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The problem of prevention of coronavirus disease 2019 (COVID-19) in patients with immune-mediated inflammatory rheumatic diseases (IMRD) remains highly relevant. The presence of IRD is associated with a high risk of disease and severe course of COVID-19 during immunosuppressive treatment, primarily anti-B cell therapy with rituximab (RTX), and a low level of post-vaccination response in such patients. A new strategy for the prevention and treatment of COVID-19 are virus-neutralizing monoclonal antibodies to coronavirus;currently, combined long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld) are registered for prevention in the world and the Russian Federation. . Tixagevimab and cilgavimab (TC) show neutralizing activity against SARS-CoV-2, including the Omicron strain, primarily its variants BA.4, BA.5, BA.2.75 ("Centaur"). Objective - to evaluate the efficacy and safety of TC for pre-exposure prophylaxis of COVID-19 in rheumatic patients receiving RTX, based on a prospective observational study. Materials and methods. The main group included 86 patients with various IMRD receiving RTX: 50 of them had ANCA-associated systemic vasculitis (AAV), 15 - rheumatoid arthritis, 9 - Sjogren's syndrome (SS), 4 - IgG4-related disease, 3 - systemic lupus erythematosus (SLE), 3 - dermatomyositis (DM), 2 - systemic scleroderma (SSD). Median age was 59 (19-82) years;male: female ratio - 1:1,8. From March 26 to August 30 2022, patients received a single intramuscular injection of TC in a total dose of 300 mg, mainly after RTX (in 52% of cases, in 28% on the next day after RTX). The control group included 42 patients with AAV (median age - 45 (35-71) years;male: female ratio - 1:1), also treated with RTX, who did not receive pre-exposure prophylaxis of TC. The duration of observation was 7 months, until November 1 2022. At this time, 98% of confirmed cases of coronavirus in the Russian Federation were Omicron. A telephone and/or online survey of patient has been conducted to detect cases of COVID-19 and adverse reactions. Results. In the TC group, confirmed coronavirus infection have been detected in 17 (20%) patients (AAV - 10, SS - 3, SSD - 2, SLE - 1, DM - 1), with fever in 7 (8%), only in one case hospitalization was required (lung damage was not detected in computed tomography), in two cases, according to CT mild lung damage (CT 1-2), there were no deaths. Good TC's tolerability was noted, signs not associated with COVID-19 or progression of IMRD after administration of TC were observed in 8 (9%) patients (GPA - 3 MPA - 1, RA - 2, SLE - 1, IgG4-related disease - 1), adverse reactions definitely associated with the use of TC were not found. The most serious event not associated with coronavirus infection was the progression of polyneuropathy in a patient with RA. In the control group, 3 (7%) patients were diagnosed with COVID-19, one with severe lung injury (CT 3, pulmonary embolism) and death. Conclusions. The data of clinical studies and our own clinical experience evidence the effectiveness of the use of a combination of long-acting monoclonal antibodies TC (Evusheld), registered for indications for pre-exposure prophylaxis and treatment of COVID-19. Patients with IMRD treated with RTX have a favorable safety profile of TC. The introduction of virus-neutralizing monoclonal antibodies, a new drug class for the prevention and treatment of infectious diseases, opens significant prospects for improving the prognosis of patients with IRD.Copyright © 2023 Ima-Press Publishing House. All rights reserved.
