Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate to severe plaque psoriasis. Deucravacitinib was efficacious and well tolerated in the global, 52-week, phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials. The ongoing, open-label POETYK long-term extension (LTE) (NCT04036435) trial overlapped with the global COVID-19 (SARS-CoV-2) pandemic. COVID-19–related serious adverse events (SAEs) and mortality rates in patients treated with deucravacitinib were similar to expected infection rates in the placebo arm of a contemporaneous COVID-19 vaccine trial. Most COVID-19 infections in the LTE trial were not serious and did not lead to treatment discontinuation. The majority of COVID-19 AEs and SAEs occurred in unvaccinated patients. Serological responses and predictors of seroconversion to SARS-CoV-2 vaccination and/or infection were investigated in patients in the LTE trial.

Methods: The LTE trial started in Aug 2019 and overlapped with the COVID-19 pandemic, which emerged in Dec 2019. The first infection in the POETYK program was reported on March 24, 2020, the first vaccination occurred Dec 17, 2020, and samples were collected through August 2, 2023. Patients in the LTE trial who (1) were fully vaccinated with an mRNA vaccine (ie, 2 doses of the Moderna or Pfizer-BioNTech vaccine) or a non-mRNA vaccine (ie, 2 doses of Novavax or 1 dose of the Johnson & Johnson/Janssen vaccine) or had a reported SARS-CoV-2 infection during the LTE and (2) had their first serum sample available ≥ 15 days after the second mRNA dose or ≥ 30 days and ≤ 229 days after a non-mRNA vaccine or infection were included. Spike receptor binding domain (RBD) antibody level ≥ 0.8 U/mL and nucleocapsid antibody level ≥ 1.0 cutoff index indicated seroconversion; nucleocapsid antibody levels ≥ 1.0 U/mL were used as an indicator of prior SARS-CoV-2 infection.

Results: 596 (87.8%) patients were vaccinated (mRNA vaccine, n = 498; non-mRNA vaccine, n = 98). Baseline characteristics were similar among vaccinated (n = 406), infected (n = 83), and both vaccinated and infected (n = 190) patients. Seroconversion occurred in 99.2% of mRNA vaccine recipients and 98.9% of non-mRNA vaccine recipients (mean RBD antibody levels, 9085.1 U/mL and 4277.9 U/mL, respectively; range, 0.4-75,000 U/mL [seroconversion, ≥ 0.8 U/mL titer]). Seroconversion occurred in 100% of infected unvaccinated patients (3663.8 U/mL), 99.1% of noninfected vaccinated patients (6384.2 U/mL), and 100% of infected vaccinated patients (23,636.2 U/mL). Mean duration between reported infection and sample collection was 177 days. RBD antibody levels remained high for > 24 weeks in mRNA vaccine recipients, regardless of time after vaccination or infection. Age, BMI, and sex were not predictors of antibody levels or seroconversion.

Conclusion: In the LTE trial, > 98% of patients mounted a serologic response to SARS-CoV-2 vaccination and/or infection, with more robust responses in vaccinated than unvaccinated patients. Deucravacitinib did not impact immune responses to vaccines that protect against COVID-19.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/deucravacitinib-treatment-did-not-impact-immune-response-to-sars-cov-2-vaccines-and-infection-in-patients-with-plaque-psoriasis-results-from-the-phase-3-poetyk-long-term-extension-trial/