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Biomedical subjects

Alan B Fleischer

Publications and source records attributed to Alan B Fleischer.

At least 19 recordsLinked to original sources

Stealth monitoring of adherence to topical medication: adherence is very poor in children with atopic dermatitis.

BACKGROUND: Atopic dermatitis is a common problem for which topical agents are the primary treatment. When topical medications fail, further therapy may include systemic agents with the potential for greater toxicity. Adherence to topical treatment of atopic dermatitis has not been well characterized. Poor adherence to topical medication could account for failure of topical therapy. PURPOSE: To determine adherence to topical treatment in patients with atopic dermatitis. METHODS: Thirty-seven children were given 0.1% triamcinolone ointment and were counseled to use it twice daily. They were told to return in 4 weeks, at which time they were told to continue treatment for another 4 weeks. Electronic monitors were used to measure adherence over the entire 8 week study. Patients were not informed of the compliance monitoring until the end of the study. RESULTS: Twenty-six patients completed 8 weeks of treatment. Mean adherence from the baseline to the end of the study was 32%. Adherence was higher on or near office visit days and subsequently decreased rapidly. LIMITATIONS: This study was limited by the large number of subjects who failed to return for follow-up appointments or withdrew from the study. CONCLUSIONS: Adherence to topical medications is very poor in a clinic population of children with atopic dermatitis. Office visits are one means to increase adherence. If adherence to topical treatment can be improved, exposure to more costly and potentially toxic systemic agents may be avoidable.

Administration, Topical↗

Black box warning for topical calcineurin inhibitors and the death of common sense.

OBJECTIVE: This commentary is designed to provide a clinical viewpoint regarding the Food and Drug Administration (FDA) and its recent decision to imposed a "black box warning" on the topical calcineurin inhibitors, pimecrolimus and tacrolimus. DESIGN: Select references were used to review the relevant data. RESULTS: Although there is a theoretic risk of oncogenesis because of the trivial systemic absorption of these agents and there exist anecdotes of cancer occurring amongst the millions of people who have used these agents, human data from randomized controlled trials suggest a protective effect from cancer. Although results from randomized controlled trials provide the highest level of evidence, the FDA chose to warn the public on the basis of weak and likely faulty data. Subsequent to the FDA actions, utilization of the best-studied class of agents for atopic dermatitis has fallen significantly. CONCLUSIONS: These actions represent a "death of common sense" and have profound impact both on our ability to safely and effectively care for patients and our medicolegal risk.

Administration, Topical↗

Errors in the Archives of Dermatology and the Journal of the American Academy of Dermatology from January through December 2003.

OBJECTIVE: To assess the frequency of statistical errors in the dermatology literature. DESIGN: Original studies published in the Archives of Dermatology and the Journal of the American Academy of Dermatology from January through December 2003 were analyzed for correctness of statistical methods and reporting of the results. RESULTS: Of 364 studies published, 155 included statistical analysis. Of these, 59 (38.1%) contained errors in the methods or omissions in reporting of the statistical results. Fourteen percent of the articles with statistical analysis contained errors in the methods used (considered to be more significant errors), 26.5% contained errors in the presentation of the results, and 2.6% contained errors in both. CONCLUSIONS: The misuse of statistical methods is prevalent in the dermatology literature, and the appropriate use of these methods is an integral component of all studies. Readers should critically analyze the methods and results of studies published in the dermatology literature.

Bibliometrics↗

Induction of withdrawal-like symptoms in a small randomized, controlled trial of opioid blockade in frequent tanners.

Frequent tanning has reinforcing properties. We tested whether opioid antagonism blocks potential reinforcing effect of indoor tanning in 8 frequent tanners and 8 infrequent tanner control subjects. Opioid blockade reduced ultraviolet preference in frequent tanners. Four of 8 frequent tanners, but no infrequent tanners, exhibited withdrawal-like symptoms with naltrexone administration. A limitation of this study is its small size.

Adolescent↗

The negative impact of psoriasis on the workplace.