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Objectives: To investigate the impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) infection on anti-apolipoprotein A-1 IgG (AAA1) humoral response in immunosuppressed inflammatory rheumatic diseases (IRD) patients. Methods: This is a nested cohort study from the prospective Swiss Clinical Quality Management registry. A total of 368 IRD patients for which serum samples were available before and after the SARS-CoV2 pandemic were included. Autoantibodies against ApoA-1 (AAA1) and its c-terminal region (AF3L1) were measured in both samples. The exposure of interest was anti-SARS-CoV2 spike subunit 1 (S1) seropositivity measured in the second sample. The effect of SARS-CoV2 infection (anti-S1 seropositivity) on becoming AAA1 or AF3L1 positive and on the change of AAA1 or AF3L1 optical density (OD) between the two samples was tested with multivariable regressions. Results: There were 12 out of 368 IRD patients who were seroconverted against S1. The proportion of patients becoming AF3L1 seropositive was significantly higher in anti-S1-positive patients, compared with anti-S1-negative patients (66.7% versus 21.6%, p = 0.001). Adjusted logistic regression analyses indicated that anti-S1 seroconversion was associated with a sevenfold increased risk of AFL1 seropositivity (odds ratio: 7.4, 95% confidence interval (95% CI): 2.1-25.9) and predicted median increase in AF3L1 OD values (+0.17, 95% CI: 0.08-0.26). Conclusions: SARS-CoV2 infection is associated with a marked humoral response against the immunodominant c-terminal region of ApoA-1 in IRD patients. The possible clinical impact of AAA1 and AF3L1 antibodies on disease progression, cardiovascular complications, or long COVID syndrome deserves future investigations.
Subject(s)
COVID-19 , Rheumatic Fever , Humans , SARS-CoV-2 , Apolipoprotein A-I , Post-Acute COVID-19 Syndrome , Prospective Studies , Cohort Studies , Immunoglobulin GABSTRACT
The problem of COVID-19 vaccination in patients with autoimmune inflammatory rheumatic diseases is discussed. There is an increased risk of viral infections in these patients. Attending physicians should provide patients with rheumatic diseases with complete information about the risks and benefits of COVID-19 immunoprophylaxis. The use of immunosuppressive drugs, rather than the diseases themselves, can reduce the level of post-vaccination immune response. This requires choosing the optimal time for carrying out COVID-19 vaccination in this group of patients. Fragments of European and American recommendations on vaccination against COVID-19 in patients with rheumatic diseases are given.Copyright © 2022 Infectious Diseases: News, Opinions, Training.
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In rheumatology, the problem of infectious pathology is quite acute. This is primarily due to the participation of various infectious agents in the development of immuno-inflammatory rheumatic diseases (IIRD), in which microorganisms play a trigger role, triggering the immunopathological mechanisms of inflammation. Vivid examples of such diseases are acute rheumatic fever and reactive arthritis. The infectious etiology of Lyme disease has been proven. An equally difficult task is the fight against comorbid infection (CI), which often complicates the course of many IIRD due to a violation of the immune status caused by both the background disease and the use of immunosuppressive drugs. The predominance of respiratory tract lesions in the structure of CI in patients with IIRD makes it necessary to use influenza and pneumococcal vaccines in them, since the risk of deaths from these infections among these patients is quite high. During the development of the COVID-19 pandemic, which has become a challenge to all mankind, a large number of new fundamental and medical problems have been revealed concerning the relationship between viral infection and many widespread chronic non-communicable diseases, among which IIRDs occupy an important position. As one of the methods of combating the current COVID-19 pandemic, great hopes are pinned on the widespread use of vaccination. The possibility of using monoclonal antibodies for pre-exposure prophylaxis of COVID-19, including in patients with IIRD, is discussed.Copyright © 2023 Ima-Press Publishing House. All rights reserved.
