Recommended Citation
Foy O, Berber L, Adimi N, Ehrenpreis ED. Alopecia Associated with TNF-α Inhibitors: A FAERS Review of Combination Therapy Effects that Miraculously Spare IBD Patients. Presented at Scientific Day; May 20, 2026; Milwaukee, WI.
Abstract
Background/Significance:
Tumor necrosis factor-α (TNF-α) inhibitors are widely used in the management of inflammatory bowel disease (IBD), often combined with Methotrexate (MTX) to reduce immunogenicity. Agents such as Infliximab and Adalimumab are effective for moderate to severe ulcerative colitis and Crohn's disease. Although generally well tolerated, both have been linked to dermatologic adverse effects. Alopecia is a visible and distressing side effect that may affect quality of life and adherence. The magnitude of this risk in IBD patients receiving combination therapy remains unclear. Post-marketing databases allow detection of rare adverse drug reactions and potential interactions.
Purpose:
We used OpenVigil, a validated interface for the FDA Adverse Event Reporting System (FAERS), to evaluate alopecia reporting with infliximab or adalimumab plus MTX and determine whether signals persist within IBD.
Methods:
We performed a retrospective pharmacovigilance analysis using OpenVigil 2.1, extracting FAERS reports from inception through the most recent quarter. Disproportionality analyses identified signals for alopecia associated with infliximab or adalimumab, alone and with MTX. Reporter odds ratios (RORs) with 95% confidence intervals (CIs) were calculated for all indications and IBD-restricted reports. Signal persistence after stratification by diagnosis and the impact of MTX were assessed. Duplicate and incomplete reports were excluded.
Results:
There were 186,551 alopecia reports without indication of restriction, 944 for UC, and 468 for Crohn’s disease. Without restriction, significant signals were observed for infliximab (ROR 5.83, CI 5.72–5.94), MTX (ROR 4.15, CI 4.09–4.22), infliximab + MTX (ROR 20.94, CI 20.48–21.42), adalimumab (ROR 2.67, CI 2.63–2.72), and adalimumab + MTX (ROR 11.58, CI 11.50–11.82). In ulcerative colitis, significant signals were seen with adalimumab (ROR 1.16, CI 1.02–1.32) and adalimumab + MTX (ROR 2.39, CI 1.53–3.75). In Crohn’s disease, significant findings included infliximab (ROR 0.63, CI 0.51–0.79) and adalimumab (ROR 1.66, CI 1.37–2.00).
Conclusion:
A strong disproportional signal for alopecia was observed with infliximab–MTX, with a smaller signal for adalimumab–MTX. When restricted to IBD reports, the signal diminished or disappeared, suggesting a possible indication-dependent effect. Although reporting bias cannot be excluded, further study is warranted. Recognizing adverse effect profiles in IBD populations is important for counseling and long-term adherence.
Presentation Notes
Presented at Scientific Day; May 20, 2026; Milwaukee, WI.
Full Text of Presentation
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Document Type
Oral/Podium Presentation
Alopecia Associated with TNF-α Inhibitors: A FAERS Review of Combination Therapy Effects that Miraculously Spare IBD Patients
Background/Significance:
Tumor necrosis factor-α (TNF-α) inhibitors are widely used in the management of inflammatory bowel disease (IBD), often combined with Methotrexate (MTX) to reduce immunogenicity. Agents such as Infliximab and Adalimumab are effective for moderate to severe ulcerative colitis and Crohn's disease. Although generally well tolerated, both have been linked to dermatologic adverse effects. Alopecia is a visible and distressing side effect that may affect quality of life and adherence. The magnitude of this risk in IBD patients receiving combination therapy remains unclear. Post-marketing databases allow detection of rare adverse drug reactions and potential interactions.
Purpose:
We used OpenVigil, a validated interface for the FDA Adverse Event Reporting System (FAERS), to evaluate alopecia reporting with infliximab or adalimumab plus MTX and determine whether signals persist within IBD.
Methods:
We performed a retrospective pharmacovigilance analysis using OpenVigil 2.1, extracting FAERS reports from inception through the most recent quarter. Disproportionality analyses identified signals for alopecia associated with infliximab or adalimumab, alone and with MTX. Reporter odds ratios (RORs) with 95% confidence intervals (CIs) were calculated for all indications and IBD-restricted reports. Signal persistence after stratification by diagnosis and the impact of MTX were assessed. Duplicate and incomplete reports were excluded.
Results:
There were 186,551 alopecia reports without indication of restriction, 944 for UC, and 468 for Crohn’s disease. Without restriction, significant signals were observed for infliximab (ROR 5.83, CI 5.72–5.94), MTX (ROR 4.15, CI 4.09–4.22), infliximab + MTX (ROR 20.94, CI 20.48–21.42), adalimumab (ROR 2.67, CI 2.63–2.72), and adalimumab + MTX (ROR 11.58, CI 11.50–11.82). In ulcerative colitis, significant signals were seen with adalimumab (ROR 1.16, CI 1.02–1.32) and adalimumab + MTX (ROR 2.39, CI 1.53–3.75). In Crohn’s disease, significant findings included infliximab (ROR 0.63, CI 0.51–0.79) and adalimumab (ROR 1.66, CI 1.37–2.00).
Conclusion:
A strong disproportional signal for alopecia was observed with infliximab–MTX, with a smaller signal for adalimumab–MTX. When restricted to IBD reports, the signal diminished or disappeared, suggesting a possible indication-dependent effect. Although reporting bias cannot be excluded, further study is warranted. Recognizing adverse effect profiles in IBD populations is important for counseling and long-term adherence.
Affiliations
Advocate Lutheran General Hospital