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3.
J Clin Rheumatol ; 28(8): 381-389, 2022 Dec 01.
Article in English | MEDLINE | ID: covidwho-2135822

ABSTRACT

OBJECTIVE: The aim of this study was to conduct a systematic review and meta-analysis examining the immunogenicity and safety of SARS-CoV-2 vaccination in patients with RD. METHODS: We systematically searched PubMed/MEDLINE and Scopus to identify observational studies that examined the immunogenicity and safety of SARS-CoV-2 vaccination in RD patients. Information on disease, immunosuppressant, vaccine type, and proportion of patients with serologic response was obtained from each study. RESULTS: There were 25 eligible studies. The pooled rate of seroconversion was 0.79 (95% confidence interval [CI], 0.72-0.86). Compared with control subjects, the odds of seroconversion were significantly lower (odds ratio, 0.11; 95% CI, 0.05-0.24). Users of rituximab showed the lowest rate of seroconversion (0.39; 95% CI, 0.29-0.51) followed by mycophenolate (0.56; 95% CI, 0.40-71). On the other hand, users of interleukin 17 (0.94; 95% CI, 0.78-0.98) and tumor necrosis factor inhibitors (0.94; 95% CI, 0.84-0.98) showed high seroconversion rate. Regarding safety of COVID-19 vaccine, approximately 2% of patients reported severe adverse events and 7% reported diseases flares following the first or second dose. CONCLUSION: Vaccination against SARS-CoV-2 appears to be safe. Most RD patients developed humoral immune response following vaccination. However, the odds of seroconversion were significantly lower in RD patients compared with controls. This is likely driven by certain immunosuppressants including rituximab and mycophenolate. Future studies need to identify strategies to improve vaccine response in these patients.


Subject(s)
COVID-19 , Rheumatic Diseases , Humans , COVID-19 Vaccines/adverse effects , SARS-CoV-2 , Rituximab , COVID-19/prevention & control , Rheumatic Diseases/drug therapy , Vaccination , Immunosuppressive Agents/adverse effects
4.
Clin Exp Rheumatol ; 40(11): 2044-2051, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-2111742

ABSTRACT

OBJECTIVES: To study treatment decisions of patients with chronic inflammatory rheumatic diseases (CIRD) at the beginning of the SARS- CoV-2 pandemic in relation to disease characteristics with focus on anxiety. METHODS: A total of 970 CIRD patients diagnosed with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriasis arthritis (PsA) and connective tissue diseases (CTD), selected from our records who had presented to our hospital at least twice during last year, were contacted by telephone to be asked about medication changes, health status and therapy satisfaction. Standardised tools were used to assess disease activity, anxiety and depression, the latter by Hospital Anxiety and Depression Score (HADS) with a score ≥8 denoting definite anxiety and/or depression. The cut-off for RADAI was set at ≥3.2 and for BASDAI ≥4. Compliance with prevention rules and vaccination status were assessed. RESULTS: Complete interviews of 557 patients (57.4%) made between April and July 2020 were available for analysis. The median age was 55 (47-63), disease duration 9.0 (4.5-17.0) years, 61.9% females. A recent change in medication was reported by 197 patients (35.4%), 51.2% of which admitted that this decision was mainly made due to the pandemic with more changes occurring with bDMARDs (21.8%) than cDMARDs (6.6%) and corticosteroids (5.4%). There was no major difference between patients who changed because of the pandemic or self-reported inactive disease versus patients who did not change therapy regarding disease activity, depression and anxiety (41%, 17.2%, 31.3% vs. 47.5%, 22.5%, 35.0% vs. 48.9%, 27.7%, 34.1%). More than 90% of patients reported that they rigorously followed Corona prevention rules. The majority of patients were vaccinated against influenza (55.3%) and pneumococci (61.3%), respectively. CONCLUSIONS: Anxiety, depression and disease activity did not play an important role in decisions favouring change of therapy, even though many patients changed medication due to the pandemic. Patients probably protected themselves by strictly adhering to hygiene recommendations. Vaccination rates against influenza and pneumococci were better than previously reported, but still too low.


