Adverse Events and Serological Responses After SARS-CoV-2 Vaccination in Individuals With Inflammatory Bowel Disease.

INTRODUCTION: We determined adverse events after 4 doses of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccine in those with inflammatory bowel disease (IBD), associations between antibodies and injection site reactions (ISR), and risk of IBD flare. METHODS: Individuals with IBD were interviewed for adverse events to SARS-CoV-2 vaccine. Multivariable linear regression assessed the association between antibody titers and ISR. RESULTS: Severe adverse events occurred in 0.03%. ISR were significantly associated with antibody levels after the fourth dose (geometric mean ratio = 2.56; 95% confidence interval 1.18-5.57). No cases of IBD flare occurred. DISCUSSION: SARS-CoV-2 vaccines are safe for those with IBD. ISR after the fourth dose may indicate increased antibodies.

Outcomes associated with antiphospholipid antibodies in COVID-19: A prospective cohort study.

Background: The significance of antiphospholipid antibodies (aPL) in COVID-19 remains uncertain. Objectives: We determined whether aPL are associated with COVID-19 and/or thrombosis or adverse outcomes during hospitalization for COVID-19. Methods: Symptomatic adults tested for SARS-CoV-2 for clinical reasons (March-July 2020) with either ≥1 positive polymerase chain reaction (COVID-19+) or all negative (non-COVID-19) results were recruited to a biobank collecting plasma, clinical data, and outcomes. We tested baseline plasma samples (days 0-7) of all subjects (and day-30 samples in the COVID-19+ subjects, when available) for aPL (anticardiolipin immunoglobulin [Ig]M/IgG, anti-ß2-glycoprotein I IgM/IgG, antiphosphatidylserine/prothrombin IgM/IgG, and lupus anticoagulant). We compared the baseline prevalence of aPL between the COVID-19+ and non-COVID-19 subjects. Among hospitalized COVID-19+ subjects, multivariable logistic regression was used to evaluate the association of aPL (and their subtypes) with arterial or venous thromboembolic events, acute kidney injury, intensive care unit admission, mechanical ventilation, and death after adjusting for potential confounders. Results: At baseline, 123 of 289 (43%) COVID+ subjects had ≥1 aPL versus 116 of 261 (32%) non-COVID-19 subjects (difference, 10%; 95% CI, 3%-18%). Among 89 COVID+ subjects with repeated samples, aPL persisted on day 30 in 15 of 34 (44%) subjects with baseline aPL positivity, and half of those without aPL at baseline developed one or more new aPL. In hospitalized COVID-19 subjects (n = 241), baseline aPL positivity was associated with acute kidney injury (odds ratio [OR], 1.8; 95% CI, 1.1-3.2) and mechanical ventilation (OR, 3.2; 95% CI, 1.5-6.8) but not death (OR, 1.2; 95% CI, 0.6-2.5). In secondary analyses, medium-to-high titers of anticardiolipin IgG (>40) were associated with thromboembolic events (OR, 7.3; 95% CI, 1.8-30.1). Conclusion: In patients with COVID-19, aPL may help identify an increased risk of thrombosis and other adverse outcomes.

Understanding COVID-19 Risk in Patients With Immune-Mediated Inflammatory Diseases: A Population-Based Analysis of SARS-CoV-2 Testing.

