A new study shows the AD drug does not interfere with vaccinations or increase severity.
A new study found that patients with severe atopic dermatitis (AD) who are treated with tralokinumab do not face a greater COVID-19 infection risk, nor does it compromise the COVID-19 vaccines’ efficacy.1
Tralokinumab, an IgG4 monoclonal antibody that neutralizes interleukin (IL-13), has demonstrated safety and efficacy in clinical trials investigating the drug as a potential treatment for adults with moderate to severe AD. Meanwhile, concerns grew during the COVID-19 pandemic that immunomodulatory drugs could increase susceptibility or severity of diseases or affect the efficacy of the SARS-CoV-2 vaccination.
Study investigators evaluated data from 1442 AD patients enrolled in the ECZTEND study, a long-term, open-label extension trial. Participants were given 300 mg of tralokinumab subcutaneously every 2 weeks and optional topical corticosteroids after a 600-mg loading dose. They also reported COVID-19 as an adverse event during routine clinic visits.
The ECZTEND trial enrolled 77 patients diagnosed with COVID-19 and 76 unvaccinated when infected. Many patients had established or probable risk factors for severe illness according to the Centers for Disease Control and Prevention classification: 4 (5%) were 60 years or older, 10 (13%) had hypertension, 42 (55%) had asthma, and 51 (66%) had a body mass index of 25 or greater (overweight or obesity).
The study’s authors found severity to be mild (n=52 [68%]) or moderate (n=23 [30%]). Two patients had several risk factors who reported more severe symptoms. Tralokinumab was not reported to play a role in their symptoms.
There were 2 reported cases that investigators said were potentially associated with tralokinumab therapy. Both of those COVID-19 patients were under 30-years-old and neither case lasted more than 22 days. The authors found no new safety signals or evidence for any reduced effectiveness of the SARS-CoV-2 vaccines, parallel to the tralokinumab therapy.
AD affects more than 16.5 million adults in the United States and is the most common type of eczema.2 As a chronic condition, it can flare up at any time and even overlap with other types of eczema.
The authors noted limitations in this study. First, asymptomatic, or mild COVID-19 may not have been recognized. Second, the series lacked a comparison group of COVID-19 patients with AD not treated with tralokinumab. This research letter, “Outcomes of COVID-19 and Vaccination in Patients with Moderate to Severe Atopic Dermatitis Treated with Tralokinumab,” was published online in JAMA Dermatology.