Breakthrough SARS-CoV-2 infections, morbidity, and seroreactivity following initial COVID-19 vaccination series and additional dose in patients with SLE in New York City

Saxena, Amit; Engel, Alexis; Banbury, Brittany; Hasan, Ghadeer; Fraser, Nicola; Zaminski, Devyn; Masson, M; Haberman, Rebecca H.; Scher, Jose U.; Ho, Gary H.; Law, Jammie; Rackoff, Paula; Tseng, Chung‐E; Belmont, H. Michael; Clancy, Robert M.; Buyon, Jill P.; Izmirly, Peter

doi:10.1016/s2665-9913(22)00190-4

Cited by 10 publications

(14 citation statements)

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“…Sixth, since the present study was conducted in the pre-Omicron era, we did not examine the effectiveness of current COVID-19 vaccines as well as the booster doses against the Omicron variant. Although previous studies reported that an additional dose of the COVID-19 vaccine could protect patients with SLE from the COVID-19 infection during the Omicron BA.1 wave, 23 future studies are needed to evaluate the COVID-19 vaccines against new variant of COVID-19 among patients with SLE.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, Saxena et al reported a lower rate of COVID-19 breakthrough infection after receiving an additional vaccination dose in patients with SLE; however, the study did not assess the risk of severe sequelae of COVID-19 (eg, hospitalisation and death) and did not include the healthy individuals as a comparison group. 23 Despite the indirect evidence regarding immunogenicity, [24][25][26][27] there is still a paucity of data on the effect of COVID-19 vaccination, especially its long-term effect, on the risk of SARS-CoV-2 breakthrough infection and its related sequelae among patients with SLE. Therefore, knowledge gaps exist regarding the efficacy or effectiveness of vaccination in the face of waning immunity, as well as the need for additional vaccination and preventive measures in patients with SLE.…”

Section: How This Study Might Affect Research Practice or Policymentioning

confidence: 99%

“…In addition, the majority of these studies were conducted during the prevaccination or early vaccination period. Recently, Saxena et al reported a lower rate of COVID-19 breakthrough infection after receiving an additional vaccination dose in patients with SLE; however, the study did not assess the risk of severe sequelae of COVID-19 (eg, hospitalisation and death) and did not include the healthy individuals as a comparison group 23. Despite the indirect evidence regarding immunogenicity,24–27 there is still a paucity of data on the effect of COVID-19 vaccination, especially its long-term effect, on the risk of SARS-CoV-2 breakthrough infection and its related sequelae among patients with SLE.…”

Section: Introductionmentioning

confidence: 99%

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Risk of COVID-19 among unvaccinated and vaccinated patients with systemic lupus erythematosus: a general population study

et al. 2023

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ObjectiveTo compare the risk of SARS-CoV-2 infection and its related severe sequelae between patients with systemic lupus erythematosus (SLE) and the general population according to COVID-19 vaccination status.MethodsWe performed cohort studies using data from The Health Improvement Network to compare the risks of SARS-CoV-2 infection and severe sequelae between patients with SLE and the general population. Individuals aged 18–90 years with no previously documented SARS-CoV-2 infection were included. We estimated the incidence rates and HRs of SARS-CoV-2 infection and severe sequelae between patients with SLE and the general population according to COVID-19 vaccination status using exposure score overlap weighted Cox proportional hazards model.ResultsWe identified 3245 patients with SLE and 1 755 034 non-SLE individuals from the unvaccinated cohort. The rates of SARS-CoV-2 infection, COVID-19 hospitalisation, COVID-19 death and combined severe outcomes per 1000 person-months were 10.95, 3.21, 1.16 and 3.86 among patients with SLE, and 8.50, 1.77, 0.53 and 2.18 among general population, respectively. The corresponding adjusted HRs were 1.28 (95% CI: 1.03 to 1.59), 1.82 (95% CI: 1.21 to 2.74), 2.16 (95% CI: 1.00 to 4.79) and 1.78 (95% CI: 1.21 to 2.61). However, no statistically significant differences were observed between vaccinated patients with SLE and vaccinated general population over 9 months of follow-up.ConclusionWhile unvaccinated patients with SLE were at higher risk of SARS-CoV-2 infection and its severe sequelae than the general population, no such difference was observed among vaccinated population. The findings indicate that COVID-19 vaccination provides an adequate protection to most patients with SLE from COVID-19 breakthrough infection and its severe sequelae.

