Publications

Psoriasis is a chronic inflammatory skin condition with significant physical and psychosocial comorbidity. A workshop of leading experts in dermatology and psychology with the purpose of better understanding the current role of psychological comorbidities in psoriasis was held by the International Psoriasis Council in November 2013. The role of stress reactivity with a focus on the hypothalamic-pituitary-adrenal axis was emphasized. While cognitive behavioral therapy remains the most extensively studied and successful treatment strategy in patients with psoriasis and various psychological comorbidities, new and innovative interventions such as online-based therapies have recently emerged. Strategies and recommendations toward approaching psychological comorbidities are discussed.

BACKGROUND: Psoriasis is a debilitating skin disease associated with substantial pruritus, work impairment, and sleep disturbance.

OBJECTIVE: This study evaluated associations between pruritus and work productivity, and the role of sleep problems as a possible mediator of the relationship between the two.

METHODS AND MATERIALS: Data from a pruritus visual analog scale (Itch VAS), the Medical Outcomes Study Sleep Scale (MOS-SS), and the Work Productivity and Activity Impairment Questionnaire (WPAI) were collected in a phase 2 clinical trial in patients with psoriasis treated with ixekizumab or placebo. Mediating effects of sleep were tested in multiple regressions with pruritus severity (independent variable) and work productivity (dependent variable). Sobel tests evaluated the significance of sleep's effect.

RESULTS: Several MOS-SS domains were significantly associated with the WPAI presenteeism, work productivity, and activity impairment scores, and decreased the effect of pruritus. Sobel tests indicated that the Sleep Problems Index I had a significant effect (P<.05) in mediating the relationship between pruritus and presenteeism, work productivity, and activity impairment.

CONCLUSION: Sleep may mediate the role of pruritus on work productivity, but both factors appear to have independent negative effects on work.

AIMS: Cardiac e-consults may be an effective way to deliver value-oriented outpatient cardiology care in an accountable care organization. Initial results of cardiac e-consults have demonstrated high satisfaction among both patients and referring providers, no known adverse events, and low rates of diagnostic testing. Nevertheless, differences between e-consults and traditional consults, effects of e-consults on traditional consult volume, and whether patients seek traditional consults after e-consults are unknown.

METHODS AND RESULTS: We established a cardiac e-consult program on January 13, 2014. We then conducted detailed medical record reviews of all patients with e-consults to detect any adverse clinical events and detect subsequent traditional visits to cardiologists. We also performed 2 comparisons. First, we compared age, gender, and referral reason for e-consults vs traditional consults. Second, we compared changes in volume of referrals to cardiology vs other medical specialties that did not have e-consults. From January 13 to December 31, 2014, 1,642 traditional referrals and 165 e-consults were requested. The proportion of e-consults of all evaluations requested over that period was 9.1%. Gender balance was similar among traditional consults and e-consults (44.8% male for e-consults vs 45.0% for traditional consults, P = .981). E-consult patients were younger than traditional consult patients (55.3 vs 60.4 years, P < .001). After the introduction of cardiac e-consults, the increase in traditional cardiac visit requests was less than the increase in traditional visit requests for control specialties (4.5% vs 10.1%, P < .001). For e-consults with at least 6 months of follow-up, 75.6% patients did not have any type of traditional cardiology visit during the follow-up period.

CONCLUSION: E-consults are an effective and safe mechanism to enhance value in outpatient cardiology care, with low rates of bounceback to traditional consults. E-consults can account for nearly one-tenth of total outpatient consultation volume at 1 year within an accountable care organization and are associated with a reduction in traditional referrals to cardiologists.

There are numerous barriers to conducting clinical research in pregnancy, including ethical considerations, logistical difficulties, and federal regulations. Due to these challenges, there is a paucity of data on the safe and appropriate use of dermatologic therapies in pregnancy, even for easily accessed over-the-counter topical products, as well as for commonly prescribed medications. Given the lack of human safety data, the Food and Drug Administration pregnancy labeling system previously placed a high priority on animal data but was recently revised to highlight human data and pregnancy registries. The latter can provide prospective observational data on medication use in pregnant women, while avoiding many of the pitfalls of conducting clinical trials in this population; nevertheless, registry enrollment for dermatologic drugs remains low. Dermatologists must increase awareness of pregnancy registries and encourage patient enrollment to close this knowledge gap.

BACKGROUND: Comparing effectiveness of biologics in real-world settings will help inform treatment decisions.

OBJECTIVES: We sought to compare therapeutic responses among patients initiating infliximab, adalimumab, or etanercept versus ustekinumab during the Psoriasis Longitudinal Assessment and Registry (PSOLAR).

METHODS: Proportions of patients achieving a Physician Global Assessment score of clear (0)/minimal (1) and mean decrease in percentage of body surface area with psoriasis were evaluated at 6 and 12 months. Adjusted logistic regression (Physician Global Assessment score 0/1) and analysis of covariance (percentage of body surface area with psoriasis) were performed to determine treatment factors associated with effectiveness.

