Skin and Cancer Associates - Hallandale Beach

February 11, 2019

Hidradenitis suppurativa has a significant negative impact on patient quality of life, which has been reported to be greater than that of atopic eczema and psoriasis.

The HIDRAdisk, a validated, visual, interactive electronic instrument completed together by patients and dermatologists, is an easy-to-use quality of life tool that could improve the management of hidradenitis suppurativa while also strengthening patient-clinician relationships, according to a study published in Journal of the European Academy of Dermatology and Venerology.

The chronic relapsing inflammatory skin disease hidradenitis suppurativa has a significant negative impact on patient quality of life, which has been reported to be greater than that of atopic eczema and psoriasis. This multicenter, longitudinal, observational study was designed to demonstrate the reliability, responsiveness, and overall validity of HIDRAdisk, a new tool designed to rapidly assess hidradenitis suppurativa burden with an intuitive graphic visual of the measurement outcome. Study authors compared HIDRAdisk with the following validated questionnaires: Work Productivity and Activity Impairment-General Health (WPAI:GH), Dermatology Life Quality Index (DLQI), and Skindex-16. They evaluated HIDRAdisk’s correlation with disease severity as measured by Hurley stage and Hidradenitis Suppurativa Physician Global Assessment (HS-PGA).

Participants were identified from 27 Italian dermatologic centers (N=140; mean age 34.9±11.0 years, 59% women). HIDRAdisk showed a statistically significant correlation with both Hurley stage (P =.0002) and HS-PGA (P =.0041), a good correlation with WPAI:GH (correlation coefficient: 0.5947), and a strong correlation with Skindex-16 (correlation coefficient: 0.7568) and DLQI (correlation coefficient: 0.6651). Very good internal consistency was demonstrated, with raw and standardized Cronbach coefficient values greater than >0.80 (0.894 and 0.898, respectively), correlation between the 10 items ranging between 0.308 and 0.673, good test-retest reliability (Spearman correlation coefficient, 0.8331; P <0.0001), and statistically significant responsiveness to changes.

Study investigators concluded that “the HIDRAdisk is a validated visual instrument administered on electronic devices, completed by patient and dermatologist together, making it an easy-to-use [quality of life] tool that, in our wishes, should be implemented soon in routine clinical practice to improve the management of [hidradenitis suppurativa], as well as strengthen the patient–physician relationship.”

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Reference

Peris K, Lo Schiavo A, Fabbrocini G, et al. HIDRAdisk: validation of an innovative visual tool to assess the burden of hidradenitis suppurativa [published online January 11, 2019]. J Eur Acad Dermatol Venereol. doi: 10.1111/jdv.15425

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February 08, 2019

There was no correlation between itch visual analogue scale score and modified Psoriasis Area and Severity Index at baseline,

The use of calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g cutaneous (Cal/BD) foam in patients with psoriasis provides quicker, more effective relief of itch compared with foam vehicle, with significant improvements in sleep and Dermatology Life Quality Index (DLQI) scores, according to a study published in the Journal of the European Academy of Dermatology and Venereology.

Investigators pooled data from 3 multicenter, randomized, parallel-group, blinded trials (ClinicalTrials.gov identifiers: NCT01536886 [phase 2], NCT01866163 [phase3], and NCT02132936 [phase 3]) and sought to assess the efficacy of topical fixed-dose combination therapy with Cal/BD on itch, itch-associated loss of sleep, and health-related quality of life vs foam vehicle among adults with mild to severe psoriasis.

Patients with visual analogue scale (VAS) scores >40 (range, 1-100) were evaluated. Study outcomes included the following: itch VAS score reduction >40, ≥70% improvement in itch (Itch70) or itch-related loss of sleep, 75% improvement in modified Psoriasis Area and Severity Index (excluding the head; mPASI75), and DLQI scores 0/1 through 4 weeks.

Among a total of 837 patients with itch measurements available, 37 had baseline itch VAS=0 and were excluded from the analysis. Of the remaining 800 patients (Cal/BD foam: n=610; foam vehicle: n=190), 484 had baseline itch VAS >40. No association was reported between itch VAS score and mPASI at baseline. In patients with baseline itch VAS >40, significantly more individuals attained itch VAS reduction >40 in the active treatment vs vehicle treatment group from day 5 on (day 5: 57.5% vs 40.2% [P <.05]; and week 4: 83.0% vs 45.8% [P <.001]).

