Acne Seen as Adverse Effect of Trikafta Treatment in Case Study

Eruptions could be caused by changes in salt or chloride in sweat

Andrea Lobo, PhD avatar

by Andrea Lobo, PhD |

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Acne might be a side effect of Trikafta therapy in cystic fibrosis (CF) patients, according to a new case series in the U.S.

Trikafta (elexacaftor, tezacaftor, ivacaftor) is a CFTR (cystic fibrosis transmembrane conductance regulator) modulator that helps the defective CFTR protein function more effectively in CF patients. It’s developed by Vertex Pharmaceuticals and approved for CF patients, including those with the F508del mutation, the most common CF-causing CFTR gene mutation.

The study “Drug-induced acne with elexacaftor/ tezacaftor/ ivacaftor in people with cystic fibrosis,” was published in the Journal of Cystic Fibrosis.

Acne can be an adverse effect of medication and may be marked by the appearance of inflammatory papules (small bumps), pustules (white bumps surrounded by red skin containing fluid or pus), comedones (skin-colored small bumps), or cysts.

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Rash — abnormal changes in skin color and texture — is a known dermatologic side effect of Trikafta, affecting 4–10.9% of patients in clinical trials. Being a woman and using hormonal contraceptives seem to be risk factors for rash associated with the treatment.

Researchers in the United States describe 19 patients with acne appearing or getting worse after starting Trikafta. All were eligible for Trikafta treatment, according to age (21–38 years old) and genotype (at least one copy of the F508del mutation).

Nine had acne before starting treatment and 18 reported acne within eight months of initiating therapy, including nine who reported it within the first three months and four who reported it at six months or later.

“Due to the non-emergent nature of this adverse effect and unclear association with the drug, not all patients reported it to their CF care team at the time it first occurred, so our understanding of the true time of onset is limited by patient recall,” the researchers noted.

The face was the most commonly affected part of the body, with some patients referring also to involvement of the chest and back.

No patient discontinued Trikafta due to acne as the therapy’s benefits in lung function outweighed the risk.

There is no standard treatment for acne in people with CF. In this study, the therapeutic approaches varied from over-the-counter products to medicines used to treat acne in the general population. These include topical therapies, such as benzoyl peroxide, antibiotics, and retinoids; and systemic therapies for moderate or severe cases resistant to topical therapies.

Although only one-third of the patients went to a dermatologist to treat their acne, the majority (16 patients) referred at least a partial improvement.

“Based on the wide range of treatment regimens observed in these patient cases and overall positive reports from patients regardless of treatment regimen selected, we cannot conclude from this case series alone that any specific regimen is superior,” the research team wrote.

How Trikafta results in acne is unknown. The researchers hypothesized that it might be related to alterations in the salt content of sweat, due to changes in the skin microbiome. This would be similar to changes in the lung microbiome observed in patients treated with Trikafta.

There is little research in CF patients on the skin microbiome, the collection of microbes, such as fungi, bacteria, and viruses, that naturally live in the body.

“An alternate hypothesis could be that the rapid decrease in sweat chloride itself precipitates an inflammatory response,” the researchers wrote. The researchers emphasized “further research is needed to obtain a better understanding of various dermatologic changes that may occur with initiation [Trikafta].”

The researchers encourage “patients to report their symptoms to their CF care teams and CF care teams to report new onset or worsening acne to the drug manufacturer and the Food and Drug Administration for post-marketing surveillance.”