Subject(s)
Arthritis, Psoriatic , Arthritis, Rheumatoid , COVID-19 , Influenza, Human , Rheumatic Diseases , Female , Humans , Middle Aged , Male , Influenza, Human/prevention & control , Anxiety/epidemiology , Depression/epidemiology , Depression/etiology , Arthritis, Rheumatoid/diagnosis , Arthritis, Rheumatoid/drug therapy , Arthritis, Rheumatoid/epidemiology , SARS-CoV-2 , Chronic Disease , Rheumatic Diseases/drug therapy , Rheumatic Diseases/epidemiology
5.
RMD Open ; 8(2)2022 11.
Article in English | MEDLINE | ID: covidwho-2098013

ABSTRACT

OBJECTIVE: To conduct a systematic literature review (SLR) on the screening and prophylaxis of opportunistic and chronic infections in autoimmune inflammatory rheumatic diseases (AIIRD). METHODS: SLR (inception-12/2021) based on the following search domains: (1) infectious agents, (2) AIIRD, (3) immunosuppressives/immunomodulators used in rheumatology, (4) screening terms and (5) prophylaxis terms. Articles were retrieved having the terms from (1) AND (2) AND (3) plus terms from (4) OR(5). Databases searched: PubMed, Embase and Cochrane Library. EXCLUSION CRITERIA: studies on postoperative infections, paediatric AIIRD, COVID-19, vaccinations and non-Εnglish literature. Study quality was assessed with Newcastle-Ottawa scale for non-randomised controlled trials (RCTs), RoB-Cochrane for RCTs, AMSTAR2 for SLRs. RESULTS: From 5641 studies were retrieved, 568 full-text articles were assessed for eligibility, with 194 articles finally included. For tuberculosis, tuberculin skin test (TST) is affected by treatment with glucocorticoids and conventional synthetic disease modifying anti-rheumatic drugs (DMARDs) and its performance is inferior to interferon gamma release assay (IGRA). Agreement between TST and IGRA is moderate to low. For hepatitis B virus (HBV): risk of reactivation is increased in patients positive for hepatitis B surface antigen. Anti-HBcore positive patients are at low risk for reactivation but should be monitored periodically with liver function tests and/or HBV-viral load. Risk for Hepatitis C reactivation is existing but low in patients treated with biological DMARDs. For Pneumocystis jirovecii, prophylaxis treatment should be considered in patients treated with prednisolone ≥15-30 mg/day for >2-4 weeks. CONCLUSIONS: Different screening and prophylaxis approaches are described in the literature, partly determined by individual patient and disease characteristics.


Subject(s)
Antirheumatic Agents , COVID-19 , Opportunistic Infections , Rheumatic Diseases , Adult , Humans , Child , COVID-19/diagnosis , COVID-19/prevention & control , Antirheumatic Agents/adverse effects , Hepatitis B virus , Opportunistic Infections/diagnosis , Opportunistic Infections/etiology , Opportunistic Infections/prevention & control , Rheumatic Diseases/complications , Rheumatic Diseases/drug therapy
6.
Ter Arkh ; 94(5): 636-641, 2022 Jun 17.
Article in Russian | MEDLINE | ID: covidwho-2091499

ABSTRACT

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 , Pneumonia, Viral , Rheumatic Diseases , Humans , COVID-19/drug therapy , 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 effects
7.
Ter Arkh ; 94(5): 605-609, 2022 Jun 17.
Article in Russian | MEDLINE | ID: covidwho-2091498

ABSTRACT

Despite great advances in the diagnosis and treatment of immunoinflammatory rheumatic diseases, which have led to a significant improvement in the prognosis in many patients, the fundamental medical problems of this pathology the restoration of the quality of life and the reduction of mortality to the population level are far from being resolved. This served as a stimulus for the study of new approaches to the pharmacotherapy of IVRD, one of which is associated with the use of low molecular weight chemically synthesized drugs that inhibit intracellular "signaling" molecules Janus kinase. Modern advances regarding the use of Janus kinase inhibitors in the treatment of immunoinflammatory rheumatic diseases and COVID -19 are considered.


