Treating moderate plaque psoriasis: prospective 6-month chart review of patients treated with apremilast.

Purpose: Apremilast, an oral phosphodiesterase 4 inhibitor, was effective in clinical trials in patients with moderate plaque psoriasis (affected body surface area [BSA] 5% to 10%). However, findings from real-world clinical practice are limited. Materials and methods: An online survey and chart review was conducted among US dermatologists during October 2015 to identify clinical characteristics and 6-month treatment outcomes among patients with moderate psoriasis treated with apremilast. Results: A total of 83 dermatologists provided patient chart information at the initial and 6-month follow-up time points for 70 patients with moderate plaque psoriasis initially receiving apremilast, of whom 65 were receiving it as their primary therapy (mean age: 47.3 years; 45% were men). Among apremilast-treated patients, 91% (64 of 70) remained on apremilast and 54% were rated as having improved to mild psoriasis at follow-up; mean BSA decreased from 9.9% at initial chart review to 4.9%. There were 8 of 66 (12%) patients who experienced ≥1 side effect, including diarrhea (7.6%), nausea (4.5%), headache (1.5%), and abdominal pain (4.5%). Most dermatologists (68%) stated that apremilast exceeded or met their expectations. Conclusions: Most patients with moderate psoriasis receiving apremilast had improved at 6-month follow-up. Safety and tolerability were consistent with the safety profile of apremilast.

Defining and treating moderate plaque psoriasis: a dermatologist survey.

PURPOSE: Patients with moderate plaque psoriasis are often undertreated and may experience unsatisfactory clinical outcomes. Undertreatment may stem partly from a lack of consensus on the definition of moderate psoriasis and appropriate treatments for patients with moderate disease severity. MATERIALS AND METHODS: An online survey was conducted during October 2015 to determine how US dermatologists in the clinical setting define and treat moderate psoriasis. RESULTS: A total of 150 dermatologists responded to the survey (mean time in practice: 13.5 years). On average, they saw 72 patients with psoriasis per month; 40% of these patients were considered to have moderate psoriasis. Most (95%) reported assessing disease severity based on the percentage of psoriasis-affected body surface area (BSA); 59% also considered location of the affected area. BSA cutoffs used to define moderate psoriasis varied widely (median low and high cutoffs: 5-10%; range: 1-70%). Similarly, wide variation in cutoff ranges was observed for the Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA), and Dermatology Life Quality Index (DLQI). Primary therapy comprised biologics (47%), prescription topicals (28%), and oral systemics (18%). CONCLUSIONS: The current findings indicate lack of consensus surrounding the definition of moderate psoriasis among US dermatologists.

Improvement in Extensive Moderate Plaque Psoriasis With a Novel Emollient Spray Formulation of Betamethasone Dipropionate 0.05.

BACKGROUND: A novel formulation of 0.05% betamethasone dipropionate in an emollient spray vehicle (DFD-01) was developed to deliver steroid to the skin layers most affected by psoriasis. OBJECTIVE: To compare the efficacy and safety of DFD-01 to its vehicle for the treatment of moderate plaque psoriasis over 4 weeks. METHODS: Two Phase 3 trials enrolled adults with moderate psoriasis (Investigator Global Assessment [IGA]=3; 10-20% body surface area [BSA]) and randomized them 2:1 to DFD-01 or Vehicle. Products were applied twice daily to affected areas for 28 days. Treatment success was defined as an IGA=0 or 1 and ≥ 2-grade improvement from baseline. Primary endpoint was the proportion of subjects achieving treatment success at day 15. RESULTS: Moderate psoriasis subjects were enrolled in Study 1 (174 DFD-01; 87 Vehicle) and Study 2 (182 DFD-01; 95 Vehicle). Mean BSA was 13-14%. Treatment success was achieved in significantly more subjects using DFD-01 than Vehicle at day 15 in both Study 1 (P<0.001) and Study 2 (P=0.002), and at day 29 (both studies P<0.001). Treatment success with DFD-01 was significant at day 8 in Study 1 (P=0.003) but not in Study 2 (P=0.156). Erythema, scaling, and plaque elevation scores of target lesions were significantly reduced as early as day 4 with DFD-01. Adverse events were similar between groups, with no increase between 2 and 4 weeks. CONCLUSION: These studies demonstrate DFD-01's excellent efficacy and safety for the treatment of extensive psoriasis (10-20% BSA). DFD-01 achieved treatment success in significantly more subjects than Vehicle after 2 and 4 weeks of treatment, and showed early onset of action with improved signs of erythema, scaling and elevation of target lesions after 4 days of treatment. This medium potency formulation provides a safe and effective choice for topical steroid treatment of psoriasis.

Real-life treatment profile of calcipotriene and betamethasone dipropionate topical suspension in patients with psoriasis vulgaris.

BACKGROUND: Treatment with calcipotriene plus betamethasone dipropionate (CBD) fixed-combination topical suspension has been shown to be effective and well tolerated in patients with psoriasis vulgaris. AIM: To document experiences with CBD topical suspension in a US clinical dermatology setting using patient-reported outcomes (PROs). METHODS: In total, 147 patients were enrolled in this 8-week, prospective, noninterventional, multicenter, one-arm study. Data were collected at baseline and week 8 at the office, and at one time at home (week 2). PROs were assessed using the Dermatology Life Quality Index (DLQI), Patient's Global Assessment of disease severity (PtGA) using a 5-point Likert scale, patient-reported level of itching using a 0-100 graduated visual analog scale, and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Treatment adherence and adverse events (AEs) were assessed at week 8. RESULTS: After 8 weeks of treatment, DLQI score significantly improved compared with baseline (-5.5 ± 5.93; P<.0001), starting as early as week 2 (-4.2 ± 5.28; P<.0001). The level of itching was significantly reduced from baseline to week 2 (-19% ± 25.94%; P<.0001) and week 8 (-28.6% ± 29.14%; P<.0001). The percentage of patients with "controlled disease" (PtGA score of "clear" or "very mild") was 34.1% at week 2 and 60.2% at week 8. At the end of treatment, mean TSQM-9 scores for effectiveness, convenience, and satisfaction domains ranged from 68 to 74. Patients reported the need to use CBD topical suspension for an average of 53.62 ± 8.05 days. Treatment-emergent AEs occurred in 3 patients. CONCLUSION: The results of this noninterventional study are consistent with previously reported data from interventional trials and suggest that treatment with CBD topical suspension is efficacious and well tolerated and improves quality of life in patients with psoriasis vulgaris.