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In 2020, the International League of Associations for Rheumatology published recommendations for managing psoriatic arthritis (PsA), aiming to adapt the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and the European Alliance of Associations for Rheumatology recommendations to low-income countries. At that time, the paucity of clinical studies examining the management of patients with PsA in Latin America was remarked on by the international working group. Therefore, the primary objective of this systematic literature review was to investigate the main challenges in managing PsA in Latin America as described in recent publications. A systematic literature review of trials reporting at least one challenge/difficulty in the management of PsA in Latin America was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. References published in the PubMed, EMBASE, and LILACS (Latin American and Caribbean Health Sciences Literature) databases between 1980 and February 2023 were included. The selection of references was conducted independently by 2 researchers in the Rayyan Qatar Computing Research Institute program. Two other reviewers independently extracted data. All challenges were noted and categorized into domains. Data analysis was descriptive. The search strategy yielded 2085 references, with 21 studies included in the final analysis. Most studies were conducted in Brazil (66.6%; n = 14) and were observational studies (100%; N = 21). Difficulties faced by PsA patients and physicians included the high incidence of opportunistic infections (described in 42.8% of the publications; n = 9), followed by nonadherence to therapy, discordance between patients and physicians regarding remission rates, low drug persistence, limited access to disease-modifying antirheumatic drugs, issues related to the storage of biologic drugs, elevated cost of biologic drugs, limited access to medical care, diagnostic delay, and the individual- and country-level impact of socioeconomic factors on work- and health-related outcomes. Challenges in the management of PsA in Latin America extend beyond the care of opportunistic infections, encompassing several other socioeconomic factors. More research is needed to better understand the peculiarities of treating PsA in Latin America to improve patient care. PROSPERO identifier: CRD42021228297.

IntroductionThe TNF inhibitors were the first immunobiologicals used to treat rheumatic diseases, but their use is associated with an increased risk of tuberculosis. The primary objective is to estimate the incidence of tuberculosis in patients with rheumatic diseases exposed to anti-TNF therapy. The secondary objectives are to evaluate the incidence of tuberculosis by region and subgroups of diseases, to review the presentation of tuberculosis in these patients, and to assess the time elapsed between onset of anti-TNF therapy and development of active granulomatous disease.MethodsA systematic review of the literature was conducted in MEDLINE, the Cochrane Library, and LILACS. The primary endpoint was described as incidence and secondary outcomes, through subgroup analyses and comparisons of means.ResultsWe included 52 observational studies. Among the exposed patients, 947 cases of tuberculosis were documented (62.2% pulmonary), with a cumulative incidence of 9.62 cases per 1000 patients exposed. TB incidence across different continents was distributed as follows: South America, 11.75 cases/1000 patients exposed; North America, 4.34 cases/1000 patients exposed; Europe, 6.28 cases/1000 patients exposed; and Asia, 13.47 cases/1000 patients exposed. There were no significant differences in TB incidence among the described diseases. The mean time elapsed from start of anti-TNF therapy until the endpoint was 18.05 months.ConclusionThe incidence of TB in patients with rheumatic diseases exposed TNF inhibitor considering all countries was 9.62 cases per 1000 patients exposed. TB incidence was higher in South America and Asia compared with North America and Europe. Most cases occurred in the first XX months of use, and the pulmonary form predominated.Key Points• Higher incidence of tuberculosis in patients exposed to anti-TNF compared with the general population.• Higher incidence of TB in countries of South America and Asia compared with North America and Europe.

Tuberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis. The advent of immunobiologic therapy with TNF inhibitors agents, has been associated with a significant increase in incident cases of tuberculosis in this population. To estimate the incidence of tuberculosis in patients receiving TNF inhibitors therapy for rheumatic diseases. As secondary objectives, we sought to evaluate mortality and the clinical impact of screening for latent tuberculosis infection. This retrospective study included patients with rheumatic diseases of Public Health System from the Brazilian state, a high TB incidence area, who received prescriptions of TNF inhibitors agents between 2006 and 2016. A total of 5853 rheumatic disease patients were included. Patients were predominantly women (68.7%) aged 49.5 (± 14.7) years old. Forty-three cases of TB were found (2.86 cases per 1000 person-years; 18 times higher than in the general population). Adalimumab and certolizumab users presented a higher risk for TB development compared to etanercept users (RR: 3.11, 95%CI 1.16-8.35; 7.47, 95%CI 1.39-40.0, respectively). In a subgroup of patients, screening for latent tuberculosis infection was performed in 86% of patients, and 30.2% had a positive tuberculin skin test. Despite latent TB treatment, TB was diagnosed in 2 out of 74 (2.7%) patients. Overall, TB diagnosis did not increase mortality. In this population-based study of rheumatic disease patients from a high incident area, TNF inhibitor exposure was associated with an 18-time increased TB incidence. Adalimumab and certolizumab were associated with greater and earlier TB diagnosis compared to etanercept.

Patients with systemic vasculitis faced the risk of severe COVID-19 and high mortality during the pandemic. Although SARS-CoV-2 vaccination mitigates these outcomes, vaccine hesitancy persists, and data on immunogenicity and safety in vasculitis is still limited. This study aims to assess response to primary and booster doses of SARS-CoV-2 vaccination in systemic vasculitis. This multicenter cohort study including systemic vasculitis included patients from SAFER study (Safety and Efficacy of COVID-19 Vaccines in Rheumatic Diseases). We evaluated serum IgG levels against the SARS-CoV-2 spike protein receptor-binding domain (IgG anti-RBD) at baseline and 28 days post-vaccination, disease activity scores, new cases of COVID-19 infections, and adverse events. Seventy-three patients with systemic vasculitis were included. Behçet's disease (n=39), Takayasu arteritis (n=15), and antineutrophil cytoplasmic antibody-associated vasculitis (n=14) were the most common vasculitis forms. The majority of the patients had no comorbidities and were in remission. Seventy patients received one, 65 two, and 60 three vaccine doses. ChAdOx1 nCoV-19 (AstraZeneca/Oxford) (n=36) and CoronaVac (Sinovac) (n=25) were primarily the most common vaccines, while BNT162b2 (Pfizer-BioNTech) was usually the booster vaccine. ChAdOx1 nCoV-19 induced higher IgG anti-RBD than CoronaVac after two doses ( =0.002), but this difference disappeared after the booster dose. No differences in vaccine response were noted between heterologous and homologous regimens or vasculitis types. The new cases of COVID-19 (16.9%), hospitalization (1.5%), and mortality (1.5%) rates were relatively low following vaccination. Disease activity remained stable, and adverse events were mostly mild. Only one severe adverse event was observed. Different SARS-CoV-2 vaccines demonstrated immunogenicity and clinical effectiveness in systemic vasculitis. The three-dose schedule was safe without increasing relapse risk.

