Publications

2016

Shah SJ, Cronin P, Hong CS, et al. Targeted Reminder Phone Calls to Patients at High Risk of No-Show for Primary Care Appointment: A Randomized Trial.. Journal of general internal medicine. 2016;31(12):1460-1466.

BACKGROUND: No-shows, or missed appointments, are a problem for many medical practices. They result in fragmented care and reduce access for all patients.

OBJECTIVE: To determine whether telephone reminder calls targeted to patients at high risk of no-show can reduce no-show rates.

DESIGN: Single-center randomized controlled trial.

PARTICIPANTS: A total of 2247 primary care patients in a hospital-based primary care clinic at high risk of no-show (>15 % risk) for their appointment in 7 days.

INTERVENTION: Seven days prior to their appointment, intervention arm patients were placed in a calling queue to receive a reminder phone call from a patient service coordinator. Coordinators were trained to engage patients in concrete planning. All patients received an automated phone call (usual care).

MAIN MEASURES: Primary outcome was no-show rate. Secondary outcomes included arrival rate, cancellation rate, reschedule rate, time to cancellation, and change in revenue.

KEY RESULTS: The no-show rate in the intervention arm (22.8 %) was significantly lower (absolute risk difference -6.4 %, p < 0.01, 95 % CI [-9.8 to -3.0 %]) than that in the control arm (29.2 %). Arrival, cancellation, and reschedule rates did not differ significantly. In the intervention arm, rescheduling and cancellations occurred further in advance of the appointment (mean difference, 0.35 days; 95 % CI [0.07-0.64]; p = 0.01). Reimbursement did not differ significantly.

CONCLUSIONS: A phone call 7 days prior to an appointment led to a significant reduction in no-shows and increased reimbursement among patients at high risk of no-show. The use of targeted interventions may be of interest to practices taking on increased accountability for population health.

Kimball AB, Luger T, Gottlieb A, et al. Impact of ixekizumab on psoriasis itch severity and other psoriasis symptoms: Results from 3 phase III psoriasis clinical trials.. Journal of the American Academy of Dermatology. 2016;75(6):1156-1161. doi:10.1016/j.jaad.2016.07.034

BACKGROUND: Itch is a prevalent symptom of psoriasis that impacts quality of life.

OBJECTIVE: We sought to describe improvements in itch severity, skin pain, and bothersomeness of skin appearance caused by psoriasis among patients who received ixekizumab, etanercept, or placebo in three 12-week, phase III clinical trials (UNCOVER-1, -2, and -3).

METHODS: The itch numeric rating scale evaluated psoriasis itch severity in all 3 trials. Skin pain was assessed by skin pain visual analog scale. Bothersomeness because of redness/discoloration, thickness, and scaling/flaking was assessed with the Psoriasis Skin Appearance Bothersomeness instrument. Psoriasis skin appearance bothersomeness and skin pain were assessed at baseline and week 12; itch numeric rating scale score was assessed at baseline and weeks 1, 2, 4, 8, and 12.

RESULTS: Patients who received ixekizumab demonstrated statistically significant improvements (P < .001) in itch severity, reduction in skin pain, and degree of bothersomeness compared with those who received etanercept or placebo. Clinically meaningful improvements in itch severity were achieved as early as week 1.

LIMITATIONS: Longer-term evaluations of psoriasis symptom improvement with ixekizumab treatment are needed.

CONCLUSION: After treatment with ixekizumab, patients reported fast, significant, and clinically meaningful improvements in itch severity and other psoriasis-related symptoms such as skin pain and skin appearance bothersomeness.

Shahwan KT, Kimball AB. Managing the dose escalation of biologics in an era of cost containment: the need for a rational strategy.. International journal of women’s dermatology. 2016;2(4):151-153. doi:10.1016/j.ijwd.2016.09.003

Although biologic medications have demonstrated great efficacy for the treatment of psoriasis, a subset of patients fails to respond and others lose response later in the course. In treating a patient who has failed to respond to biologic therapy, clinicians must decide between dose escalation, switching biologics, and adding or switching to a non-biologic systemic drug or phototherapy. Although dose escalation is perhaps the simplest strategy and generally well-tolerated, it confers a tremendous cost burden because doubling the dosage is likely to double the wholesale price. We call for the development of rational strategies for the pricing of dose escalation in order to minimize this phenomenon. We also call for increased transparency surrounding negotiated pricing to ensure that all patients have access to the most effective, affordable treatment options available.