RESULTS: Of 2541 new users on registry, 2076 had efficacy data: ustekinumab (n = 1041), infliximab (n = 116), adalimumab (n = 662), and etanercept (n = 257). Patients receiving tumor necrosis factor-alpha(-α) inhibitors were significantly less likely to achieve Physician Global Assessment score 0/1 versus ustekinumab (infliximab [odds ratio {OR} 0.396, P < .0001], adalimumab [OR 0.686, P = .0012], etanercept [OR 0.554, P = .0003] at 6 months and infliximab [OR 0.449, P = .0040] at 12 months). Mean decrease in percentage of body surface area with psoriasis was significantly greater for ustekinumab versus adalimumab (point estimate 1.833, P = .0020) and etanercept (point estimate 3.419, P < .0001) at 6 months and versus infliximab (point estimate 3.945, P = .0005) and etanercept (point estimate 2.778, P = .0007) at 12 months.

LIMITATIONS: Treatment selection bias and limited data for doing adjustments are limitations.

CONCLUSIONS: In PSOLAR, effectiveness of ustekinumab was significantly better versus all 3 tumor necrosis factor-α inhibitors studied for the majority of comparisons at 6 and 12 months.

BACKGROUND: Determining treatment response for patients with hidradenitis suppurativa (HS) can be challenging due to limitations of current disease activity evaluations.

OBJECTIVE: Evaluate the novel, validated endpoint, Hidradenitis Suppurativa Clinical Response (HiSCR) and its utility as an outcome measure.

METHODS: Patients with baseline total abscess and inflammatory nodule count (AN count) of at least three and draining fistula count of 20 or fewer comprised the post hoc subpopulation analysed. HiSCR (at least a 50% reduction in total AN count, with no increase in abscess count, and no increase in draining fistula count relative to baseline) and HS-PGA Response [Hidradenitis Suppurativa-Physician's Global Assessment score of clear, minimal, or mild, with at least a 2-grade improvement from baseline] were used to evaluate patient response after adalimumab treatment weekly, every other week, or placebo (1 : 1 : 1).

RESULTS: The subpopulation included 132 (85.7%) patients; 70.5% women and 73.5% white. At week 16, HiSCR was achieved by 54.5% receiving weekly adalimumab, 33.3% every other week, and 25.6% placebo and HS-PGA Response was achieved by 20.5% receiving weekly adalimumab, 6.7% every other week and 2.3% placebo.

CONCLUSION: HiSCR was more responsive to change than HS-PGA Response in this subpopulation.

Previous studies have established migration patterns between the geographic location of physicians' residency programs and their first post-training job. Our study explores the patterns of migration of pre-residency education locations with residency and post-residency geography. We analyzed responses to an annual survey administered between 2008 and 2013 to participants of the board examination review courses organized by Galderma Laboratories. Geography of high school (HS), medical school (MS), residency, and first job location were highly correlated. The Midwest and South retained the most residents from HS (70% each), whereas the West retained the lowest percent of residents from HS (33%). The West and Northeast exported about half of their HS graduates to the South and MW for residency. The South retained the largest proportion of its trainees post-residency (75%). Our data revealed that both HS and MS locations are closely related to residents' ultimate employment locations. This information may be useful to training program directors and chairpersons as they manage recruitment and retention of trainees and faculty and may inform plans to address geographic workforce imbalances.

BACKGROUND: Itching is a profoundly distressing symptom for many patients with psoriasis, but it has not been rigorously studied using validated tools for this condition.

OBJECTIVES: This study investigated the psychometric properties of the Itch Numeric Rating Scale (Itch NRS), a single-item patient-reported outcome (PRO) measuring the worst itching severity due to psoriasis in the past 24 h.

METHODS: Using disease-specific clinician-rated and PRO data from one phase II and three phase III randomized clinical studies of subjects with moderate-to-severe plaque psoriasis, the Itch NRS was evaluated for test-retest reliability, construct validity and responsiveness. A responder definition was explored using anchor- and distribution-based methods.

RESULTS: Test-retest reliability analyses supported the reproducibility of the measure (intraclass correlation coefficient range 0·71-0·74). To support the construct validity of the Itch NRS, large cross-sectional correlations with the Dermatology Life Quality Index (DLQI) Symptoms and Feelings domain (r ≥ 0·60 at baseline and r ≥ 0·80 at week 12) supported a priori hypotheses, while large correlations (r ≥ 0·71) between changes in Itch NRS scores and changes in DLQI Symptoms and Feelings domain scores from baseline to week 12 established responsiveness. A 4-point change was optimal for demonstrating a level of clinically meaningful improvement in itch severity after 12 weeks of treatment, which corresponds with marked clinical improvements in plaque psoriasis.

CONCLUSIONS: The Itch NRS demonstrated sufficient reliability, validity and responsiveness, and appropriate interpretation standards for evaluating change over time in itch severity among patients with moderate-to-severe plaque psoriasis when validated using clinical trial data for this condition.