Background: To prospectively evaluate the safety and clinical impact of SARS-CoV-2 vaccines in patients with systemic lupus erythematosus (SLE). Methods: Subanalysis of the Brazilian multicenter observational study “Safety, Effectiveness and Duration of Immunity after Vaccination against SARS-CoV-2 in Patients with Immune-Mediated Inflammatory Diseases (SAFER)”, which included SLE patients vaccinated with CoronaVac, ChAdOx1, or BNT162b2. Patients with HIV infection, pregnant women, or those with immunosuppression not related to SLE were excluded. Safety data related to adverse events and underlying disease activity were assessed. Additionally, COVID-19 cases were monitored throughout the follow-up period. Results: The study included 373 patients with systemic lupus erythematosus (SLE), with a mean age of 36 years, the majority being women (89.8%). The most common adverse events after SARS-CoV-2 vaccination were injection site reactions and headache, observed both after the first and subsequent doses. The ChAdOx-1 vaccine was associated with a higher frequency of adverse events compared to CoronaVac. At baseline, 38.3% of patients were in remission, 32.8% had low disease activity, and 28.9% had moderate to high activity. Following CoronaVac vaccination, there was an increase in remission rates (from 34.6% to 51.1%) and a significant reduction in moderate to high activity (from 37.6% to 15.0%) after the first dose, with this reduction partially maintained after the second dose. In contrast, patients vaccinated with ChAdOx-1 showed an increase in moderate to high activity (from 14.5% to 38.2% after the first dose), a trend that persisted after the second dose. No statistically significant changes in disease activity were observed among those who received BNT162b2. During follow-up, 44 cases of COVID-19 were reported, all mild, with no deaths or need for intensive care unit admission. Conclusions: Vaccination against SARS-CoV-2 demonstrated a favorable safety profile in patients with SLE, with a low frequency of serious adverse events. While analysis of disease activity revealed variations across vaccine platforms, most notably an increased proportion of moderate to high disease activity among those receiving ChAdOx-1 compared with CoronaVac and BNT162b2, the overall occurrence of COVID-19 during follow-up was limited to mild cases, with no severe outcomes. These findings highlight that, despite potential risks of disease exacerbation, the clear protection against severe COVID-19 supports vaccination as a beneficial strategy for this immunocompromised population.

BackgroundPatients with immune-mediated rheumatic diseases (IMRDs) have been prioritized for COVID-19 vaccination to mitigate the infection severity risks. Patients with rheumatoid arthritis (RA) are at a high risk of severe COVID-19 outcomes, especially those under immunosuppression or with associated comorbidities. However, few studies have assessed the safety of the COVID-19 vaccine in patients with RA.ObjectiveTo evaluate the safety of vaccines against SARS-CoV-2 in patients with RA.MethodsThis data are from the study “Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases,” a Brazilian multicentric prospective phase IV study to evaluate COVID-19 vaccine in IMRDs in Brazil. Adverse events (AEs) in patients with RA of all centers were assessed after two doses of ChAdOx1 (Oxford/AstraZeneca) or CoronaVac (Sinovac/Butantan). Stratification of postvaccination AEs was performed using a diary, filled out daily and returned at the end of 28 days for each dose.ResultsA total of 188 patients with RA were include, 90% female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed, mainly after the first dose. The most common AEs after the first dose were pain at the injection (46,7%), headache (39,4%), arthralgia (39,4%), myalgia (30,5%) and fatigue (26,6%), and ChAdOx1 had a higher frequency of pain at the injection (66% vs 32 %, p < 0.001) arthralgia (62% vs 22%, p < 0.001) and myalgia (45% vs 20%, p < 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection (37%), arthralgia (31%), myalgia (23%), headache (21%) and fatigue (18%). Arthralgia (41,4% vs 25%, p = 0.02) and pain at injection (51,4% vs 27%, p = 0.001) were more common with ChAdOx1. No serious AEs were related. With Regard to RA activity level, no significant difference was observed between the three time periods for both COVID-19 vaccines.ConclusionIn the comparison between the two immunizers in patients with RA, local reactions and musculoskeletal symptoms were more frequent with ChAdOx1 than with CoronaVac, especially after the first dose. In summary, the AE occurred mainly after the first dose, and were mild, like previous data from others immunizing agents in patients with rheumatoid arthritis. Vaccination did not worsen the degree of disease activity.

