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Article ; Online: Breakthrough COVID-19 After Tixagevimab/Cilgavimab Among Patients With Systemic Autoimmune Rheumatic Diseases.

Kawano, Yumeko / Wang, Xiaosong / Patel, Naomi J / Qian, Grace / Kowalski, Emily / Bade, Katarina J / Vanni, Kathleen M M / Jonsson, A Helena / Williams, Zachary K / Cook, Claire E / Srivatsan, Shruthi / Wallace, Zachary S / Sparks, Jeffrey A

The Journal of rheumatology

2024 Volume 51, Issue 3, Page(s) 305–312

Abstract: Objective: To determine the incidence and baseline factors associated with breakthrough coronavirus disease 2019 (COVID-19) after preexposure prophylaxis (PrEP) with tixagevimab/cilgavimab among patients with systemic autoimmune rheumatic diseases ( ... ...

Abstract	Objective: To determine the incidence and baseline factors associated with breakthrough coronavirus disease 2019 (COVID-19) after preexposure prophylaxis (PrEP) with tixagevimab/cilgavimab among patients with systemic autoimmune rheumatic diseases (SARDs). Methods: We performed a retrospective cohort study among patients with SARDs who received tixagevimab/cilgavimab between January 2, 2022, and November 16, 2022. The primary outcome was breakthrough COVID-19 after tixagevimab/cilgavimab. We performed multivariable Cox regression models adjusted for baseline factors to identify risk factors for breakthrough COVID-19. Results: We identified 444 patients with SARDs who received tixagevimab/cilgavimab (mean age 62.0 years, 78.2% female). There were 83 (18.7%) breakthrough COVID-19 cases (incidence rate 31.5/1000 person-months, 95% CI 24.70-38.24), 7 (1.6%) hospitalizations, and 1 (0.2%) death. Older age was inversely associated with breakthrough COVID-19 (adjusted hazard ratio [aHR] 0.86/10 years, 95% CI 0.75-0.99). Higher baseline spike antibody levels were associated with lower risk of breakthrough COVID-19 (aHR 0.42, 95% CI 0.18-0.99 for spike antibody levels > 200 vs < 0.4 units). CD20 inhibitor users had a similar risk of breakthrough COVID-19 (aHR 1.05, 95% CI 0.44-2.49) compared to conventional synthetic disease-modifying antirheumatic drug (DMARD) users. Conclusion: We found that patients with SARDs had frequent breakthrough COVID-19, but the proportion experiencing severe COVID-19 was low. DMARD type, including CD20 inhibitors, did not significantly affect risk of breakthrough COVID-19. Evidence of prior humoral immunity was protective against breakthrough infection, highlighting the continued need for a multimodal approach to prevent severe COVID-19 as novel PrEP therapies are being developed.
MeSH term(s)	Humans ; Female ; Middle Aged ; Male ; COVID-19 ; Retrospective Studies ; Antirheumatic Agents/therapeutic use ; Rheumatic Diseases/complications ; Rheumatic Diseases/drug therapy ; Antibodies, Monoclonal
Chemical Substances	cilgavimab (1KUR4BN70F) ; tixagevimab ; Antirheumatic Agents ; Antibodies, Monoclonal
Language	English
Publishing date	2024-03-01
Publishing country	Canada
Document type	Journal Article
ZDB-ID	194928-7
ISSN	1499-2752 ; 0315-162X
ISSN (online)	1499-2752
ISSN	0315-162X
DOI	10.3899/jrheum.2023-0742
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Article ; Online: Validation of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis as the Cause of End-Stage Renal Disease in the US Renal Data System.

Cook, Claire E / Fu, Xiaoqing / Zhang, Yuqing / Stone, John H / Choi, Hyon K / Wallace, Zachary S

ACR open rheumatology

2021 Volume 4, Issue 1, Page(s) 8–12

Abstract: Objective: The objective of this study was to validate the diagnosis of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) as the primary cause of end-stage renal disease (ESRD) in the US Renal Data System (USRDS).: Methods: We ... ...

