Effect of same-arm versus cross-arm administration of sequential doses of BNT162b2 on short-term vaccine effectiveness - A retrospective cohort study.

OBJECTIVE: We sought to test whether administering the second BNT162B2 vaccine dose on the cross-arm or the same arm as the first dose creates a more robust local and systemic immune response leading to favorable clinical results. METHODS: A retrospective cohort study, conducted on all Clalit Health Services members who received the BNT162b2 vaccine between December 2020 and December 2021. The primary endpoint was a positive RT-PCR test for SARS-CoV-2 38 days after the administration of the second dose. RESULTS: During the study, 2,678,226 CHS members received both doses of bnt162b and were eligible for analysis. Of these, 2,367,694 (88.41%) received the first two doses of the vaccine on the same arm. The primary endpoint was observed in 2061 (0.077%) participants. The primary endpoint was observed less frequently in the same-arm vs. the cross-arm group (1760/2365934 and 301/310231 respectively) with an adjusted odds ratio of 0.83 (95% CI 0.73-0.94 P=0.004). CONCLUSIONS: Administration of the first and second BNT162b2 doses in the same arm might increase vaccine effectiveness in the short term, possibly due to more robust local lymph node activation. This easy intervention could have a public health impact and on the implementation of future mRNA vaccines. Further studies are needed to assess the long-term effectiveness of our findings.

Nineteen months into the pandemic, what have we learned about COVID-19-related outcomes in patients with psoriasis?

BACKGROUND: The impact of psoriasis on the outcomes of Coronavirus disease 2019 (COVID-19) is yet to be precisely delineated. OBJECTIVES: To assess the risk of COVID-19, COVID-19-associated hospitalization, and mortality among patients with psoriasis as compared with age-, sex-, and ethnicity-matched control subjects. In addition, we aim to delineate determinants of COVID-19-associated hospitalization and mortality in patients with psoriasis. METHODS: A population-based retrospective cohort study was performed to longitudinally follow patients with psoriasis and their matched controls with regard to COVID-19-related outcomes. The risk of COVID-19 infection, COVID-19-associated hospitalization, and mortality were assessed using uni- and multi-variable Cox regression analyses. Determinants of COVID-19-associated hospitalization and mortality were evaluated using multivariable logistic regression analysis. RESULTS: The study population included 144 304 patients with psoriasis and 144 304 age- and sex-matched control individuals. Patients with psoriasis displayed a slightly elevated risk of SARS-CoV-2 infection (fully-adjusted HR, 1.05; 95% CI, 1.03-1.08; p < 0.001). Relative to controls, patients with psoriasis had comparable multivariate risk of COVID-19-associated hospitalization (fully-adjusted HR, 1.08; 95% CI, 0.99-1.18; p = 0.065) and COVID-19-associated mortality (fully-adjusted HR, 0.88; 95% CI, 0.73-1.05; p = 0.162). When evaluating individuals hospitalized due to COVID-19, patients with psoriasis were more likely to have type-2 diabetes mellitus (adjusted OR, 1.24; 95% CI, 1.03-1.50; p = 0.027) and obesity (adjusted OR, 1.37; 95% CI, 1.13-1.65; p = 0.001) relative to controls. CONCLUSIONS: While patients with psoriasis are at a higher risk of contracting SARS-CoV-2 infection, they are not more susceptible to the complications of COVID-19.

Determinants and Effectiveness of BNT162b2 mRNA Vaccination Among Patients with Atopic Dermatitis: A Population-Based Study.