BackgroundPatients with immune-mediated rheumatic diseases (IMRD) are at increased risk for infections due to both disease-related immune dysregulation and immunosuppressive therapy. Despite the benefits of vaccination, immunization rates in this population remain suboptimal, often due to concerns about safety, efficacy, and their potential for inducing disease flare. Regional-specific guidelines are necessary to address the particular epidemiological issues and aspects of the healthcare systems, especially in countries like Brazil.ObjectiveTo provide updated, evidence-based, and nationally relevant recommendations on vaccination in adult patients with IMRD in Brazil, focusing on immunogenicity, safety and disease activity outcomes.MethodsA multidisciplinary task force from the Brazilian Society of Rheumatology conducted a systematic review and meta-analysis of studies addressing eleven clinical questions related to vaccine safety and efficacy in IMRD. Studies were selected using predefined PICO criteria. Risk of bias was assessed using JBI tools, and the certainty of evidence was evaluated with the GRADE approach. Statements were developed and submitted to a Delphi-based voting process; consensus was achieved if ≥80% of the panelists voted “agree” or “strongly agree” for all the statements.ResultsEleven recommendations were developed based on a systematic review of the literature, with meta-analyses conducted when appropriate. Inactivated vaccines demonstrated a favorable safety profile, with low flare rates and no significant increase in disease activity, even under immunosuppression. Live attenuated vaccines, including yellow fever, were considered safe when administered according to timing protocols. Immunogenicity may be reduced in patients receiving methotrexate, mycophenolate, corticosteroids, rituximab, and JAK inhibitors, although this does not appear to compromise clinical protection in most cases. Temporary treatment interruption was associated with improved immunogenicity in selected contexts, but without consistent evidence of clinical benefit and with potential risks related to disease control. Specific guidance was provided for influenza and hepatitis B vaccination, as well as for prioritizing vaccination before initiating immunosuppression whenever feasible. Statements also addressed the approach to revaccination and post-vaccination serologic testing. Despite the overall very low to moderate certainty of evidence, most recommendations reached strong consensus (≥80% agreement). Shared decision-making and individualized strategies were emphasized across all scenarios.ConclusionThese recommendations offer tailored guidance for improving vaccination strategies in IMRD patients in Brazil. Given the heterogeneity of evidence, clinical decisions should be individualized, considering disease activity, treatment regimen, vaccine availability, and patient preferences. Shared decision-making is essential in all scenarios to enhance vaccine uptake and align preventive care with patient-centered management.

Objective: To evaluate the humoral response to and impact of SARS-CoV-2 vaccination in patients with systemic lupus erythematosus in a multicenter cohort design. Methods: Data for this analysis were obtained from the Study of Safety, Effectiveness and Duration of Immunity after Vaccination against SARS-CoV-2 in Patients with Immune-Mediated Inflammatory Diseases (SAFER), a prospective, multicenter, phase IV, real-world study conducted across different regions of Brazil from June/2021 to March/2024. Patients aged >18 years with systemic lupus erythematosus (SLE) who received any one of the SARS-CoV-2 vaccines approved by the Brazilian health regulatory agency (CoronaVac [inactivated SARS-CoV-2 vaccine], ChAdOx-1 [AstraZeneca], or BNT162b2 [Pfizer-BioNTech]) were included. Immunogenicity was assessed in pre- and post-vaccination blood samples, and patients were monitored in person and remotely for the occurrence and severity of COVID-19. Results: Two hundred and thirty-five patients with SLE who had completed their vaccination schedules (two doses + booster dose) were included in this study. Most patients were female (89.3%) and had low disease activity or were in remission (72.4%); the majority were also on some form of immunosuppressive therapy (58.1%). One hundred and sixteen patients received two doses of CoronaVac followed by one dose of BNT162b2 (Pfizer-BioNTech) vaccine, eighty-seven received two doses of ChAdOx1-S (AstraZeneca) followed by one dose of BNT162b2 (Pfizer-BioNTech) vaccine, and thirty-two received three doses of BNT162b2 (Pfizer-BioNTech) vaccine. Twenty-eight cases of COVID-19, none meeting criteria for severe COVID-19, were recorded in patients with respiratory symptoms after the second dose of a SARS-CoV-2 vaccine. Regarding immunogenicity, an increase in seroconversion rate was observed following consecutive vaccine doses, with no difference between vaccination schedules, reaching 97.57% seropositivity after a booster dose. The geometric mean IgG titers differed between the different vaccination schedules after the first and the second vaccine dose, being lowest for the CoronaVac-based schedule, but titers were similar after the administration of a booster dose. Conclusion: In patients with SLE, SARS-CoV-2 vaccines are immunogenic, inducing a robust humoral response. No severe outcomes associated with death or hospitalization were found in the evaluated patient sample. Complete vaccination schedules including a booster dose induced higher humoral responses than incomplete schedules, especially in patients initially immunized with an inactivated virus vaccine schedule and those with a suboptimal humoral response.

