Following Arcutis Biotherapeutics’ announcement of new data from its pivotal DERMIS-1 and DERMIS-2 studies of topical phosphodiesterase-4 (PDE4) inhibitor roflumilast for plaque psoriasis (PsO) at the EADV Spring Symposium, leading data and analytics company, GlobalData, notes that this additional data supports rofilumast’s robust safety and efficacy profile.

Tiffany Chan, Immunology Analyst at GlobalData comments: “In the announced clinical trial results, roflumilast cream was generally safe and well tolerated. In fact, 90% of patients within the randomized roflumilast treatment arm completed a full eight weeks. However, while such a favorable safety and efficacy profile is promising, the drug may still face logistical hurdles establishing itself in the crowded PsO disease space. If approved in PsO, roflumilast would be the second PDE4 inhibitor to market, following Amgen’s Otezla (apremilast), which is set to lose patent protection in 2028. GlobalData anticipates that roflumilast will launch in 2022 across the seven major markets (7MM)*.”

Unlike Otezla, roflumilast is a topical cream. The current standard topical therapies for PsO are corticosteroids, a class that has not seen innovations since the 1970s. Arcutis will likely position roflumilast as a first-line therapy, prior to the use of injectable biologics. The addition of a new topical would likely be an easy transition for mild and moderate patients who are already accustomed to using topical corticosteroids.

Chan adds: “However, roflumilast is entering an increasingly crowded and competitive field with numerous existing branded agents, as well as several generics and biosimilars set to launch in the next decade. Roflumilast would be Arcutis’ first agent to market and will compete with agents coming from pharmaceutical stalwarts such as AbbVie and Johnson & Johnson – companies that are already well established in the PsO market with prescribers and payers. Therefore, additional post-marketing active comparator trials may prove to be essential for Arcutis to further inform physician prescribing patterns and establish Arcutis’ reputation in the field.”

*7MM: The UK, the US, France, Germany, Italy, Spain and Japan.