2015

Kimball AB, Rothman KJ, Kricorian G, et al. OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results.. Journal of the American Academy of Dermatology. 2015;72(1):115-22. doi:10.1016/j.jaad.2014.08.050

BACKGROUND: OBSERVE-5 was a 5-year Food and Drug Administration-mandated surveillance registry of patients with psoriasis.

OBJECTIVE: We sought to assess long-term etanercept safety and effectiveness.

METHODS: Patients with moderate to severe psoriasis enrolled; a single baseline dose of etanercept was required. Key outcome measures included serious adverse events, serious infectious events, events of medical interest, psoriasis-affected body surface area, physician global assessment score, and Dermatology Life Quality Index score. Safety outcomes were assessed relative to data from the MarketScan database.

RESULTS: For 2510 patients, 5-year cumulative incidence was 22.2% (95% confidence interval [CI] 20.3%-24.2%) for serious adverse events; 6.5% (95% CI 5.4%-7.7%) for serious infectious events; 3.2% (95% CI 2.3%-4.1%) for malignancies excluding nonmelanoma skin cancer; 3.6% (95% CI 2.7%-4.5%) for nonmelanoma skin cancer; 2.8% (95% CI 2.0%-3.6%) for coronary artery disease; 0.7% (95% CI 0.3%-1.2%) for psoriasis worsening; 0.2% (95% CI 0.0%-0.4%) for central nervous system demyelinating disorder; 0.1% (95% CI 0.0%-0.3%) for lymphoma and for tuberculosis; and 0.1% (95% CI 0.0%-0.2%) for opportunistic infection and for lupus; 55 fatal events were reported. Rates of malignancies, lymphomas, nonmelanoma skin cancer, and hospitalization-associated infections were not higher than expected relative to administrative claims data. The percentage of patients rated as clear/almost clear was 12% at baseline, which increased to 51% at month 6 and remained relatively stable throughout 5 years.

LIMITATIONS: No internal comparator group was included; rare events may not have been detected.

CONCLUSION: No new safety signals were observed with long-term, real-world etanercept use.

Wanner M, Houston N, Javorsky E, Yuan M, Alora-Palli M, Kimball AB. Single blind, randomized, controlled trial of a lightening product with and without iontophoresis versus tretinoin and vehicle for hyperpigmentation.. Journal of drugs in dermatology : JDD. 2015;14(1):13-8.

BACKGROUND: Hyperpigmentation is a common concern and has many causes including lentigines and melasma. Currently available topical products for hyperpigmentation are limited by their potential for irritation, lack of demonstrated efficacy or regulatory concerns.

OBJECTIVE: To compare the efficacy of a new skin lightening product with and without iontophoresis to a known effective product (tretinoin) and placebo on hyperpigmentation caused by lentigines and/or melasma. Secondary objectives included an assessment of the product's effects on the appearance of rhytides and roughness.

METHODS AND MATERIALS: Eighty subjects were randomized into one of four treatment groups: proprietary lightening product, proprietary lightening product with iontophoresis, tretinoin 0.05% cream, or vehicle control. Seventy-four subjects completed all study visits. Blinded assessments of subjects were performed at each visit under ambient and Wood's light.

RESULTS: The proprietary skin lightening product improved facial hyperpigmentation versus placebo under ambient light (P= 0.05) and Wood's lamp (P= 0.01) examination. Tretinoin also improved facial hyperpigmentation versus placebo under Wood's lamp (P= 0.01). The proprietary product was better tolerated than tretinoin, with fewer subject reported side effects.

CONCLUSION: The investigational product was effective and may be better tolerated than tretinoin cream.

Garshick MK, Kimball AB. Psoriasis and the life cycle of persistent life effects.. Dermatologic clinics. 2015;33(1):25-39. doi:10.1016/j.det.2014.09.003

Psoriasis is associated with significant physical, social, and behavioral comorbidities that create a substantial burden. We outline herein that these comorbidities start early in life and persist for decades, ultimately impacting the entire life course of patients with psoriasis. By highlighting the ages that psoriasis patients are affected with physical, social, behavioral and emotional comorbidities, we demonstrate the age-appropriate considerations for psoriasis patients.