Abstract	Objective: The objective of this study was to validate the diagnosis of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) as the primary cause of end-stage renal disease (ESRD) in the US Renal Data System (USRDS). Methods: We identified patients with ESRD in the Mass General Brigham (MGB) health care system who were enrolled in the USRDS. The health records of those with AAV listed as the primary cause of ESRD in the USRDS were reviewed to confirm the diagnosis and estimate positive predictive value (PPV). Sensitivity was estimated by evaluating the primary cause of ESRD listed in the USRDS for patients with ESRD due to AAV in the MGB AAV cohort. Results: We identified 89 MGB patients with ESRD due to AAV in the USRDS. Of these, 85 cases were confirmed to be true cases of AAV (PPV = 94%). Among the patients classified as having AAV, 84 (99%) had an ANCA test, which was predominantly myeloperoxidase/P-ANCA (47 [55%]); 36 (42%) had a renal biopsy, and all biopsies were supportive of the diagnosis. The majority (81 [90%]) was identified as AAV by International Classification of Diseases Ninth Revision or International Classification of Diseases 10th Revision codes for granulomatosis with polyangiitis (446.4 or M313.1). Of the 77 MGB AAV cohort patients with ESRD who were linked to the USRDS, 41 (53%) had AAV listed as the cause of ESRD; in the remainder, ESRD was attributed to nonspecific nephritis. Conclusion: The diagnosis of AAV as the cause of ESRD in the USRDS has a high PPV; sensitivity was moderate. These findings support the continued use of the USRDS to study ESRD due to AAV.
Language	English
Publishing date	2021-10-12
Publishing country	United States
Document type	Journal Article
ISSN	2578-5745
ISSN (online)	2578-5745
DOI	10.1002/acr2.11359
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Article ; Online: Factors Associated With an Electronic Health Record-Based Definition of Postacute Sequelae of COVID-19 in Patients With Systemic Autoimmune Rheumatic Disease.

Patel, Naomi J / Wang, Xiaosong / Lin, Miao / Kowalski, Emily N / Cook, Claire E / Vanni, Kathleen M M / Guzzo, Krishan / Qian, Grace / Bade, Katarina J / Saavedra, Alene / Venkat, Rathnam / Srivatsan, Shruthi / Williams, Zachary K / Hanberg, Jennifer S / Kawano, Yumeko / Schiff, Abigail E / Sparks, Jeffrey A / Wallace, Zachary S

The Journal of rheumatology

2024 Volume 51, Issue 5, Page(s) 529–537

Abstract: Objective: Many individuals with rheumatic disease are at higher risk for severe acute coronavirus disease 2019 (COVID-19). We aimed to evaluate risk factors for postacute sequelae of COVID-19 (PASC) using an electronic health record (EHR)-based ... ...