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Introduction: Autoimmune/inflammatory rheumatic diseases (AIRDs) patients might be at-risk of severe COVID-19. However, whether this is linked to the disease or to its treatment is difficult to determine. This study aimed to identify factors associated with occurrence of severe COVID-19 in AIRD patients and to evaluate whether having an AIRD was associated with increased risk of severe COVID-19 or death. Materials and methods: Two databases were analyzed: the EDS (Entrepôt des Données de Santé, Clinical Data Warehouse), including all patients followed in Paris university hospitals and the French multi-center COVID-19 cohort [French rheumatic and musculoskeletal diseases (RMD)]. First, in a combined analysis we compared patients with severe and non-severe COVID-19 to identify factors associated with severity. Then, we performed a propensity matched score case-control study within the EDS database to compare AIRD cases and non-AIRD controls. Results: Among 1,213 patients, 195 (16.1%) experienced severe COVID-19. In multivariate analysis, older age, interstitial lung disease (ILD), arterial hypertension, obesity, sarcoidosis, vasculitis, auto-inflammatory diseases, and treatment with corticosteroids or rituximab were associated with increased risk of severe COVID-19. Among 35,741 COVID-19 patients in EDS, 316 having AIRDs were compared to 1,264 Propensity score-matched controls. AIRD patients had a higher risk of severe COVID-19 [aOR = 1.43 (1.08-1.87), p = 0.01] but analysis restricted to rheumatoid arthritis and spondyloarthritis found no increased risk of severe COVID-19 [aOR = 1.11 (0.68-1.81)]. Conclusion: In this multicenter study, we confirmed that AIRD patients treated with rituximab or corticosteroids and/or having vasculitis, auto-inflammatory disease, and sarcoidosis had increased risk of severe COVID-19. Also, AIRD patients had, overall, an increased risk of severe COVID-19 compares general population.
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Background. Patients with autoimmune and inflammatory rheumatic diseases (AIRDs) are at high risk of developing COVID-19. Vaccination is an effective method of preventing this disease, which may be unsafe for patients with AIRDs. The aim of the study is to assess the safety of Gam-COVID-Vac in patients with IVRD in real clinical practice. Material and methods. A cross-sectional study was carried out. The main group consisted of patients with AIRDs, the control group consisted of individuals without AIRDs. All participants were interviewed by the research physician using a unified questionnaire, additional information was obtained from medical records. Results. The study included 222 patients with AIRDs (119 with rheumatoid arthritis, 36 with ankylosing spondylitis, 17 with psoriatic arthritis, 17 with Sjogren's disease, 10 with undifferentiated spondyloarthritis, 8 with systemic lupus erythematosus, 4 with metabolic arthritis, 3 with systemic scleroderma, 3 with systemic vasculitis, 2 with polymyalgia rheumatica, 2 with undifferentiated systemic connective tissue disease, 1 with adult Still's disease) and 111 patients without AIRDs. The number of patients with AIRDs who had a combination of local and systemic adverse events (AE) on the introduction of the first component of the vaccine was significantly less than in the control group (22.1 and 44.1%, respectively, P<0.001). Similar differences were also noted after the introduction of the second component (14.0 and 29.7%, respectively, P<0.001). AEs such as pain at the injection site without restriction of movement, weakness, fever, arthralgia/myalgia, headache, and chills were significantly more common in the control group after the introduction of the first component of the vaccine. After complete immunization, AEs were absent in 35.6% of patients with AIRDs and in 21.6% of control group patients (P=0.01). Exacerbations of AIRDs and new autoimmune phenomena were not registered in any cases. Conclusions. According to preliminary data, immunization of patients with AIRDs with the Gam-COVID-Vac combined vector vaccine appears to be quite safe.Copyright © Team of Authors, 2022.
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The problem of coronavirus disease 2019 (COVID-19) still remains relevant even now, after two years. As one of the methods of combating the current COVID-19 pandemic, most experts suggest the widespread use of vaccination. The use of anticovid vaccines in patients with rheumatic diseases raises a number of questions related to efficacy, immunogenicity (especially in patients receiving immunosuppressive therapy), as well as safety of immunization. With that in mind, it is very important to analyze the data on the above-mentioned aspects in real time. This review presents the results of studies on COVID-19 vaccination immunogenicity in rheumatology conducted over the past two years. The ability of a number of antirheumatic drugs to have a negative effect (to varying degrees) on the post-vaccination response has been demonstrated. Interpretation and comparison of the results of vaccine immunogenicity studies are complicated by a number of factors usually associated with the design of works. Within the framework of the problem under consideration, there are still a sufficient number of questions, the answers to which should be found in further research.Copyright © Team of Authors, 2022.
