Original article
The clinical utility of laboratory monitoring during isotretinoin therapy for acne and changes to monitoring practices over time

https://doi.org/10.1016/j.jaad.2019.06.025Get rights and content

Background

As a result of concerns about hypertriglyceridemia, liver enzyme abnormalities, and leukopenia during isotretinoin therapy for acne, patients are often monitored closely with routine laboratory assessments, although the value of this practice has been questioned.

Methods

We conducted a cohort study of patients receiving isotretinoin for acne between January 1, 2008, and June 30, 2017, using the OptumInsights Electronic Health Record Database (Optum, Eden Prairie, MN) to evaluate the frequency of laboratory abnormalities. Poisson regression was used to evaluate for changes to the frequency of routine laboratory monitoring over time.

Results

Among 1863 patients treated with isotretinoin, grade 3 or greater triglyceride and liver function testing abnormalities were noted in fewer than 1% and 0.5% of patients screened, respectively. No grade 3 or greater cholesterol or complete blood count abnormalities were observed. There were no meaningful changes in the frequency of laboratory monitoring over time.

Limitations

Limitations include that we are unable to evaluate the clinical notes to understand the exact clinical decision making when clinicians encountered abnormal laboratory values.

Conclusion

Although laboratory abnormalities are rare and often do not influence management, frequent laboratory monitoring remains a common practice. There are opportunities to improve the quality of care among patients being treated with isotretinoin for acne by reducing the frequency of lipid and liver function monitoring and by eliminating complete blood count monitoring.

Section snippets

Study design and data source

We performed a cohort study using a 10% random sample of the OptumInsights Electronic Health Record database (Optum, Eden Prairie, MN) that included data from January 1, 2007, to June 30, 2017; this was the data set available to the investigators. The full data set includes deidentified data abstracted from the electronic medical records of more than 150,000 providers, 2000 hospitals, and 7000 clinics and is based on integrating data from the electronic medical record and other health

Cohort

The analysis included 1863 patients, and 49.0% were women. The median age was 18.2 years (interquartile range, 16.3-24.5 years). The median course duration for isotretinoin treatment was 148 days (interquartile range, 65-183 days) (Table II). Regional distribution of patients across the United States was 11.5% Northwest, 61.9% Midwest, 13.6% South, and 9.7% West.

Monitoring frequency and changes over time

In general, the absolute numbers of patients on therapy and, consequently, the absolute numbers of patients being monitored decreased

Discussion

In this cohort study of patients across the United States, clinically significant abnormalities for patients receiving isotretinoin for acne were rare and often did not result in changes in management. In particular, no significant WBC or platelet count abnormalities were noted. These findings are consistent with prior studies and suggest that extensive laboratory monitoring in this population may be of low value.5, 6, 7 In addition, changes to lipid levels observed in this study typically

Conclusions

Among acne patients undergoing treatment with isotretinoin, laboratory abnormalities are rare and often do not influence management. However, frequent laboratory monitoring remains a common practice, and the rate of laboratory monitoring has not decreased substantially over time. There are opportunities to improve the quality and cost of care by reducing the frequency of lipid and liver function monitoring and by eliminating the practice of complete blood count monitoring in this patient

References (20)

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    Further research is required to clarify the optimum dosing regimens.53 Studies have suggested that routine laboratory monitoring including full blood count is not required when prescribing oral isotretinoin.56,57 Mild increases in triglycerides are observed in approximately a quarter of patients receiving oral isotretinoin, but severe clinically relevant concentrations are said to be infrequent.56,57

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Funding sources: Funded in part through National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) grant 1P30-AR-069589-01. Dr Barbieri is supported by the NIAMS of the National Institutes of Health under award number T32-AR-007465 and receives partial salary support through a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr Takeshita is supported by NIAMS K23-AR-068433. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Conflicts of interest: Dr Takeshita receives a research grant from Pfizer Inc (to the Trustees of the University of Pennsylvania) for work that is unrelated to this study and has received payment for continuing medical education work related to psoriasis that was supported indirectly by Eli Lilly and Novartis. Dr Barbieri, Dr Shin, Shiyu Wang, and Dr Margolis, have no conflicts of interest to disclose.

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