Abstract	Objective: Many individuals with rheumatic disease are at higher risk for severe acute coronavirus disease 2019 (COVID-19). We aimed to evaluate risk factors for postacute sequelae of COVID-19 (PASC) using an electronic health record (EHR)-based definition. Methods: We identified patients with prevalent rheumatic diseases and COVID-19 within the Mass General Brigham healthcare system. PASC was defined by the International Classification of Diseases, 10th revision (ICD-10) codes, relevant labs, vital signs, and medications at least 30 days following the first COVID-19 infection. Patients were followed until the earliest of incident PASC, repeat COVID-19 infection, 1 year of follow-up, death, or February 19, 2023. We used multivariable Cox regression to estimate the association of baseline characteristics with PASC risk. Results: Among 2459 patients (76.37% female, mean age 57.4 years), the most common incident PASC manifestations were cough (14.56%), dyspnea (12.36%), constipation (11.39%), and fatigue (10.70%). Serious manifestations including acute coronary disease (4.43%), thromboembolism (3.09%), hypoxemia (3.09%), stroke (1.75%), and myocarditis (0.12%) were rare. The Delta wave (adjusted hazard ratio [aHR] 0.63, 95% CI 0.49-0.82) and Omicron era (aHR 0.50, 95% CI 0.41-0.62) were associated with lower risk of PASC than the early pandemic period (March 2020-June 2021). Age, obesity, comorbidity burden, race, and hospitalization for acute COVID-19 infection were associated with greater risk of PASC. Glucocorticoid (GC) use (aHR 1.19, 95% CI 1.05-1.34 compared to no use) was associated with greater risk of PASC. Conclusion: Among patients with rheumatic diseases, following their first COVID-19 infection, we found a decreased risk of PASC over calendar time using an EHR-based definition. Aside from GCs, no specific immunomodulatory medications were associated with increased risk, and risk factors were otherwise similar to those seen in the general population.
MeSH term(s)	Humans ; COVID-19/epidemiology ; COVID-19/complications ; Female ; Male ; Middle Aged ; Electronic Health Records ; Rheumatic Diseases/epidemiology ; Rheumatic Diseases/complications ; Aged ; Risk Factors ; SARS-CoV-2 ; Adult ; Autoimmune Diseases/epidemiology ; Autoimmune Diseases/complications ; Post-Acute COVID-19 Syndrome ; Comorbidity
Language	English
Publishing date	2024-05-01
Publishing country	Canada
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	194928-7
ISSN	1499-2752 ; 0315-162X
ISSN (online)	1499-2752
ISSN	0315-162X
DOI	10.3899/jrheum.2023-1092
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Zs.A 1168: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Immunomodulators and risk for breakthrough COVID-19 after third SARS-CoV-2 mRNA vaccine among patients with rheumatoid arthritis: a cohort study.

Schiff, Abigail E / Wang, Xiaosong / Patel, Naomi J / Kawano, Yumeko / Hanberg, Jennifer L / Kowalski, Emily N / Cook, Claire E / Vanni, Kathleen Mm / Qian, Grace / Bade, Katarina J / Saavedra, Alene A / Srivatsan, Shruthi / Williams, Zachary K / Venkat, Rathnam K / Wallace, Zachary S / Sparks, Jeffrey A

Annals of the rheumatic diseases

2024 Volume 83, Issue 5, Page(s) 680–682

MeSH term(s)	Humans ; SARS-CoV-2 ; COVID-19 Vaccines ; Cohort Studies ; mRNA Vaccines ; COVID-19/prevention & control ; Immunologic Factors ; Arthritis, Rheumatoid ; Vaccination ; Antibodies, Viral
Chemical Substances	COVID-19 Vaccines ; mRNA Vaccines ; Immunologic Factors ; Antibodies, Viral
Language	English
Publishing date	2024-04-11
Publishing country	England
Document type	Letter
ZDB-ID	7090-7
ISSN	1468-2060 ; 0003-4967
ISSN (online)	1468-2060
ISSN	0003-4967
DOI	10.1136/ard-2023-225162
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Article ; Online: Comparative Effectiveness of BNT162b2 and mRNA-1273 Vaccines Against COVID-19 Infection Among Patients With Systemic Autoimmune Rheumatic Diseases on Immunomodulatory Medications.

Cook, Claire E / Patel, Naomi J / Fu, Xiaoqing / Wang, Xiaosong / Kawano, Yumeko / Vanni, Kathleen M M / Qian, Grace / Banasiak, Emily / Kowalski, Emily / Choi, Hyon K / Zhang, Yuqing / Sparks, Jeffrey A / Wallace, Zachary S

The Journal of rheumatology

2023 Volume 50, Issue 5, Page(s) 697–703

Abstract: Objective: To compare the effectiveness of mRNA vaccines (BNT162b2 vs mRNA-1273) against coronavirus disease 2019 (COVID-19) infection among patients with systemic autoimmune rheumatic diseases (SARDs) on immunomodulatory medications.: Methods: We ... ...

