Joslyn S. Kirby

Intralesional chemotherapy for nonmelanoma skin cancer: A practical review

Intralesional chemotherapy for nonmelanoma skin cancer has existed for more than 5 decades. However, it is used so infrequently that recent consensus guidelines for the treatment of basal cell and squamous cell carcinoma do not include intralesional chemotherapy. Barriers to the use of intralesional chemotherapy include the off-label use of these agents, absence of therapeutic guidelines, a relatively small number of patients treated, and a lack of large, well-designed trials with long-term follow-up. Surgical intervention remains the gold standard for the treatment of nonmelanoma skin cancer; however, intralesional chemotherapy remains an option for well-selected patients who cannot or will not undergo surgery. The objectives of this article are to determine response rates and suggest reasonable treatment guidelines for the treatment of squamous cell carcinoma, keratoacanthoma, and basal cell carcinoma with the most widely available intralesional agents (methotrexate, 5-fluorouracil, bleomycin, and interferon).

Sex- and Age-Adjusted Population Analysis of Prevalence Estimates for Hidradenitis Suppurativa in the United States

Importance The true prevalence of hidradenitis suppurativa (HS) is unknown. Objective To establish standardized overall and group-specific prevalence estimates for HS in the United States. Design, Setting, and Participants This retrospective analysis included a demographically heterogeneous population-based sample of more than 48 million unique patients across all US census regions. As of October 27, 2016, a total of 47 690 patients with HS were identified using electronic health record data. Main Outcomes and Measures Standardized overall point prevalence for HS and sex-, age-, and race-specific prevalence estimates of HS in the general US population. Results Of the 47 690 patients with HS (26.2% men and 73.8% women), the overall HS prevalence in the US population sample was 0.10%, or 98 per 100 000 persons (95% CI, 97-99 per 100 000 persons). The adjusted prevalence in women was 137 per 100 000 (95% CI, 136-139 per 100 000), more than twice that of men (58 per 100 000; 95% CI, 57-59 per 100 000; P < .001). The prevalence of HS was highest among patients aged 30 to 39 years (172 per 100 000; 95% CI, 169-275 per 100 000) compared with all other age groups (range, 15-150 per 100 000; P < .001). Adjusted HS prevalences among African American (296 per 100 000; 95% CI, 291-300 per 100 000) and biracial (218 per 100 000; 95% CI, 202-235 per 100 000) patients were more than 3-fold and 2-fold greater, respectively, than that among white patients (95 per 100 000; 95% CI, 94-96 per 100 000; P < .001). Conclusions and Relevance Hidradenitis suppurativa is an uncommon, but not rare, disease in the United States that disproportionately affects female patients, young adults, and African American and biracial patients.

Health Care Utilization Patterns and Costs for Patients With Hidradenitis Suppurativa

IMPORTANCE Hidradenitis suppurativa (HS) is a chronic cutaneous disease with acutely painful flares that require appropriate and timely treatment. OBJECTIVE To assess how individuals with HS utilize medical care, especially emergency department (ED) care, a high-cost setting, and to describe the health care costs for this group. DESIGN, SETTING, AND PARTICIPANTS Cohort cost-identification study of 150 493 individuals with claims from the MarketScan medical claims database. Patients with claims for HS and psoriasis (16 736 and 110 266, respectively) and a control group with neither condition (23 491) during the study period, January 2008 to December 2010, were included. EXPOSURES An HS cohort was formed from all the patients who had 2 or more claims for HS (International Classification of Diseases, Ninth Revision [ICD-9] code 705.83) during the 3-year period. A psoriasis cohort was used as a comparison group, since it is another chronic inflammatory condition with prominent skin findings. This group included randomly selected patients who had 2 or more claims for psoriasis (ICD-9 code 696.1) during the 3-year period. A second control group included randomly selected patients who had no claims for either condition during the 3-year period. From these cohorts only patients that were continuously enrolled for the 3-year period were included. MAIN OUTCOMES AND MEASURES Health care utilization measures including inpatient length of stay, emergency department and outpatient visits, and number of days supplied of prescription medication were investigated. Cost variables were also investigated and included inpatient, outpatient, emergency department, prescription drug, and total all-cause health care expenditures, which were adjusted for inflation and reported in 2010 US dollars. RESULTS The largest component of the total 3-year cost for the HS group was inpatient cost (37.4%). In contrast, for the psoriasis group this was drug costs (46.5%) and for the control group, inpatient costs (40.9%). The proportion of people who were hospitalized in the HS cohort (15.8%) was higher than the psoriasis (10.8%) or control (8.6%) groups (P < .001). The proportion of patients who used the ED over the 3-year period was higher in the HS cohort (27.1%) than the psoriasis (17.4%) or control groups (17.2%) (P < .001). Similarly, the mean (SD) 3-year ED cost for the HS group was