Kim GE, Seidler E, Kimball AB. A measure of chronic quality of life predicts socioeconomic and medical outcomes in psoriasis patients.. Journal of the European Academy of Dermatology and Venereology : JEADV. 2015;29(2):249-254. doi:10.1111/jdv.12503

BACKGROUND: Psoriasis is a chronic skin disorder that detracts from quality of life, including elements of physical, psychological and social functioning.

OBJECTIVE: This study investigated whether retrospective questions about chronic quality of life (CQoL) were better predictors of poor socioeconomic and medical outcomes than the current Dermatology Life Quality Index (DLQI).

METHODS: One hundred fourteen participants answered the 10 questions used in the standard DLQI for 'over the last week', 'over the last year' and 'over your lifetime with psoriasis'. Subjects were examined and completed a self-administered questionnaire regarding disabilities, relationships, education and medical and economic outcomes (a smaller subset of 58 subjects also answered questions regarding religion and discrimination).

RESULTS: Greater lifetime DLQI (LT DLQI) correlated with lower satisfaction with treatment (P = 0.007), greater concern that psoriasis will worsen (P = 0.012), worse perceived general health (P = 0.003), younger age at which weight became problematic (P = 0.002), greater likelihood of believing psoriasis had caused weight gain (P < 0.001), shorter retention of current job (P = 0.001), more experiences of discrimination at work (P = 0.002) and in social settings (P < 0.001) over one's lifetime and more severe discrimination in social settings over one's lifetime (P = 0.002). Greater LT DLQI predicted more packs smoked per day (P = 0.005), greater likelihood of believing psoriasis caused smoking (P = 0.012), greater likelihood of recreational drug use (P = 0.004), greater likelihood of a depression diagnosis (P < 0.001), greater likelihood of having felt depressed (P = 0.011) and greater likelihood of believing psoriasis caused depression (P < 0.001).

CONCLUSION: Compared to the standard LW DLQI, LT DLQI was a better predictor of patient outcomes related to weight, discrimination and depression.

Pascoe VL, Enamandram M, Corey KC, et al. Using the Physician Global Assessment in a clinical setting to measure and track patient outcomes.. JAMA dermatology. 2015;151(4):375-81. doi:10.1001/jamadermatol.2014.3513

IMPORTANCE: In dermatology, the development of objective, standardized quality measures that can be used in a clinical setting is important to be able to respond to the needs of payers and credentialing and licensure bodies and to demonstrate dermatologic value.

OBJECTIVE: To examine the feasibility of using Physician Global Assessment (PGA) scores to collect and track patient acne and psoriasis outcomes over time.

DESIGN, SETTING, AND PARTICIPANTS: The PGA severity scores were included on physicians' billing sheets for patients with acne and psoriasis seen at a tertiary care center outpatient dermatology clinic from June 2011 through October 2012. A subset of patients from 5 clinics completed Patient Global Assessments (PtGAs) between November 2011 and May 2012. Thirty dermatology clinicians saw a total of 2770 patients with acne and 1516 patients with psoriasis in clinic, recording PGA scores for each patient. The PtGA scores were collected from 52 and 103 patients with acne and psoriasis, respectively, within the larger sample.

MAIN OUTCOMES AND MEASURES: Longitudinal PGA severity scores were collected for acne and psoriasis. The PGA severity scores were analyzed over time, with the hypothesis that patient scores for both acne and psoriasis would improve between the initial and follow-up visits. The PtGA scores from a subset of clinics and dates were compared with PGA scores to assess within-clinic reliability, with the hypothesis that there would be good agreement between clinician and patient assessments.

RESULTS: New patient PGA outcomes showed considerable improvement over time. At 3-month follow-up, 14.6% of the acne cohort was graded as effectively clear, compared with 2.1% at baseline (P < .001). Similarly, at 3-month follow-up, 22.3% of the psoriasis cohort was graded as effectively clear, compared with 3.1% at baseline (P < .001). Additionally, interobserver agreement between PGA and PtGA scores was good (acne, κ = 0.68; psoriasis, κ = 0.70).

CONCLUSIONS AND RELEVANCE: The PGA can be readily incorporated into practice to track patient acne and psoriasis outcomes over time, representing an opportunity for dermatologists to evaluate performance and validate practice guidelines.