Findings from a recent study, presented at the 2019 Maui Derm for Dermatologists meeting, suggest apremilast (Otezla), an oral PDE4 inhibitor, may effectively treat bothersome symptoms of scalp psoriasis. Nearly half of participants experienced reductions in itch and clear or almost clear skin after 16 weeks of treatment.
The scalp is one of the most commonly affected areas among patients with psoriasis. Due to its location, scalp psoriasis can be difficult to treat and affect patients’ quality of life. “Scalp psoriasis can be devastating for patients because it is itchy, uncomfortable, and highly visible. Because they suffer from obvious lesions, it can be difficult to wear certain hair styles and dark clothing that may reveal flakes,” said study investigator Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health System in Detroit, Michigan, in an interview with The Dermatologist. She added, “treatments can also be challenging as often topical therapy can leave a residue that makes hair look and feel unclean.”
The Study
In the phase 3, multicenter, double-blind, placebo-controlled study, the investigators recruited 303 participants with moderate to severe plaque psoriasis on the scalp with inadequate response or intolerance to 1 or more topical therapies. For 16 weeks, 201 participants received twice-daily 30 mg of apremilast and 102 participants received placebo. Participants started on apremilast continued the study drug through week 32, while those treated with placebo switched to apremilast for the remainder of the treatment period.
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The primary endpoint included the proportion of participants who achieved a score of clear or almost clear on the scalp Physician Global Assessment (ScPGA), with a 2-point or greater reduction from baseline at week 16. Secondary endpoints assessed at week 16 included the proportion of participants who achieved an improvement of 4 points or greater from baseline in whole body itch and scalp itch Numerical Rating Scale (NRS) scores and changes in Dermatology Quality Life Index scores from baseline.
Results
After 16 weeks of treatment, significantly more participants in the apremilast group achieved the primary endpoint compared with those in the placebo group (43.4% vs 13.8%). Likewise, 47% and 45.3% of participants treated with apremilast achieved an improvement of 4 points or greater on scalp itch and whole-body itch NRS, respectively, compared with 21.3% and 22.5% of those treated with placebo. Participants treated with apremilast also showed greater improvements in DLQI scores from baseline compared with those on placebo at week 16.
Improvements with apremilast compared with placebo were seen early. “About 20% of participants achieved clear or almost clear results at 4 weeks,” said Dr Stein Gold. “Improvement in itching was also seen rapidly, with statistically significant improvement compared with placebo at 2 weeks.”
Common adverse events among apremilast and placebo treatment groups included diarrhea (30.5% vs 10.8%, respectively), nausea (21.5% vs 5.9%), headache (11.5% vs 4.9%), and vomiting (5.5% vs 2%). These were consistent with the known safety profile of apremilast.
Conclusion
Apremilast improved both visible symptoms of scalp psoriasis and pruritus, Dr Stein Gold said. “Itch is the symptom that psoriasis patients find the most bothersome,” she noted. Alleviating pruritus is important because “scalp itch is especially troublesome in that it causes progression of the disease, can be socially unacceptable, and intensifies the spreading of flakes,” added Dr Stein Gold. Overall, the results of this study are promising for patients with scalp psoriasis and concomitant pruritus.
Reference
Voorhees AV, Gold LS, Lebwohl M, et al. Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: Results of a phase 3, multicenter, randomized, placebo-controlled, double-blind study. Presented at: Maui Derm for Dermatologists 2019 Meeting; Maui, HI; January 26-30, 2019.
