Maintenance of Investigator's Static Global Assessment Response with Once-Daily Crisaborole in Participants with Mild to Moderate Atopic Dermatitis.

INTRODUCTION: Treatments for atopic dermatitis (AD) often fail to achieve lasting disease control. In the CrisADe CONTROL phase III study (ClinicalTrials.gov: NCT04040192), participants aged ≥ 3 months with mild to moderate AD treated with once-daily (QD) crisaborole, following initial treatment success with crisaborole twice daily (BID), had longer periods of flare-free maintenance, a higher number of flare-free days, and a lower number of flares compared with those who received vehicle. The study was an exploratory analysis of data on the maintenance of response per Investigator's Static Global Assessment (ISGA; ISGA score of 0 [clear] or 1 [almost clear]) during the CrisADe CONTROL study through week 52. METHODS: Exploratory endpoints were the time to ISGA response during the open-label run-in period, and the maintenance of ISGA response and the severity and duration of flares during the double-blind maintenance period. Outcomes were stratified by age (participants aged 3 months to < 12 years and ≥ 12 years) and duration of crisaborole BID treatment (< 4 weeks or ≥ 4 weeks) during the open-label run-in period. RESULTS: During the open-label run-in period, the median time to ISGA response was 41.5 days. From week 4 to week 52 of the double-blind maintenance period, the proportion of participants who maintained ISGA response was greater with crisaborole versus vehicle, and this difference was statistically significant up to week 36 (P < 0.05). Duration of flare periods during the maintenance period were 54.1 and 54.0 days for the vehicle and crisaborole-treated groups, respectively. Numerically fewer crisaborole-treated participants experienced a flare with an ISGA score of ≥ 2 compared with vehicle-treated participants (64.8% vs. 74.4%, respectively). Findings were comparable across most subgroups. CONCLUSIONS: Adult and pediatric participants with mild to moderate AD at baseline who had achieved responder criteria (treatment success) with crisaborole BID during the run-in period maintained response per ISGA with crisaborole QD during the double-blind maintenance period through week 52. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04040192.

Atopic dermatitis is a skin disease that causes itchy, red, and dry patches of skin that can affect a person for a long time. Current treatments for atopic dermatitis often fail to keep the symptoms under control. Some creams and ointments applied to the skin (known as topical treatments) can ease the discomfort of atopic dermatitis. Crisaborole is a steroid-free ointment that has been shown to improve symptoms of atopic dermatitis in clinical studies. In a study called the CrisADe CONTROL trial, crisaborole was tested to see if it can keep atopic dermatitis symptoms under control. People who participated in the study were aged 3 months and older and they had mild-to-moderate atopic dermatitis. Participants were asked to use crisaborole on their itchy, red, and dry skin twice daily for 8 weeks. Patients were called "responders" if their symptoms became nearly clear or completely clear based on a doctor's assessment called the Investigator's Static Global Assessment, which rates atopic dermatitis between clear to severe. Some responders were asked to use crisaborole once daily for 52 weeks and another group of responders was asked to use a control (an ointment with no medicine) once daily for 52 weeks. Investigators looked at how long the skin remained nearly clear or completely clear during the 52 weeks. Results of this study showed that after initial treatment success with crisaborole twice daily, adult and pediatric participants who had mild-to-moderate atopic dermatitis were able to keep their skin nearly clear or completely clear with crisaborole once daily.

Patient impact and economic burden of mild-to-moderate atopic dermatitis.

OBJECTIVE: To present a systematic review of studies conducted to evaluate patient impact and economic burden of mild-to-moderate atopic dermatitis. METHODS: A MEDLINE (via PubMed), Excerpta Medica database (Embase), and Cochrane Library search for English-language articles published January 1, 1996-December 31, 2016 was performed. Abstracts were manually reviewed from 2015-2016 from 10 leading conferences and congresses associated with atopic dermatitis. Manuscripts were reviewed for inclusion in two main categories within the review: patient impact of mild-to-moderate atopic dermatitis and economic burden of atopic dermatitis. Excluded from this dataset were any patients in these studies who had severe atopic dermatitis, moderate-to-severe atopic dermatitis, or atopic dermatitis of unspecified severity. RESULTS: In total, 222 studies qualified for inclusion in the analysis; this report focuses on the 76 studies that reported results stratified by disease severity. Measured by general and specific instruments, even mild-to-moderate atopic dermatitis reduces the overall quality-of-life of patients and their caregivers/families. Disease severity assessed by validated severity instruments directly correlated with quality-of-life. Treatment of atopic dermatitis can improve the quality-of-life of patients and their caregivers/families by alleviation of symptoms and reduction in severity. In general, total costs increased as disease severity increased; even mild atopic dermatitis imposed substantial costs. CONCLUSIONS: The results emphasize the impact of atopic dermatitis, especially mild atopic dermatitis, on patient lives and finances, including education of clinicians, payers, and patients regarding benefits associated with treatment adherence.