OBJECTIVE: To investigate the incidence of and factors associated with SARS-CoV-2 testing and infection in immune-mediated inflammatory disease (IMID) patients versus matched non-IMID comparators from the general population. METHODS: We conducted a population-based, matched cohort study among adult residents from Ontario, Canada, from January 2020 to December 2020. We created cohorts for the following IMIDs: rheumatoid arthritis (RA), psoriasis, psoriatic arthritis, ankylosing spondylitis, systemic autoimmune rheumatic diseases, multiple sclerosis (MS), iritis, inflammatory bowel disease (IBD), polymyalgia rheumatica, and vasculitis. Each patient was matched with 5 patients without IMIDs based on sociodemographic factors. We estimated the incidence of SARS-CoV-2 testing and infection in IMID patients and non-IMID patients. Multivariable logistic regressions assessed odds of SARS-CoV-2 infection. RESULTS: We studied 493,499 patients with IMIDs and 2,466,946 patients without IMIDs. Patients with IMIDs were more likely to have at least 1 SARS-CoV-2 test versus patients without IMIDs (27.4% versus 22.7%), but the proportion testing positive for SARS-CoV-2 was identical (0.9% in both groups). Overall, IMID patients had 20% higher odds of being tested for SARS-CoV-2 (odds ratio 1.20 [95% confidence interval 1.19-1.21]). The odds of SARS-CoV-2 infection varied across IMID groups but was not significantly elevated for most IMID groups compared with non-IMID comparators. The odds of SARS-CoV-2 infection was lower in IBD and MS and marginally higher in RA and iritis. CONCLUSION: Patients across all IMIDs were more likely to be tested for SARS-CoV-2 versus those without IMIDs. The risk of SARS-CoV-2 infection varied across disease subgroups.

Systemic Lupus Erythematosus Risk: The Role of Environmental Factors.

Systemic lupus erythematosus (SLE) is a complex, chronic autoimmune disease. The etiology of SLE is multifactorial and includes potential environmental triggers, which may occur sequentially (the "multi-hit" hypothesis). This review focuses on SLE risk potentially associated with environmental factors including infections, the microbiome, diet, respirable exposures (eg, crystalline silica, smoking, air pollution), organic pollutants, heavy metals, and ultraviolet radiation.

Preferences for COVID-19 Vaccination in People With Chronic Immune-Mediated Inflammatory Diseases.

OBJECTIVE: To understand how people with chronic immune-mediated inflammatory diseases (IMIDs) trade off the benefits and risks of coronavirus disease 2019 (COVID-19) vaccine options. METHODS: We conducted an online discrete-choice experiment in people with IMIDs to quantify the relative importance (RI) of attributes relevant to COVID-19 vaccination. Participants were recruited between May and August 2021 through patient groups and clinics in Canada, and completed 10 choices where they selected 1 of 2 hypothetical vaccine options or no vaccine. The RI of each attribute was estimated and heterogeneity was explored through latent class analysis. RESULTS: The survey was completed by 551 people (89% female, mean age 46 yrs) with a range of IMIDs (inflammatory bowel disease [48%], rheumatoid arthritis [38%], systemic lupus erythematosus [16%]). Most had received 1 (94%) or 2 (64%) COVID-19 vaccinations. Across the ranges of levels considered, vaccine effectiveness was most important (RI = 66%), followed by disease flare (21%), rare but serious risks (9%), and number/timing of injections (4%). Patients would accept a risk of disease flare requiring a treatment change of ≤ 8.8% for a vaccine with a small absolute increase in effectiveness (10%). Of the 3 latent classes, the group with the greatest aversion to disease flare were more likely to be male and have lower incomes, but this group still valued effectiveness higher than other attributes. CONCLUSION: Patients perceived the benefits of COVID-19 vaccination to outweigh rare serious risks and disease flare. This supports COVID-19 vaccine strategies that maximize effectiveness, while recognizing the heterogeneity in preferences that exists.

