Tralokinumab treatment in patients with moderate to severe atopic dermatitis (AD) does not produce new safety concerns and does not present evidence of SARS-CoV-2 vaccine reduced effectiveness, according to research letter findings published in the Journal of the American Medical Association Dermatology.
Immunomodulatory drugs such as tralokinumab, an IgG4 monoclonal antibody that neutralizes interleukin 13, were thought to interfere with SARS-CoV-2 vaccination or possibly increase disease severity or susceptibility. Investigators sought to evaluate outcomes of SARS-CoV-2 vaccination and COVID-19 in adult patients treated with tralokinumab for AD.
They conducted a case series review that included a subset of adult patients with moderate to severe AD enrolled in the ECZTEND trial (ClinicalTrials.gov Identifier: NCT03587805) through April 2021. Patients in this trial received a 600 mg loading dose of topical corticosteroids (subsequent treatment optional) and subcutaneous tralokinumab 300 mg every 2 weeks. Of these 1442 patients, the current subgroup consisted of 77 adult patients with confirmed COVID-19, many of whom had probable or established risk factors for severe illness: body mass index 25 or greater (66%), asthma (55%), hypertension (13%), at least 60 years of age (5%).
Investigators noted that 99% patients were unvaccinated at the time of COVID-19 infection and 1 patient had received 1 of 2 vaccination doses.
Investigators reported COVID-19 severity was mild in 68% of patients or moderate in 30% of patients. They noted that 2 patients with multiple risk factors associated with severe COVID-19 experienced severe symptoms; both recovered following hospitalization. Neither of these cases was reportedly associated with tralokinumab, but 2 other patients with COVID-19 (1 mild, 1 moderate) were possibly associated with tralokinumab treatment. Both of these patients’ symptoms resolved within 22 days and occurred in patients younger than 30 years of age, it was noted.
In this subgroup all patients continued tralokinumab treatment following COVID-19, and 78% never interrupted treatment. No deaths were reported from COVID-19 in this subgroup.
Overall, in the ECZTEND trial through April 2021, 6% of the 1442 patients were fully vaccinated with the SARS-CoV-2 vaccine and 9% were partially vaccinated. There were 2 patients who may have been partially or fully vaccinated (data unconfirmed) and at least 1211 patients unvaccinated. Among the 6% who were vaccinated, none reported adverse events followed by permanent discontinuation of tralokinumab treatment.
Case series limitations include possible failure to recognize asymptomatic or mild COVID-19 cases, and lack of a control group of patients with COVID-19 with AD not treated with tralokinumab.
Investigators concluded in their case series of adults with moderate to severe AD, “confirmed COVID-19 infections were predominantly mild or moderate (97%), and all but 1 occurred in unvaccinated patients.” They added, “No new safety signals or evidence for reduced effectiveness of SARS-CoV-2 vaccines administered during tralokinumab treatment were reported.” Investigators believe their current analysis suggests there may not be an association between tralokinumab treatment and increased COVID-19 severity or worse clinical outcomes.
Disclosure: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Blauvelt A, Pink A, Worm M, et al. Outcomes of COVID-19 and vaccination in patients with moderate to severe atopic dermatitis treated with tralokinumab. JAMA Dermatol. Published online October 12, 2022. doi:10.1001/jamadermatol.2022.3488