Laboratory Monitoring During Isotretinoin Therapy for Acne: A Systematic Review and Meta-analysis

2002 (

Protocol for the development of a core domain set for hidradenitis suppurativa trial outcomes

6632) and was higher than both comparison groups (P < .001). After adjustment for age, sex, and comorbidities, ED utilization remained higher in the HS group compared with the control (P < .001) and psoriasis (P = .02) cohorts. CONCLUSIONS AND RELEVANCE Hidradenitis suppurativa affects a younger, predominantly female population of patients. High-cost settings, such as ED and inpatient care, are used more frequently for patients with HS. Both patients and clinicians should be aware of this finding, and further research is needed to investigate the impact of health care utilization on patient outcomes.

Influence of Information Framing on Patient Decisions to Treat Actinic Keratosis

IMPORTANCE Oral isotretinoin has been associated with several adverse effects, but evidence-based estimates of laboratory changes during isotretinoin therapy in large patient samples are limited. OBJECTIVE To develop estimates of the laboratory changes that occur during isotretinoin therapy for acne using extant data and meta-analytic methods. DATA SOURCES A comprehensive search strategy using Ovid/MEDLINE, EMBASE, and gray literature was conducted (1960-August 1, 2013) to identify all relevant studies of isotretinoin use in acne vulgaris. Terms related to acne treatment, isotretinoin, and diagnostic procedures were searched with all available synonyms. STUDY SELECTION Inclusion criteria consisted of clinical trials using oral isotretinoin, doses of 40 mg/d or more, duration of at least 4 weeks, patients aged 9 to 35 years with acne vulgaris, and 10 or more participants. Studies from all countries published in any language were included. Exclusion criteria were use of modified isotretinoin products, isotretinoin therapy for conditions other than acne vulgaris, and concomitant acne therapy. The initial search yielded 342 records; 116 of these were screened for full-text examination. DATA EXTRACTION AND SYNTHESIS Two authors independently reviewed the publications to determine eligibility, and disagreements were resolved by a third author. Generated weighted means and 99% CIs were calculated using the reported means (SDs or SEs). A random effects model was created, and statistical heterogeneity was quantified. Data were analyzed from August 25, 2014, to December 4, 2015. MAIN OUTCOMES AND MEASURES Laboratory values for lipid levels, hepatic function, and complete blood cell count were evaluated. RESULTS Data from 61 of the 116 studies were evaluated; 26 studies (1574 patients) were included in the meta-analysis. The mean (99% CI) values during treatment (nonbaseline) for triglycerides was 119.98 mg/dL (98.58-141.39 mg/dL); for total cholesterol, 184.74 mg/dL (178.17-191.31 mg/dL); for low-density lipoprotein cholesterol, 109.23 mg/dL (103.68-114.79 mg/dL); for high-density lipoprotein cholesterol, 42.80 mg/dL (39.84-45.76 mg/dL); for aspartate aminotransferase, 22.67 U/L (19.94-25.41 U/L); for alanine aminotransferase, 21.77 U/L (18.96-24.59 U/L); for alkaline phosphatase, 88.35 U/L (58.94-117.76 U/L); and for white blood cell count, 6890/µL (5700/µL-8030/µL). This meta-analysis showed that (1) isotretinoin is associated with a statistically significant change in the mean value of several laboratory tests (white blood cell count and hepatic and lipid panels), yet (2) the mean changes across a patient group did not meet a priori criteria for high-risk and (3) the proportion of patients with laboratory abnormalities was low. CONCLUSIONS AND RELEVANCE The evidence from this study does not support monthly laboratory testing for use of standard doses of oral isotretinoin for the standard patient with acne.