SARS-CoV-2 vaccine safety and side effects in people with SLE

BackgroundPeople with SLE (and their doctors) are concerned about the risk of COVID-19 infection, yet some patients still harbor concerns regarding vaccination. The first mRNA SARS-CoV-2 vaccines were not studied in this population.1, 2 To address this knowledge gap, we evaluated the safety and side effects of mRNA SARS-CoV-2 vaccines in people with SLE.MethodsAt a Canadian tertiary care centre, we studied SLE cohort patients who were followed with standardized annual assessments. From January 2021 to May 2022, 345 SLE patients consecutively seen for their annual research visit reported information on SARS-CoV-2 vaccinations. We performed descriptive data analysis on the type of vaccination received, side effects, ER visits, and hospitalizations.ResultThe patients were mostly female (n=306, 88.7%) and Caucasian (n=209, 60.6%) and the average SLE duration was 19.7 years (SD 11.9). Most patients (n=298, 86.4%) had received at least one SARS- CoV-2 vaccination and 248 (71.9%) has received at least 2 doses. Specifically, 50 (14.5%) had received one dose, 150 (43.5%) had received 2 doses and 98 (28.4%) had received at least 3. Most (n=181, 60.7%) of initial doses were Pfizer, followed by Moderna (n=54, 18.1%), AstraZeneca (n=12, 4.0%) and Johnson & Johnson (n=1, 0.3%). (The remaining (n=50, 16.8%) were unknown type.) About two-thirds (n=159, 63.3%) of the second doses were Pfizer, and 49 (19.5%) were Moderna.Among those receiving at least 1 vaccination dose, 34 of 128 patients who responded to the question reported symptoms post-vaccine (26.6%). The most common symptoms were fever and injection- related arm pain;both were reported at equal frequency (n=9, 7.0%). Other symptoms were fatigue and headache (n=6, 4.6% for both). There were 3 cases of myalgia and 2 cases of arthralgia. One patient reported hypertension after the first dose of vaccine which required a short 24h ER visit. The remaining did not specify their symptoms. No patients reported disease flare in the post vaccination period.Amongst those who provided information about SARS-CoV-2 infection (n=243), 19.3% reported testing positive for SARS-CoV-2. Only one patient required hospitalization for SARS-CoV-2 infection and was vaccine naïve at the time.ConclusionSARS-CoV-2 mRNA vaccine side effects in this SLE population were reported in about a quarter of subjects but symptoms were mild, similar to reports in the general population. We did not detect any side effects requiring hospitalization. Since, in our cohort, the one subject requiring hospitalization for SARS-CoV-2 infection was vaccine-naïve, a benefit for SARS-CoV-2 vaccination in SLE seems evident.ReferencesPolack FP et al;C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid- 19 Vaccine. N Engl J Med. 2020;383(27):2603–2615. doi: 10.1056/NEJMoa2034577.Baden LR et al. COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021;384(5):403–416. doi: 10.1056/NEJMoa2035389.

Adverse Events and Serological Responses Following SARS-CoV-2 Vaccination in Individuals With Inflammatory Bowel Disease