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The problem of coronavirus disease 2019 (COVID-19) still remains relevant even now, after two years. As one of the methods of combating the current COVID-19 pandemic, most experts suggest the widespread use of vaccination. The use of anticovid vaccines in patients with rheumatic diseases raises a number of questions related to efficacy, immunogenicity (especially in patients receiving immunosuppressive therapy), as well as safety of immunization. With that in mind, it is very important to analyze the data on the above-mentioned aspects in real time. This review presents the results of studies on COVID-19 vaccination immunogenicity in rheumatology conducted over the past two years. The ability of a number of antirheumatic drugs to have a negative effect (to varying degrees) on the post-vaccination response has been demonstrated. Interpretation and comparison of the results of vaccine immunogenicity studies are complicated by a number of factors usually associated with the design of works. Within the framework of the problem under consideration, there are still a sufficient number of questions, the answers to which should be found in further research.Copyright © Team of Authors, 2022.
ABSTRACT
The problem of coronavirus disease 2019 (COVID-19) still remains relevant even now, after two years. As one of the methods of combating the current COVID-19 pandemic, most experts suggest the widespread use of vaccination. The use of anticovid vaccines in patients with rheumatic diseases raises a number of questions related to efficacy, immunogenicity (especially in patients receiving immunosuppressive therapy), as well as safety of immunization. With that in mind, it is very important to analyze the data on the above-mentioned aspects in real time. This review presents the results of studies on COVID-19 vaccination immunogenicity in rheumatology conducted over the past two years. The ability of a number of antirheumatic drugs to have a negative effect (to varying degrees) on the post-vaccination response has been demonstrated. Interpretation and comparison of the results of vaccine immunogenicity studies are complicated by a number of factors usually associated with the design of works. Within the framework of the problem under consideration, there are still a sufficient number of questions, the answers to which should be found in further research.Copyright © Team of Authors, 2022.
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BACKGROUND: The currently disseminating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic and limited capacities in outpatient rheumatological care, pose questions about possible alternatives to clinical visits, also in view of the digital revolution. It is unclear whether and to what extent patients with inflammatory rheumatic diseases are willing and in a position to deal with the new media, such as video consultation. METHODS: In the middle of the pandemic in May 2020 outpatients were surveyed using a standardized questionnaire in order to document their possibilities and willingness to participate in a video consultation. The treating physicians were asked whether carrying out a video consultation was considered to be a possible and meaningful option. RESULTS: Overall, 232 patients with inflammatory rheumatic diseases were surveyed (64.7% female, average age 54.0⯱ 15.2 years), seropositive (nâ¯= 58) and seronegative (nâ¯= 51) rheumatoid arthritis (RA), spondyloarthritis (SpA, nâ¯= 77) including axial SpA (axSpA) and psoriatic arthropathy (PsA) as well as collagenosis and vasculitis (CoV, nâ¯= 46). The mean duration of disease was 5.5⯱ 8.2 years, whereby in 75 patients (32.3%) it was the first diagnosis. The mean disease activity (0-10, subjective patient self-estimation) was 4.7⯱ 2.5. Overall, 176 patients were basically aware of the possibility to carry out video consultations (75.9%) and 166 considered that they were technically capable to participate (71.6%) but only 131 were principally willing to participate (56.5%). Logistic regression analyses showed that the willingness to participate in video consultations decreased with increasing age (ßâ¯= 0.28, pâ¯= 0.01). According to the medical estimation video consultations were thought to be principally possible for 161 patients for technical reasons (69.4%) and for 127 for medical reasons (54.7%); however, a video consultation within the framework of treatment was only considered to be meaningful by the physician for 76 patients (32.8%). CONCLUSION: Not all patients can or want to participate in video consultations and the willingness declines with increasing age. The estimation of the meaningfulness of video consultations by physicians was also limited to approximately one third of the patients surveyed. This must be taken into consideration for the future planning of video consultations.