Abstract	Objective: To compare the effectiveness of mRNA vaccines (BNT162b2 vs mRNA-1273) against coronavirus disease 2019 (COVID-19) infection among patients with systemic autoimmune rheumatic diseases (SARDs) on immunomodulatory medications. Methods: We identified patients with SARDs being treated with disease-modifying antirheumatic drugs (DMARDs) and/or glucocorticoids in the Mass General Brigham healthcare system who received either BNT162b2 or mRNA-1273 as their initial vaccine series. Patients were followed until positive SARS-CoV-2 test, death, or February 22, 2022. We compared the risk of breakthrough infection between BNT162b2 and mRNA-1273 vaccine recipients using time-stratified, overlap propensity score (PS)-weighted Cox proportional hazard models. Results: We identified 9838 patients with SARDs who received BNT162b2 or mRNA-1273. Demographic and clinical characteristics were similar in both groups after overlap weighting: mean age 61 years, 75% female, 52% with rheumatoid arthritis, 74% receiving conventional synthetic DMARDs, and 43% receiving biologic DMARDs. Of 5516 BNT162b2 and 4322 mRNA-1273 recipients, 446 and 329 had a breakthrough infection, respectively. The corresponding time-stratified PS-weighted rate difference of breakthrough infection was 0.71 (95% CI -0.70 to 2.12) per 1000 person-months with a weighted hazard ratio (HR) of 1.12 (95% CI 0.90 to 1.39). When follow-up was censored prior to the Omicron wave, there was a trend toward higher breakthrough risk with BNT162b2 vs mRNA-1273 (weighted HR 1.34, 95% CI 0.91 to 1.98). Conclusion: Among patients with SARDs, the risk of breakthrough COVID-19 infection is similar after receiving either BNT162b2 or mRNA-1273. Patients with SARDs initiating the vaccine series should be encouraged to receive whichever mRNA vaccine is available.
MeSH term(s)	Humans ; Female ; Middle Aged ; Male ; BNT162 Vaccine ; 2019-nCoV Vaccine mRNA-1273 ; COVID-19 ; COVID-19 Vaccines ; SARS-CoV-2 ; mRNA Vaccines ; Antirheumatic Agents ; Arthritis, Rheumatoid
Chemical Substances	BNT162 Vaccine ; 2019-nCoV Vaccine mRNA-1273 (EPK39PL4R4) ; COVID-19 Vaccines ; mRNA Vaccines ; Antirheumatic Agents
Language	English
Publishing date	2023-01-15
Publishing country	Canada
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	194928-7
ISSN	1499-2752 ; 0315-162X
ISSN (online)	1499-2752
ISSN	0315-162X
DOI	10.3899/jrheum.220870
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Zs.A 1168: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Risk factors and outcomes for repeat COVID-19 infection among patients with systemic autoimmune rheumatic diseases: A case-control study.

Kowalski, Emily N / Wang, Xiaosong / Patel, Naomi J / Kawano, Yumeko / Cook, Claire E / Vanni, Kathleen M M / Qian, Grace / Bade, Katarina J / Srivatsan, Shruthi / Williams, Zachary K / Wallace, Zachary S / Sparks, Jeffrey A

Seminars in arthritis and rheumatism

2023 Volume 63, Page(s) 152286

Abstract: Objective: To investigate risk factors and outcomes of repeat COVID-19 infections among patients with systemic autoimmune rheumatic diseases (SARDs).: Methods: We performed a case-control study investigating repeat COVID-19 infection within the Mass ... ...