BACKGROUND: The effectiveness of messenger RNA coronavirus disease 2019 (COVID-19) vaccines in patients with atopic dermatitis (AD) is yet to be delineated. It remains largely unknown how AD-related immunosuppressive medications affect the development of vaccine-induced immunity. OBJECTIVE: We aimed to evaluate the prevalence of the BNT162b2 messenger RNA vaccine among patients with AD and to assess its effectiveness in protecting against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, COVID-19-associated hospitalization, and mortality. A specific analysis additionally examined whether AD-related immunosuppressive drugs influenced the effectiveness of the vaccine. METHODS: A population-based cohort study was performed using the database of Clalit Heath Services, Israel, to follow adult patients with AD. Multivariate Cox and logistic regression analyses were utilized to calculate the adjusted hazard ratio (HR) and odds ratio (OR) of the incident outcomes. RESULTS: As of 26 June, 2021, 58,582 (75.4%) out of 77,682 adult patients with AD completed two BNT162b2 vaccine doses in Israel. Adulthood-onset AD (adjusted OR, 1.34; 95% CI 1.28-1.40; p < 0.001) and moderate-to-severe AD (adjusted OR, 1.13; 95% CI 1.05-1.21; p = 0.001) predicted an increased vaccination rate. Vaccinated patients with AD demonstrated a significantly decreased risk of SARS-CoV-2 infection (adjusted HR, 0.20; 95% CI 0.16-0.26; p < 0.001), COVID-19-associated hospitalization (adjusted HR, 0.08; 95% CI 0.04-0.18; p < 0.001), and COVID-19-associated mortality (adjusted HR, 0.04; 95% CI 0.01-0.20; p < 0.001). Exposure to immunosuppressive drugs (n = 597; 0.8% of patients) did not impair the protection against SARS-CoV-2 infection after vaccination (adjusted HR, 0.95; 95% CI 0.13-6.81; p = 0.958). CONCLUSIONS: In patients with AD, COVID-19 vaccination is highly effective for a wide range of COVID-19-related outcomes. Immunosuppressive drugs did not impair the effectiveness of the vaccine in preventing SARS-CoV-2 infection in this retrospective analysis.

Risk of COVID-19 and its complications in patients with atopic dermatitis undergoing dupilumab treatment-a population-based cohort study.

The risk of coronavirus disease (COVID-19) infection and its complications among patients with atopic dermatitis (AD) treated by dupilumab is yet to be determined. We aimed to assess the risk of SARS-CoV-2 infection, COVID-19-associated hospitalization, and mortality among patients with AD treated by dupilumab. A population-based cohort study was conducted to compare AD patients treated by dupilumab (n = 238) with those treated by prolonged systemic corticosteroids (≥ 3 months; n = 1,023), phototherapy (n = 461), and azathioprine or mycophenolate mofetil (MMF; n = 194) regarding the incidence of COVID-19 and its complications. The incidence rate of COVID-19, COVID-19-associated hospitalization, and mortality among patients treated by dupilumab was 70.1 (95% CI, 40.5-116.4), 5.0 (95% CI, 0.3-24.7), and 0.0 per 1,000 person-year, respectively. The use of dupilumab was not associated with an increased risk of SARS-CoV-2 infection [adjusted HR for dupilumab vs. prolonged systemic corticosteroids: 1.13 (95% CI, 0.61-2.09); dupilumab vs. phototherapy: 0.80 (95% CI, 0.42-1.53); dupilumab vs. azathioprine/MMF: 1.10 (95% CI, 0.45-2.65)]. Dupilumab was associated with a comparable risk of COVID-19-associated hospitalization [adjusted HR for dupilumab vs. prolonged systemic corticosteroids: 0.35 (95% CI, 0.05-2.71); dupilumab vs. phototherapy: 0.43 (95% CI, 0.05-3.98); dupilumab vs. azathioprine/MMF: 0.25 (95% CI, 0.02-2.74)]. When applicable, the risk of mortality was not elevated in patients with AD treated by dupilumab [HR for dupilumab vs. prolonged systemic corticosteroids: 0.04 (95% CI, 0.00-225.20)]. To conclude, dupilumab does not impose an increased risk of SARS-CoV-2 infection or COVID-19 complications in patients with AD. Dupilumab should be continued and considered as a safe drug for moderate-to-severe AD during the pandemic.

The Burden of Coronavirus Disease 2019 and Its Complications in Patients With Atopic Dermatitis-A Nested Case-Control Study.