Subject(s)
COVID-19 , Janus Kinase Inhibitors , Rheumatic Diseases , Synthetic Drugs , Humans , Janus Kinase Inhibitors/adverse effects , Quality of Life , COVID-19/drug therapy , Rheumatic Diseases/drug therapy , Janus Kinases/therapeutic use , Synthetic Drugs/therapeutic use
8.
Medicine (Baltimore) ; 101(42): e31288, 2022 Oct 21.
Article in English | MEDLINE | ID: covidwho-2087900

ABSTRACT

We investigated serum total antibody titers against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein receptor-binding domain after BNT162b2 mRNA vaccination against coronavirus disease 2019 (COVID-19) in Japanese patients taking various immunosuppressive medications for rheumatic disease. In 212 outpatients with rheumatic diseases at Kagawa University Hospital and 43 healthy volunteers (controls), all of whom had received 2 doses of BNT162b2 vaccine, serum antibody titers of SARS-CoV-2 spike protein were analyzed at least 14 days after the second dose. Many of the patients were taking immunosuppressive agents to manage their rheumatic disease. The antibody titers against SARS-CoV-2 spike protein in these patients were significantly lower than those in controls. The analysis of therapeutic agents revealed that the antibody titers in patients treated with rituximab were much lower than those in controls. In patients treated with tacrolimus, baricitinib, azathioprine, mycophenolate mofetil, abatacept, tumor necrosis factor inhibitors, cyclosporine, interleukin-6 inhibitors, methotrexate, or glucocorticoids, antibody titers were moderately lower than those of controls. Interleukin-17 and interleukin-23 inhibitors did not impair the humoral response. In addition, the combination of methotrexate with various immunosuppressive agents reduced titers, although not significantly. In Japanese patients with rheumatic disease, many immunosuppressants impaired the immune response to the BNT162b2 vaccine. The degree of decline in antibody titers differed according to immunosuppressant. When used concomitantly with other immunosuppressants, methotrexate may impair the immune response to the BNT162b2 vaccine. However, immunomodulatory treatments such as interleukin-17 and -23 inhibitors may not attenuate this response in patients with rheumatic disease.


Subject(s)
BNT162 Vaccine , COVID-19 , Immunity, Humoral , Immunosuppression Therapy , Rheumatic Diseases , Humans , Antibodies, Viral , BNT162 Vaccine/immunology , COVID-19/prevention & control , Immunosuppressive Agents/therapeutic use , Japan , Rheumatic Diseases/drug therapy , SARS-CoV-2 , Spike Glycoprotein, Coronavirus
9.
Sci Rep ; 12(1): 17955, 2022 Oct 26.
Article in English | MEDLINE | ID: covidwho-2087312

ABSTRACT

Progress has been made in COVID-19 vaccine development, with encouraging safety and efficacy data. The purpose of this study was to investigate the immunogenicity of inactivated COVID-19 vaccine in patients with autoimmune inflammatory rheumatic diseases (AIIRD). Patients with AIIRD (n = 101) were included in this study. All patients received 2 doses of inactivated COVID-19 vaccine. Serum anti-S1/RBD protein IgG was detected 2-16 weeks after the second vaccination. Seropositivity was defined as IgG ≥ 1.00 bound antibody unit S/CO. Immunogenicity of inactivated COVID-19 vaccine was assessed by seropositivity rate and the levels of serum IgG antibody against anti-S1/RBD protein, compared with the general population (n = 46). There was no difference by statistical significance in the seropositivity rate between patients with AIIRD (82.2%) and SLE (86.1%) and the control group (93.5%), p > 0.05. The level of anti-S1/RBD protein IgG antibodies in patients with AIIRD (median [IQR], 8.8 [2.2-17.3]) and SLE (median [IQR], 9.6 [2.4-20.4]) was comparable to that in the control group (median [IQR], 7.2 [3.1-14.2]), p > 0.05. Patients treated with glucocorticoids(GCs) (median dose, [IQR]: 2.5 mg/day [IQR 2.5-5.0]) or hydroxychloroquine(HCQ) or GCs + HCQ without other immunomodulatory medications, had an appropriate immunogenic response(88.1%) with high levels of anti-S1/RBD protein IgG(median [IQR], 12.1 [6.5-20.4]). Neither of patients treated with rituximab had positive serum antibodies, which was statistically significant, compared with the control group (p < 0.01). Compared with the control group, methotrexate(MTX) and iguratimod(IGU) was significantly reduced the level of anti-S1/RBD protein IgG antibodies. Inactivated COVID-19 vaccine had appropriate immunogenicity in patients with AIIRD. Immunogenicity of inactivated COVID-19 vaccine was severely impaired by rituximab, and also suppressed by MTX and IGU, while low doses of GC and HCQ had negligible effect.


