With Dupixent only capturing a piece of the potential candidate pie, there remains ample runway for new agents in development to enter this highly dynamic market.
EXTON, Pa., Nov. 7, 2018 /PRNewswire/ – After over a year and a half on the market, U.S. dermatologists (n=102) remain extremely pleased with Sanofi/Regeneron’s Dupixent. In Spherix’s fourth quarter update of RealTime Dynamix™: Atopic Dermatitis (US), collaborating dermatologists indicated that the first biologic to treat moderate-to-severe atopic dermatitis has consistently exceeded expectations, and satisfaction with the IL-4/13 inhibitor remains extremely high. Furthermore, Dupixent has exhibited impressive efficacy as only a small minority of patients have experienced a flare since beginning treatment.
More positive news for the brand – Dupixent recently received a label expansion as an add-on maintenance therapy for patients with moderate-to-severe asthma, aged twelve and up, making it the first biologic to treat both atopic dermatitis and asthma. While the majority of collaborating dermatologists believe Dupixent will have an additional advantage over pipeline agents that will not have the dual indication, many are unsure if they will prescribe more Dupixent at this time based on the expanded label. One aspect that is likely to provide additional lift for the brand among dermatologists is an approval to treat adolescents with atopic dermatitis. Indeed, Sanofi/Regeneron reported that they have submitted a supplemental BLA for Dupixent in adolescents with moderate-to-severe atopic dermatitis, and the FDA has granted priority review with an action date of March 11, 2019. While respondents are divided regarding their level of comfort prescribing biologic options to patients under the age of 18, they did identify that one out of three severe adolescents are candidates for the brand or other advanced systemic treatments. Furthermore, over one-quarter of respondents indicated they already have experience prescribing off-label biologics to their atopic dermatitis patients under the age of 18, though it is typically limited to extremely severe cases and for those on the cusp of adulthood.
While most news for Dupixent is positive, dermatologists are still navigating the biologic treatment protocol for atopic dermatitis. Of note, nearly 90% of respondents agree that patients with atopic dermatitis require long-term systemic therapies, however, one-in-ten Dupixent patients are reportedly using the biologic only for short-term treatment. Acute use of Dupixent is most commonly attributed to improving patient symptoms, flare management, cost/coverage issues, and patient requests. As one dermatologist explained, “patients decide to stop [Dupixent] once their flare is cleared to see how much of a residual effect it has; also, some just have seasonal flares and only need it for winter or summer.” While overall brand persistency is positive, acute use may call into question the longevity of prescriptions at the patient level.
Dupixent is undoubtedly enjoying its status as the only biologic/advanced small molecule in town (for now), and while most current patients are doing well, there is still plenty of room for healthy competition in this market. Dermatologists continue to report that there is a high unmet need for additional atopic dermatitis treatments. In juxtaposition to psoriasis, more than half of severe psoriasis patients are currently being treated with biologics compared to just one-fifth of severe atopic dermatitis patients; this is particularly of interest considering that respondents identified that 60% of this population are considered candidates for biologic-treatment, indicating a vast untapped patient pool.
Regarding new agents for the treatment of moderate-to-severe atopic dermatitis, nearly two-thirds of respondents believe that an oral small molecule agent would be preferred over a subcutaneously-administered biologic, assuming comparable efficacy. Thus, JAK inhibitors could disrupt the market with a potential new mechanism of action and sought-after administration. If limited to just one agent to gain US FDA approval, nearly half selected an oral JAK inhibitor (AbbVie’s upadacitinib, Eli Lilly’s baricitinib, or Pfizer’s PF-04965842), while Galderma’s IL-31-inhibitor, nemolizumab, was also a leading contender. Though few respondents selected LEO Pharma’s tralokinumab and Dermira’s lebrikizumab as the agents they would most like to see gain approval, IL-13 inhibition was selected as one of the top mechanisms of action with the greatest potential for treating atopic dermatitis. Despite current perceptions on the leading preferred pipeline agents and mechanisms, any new option would likely be met by treating specialists with open arms. Candidacy for biologics and small molecules are further explored in Spherix’s large scale patient chart audit, RealWorld Dynamix™: Moderate-to-Severe Atopic Dermatitis (n=1,002 adult moderate-to-severe atopic dermatitis patients), published earlier this year.
About RealTime Dynamix™: Atopic Dermatitis
The RealTime Dynamix™: Atopic Dermatitis (US) report series provides a detailed and timely look at current and future trends in the AD market, and the effects of the future shifting landscape. The quarterly releases allow for close monitoring and trending of key performance metrics. In addition to the fixed trended measures, the report also includes variable content addressing key current issues updated quarterly. The rapid field-to-insight turnaround time, highly relevant content, and unparalleled knowledge of the dermatology market make this an essential tool for companies competing in the space, as well as those with near-term plans to enter it.
About RealWorld Dynamix™: Moderate-to-Severe Atopic Dermatitis
RealWorld Dynamix™: Moderate-to-Severe Atopic Dermatitis (US) is a large-scale patient audit of recently seen moderate-to-severe atopic dermatitis patients. To qualify, patients must be adults, seen within the past three months, currently pharmacologically treated (specifically for their AD), and classified as having moderate to severe disease. The audit will include approximately 1,000 patient records which will include clinical and non-clinical demographics, robust patient histories, current and past treatment regimens, referral patterns, co-morbidities, quality of life metrics, office visits and touchpoints, candidacy for biologic therapy, physician feedback about therapy satisfaction (specifically if currently treated with Dupixent or Eucrisa), and candidacy for pipeline agents.
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.
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