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BACKGROUND: Studies of flares of autoimmune inflammatory rheumatic diseases (AIIRD) after COVID-19 mRNA vaccination are limited by small sample size, short follow up or at risk of selection bias. METHODS: A national retrospective cohort study of consecutive AIIRD patients ≥12 years old, across 8 hospitals who received at least one dose of a COVID-19 mRNA vaccine. Patients were included from the date of 1st vaccine dose and censored at the time of flare or on the date of the clinic visit at least 3 months from cohort entry, whichever came first. Predictors of flare were determined by Cox proportional hazards analysis. FINDINGS: 4627 patients (73% Chinese, 71% female) of median (IQR) age 61 (48, 70) years were included; 42% Rheumatoid arthritis, 14% Systemic lupus erythematosus and 11% Psoriatic arthritis. 47% were in remission, 41% low disease activity, 10% moderate disease activity and 1% in high disease activity. 18% patients flared, of which 11.7% were within the 3-month period of interest. 11.8% patients improved. Median (IQR) time-to-flare was 60 (30, 114) days. 25% flares were self-limiting, 61% mild-moderate and 14% severe. Older patients (53-65 years and >66 years) had a lower risk of flare [HR 0.6 (95% CI 0.5-0.8) and 0.7 (0.6-0.8) respectively]. Patients with inflammatory arthritis and with active disease had a higher risk of flare [HR 1.5 (1.2-2.0) and 1.4 (1.2-1.6), respectively]. Treatment with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), immunosuppression and prednisolone was also associated with an increased risk of flare [HR 1.5 (1.1-2), 1.2 (1.1-1.4) and 1.5 (1.2-1.8) for prednisolone ≤7.5 mg respectively]. INTERPRETATION: There was a moderately high rate of AIIRD flares after mRNA vaccination but also improvement in several patients. Severe flares and hospitalisation were rare. Thus, vaccination remains safe and highly recommended.
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Recently, varicella-zoster virus (VZV) reactivation has been observed after the administration of coronavirus disease 2019 (COVID-19) vaccines. Autoimmune inflammatory rheumatic diseases (AIIRDs) patients are at a higher risk for VZV reactivation for immunocompromised status. The study aimed to investigate the adverse events (AEs), especially VZV reactivation, following vaccination against severe acute respiratory syndrome coronavirus-2 in a Chinese cohort of AIIRD patients. A cross-sectional survey using an online questionnaire was conducted among AIIRD patients and healthy controls (HCs). Multivariate logistic regression was used to identify potential factors associated with VZV reactivation. 318 AIIRD patients and 318 age and sex-matched HCs who got COVID-19 inactivated vaccines were recruited. The main AIIRDs are rheumatoid arthritis (31.8%) and systemic lupus erythematous (23.9%). Most of patients (85.5%) had stable disease and 13.2% of them had aggravation after vaccination. Compared to HCs, patients had higher rates of rash (p = 0.001), arthralgia (p < 0.001) and insomnia (p = 0.007). In addition, there were 6 (1.9%) AIIRD patients and 5 (1.6%) HCs reported VZV reactivation after the COVID-19 vaccination (p = 0.761). Multivariate logistic regression analysis illustrated that diabetes mellitus (odd ratio [OR], 20.69; 95% confidence interval [CI], 1.08-396.79; p = 0.044), chronic hepatitis B virus infection (OR, 24.34; 95% CI, 1.27-466.74; p = 0.034), and mycophenolate mofetil (OR, 40.61; 95% CI, 3.33-496.15; p = 0.004) independently identified patients with VZV reactivation. Our findings showed that the inactivated COVID-19 vaccination was safe for AIIRD patients though some patients could suffer from VZV reactivation.
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The problem of COVID-19 vaccination in patients with autoimmune inflammatory rheumatic diseases is discussed. There is an increased risk of viral infections in these patients. Attending physicians should provide patients with rheumatic diseases with complete information about the risks and benefits of COVID-19 immunoprophylaxis. The use of immunosuppressive drugs, rather than the diseases themselves, can reduce the level of post-vaccination immune response. This requires choosing the optimal time for carrying out COVID-19 vaccination in this group of patients. Fragments of European and American recommendations on vaccination against COVID-19 in patients with rheumatic diseases are given. © 2022 Infectious Diseases: News, Opinions, Training.