Subject(s)
Autoimmune Diseases , COVID-19 , Lupus Erythematosus, Systemic , Rheumatic Diseases , Rheumatic Fever , Humans , COVID-19 Vaccines , Rheumatic Diseases/drug therapy , Rheumatic Diseases/epidemiology , Hydroxychloroquine/therapeutic use , Methotrexate/therapeutic use , Rituximab/therapeutic use , Autoimmune Diseases/epidemiology , COVID-19/prevention & control , Immunoglobulin G/therapeutic use , Antibodies, Viral/therapeutic use , Immunogenicity, Vaccine
10.
Inflammopharmacology ; 30(6): 2089-2096, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2085447

ABSTRACT

OBJECTIVES: To determine the seroconversion (SC) rate after CoronaVac and BNT162b2 vaccines in adults with inflammatory rheumatic disease (IRD). METHODS: Patients who were followed up with IRD and who received two doses of either CoronaVac or BNT162b2 vaccines were included in this prospective observational single-center study. Subjects with two doses of CoronaVac or BNT162b2 without known IRD were included in the healthy controls. The blood samples were taken at a minimum of two and a maximum of 12 weeks after the second dose of vaccine. RESULTS: A total of 81 patients with IRD (61 CoronaVac, 20 BNT162b2) and 100 healthy controls (70 CoronaVac, 30 BNT162b2) were included. The SC rate was slightly lower among patients with IRD versus controls (84 vs 97%, p = 0.002). The SC rate was 100% in all participants who received BNT162b2 both in the patient and control group. The IgG antibody level after CoronaVac in the patient group was significantly lower than both the BNT162b2 (p = 0.031) and the healthy group (p < 0.001). Among patients with IRD, those on rituximab (RTX) (12/81,14.8%) had significantly less SC rate (5/12, 41.7%). The median neutralizing antibody titers were significantly higher in patients with BNT162b2 compared with CoronaVac (1.97 vs. 16.34, p < 0.001). CONCLUSIONS: This study showed that all patients with BNT162b2 vaccine developed immunogenicity in patients with IRD, while there was a decreased antibody response with CoronaVac vaccine compared to that of BNT162b2. In particular, RTX significantly reduces the SC rate.


Subject(s)
COVID-19 Vaccines , COVID-19 , Rheumatic Diseases , Vaccines , Adult , Humans , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Rheumatic Diseases/drug therapy
11.
Front Immunol ; 13: 920865, 2022.
Article in English | MEDLINE | ID: covidwho-2071086

ABSTRACT

Objectives: To investigate the differences between the vector vaccine ChAdOx1 nCoV-19/AZD1222 (Oxford-AstraZeneca) and mRNA-based vaccine mRNA-1273 (Moderna) in patients with autoimmune rheumatic diseases (AIRD), and to explore the cell-cell interactions between high and low anti-SARS-CoV-2 IgG levels in patients with rheumatic arthritis (RA) using single-cell RNA sequencing (scRNA-seq). Methods: From September 16 to December 10, 2021, we consecutively enrolled 445 participants (389 patients with AIRD and 56 healthy controls), of whom 236 were immunized with AZD1222 and 209 with mRNA-1273. The serum IgG antibodies to the SARS-CoV-2 receptor-binding domain was quantified by electrochemiluminescence immunoassay at 4-6 weeks after vaccination. Moreover, peripheral blood mononuclear cells (PBMCs) were isolated from RA patients at 4-6 weeks after vaccination for scRNA-seq and further analyzed by CellChat. ScRNA-seq of PBMCs samples from GSE201534 in the Gene Expression Omnibus (GEO) database were also extracted for analysis. Results: The anti-SARS-CoV-2 IgG seropositivity rate was 85.34% for AIRD patients and 98.20% for healthy controls. The anti-SARS-CoV-2 IgG level was higher in patients receiving mRNA-1273 than those receiving AZD1222 (ß: 35.25, 95% CI: 14.81-55.68, p=0.001). Prednisolone-equivalent dose >5 mg/day and methotrexate use in AIRD patients, and non-anti-tumor necrosis factor-α biologics and Janus kinase inhibitor use in RA patients were associated with inferior immunogenicity. ScRNA-seq revealed CD16-monocytes were predominant in RA patients with high anti-SARS-CoV2-IgG antibodies, and enriched pathways related to antigen presentation via MHC class II were found. HLA-DRA and CD4 interaction was enhanced in high anti-SARS-CoV2-IgG group. Conclusions: mRNA-1273 and AZD1222 vaccines exhibited differential immunogenicity in AIRD patients. Enriched pathways related to antigen presentation via MHC class II in CD16-monocytes might be associated with higher anti-SARS-CoV2-IgG level in RA patients and further study is warranted.