BackgroundThe immune response and safety using different COVID-19 vaccine platforms in patients with immune mediated rheumatic diseases is still uncertain. The objective of this study is to compare the immunogenicity and safety after two doses of BNT162b2, CoronaVac and ChadOx-1 in SLE patients.MethodsProspective study including SLE patients who received a primary schedule to COVID-19 vaccination between May and August 2021. Immunogenicity, events supposedly attributable to vaccination or immunization (ESAVI) and disease activity were assessed at baseline and after each vaccine dose.Results121 SLE patients were included in the cohort, 88 in the immunogenicity analysis and 118 in the safety analysis. The groups were homogenous concerning sex, age, and comorbidities. Seropositivity after two doses of vaccines was similar between CoronaVac (68%), ChadOx1 (80,6%) and BNT162b2 (88%) (p=0.231). However, CoronaVac and ChadOx-1 presented lower titers in comparison with BNT162b2. Regarding ESAVI, the most frequent reported following first and second vaccine doses were, respectively: injection site pain (65.2%/41.1%), headache (50.9%/29.9%) and arthralgia (37.5%/22.5%). Fever and myalgia were more related to ChAdOx1 than CoronaVac (23.3 vs. 5.0%; p=0.025). There was no difference in MEX-SLEDAI between vaccine platforms. No serious ESAVI were reported.ConclusionAfter two doses, the three COVID-19 vaccine platforms induced a significant increase in antibody titers against SARS-CoV-2. Patients who received BNT162b2 exhibited a higher serological response compared to the other vaccines. All three vaccine platforms demonstrated a favorable safety profile, with no serious ESAVI or worsening of disease activity.Clinical trial NumberThe study was registered in The Brazilian Registry of Clinical Trials (ReBEC) in 04/14/2021 with code RBR-108fyykd.

Breakthrough COVID-19 (occurring in fully vaccinated people) has been described. Data on its characteristics among immune-mediated rheumatic disease (IMRD) patients are scarce. This study describes breakthrough COVID-19 occurring in IMRD patients participating in the SAFER-study, a Brazilian multicentric cohort evaluating the safety, effectiveness, and immunogenicity of SARS-CoV-2 vaccines in patients with autoimmune diseases. A descriptive analysis of the population and a binary logistic regression model were performed to evaluate the predictors of COVID-19-related hospitalization. A p-value < 0.05 was significant. The included 160 patients were predominantly females (83.1%), with a mean (SD) age of 40.23 (13.19) years. The patients received two (19%), three (70%), or four (11%) vaccine doses. The initial two-dose series was mainly with ChAdOx1 (Oxford/AstraZeneca) (58%) or BBIBP-CorV (Sinopharm-Beijing) (34%). The first booster (n = 150) was with BNT162b2 (BioNtech/Fosun Pharma/Pfizer) (63%) or ChAdOx1 (29%). The second booster (n = 112) was with BNT162b2 (40%) or ChAdOx1 (26%). The COVID-19 hospitalization rate was 17.5%. IMRD moderate/high activity (OR: 5.84; CI: 1.9–18.5; p = 0.002) and treatment with corticosteroids (OR: 2.94; CI: 1.02–8.49; p = 0.0043) were associated with higher odds of hospitalization, while increasing the number of vaccine doses was protective (OR: 0.37; CI: 0.15–0.9; p = 0.032). These findings, along with previous reassuring results about the safety of the COVID-19 vaccines, argue in favor of booster vaccination in IMRD patients.