Introduction: The rapid development and distribution of SARS-CoV-2 vaccines has raised concerns surrounding vaccine safety in immunocompromised populations, such as those with inflammatory bowel disease (IBD). Analysis found elevated GMT levels in those with injection site reactions compared to those without injection site reactions following all four doses, with second dose serological responses being statistically significantly different (8614/mL vs 6841 AU/mL [p< 0.05], respectively) (Figure). Participant characteristics and adverse events following first, second, third, and fourth dose of a SARS-CoV-2 vaccine Characteristics Dose 1 (/331) Dose 2 (/331) Dose 3 (/195) Dose 4 (/100) Sex, n (%)  Male  Female 155 (46.8%) 176 (53.2%) 155 (46.8%) 176 (53.2%) 86 (44.1%) 109 (55.9%) 49 (49.0%) 51 (51.0%) Mean age (SD) 52.05 (14.52) 52.05 (14.52) 51.81 (15.20) 57.98 (14.01) IBD Type, n (%)  Crohn’s Disease  Ulcerative Colitis & IBD-U 238 (71.9%) 93 (28.1%) 238 (71.9%) 93 (28.1%) 150 (76.9%) 45 (23.1%) 75 (75.0%) 25 (25.0%) Medication, n (%)  No immunosuppressives  Anti-TNF only†  Immunomodulators only  Vedolizumab only  Ustekinumab only  Tofacitinib only  Combination therapy‡  Oral Corticosteroids 33 (10.0%) 118 (35.7%) 7 (2.1%) 37 (11.2%) 76 (23.0%) 5 (1.5%) 49 (14.8%) 6 (1.8%) 32 (9.7%) 119 (36.0%) 7 (2.1%) 39 (11.8%) 74 (22.4%) 5 (1.5%) 47 (14.2%) 8 (2.4%) 14 (7.2%) 74 (38.0%) 5 (2.6%) 19 (9.7%) 42 (21.5%) < 5 36 (18.5%) < 5 27 (27.0%) 20 (20.0%) < 5 9 (9.0%) 16 (16.0%) — 18 (18.0%) 7 (7.0%) Vaccine Type, n (%)  Pfizer  Moderna  AstraZeneca 271 (81.9%) 45 (13.6%) 15 (4.5%) 275 (83.1%) 49 (14.8%) 7 (2.1%) 179 (91.8%) 16 (8.2%) — 82 (82.0%) 18 (18.0%) — Adverse Events Dose 1 (/331) Dose 2 (/331) Dose 3 (/195) Dose 4 (/100) Injection site, n (%) 250 (75.5%) 231 (70%) 138 (70.8%) 55 (55.0%) Lymph node swelling, n (%) 1 (0.3%) 9 (2.7%) 14 (7.2%) 1 (1.0%) Gastrointestinal, n (%) 17 (5.1%) 16 (4.8%) 6 (3.1%) 2 (2.0%) Fatigue or malaise, n (%) 86 (26.0%) 87 (26.3%) 45 (23.1%) 22 (22.0%) Fever or chills, n (%) 27 (8.2%) 35 (10.6%) 19 (9.7%) 5 (5.0%) Musculoskeletal, n (%) 34 (10.3%) 41 (12.4%) 25 (12.8%) 9 (9.0%) Headache or migraine, n (%) 34 (10.3%) 46 (13.9%) 23 (11.8%) 11 (11.0%) Other, n (%) 16 (4.8%)α 14 (4.2%)β 7 (3.6%)γ 2 (2.0%)δ Any symptoms, n (%) 275 (83.3%) 261 (79.1%) 151 (77.4%) 67 (67.0%) †One of golimumab, adalimumab, or infliximab (originator or biosimilar) ‡Any combination of anti-TNF and one or more of the following therapies: vedolizumab, ustekinumab, tofacitinib, azathioprine, 6-mercaptopurine, or methotrexate αParesthesia, chin swelling, dysgeusia, numbness, hot flashes, irritability, ennui, hyperactivity, brain fog, congestion, dry eyes, sleep trouble, testicular swelling, angioedema, sinus swelling, throat swelling βShingles, hot flashes, brain fog, sleep troubles, rapid heartbeat, forced breathing, congestion, angioedema, throat swelling, leg swelling γHot flashes, brain fog, sleep troubles, sore throat, congestion, angioedema, ITP δParesthesia, sleep troubles

Health information use by patients with systemic lupus erythematosus (SLE) pre and during the COVID-19 pandemic.

