Improvements in Psoriasis, Including Sexual Function and Personal Relationships, With Roflumilast Cream 0.3% and Foam 0.3%: Outcomes From the Phase 3 DERMIS-1/2 and ARRECTOR Trials

Psoriasis can occur on any body area, including the genitals. Genital involvement impacts quality of life, particularly intimacy/relationships. Topical treatment of genital psoriasis requires special considerations based on thinner skin and greater absorption. Roflumilast cream 0.3% and foam 0.3% are phosphodiesterase 4 inhibitor-based advanced targeted topical treatments that do not contain potentially irritating excipients; their efficacy and safety were demonstrated in patients with plaque psoriasis in the phase 3 DERMIS-1/2 and ARRECTOR trials, respectively. Efficacy and quality-of-life outcomes based on presence of genital involvement are reported here. Roflumilast cream 0.3% or foam 0.3%, or vehicle, were applied once daily for 8 weeks in eligible patients in the DERMIS-1/2 (aged ≥2 years with at least mild plaque psoriasis) and ARRECTOR (aged ≥12 years with psoriasis of the scalp [at least moderate] and body [at least mild]) studies, respectively. The primary endpoint of DERMIS-1/2 was Investigator Global Assessment (IGA) success at week 8 and the co-primary endpoints of ARRECTOR were IGA of the scalp (S-IGA) and body (B-IGA) success at week 8, each defined as clear (0) or almost clear (1) plus ≥2-point improvement from baseline. Additional assessments were Worst Itch-Numeric Rating Scale (WI-NRS), Dermatology Life Quality Index (DLQI), safety, and tolerability. At week 8, higher proportions of patients had improved psoriasis signs/symptoms with roflumilast versus vehicle for IGA/B-IGA success overall (DERMIS-1/2, 39.9% vs 6.5%; ARRECTOR, 45.5% vs 20.1%; both P<0.0001) and in those with baseline genital involvement (39.3% vs 5.4%; 45.1% vs 5.7%; both P<0.005), and for WI-NRS success overall (68.5% vs 31.3%; 63.1% vs 30.1%; both P<0.0001) and in those with baseline genital involvement (71.0% vs 16.7%, P<0.005; 63.6% vs 37.9%). At week 8, DLQI improved (minimally important difference, ≥4-point reduction from baseline in patients aged ≥17 years with baseline DLQI ≥4) with roflumilast versus vehicle overall (DERMIS-1/2, 73.3% vs 40.4%; ARRECTOR, 69.4% vs 36.2%; both P<0.0001) and in those with baseline genital involvement (64.4% vs 34.6%, P=0.0067; 81.8% vs 33.3%, P<0.001). Proportions of patients responding on the DLQI that their psoriasis caused no/no relevant ‘sexual difficulties’ increased more with roflumilast than with vehicle from baseline to week 8 in the overall population of DERMIS-1/2 (roflumilast, 79.7% to 92.1%; vehicle, 77.0% to 83.3%) and ARRECTOR (80.4% to 94.3%; 84.6% to 89.4%) and in those with baseline genital involvement in DERMIS-1/2 (61.1% to 84.2%; 81.6% to 80.0%) and ARRECTOR (52.2% to 90.2%; 75.0% to 78.3%). Similar trends were observed for improvements in ‘problems with partners or relatives. Application-site pain adverse events were reported for 6 (1.0%) and 1 (0.4%) patients in the roflumilast groups of DERMIS-1/2 and ARRECTOR, respectively. ≤2.1% of patients discontinued study medication because of an adverse event. ≥95.0% of patients reported no or mild irritation after the first roflumilast application. Roflumilast cream and foam were both well tolerated and improved signs/symptoms of plaque psoriasis and sexual function/relationships. Improvements in the overall population and in those with baseline genital involvement support both roflumilast cream and roflumilast foam for the treatment of psoriasis.