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Objective: To evaluate the effects of the COVID-19 pandemic on the pain experienced by patients with CIRD and to analyze the associated factors. Method(s): A cross-sectional study was conducted amongst patients with rheumatic diseases using a questionnaire providing information on patients and disease characteristics. Patients were asked to assess the level of pain they had experienced before and during the pandemic, using a single Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (greatest pain). Statistical Analysis System IBM SPSS Statistics V20.0.0 was used to analyze the study data. We performed univariate multivariate analysis to search for any related factors to pain perception during the COVID-19 pandemic. Qualitative values were analyzed by the chi2 test. Quantitative values were analyzed by the Student test when the measures were normally distributed or by nonparametric tests (Mann-Whitney U) when the measures were not normally distributed (the Kolmogorov-Smirnov test was used to test normality). Result(s): Amongst the 350 patients who answered the questionnaire online, rheumatoid arthritis represented 62.3%, spondyloarthropathy 34.3%, and undifferentiated CIRD 3.4%. CIRD-related pain was reported by 79.1% of the patients The level of pain, using the VAS of Pain, increased significantly during the COVID-19 pandemic (4,6 +/- 2,8 and 5,4 +/- 3 before and during the pandemic;p<0.001). In the multivariate analysis, the factors causing the pain were: the negative impact of the coronavirus on accessing rheumatology care, the discontinuation of treatment, the disturbed sleep, and the negative psychological impact. Conclusion(s): This survey showed that the COVID-19 pandemic had increased CIRD-related pain in patients. Factors influencing this pain should be considered to help patients cope with their chronic rheumatism in this global health crisis. Copyright © 2022, Bentham Science Publishers. All rights reserved.
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Objectives: COVID-19 led to rapid uptake of digital health care. We sought to examine digital access, health and digital literacy, and impact on confidence and satisfaction with remote consultations in people with inflammatory rheumatic diseases (IRDs). Methods: People with IRDs (n = 2024) were identified from their electronic health record and invited to participate in a cross-sectional survey, using short message service (SMS) and postal approaches. Data were collected on demographics, self-reported diagnosis, access to and use of internet-enabled devices, health and digital literacy, together with confidence and satisfaction with remote consultations. Ethical approval was obtained (Ref 21/PR/0867). Results: Six hundred and thirty-nine (639) people completed the survey [mean (s.d.) age 64.5 (13.1) years, 384 (60.1%) female]. Two hundred and eighty-seven (44.9%) completed it online. One hundred and twenty-six (19.7%) people reported not having access to an internet-enabled device. Ninety-three (14.6%) reported never accessing the internet; this proportion was highest (23%) in people with RA. One hundred and seventeen (18%) reported limited health literacy. Even in those reporting internet use, digital literacy was only moderate. People with limited health or digital literacy or without internet access were less likely to report confidence or satisfaction with remote consultations. Conclusion: Limited health and digital literacy, lack of digital access and low reported internet use were common, especially in older people with RA. People with limited health literacy or limited digital access reported lower confidence and satisfaction with remote consultations. Digital implementation roll-out needs to take account of people requiring extra support to enable them to access care digitally or risks exacerbating health inequalities.
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BACKGROUND: Currently, observations are accumulating indicating the negative effect of therapy with a number of biologic disease-modifying anti-rheumatic drugs (bDMARDs) drugs on the course of COVID-19. These facts determine the relevance of studying the factors of severe course and unfavorable outcome in immuno-inflammatory rheumatic diseases (IIRD) patients treated with bDMARDs in order to develop tactics for managing this category of patients in a pandemic. AIM: To evaluate the influence of clinical and demographic factors on the risk of development, severity of the course and clinical outcomes of a new coronavirus infection in patients suffering from IIRD and receiving therapy with genetically engineered biological drugs. MATERIALS AND METHODS: A retrospective analysis of the database of the register of patients with IIRD receiving bDMARDs in the Novosibirsk region was performed, which included 318 patients, 94 of whom had indications of having suffered viral infection/pneumonia for the period from 01.04.2020 to 31.12.2020. RESULTS: According to the data obtained, at the time of the analysis, 94 people out of 318 patients with IIRD had a new coronavirus infection. Most (53%) of the patients had a mild infection. At the same time, the nosological form, the use of anti-rheumatic drugs and glucocorticoids did not increase the risks of severe coronavirus infection. When using bDMARDs, only anti-B-cell therapy (rituximab) associated with statistically significant increase in the risk of severe/extremely severe COVID-19. The mortality rate according to the analysis of the register was 6,38%. CONCLUSION: Patients with IIRD have a high risk of severe coronavirus infection, while the severity of the disease is associated with the type of therapy performed.