Canadian Clinical Practice Guidelines for Rosacea.

Rosacea is a chronic facial inflammatory dermatosis characterized by background facial erythema and flushing and may be accompanied by inflammatory papules and pustules, cutaneous fibrosis and hyperplasia known as phyma, and ocular involvement. These features can have adverse impact on quality of life, and ocular involvement can lead to visual dysfunction. The past decade has witnessed increased research into pathogenic pathways involved in rosacea and the introduction of novel treatment innovations. The objective of these guidelines is to offer evidence-based recommendations to assist Canadian health care providers in the diagnosis and management of rosacea. These guidelines were developed by an expert panel of Canadian dermatologists taking into consideration the balance of desirable and undesirable outcomes, the quality of supporting evidence, the values and preferences of patients, and the costs of treatment. The 2015 Cochrane review "Interventions in Rosacea" was used as a source of clinical trial evidence on which to base the recommendations.

Economic burden of moderate to severe plaque psoriasis in Canada.

BACKGROUND: Psoriasis is a chronic debilitating disease affecting approximately one million Canadians. The objective of this study is to estimate the economic burden in $CDN (2008) of moderate to severe plaque psoriasis among Canadian adults. METHODS: Using a cross-sectional design, direct resource use, costs, lost productivity, and quality of life were obtained for 90 subjects diagnosed with psoriasis in three dermatology clinics in British Columbia, Ontario, and Québec. An Excel-based economic model was developed to project the annual cost of psoriasis, from the societal perspective. RESULTS: The estimated mean annual cost of psoriasis was $7999/subject (95% CI: $3563-$12,434) with direct costs accounting for 57%. Mean lost productivity costs, which accounted for 43% of the mean annual costs of psoriasis, were $3442/subject (95% CI: $1293-$5590). CONCLUSION: Projecting the mean costs per patient to the afflicted population yields an estimated total annual cost of $1.7 billion (95% CI: $0.8-$2.6 billion) attributable to moderate to severe psoriasis in Canada. Understanding the interplay between direct costs, lost productivity, and quality of life is critical for accurately identifying and evaluating effective treatments for this disease.

Work productivity and healthcare resource utilization outcomes for patients on etanercept for moderate-to-severe plaque psoriasis: results from a 1-year, multicentre, open-label, single-arm study in a clinical setting.

BACKGROUND: Data investigating the effect of etanercept on work productivity and healthcare resource utilization in Canadian patients in a clinical setting is limited. OBJECTIVE: The aim of the study was to describe work productivity and healthcare resource utilization in patients with psoriasis prescribed etanercept. METHODS: A 12-month, phase IV, non-randomized, multicentre, open-label, single-arm prospective trial of patients with moderate-to-severe plaque psoriasis was conducted between March 2006 and July 2009 in 37 community dermatology practice sites across Canada. A total of 246 patients were enrolled. Major eligibility criteria: ≥18 years of age; diagnosis of moderate-to-severe plaque psoriasis at baseline (Physician Global Assessment [PGA] ≥3, scale 0-5); able to start etanercept therapy as per product monograph. Patients received etanercept (Enbrel(®)) 50 mg subcutaneously twice weekly for 3 months, then 50 mg once weekly for 9 months. Outcomes were measured by average change and average percent change from baseline at months 3, 6, 9 and 12 on the Work Productivity and Activity Impairment (WPAI) and Healthcare Resource Utilization (HRU) questionnaires. RESULTS: The mean degree of impairment while working ± standard deviation (SD) in the total population decreased from 22.7% ± 23.2 at baseline to 6.6% ± 14 after 3 months of treatment (p < 0.0001). From baseline to 3 months, overall work impairment ± SD decreased from 23.7% ± 23.7 to 8.3% ± 16.5 (p < 0.0001) and mean activity impairment outside the workplace decreased from 31.4% ± 26.4 to 12.9% ± 22.4 (p < 0.0001). All these improvements were sustained to month 12. Other variables that decreased on average from baseline to month 3, sustained to month 12, included physician office visits (2.3/month ± 3.5 at baseline to 0.6/month ± 1.0 at month 3; p < 0.0002), hours of assistance required of family and friends to assist with psoriasis (1.1 hours/week ± 2.6 at baseline to 0.3 hours/week ± 1.5 at month 3; p = 0.0002) and amount of time spent on activities to manage psoriasis (5.5 hours/week ± 6.2 at baseline to 1.9 hours/week ± 3.7 at month 3; p < 0.0001). Also, the amount of out-of-pocket expenses to manage psoriasis decreased from $Can94.9/month ± 331.6 at baseline to $Can35.7 ± 69.1 at month 12 (p = 0.0153). CONCLUSIONS: Use of etanercept in Canadian patients in a clinical practice setting correlated with improvement in work productivity and reduced HRU after 3 months of treatment, and improvement was sustained up to 12 months.

