FDA Adverse Events Reporting System Shows Rise in Alopecia Cases, Use of Monoclonal Antibodies

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These data represent a significant step toward finding a causal connection for drug-induced alopecia, though further controlled studies may be necessary to isolate certain variables.

Advaitaa Ravipati, MD,

Credit: ResearchGate

Advaitaa Ravipati, MD,

Credit: ResearchGate

Six out of 10 of the most common alopecia areata treatments were monoclonal antibodies, according to recent findings, and males were more likely than females to report alopecia if taking either dupilumab or adalimumab.1

Summary of Research

  • Recent analysis of FDA Adverse Events Reporting System (FAERS) data revealed six out of the top 10 alopecia areata treatments were monoclonal antibodies.
  • Males were more likely than females to report alopecia with dupilumab or adalimumab, addressing a gap in establishing causal connections between drugs and alopecia areata.
  • The study identified 1,331 alopecia areata cases linked to medication adverse events, with individuals aged 42 to 64 years accounting for 46.7% of cases, and older females having greater odds of alopecia development than males.
  • Future research is needed to control for gender-based drug use variations and acknowledge limitations in scope, focusing on medication-related cases reported by the general public on FAERS.

These findings and more were the results of a recent analysis of US Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) data, designed to expand upon existing literature on different cases in which alopecia areata was reported as an adverse event from medication. The investigators sought to look at the associated treatments and characteristics of patients, primarily.

The investigators also noted that, prior to this research, a causal connection was difficult to find between different drugs and alopecia areata, though case reports have been released on the topic.2 In light of this gap, the new research was led by Advaitaa Ravipati, from the Phillip Frost department of dermatology and cutaneous surgery at University of Miami’s Miller School of Medicine in Florida.

“The FDA Adverse Events Reporting System (FAERS) has been used to categorize real-world side effects with particular drugs and inversely, to assess medications that have been associated with a specific reaction,” Ravipati and colleagues wrote. “The aim of this paper was to report associated medications and patient characteristics associated with alopecia areata cases, documented on the FAERS.”

Background

The investigators looked into data which had been drawn from the FAERS database, with their research aimed at investigating adverse events which were specifically related to 'alopecia areata' as their selected reaction type. All of the instances of alopecia areata which had been reported by subjects were identified by the research team, followed by the application of descriptive statistics.

The team decided to document the total number of adverse events linked with the most commonly prescribed treatments, connecting these to alopecia cases to determine the rate of the skin disease in comparison to the rates of other types of reactions. Cases which were shown not to have information on age and on sex were excluded by the investigators from their calculations related to characteristics of subjects.

During their initial regression analysis, the team utilized predictor variables which were monoclonal antibodies, specifically dupilumab, trastuzumab, adalimumab, infliximab, and etanercept. The research team used logistic regression analysis and implemented the sex of subjects as the main parameter in their analysis.

The investigator’s regression analysis that occurred compared the 2 alkylating chemotherapies which had been the most prevalent: cyclophosphamide and carboplatin. The research team’s final regression analysis involved docetaxel, a taxane chemotherapeutic, and they also looked at alkylating treatments.

Findings

Overall, the investigators reported that there were 1,331 reports of cases of alopecia areata that had been shown to be linked with medication implementation as an adverse event. They also found that out of the main 10 treatments connected to the highest number of disease cases, 6 of the 10 were shown to be monoclonal antibodies,

The research team noted that the age group comprising individuals between 42 - 64 years accounted for a total of 46.7% of alopecia cases. Additionally, the team found that females in the older age ranges were shown to have greater odds of alopecia development versus male subjects (OR: 1.03, P<0.01).

The team added that the age group between age 18 - 41 years were shown to have the next highest number of disease cases. In 1 notable finding by the investigators, it was also shown to be the case that male subjects had a higher likelihood of reporting alopecia areata when treated with dupilumab (OR: 2.56, P=0.03) and with adalimumab (odds ratio [OR]: 1.79, P=0.04) as opposed to female subjects.

The team lastly noted that this large data set may contribute to current research on drug-induced alopecia, adding that future studies may need to control for drug use variations among both sexes to further confirm the at-risk profile for those with skin disease

“We acknowledge the limitations to our study. It does not gen-eralize to all types of AA, as we limit its scope to medication-related cases,” they wrote. “Adverse events documented on the FAERS can be reported by general members of the public, who may not have sufficient medical knowledge to accurately report their reactions.”

References

  1. Ravipati A, Pradeep T, Tosti A. A cross-sectional analysis of medications used by patients reporting alopecia areata on the FDA adverse events reporting system. Int J Dermatol. Published online January 12, 2024. doi:10.1111/ijd.17014.
  2. Wang H, Pan L, Wu Y. Epidemiological trends in alopecia areata at the global, regional, and national levels. Front Immunol. 2022;13:874677. https://doi.org/10.3389/fimmu.2022.874677.
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