Subject(s)
Antirheumatic Agents , Biological Products , COVID-19 Drug Treatment , Pneumonia, Viral , Rheumatic Diseases , Humans , Rheumatic Diseases/drug therapy , Rheumatic Diseases/epidemiology , Retrospective Studies , Rituximab/therapeutic use , Pneumonia, Viral/chemically induced , Pneumonia, Viral/complications , Pneumonia, Viral/drug therapy , Antirheumatic Agents/adverse effects , Biological Products/adverse effectsABSTRACT
The key role in the development of chronic autoimmune inflammation is played by pro-inflammatory cytokines, in particular, interleukin 6 (IL-6). The introduction into clinical practice of monoclonal antibodies inhibiting IL-6 is a significant event in rheumatology and is currently considered as a promising direction in the treatment of immuno-inflammatory rheumatic diseases. The first inhibitor of IL-6 (IL-6), which entered the practice of rheumatologists, was tocilizumab (TCZ), the second – sarilumab (SAR). Numerous studies have shown the high effectiveness of iIL-6: the use of drugs leads to a rapid decrease in the clinical manifestations of rheumatoid arthritis (RA) and a decrease in laboratory signs of inflammation, contributing to the achievement of low activity or remission, improves the quality of life of patients, and also slows down the X-ray progression of the disease. At the same time, iIL-6 has a satisfactory safety profile. The universal problem of our time – the pandemic of a new coronavirus infection – has led to attempts to use IL-6 in patients with severe and critical disease, since IL-6 plays an important role in the pathogenesis of COVID-19, which is confirmed by the results of numerous studies. However, data on the efficacy and safety of these drugs in COVID-19 are contradictory, which requires conducting larger-scale controlled studies. This review examines the issues of the effectiveness and safety of TCZ and SAR in rheu-matological patients and in patients with COVID-19. The review is illustrated with examples from real clinical practice. © 2022.
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Objective: To identify risk factors for SARS-CoV-2 infection and for severe/critical COVID-19, and to assess the humoral response after COVID-19 in these patients. Methods: Nationwide study of adult patients with inflammatory RMDs prospectively followed in the Rheumatic Diseases Portuguese Register-Reuma.pt-during the first 6 months of the pandemic. We compared patients with COVID-19 with those who did not develop the disease and patients with mild/moderate disease with those exhibiting severe/critical COVID-19. IgG antibodies against SARS-CoV-2 were measured ≥3 months after infection and results were compared with matched controls. Results: 162 cases of COVID-19 were registered in a total of 6,363 appointments. Patients treated with TNF inhibitors (TNFi; OR = 0.160, 95% CI 0.099-0.260, P < 0.001) and tocilizumab (OR 0.147, 95% CI 0.053-0.408, P < 0.001) had reduced odds of infection. Further, TNFi tended to be protective of severe and critical disease. Older age, major comorbidities, and rituximab were associated with an increased risk of infection and worse prognosis. Most patients with inflammatory RMDs (86.2%) developed a robust antibody response. Seroconversion was associated with symptomatic disease (OR 13.46, 95% CI 2.21-81.85, P = 0.005) and tended to be blunted by TNFi (OR 0.17, 95% CI 0.03-1.05; P = 0.057). Conclusions: TNFi and tocilizumab reduced the risk of infection by SARS-CoV-2. Treatment with TNFi also tended to reduce rates of severe disease and seroconversion. Older age, general comorbidities and rituximab were associated with increased risk for infection and worse prognosis, in line with previous reports. Most patients with RMDs developed a proper antibody response after COVID-19, particularly if they had symptomatic disease.