BACKGROUND: The health-related quality of life and economic impact of psoriasis has been documented. However, the negative impact of psoriasis on the workplace is poorly understood. AIM/METHODS: Through anonymous surveys from 30 subjects of each of three psoriasis severity groups we aim to quantify the workplace impact experienced by psoriasis patients and factors that may contribute to this impact. Data were collected using several previously validated measures including the Work Productivity Assessment Index (WPAI), SF-8, Hospital Anxiety and Depression (HADS) and past medical/psoriasis history. RESULTS: Psoriasis patients experienced negative impact at work as measured by the WPAI; this impact is directly associated with disease severity. The other instruments confirmed the negative impact of psoriasis though the degree of impact did not always correlate with disease severity or work impact. Owing to the relatively small numbers, the significance of these findings is not certain. CONCLUSIONS: This preliminary study finds that psoriasis is associated with a reduction in work productivity and social functioning; this may explain the relatively high cost of this disease on both a macro- and microeconomic level. As there was a lack of significant trends in this study, formal inferences are limited and further investigation is warranted.

Adult↗

The cost-effectiveness and cost of treatment failures associated with systemic psoriasis therapies.

BACKGROUND: Psoriasis is difficult at times to treat and treatment failures are not uncommon regardless of approach. With the advent of expensive biologic therapies for psoriasis there is increasing discussion on the cost efficacy of a given systemic or biologic agent. An alternative and overlooked aspect of cost efficacy is the cost that accrues from treatment failures. METHODS: We review the literature and develop a model to analyze the cost-effectiveness and the cost of treatment failures per success for various systemic psoriasis agents using a 12-week treatment period. RESULTS: For continuous-dose agents, the cost-effectiveness results are: methotrexate $623, acitretin $2729, cyclosporine $2969, nUVB $3692, PUVA $4668, etanercept $16 312, and efalizumab $17 196. The cost of expected treatment failures to achieve one success for the same agents were: methotrexate $187, cyclosporine $505, PUVA $767, nUVB $1034, acitretin $1310, etanercept $8319, and efalizumab $12 897. CONCLUSIONS: Methotrexate appears to be the most cost-effective agent for the treatment of severe psoriasis. However, greater efficacy can be achieved with cyclosporine and PUVA, albeit at a greater cost. Because of the high cost of treatment failures, access to a wide array of therapies and combination regimens should not be discouraged by physicians or insurers.

Cost-Benefit Analysis↗

New treatments for psoriasis: which biologic is best?

Psoriasis is a chronic, debilitating disease affecting not only the skin, but also having a significant impact on a patient's quality of life. The treatment of severe psoriasis is quite challenging due to the chronic, relapsing nature of the disease and the difficulties inherent in treatment planning. Though the biologics are perhaps the most promising of available psoriasis treatments, the decision to institute a given therapy may be fraught with complexity for the clinician. Patients now hear of these promising new treatments for psoriasis via print, television and radio advertising; they frequently come to their physician asking if they are eligible for any of these agents and, if so, 'which biologic is best?'. This paper attempts to determine the ideal biologic agent based upon several parameters: FDA- and EU-approved indications, therapeutic efficacy, impact on quality of life, cost-effectiveness, and safety profile. Certainly the physician is central to medical decision-making, though ultimately patient preference may play the largest role in determining the 'best' biologic agent. There is no single ideal biologic for all patients and a physician's job is to educate patients on the relative advantages and disadvantages of each agent. Through informed discussion, the clinician can help each individual patient decide which biologic agent is ideal for them.

Adalimumab↗

Trends in on and off-label calcipotriene use.

Following its introduction in 1994, calcipotriene quickly became the single most prescribed medication for psoriasis according to National Ambulatory Medical Care Survey (NAMCS) data. Primarily through regulation of cellular differentiation, calcipotriene may be effective in dermatoses other than psoriasis. We characterize the clinical trends in the utilization of calcipotriene by analyzing a representative sample of visits to US physicians. Demographic characteristics, specialty of the provider, and off-label uses are reported. Calcipotriene was mentioned at 5.8 million of all NAMCS visits during the study period. Nearly 57% of mentions of calcipotriene were not linked to a diagnosis of psoriasis. Adjusted use for gender and race were relatively stable; there was a rise in non-psoriasis uses and use among non-dermatologists in 1997. Our findings support previous reports of the utility of calcipotriene in treating other dermatoses as witnessed by the numerous conditions for which its use was observed. Physicians and policy-makers should be aware of the role that this medication plays in the delivery of dermatologic care.

Calcitriol↗

How much of a topical agent should be prescribed for children of different sizes?