Abstract	Objective: To investigate risk factors and outcomes of repeat COVID-19 infections among patients with systemic autoimmune rheumatic diseases (SARDs). Methods: We performed a case-control study investigating repeat COVID-19 infection within the Mass General Brigham Health Care System. We systematically identified all SARD patients with confirmed COVID-19 (15/Mar/2020 to 17/Oct/2022). Cases had confirmed repeat COVID-19 infections >60 days apart (index date: repeat COVID-19 date). Controls were matched to cases (up to 3:1) by calendar date of first infection and duration between first COVID-19 infection and index dates. We collected demographics, lifestyle, comorbidities, SARD features, and COVID-19 characteristics at initial infection and index date by medical record review. We used conditional logistic regression to identify associations with repeat COVID-19 infection, adjusting for potential confounders. We described the severity of repeat COVID-19 infection among cases. Results: Among 2203 SARD patients with COVID-19, we identified 76 cases with repeat COVID-19 infection (80.3 % female) and matched to 207 matched controls (77.8 % female) with no repeat infection. At first infection, cases were younger (mean 49.5 vs. 60.3 years, p < 0.0001), less likely to have hypertension (32.9 % vs. 45.9 %, p = 0.050), and less likely to have been hospitalized for COVID-19 (13.2 % vs. 24.6 %, p = 0.037) than controls. At index date, cases were more likely than controls to be rituximab users (18.4 % vs. 6.3 %, p = 0.0021). In the multivariable model, younger age (OR 0.67 per 10 years, 95 %CI 0.54-0.82), rituximab use vs. non-use (OR 3.38, 95 %CI 1.26-9.08), and methotrexate use vs. non-use (OR 2.24, 95 %CI 1.08-4.61) were each associated with repeat COVID-19 infection. Among those with repeat COVID-19 infection, 5/76 (6.6 %) were hospitalized and there were no deaths. Conclusion: Younger age, rituximab, and methotrexate were each associated with repeat COVID-19 infection risk among patients with SARDs. Reassuringly, there were no deaths, and the hospitalization rate was low among those with repeat COVID-19 infection.
MeSH term(s)	Humans ; Female ; Child ; Male ; COVID-19 ; Case-Control Studies ; Methotrexate ; Rituximab ; Rheumatic Diseases/complications ; Rheumatic Diseases/drug therapy ; Rheumatic Diseases/epidemiology ; Risk Factors ; Autoimmune Diseases/complications ; Autoimmune Diseases/epidemiology
Chemical Substances	Methotrexate (YL5FZ2Y5U1) ; Rituximab (4F4X42SYQ6)
Language	English
Publishing date	2023-10-29
Publishing country	United States
Document type	Journal Article
ZDB-ID	120247-9
ISSN	1532-866X ; 0049-0172
ISSN (online)	1532-866X
ISSN	0049-0172
DOI	10.1016/j.semarthrit.2023.152286
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Article ; Online: Humoral immunity to an endemic coronavirus is associated with postacute sequelae of COVID-19 in individuals with rheumatic diseases.

Herman, Jonathan D / Atyeo, Caroline / Zur, Yonatan / Cook, Claire E / Patel, Naomi J / Vanni, Kathleen M / Kowalski, Emily N / Qian, Grace / Srivatsan, Shruthi / Shadick, Nancy A / Rao, Deepak A / Kellman, Benjamin / Mann, Colin J / Lauffenburger, Douglas / Wallace, Zachary S / Sparks, Jeffrey A / Alter, Galit

Science translational medicine

2023 Volume 15, Issue 712, Page(s) eadf6598

Abstract: Beyond the acute illness caused by severe acute respiratory coronavirus 2 (SARS-CoV-2) infection, about one-fifth of infections result in long-term persistence of symptoms despite the apparent clearance of infection. Insights into the mechanisms that ... ...

