EXTON, Pa., June 9, 2020 /PRNewswire/ -- The 2020 audit included in Spherix's RealWorld Dynamix™: Biologic/Small Molecule New Starts in Plaque Psoriasis (US) service focuses on one of the most dynamic aspects of the psoriasis market – the newly initiated patient. In the third annual edition of the study, 164 US dermatologists profiled 1,011 of their psoriasis patients who had recently been started on their first-line biologic or apremilast therapy.
The advanced systemic market in psoriasis has certainly evolved over the past five years, beginning with the approval of the first IL-17 inhibitor (Novartis' Cosentyx) in 2015 and the first IL-23 inhibitor (Janssen's Tremfya) in 2017. Thus, it has become increasingly important for a brand to differentiate itself from the competition and for manufacturers to understand the driving forces behind brand selection.
In April 2019, the FDA approved AbbVie's third-in-class IL-23 inhibitor, Skyrizi, for the treatment of psoriasis - which has yet again shifted the ever-evolving biologic market. Spherix captured early success of the new market entrant via their US RealTime Dynamix™ service, with dermatologists reporting widespread utilization of the brand and preference over fellow IL-23 inhibitors for the treatment of psoriasis. Patient chart data included in the RealWorld Dynamix™ service further corroborates the brand's success, as more biologic-naïve patients were started on Skyrizi as their first-line advanced systemic psoriasis treatment than any other approved alternative mechanism of action (AMOA) biologic.
First-line shares for the long-standing TNF inhibitors (AbbVie's Humira and Amgen's Enbrel), as well as Janssen's IL-12/23 inhibitor, Stelara, have all significantly declined over the past few years. Indeed, dermatologists increasingly view the newer and more targeted market entrants as safer and more efficacious, and each year they are incorporating these brands earlier and earlier into their psoriasis treatment protocol. Interestingly, however, audited first-line share for both Cosentyx and Tremfya are slightly down compared to 2019, while Eli Lilly's Taltz has made year over year incremental gains – and for the first time, use of Taltz in previously biologic-naïve patients has just edged past that of Cosentyx.
Similar to AbbVie's strategy with Skyrizi and Humira, Amgen's acquisition of Otezla in late 2019 was also likely a play to protect their psoriasis portfolio; however, Amgen is not having the same degree of success as its long-time rival. Indeed, the Enbrel-Humira playing field in psoriasis has never been level, with Enbrel's presence in the new start patient population a small fraction of what is seen for Humira. Furthermore, while part of the Celgene portfolio, Otezla captured a substantial portion of the first-line market; but according to the 2020 audit, Otezla experienced a marked decline in the pre-biologic setting since coming under the management of Amgen. Of note though, use of the oral PDE4-inhibitor in this patient segment still outpaces any single biologic.
The study also captured opportunity (or "missed share") for each agent, representing patients for whom the brand was the back-up choice in the event of the current brand not being available. Unfortunately for Amgen, Otezla was the back-up choice for only 3% of patients, suggesting the oral PDE4 inhibitor has nearly maxed out its first-line potential. Otezla also misses out in the next switch scenario, as projected share dwindles into the single digits in the potential second-line setting – highlighting the need for Amgen to capitalize on the key opportunity of the pre-biologic patient.
The missed share analysis also reveals that the IL-17 and IL-23 inhibitors left the most on the table, each having had the potential to more than double the percent of patients prescribed the brand in the first-line setting, had dermatologists prescribed their "back-up" choice instead of the current agent. Interestingly, in most instances where an AMOA agent was the runner-up, the brand ultimately lost out on that share to patients being started on their in-class competitor. This is likely an indicator that the AMOA agents will continue their dominance and forward momentum in the US biologic market, particularly in earlier lines of therapy.
Reasons for brand selection are relatively unchanged year over year, with efficacy in skin clearance remaining the top driver for brand choice in the new start population and the IL-23 inhibitors benefiting the most regarding that aspect. Brands that boast efficacy in both skin and joints also hold a key competitive edge, as this attribute continues to be a top primary reason behind brand choice, currently giving an edge to the IL-17 inhibitors over the IL-23s. However, with Janssen eyeing a label expansion including psoriatic arthritis (PsA) for Tremfya potentially as early as this summer, and AbbVie's Skyrizi under investigation, the competition between the two classes will likely continue into the foreseeable future.
Despite the magnitude of change that the advanced systemic psoriasis market has undergone over the past several years, it is likely not slowing down any time soon – with a rich pipeline of new mechanisms of action, different modes of administration, higher-efficacy agents, and the next potential game changer in plaque psoriasis. The chart audit captures the likelihood of penetration for each late-stage pipeline asset in the new start segment by current agent prescribed – indicating which brands should be on the lookout for future direct competitors. Analysis reveals vast potential for UCB's bimekizumab (competing most with Taltz), Lilly's mirikizumab (competing most with Stelara), BMS' TYK2 inhibitor (competing with Otezla – with both being orally administered), and Merck/EMD's IL-17A/F agent (competing with the IL-17 inhibitors). The majority of dermatologists report they are unaware if they would prescribe Pfizer's TYK2/JAK1 agent, likely due to a lack of knowledge about the product.
Lastly, while the new start audit provides insight into the next likely switch if the patients' first-line therapy is ultimately deemed unsuccessful (and the key metrics used to measure that success), Spherix will be collecting real-world data to measure each brands' actual presence in the second- or later-line treatment landscape. The 2020 audit included in a parallel service, publishing later this year, focuses on patients that have recently switched from one biologic/small molecule agent to another. This will be the second patient chart analysis in which Skyrizi is included and will show the growing impact it has had on the switch population.
About RealWorld Dynamix™
RealWorld Dynamix™: Biologic/Small Molecule New Starts in Plaque Psoriasis (US) is an independent, data-driven service unmasking real patient management patterns through annual reports based on chart audits of ~1,000 patients. The report uncovers the "why" behind treatment decisions, includes year over year trending to quantify key aspects of market evolution, and integrates specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns.
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.
All company, brand or product names in this document are trademarks of their respective holders.
SOURCE Spherix Global Insights