US and EU5 dermatologists are excited about the potential approvals of Eli Lilly’s Olumiant (baricitinib), Pfizer’s abrocitinib, and AbbVie’s Rinvoq (upadacitinib), though challenges likely lie ahead for the future atopic dermatitis JAKs
EXTON, Pa., August 20, 2020 /PRNewswire/ — Atopic dermatitis (AD), commonly referred to as eczema, affects millions of patients across the globe. In 2017, Sanofi/Regeneron’s Dupixent, an IL-4/13 blocker, became the first commercially available biologic to treat adults with moderate to severe forms of the disease in both the US and the EU. Two years later, the FDA and European Commission approved Dupixent’s label expansion into the adolescent (aged 12 to 17) population. In May of this year, the brand was also approved in the US for use in children (aged 6 to 11) with moderate to severe AD.
According to Spherix’s Q3 report included in their RealTime Dynamix™: Atopic Dermatitis (US) service, nearly all of the 103 sampled US dermatologists are users of the first-to-market biologic for treatment of the adult population, a figure that has remained stable quarter over quarter since early 2020. Although the breadth of current users prescribing to the adolescent population is much less than those prescribing to adults, progressively more dermatologists have begun prescribing to patients under the age of 18. Additionally, Dupixent share for both of these patient populations have experienced significant growth year over year, and comfort prescribing the agent to adolescents has been slowly increasing since the brand formally gained the indication.
Despite Dupixent’s second AD label expansion to include children, the majority of dermatologists report low comfort levels prescribing the biologic to this patient population. Subsequently, treatment share and brand use in these patients are minimal. On the other hand, Spherix experts found that the expansion does boost overall safety perceptions for the drug, which may bode well during the current COVID-19 pandemic – especially given physicians’ growing hesitation to prescribe immunosuppressive drugs (for which Dupixent is not) for the sake of mitigating risk of infection.
Despite the brand’s overwhelming success and favorable reception among prescribers, the market is still just a one-man show. As such, nearly 60% of US dermatologists agree that Dupixent does not work for all patients with moderate to severe AD, implying the brand is leaving gaps in the market and shedding light on the opportunity for pipeline assets to fill that void. Dermatologists commonly identify these patients as those with extremely severe disease, those with comorbidities, who are non-compliant, and often who have facial involvement (an area Dupixent seems to struggle in). Over 90% of Dupixent users stated that they would be willing to switch at least one of their Dupixent patients to a new biologic/small molecule agent once approved.
According to the most recent report included in the RealTime Dynamix™: Atopic Dermatitis (EU) service, surveyed EU5 dermatologists (n=251) are in alignment with their US counterparts on Dupixent’s shortcomings and estimate that a similar percentage of current Dupixent patients would be switched to a new advanced systemic agent if available. In Spherix’s large scale patient chart audit (n=1,003) via their RealWorld Dynamix™: Moderate-to-Severe Atopic Dermatitis (US) service, those patients that have previously been treated with Dupixent were assessed to determine which patient type would be appropriate for pipeline assets. The audit revealed that many of the discontinued Dupixent patient characteristics matched those of the physician-reported attributes mentioned above, implying these patients need an agent that will tackle severe forms of the disease.
Dermatologists in the states and EU5 estimate the biologic/small molecule candidate pool for moderate to severe adolescent and adult AD patients to be substantially larger than those currently treated with Dupixent. Despite an extremely robust pipeline, US and EU5 dermatologists overwhelmingly select JAK inhibitors as having the greatest potential to treat moderate to severe AD and most commonly select a pipeline JAK inhibitor as their top choice for FDA or EMA approval. This is likely a result of the MOA’s unique administration, perceived efficacy, and imminent projected launch in AD. However, looming safety concerns surrounding JAK inhibitors will likely trickle to the AD market if/when approved for treatment. Fortunately for manufacturers with JAKs in the pipeline, according to Spherix’s large-scale patient audit, the majority of moderate to severe AD adult patients are at no obvious increased risk for malignancy or cardiovascular events and present with good to moderate overall health.
Although the majority of dermatologists believe the safety profiles of oral and topical JAK inhibitors will be very different, a potential black box warning could impact possible prescribing behavior for both US and EU5 dermatologists. Regardless, topical JAKs are expected to be used prior to oral JAKs and are more likely to be prescribed to patients under 18. The majority of US and EU5 dermatologists estimate a high likelihood of prescribing a topical JAK after a patient has failed an average of three topical steroid agents. On the other hand, oral JAKs will likely be prescribed within the injectable biologic space, with a focus on adult patients.
When prompted with a blinded profile based on AbbVie’s Rinvoq (upadacitinib) Phase 3 clinical trial data, one-half of US dermatologists report a higher likelihood of prescribing the 15 mg dose over the 30 mg dose to both adult and adolescent patients. Nonetheless, when assessing Dupixent’s risk benefit ratio compared to the 15 mg and 30 mg of Rinvoq, the former is perceived substantially more positive than the two doses of Rinvoq. In fact, one-half of US dermatologists report a low likelihood of prescribing the oral JAK over Dupixent once commercially available, and nearly 60% of US respondents report the current safety profile hinders potential prescribing. This highlights the need for oral JAKs to not only overcome safety concerns, but to also prove their efficacy against Dupixent and potentially LEO’s tralokinumab (which is slated to gain FDA approval early next year). Regardless, according to the Spherix chart audit, half of the patients considered candidates for biologics/small molecules are deemed good candidates for Rinvoq.
About RealTime Dynamix™
RealTime Dynamix™: Atopic Dermatitis (US) is an independent service providing strategic guidance through rapid and comprehensive quarterly reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave (n=100 US dermatologists). A parallel service, RealTime Dynamix™: Atopic Dermatitis (EU), tracks the evolution of the AD market in the EU5 (France, Germany, Italy, Spain, UK) though bi-annual reports (n=250 EU dermatologists).
About RealWorld Dynamix™
RealWorld Dynamix™: Moderate-to-Severe Atopic Dermatitis (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.
For more information contact:
Kristen Henn, Business Development Manager
Email: [email protected]
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