Canadian hand dermatitis management guidelines.

BACKGROUND: Hand dermatitis (HD) is one of the most common skin conditions; however, it is not a homogeneous disease entity. The severity of HD may range from very mild cases to severe chronic forms, which may result in prolonged disability and, occasionally, refractory HD. Chronic hand dermatitis (CHD) is associated with a high health- economic burden and significant loss of quality of life. OBJECTIVE: Although numerous treatment options are available, the management of CHD is often difficult and unsatisfactory. There is a paucity of well-designed, randomized, controlled clinical trials in support of the efficacy of established treatment modalities. CONCLUSION: These guidelines cover the epidemiology, burden, quality of life, etiology, diagnosis, classification, and prevention of HD and provide guidance on management using an approach that is as evidence based as possible.

Work-related lost productivity and its economic impact on Canadian patients with moderate to severe psoriasis.

BACKGROUND: Psoriasis impacts many different areas of a patient's life, including work productivity. There is no information regarding lost productivity owing to psoriasis in a Canadian population. OBJECTIVE: The objective of this study was to determine the lost productivity of Canadian patients with moderate to severe psoriasis. METHODS: Seventy-nine consecutive Canadian dermatology patients were interviewed and completed the Work Productivity and Activity Impairment Questionnaire (WPAIQ). RESULTS: On average, 2.2 hours (+/- 5.6 hours) were lost from work per week owing to psoriasis-related events. Absence from work may result in lost mean patient wages of C$2,270.84 per person per year. Total lost wages owing to moderate to severe psoriasis may cost up to approximately $749 million for all moderate to severe psoriasis patients in Canada. CONCLUSION: The results from our study indicate that moderate to severe psoriasis may have a substantial impact on the work productivity of patients with this disease.

International multicenter psoriasis and psoriatic arthritis reliability trial for the assessment of skin, joints, nails, and dactylitis.

OBJECTIVE: Clinical trials in psoriasis and psoriatic arthritis (PsA) involve assessment of the skin and joints. This study aimed to determine whether assessment of the skin and joints in patients with PsA by rheumatologists and dermatologists is reproducible. METHODS: Ten rheumatologists and 9 dermatologists from 7 countries met for a combined physical examination exercise to assess 20 PsA patients (11 men, mean age 51 years, mean PsA duration 11 years). Each physician assessed 10 patients according to a modified Latin square design that enabled the assessment of patient, assessor, and order effect. Tender joint count (TJC), swollen joint count (SJC), dactylitis, physician's global assessment (PGA) of PsA disease activity (PGA-PsA), psoriasis body surface area (BSA), Psoriasis Area and Severity Index (PASI), Lattice System Physician's Global Assessment of psoriasis (LS-PGA), National Psoriasis Foundation Psoriasis Score (NPF-PS), modified Nail Psoriasis Severity Index (mNAPSI), number of fingernails with nail changes (NN), and PGA of psoriasis activity (PGA-Ps) were assessed. Variance components analyses were carried out to estimate the intraclass correlation coefficient (ICC), adjusted for the order of measurements. RESULTS: There is excellent agreement (ICC >/=0.80) on the mNAPSI, substantial agreement (0.6 >/= ICC < 0.80) on the TJC, PASI, and NN, moderate agreement (0.4 >/= ICC < 0.60) on the PGA-Ps, LS-PGA, NPF-PS, and BSA, and fair agreement (0.2 >/= ICC < 0.40) on the SJC, dactylitis, and PGA-PsA. The only measure that showed a significant difference between dermatologists and rheumatologists was dactylitis (P = 0.0005). CONCLUSION: There is substantial to excellent agreement on the TJC, PASI, NN, and mNAPSI among rheumatologists and dermatologists.