Background/Purpose:

Cases of alopecia occurring on TNF-alpha antagonists have been described. Nevertheless, no epidemiological study has been conducted to assess the link between TNF-alpha antagonists exposure and occurrence of alopecia. The aim of this study was to describe the cases of TNF-alpha antagonist-related alopecia reported in the French PharmacoVigilance Database (FPVD), and to assess the putative association.

Methods:

All spontaneous reports of TNF-alpha antagonist-related alopecia recorded in the FPVD between January 2000 and April 2012 were described. We conducted disproportionality analyses (case/non-case method) to assess the link between alopecia and exposure to TNF-alpha antagonists. Cases were all reports of alopecia recorded during the study period. Non-cases were all other reports recorded during the same period. Exposure to TNF-alpha antagonists was searched in cases and non-cases. Reporting odds ratios (ROR) were calculated to assess the association. To assess the validity of the method we used exposure to docetaxel (well-known as alopecia inducer) as positive control and to acetaminophen as negative one.

Results:

During the study period, 283 658 spontaneous reports were colligated in the FPVD, of which 4742 (1.7%) involved TNF-alpha antagonists. Among these 4742 reports, 51 (1.1%) were alopecia (mainly, alopecia areata): 18 involved infliximab, 17 adalimumab, 15 etanercept and 1 certolizumab. Male:female sex-ratio was 0.18 and mean age was 39 years. Seventeen patients were treated for rheumatoid arthritis, 13 for ankylosing spondylitis, 11 for Crohn disease and 6 for psoriasis. Mean delay from TNF-alpha antagonist introduction to alopecia onset was 11.3 months (extremes: 4 days – 8 years). An improvement was observed in 12 cases after TNF-alpha antagonist withdrawal (available data for 24 reports). Association between TNF-alpha antagonist exposure and alopecia was significant for all TNF-alpha antagonists pooled (ROR=3.0; 95%CI [2.3-4.0]), as well as for infliximab, ROR=2.0; 95%CI [1.2-3.1], adalimumab, ROR=4.7; 95%CI [2.9-7.7] and etanercept, ROR=3.3; 95%CI [2.0-5.4]. The ROR with docetaxel was 29.9; 95%CI [25.3–35.5] and with acetaminophen was 0.3; 95%CI [0.2–0.4].

Conclusion:

These results suggest a link between TNF-alpha antagonists exposure and occurrence of alopecia. A channeling bias cannot be excluded, but improvement in half of the cases after TNF-alpha antagonist withdrawal is a strong argument for the drug responsibility.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/tumour-necrosis-factor-alpha-antagonists-and-alopecia-a-casenon-case-study-in-a-nationwide-pharmacovigilance-database/