Subject(s)
Autoimmune Diseases , COVID-19 , Rheumatic Diseases , 2019-nCoV Vaccine mRNA-1273 , Antibodies, Viral , COVID-19/prevention & control , ChAdOx1 nCoV-19 , Humans , Immunoglobulin G , Leukocytes, Mononuclear , Rheumatic Diseases/drug therapy , SARS-CoV-2 , Sequence Analysis, RNA , mRNA Vaccines
12.
Expert Opin Pharmacother ; 23(15): 1695-1700, 2022 Oct.
Article in English | MEDLINE | ID: covidwho-2050981

ABSTRACT

INTRODUCTION: Over the last two decades, rituximab has become an increasingly popular drug in the treatment of a wide range of rheumatic diseases. However, with the advent of the COVID-19 pandemic, clinicians face challenges in weighing risk against benefit in its use. AREAS COVERED: A review of existing data was performed to examine the relationship between rituximab use, morbidity and mortality from COVID-19, and vaccine efficacy in patients with rheumatic diseases, aiming to guide clinicians in continued use of the medication and consider the direction of future research. A literature review was performed through a search of the PubMed database, using the terms ((SARS-CoV-2) OR (COVID-19)) AND (rituximab) AND (rheumatic), which generated an initial 55 results, with relevant articles then selected for inclusion. EXPERT OPINION: In order to safeguard patients with an ongoing need for rituximab therapy, vaccination remains the primary concern. A target of performing booster doses 6 months after last rituximab dose is a reasonable estimate, which may be made more precise by use of B cell counts, although primary immunization should not be delayed. In those patients who remain seronegative, the use of newer antivirals and broadly neutralizing antibody infusions may help provide further safeguards.


Subject(s)
COVID-19 , Rheumatic Diseases , Humans , COVID-19/drug therapy , Rituximab , SARS-CoV-2 , Pandemics , Rheumatic Diseases/drug therapy , Rheumatic Diseases/chemically induced , Vaccination
13.
Nat Commun ; 13(1): 5801, 2022 10 03.
Article in English | MEDLINE | ID: covidwho-2050373

ABSTRACT

The determination of durability and vaccine-associated protection is essential for booster doses strategies, however data on the stability of SARS-CoV-2 immunity are scarce. Here we assess anti-SARS-CoV-2 immunogenicity decay and incident cases six months after the 2nd dose of Sinovac-CoronaVac inactivated vaccine (D210) in 828 autoimmune rheumatic diseases patients compared with 207 age/sex-balanced control individuals. The primary outcome is the presence of anti-S1/S2 SARS-CoV-2 IgG at 6 months compared to 6 weeks after 2nd vaccine dose for decay evaluation. Secondary outcomes are presence of neutralizing antibodies, percent inhibition by neutralizing, geometric mean titers and cumulative incident cases at 6 months after 2nd dose. Anti-S1/S2 IgG positivity and titers reduce to 23.8% and 38% in patients (p < 0.001) during the six-month follow up and 20% and 51% in controls (p < 0.001), respectively. Neutralizing antibodies positivity and percent inhibition declines 41% and 54% in patients (p < 0.001) and 39.7% and 47% in controls (p < 0.001). Multivariate logistic regression analysis show males (OR = 0.56;95% CI0.40-0.79), prednisone (OR = 0.56; 95% CI0.41-0.76), anti-TNF (OR = 0.66;95% CI0.45-0.96), abatacept (OR = 0.29; 95% CI0.15-0.56) and rituximab (OR = 0.32;95% CI0.11-0.90) associate with a substantial reduction in IgG response at day 210 in patients. Although cellular immunity was not assessed, a decrease of COVID-19 cases (from 27.5 to 8.1/100 person-years; p < 0.001) is observed despite the concomitant emergence and spread of the Delta variant. Altogether we show a reduction in immunity 6-months of Sinovac-CoronaVac 2nd dose, particularly in males and those under immunosuppressives therapies, without a concomitant rise in COVID-19 cases. (CoronavRheum clinicaltrials.gov:NCT04754698).


