Side effects and flares risk after SARS-CoV-2 vaccination in patients with systemic lupus erythematosus

Zavala-Flores, Ernesto; Salcedo-Matienzo, Jannin; Quiroz-Alva, Ana; Berrocal-Kasay, Alfredo

doi:10.1007/s10067-021-05980-5

Cited by 42 publications

(82 citation statements)

References 16 publications

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“…While the latter phenomenon could be also associated with recently started secukinumab use as previously reported [ 45 ], the role of the vaccine in exacerbating inflammation could not be ignored. The low rate of disease flares in RD was consistent with other publications [ 17 – 25 ]. It has been also suggested that the underlying risk of flare may differ among RD [ 17 ].…”

Section: Discussionsupporting

confidence: 92%

“…Only 29.2% were willing to be vaccinated, 19.0% were unwilling and 51.8% were undecided [ 16 ]. Several observational studies reported that the incidence and profile of adverse events of these vaccines in this patient population have been similar to the general population and severe AEs have been rarely observed [ 17 – 25 ]. On the other hand, post-vaccination flares in several patients with RD as well as new-onset RD in previously healthy individuals have been documented in a number of case series and registries [ 26 – 30 ].…”

Section: Introductionmentioning

confidence: 88%

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Safety of SARS-CoV-2 vaccination in patients with Behcet’s syndrome and familial Mediterranean fever: a cross-sectional comparative study on the effects of M-RNA based and inactivated vaccine

et al. 2022

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Most of the published data relate to classical forms of rheumatic diseases (RD) and information on rare inflammatory disorders such as Behçet’s syndrome (BS) and familial Mediterranean fever (FMF) is limited. We studied the frequency of side effects and disease flares after COVID-19 vaccination with either Pfizer/BioNTech or Sinovac/CoronaVac in 256 patients with BS, 247 with FMF, and 601 with RD. Telephone interviews were conducted using a questionnaire survey in a cross-sectional design in patients with BS, FMF, and RD followed by a single university hospital. Study participants were vaccinated either with CoronaVac (BS:109, FMF: 90, and RD: 343,) or BioNTech (BS: 147, FMF: 157 and RD: 258). The majority have received double dose (BS: 94.9%, FMF 92.3% and RD: 86.2%). BioNTech ensured a significantly better efficacy than CoronaVac against COVID-19 in all patient groups (BS: 1.4% vs 10.1%; FMF: 3.2% vs 12.2%, RD:2.7% vs 6.4%). Those with at least one adverse event (AE) were significantly more frequent among those vaccinated with BioNTech than those with CoronaVac (BS: 86.4% vs 45%; FMF: 83.4% vs 53.3%; and RD: 83.3% vs 45.5%). The majority of AEs were mild to moderate and transient and this was true for either vaccine. There were also AEs that required medical attention in all study groups following CoronaVac (BS: 5.5%, FMF: 3.3%, and RD:2.9%) or BioNTech (BS: 5.4%, FMF: 1.9%, and RD: 4.7%). The main causes for medical assistance were disease flare and cardiovascular events. Patients with BS (16.0%) and FMF (17.4%) were found to flare significantly more frequently when compared to those with RD (6.0%) ( p < 0.001). This was true for either vaccine. BS patients reported mainly skin-mucosa lesions; there were however, 11 (4.3%) who developed major organ attack such as uveitis, thrombosis or stroke. Flare in FMF patients were associated mainly with acute serositis with or without fever. Arthralgia/arthritis or inflammatory back pain were observed mainly in the RD group. Our study demonstrates that BS and FMF patients vaccinated with either CoronaVac or BioNTech demonstrated similar AE profile and frequency compared to RD patients. AEs that required physician consultation or hospitalization occurred in all study groups after either CoronaVac or BioNTech. Increased frequency of flares in BS and FMF compared to that seen in RD might reflect defects in innate immunity and deserves further investigation. Caution should be required when monitoring these patients after vaccination.

