Arcutis Biotherapeutics has announced positive results following its pivotal phase three trial (ARRECTOR), which evaluated roflumilast foam 0.3% for scalp and body psoriasis.
Research shows that approximately 40 percent of the estimated 9 million Americans with plaque psoriasis have involvement of the scalp. And although scalp psoriasis plaques are identical to psoriatic plaques on other areas of the body, topical treatment is challenging due to the presence of hair. Scalp psoriasis can also cause hair loss, and often, patients require two or more medications to manage the disease.
The results from Arrector are promising. The study met both of its primary endpoints. At week 8, Scalp Investigator Global Assessment (S-IGA) Success was measured at 67.3% for participants treated with roflumilast foam compared to 28.1% of participants treated with a matching vehicle foam. For the same period, the Body Investigator Global Assessment (B-IGA) Success was measured at 46.5% of participants treated with roflumilast foam compared to only 20.8% of participants treated with a matching vehicle foam.
The secondary endpoints also showed significant improvements. These included scalp itch and worst itch as measured by the Scalp Itch-Numeric Rating Score (SI-NRS) and the Worst Itch-Numeric Rating Score (WI-NRS), respectively.
According to Arcutis, roflumilast foam was well-tolerated, and the overall safety and tolerability profile was consistent with previous studies of roflumilast cream 0.3% and foam. The most common adverse effects reported in the study population included headache, diarrhea, and COVID-19.
“We are excited to share these topline results of roflumilast foam, a once-daily non-steroidal treatment option designed to overcome limitations of traditional creams and ointments for hair-bearing areas of the body. These pivotal Phase 3 results demonstrate the strong efficacy and tolerability of roflumilast foam for the treatment of scalp and body psoriasis and, with the recently announced Phase 3 results in seborrheic dermatitis, the overall potential for roflumilast foam for the treatment of these skin diseases,”