BACKGROUND: Compared with guidelines for the quantity of topical corticosteroids to apply in adults, standards for the use of topical corticosteroids in children are not well described. OBJECTIVE: To devise simple-to-use guidelines for topical corticosteroid quantities needed in infants, children, pre-teens, and adults. METHODS: We determined body surface area (BSA) using mean heights and weights in order to calculate the appropriate quantities of medication to be prescribed. RESULTS: As a rough estimate, infants require one-fifth of adult doses, children two-fifths of adult doses, and adolescents two-thirds of adult doses. However, the assessment of BSA may vary considerably between clinicians. Patients may also vary in how thickly they apply topical medication. CONCLUSIONS: A simple guideline for how much topical corticosteroid to prescribe may facilitate the treatment of young children with skin disease.

Administration, Topical↗

Adverse events from systemic therapies for psoriasis are common in clinical practice.

BACKGROUND: Patients with moderate-to-severe psoriasis frequently require systemic treatment and these medications may be associated with adverse effects. Little is known about the frequency of these events when systemic agents are used in true clinical practice. OBJECTIVE: To determine the frequency of adverse events associated with various systemic psoriasis therapies. METHODS: A retrospective chart review of 753 patients treated in an academic dermatology practice was performed to identify the frequency of adverse events. Poisson regression was used to estimate the odds of significant events for each systemic therapy; UVB-treated patients served as a control population. RESULTS: Methotrexate seemed to be the most prescribed medication. Adverse events were noted with all forms of systemic psoriasis therapy. The highest event rate was seen with oral retinoids, though most of these were considered minor (64%). Cyclosporine had the highest significant adverse event rate (0.9 events/patient). For 'significant' adverse events, oral agents had an adjusted odds ratio>6 compared to standard UVB therapy. The highest risk was for cyclosporine (OR = 20.3); however, the estimate was imprecise (95% confidence interval [4.3, 96.6]). CONCLUSIONS: Traditional psoriasis therapies are associated with significant adverse events in some patients despite toxicity-sparing approaches such as combination therapy. Clinicians need to be aware of screening for adverse events in order to best ensure the safety of their patients and to maximize the efficacy of a given agent. There is still a need for the development of safe and effective treatments for patients with moderate-to-severe psoriasis.

Adult↗

Psoriasis treatment in the United States at the end of the 20th century.

BACKGROUND: Psoriasis presents many management complexities. A cornerstone of therapy has been topical corticosteroids, although over the past 10 years there have been many additions to the medication armamentarium. Furthermore, various combination regimens and approaches have been advocated. OBJECTIVE: We sought to characterize various patterns of psoriasis health care delivery and the changes associated with these patterns from 1990 to 2001. METHODS: Visits for psoriasis were identified using National Ambulatory Medical Care survey data, a representative survey of visits to physician offices in the United States. We determined basic demographic characteristics, specialty of the physician provider and medications listed at these visits over the 1990-2001 interval. RESULTS: There were more than 13.5 million visits for psoriasis during the 12-year study period. Dermatologists were responsible for the majority of the visits over the study interval (82%) although there was an overall decline in the proportion of psoriasis visits to dermatologists. As a category, the most common medications used for psoriasis were topical steroids. Topical calcipotriene was the single-most listed medication. There was no observed use of non-corticosteroid topical agents at visits to non-dermatologists. Non-dermatologists were as likely as dermatologists to list a systemic medication at a visit as well as use a systemic as monotherapy. DISCUSSION: In conclusion, the primary topical therapies for psoriasis remain clobetasol and calcipotriene. The decreasing role of dermatologists in the treatment of psoriasis is probably a complex issue, but may relate in part to the difficulty of obtaining access to dermatology care.

Administration, Topical↗

Frequency and cost of actinic keratosis treatment.

