A new highly selective oral sphingosine receptor modulator (S1P) has proven to be promising as a treatment for atopic dermatitis (AD) in a 12-week phase 2b trial, according to the researchers who published their findings in the Experience of virtual meetings of the American Academy of Dermatology.
The drug, called etrasimod, did not meet the main endpoint of improving the severity index and eczema area. However, almost a third (29.8%) of those treated with a dose of 2 mg daily reached “clear” or “almost clear” skin at 12 weeks compared with 13% of placebo, measured with the overall evaluation of the validated researcher (vIGA)) scores of 0 or 1 (Pg = .0450), presenter of the study Emma Guttman-Yassky, MD, PhD, a professor and chair of the dermatology department at Mount Iinahn School of Medicine in Mount Sinai, New York, noted in an interview.
“This was a brief proof-of-concept study to show that this mechanism is valid. The results are promising,” Guttman-Yassky said. “We are told that this may be a valid treatment for atopic dermatitis, a completely new mechanism of action that has the potential to improve and even modify the disease.”
Arena Pharmaceuticals, which developed the drug, hopes to launch a phase 3 study of the drug.
He ADVISE the study enrolled 140 people in the United States, Australia, and Canada with chronic, moderate to severe eczema that lasted at least a year. (Their average age was 43, 61% were women, and 60% were white). They were randomly assigned to cohorts that took 1 mg or 2 mg daily of etrasimod or placebo for 12 weeks.
Those in the 2 mg cohort saw their scores on the peak itch numerical score scale (PP-NRS) fall 15.3% at week 4, compared with 1% for placebo (Pg = .0380); at week 12, scores fell 34.1% among those taking 2 mg and 23.9% for placebo (Pg = .15 49). At 12 weeks, patients with 2 mg doses also had further improvements in the dermatology quality of life index or DLQI (a decrease of 7.6 points in the degree of deterioration vs. 4.2 points in the case of placebo, Pg = .0122) and in the measure of patient-oriented eczema or POEM (reduction of 8.4 points versus 4 points for placebo, Pg = .0045).
“Basically, there was a dose response. It doesn’t show a plateau,” Guttman-Yassky said. “I think the data will be even better in a longer study.”
Regarding adverse events, participants taking etrasimod reported nausea, constipation, back painand dizziness at levels above 5% and above placebo.
According to Guttman-Yassky, the drug appears to work by preventing the entry of immune cells into the skin, and can treat existing lesions and prevent new ones from appearing. Etrasimod is also being explored as a treatment for ulcerative colitis, area alopecia, i multiple sclerosis, she said.
Guttman-Yassky noted that 12 weeks is a short time in our era, and said some participants left the study because it occurred during the coronavirus pandemic.
“There is a huge unmet need in atopic dermatitis,” he said. “We need more drugs and different kinds of drugs to treat the disease in all patients.” While organic products are usually useful, he said, they don’t work in many cases. And “some patients just don’t want a biological product, no matter how much we tell them it’s safe, and they may want an oral medication,” he said.
Guttman-Yassky is a paid consultant and researcher for Arena.
This article originally appeared on MDedge.com, which is part of the Medscape professional network.
