At the EADV Spring Symposium, Arcutis Biotherapeutics announced new data from its pivotal DERMIS-1 and DERMIS-2 studies of roflumilast for plaque psoriasis (PsO). Roflumilast is a topical phosphodiesterase-4 (PDE4) inhibitor currently under investigation for a number of additional dermatological indications such as atopic dermatitis and seborrhea. Both of its Phase III trials in PsO achieved the primary efficacy endpoint of Investigator Global Assessment (IGA) success at week eight, with significantly more patients treated with roflumilast cream 0.3% reaching IGA success compared to the control group of placebo-treated patients (DERMIS-1: 42.4% vs 6.1%, DERMIS-2: 37.5% vs. 6.9%, respectively, P<0.001 for both).  Roflumilast cream was generally safe and well-tolerated and 90% of patients who were randomised to it in the studies completed the full eight weeks of treatment. Although its favourable safety and efficacy profiles are promising, GlobalData believes that roflumilast may still face logistical hurdles establishing itself in the crowded PsO disease space.

GlobalData anticipates that roflumilast will launch in 2022 across the 7MM (seven major markets, namely the US, France, Germany, Italy, Spain and Japan). 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. However, 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 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.

Nonetheless, 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 (JNJ), 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.