Use of Biologics in Private Practice: Nine Years of Lessons and Learning
March 2017 | Volume 16 | Issue 3 | Original Article | 215 | Copyright © 2017
Lilia M. Correa-Selm MD,a Mahin Alamgir MD,b Babar K. Rao MDc
aAffiliated Dermatologists and Dermatologic Surgeons, Morristown, NJ bDepartment of Medicine, Maimonides Medical Center, Brooklyn, NY cDepartment of Dermatology, Rutgers-RWJMS, Somerset, NJ
Over a decade ago, the FDA approved biologics for psoriasis, which changed how the disease is treated and, in most cases, has a significant positive impact on the lives of patients. Side effects primarily identified during the investigational and research phase led to the development of specific guidelines for treatment. The treatment guidelines have been amended to incorporate better understandings of side-effects over the years that the disease has been treated. In this study, we focused on a chart review that included assessing the current guidelines and their alignment with modern patient management and the recent side effects presented. This life-cycle evaluation included over 100 patients, management of their treatment, laboratory abnormalities, criteria for choosing or changing to a different biologic, and the effects of the treatments management throughout the years. The review identified some recommended changes in the application and treatment of psoriasis with biologics. To further evidence our findings, we hope to expand this study to a larger scale with more patients.
J Drugs Dermatol. 2017;16(3):215-217.
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Psoriasis is one of the common conditions seen by dermatologists. The worldwide prevalence is described at 2%. One-third of the patients have severe involvement and 5-30% are affected by psoriatic arthritis.1,2 Biologics are medications that have revolutionized the treatment for psoriasis hence constituting a life changing alternative for many patients. Biologics have been approved for over ten years by the FDA, etanercept being the first to be approved in 2004 for psoriasis, followed by adalimumab and ustekinumab, with many more approved in the past few years.3 The guidelines for the surveillance of side effects while using biologics are based mainly on pre-approval data and post-marketing clinical data. The indications for blood workup while using each drug vary by source, including package inserts, published studies, and different practitioners (Table 1).3-7 For the purposes of this study, we conducted a retrospective chart review that included data on the use of biologics in three private practices in the last 10 years. Current guidelines can be improved with this information on what tests to order, when to order them, and how often to repeat them. This has implications for cost-effectiveness as well as in helping to avoid unnecessary harm to patients.
A retrospective chart review of patients being served by three private practices located in California and New York was performed. First, charts of patients to whom biologics were prescribed for the treatment of psoriasis were selected. For each of these patients, we collected their demographics and cataloged their complete blood count (CBC), comprehensive metabolic panel (CMP), and results of tuberculosis (TB) screen- ing tests (PPD or interferon-gamma release assay) obtained before treatment initiation and during treatment. Additionally, biologic treatment-related information was also extracted from the charts and collected. The data was de-identified once the collection was complete. Abnormalities on the CMP were classified according to the CommonTerminology Criteria for Adverse Events version 4.0 of the National Cancer Institute, which uses a scale graded from 1 to 4 for stratification.6 A baseline abnormality was any laboratory abnormality present before starting treatment with the biologic agent. On the other hand, a new abnormality was considered a laboratory abnormality present after the patient was started on biologics.
Following chart review, 114 patients met the criteria to be enrolled in the study. Eleven (11) patients were excluded as they were still waiting to receive a biologic agent, leaving a total of 103 patients. The median and mean age at which the biologic was started was 48 years, and 64% of patients were in the age range of 30 to 60 years (Table 2), with only one patient under the age of 20. In almost every age range, males outnumbered females with males making up 68% of the total patients. Blood workup was done in periods ranging from 3 to 6 months after treatment initiation, depending both on the patient’s clinical condition and clinician judgment. Only 28 (27%) patients had