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A recent study confirmed the safety of tralokinumab with regard to COVID-19 and related vaccinations.
Research suggests that tralokinumab treatment for patients with severe atopic dermatitis (AD) does not interfere with SARS-CoV-2 vaccinations or increase COVID-19 severity.
Tralokinumab is an IgG4 monoclonal antibody used as a therapy to neutralize interleukin (IL) 13, one of the Th2 cytokines leading to AD. During the COVID-19 pandemic, discussions arose regarding immunomodulatory drugs’ possible effects on disease susceptibility and on SARS-CoV-2 vaccination disruption.
This study, led by Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, sought to analyze both SARS-CoV-2 vaccination and COVID-19 outcomes with adult AD patients given tralokinumab. In order to assess both of these outcomes, Blauvelt and colleagues used a subset of adult AD patients enrolled in the ongoing ECZTEND trial through April 2021.
The investigators assessed data from AD patients enrolled in the ECZTEND trial who had been treated with 300 mg of subcutaneous tralokinumab every 2 weeks, in addition to optional topical corticosteroids following a 600-mg loading dose. The ECZTEND trial patients included had also reported COVID-19 as an adverse event (AE) while their routine clinic visits took place.
The ECZTEND trial had a total of 1442 patients enrolled, with 77 of them diagnosed with COVID-19 and 76 unvaccinated at the time of infection. “The ECZTEND trial was approved by institutional review boards at participating institutions, and all participants provided written informed consent; approval extended to this post hoc case series,” the researchers wrote.
The investigators found that most of the trial’s participants with COVID-19 had probable risk factors for severe illness, including 51 with a body mass index of 25 or greater, 42 with asthma, and 10 with hypertension. The trial also saw zero deaths related to COVID-19, with every patient continuing tralokinumab treatment after recovering from COVID-19, and 60 of the 77 not interrupting tralokinumab therapy.
In the 77 patients with COVID-19, the investigators found severity to be predominantly mild (n = 52 [68%]) or moderate (n = 23 [30%]). They noted that 2 patients had multiple risk factors associated with severity who reported more severe symptoms. Tralokinumab treatment was reported not to be associated with their symptoms.
The investigators reported 2 cases as potentially associated with tralokinumab therapy, with both COVID-19 patients being younger than 30-years-old and both cases resolving within 22 days. They found no new safety signals or evidence for any reduced effectiveness of the SARS-CoV-2 vaccines administered during tralokinumab therapy.
The researchers noted previous studies had found that non-live vaccines could be administered safely while tralokinumab treatments occurred, continuing to result in normal immune responses.
“This work provides clinically relevant information on adults with AD treated with tralokinumab who were diagnosed with COVID-19 or received SARS-CoV-2 vaccination during the COVID-19 pandemic,” they wrote. “New SARS-CoV-2 variants, evolving vaccination guidelines, and COVID-19 treatments may affect decision-making in the future.”
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.