BACKGROUND: Actinic keratosis (AK) is a common lesion with its highest incidence in the aged population. Although treatment strategies for AK have continued to develop, the cost of such treatments has not been recently investigated. PURPOSE: The purpose of this article is to determine the frequency of visits for AK, the methods used to treat AK, and the cost of the treatments used annually. METHODS: Data from the Medicare Current Beneficiary Survey and National Ambulatory Medical Care Survey were used to determine the frequency of office visits for AK and the frequency of destructive procedures and topical treatment of AK. Medicare reimbursement rates were used to estimate the cost of the procedures performed. Costs of medications were based on published wholesale costs. RESULTS: There are an estimated 5.2 million AK visits annually, 60% of which are made by the Medicare population. A total of Dollars 920 million was spent on the treatment of AK annually, 6% being spent on topical therapy, 43% on office visits, and 51% on destructive procedures. CONCLUSIONS: Even though new topical therapies are evolving for the treatment of AK, destructive procedures remain the standard of care when considering frequency of use, efficacy, and cost control.

Aged↗

Nonmelanoma skin cancer: is the incidence really increasing among patients younger than 40? A reexamination using 25 years of U.S. outpatient data.

OBJECTIVE: An increasing incidence of basal cell carcinomas and squamous cell carcinomas in patients younger than 40 years old diagnosed during years 1973 to 2003 was found in a recent population-based study in Olmsted County, Minnesota. We performed additional analyses using nationally representative patient samples to confirm these trends. STUDY DESIGN: We analyzed a cross-sectional survey data on outpatient diagnoses, the National Ambulatory Medical Care Survey data from 1979 to 2003, for melanoma skin cancer. RESULTS: A total of 4,100 office visits for nonmelanoma skin cancers were recorded, including 230 in patients younger than 40. Multivariate analysis indicated no significant increase in the number of office visits related to nonmelanoma skin cancer in younger patients [odds ratio (OR), 2.77; 95% CI, 0.75-10.26]. The mean age of office visits for nonmelanoma skin cancer did not change significantly. The ages of the office visit patients were 64.7 years and 69.02 years in the years 1979 and 2003, respectively. CONCLUSIONS: Based on a representative sample of outpatient visit diagnoses, visits are not increasing for nonmelanoma skin cancer among patients 40 years and younger in the United States, albeit direct measurement of tumor incidence was not possible with this database.

Adult↗

Tacrolimus: focusing on atopic dermatitis.

Tacrolimus ointment is an effective treatment for atopic dermatitis. As a calcineurin inhibitor, it works through the FK-binding protein, inhibiting calcineurin and preventing dephosphorylation of nuclear factor of activated T cells (NFAT). Systemic absorption from the drug is minimal, allowing a favorable safety profile. In head-to-head clinical trials with pimecrolimus, tacrolimus proved to be a more effective treatment. Tacrolimus ointment has also been compared to standard topical cortico-steroid treatments and is equally effective if not superior to several topical steroids. Overall, tacrolimus ointment is a safe and effective treatment for atopic dermatitis and can be used as an adjunctive treatment to standard management with topical corticosteroids.

Calcineurin↗

The Acne Quality of Life Index (Acne-QOLI): development and validation of a brief instrument.

BACKGROUND: Acne affects many people and can be detrimental to affected patients' quality of life. Assessing the impact of acne on quality of life requires well-validated and reliable measures of acne-specific quality of life that are brief and easy to administer and interpret. OBJECTIVES: This paper reports on the development and validation of the Acne Quality of Life Index (Acne-QOLI) for use in clinical care, research, and product development. METHODS: Focus groups consisting of people from demographically different populations were conducted to identify the most relevant domains of functioning affected by acne; on the basis of these findings, candidate items were developed. An initial item pool of 58 items was included in a survey of 480 persons with mild to severe acne ranging in age from 12 to 62 years. Factor analysis and qualitative analysis were used to reduce the item pool to 21 items. The construct validity, concurrent validity, internal consistency, and test-retest reliability of the items were evaluated. RESULTS: The 21-item Acne-QOLI showed excellent face validity, content validity, concurrent validity, and construct validity. High internal consistency and test-retest reliability were also found. CONCLUSIONS: Quality of life is now recognized as an important outcome in medical care. The Acne-QOLI is a brief and easily administered and interpreted measure of acne-related quality of life that can be used in clinical care, research, and product development.

Acne Vulgaris↗

The evolution of azelaic acid.

Azelaic acid (AzA) is a naturally occurring dicarboxylic acid that has a long and complex history in the treatment of skin disorders. We summarize research on AzA from the past 25 years and follow its progress from a treatment of hyperpigmentation to a therapy for acne vulgaris and inflammatory (papulopustular) rosacea.

Acne Vulgaris↗