OBJECTIVE: Patients with rheumatoid arthritis (RA) and other systemic rheumatic diseases (SRDs) are at increased risk of developing herpes zoster (HZ). Zoster recombinant adjuvanted (ZRA) is a recombinant vaccine approved by the Food and Drug Administration in 2018. Concern has been raised that the ZRA may trigger disease flares in rheumatology patients who are immunocompromised. We investigated the impact of the ZRA vaccine in patients with RA and SRD and measured the incidence of flares and side effects. METHODS: A flare was defined as occurring within 12 weeks of vaccine administration by either 1) documentation of RA flare in office notes, telephone encounter, or patient portal communication or 2) new or increased dose of corticosteroids. RESULTS: We identified 403 patients (239 patients with RA and 164 patients with SRD) who received the ZRA vaccine from February 1, 2018, to February 1, 2019. We measured a 6.7% (n = 27) incidence of flare. Side effects occurred in 12.7% (n = 51) of patients. All flares and side effects were regarded as mild. Three cases of HZ were reported as occurring 2, 10, and 11 months after the vaccination. CONCLUSION: In 403 patients who received the ZRA vaccine, the incidence of disease flares was 7% or less and that of side effects was 13% or less, both of which are less than the incidence rates observed in the pivotal trials.
OBJECTIVE:Patients with rheumatoid arthritis (RA) and other systemic rheumatic diseases (SRDs) are at increased risk of developing herpes zoster (HZ). Zoster recombinant adjuvanted (ZRA) is a recombinant vaccine approved by the Food and Drug Administration in 2018. Concern has been raised that the ZRA may trigger disease flares in rheumatology patients who are immunocompromised. We investigated the impact of the ZRA vaccine in patients with RA and SRD and measured the incidence of flares and side effects. METHODS: A flare was defined as occurring within 12 weeks of vaccine administration by either 1) documentation of RA flare in office notes, telephone encounter, or patient portal communication or 2) new or increased dose of corticosteroids. RESULTS: We identified 403 patients (239 patients with RA and 164 patients with SRD) who received the ZRA vaccine from February 1, 2018, to February 1, 2019. We measured a 6.7% (n = 27) incidence of flare. Side effects occurred in 12.7% (n = 51) of patients. All flares and side effects were regarded as mild. Three cases of HZ were reported as occurring 2, 10, and 11 months after the vaccination. CONCLUSION: In 403 patients who received the ZRA vaccine, the incidence of disease flares was 7% or less and that of side effects was 13% or less, both of which are less than the incidence rates observed in the pivotal trials.
Authors: Karina Rossi Bonfiglioli; Licia Maria Henrique da Mota; Ana Cristina de Medeiros Ribeiro; Adriana Maria Kakehasi; Ieda Maria Magalhães Laurindo; Rina Dalva Neubarth Giorgi; Angela Luzia Branco Pinto Duarte; Ana Paula Monteiro Gomides Reis; Mariana Peixoto Guimarães Ubirajara E Silva de Souza; Claiton Viegas Brenol; Geraldo da Rocha Castelar Pinheiro; Cleandro Pires de Albuquerque; Charlles Heldan de Moura Castro; Gustavo Luiz Behrens Pinto; Jose Fernando Verztman; Luciana Feitosa Muniz; Manoel Barros Bertolo; Maria Raquel da Costa Pinto; Paulo Louzada Júnior; Vitor Alves Cruz; Ivanio Alves Pereira; Max Vitor Carioca de Freitas; Bóris Afonso Cruz; Eduardo Paiva; Odirlei Monticielo; José Roberto Provenza; Ricardo Machado Xavier Journal: Adv Rheumatol Date: 2021-11-24
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