Duration of oral antibiotic therapy for the treatment of adult acne: A retrospective analysis investigating adherence to guideline recommendations and opportunities for cost-savings

Introduction Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes to answer questions generated by the main hypotheses. However, for the chronic, inflammatory skin disease hidradenitis suppurativa (HS), the reported outcome measures are numerous and diverse. A recent systematic review found a total of 30 outcome measure instruments in 12 RCTs. This use of a broad range of outcome measures can increase difficulties in interpretation and comparison of results and may potentially obstruct appropriate evidence synthesis by causing reporting bias. One strategy for dealing with these problems is to develop a core outcome set (COS). A COS is a list of outcomes that are meant as mandatory and should be measured and reported in all clinical trials. The aim of this study is to develop a COS for the management of HS. Method and analysis An international steering group of researchers, clinicians and a patient research partner will guide the COS development. 6 stakeholder groups are involved: patients, dermatologists, surgeons, nurses, industry representatives and drug regulatory authorities. A 1:1 ratio of patients:healthcare professionals is aimed for. The initial list of candidate items will be obtained by combining three data sets: (1) a systematic review of the literature, (2) US and Danish qualitative interview studies involving patients with HS and (3) an online healthcare professional (HCP) item generation survey. To reach consensus on the COS, 4 anonymous online Delphi rounds are then planned together with 2 face-to-face consensus meetings (1 in Europe and 1 in the USA) to ensure global representation. Ethics and dissemination The study will be performed according to the Helsinki declaration. All results from the study, including inconclusive or negative results, will be published in peer-reviewed indexed journals. The study will involve different stakeholder groups to ensure that the developed COS will be suitable and well accepted.

Actinic Keratosis Clinical Practice Guidelines: An Appraisal of Quality

Importance Actinic keratosis (AK) is a skin growth induced by UV light exposure that requires long-term management because a small proportion of the disease can progress to squamous cell carcinoma. The influence of how clinicians frame or present information to patients may affect decision making about AK. Objective To evaluate the differences in patients’ decisions on whether to receive treatment for AK related to information presentation or choice framing. Design, Setting, and Participants A prospective survey study was performed from June 1 to July 31, 2016, in participants who were able to read English. Participants were recruited through the Penn State Milton S. Hershey Dermatology Clinic and an online survey site. The survey was conducted through an online portal. A total of 571 individuals were recruited. Regression analysis, correlation coefficient analysis, and test-retest validation were conducted. Main Outcomes and Measures The proportions of patients choosing to receive treatment for AK. Analyses were performed to adjust for age, sex, educational level, history of skin cancer, and history of AK. Results Of the 571 recruited participants, 539 (94.4%) returned completed surveys. The mean (SD) age of respondents was 42.9 (17.8) years; 306 (56.8%) were women. The decision to receive treatment for AK varied from 57.7% (n = 311) to 92.2% (n = 497) for the 5 scenarios presented in the questions (P < .001). The question that presented AK as a “precancer” had the highest proportion of participants who preferred treatment (497 [92.2%]). Two questions that presented the risk of AK as not progressing to cancer had the lowest proportion of individuals who chose treatment (311 [57.7%] and 328 [60.9%]). Participants from the clinic and from the online portal were significantly different in age (mean [SD] age, 56.1 [17.6] vs 33.3 [10.0] years), sex (145 [63.6%] vs 161 [51.8%] were females), educational level (40 [17.5%] vs 80 [25.7%] had completed some graduate school), history of AK (46 [20.2%] vs 19 [6.1%] answered yes), and history of skin cancer (76 [33.3%] vs 15 [4.8%] answered yes) (all P ⩽ .001). Based on a regression analysis, age, sex, and previous diagnosis of skin cancer were not significantly associated with the participants’ responses. Conclusions and Relevance This study found that patients’ decisions on whether to receive treatment for AK is significantly affected by physician wording, especially with alterations in the presentation of risk of malignant transformation.

Bundled Payment Models for Actinic Keratosis Management

BACKGROUND The duration of oral antibiotic acne therapy for adolescents compared with guidelines was recently investigated; however it was uncertain if duration of antibiotics for adult acne therapy differed. OBJECTIVE This study aimed to evaluate duration of oral antibiotics for adult acne compared with guidelines and determine possible cost-savings. METHODS This was a retrospective cohort study of MarketScan Commercial Claims and Encounters database that incorporated claims data to determine duration and costs of antibiotic treatment among adults ages 21 years and older. RESULTS Of 17,448 courses, 84.5% (14,737) aligned with duration guidelines, although 12,040 (69.0%) courses did not include concomitant topical retinoid therapy. Mean savings of

Development of a Quality-of-Life Measure for Hidradenitis Suppurativa

592.26 per person could result if prolonged courses met guidelines. Mean (median) costs of generic and branded formulations for the most frequent course duration (90-179 days) were