OBJECTIVE: We conducted an international survey of patients with SLE to assess their access, preference and trust in various health information sources pre-COVID-19 and during the COVID-19 pandemic. METHODS: Patients with SLE were recruited from 18 observational cohorts, and patients self-reporting SLE were recruited through five advocacy organisations. Respondents completed an online survey from June 2020 to December 2021 regarding the sources of health information they accessed in the 12 months preceding (pre-11 March 2020) and during (post-11 March 2020) the pandemic. Multivariable logistic regressions assessed factors associated with accessing news and social media post-11 March 2020, and self-reporting negative impacts from health information accessed through these sources. RESULTS: Surveys were completed by 2111 respondents; 92.8% were female, 76.6% had postsecondary education, mean (SD) age was 48.8 (14.0) years. Lupus specialists and family physicians were the most preferred sources pre-11 March 2020 and post-11 March 2020, yet were accessed less frequently (specialists: 78.5% pre vs 70.2% post, difference -8.3%, 95% CI -10.2% to -6.5%; family physicians: 57.1% pre vs 50.0% post, difference -7.1%, 95% CI -9.2% to -5.0%), while news (53.2% pre vs 62.1% post, difference 8.9%, 95% CI 6.7% to 11.0%) and social media (38.2% pre vs 40.6% post, difference 2.4%, 95% CI 0.7% to 4.2%) were accessed more frequently post-11 March 2020 vs pre-11 March 2020. 17.2% of respondents reported negative impacts from information accessed through news/social media. Those outside Canada, older respondents or with postsecondary education were more likely to access news media. Those in Asia, Latin America or younger respondents were more likely to access social media. Those in Asia, older respondents, males or with postsecondary education in Canada, Asia or the USA were less likely to be negatively impacted. CONCLUSIONS: Physicians, the most preferred and trusted sources, were accessed less frequently, while news and social media, less trusted sources, were accessed more frequently post-11 March 2020 vs pre-11 March 2020. Increasing accessibility to physicians, in person and virtually, may help reduce the consequences of accessing misinformation/disinformation.

The Impact of COVID-19 on Maternal Mental Health during Pregnancy: A Comparison between Canada and China within the CONCEPTION Cohort.

The effect of the COVID-19 pandemic on maternal mental health has been described in Canada and China but no study has compared the two countries using the same standardized and validated instruments. In this study, we aimed to evaluate and compare the impact of COVID-19 public health policies on maternal mental health between Canada and China, as we hypothesize that geographical factors and different COVID-19 policies are likely to influence maternal mental health. Pregnant persons >18 years old were recruited in Canada and China using a web-based strategy. All participants recruited between 26 June 2020 and 16 February 2021 were analyzed. Self-reported data included sociodemographic variables, COVID-19 experience and maternal mental health assessments (Edinburgh Perinatal Depression Scale (EPDS), Generalized Anxiety Disorders (GAD-7) scale, stress and satisfaction with life). Analyses were stratified by recruitment cohort, namely: Canada 1 (26 June 2020-10 October 2020), Canada 2 and China (11 October 2020-16 February 2021). Overall, 2423 participants were recruited, with 1804 participants within Canada 1, 135 within Canada 2 and 484 in China. The mean EDPS scores were 8.1 (SD, 5.1) in Canada 1, 8.1 (SD, 5.2) in Canada 2 and 7.7 (SD, 4.9) in China (p-value Canada 2/China: p = 0.005). The mean GAD-7 scores were 2.6 (SD, 2.9) in China, 4.3 (SD, 3.8) in Canada 1 (p < 0.001) and 5.8 (SD, 5.2) in Canada 2 (p < 0.001). When adjusting for stress and anxiety, being part of the Chinese cohort significantly increased the chances of having maternal depression by over threefold (adjusted OR 3.20, 95%CI 1.77-5.78). Canadian and Chinese participants reported depressive scores nearly double those of other crises and non-pandemic periods. Lockdowns and reopening periods have an important impact on levels of depression and anxiety among pregnant persons.

High Frequency of COVID-19 Vaccine Hesitancy among Canadians Immunized for Influenza: A Cross-Sectional Survey.

