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TNF-alpha inhibitors are the most frequent biological agents associated with de novo vitiligo developmentBiological Therapies Linked to New Vitiligo Cases in Patients

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Key Takeaway
Note that while TNF-alpha inhibitors are frequently associated with de novo vitiligo, a direct causal link is not established.

This scoping review examines 39 cases of de novo vitiligo occurring after the initiation of biological therapies, including TNF-alpha inhibitors, anti-IL-17A, anti-IL-12/23, and anti-IL-4/13 agents. The review identifies a male predominance (62%) among patients with a mean age of 43 years. The median onset of vitiligo was 5 months post-initiation, with a reported range of 1.5 to 24 months.

TNF-alpha inhibitors, including infliximab, adalimumab, and certolizumab pegol, were the most frequently suspected drugs, involving more than 50% of patients. Regarding clinical outcomes, 41% of patients experienced stabilization, 36% achieved repigmentation, and 8% experienced progression. One-third of cases involved the face and neck.

The authors note that evidence for a direct causal relationship remains weak. Cases involving non-anti-TNF-alpha agents are considered anecdotal. The co-occurrence of underlying autoimmune comorbidities suggests that the development of vitiligo may be a coincidental rather than a causal relationship. Clinicians should interpret these findings as a potential temporal association rather than a confirmed causal link between specific biologics and vitiligo.

How this fits prior evidence

This scoping review addresses a gap in understanding the relationship between biologics and skin manifestations. It specifically addresses the finding that vitiligo after dupilumab is a possible temporal association only, as causality is not established. The current review reinforces this by noting that evidence for a direct causal relationship remains weak and that co-occurrence of autoimmune comorbidities suggests a coincidental rather than causal relationship.

A review of 39 patients found a link between certain biological therapies and the development of new vitiligo. These medications, which target inflammatory cytokines, were used to treat various conditions. The study noted that more than 50% of these patients were taking TNF-alpha inhibitors, such as infliximab or adalimumab.

In these cases, vitiligo typically appeared between 1.5 and 24 months after the medication began. About one-third of the patients saw skin changes on their face and neck. While 26% of the cases resulted in the patient stopping their medication, many others saw their skin condition stabilize or even improve with repigmentation.

It is important to note that the evidence for a direct cause is currently weak. Because many of these patients already had autoimmune conditions, the link might be a coincidence rather than a direct side effect of the drug. Because the data is limited and some cases are anecdotal, patients should talk to their doctor about these risks.

What this means for you:
Some patients on biological therapies may develop vitiligo, but the direct link between the drugs and the condition is uncertain.

Common questions

What medications are linked to vitiligo?

The study looked at biological therapies that target inflammatory cytokines. Specifically, more than 50% of the 39 patients were taking TNF-alpha inhibitors, such as infliximab, adalimumab, or certolizumab pegol. Other medications included ixekizumab, secukinumab, ustekinumab, and dupilumab.

How quickly can vitiligo appear after starting treatment?

In the cases reviewed, the median time for vitiligo to appear was 5 months after starting the medication. The reported range for the onset of vitiligo was between 1.5 and 24 months after the treatment began.

Is the vitiligo caused by the medication?

The evidence for a direct causal relationship is currently weak. Because many patients already had underlying autoimmune conditions, the appearance of vitiligo might be a coincidence rather than a direct result of the medication. You should discuss these findings with your doctor.

Study Details

Study typeSystematic review
EvidenceLevel 1
PublishedOct 2026
View Original Abstract ↓
IntroductionVitiligo is a chronic autoimmune depigmentation skin disorder characterized by the acquired loss of melanocytes, with a complex multifactorial pathophysiology. Among the potential predisposing factors, some drugs, including monoclonal antibodies, have been associated to disease onset.MethodsThe aim of the present review is to summarize and discuss current literature findings in de novo vitiligo following biological targeting inflammatory cytokines.ResultsOverall, 18 articles were considered eligible for the present review, and details of demographics, clinical characteristics, vitiligo type and localization, biological drug administered and treatment outcomes were reported.The mean age of the 39 patients was 43 years (±16.3), with a male predominance (62%). Tumor necrosis factor-alpha (TNFα) inhibitors (infliximab, adalimumab, certolizumab pegol) were the most frequent suspected drugs (>50% of patients), followed by anti-IL-17A (ixekizumab, secukinumab) and anti-IL-12/23 (ustekinumab). Four cases were linked to anti-IL-4/13 (dupilumab). The median onset of vitiligo was 5 months post-initiation (range 1.5–24), with one-third of cases involving the face and neck, and two cases of segmental vitiligo. Biologic discontinuation or switching occurred in 26% of cases. Regarding outcomes, 41% experienced stabilization, 36% achieved varying degrees of repigmentation, and 8% progressed.DiscussionWhile de novo vitiligo is reported as a potential adverse event of biological therapies, evidence for a direct causal relationship remains weak, with cases involving non-anti-TNFα agents appearing anecdotal. The co-occurrence of underlying autoimmune comorbidities in these patients points towards a coincidental rather than a causal relationship, highlighting the need for further research to fully elucidate this association.
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