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Background: Recent surveys in chronic inflammatory rheumatic diseases (CIRD) showed a high degree of vaccine hesitancy. Current knowledge about patients' attitudes toward vaccination against SARS-CoV-2 is limited. Objectives: To assess the willingness of CIRD patients to be vaccinated against SARS-CoV-2 and to identify the influencing factors compared with non-CIRD patients. Methods: In this cross-sectional study, two cohorts of consecutive patients with and without CIRD were recruited in parallel when presenting to our tertiary hospital and asked to answer questions of a structured interview to assess vaccination willingness to SARS-CoV-2 their experience with SARS-CoV-2 and their personal history of infections and vaccinations. Vaccination willingness was assessed using a numerical rating scale (0: fully disagree; 10: fully agree). Arbitrarily defined cut-offs were used to define definite (score ⩾7) and probable willingness (score of 5 or 6) to be vaccinated. Factors associated with willingness were assessed using Kendall's tau-b correlation measure and linear regression analysis. Results: A total of 514 CIRD and 100 non-CIRD patients, mean age of 54.7 ± 12.8 and 55.6 ± 9.8 years, respectively, were included. Definite and probable willingness to be vaccinated against SARS-CoV-2 was declared by 79.6% and 90.7% versus 76.0% and 85.0% of CIRD and non-CIRD patients, respectively. Only 60% of CIRD patients believed that the vaccines against SARS-CoV-2 were safe, and 42% indicated to be afraid of side effects. Vaccination willingness was significantly correlated with being in a risk group for COVID-19 (tau-b = -0.149), hypertension (tau-b = 0.14), and information about disease prevention (tau-b = 0.19), while a history of infections or immunosuppressive therapy was not. Vaccination willingness was significantly associated with higher education (b = 0.65) and age (b = 0.06). Conclusion: This survey highlights several predictors of relevance for the vaccination willingness of patients with CIRD and controls including appropriate information about its relevance. The good news, however, is that the vast majority of CIRD patients indicated their willingness to be vaccinated. However, there was some uncertainty regarding the safety and efficacy of the vaccines. Since the major influencing factors were education and information about SARS-CoV-2 Vaccine and COVID-19 Disease, patient education should be improved soon.
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INTRODUCTION: Vaccination is considered as a cornerstone of the management of COVID-19 pandemic. However, while vaccines provide a robust protection in immunocompetent individuals, the immunogenicity in patients with inflammatory rheumatic diseases (IRD) is not well established. METHODS: A monocentric observational study evaluated the immunogenicity of a two-dose regimen vaccine in adult patients with IRD (n=123) treated with targeted or biological therapies. Serum IgG antibody levels against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike proteins were measured after the second vaccination. In addition, a search for observational studies performed in IRD under biologic or targeted therapies up to September 31, 2021 (PROSPERO registration number: CRD42021259410) was undertaken in publication databases, preprint servers, and grey literature sources. Studies that reported sample size, study date, location, and seroprevalence estimate were included. A meta-analysis was conducted to identify demographic differences in the prevalence of SARS-CoV-2 antibodies. RESULTS: Of 123 patients (median age 66 IQR 57-75), 69.9% have seroconverted after vaccination. Seroconverted patients were older than non-seroconverted ones in our cohort. Rituximab was associated with a significantly low antibody response. Besides, we identified 20 seroprevalence studies in addition to our cohort including 4423 participants in 11 countries. Meta-analysis confirmed a negative impact of rituximab on seroconversion rate and suggested a less substantial effect of abatacept, leflunomide and methotrexate. CONCLUSION: Rituximab impairs serological response to SARS-CoV-2 vaccines in patients with IRD. This work suggests also a negative impact of abatacept, methotrexate or leflunomide especially when associated to biological therapy.