We assessed the frequency and correlates of COVID-19 vaccine hesitancy before Canada's vaccine rollout. A cross-sectional vaccine hesitancy survey was completed by consecutive patients/family members/staff who received the influenza vaccine at McGill University affiliated hospitals. Based on the self-reported likelihood of receiving a future vaccine (scale 0-10), the following three groups were defined: non-hesitant (score 10), mildly hesitant (7.1-9.9), and significantly hesitant (0-7). Factors associated with vaccine hesitancy were assessed with multivariate logistic regression analyses and binomial logistic regression machine learning modelling. The survey was completed by 1793 people. Thirty-seven percent of participants (n = 669) were hesitant (mildly: 315 (17.6%); significantly: 354 (19.7%)). Lower education levels, opposition and uncertainty about vaccines being mandatory, feelings of not receiving enough information about COVID-19 prevention, perceived social pressure to get a future vaccine, vaccine safety concerns, uncertainty regarding the vaccine risk-benefit ratio, and distrust towards pharmaceutical companies were factors associated with vaccine hesitancy. Vaccine safety concerns and opposition to mandatory vaccinations were the strongest correlates of vaccine hesitancy in both the logistic regressions and the machine learning model. In conclusion, in this study, over a third of people immunized for influenza before the COVID-19 vaccine rollout expressed some degree of vaccine hesitancy. Effectively addressing COVID-19 vaccine safety concerns may enhance vaccine uptake.

Vaccine effectiveness against SARS-CoV-2 infection and severe outcomes among individuals with immune-mediated inflammatory diseases tested between March 1 and Nov 22, 2021, in Ontario, Canada: a population-based analysis.

Background: We estimated COVID-19 vaccine effectiveness against SARS-CoV-2 infection and severe COVID-19 outcomes among individuals with immune-mediated inflammatory diseases in Ontario, Canada. Methods: In this population-based analysis, we used a test-negative design across four immune-mediated inflammatory disease population-based cohorts, comprising individuals with rheumatoid arthritis, ankylosing spondylitis, psoriasis, and inflammatory bowel disease. We identified all SARS-CoV-2 tests done in these populations between March 1 and Nov 22, 2021 (a period in which there was rapid uptake of vaccines, and the alpha [B.1.1.7] and delta [B.1.617.2] SARS-CoV-2 variants were predominantly circulating in Canada) and separately assessed outcomes of SARS-CoV-2 infection and severe COVID-19 outcomes (hospitalisation due to COVID-19 and death due to COVID-19) for each disease group. We used multivariable logistic regression to estimate the effectiveness of one, two, and three doses of mRNA-based COVID-19 vaccine (BNT162b2 [Pfizer-BioNTech], or mRNA-1273 [Moderna]) among individuals at the time of SARS-CoV-2 testing. Findings: Between March 1 and Nov 22, 2021, we identified 2127 (5·9%) test-positive cases among 36 145 individuals (26 476 [73·2%] were female and 9669 [26·8%] were male) with rheumatoid arthritis tested, 476 (6·1%) test-positive cases among 7863 individuals (4130 [52·5%] were female and 3733 [47·5%] were male) with ankylosing spondylitis tested, 3089 (6·5%) test-positive cases among 47 199 individuals (26 062 [55·2%] were female and 21 137 [44·8%] were male) with psoriasis tested, and 1702 (5·4%) test-positive cases among 31 311 individuals (17 716 [56·6%] were female and 13 595 [43·4%] were male) with inflammatory bowel disease tested. Adjusted vaccine effectiveness of two doses against infection was 83% (95% CI 80-86) in those with rheumatoid arthritis, 89% (83-93) among those with ankylosing spondylitis, 84% (81-86) among those with psoriasis, and 79% (74-82) among those with inflammatory bowel disease. After two vaccine doses, effectiveness against infection generally peaked 31-60 days after vaccination and waned gradually with each additional month. Vaccine effectiveness against severe outcomes after two doses was 92% (95% CI 88-95) in those with rheumatoid arthritis, 97% (83-99) among those with ankylosing spondylitis, 92% (86-95) among those with psoriasis, and 94% (88-97) among those with inflammatory bowel disease. Vaccine effectiveness after a third dose against infection was similar to or higher than after the second dose (ranging from 76% [47-89] to 96% [72-99]), although due to a paucity of events, estimates could not be calculated for some subgroups for severe outcomes. Interpretation: Two vaccine doses were found to be highly effective against both SARS-CoV-2 infection and severe COVID-19 outcomes in patients with rheumatoid arthritis, ankylosing spondylitis, psoriasis, and inflammatory bowel disease during the study period. Research is needed to determine the durability of effectiveness of three doses over time, particularly against emerging variants. Funding: Public Health Agency of Canada.

