According to a recent report by Spherix Global Insights, Eli Lilly’s Olumiant and Regeneron’s Kevzara enjoy continued uptake, though rising safety concerns associated with the JAK inhibitor class may blunt Olumiant’s trajectory

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EXTON, Pa., March. 25, 2019 /PRNewswire/ — Overall brand share among biologic/JAK-treated patients in the US rheumatoid arthritis (RA) market has remained relatively stagnant over the past year, according to Spherix Global Insights’ latest quarterly wave of RealTime Dynamix™: Rheumatoid Arthritis (US). Unsurprisingly, the established TNFs, primarily AbbVie’s Humira and Amgen’s Enbrel, still dominate the market, though surveyed rheumatologists (n=101) report a slight decrease in share of the prevailing brands over time. This is at least partially due to the entrance of Regeneron’s Kevzara and more recently Eli Lilly’s Olumiant, both of which have shown a consistent increase in share since their respective launches.

Indeed, nearly half of respondents report current use of Eli Lilly’s JAK inhibitor in at least one of their RA patients, a notable increase from the previous quarter. Awareness and familiarity with Olumiant continue to grow, with half reporting they are very familiar with the brand. However, the number of patients being treated with Olumiant as a monotherapy has decreased considerably since the prior quarter, with two-thirds of patients also being treated with methotrexate or DMARDs – perhaps due the lack of an approved (and presumably more efficacious) 4mg dose. Nearly one-third of surveyed rheumatologists agreed they do not believe the 2mg dose of Olumiant will be as efficacious as Pfizer’s Xeljanz, the only other approved JAK inhibitor to treat RA. Additionally, while overall rates of Olumiant discontinuation are the lowest for any agent (likely due to the short tenure on the market), a lack of efficacy is the leading reason behind discontinuation 70% of the time, a figure higher than that of Xeljanz and any other alternate mechanism of action (MOA) agent used to treat RA.

While the lack of an approved 4mg dose of Olumiant may lead to subpar efficacy in its current dosing, it also brings attention to the controversial safety concerns associated with higher doses of JAK inhibitors. Approximately one-quarter of rheumatologists selected “long-term safety concern” as the leading barrier to Olumiant and over half indicated that long-term safety data would lead to an increase in actual prescribing of Olumiant.  Spherix also found that while a little over one-third of Olumiant non-users plan to start prescribing the agent to their RA patients within the next six months, this number has decreased dramatically from the previous quarter.  As one rheumatologist put it, “There is no known advantage over available agents, all of which have much more efficacy and safety data at the approved dose. Lilly needs more trials at the 2mg dose since that’s what is marketed.”

Another aspect that could impact negatively impact Olumiant is increased safety signals recently reported for Xeljanz. Last month, just after fielding of this study, Pfizer announced preliminary results of an ongoing post-marketing study required by the FDA to investigate the risk of cardiovascular (CV) events for RA patients over the age of 50 taking 10mgs of Xeljanz twice daily for the treatment of RA. Findings indicated that patients on the 10mg BID dose of Pfizer’s JAK were statistically more likely to experience pulmonary embolism than those treated with a TNF inhibitor. Additionally, those on the 10mg twice daily dose of Xeljanz were also at an increased risk of overall mortality than those treated with a 5mg BID dose of Xeljanz or those on a TNF inhibitor. 1 This news is sure to raise some eyebrows not only regarding the safety of Xeljanz, but potentially the overall JAK class, adding further pressure to both JAK brands to prove their safety.

As for Xeljanz, the safety data may have a slight impact on prescribing trends, but the 10mg BID dose is not currently approved in RA. Overall, it is expected that rheumatologists will take precaution with JAK use in at-risk patients, with rheumatologists’ estimating that 40% of their RA patients are considered at moderate or high risk of a venous thromboembolic event (VTE). Indeed, over one-third of respondents agreed that they avoid using JAK inhibitors in patients who are considered with moderate or high risk of VTEs. Spherix will continue to monitor US rheumatologists’ views on JAK safety and will assess the impact of Pfizer’s recent news on both JAK brands.

Safety concerns aside, it is up to the manufacturer to get the right message across to practicing rheumatologists, and that is where Pfizer seems to be outperforming Lilly. Indeed, when examining respondents’ last five prescriptions, when Xeljanz was the agent prescribed, Olumiant was only a consideration in one-fifth of recent Xeljanz scripts. Pfizer’s JAK inhibitor was also selected with the greatest frequency as respondents’ preferred alternate MOA for the treatment of RA. On top of that, Pfizer outperformed Lilly in all sales representative performance metrics, likely due to their time on the market, stressing the fact that Lilly has more work to do in order to highlight their brand as one of the leading alternate MOA options for the treatment of RA. Where Lilly may find some reprieve is in Olumiant’s publicized lower price point, which is advertised at a substantial discount to Xeljanz. It seems Lilly is working on transferring this into a favorable market access position, as pricing/cost was the most frequently noted topic of conversation covered during the most recent Olumiant detail.

Other aspects that will impact the US landscape include the evolving RA pipeline. When queried specifically on what exactly a new agent could provide to disrupt the RA market, about one-third of rheumatologists mention higher remission rates when compared to the gold standard TNFs, oral formulations, and the existence of predictive biomarkers to determine efficacy. Despite relatively low familiarity for pipeline agents, more respondents venture to say they anticipate AbbVie’s upadacitinib will have a greater role in treatment, indicating there might still be room for another JAK in the mix, if it provides a safer value proposition than Olumiant and Xeljanz.

About RealTime Dynamix™
The RealTime Dynamix™ Rheumatoid Arthritis (US) report series (n=100 rheumatologists per quarter) provides a detailed and timely look at current and future trends in the RA market and the effects of the future shifting landscape. The fifteenth wave of this US study will field in May 2019 and will continue to track the launch of Olumiant, uptake of biosimilars, as well as the overall evolving US RA market. The fifth bi-annual wave of a parallel study tracking the evolution of the European RA market, RealTime Dynamix™ Rheumatoid Arthritis (EU), will field in Q2 2019 (n=250 rheumatologists per wave).

About Spherix Global Insights
Spherix Global Insights is an independent business intelligence and market research company, specializing in renal, autoimmune, neurologic and rare disease markets. Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions.

All company, brand or product names in this document are trademarks of their respective holders.

For more information contact:
Lynn Price, Immunology Franchise Head
Email: [email protected]
www.spherixglobalinsights.com

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1. Pfizer Announces Modification to Ongoing Tofacitinib FDA Post-Marketing Requirement Study In Patients With Rheumatoid Arthritis. Pfizer. February 19, 2019.  https://investors.pfizer.com/investor-news/press-release-details/2019/