Although, the IL-17 inhibitors, namely Novartis' Cosentyx and Eli Lilly's Taltz, have begun to chip away at their dominance. Cosentyx has historically been the IL-17 inhibitor of choice for treating AS (and psoriatic arthritis for that matter), and rheumatologists largely indicate habit/experience with the product as reasons for that preference. When asked the same question about preference for Taltz, the motives are efficacy-based, which may indicate an emerging change in the preference paradigm.
According to Spherix experts, rheumatologists have a difficult time differentiating the rival IL-17 inhibitors, with Cosentyx holding an edge in ease of managed care approvals and long-term safety and Taltz perceived as having a preferred dosing schedule and better patient support programs. In a situation where there is a lack of distinction, experience and comfort with a brand oftentimes play to its advantage. However, with only a small number of respondents citing an explicit difference, there is ample room for the two brands to further cement their advantages among this audience.
Both Cosentyx and Taltz have an off-label presence in nr-axSpA, and both have recently completed successful clinical trials – leaving the majority of rheumatologists unsure as to which brand will come out ahead. Nonetheless, nearly three-quarters of respondents indicate that the brand with better insurance coverage and/or the brand that secures the FDA approval first will hold a substantial advantage.
As for the future of treatment in these conditions, the pipelines in both AS and nr-AxSpA are full of currently-approved medications for other rheumatological conditions, like Pfizer's Xeljanz and AbbVie's recent blockbuster, Rinvoq. Time will tell whether these and other JAK inhibitors will carve out a meaningful niche in the AS/nr-axSpA treatment landscape. UCB's IL-17a/f inhibitor, bimekizumab, is a leading candidate and has already garnered significant preference among all pipeline agents for the treatment of AS. Should bimekizumab be approved, UCB's portfolio, along with positive perceptions among rheumatologists, may very well be a force to be reckoned with.
About RealTime Dynamix™
RealTime Dynamix™: Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis (US) is an independent service providing strategic guidance through rapid and comprehensive semiannual reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave.
About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.
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SOURCE Spherix Global Insights