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Войти в исследования Prospective SARS-CoV-2 additional vaccination in immunosuppressant-treated individuals with autoimmune diseases in a randomized controlled trial.
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Mackay Meggan, Wagner Catriona A, Pinckney Ashley, Cohen Jeffrey A, Wallace Zachary S, Khosroshahi Arezou, Sparks Jeffrey A, Lord Sandra, Saxena Amit, Caricchio Roberto, Kim Alfred Hj, Kamen Diane L, Koumpouras Fotios, Askanase Anca D, Smith Kenneth, Guthridge Joel M, Pardo Gabriel, Mao-Draayer Yang, Macwana Susan, McCarthy Sean, Sherman Matthew A, Daneshfar Hamrah Sanaz, Veri Maria, Walker Sarah, York Kate, Tedeschi Sara K, Wang Jennifer, Dziubla Gabrielle E, Castro Mike, Carroll Robin, Narpala Sandeep R, Lin Bob C, Serebryannyy Leonid, McDermott Adrian B, Barry William T, Goldmuntz Ellen, McNamara James, Payne Aimee S, Bar-Or Amit, Khanna Dinesh, James Judith A
Аннотация
METHODS: In this open-label, multicenter, randomized trial, 22 participants taking MMF/MPA, 26 taking MTX, and 93 treated with BCDT who had suboptimal antibody responses to initial COVID-19 vaccines (2 doses of BNT162b2 or mRNA-1273 or 1 dose of AD26.COV2.S) received an additional homologous vaccine. Participants taking MMF/MPA and MTX were randomized (1:1) to continue or withhold treatment around vaccination. The primary outcome was the change in anti-Wuhan-Hu-1 receptor-binding domain (RBD) concentrations at 4 weeks post-additional vaccination. Secondary outcomes included adverse events, COVID-19 , and AD activity through 48 weeks.
RESULTS: Additional vaccination increased anti-RBD concentrations in participants taking MMF/MPA and MTX , irrespective of immunosuppressant withholding. BCDT-treated participants also demonstrated increased anti-RBD concentrations, albeit lower than MMF/MPA- and MTX-treated cohorts. COVID-19 occurred in 33% of participants; infections were predominantly mild and included only three non-fatal hospitalizations. Additional vaccination was well-tolerated, with low frequencies of severe disease flares and adverse events.
CONCLUSION: Additional COVID-19 vaccination is effective and safe in individuals with ADs treated with immunosuppressants, regardless of whether MMF/MPA or MTX is withheld.
CLINICALTRIALS: gov (NCT05000216; registered August 6, 2021: https://clinicaltrials.gov/ct2/show/NCT05000216).