Latest news with #roflumilast
Medscape
22-05-2025
- Health
- Medscape
FDA Approves Roflumilast Foam for Scalp, Body Psoriasis
The foam formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast has been approved by the US Food and Drug Administration (FDA) for treating plaque psoriasis of the scalp and body in adults and adolescents aged 12 years and older, according to an announcement from the manufacturer Arcutis Biotherapeutics. The 0.3% foam formulation of roflumilast (Zoryve) was previously approved for the treatment of seborrheic dermatitis in adults and children aged 9 years and older. The company has since then filed a supplemental New Drug Application with the FDA in September 2024. A 0.3% cream version is approved as a topical treatment for plaque psoriasis in adults and children aged 6 years and older. And the 0.15% cream formulation of roflumilast is approved for treatment of mild-to-moderate atopic dermatitis for the same population. Approval is based on data from phase 2b and 3 studies. In the pivotal phase 3 ARRECTOR study recently published in JAMA Dermatology , 432 patients with scalp and body psoriasis aged 12 years and older were randomized to once-daily application of 0.3% roflumilast foam or a vehicle for 8 weeks. Medscape also reported the findings. Significantly more patients in the roflumilast group vs the vehicle group achieved the primary endpoints of Scalp-Investigator Global Assessment (S-IGA) and Body-IGA (B-IGA) success — defined as clear or almost clear — plus two or more grades of improvement from baseline after 8 weeks of treatment (66.4% vs 27.8% for S-IGA; 45.5% vs 20.1% for B-IGA; P < .001 for both). In addition, significantly more patients who received roflumilast achieved a clinically significant reduction of itch (defined as a change of ≥ 4 points from baseline on the Scalp Itch-Numeric Rating Scale) compared with those on the vehicle after 8 weeks (65.3% vs 30.3%). Significantly more roflumilast-treated patients with baseline scalp itch also showed significant improvement compared with placebo patients after 2 weeks and 4 weeks of treatment (25.2% vs 8.0%; 46.2% vs 16.8%, respectively; P < .001 for all). Body itch scores also improved significantly in the roflumilast patients compared to those in the vehicle group. Rates of adverse events were similar and low in both treatment and placebo groups, as were treatment-emergent adverse events and rates of discontinuation because of adverse events, the researchers noted. The most common adverse events reported among patients treated with 0.3% roflumilast foam were headache (1.1%), nausea (1.3%), and nasopharyngitis (1.5%), according to the company's press release. It is contraindicated in patients with moderate-to-severe liver impairment (Child-Pugh B or C).
Medscape
08-05-2025
- Health
- Medscape
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.