Furthermore, significantly more Cal/BD foam-treated patients compared with foam vehicle-treated patients achieved Itch70 at day 3 (34.2% vs 22.5%; P <.05) through week 4 (79.3% vs 38.1%; P <.001). Among patients with baseline itch VAS >40 and sleep loss >20, improvements in itch-associated sleep loss were seen at week 1 and continued through 4 weeks, with itch-related improvements occurring before mPASI75 improvements.

Moreover, significant differences were observed in the proportion of Cal/BD foam-treated patients vs foam vehicle-treated patients with baseline DLQI >10 (n=172 vs n=50) attaining DLQI ≤1 (25.0% vs 4.0%; P =.001) and DLQI 0 (17.4% vs 2.0%, respectively; P =.006) at week 4.

Limitations of the current study include the lack of validated itch-related sleep loss measurement tools, as well as the need for different patient pools, the lower patient numbers available for the earlier times (ie, days 3 and 5), and the lack of pooled efficacy data that compared Cal/BD foam and its monocomponents.

The investigators concluded that this pooled analysis of patients with psoriasis demonstrated that Cal/BD foam provides more rapid, effective relief from itch than foam vehicle, and is linked to significant improvements in DLQI and sleep among this population.

Disclosures: LEO Pharma sponsored this study. Multiple authors disclosed affiliations with pharmaceutical companies. See the reference for complete disclosure information.

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Reference

Jalili A, Lebwohl M, Gold LS, et al. Itch relief in patients with psoriasis: effectiveness of calcipotriol plus betamethasone dipropionate foam [published December 6, 2018]. J Eur Acad Dermatol Venereol. doi: 10.1111/jdv.15393

February 08, 2019

Although associations were consistent, a key limitation of this meta-analysis was that included studies were heterogeneous in several aspects.

Psoriasis is associated with elevated rates of all-cause mortality in a dose-response manner with disease severity, as well as with cause-specific mortality, according to the results published in the Journal of the American Academy of Dermatology.

With the recognition that an overview of the mortality risk associated with psoriasis is lacking, investigators conducted a meta-analysis and systematic review of risk for mortality among individuals with psoriasis. Included in the review were studies that reported all-cause or cause-specific mortality risk estimates in persons with psoriasis compared with the general population or with individuals free of psoriasis. A total of 12 studies were included in the analysis.

Among 6 studies of 299,374 patients with psoriasis, the pooled risk ratio (RR) for all-cause mortality was 1.21 (95% CI, 1.14-1.28; P <.001). Among 4 studies of 265,292 individuals with mild psoriasis, the pooled RR for all-cause mortality was 1.13 (95% CI, 1.09-1.16; P =.048). Among 6 studies of 36,428 patients with severe psoriasis, the pooled RR for all-cause mortality was 1.52 (95% CI, 1.35-1.72; P <.001).

Among 5 studies of 285,675 patients with psoriasis, the pooled RR for cardiovascular (CV) mortality was 1.15 (95% CI, 1.09-1.21; P =.02). Among 3 studies of 188,223 individuals with mild psoriasis, the pooled RR for CV mortality was 1.05 (95% CI, 0.92-1.20; P <.001). Among 4 studies of 17,317 patients with severe psoriasis, the pooled RR for CV mortality was 1.38 (95% CI, 1.09-1.74; P <.001).

With respect to non-CV causes of death, the risk for mortality from kidney and liver disease was highest. The RRs for mortality from kidney disease was 2.16 (95% CI, 1.37-3.40) among all patients with psoriasis, 2.20 (95% CI, 1.36-3.56) among individuals with mild psoriasis, and 3.54 (95% CI, 1.73-7.26) among those with severe psoriasis. In addition, the RRs for mortality from liver disease were 2.00 (95% CI, 1.34-2.99) among all patients with psoriasis, 4.26 (95% CI, 1.87-9.73) among individuals with mild psoriasis, and 3.97 (95% CI, 2.87-5.50) among those with severe psoriasis.

