Maria C. Schneeweiss, MD

Credit: HMP Global Learning Network

Less than 60% of individuals in the US with chronic inflammatory skin diseases (CISD) who are beginning systemic immunomodulatory treatment are given the requisite testing in the pretreatment period, according to new findings.¹

These findings were drawn from a new analysis of current patterns of treatment in the US, conducted given the potential dangers of biologic immunomodulatory treatments for skin diseases such as psoriasis. The research was led by Maria C. Schneeweiss, MD, from the department of medicine’s division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital in Boston.

The investigators noted present concerns that some such immunomodulatory agents may reactivate hepatitis B and C or tuberculosis (TB), as well as other conditions.

“Although risk of disease varies by drug, mechanism, and baseline risk factors, guidelines often do not differentiate between agents and baseline risk,” Schneeweiss and colleagues wrote. “This descriptive study aims to quantify current practices of laboratory screening in the US before and after the initiation of a range of systemic immunomodulatory agents in dermatology.”²

Background and Findings

The investigators looked at national commercial insurance claims data through MarketScan, with the period they assessed spanning from December 2002 - December 2020. This information was de-identified health data related to utilization of healthcare, plan enrollment, data related to demographics, and specific diagnoses.

The research team looked at adult patients as subjects, specifically those who initiated immunomodulatory therapy (methotrexate, TNFαi, IL-17Ai, IL-23i, IL-12/23i, IL-4/13i, and PDE-4i) based on a single prescription at minimum. The subjects’ therapy initiation day was considered their time of entry for the study, following 180 days without the index treatment, and they could have utilized other systemic drugs.

The main outcome assessed by the research team was whether participants had been given a lab test within a 180 days pre-treatment period and a 780 days post-initiation period, measured in intervals of 60-days. Characteristics of the subjects were evaluated in the pre-entry phase, with the team assessing sex, age, region, and previous systemic immunomodulatory drug use.

During the 180 days of pre-treatment, the investigators determined subjects had to have a recorded diagnosis of atopic dermatitis, psoriasis, or hidradenitis suppurativa, as well as a meeting with a dermatologist and continuous enrollment. The period designed for follow-up began the day following entry in the study and went on until 1 of these events: disenrollment, loss of life, end of data stream, index medication discontinuation, or 780 days after their entry.

The investigators also looked at testing frequency from 6 months prior to the first treatment implementation to 26 months after. They also used sensitivity analyses that included test frequency in the year just before initiation.

Overall, the research team reported 122,308 individuals in total who had chronic inflammatory skin diseases were included, and there was a median age among the participants of 49 years. 52.1% of them had been reported as male.

The team noted that the most common pre-treatment assessment of the subjects had been a complete blood cell count, done among 41% - 69% of the observed cases. Some of the biggest modalities of treatment included methotrexate, ustekinumab, tumor necrosis factor α inhibitors, dupilumab, IL-17A inhibitors, IL-23 inhibitors, and apremilast.

The investigators also found that tuberculosis screening in the 6 months just before initiation of treatment had a range from 11% - 59%. They added that anywhere from 3% - 26% were shown to have updated tests in the 1 year period afterward.

The research team noted that hepatitis panels prior to treatment had been done for anywhere from 13% - 41% of the observed cases. They also pointed out that lower pretreatment testing levels continued following the 1-year mark for those on apremilast, adding that the rates were comparable to those of dupilumab.

“The observed variations underscore the need for future research to elucidate the rationale behind testing decisions and to optimize testing practices for individuals initiating these therapies, taking into consideration the specific recommendations for each agent and the patient’s overall clinical profile and history,” they concluded.

References

1. ^{Schneeweiss MC, Shay D, Ly S, et al. Prevalence of Pretreatment Testing Recommended for Patients With Chronic Inflammatory Skin Diseases. JAMA Dermatol. Published online January 31, 2024. doi:10.1001/jamadermatol.2023.5895.}
2. ^{Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072. doi:10.1016/j.jaad.2018.11.057.}