The COVID-19 Pandemic Impacted Maternal Mental Health Differently Depending on Pregnancy Status and Trimester of Gestation.

INTRODUCTION: We aimed to measure the impact of the COVID-19 pandemic on maternal mental health, stratifying on pregnancy status, trimester of gestation, and pandemic period/wave. METHODS: Pregnant persons and persons who delivered in Canada during the pandemic, >18 years, were recruited, and data were collected using a web-based strategy. The current analysis includes data on persons enrolled between 06/2020-08/2021. Maternal sociodemographic indicators, mental health measures (Edinburgh Perinatal Depression Scale (EPDS), Generalized Anxiety Disorders (GAD-7), stress) were self-reported. Maternal mental health in pregnant women (stratified by trimester, and pandemic period/wave at recruitment) was compared with the mental health of women who had delivered; determinants of severe depression were identified with multivariate logistic regression models. RESULTS: 2574 persons were pregnant and 626 had already delivered at recruitment. Participants who had delivered had significantly higher mean depressive symptom scores compared to those pregnant at recruitment (9.1 (SD, 5.7) vs. 8.4 (SD, 5.3), p = 0.009). Maternal anxiety (aOR 1.51; 95%CI 1.44-1.59) and stress (aOR 1.35; 95%CI 1.24-1.48) were the most significant predictors of severe maternal depression (EDPS ˃ 13) in pregnancy. CONCLUSION: The COVID-19 pandemic had a significant impact on maternal depression during pregnancy and in the post-partum period. Given that gestational depression/anxiety/stress has been associated with preterm birth and childhood cognitive problems, it is essential to continue following women/children, and develop strategies to reduce COVID-19's longer-term impact.

Characteristics associated with poor COVID-19 outcomes in individuals with systemic lupus erythematosus: data from the COVID-19 Global Rheumatology Alliance.

AIM: To determine characteristics associated with more severe outcomes in a global registry of people with systemic lupus erythematosus (SLE) and COVID-19. METHODS: People with SLE and COVID-19 reported in the COVID-19 Global Rheumatology Alliance registry from March 2020 to June 2021 were included. The ordinal outcome was defined as: (1) not hospitalised, (2) hospitalised with no oxygenation, (3) hospitalised with any ventilation or oxygenation and (4) death. A multivariable ordinal logistic regression model was constructed to assess the relationship between COVID-19 severity and demographic characteristics, comorbidities, medications and disease activity. RESULTS: A total of 1606 people with SLE were included. In the multivariable model, older age (OR 1.03, 95% CI 1.02 to 1.04), male sex (1.50, 1.01 to 2.23), prednisone dose (1-5 mg/day 1.86, 1.20 to 2.66, 6-9 mg/day 2.47, 1.24 to 4.86 and ≥10 mg/day 1.95, 1.27 to 2.99), no current treatment (1.80, 1.17 to 2.75), comorbidities (eg, kidney disease 3.51, 2.42 to 5.09, cardiovascular disease/hypertension 1.69, 1.25 to 2.29) and moderate or high SLE disease activity (vs remission; 1.61, 1.02 to 2.54 and 3.94, 2.11 to 7.34, respectively) were associated with more severe outcomes. In age-adjusted and sex-adjusted models, mycophenolate, rituximab and cyclophosphamide were associated with worse outcomes compared with hydroxychloroquine; outcomes were more favourable with methotrexate and belimumab. CONCLUSIONS: More severe COVID-19 outcomes in individuals with SLE are largely driven by demographic factors, comorbidities and untreated or active SLE. Patients using glucocorticoids also experienced more severe outcomes.