Subject(s)
COVID-19 , Rheumatic Diseases , Viral Vaccines , Abatacept , Antibodies, Neutralizing , Antibodies, Viral , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , Humans , Immunoglobulin G , Incidence , Male , Prednisone , Rheumatic Diseases/drug therapy , Rheumatic Diseases/epidemiology , Rituximab/therapeutic use , SARS-CoV-2 , Tumor Necrosis Factor Inhibitors , Vaccines, Inactivated
15.
Clin Rheumatol ; 41(12): 3879-3885, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2007159

ABSTRACT

BACKGROUND: The COVID-19 outbreak has led to the rapid development and administration of the COVID-19 vaccines worldwide. Data about the immunogenicity and adverse effects of the vaccine on patients with systemic autoimmune rheumatic diseases (SARDs) is emerging. AIM: To evaluate Pfizer/BioNTech (BNT162b2) mRNA-based vaccine second-dose immunogenicity and safety, and the relation between them, in patients with SARDs. METHODS: A total of one hundred forty tow adults who received two doses of the BNT162b2 vaccine were included in the study. The SARDs group included Ninety-nine patients and the control group (forty-three participants) comprised a mixture of healthy participants and patients who were seen at the rheumatology clinic for non-SARDs. Anti-SARS-CoV-2 IgG antibodies against the Spike protein were evaluated using a SARS-CoV-2 IgG immunoassay. A level of > 150 AU/mL was considered positive. An adverse effects questionnaire was given to the participants upon their first visit to the clinic after their BNT162b2 vaccination. RESULTS: Of the 142 participants, 116 were seropositive (81.7%) and 26 (18.3%) were seronegative. Of the seronegative participants, 96.2% were SARDs patients. The proportion of seropositivity in the SARDs patients treated with any immunosuppressant was significantly lower (69.9%) compared to the control group and SARDs patients not receiving immunosuppressants (96.8%). A significant negative correlation between seronegativity and treatment with rituximab, mycophenolate mofetil (MMF), and prednisone was found in the SARDs group (p = 0.004, 0.044, 0.007 respectively). No fever was observed following the BNT162b2 vaccine in seronegative patients, and the frequency of musculoskeletal adverse effects upon the second dose of the BNT162b2 vaccine was significantly higher in seropositive compared to seronegative patients and in the control group compared to the SARDs patients (p = 0.045, p = 0.02 respectively). CONCLUSION: A decline in the immunogenicity to the second dose of BNT162b2 mRNA is seen in patients with SARDs, especially in patients treated with rituximab, MMF, and prednisone. Adverse effects of the vaccine including fever and musculoskeletal symptoms might be a signal for the acquisition of immunity in those patients. KEY POINTS: • BNT162b2 mRNA vaccine is less immunogenic in SARDs patients compared to the control group. • Rituximab, prednisone, and mycophenolate mofetil significantly reduced immunogenicity to the vaccine. • There is a correlation between immunogenicity and adverse effects of the vaccine.


Subject(s)
COVID-19 , Rheumatic Diseases , Adult , Humans , BNT162 Vaccine , Rituximab/therapeutic use , Prednisone/therapeutic use , COVID-19 Vaccines/adverse effects , Mycophenolic Acid/therapeutic use , COVID-19/prevention & control , SARS-CoV-2 , Rheumatic Diseases/drug therapy , Rheumatic Diseases/epidemiology , Antibodies, Viral , Immunoglobulin G/therapeutic use
16.
Intern Med ; 61(13): 1953-1958, 2022 Jul 01.
Article in English | MEDLINE | ID: covidwho-1993648

ABSTRACT

Objective To investigate the serum total antibody (immunoglobulin M and immunoglobulin G) titre against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein receptor-binding domain following BNT162b2 messenger ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccination in Japanese rheumatic disease patients undergoing immunosuppressive therapy. Methods The serum antibody titre against SARS-CoV-2 spike protein was analysed in 123 outpatients with rheumatic diseases at Kagawa University Hospital and 43 healthy volunteers who had received 2 doses of the BNT162b2 mRNA vaccine with at least 14 days elapsing since the second dose. Results The antibody titre in rheumatic disease patients was significantly lower than that in healthy subjects (p<0.0001). The antibody titres of the 41 patients who received biologics or Janus kinase inhibitors and the 47 patients who received conventional immunosuppressive agents were significantly lower than those of the 35 patients who did not receive immunosuppressive agents (p<0.0001 and p<0.0001, respectively). In addition, the mean antibody titre of the 43 patients on methotrexate was significantly lower than that of the 80 patients not on methotrexate (p=0.0017). Conclusion Immunogenicity to the BNT162b2 mRNA COVID-19 vaccine in rheumatic disease patients was found to be reduced under immunosuppressive treatment. In particular, methotrexate seems to be associated with a decreased antibody response.