Abstract	Beyond the acute illness caused by severe acute respiratory coronavirus 2 (SARS-CoV-2) infection, about one-fifth of infections result in long-term persistence of symptoms despite the apparent clearance of infection. Insights into the mechanisms that underlie postacute sequelae of COVID-19 (PASC) will be critical for the prevention and clinical management of long-term complications of COVID-19. Several hypotheses have been proposed that may account for the development of PASC, including persistence of virus and dysregulation of immune responses. Among the immunological changes noted in PASC, alterations in humoral immunity have been observed in some patient subsets. To begin to determine whether SARS-CoV-2- or other pathogen-specific humoral immune responses evolve uniquely in PASC, we performed comprehensive antibody profiling against SARS-CoV-2, a panel of endemic pathogens, and a panel of routine vaccine antigens using systems serology in two cohorts of patients with preexisting systemic autoimmune rheumatic disease (SARD) who either developed or did not develop PASC. A distinct qualitative shift observed in Fcγ receptor (FcγR) binding was observed in individuals with PASC. Specifically, individuals with PASC harbored weaker FcγR-binding anti-SARS-CoV-2 antibodies and stronger FcγR-binding antibody responses against the endemic coronavirus OC43. Individuals with PASC developed an OC43 S2-specific antibody response with stronger FcγR binding, linked to cross-reactivity across SARS-CoV-2 and common coronaviruses. These findings identify previous coronavirus imprinting as a potential marker for the development of PASC in individuals with SARDs.
MeSH term(s)	Immunity, Humoral ; Rheumatic Diseases/complications ; Rheumatic Diseases/immunology ; SARS-CoV-2/immunology ; Humans ; Male ; Female ; Middle Aged ; Aged ; Post-Acute COVID-19 Syndrome/complications ; Post-Acute COVID-19 Syndrome/immunology ; Endemic Diseases ; Receptors, Fc/metabolism ; Antibodies, Viral/blood ; Antibodies, Viral/immunology ; Spike Glycoprotein, Coronavirus/immunology
Chemical Substances	Receptors, Fc ; Antibodies, Viral ; spike protein, SARS-CoV-2 ; Spike Glycoprotein, Coronavirus
Language	English
Publishing date	2023-09-06
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2518854-9
ISSN	1946-6242 ; 1946-6234
ISSN (online)	1946-6242
ISSN	1946-6234
DOI	10.1126/scitranslmed.adf6598
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Article ; Online: Associations of DMARDs with post-acute sequelae of COVID-19 in patients with systemic autoimmune rheumatic diseases: a prospective study.

Venkat, Rathnam K / Wang, Xiaosong / Patel, Naomi J / Kawano, Yumeko / Schiff, Abigail / Kowalski, Emily N / Cook, Claire E / Vanni, Kathleen M M / Qian, Grace / Bade, Katarina J / Saavedra, Alene / Srivatsan, Shruthi / Williams, Zachary K / Wallace, Zachary S / Sparks, Jeffrey A

Rheumatology (Oxford, England)

2023

Abstract: Objective: We investigated the baseline disease-modifying antirheumatic drug (DMARD) use and post-acute sequelae of COVID-19 (PASC) risk among patients with systemic autoimmune rheumatic diseases (SARDs).: Methods: Patients with SARDs and confirmed ... ...

Abstract	Objective: We investigated the baseline disease-modifying antirheumatic drug (DMARD) use and post-acute sequelae of COVID-19 (PASC) risk among patients with systemic autoimmune rheumatic diseases (SARDs). Methods: Patients with SARDs and confirmed COVID-19 infection at Mass General Brigham completed a survey ≥28 days after positive PCR/Antigen test to prospectively investigate their COVID-19 courses. We investigated DMARD use at COVID-19 onset and PASC risk. PASC was defined as any COVID-19 symptom that persisted for ≥28 days. We used logistic regression to estimate odds ratios (OR) for PASC by DMARD class. We also used restricted mean survival time to determine the difference in symptom-free days by DMARD class in the 28-day period after infection. Results: We analyzed 510 patients with SARDs and COVID-19 from 11/Mar/2021-17/Jun/2023; 202 (40%) developed PASC. CD20 inhibitor (CD20i) users had significantly higher odds of developing PASC vs csDMARD users (adjusted OR 2.69, 95%CI 1.23-5.88). IL-12/23, IL-17A, or IL-23 inhibitor (IL-12/23i, IL-17Ai, IL-23i) users also had significantly higher odds of PASC (adjusted OR 3.03, 95%CI 1.08-8.49). CD20i users had significantly fewer symptom-free days vs csDMARD users (adjusted -4.12, 95%CI -7.29 to -0.94). Conclusion: CD20i users had significantly higher odds of PASC and fewer symptom-free days over the 28 days following COVID-19 diagnosis compared with csDMARD users. Further research is needed to investigate whether PASC risk in CD20i users may be due to prolonged infection or other immune mechanisms. The association of IL-12/23i, IL-17Ai, and IL-23i and PASC calls for additional study.
Language	English
Publishing date	2023-12-09
Publishing country	England
Document type	Journal Article
ZDB-ID	1464822-2
ISSN	1462-0332 ; 1462-0324
ISSN (online)	1462-0332
ISSN	1462-0324
DOI	10.1093/rheumatology/kead662
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Article: Immunomodulators and risk for breakthrough infection after third COVID-19 mRNA vaccine among patients with rheumatoid arthritis: A cohort study.