Moreover, the RRs for mortality from infections was 1.24 (95% CI, 1.14-1.31) among all patients with psoriasis, 1.41 (95% CI, 1.11-1.79) among individuals with mild psoriasis, and 1.58 (95% CI, 1.22-2.05) among those with severe psoriasis. Significantly increased mortality risk from neoplasms was also reported among patients with severe psoriasis, as well as from chronic lower respiratory disease in all individuals with psoriasis and in those with mild psoriasis.

The investigators concluded that on the basis of the findings from this study, patients with psoriasis, and in particular those with risk factors and severe disease, should receive appropriate screening and preventive interventions. Additional research is warranted to evaluate the effect of psoriasis on mortality independent of mortality risk factors, to elucidate cause-specific mortality among patients with psoriasis, and to establish the mechanisms that induce excess mortality.

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Reference

Dhana A, Yen H, Yen H, Cho E. All-cause and cause-specific mortality in psoriasis: a systematic review and meta-analysis [published online December 24, 2018]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2018.12.037

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February 07, 2019

At week 4 of treatment, there was a common decrease in 2645 genes expressed in lesioned skin between risankizumab vs ustekinumab.

In patients with psoriasis, treatment with risankizumab is associated with changes in the molecular and histopathologic profiles of lesional skin after 4 weeks compared with ustekinumab, according to study results published in The Journal of Allergy and Clinical Immunology.

The investigators used the results of 2 studies – a phase 1 single-rising-dose study of risankizumab therapy (ClinicalTrials.gov identifier: NCT01577550) and a phase 2 study of risankizumab vs ustekinumab (ClinicalTrials.gov identifier: NCT02054481) –  to explore the similarities and differences in the histopathologic and molecular profiles of skin lesions from patients with psoriasis who had been treated with risankizumab or ustekinumab. Lesional skin biopsies obtained from patients with moderate to severe plaque psoriasis who had participated in the phase 1 (n=39) and phase 2 (n=60) studies were analyzed by histopathology, RNA-sequencing, and immunochemistry.

Results showed that treatment with risankizumab generated a rapid decrease in protein and transcriptomic biomarkers associated with the interleukin-23 (IL-23) pathway, with these reductions maintained through 8 weeks. At week 4, risankizumab decreased histopathologic biomarker expression, including K16, Ki67, CD3, CD11c, DC-LAMP, lipocalin-2, β-defensin 2, and S100A7.

Based on global histopathology scoring, 54% and 69% of patients who were treated with risankizumab 90 mg or risankizumab 180 mg, respectively, were graded as “excellent improvement,” compared with 29% of patients treated with ustekinumab. At 4 weeks, a common decrease in 2645 genes expressed in lesional skin was reported between risankizumab and ustekinumab, with a significant reduction observed in 2682 genes that are unique to risankizumab therapy.

Cytokine-induced transcriptome changes in key cell lines linked to psoriatic skin lesions— epidermal cells, keratinocytes, and monocytes—demonstrated a greater reduction in expression with risankizumab treatment compared with ustekinumab therapy.

The investigators concluded that the key pathways and types of cells identified in this study may help build hypotheses for the observed differences in efficacy reported according to biologic agent. Additional studies are warranted in order to further characterize the profile of risankizumab and compare the agent with ustekinumab and other biologics, thus enabling an improved understanding of the relationship of these agents to longer-term efficacy and the potential remission of psoriasis.

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Reference

Visvanathan S, Baum P, Vinisko R, et al. Psoriatic skin molecular and histopathological profiles following treatment with risankizumab versus ustekinumab [published online December 19, 2018]. J Allergy Clin Immunol. doi:10.1016/j.jaci.2018.11.042

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February 06, 2019

The investigators sought to determine how the natural environment or diet protects potentially at-risk populations from such allergic conditions as atopic dermatitis.

A detailed microbiome analysis conducted in a group of children from rural South African communities has revealed differences in the gut microbiota of toddlers with atopic dermatitis (AD) linked to their diet. Results were published in the Journal of Allergy and Clinical Immunology.

The investigators sought to determine how the natural environment or diet protects potentially at-risk populations from such allergic conditions as AD, thus helping to elucidate the causes of the current global increase in atopic diseases. They characterized the gut microbiota of South african black (Xhosa) children from the remote rural Mqanduli district of the Eastern Cape in association with AD. Patients with AD were recruited from the Dermatology Department of the Nelson Mandela Academic Hospital in Umtata, Eastern Cape, South Africa. Control, nonallergic, non-food-sensitized participants were recruited from areas surrounding 10 district community health clinics.