Subject(s)
BNT162 Vaccine , COVID-19 , Immunogenicity, Vaccine , Rheumatic Diseases , Antibodies, Viral/blood , BNT162 Vaccine/immunology , COVID-19/prevention & control , Humans , Immunosuppression Therapy , Immunosuppressive Agents/therapeutic use , Methotrexate/therapeutic use , Neutralization Tests , Rheumatic Diseases/drug therapy , SARS-CoV-2 , Spike Glycoprotein, Coronavirus/immunology
17.
Pediatr Rheumatol Online J ; 20(1): 64, 2022 Aug 13.
Article in English | MEDLINE | ID: covidwho-1993366

ABSTRACT

BACKGROUND: Data about safety and efficacy of the mRNA SARS-CoV-2 vaccine in adolescents with rheumatic diseases (RD) is scarce and whether these patients generate a sufficient immune response to the vaccine remains an outstanding question. OBJECTIVE: To evaluate safety and humoral and cellular immunity of the BNT162b2 vaccine in adolescents 12 to 18 years with RD and immunosuppressive treatment compared with a healthy control group. METHODS: Adolescents from 12 to 18 years with RD followed at Hospital La Paz in Madrid (n = 40) receiving the BNT162b2 mRNA vaccination were assessed 3 weeks after complete vaccination. Healthy adolescents served as controls (n = 24). Humoral response was measured by IgG antiSpike antibodies, and cellular response by the quantity of IFN-γ and IL-2 present in whole blood stimulated with SARS-CoV-2 Spike and M proteins. RESULTS: There were no differences in spike-specific humoral or cellular response between groups (median IFN-γ response to S specific protein; 528.80 pg/ml in controls vs. 398.44 in RD patients, p 0.78, and median IL-2 response in controls: 635.68 pg/ml vs. 497.30 in RD patients, p 0.22. The most frequent diagnosis was juvenile idiopathic arthritis (26/40, 65%) followed by Lupus (6/40, 15%). 60% of cases (23/40) received TNF inhibitors and 35% (14/40) methotrexate. 40% of patients (26/64) had previous SARS-CoV-2 infection, 9 in the control group and 17 in the RD patients without differences. Of note, 70% of infections were asymptomatic. A higher IFN-γ production was found in COVID-19 recovered individuals than in naive subjects in both groups (controls: median 859 pg/ml in recovered patients vs. 450 in naïve p 0.017, and RD patients: 850 in recovered vs. 278 in naïve p 0.024). No serious adverse events or flares were reported following vaccination. CONCLUSIONS: We conclude that standard of care treatment for adolescents with RD including TNF inhibitors and methotrexate did not affect the humoral and the cellular immunity to BNT162b2 mRNA vaccination compared to a healthy control group. The previous contact with SARS-CoV-2 was the most relevant factor in the immune response.


Subject(s)
COVID-19 , Rheumatic Diseases , Viral Vaccines , Adolescent , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines , Humans , Immunity, Cellular , Interleukin-2 , Methotrexate , RNA, Messenger , Rheumatic Diseases/drug therapy , SARS-CoV-2 , Tumor Necrosis Factor Inhibitors , Viral Vaccines/genetics
18.
Clin Rheumatol ; 41(12): 3661-3673, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-1990657