BACKGROUND: The burden of coronavirus disease 2019 (COVID-19) among patients with atopic dermatitis (AD) is poorly understood. OBJECTIVES: The aims of the study were to characterize a large cohort of COVID-19-positive adult patients with AD and to identify predictors of COVID-19-associated hospitalization and mortality. METHODS: A population-based nested case-control study was performed. Multivariable logistic regression was used to evaluate odds ratios and 95% confidence intervals of predictors for COVID-19-associated hospitalization and mortality. RESULTS: Of 78,073 adult patients with AD, 3618 (4.6%) tested positive for COVID-19. Subclinical COVID-19 infection occurred in 3368 (93.1%) of COVID-19-positive patients, whereas 123 (3.4%), 46 (1.3%), 55 (1.5%), and 26 (0.7%) patients developed a mild, moderate, severe, and critical disease, respectively. Altogether, 250 patients (6.0%) were hospitalized, and 40 patients (1.1%) died because of COVID-19 complications. Coronavirus disease 2019-associated hospitalization was independently associated with the intake of extended courses of systemic corticosteroids (adjusted odds ratio, 1.96; 95% confidence interval, 1.23-3.14; P = 0.005). None of AD-related variables independently predicted COVID-19-associated mortality. The presence of comorbid metabolic syndrome, chronic obstructive pulmonary disease, chronic renal failure, and depression projected both COVID-19-associated hospitalization and mortality. CONCLUSIONS: Prolonged systemic corticosteroids during the pandemic are associated with increased odds of COVID-19-associated hospitalization and should be avoided in patients with AD.

Coronavirus Disease 2019 (COVID-19)-Associated Hospitalization and Mortality in Patients with Psoriasis: A Population-Based Study.

BACKGROUND: The impact of immune-related conditions on the outcomes of coronavirus disease 2019 (COVID-19) is poorly understood. Determinants of COVID-19 outcomes among patients with psoriasis are yet to be established. OBJECTIVE: Th objective of this study was to characterize a large cohort of patients with psoriasis with COVID-19 and to identify predictors of COVID-19-associated hospitalization and mortality. METHODS: A population-based nested case-control study was performed using the computerized database of Clalit Health Services, Israel. Multivariable logistic regression was used to estimate odds ratios (ORs) and 95% confidence (CIs) of predictors for COVID-19-associated hospitalization and mortality. RESULTS: The study population included 3151 patients with psoriasis who tested positive for COVID-19. Subclinical COVID-19 infection occurred in 2818 (89.4%) of the patients while 122 (3.9%), 71 (2.3%), 123 (3.9%), and 16 (0.5%) of the patients experienced a mild, moderate, severe, and critical disease, respectively. Overall, 332 (10.5%) patients were hospitalized and 50 (1.6%) patients died because of COVID-19 complications. Intake of methotrexate independently predicted COVID-19-associated hospitalization (adjusted OR 2.30; 95% CI 1.11-4.78; p = 0.025). Use of biologic agents was not associated with COVID-19-associated hospitalization (OR 0.75; 95% CI 0.32-1.73; p = 0.491) or mortality (OR 0.85; 95% CI 0.12-6.21; p = 0.870). Older age, the presence of comorbid cardiovascular diseases, metabolic syndrome, chronic obstructive pulmonary disease, and chronic renal failure independently predicted both COVID-19-associated hospitalization and mortality. CONCLUSIONS: The use of oral methotrexate was associated with an increased odds of COVID-associated hospitalization, whereas the use of biologic drugs was not associated with worse outcomes of COVID-19 among patients with psoriasis.

The risk of COVID-19 in patients with bullous pemphigoid and pemphigus: A population-based cohort study.

BACKGROUND: The burden of COVID-19 in patients with bullous pemphigoid (BP) and pemphigus is yet to be evaluated. OBJECTIVE: To assess the risks of COVID-19 and COVID-19-associated hospitalization and mortality in patients with BP and pemphigus and to delineate determinants of severe COVID-19 illness among these patients. METHODS: A population-based cohort study compared COVID-19 and its complications in patients with BP (n = 1845) and pemphigus (n = 1236) with age-, sex-, and ethnicity-matched control subjects. RESULTS: The risks of COVID-19 (hazard rate [HR], 1.12; 95% confidence interval [CI], 0.72-1.73; P = .691) and COVID-19-associated hospitalization (HR, 1.58; 95% CI, 0.84-2.98; P = .160) was comparable between patients with BP and controls. The risk of COVID-19-associated mortality was higher among patients with BP (HR, 2.82; 95% CI, 1.15-6.92; P = .023). The risk of COVID-19 (HR, 0.81; 95% CI, 0.44-1.49; P = .496), COVID-19-associated hospitalization (HR, 1.41; 95% CI, 0.53-3.76; P = .499), and COVID-19-associated mortality (HR, 1.33; 95% CI, 0.15-11.92; P = .789) was similar in patients with pemphigus and their controls. Systemic corticosteroids and immunosuppressants did not predispose COVID-19-positive BP and pemphigus patients to a more severe illness. LIMITATIONS: Retrospective data collection. CONCLUSIONS: Patients with BP experience increased COVID-19-associated mortality and should be monitored closely. Maintaining systemic corticosteroids and immunosuppressive adjuvant agents during the pandemic is not associated with worse outcomes.