A total of 83 children were recruited for this study: 36 participants with AD and 47 control patients without AD. The fecal microbiota of these children were analyzed and compared with respect to the presence of AD, other clinical variables, and their diet.

AD was significantly associated with food sensitization (P =.0001), but not with allergic rhinitis (P =.14) or wheezing (P =.73). Moreover, children with AD had a significantly higher daily consumption of total sugar (P =.007) and saturated fat (P =.003) than control patients.

Notably, having been breastfed at all, as well as the duration of exclusive breastfeeding and total breastfeeding, was not associated with an individual’s AD status (P =.73, P =.67, and P =.72, respectively).

The relative abundance of Prevotella copri was significantly decreased in children with AD compared with those without the disorder (1.45±3.94 vs 0.38±0.53, respectively; P <.00001). Further, children with high sugar content in their diet had significantly lower P copri levels than those with lower median sugar intake (0.43±0.52 vs 1.04±3.32, respectively; P <.0001).

The investigators concluded that based on the decreased prevalence of P copri in the participants with AD, these bacteria may play a protective role against the development of this disorder. Additional studies are warranted to evaluate the underlying mechanism of this association relative to gut microbiota.

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Reference

Mahdavinia M, Rasmussen HE, Botha M, et al. Effects of diet on the childhood gut microbiome and its implications for atopic dermatitis [published online December 19, 2018]. J Allergy Clin Immunol. doi: 10.1016/j.jaci.2018.11.034

February 06, 2019

194 participants with mild to moderate atopic dermatitis were randomly assigned to receive vehicle cream or 0.1%, 0.3%, or 1.0% PAC‐14028 cream twice daily.

PAC‐14028, a transient receptor potential vanilloid subfamily member 1 (TRPV1) agonist, appears to be a safe and effective topical treatment for patients with mild to moderate atopic dermatitis, according to data published in the British Journal of Dermatology.  

Researchers in this double‐blind, multicenter, vehicle‐controlled, 8‐week, phase IIb trial randomly assigned 194 participants with mild to moderate atopic dermatitis into groups receiving vehicle cream or 0.1%, 0.3%, or 1.0% PAC‐14028 cream twice daily. The primary efficacy end point was success rate defined as percentage of participants with an Investigator’s Global Assessment (IGA) score of 1 or 0 at week 8. Secondary end points included Eczema Area and Severity Index (EASI) 75/90 and Scoring of Atopic Dermatitis (SCORAD).  

At week 8, IGA success was achieved by 14.58% of participants in the vehicle cream group compared with 42.55% in the 0.1% PAC-14028 group (P =.0025 vs vehicle), 38.30% in the 0.3% PAC‐14028 group (P =.0087 vs vehicle), and 57.45% in the 1.0% PAC‐14028 group (P <.001 vs vehicle). Statistically significant differences between treatment groups and vehicle cream were particularly observed for 2-grade IGA success rate improvements from baseline (4.2% for vehicle cream; 21.3% for 0.1% PAC‐14028, P =.0121; 27.7% for 0.3% PAC‐14028, P =.0017; and 38.3% for 1.0% PAC‐14028, P <.001). Trends towards improvement were seen in EASI 75/90, SCORAD index, pruritus visual analogue scale, and sleep disturbance score for all treatment groups, with significant improvements observed in sleep disturbance score from week 3 of treatment in the 1.0% PAC‐14028 cream group (P <.05 vs vehicle). There were no significant safety issues reported.

Study investigators concluded that PAC‐14028 cream is an effective, favorably tolerable treatment option for mild to moderate atopic dermatitis. They noted that “[b]ased on these results, a phase III programme is underway to assess the efficacy and safety of PAC‐14028 topical cream 1.0% in adolescent and adult patients with mild‐to‐moderate AD (NCT02965118).”

Disclosures: Study funding was provided by AmorePacific Corporation.

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Reference

Lee YW, Won CH, Jung K, et al. Efficacy and safety of PAC‐14028 cream – a novel, topical, nonsteroidal, selective TRPV1 antagonist in patients with mild‐to‐moderate atopic dermatitis: a phase IIb randomized trial [published online January 8, 2019]. Br J Dermatol. doi: 10.1111/bjd.17455