Spherix Global Insights

July 01, 2020

While Gilead/Galapagos’ Filgotinib Will Have to Contend with the Early Success of AbbVie’s Rinvoq in the US Rheumatoid Arthritis Market, Eli Lilly’s Olumiant is Likely to be the More Formidable Foe in the EU

A stark contrast in use and preference of the JAK inhibitors between the two regions sets varying competitive landscapes for pipeline agents in rheumatoid arthritis

EXTON, Pa., July 1, 2020 / PRNewswire / – Analysis of the most recent semiannual report included in Spherix’s RealTime Dynamix™: Rheumatoid Arthritis (EU) service, which captured the responses of 256 EU5 rheumatologists, reveals a distinct contrast between EU and US treatment patterns in rheumatoid arthritis (RA). Perhaps the most notable difference observed between the two geographies is in rheumatologists’ self-reported use and perceptions of JAK inhibitors – a matter of particular importance as the class will likely expand even further before the end of 2020.

Gilead/Galapagos’ selective JAK1 inhibitor, filgotinib, is projected to gain US FDA approval for the treatment of RA by the end of summer, with EU authorization expected to follow – making it the fourth JAK inhibitor commercially available in both regions. However, the competitive landscape is markedly different in the EU than in the US and should pose different challenges for the agent, while other market dynamics could impact the success of this launch.

In the US, swift adoption of AbbVie’s Rinvoq is already eroding the leadership position of Pfizer’s Xeljanz, the first-to-market and historically dominant JAK inhibitor in RA. According to the Q2 2020 report included in a parallel service tracking the US RA market, while Xeljanz still has the highest brand share among JAK agents, Rinvoq has made rapid and positive in-roads in adoption and has already eclipsed the brand share of Eli Lilly’s Olumiant. In fact, when prompted to select their preferred JAK inhibitor if limited to only one for the treatment of RA, 58% of US rheumatologists chose Rinvoq (up from 49% in Q1 2020), while 38% chose Xeljanz (down from 46% in the same timeframe) – placing Olumiant in a very distant third.

Contrary to the market dynamics reported in the US, Olumiant holds the top spot among European rheumatologists, and both Rinvoq and filgotinib will have to win over prescribers if they want to overcome Lilly’s JAK’s solid positioning. Indeed, brand share for Olumiant across the pond has steadily increased year over year and currently garners a greater percentage of the market than all available JAK agents (including newly authorized Rinvoq). When EU5 rheumatologists were asked to choose their preferred JAK inhibitor in RA, Olumiant was favored by far and large over both Xeljanz and Rinvoq – a drastically different outcome than what was reported in the US.

Differences in the respective launch timings and approved labeling of each JAK inhibitor between the two regions are key contributing factors to the substantial disparity between prescribing. For example, Olumiant was FDA approved for the treatment of RA in 2018, giving Xeljanz a six-year head start in the US market. On the other hand, Olumiant received EMA authorization for the RA indication one month prior to Xeljanz (both in 2017), evening out the playing field in the EU regarding the timing aspect.

However, while both the 2mg and 4mg doses of Olumiant are approved in the EU, only the 2mg dose is available in the US. Subsequently in the EU5, more than half of surveyed rheumatologists believe that Olumiant is the best option regarding cardiovascular (CV) side effects and overall risk/benefit profile (likely due to having the choice between a perceived “safer” 2mg dosing option and more efficacious 4mg dosing option). In the US, where Pfizer’s brand has tenure and is the preferred JAK for CV side effects, newcomer Rinvoq beats out Olumiant and Xeljanz as the most preferred brand when it comes to the overall risk/benefit profile. Of note, nearly one-third of US rheumatologists indicated they would prescribe substantially more Olumiant if the 4mg dose was approved.

One outcome of a growing JAK class is earlier use in the treatment algorithm and the impact it has on class cycling. Rheumatologists in both regions report more pre-biologic JAK use in addition to an increased propensity to prescribe back-to-back JAK inhibitors before moving on to other mechanisms of action. This is particularly true in cases of a first-line JAK failure due to waning efficacy, where the percent of US respondents who report they will prescribe a second JAK has increased four-fold over the past year. With additional class expansion on the horizon, this treatment pattern is only likely to become more common.

Despite the dominance of the current JAK class in both the US and EU5, filgotinib is already top-of-mind for rheumatologists, with both regions reporting they are the most familiar with Gilead/Galapagos’ pipeline asset over other late stage agents, including Merck/EMD Serono’s evobrutinib, Roche/Genentech’s fenebrutinib, Astella’s peficitinib, GSK’s otilimab, and Abivax’s ABX464. Furthermore, when prompted to choose just one agent they would most like to see gain EMA/FDA approval, the majority of both EU and US rheumatologists selected filgotinib.

Spherix will continue to track the Rinvoq launch and its impact on the JAK class and overall RA biologic market in both geographies via the report series included in their RealTime Dynamix™ services. An in-depth pre-launch analysis, assessing rheumatologists’ awareness and anticipated uptake of pipeline agents, is included in both the US and EU5 report series.

About RealTime Dynamix™
RealTime Dynamix™: Rheumatoid Arthritis (EU) 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. A parallel service, RealTime Dynamix™: Rheumatoid Arthritis (US), includes access to a quarterly report series tracking the US RA market.

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.

This summer, Spherix will be fielding the fourth annual EU5 and fifth annual US patient chart audits included in their RealWorld Dynamix ™ services, analyzing the charts of ~1,250 EU and ~1,000 US RA patients recently switched from one biologic/JAK to another. Through years of trending, the audits will uncover real-life patterns of switching and how prevalent this practice is becoming as the markets continue to evolve.

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For more information contact:
Kristen Henn, Business Development Manager
Email: info@spherixglobalinsights.com

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