Tumor necrosis factor inhibitors are associated with a decreased risk of COVID-19-associated hospitalization in patients with psoriasis-A population-based cohort study.

The risk of coronavirus disease 2019 (COVID-19) and its complications among patients with psoriasis treated by tumor necrosis factor inhibitors (TNFis) remains to be decisively delineated. We aimed to assess the risk of COVID-19 infection, COVID-19-associated hospitalization, and mortality among Israeli patients with psoriasis treated by TNFi relative to other systemic agents. A population-based cohort study was conducted to compare psoriasis patients treated by TNFi (n = 1943), with those treated by methotrexate (n = 1929), ustekinumab (n = 348), and acitretin (n = 1892) regarding COVID-19 outcomes. Risk of investigated outcomes was assessed using uni- and multi-variate Cox regression analyses. The incidence rate of COVID-19, COVID-19-associated hospitalization, and mortality in the TNFi group was 35.8 (95% CI, 26.1-47.9), 0.8 (95% CI, 0.0-4.2), and 0.0 per 1000 person-years, respectively. Exposure to TNFi was associated with a comparable risk of COVID-19 infection [adjusted hazard ration (HR) for TNFi vs methotrexate: 1.07 (95% CI, 0.67-1.71); TNFi vs ustekinumab: 1.07 (95% CI, 0.48-2.40); TNFi vs acitretin: 0.98 (95% CI, 0.61-1.57)]. TNFi was associated with a decreased risk of COVID-19-associated hospitalization relative to methotrexate (adjusted HR, 0.10; 95% CI, 0.01-0.82) and ustekinumab (adjusted HR, 0.04; 95% CI, 0.00-0.64), but not to acitretin (adjusted HR, 1.00; 95% CI, 0.16-6.16). No significant difference in COVID-19-associated mortality was found between the four different groups. TNFi was associated with a decreased risk of admissions due to COVID-19. Our findings substantiate the continuation of TNFi treatment during the pandemic. TNFi may be positively considered in patients with moderate-to-severe psoriasis warranting systemic treatment during the pandemic.

Risk of COVID-19 infection, hospitalization, and mortality in patients with psoriasis treated by interleukin-17 inhibitors.

BACKGROUND: The risk of the infection and its complications under this drug class remains to be determined. OBJECTIVE: To evaluate the risk of COVID-19, COVID-19-associated hospitalization, and mortality among patients with psoriasis treated by IL-17I. METHODS: A population-based cohort study was performed to compare psoriasis patients treated by IL-17I (n = 680) with those treated by methotrexate (n = 2153) and non-systemic/non-immunomodulatory treatments (n = 138,750) regarding the incidence of COVID-19 and its complications. RESULTS: The use of IL-17I was not associated with an increased risk of COVID-19 infection [adjusted HR for IL-17I vs. methotrexate: 0.91 (95% CI, 0.48-1.72); IL-17I vs. non-systemic/non-immunomodulatory treatments: 0.92 (95% CI, 0.54-1.59)]. IL-17I was associated with comparable risk of COVID-19-associated hospitalization [adjusted HR for IL-17I vs. methotrexate: 0.42 (95% CI, 0.05-3.39); IL-17I vs. non-systemic/non-immunomodulatory treatments: 0.65 (95% CI, 0.09-4.59)] and COVID-19-associated mortality [adjusted HR for IL-17I vs. methotrexate: 7.57 (95% CI, 0.36-157.36); IL-17I vs. non-systemic/non-immunomodulatory treatments: 7.05 (95% CI, 0.96-51.98)]. In a sensitivity analysis, neither secukinumab nor ixekizumab imposed an elevated risk of any of the outcomes of interests. CONCLUSIONS: IL-17I treatment does not confer an increased risk of COVID-19 infection or its complications in patients with psoriasis. Our findings support the continuation of IL-17I treatment during the pandemic.