Roflumilast Foam Effective for Scalp and Body Psoriasis
Once-daily 0.3% topical roflumilast foam significantly reduced severity in patients with psoriasis of the scalp and body over 8 weeks, with a favorable safety profile.
METHODOLOGY:
Researchers conducted phase 3 double-blinded, randomized ARRECTOR trial of 432 participants aged 12 years or older with plaque psoriasis (mean age, 47.3 years; 56.3% women) in Canada and the United States between August 2021 and June 2022. About 80%-85% were White, and about 4% were Black.
Participants had plaque psoriasis affecting ≤ 25% of the scalp and body, ≥ 10% scalp involvement, ≤ 20% nonscalp areas, a minimum Scalp-Investigator Global Assessment (S-IGA) score of 3, and a minimum Body-Investigator Global Assessment (B-IGA) score of 2. Participants were randomly assigned to receive either roflumilast foam 0.3% (n = 281) or vehicle foam (n = 151) applied once daily for 8 weeks. The foam formulation of roflumilast, a phosphodiesterase 4 inhibitor, is approved by the US Food and Drug Administration for treating seborrheic dermatitis in adults and children aged 9 years or older.
Primary endpoints were S-IGA and B-IGA successes, defined as achieving a clear or almost clear score with ≥ 2-grade improvement at week 8.
TAKEAWAY:
S-IGA success was reported in 66.4% of patients in the roflumilast group and 27.8% of those in the vehicle group ( P < .001) at week 8. Body-IGA success was achieved by 45.5% of those in the roflumilast group and 20.1% of those in the vehicle group ( P < .001) at week 8.
< .001) at week 8. Body-IGA success was achieved by 45.5% of those in the roflumilast group and 20.1% of those in the vehicle group ( < .001) at week 8. Early efficacy was observed, with S-IGA success at weeks 2 and 4 significantly greater with roflumilast than with vehicle (30.4% vs 11.7% and 53.8% vs 19.5%, respectively; P < .001 for both). B-IGA success at week 4 was also higher (32.8% vs 12.1%; P < .001).
< .001 for both). B-IGA success at week 4 was also higher (32.8% vs 12.1%; < .001). Roflumilast achieved significant improvements in scalp itch scores compared with vehicle at week 2 (25.2% vs 8.0%), week 4 (46.2% vs 16.8%), and week 8 (65.3% vs 30.3%; P < .001 for all). Worst itch scores also improved with roflumilast vs vehicle (63.1% vs 30.1%; P < .001) at 8 weeks. Patient-reported outcomes also favored roflumilast, with improvements in Psoriasis Symptom Diary scores for itching, pain, and scaling (mean change, −10.9 vs −5.8; P < .001).
< .001 for all). Worst itch scores also improved with roflumilast vs vehicle (63.1% vs 30.1%; < .001) at 8 weeks. Patient-reported outcomes also favored roflumilast, with improvements in Psoriasis Symptom Diary scores for itching, pain, and scaling (mean change, −10.9 vs −5.8; < .001). Treatment-emergent adverse events were reported for 26.7% of patients in the roflumilast group and 16.6% of those in the vehicle group. Most events in both groups were mild or moderate in severity.
IN PRACTICE:
'Use of roflumilast foam was associated with significant improvements in both signs and symptoms of psoriasis of the scalp and body,' the authors wrote. 'Roflumilast foam was well-tolerated with no new AEs [adverse events], and low rates of AEs consistent with those reported with vehicle,' they added, noting that roflumilast foam 'is uniquely formulated for hair-bearing areas to improve tolerance and adherence.'
SOURCE:
The study was led by Melinda J. Gooderham, MD, SKiN Centre for Dermatology, Peterborough, Ontario, Canada, and was published online on May 7 in JAMA Dermatology .
LIMITATIONS:
The short duration, lack of an active comparator, and a low proportion of patients younger than 17 years (2.3%) were study limitations.
DISCLOSURES:
The study was sponsored by Arcutis Biotherapeutics, Inc. Gooderham reported receiving honoraria, research, and speaking fees from multiple pharmaceutical companies, including Arcutis, AbbVie, Acelyrin, Amgen, Akros, Aristea, AnaptysBio, Bausch Health, and Bristol Myers Squibb. Several authors also reported receiving honoraria, speaker fees, personal fees, and nonfinancial support from pharmaceutical companies, including Arcutis. Three authors reported having stocks in Arcutis and patents related to roflumilast.
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