COVID-19 Hospitalizations, Intensive Care Unit Stays, Ventilation, and Death Among Patients With Immune-mediated Inflammatory Diseases Compared to Controls.

OBJECTIVE: To investigate coronavirus disease 2019 (COVID-19) hospitalization risk in patients with immune-mediated inflammatory diseases (IMIDs) compared with matched non-IMID comparators from the general population. METHODS: We conducted a population-based, matched cohort study using health administrative data from January to July 2020 in Ontario, Canada. Cohorts for each of the following IMIDs were assembled: rheumatoid arthritis (RA), psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis, systemic autoimmune rheumatic diseases (SARDs), multiple sclerosis (MS), iritis, inflammatory bowel disease, polymyalgia rheumatica, and vasculitis. Each patient was matched with 5 non-IMID comparators based on sociodemographic factors. We compared the cumulative incidence of hospitalizations for COVID-19 and their outcomes between IMID and non-IMID patients. RESULTS: A total of 493,499 patients with IMID (417 hospitalizations) and 2,466,946 non-IMID comparators (1519 hospitalizations) were assessed. The odds of being hospitalized for COVID-19 were significantly higher in patients with IMIDs compared with their matched non-IMID comparators (matched unadjusted odds ratio [OR] 1.37, adjusted OR 1.23). Significantly higher risk of hospitalizations was found in patients with iritis (OR 1.46), MS (OR 1.83), PsA (OR 2.20), RA (OR 1.42), SARDs (OR 1.47), and vasculitis (OR 2.07). COVID-19 hospitalizations were associated with older age, male sex, long-term care residence, multimorbidity, and lower income. The odds of complicated hospitalizations were 21% higher among all IMID vs matched non-IMID patients, but this association was attenuated after adjusting for demographic factors and comorbidities. CONCLUSION: Patients with IMIDs were at higher risk of being hospitalized with COVID-19. This risk was explained in part by their comorbidities.

Influenza Vaccine Hesitancy and Its Determinants Among Rheumatology Patients.

OBJECTIVE: Patients with rheumatic disease (RD) have an increased risk of influenza and its complications. Despite inactivated influenza vaccine (IIV) recommendations, IIV uptake in patients with RD is suboptimal, a problem of increasing importance in the COVID-19 era. We estimated the frequency of IIV hesitancy and associated factors among Canadian patients with RD. METHODS: A cross-sectional vaccine hesitancy survey was completed by rheumatology clinic patients (November 2019 to January 2020). Patients rated their likelihood of receiving the influenza vaccine (scale of 0-10). We categorized these as follows: likely to refuse (scale of 0-2), uncertain (scale of 3-7), or likely to accept (scale of 8-10). Multivariate logistical regression was used to evaluate factors associated with vaccine hesitancy. RESULTS: A total of 282 patients (63.5% of those approached) completed the survey, with 165 (58.5%) being likely to accept, 67 (23.8%) being likely to refuse, and 50 (17.7%) uncertain. Uncertain patients were younger and more likely to be employed than those in the other two groups. No previous influenza vaccination (odds ratio [OR] 36.6, 95% confidence interval [CI] 5.3-252.9), belief that vaccination should not be mandatory (OR 0.1, 95% CI 0.0-0.7), unwillingness to take time off work to be vaccinated (OR 6.8, 95% CI 1.5-30.6), and distrust in pharmaceutical companies (OR 41.0, 95% CI 5.6-301.5) predicted likeliness to refuse. Reluctance to pay for vaccination (OR 2.8, 95% CI 1.1-7.5) and no previous influenza vaccination (OR 18.9, 95% CI 3.3-109.7) predicted uncertainty. CONCLUSION: More than 40% of rheumatology patients are either likely to refuse or uncertain about receiving IIV. This contributes to suboptimal vaccine coverage in this population. Interventions addressing these concerns are needed, particularly in the COVID-19 era.