ABSTRACT

INTRODUCTION: To describe clinical characteristics of patients in Japan with coronavirus disease 19 (COVID-19) and pre-existing rheumatic disease and examine the possible risk factors associated with severe COVID-19. METHODS: Adults with rheumatic disease and a COVID-19 diagnosis who were registered in the COVID-19 Global Rheumatology Alliance (C19-GRA) physician-reported registry from Japan between 15 May 2020 and 12 May 2021 were included. Multivariable logistic regression models were used to assess factors associated with severe COVID-19 progression, defined as death or requiring oxygen inhalation. RESULTS: In total, 222 patients were included in the study. Rheumatoid arthritis (48.2%), gout (14.4%), and systemic lupus erythematosus (8.1%) were the most common types of rheumatic disease, 55.1% of patients were in remission and 66.2% had comorbid disease. Most patients were hospitalised (86.9%) for COVID-19, 43.3% received oxygen, and 9.0% died. Older age (≥ 65 years), corticosteroid use, comorbid diabetes, and lung diseases are associated with higher risk for severe COVID-19 progression (odds ratio (OR) 3.52 [95% confidence interval (CI) 1.69-7.33], OR 2.68 [95% CI 1.23-5.83], OR 3.56 [95% CI 1.42-8.88], and OR 2.59 [95% CI 1.10-6.09], respectively). CONCLUSIONS: This study described clinical characteristics of COVID-19 patients with rheumatic diseases in Japan. Several possible risk factors for severe COVID-19 progression were suggested. Key points • Clinical characteristics of 222 adult patients in Japan with coronavirus disease 19 (COVID-19) and pre-existing rheumatic diseases were described. • Most patients were hospitalised (86.9%) for COVID-19 in Japan, 43.3% received oxygen, and 9.0% died. • The COVID-19 characteristics of patients with rheumatic diseases did not show any obvious different pattern from those of the general population in Japan. • In this study, older age (≥ 65 years), corticosteroid use, comorbid diabetes, and lung diseases are associated with higher risk for severe COVID-19 progression.


Subject(s)
Antirheumatic Agents , COVID-19 , Diabetes Mellitus , Physicians , Rheumatic Diseases , Rheumatology , Adult , Humans , COVID-19/epidemiology , SARS-CoV-2 , Japan/epidemiology , COVID-19 Testing , Antirheumatic Agents/therapeutic use , Rheumatic Diseases/complications , Rheumatic Diseases/epidemiology , Rheumatic Diseases/drug therapy , Registries , Diabetes Mellitus/epidemiology , Oxygen , Adrenal Cortex Hormones/therapeutic use
19.
Ann Rheum Dis ; 81(11): 1594-1602, 2022 11.
Article in English | MEDLINE | ID: covidwho-1962122

ABSTRACT

OBJECTIVES: To evaluate long-term kinetics of the BNT162b2 mRNA vaccine-induced immune response in adult patients with autoimmune inflammatory rheumatic diseases (AIIRD) and immunocompetent controls. METHODS: A prospective multicentre study investigated serum anti-SARS-CoV-2 S1/S2 IgG titre at 2-6 weeks (AIIRD n=720, controls n=122) and 6 months (AIIRD n=628, controls n=116) after the second vaccine, and 2-6 weeks after the third vaccine dose (AIIRD n=169, controls n=45). T-cell immune response to the third vaccine was evaluated in a small sample. RESULTS: The two-dose vaccine regimen induced a higher humoral response in controls compared with patients, postvaccination seropositivity rates of 100% versus 84.72%, p<0.0001, and 96.55% versus 74.26%, p<0.0001 at 2-6 weeks and at 6 months, respectively. The third vaccine dose restored the seropositive response in all controls and 80.47% of patients with AIIRD, p=0.0028. All patients treated with methotrexate monotherapy, anticytokine biologics, abatacept and janus kinase (JAK) inhibitors regained the humoral response after the third vaccine, compared with only a third of patients treated with rituximab, entailing a 16.1-fold risk for a negative humoral response, p≤0.0001. Cellular immune response in rituximab-treated patients was preserved before and after the third vaccine and was similar to controls. Breakthrough COVID-19 rate during the Delta surge was similar in patients and controls, 1.83% versus 1.43%, p=1. CONCLUSIONS: The two-dose BNTb262 regimen was associated with similar clinical efficacy and similar waning of the humoral response over 6 months among patients with AIIRD and controls. The third vaccine dose restored the humoral response in all of the controls and the majority of patients.


Subject(s)
Autoimmune Diseases , BNT162 Vaccine , COVID-19 , Immunogenicity, Vaccine , Rheumatic Diseases , Abatacept/therapeutic use , Adult , Antibodies, Viral , Antirheumatic Agents/therapeutic use , Autoimmune Diseases/complications , Autoimmune Diseases/drug therapy , BNT162 Vaccine/immunology , COVID-19/prevention & control , Humans , Immunoglobulin G/therapeutic use , Janus Kinases , Methotrexate/therapeutic use , Prospective Studies , Rheumatic Diseases/drug therapy , Rituximab/therapeutic use
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