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Section: Discussionsupporting

confidence: 92%

Section: Introductionmentioning

confidence: 88%

Safety of SARS-CoV-2 vaccination in patients with Behcet’s syndrome and familial Mediterranean fever: a cross-sectional comparative study on the effects of M-RNA based and inactivated vaccine

et al. 2022

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“…Conversely, in a recent study on 100 SLE patients, there were 27 flares after the immunisation (9% and 20% after the first and the second dose, respectively). Seven patients presented flare after both doses [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

The Impact of Anti-SARS-CoV-2 Vaccine in Patients with Systemic Lupus Erythematosus: A Multicentre Cohort Study

Gerosa

Schioppo²,

Argolini

et al. 2022

Vaccines

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Vulnerable subjects, including systemic lupus erythematosus (SLE) patients, have been prioritised to receive anti-SARS-CoV-2 vaccines. Few data about the safety of these vaccines in SLE are available. The aim of our study is to investigate the safety of anti-SARS-CoV-2 vaccines in SLE. We included 452 SLE patients, referring to seven tertiary centres, who were immunised. A total of 119 (26%) reported side effects (SE) after the first and/or the second shot (the most frequent SE were fever, local reaction, fatigue, and arthralgia). Patients with constitutional symptoms and those on an immunosuppressive regimen (especially belimumab) showed more SE. In addition, 19 (4%) had a flare after the immunisation (flares classified by organ involvement: six musculoskeletal with constitutional symptoms, four renal, three cardio-respiratory, three haematological, two mucocutaneous). None of the patients needed hospitalisation and none died. Moreover, 15 required a transient increase in corticosteroids and four were treated with steroid pulses. One patient required an additional rituximab course. Anti-dsDNA, moderate/high DAS before vaccine, and belimumab were found more frequently in patients with disease flare. Anti-SARS-CoV-2 vaccines are safe in SLE patients, and they should be recommended in these patients, as the potential benefits widely outweigh the risk of SE. Treatment adjustment might be considered with the aim of minimising SE risk and flare.

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“…Средний интервал от момента вакцинации до начала рецидива составил 2,3±0,8 сут., продолжительность обострения -7,3±3 сут. Среди больных, получавших гидроксихлорохин, вероятность развития поствакцинальных обострений СКВ статистически значимо снижалась (ОР=0,20; 95% ДИ: 0,06-0,63), в то время как исходное применение азатиоприна вело к повышению риска рецидива болезни после иммунизации (ОР=7,96; 95% ДИ: 2,7-23,43) [32]. В качестве причины повышенной (по сравнению с другими исследованиями) частоты обострений СКВ авторы указывают на различия в этническом составе пациентов, т. к. известно, что у жителей стран Латинской Америки заболевание протекает более тяжело по сравнению с представителями европеоидной расы [47,48].…”

Section: риск поствакцинальных ня не связанных с основным иврзunclassified

Vaccination against SARS-CoV-2 in rheumatic diseases: Safety issues

Белов¹,

Лила

Насонов

2022

Naučno-praktičeskaâ revmatologiâ

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The problem of coronavirus disease 2019 (Coronavirus diseases, COVID-19) two years later still remains relevant both socially and medically. As one of the methods of combating the current COVID-19 pandemic, most experts rely on the widespread use of vaccination. However, the use of vaccines against SARS-CoV-2 in patients with rheumatic diseases (RD) raises a number of issues related to the effectiveness, immunogenicity, and safety of immunization, including leveling the risks of exacerbation of the underlying disease or the development of new autoimmune phenomena. For this reason it is very important to analyze data on the above-mentioned aspects in real time, especially given that patients of the rheumatology circle were excluded from the clinical development programs of vaccines against SARS-CoV-2. This review presents the results of last year’s research on the safety of vaccination against COVID-19 in patients with RS. A brief description of the main anticovedic vaccines is given. Post-vaccination adverse events were quite frequent after the first, second or both doses of vaccines in patients with RS, which is consistent with the data obtained in the general population. In general, the frequency of exacerbation of RD after vaccination against COVID-19 seems to be quite low (5–7%) and has no significant associations with a specific vaccine or anti-rheumatic therapy. At the same time, unambiguous interpretation of these data is difficult for at least three reasons: a) in many studies, only the symptoms developing after the first dose of the vaccine were taken into account; b) the time-limited post-vaccination follow-up period; c) significant discrepancies in the interpretation of exacerbations of the disease. Within the framework of the problem under consideration, there are still a lot of questions, the answers to which should be obtained in large prospective controlled studies.

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Side effects and flares risk after SARS-CoV-2 vaccination in patients with systemic lupus erythematosus

Cited by 42 publications

References 16 publications

Safety of SARS-CoV-2 vaccination in patients with Behcet’s syndrome and familial Mediterranean fever: a cross-sectional comparative study on the effects of M-RNA based and inactivated vaccine

Safety of SARS-CoV-2 vaccination in patients with Behcet’s syndrome and familial Mediterranean fever: a cross-sectional comparative study on the effects of M-RNA based and inactivated vaccine

The Impact of Anti-SARS-CoV-2 Vaccine in Patients with Systemic Lupus Erythematosus: A Multicentre Cohort Study

Vaccination against SARS-CoV-2 in rheumatic diseases: Safety issues

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