Efficacy and safety of apremilast and phototherapy versus phototherapy only in psoriasis vulgaris

Abstract

Phototherapy and apremilast (oral phosphodiesterase-4 inhibitor) are well-known in the treatment of moderate to severe psoriasis vulgaris. However, current evidence on the efficacy and safety of their combination is not sufficient. This multicenter, randomized controlled study compared the efficacy and safety between phototherapy as monotherapy and phototherapy and apremilast as combination therapy in patients with psoriasis vulgaris. Patients with moderate to severe psoriasis vulgaris were assigned to combination (n = 29) and monotherapy (n = 13) groups. All patients underwent an 8-week phototherapy regimen comprising irradiation with narrowband UV-B. The patients in the combination group were also administered 10 mg to 60 mg of oral apremilast. We evaluated the improvement percentage based on the Psoriasis Area and Severity Index (PASI) score from baseline to week 8. Additionally, we evaluated the percentage of patients who achieved ≥75% improvement; changes in body surface area (BSA) and scores of EuroQol 5-dimensions 5-level, Dermatology Life Quality Index, and visual analog scale for pruritis from baseline to 4 and 8 weeks; and adverse events. Compared with the monotherapy group, the combination group had significantly lower PASI scores at 4 and 8 weeks and more patients who achieved a PASI score improvement of ≥75% at 8 weeks. Both groups exhibited a significant decrease in BSA; at 8 weeks, no significant difference was observed between the two groups, although the combination group tended toward a greater reduction in BSA. The intergroup differences in the changes at the three time points were not significant. Adverse events were more frequent in the combination group than in the monotherapy group. Our findings suggest that an 8-week combined apremilast and phototherapy regimen may not be adequate in patients for improvements in their subjective assessment of psoriasis, and longer treatment periods may be necessary.

Keywords: Psoriasis Area and Severity Index; apremilast; phosphodiesterase-4 inhibitor; phototherapy; psoriasis.

FIGURE 1

Patient disposition. FAS, full analysis set; PPS, per‐protocol set; SAS, safety analysis set.

FIGURE 2

Time series variations of the Psoriasis Area and Severity Index (PASI) score and body surface area (BSA) score. (a) Changes in the PASI scores. (b) Degree of improvement in PASI scores. (c) Degree of change in the BSA scores. The round markers and solid lines represent the combination therapy group, and the diamond‐shaped markers and dotted lines represent the monotherapy group.

FIGURE 3

Percentage achievement of the Psoriasis Area and Severity Index (PASI) scores. The gray boxes represent the apremilast and phototherapy combination group, and the white boxes represent the phototherapy monotherapy group.

FIGURE 4

Percentage achievement in the Static Physician's Global Assessment (sPGA) 0/1 and sPGA 0. The gray boxes represent the apremilast and phototherapy combination group, and the white boxes represent the phototherapy monotherapy group.

FIGURE 5

Cobweb charts of the EuroQol 5‐dimensions 5‐level (EQ‐5D‐5L) scores. The red round markers and red solid lines represent the apremilast and phototherapy combination group, and the blue diamond‐shaped markers and blue dotted lines represent the phototherapy monotherapy group.