Schiff, Abigail E / Wang, Xiaosong / Patel, Naomi J / Kawano, Yumeko / Kowalski, Emily N / Cook, Claire E / Vanni, Kathleen M M / Qian, Grace / Bade, Katarina J / Saavedra, Alene A / Srivatsan, Shruthi / Williams, Zachary K / Venkat, Rathnam K / Wallace, Zachary S / Sparks, Jeffrey A

medRxiv : the preprint server for health sciences

2023

Abstract: Objectives: To investigate COVID-19 breakthrough infection after third mRNA vaccine dose among patients with RA by immunomodulator drug class, and we hypothesized that CD20 inhibitors (CD20i) would have higher risk for breakthrough COVID-19 vs. TNF ... ...

Abstract	Objectives: To investigate COVID-19 breakthrough infection after third mRNA vaccine dose among patients with RA by immunomodulator drug class, and we hypothesized that CD20 inhibitors (CD20i) would have higher risk for breakthrough COVID-19 vs. TNF inhibitors (TNFi). Methods: We performed a retrospective cohort study investigating breakthrough COVID-19 among RA patients at Mass General Brigham in Boston, MA, USA. Patients were followed from the date of 3rd vaccine dose until breakthrough COVID-19, death, or end of follow-up (18/Jan/2023). Covariates included demographics, lifestyle, comorbidities, and prior COVID-19. We used Cox proportional hazards models to estimate breakthrough COVID-19 risk by immunomodulator drug class. We used propensity score (PS) overlap-weighting to compare users of CD20i vs. TNFi. Results: We analyzed 5781 patients with RA that received 3 mRNA vaccine doses (78.8% female, mean age 64.2 years). During mean follow-up of 12.8 months, 1173 (20.2%) had breakthrough COVID_19. Use of CD20i (adjusted HR 1.74, 95%CI 1.30-2.33) and glucocorticoid monotherapy (adjusted HR 1.47, 95%CI 1.09-1.98) were each associated with breakthrough COVID-19 compared to TNFi use. In the PS overlap-weighted analysis, CD20i users also had higher breakthrough COVID-19 risk than TNFi users (HR 1.62, 95%CI 1.02-2.56). A sensitivity analysis excluding patients with cancer or interstitial lung disease yielded similar findings. Conclusions: We identified CD20i and glucocorticoid monotherapy as risk factors for breakthrough COVID-19 among patients with RA after a 3rd vaccine dose. This contemporary study highlights the real-world impact of blunted immune responses in these subgroups and the need for effective risk mitigation strategies.
Language	English
Publishing date	2023-10-09
Publishing country	United States
Document type	Preprint
DOI	10.1101/2023.10.08.23296717
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Article ; Online: Effectiveness of a fourth dose of COVID-19 mRNA vaccine in patients with systemic autoimmune rheumatic diseases using disease-modifying antirheumatic drugs: an emulated target trial.