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Section: Discussionmentioning

confidence: 99%

Section: How This Study Might Affect Research Practice or Policymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Risk of COVID-19 among unvaccinated and vaccinated patients with systemic lupus erythematosus: a general population study

et al. 2023

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“…Similar are the findings in another case series published by Fragoulis et al where no high-risk SARD patient taking MP or NM/R progressed to severe COVID-19 requiring hospitalization and, more importantly, no deaths were reported 8 . However, these anticipated differences between up-to-date vaccinated patients with and without oral antiviral treatment for breakthrough infections may have been recently mitigated given that the majority of patients with SARD and additional vaccine doses seem to recover uneventfully even without oral antiviral prophylaxis during the current Omicron wave, as Saxena et al demonstrated in an cohort of lupus patients 9 . Adding to this, a study by Wong et al, evaluating the effectiveness of MP and NM/R in a large territory-wide cohort from the general population in China, during the Omicron surge, found that early initiation of oral antivirals -especially NM/R -among non-institutionalized COVID-19 patients, was associated with reduced risks of mortality and in-hospital outcomes 10 .…”

Section: Discussionmentioning

confidence: 99%

Oral Antiviral Treatment for COVID-19 in Patients With Systemic Autoimmune Rheumatic Diseases

2022

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ObjectiveTo describe data on the safety and efficacy of molnupiravir (MP) and nirmatrelvir/ritonavir (NM/R) in patients with systemic autoimmune rheumatic diseases (SARD).MethodsAmong patients with SARD being followed in two tertiary outpatient rheumatology clinics, we retrospectively identified those infected with SARS-CoV-2 between February and August 2022 who received MP or NM/R. Patients' medical files were reviewed for demographics, disease-related characteristics as well as COVID-19 characteristics, including vaccination status, antiviral treatment, side effects and COVID-19 outcomes.ResultsSeventy-four SARD patients (52 females) were identified who had been infected with SARS-CoV-2 and received MP (n=26,35.1%) or NM/R (n=48,64.9%). Most patients were vaccinated against SARS-CoV-2 (n=62,83.8%). Among frequently used regimens were corticosteroids (n=43,58.1%), mycophenolate (n=26,35.1%), TNF-inhibitors (n=14,18.9%), methotrexate (n=13,17.6%) and rituximab (n=12,16.2%). Common adverse events were reported only by four patients receiving NM/R (metallic taste, gastrointestinal upset, hypertension), not leading to drug discontinuation. During follow up, all but two patients (n=72, 97.3%) recovered at home without COVID-19 related complications. Nonetheless, we describe two presumptive cases of COVID-19 rebound who progressed to severe COVID-19.ConclusionThis data argues in favor of a favorable outcome and acceptable safety profile of the two oral antiviral therapies among a high-risk SARD population. However, cases of COVID-19 rebound are being increasingly identified. These findings call for continuous surveillance in order to capture the realworld efficacy and safety profiles in our subpopulations of interest.

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“…[7][8][9][10][11] Breakthrough infections in patients with SARD have been described. 12 Booster doses are significantly helpful in this group, have been shown to reduce breakthrough infections, 13 and continue to show benefit with new SARS-CoV-2 subvariants. 14 Monoclonal antibodies have been helpful for those with infection who do not have detectable antibodies 15 ; however, they have not shown to be effective in newer subvariants.…”

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confidence: 99%

Molnupiravir and Nirmatelvir/Ritonavir in the Treatment of Patients With Systemic Autoimmune Rheumatic Disease With SARS-CoV-2

2023

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Breakthrough SARS-CoV-2 infections, morbidity, and seroreactivity following initial COVID-19 vaccination series and additional dose in patients with SLE in New York City

Cited by 10 publications

References 10 publications

Risk of COVID-19 among unvaccinated and vaccinated patients with systemic lupus erythematosus: a general population study

Risk of COVID-19 among unvaccinated and vaccinated patients with systemic lupus erythematosus: a general population study

Oral Antiviral Treatment for COVID-19 in Patients With Systemic Autoimmune Rheumatic Diseases

Molnupiravir and Nirmatelvir/Ritonavir in the Treatment of Patients With Systemic Autoimmune Rheumatic Disease With SARS-CoV-2

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