Hanberg, Jennifer S / Fu, Xiaoqing / Wang, Xiaosong / Patel, Naomi J / Kawano, Yumeko / Schiff, Abigail / Kowalski, Emily N / Cook, Claire E / Vanni, Kathleen M M / Guzzo, Krishan / Qian, Grace / Bade, Katarina J / Saavedra, Alene / Venkat, Rathnam / Srivatsan, Shruthi / Zhang, Yuqing / Sparks, Jeffrey A / Wallace, Zachary S

The Lancet. Rheumatology

2023 Volume 6, Issue 1, Page(s) e21–e30

Abstract: Background: Patients with systemic autoimmune rheumatic diseases using disease-modifying antirheumatic drugs (DMARDs) might have blunted responses to COVID-19 vaccines. The initial mRNA vaccine series is defined as three doses for this population and a ... ...

Abstract	Background: Patients with systemic autoimmune rheumatic diseases using disease-modifying antirheumatic drugs (DMARDs) might have blunted responses to COVID-19 vaccines. The initial mRNA vaccine series is defined as three doses for this population and a fourth booster dose is recommended. The effectiveness of the fourth dose in patients with systemic autoimmune rheumatic diseases using DMARDs is not well established. We aimed to assess the effectiveness of receiving versus not receiving a fourth dose of COVID-19 mRNA vaccine using a target trial framework, in a cohort of patients with systemic autoimmune rheumatic diseases receiving DMARD therapy. Methods: We conducted an emulated target trial using observational data from the Mass General Brigham health-care system to compare receiving versus not receiving a fourth mRNA vaccine dose. Analysed patients had systemic autoimmune rheumatic diseases, were prescribed DMARDs, and were eligible for a fourth dose of BNT162b2 or mRNA-1273 vaccines between Jan 16 and June 11, 2022. To account for temporal changes, the study period was divided into 1-week intervals. Fourth-dose-exposed patients were included in a 1-week interval if they received a fourth mRNA dose in that interval; fourth-dose-unexposed patients were eligible for but had not received the fourth dose of the vaccine. The primary outcome was a SARS-CoV-2 infection; the secondary outcome was severe SARS-CoV-2 infection (ie, admission to hospital or death within -3 to +14 days of a positive test). We assessed the effectiveness of the fourth dose using time-stratified, overlap propensity score-weighted Cox regression models. Findings: We included 4305 patients, 3126 of whom received a fourth dose of vaccine and 1179 who had not. The median follow-up time was 135 days (IQR 112-154) among patients who had received a fourth dose and 65 days (30-156) among patients who had not received a fourth dose. After overlap weighting in both groups, 1863 (72·7%) of 2563 participants were women, 700 (27·3%) were men, and 2242 (87·5%) were White. Rheumatoid arthritis was present in 1392 (54·3%) of 2563 participants; the most frequent treatments were conventional synthetic DMARDs (1489 [58·1%]) or biological DMARDs (1007 [39·3%]). SARS-CoV-2 infection risk was lower among patients receiving versus not receiving a fourth dose of vaccine (HR 0·59 [95% CI 0·47-0·74]). A fourth dose reduced the risk of admission to hospital or death within -3 to +14 days of SARS-CoV-2 infection (0·35 [0·14-0·85]). Interpretation: In this emulated target trial, a fourth dose of COVID-19 mRNA vaccine reduced the risk of SARS-CoV-2 infection and severe COVID-19 among patients with systemic autoimmune rheumatic diseases using DMARDs during the Omicron era. Patients with systemic autoimmune rheumatic diseases should be encouraged to remain up-to-date with COVID-19 vaccinations. Funding: The National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
MeSH term(s)	Female ; Humans ; Male ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid ; BNT162 Vaccine ; COVID-19/prevention & control ; COVID-19 Vaccines ; mRNA Vaccines ; RNA, Messenger ; SARS-CoV-2 ; United States
Chemical Substances	Antirheumatic Agents ; BNT162 Vaccine ; COVID-19 Vaccines ; mRNA Vaccines ; RNA, Messenger
Language	English
Publishing date	2023-11-15
Publishing country	England
Document type	Clinical Trial ; Journal Article
ISSN	2665-9913
ISSN (online)	2665-9913
DOI	10.1016/S2665-9913(23)00272-2
Database	MEDical Literature Analysis and Retrieval System OnLINE

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