Disease activity and humoral response in patients with inflammatory rheumatic diseases after two doses of the Pfizer mRNA vaccine against SARS-CoV-2

BackgroundThe registration trials of messenger RNA (mRNA) vaccines against SARS-CoV-2 did not address patients with inflammatory rheumatic diseases (IRD).ObjectiveTo assess the humoral response after two doses of mRNA vaccine against SARS-CoV-2, in patients with IRD treated with immunomodulating drugs and the impact on IRD activity.MethodsConsecutive patients treated at the rheumatology institute, who received their first SARS-CoV-2 (Pfizer) vaccine, were recruited to the study, at their routine visit. They were reassessed 4–6 weeks after receiving the second dose of vaccine, and blood samples were obtained for serology. IRD activity assessment and the vaccine side effects were documented during both visits. IgG antibodies (Abs) against SARS-CoV-2 were detected using the SARS-CoV-2 IgG II Quant (Abbott) assay.ResultsTwo hundred and sixty-four patients with stable disease, (mean(SD) age 57.6 (13.18) years, disease duration 11.06 (7.42) years), were recruited. The immunomodulatory therapy was not modified before or after the vaccination. After the second vaccination, 227 patients (86%) mounted IgG Ab against SARS-CoV-2 (mean (SD) 5830.8 (8937) AU/mL) and 37 patients (14%) did not, 22/37 were treated with B cell-depleting agents. The reported side effects of the vaccine were minor. The rheumatic disease remained stable in all patients.ConclusionsThe vast majority of patients with IRD developed a significant humoral response following the administration of the second dose of the Pfizer mRNA vaccine against SARS-CoV-2 virus. Only minor side effects were reported and no apparent impact on IRD activity was noted.

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Favourable antibody responses to human coronaviruses in children and adolescents with autoimmune rheumatic diseases

10.1101/2021.02.15.431291 ◽

2021 ◽

Author(s):

Claire T. Deakin ◽

Georgina H. Cornish ◽

Kevin W. Ng ◽

Nikhil Faulkner ◽

William Bolland ◽

...

Keyword(s):

Children And Adolescents ◽

Rheumatic Diseases ◽

Lupus Erythematosus ◽

Immunosuppressive Treatment ◽

Immune Dysfunction ◽

Inflammatory Rheumatic Diseases ◽

Igg Antibodies ◽

Autoimmune Rheumatic Diseases ◽

Human Coronaviruses ◽

The Impact

AbstractDifferences in humoral immunity to coronaviruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), between children and adults remain unexplained and the impact of underlying immune dysfunction or suppression unknown. Here, we examined the antibody immune competence of children and adolescents with prevalent inflammatory rheumatic diseases, juvenile idiopathic arthritis (JIA), juvenile dermatomyositis (JDM) and juvenile systemic lupus erythematosus (JSLE), against the seasonal human coronavirus (HCoV)-OC43 that frequently infects this age group. Despite immune dysfunction and immunosuppressive treatment, JIA, JDM and JSLE patients mounted comparable or stronger responses than healthier peers, dominated by IgG antibodies to HCoV-OC43 spike, and harboured IgG antibodies that cross-reacted with SARS-CoV-2 spike. In contrast, responses to HCoV-OC43 and SARS-CoV-2 nucleoproteins exhibited delayed age-dependent class-switching and were not elevated in JIA, JDM and JSLE patients, arguing against increased exposure. Consequently, autoimmune rheumatic diseases and their treatment were associated with a favourable ratio of spike to nucleoprotein antibodies.

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Humoral response to Pfizer mRNA vaccine against SARS CoV2, in patients with autoimmune inflammatory rheumatic diseases and the impact on the rheumatic disease activity

10.1101/2021.04.02.21254493 ◽

2021 ◽

Author(s):

Yolanda Braun-Moscovici ◽

Marielle Kaplan ◽

Doron Markovits ◽

Samy Giryes ◽

Kochava Toledano ◽

...

Keyword(s):

Side Effects ◽

Rheumatic Disease ◽

Dose Range ◽

Combined Treatment ◽

Humoral Response ◽

Inflammatory Rheumatic Diseases ◽

Low Grade ◽

Serology Test ◽

Age Range ◽

The Impact

Abstract Background: The registration trials of mRNA vaccines against SARS CoV2 did not address patients with autoimmune inflammatory rheumatoid diseases (AIRD). Aims: To assess the humoral response to mRNA vaccine against SARS CoV2, in AIRD patients treated with immunomodulating drugs and the impact on AIRD activity. Methods: Consecutive patients treated at the rheumatology institute who received their first SARS-CoV-2 (Pfizer) vaccine were recruited to the study, at their routine visit. The patients were invited for serology test 4-6 weeks after receiving the second dose of vaccine. IgG Antibodies (Ab) against SARS COV2 virus were detected using the SARS-Cov-2 IgG II Quant (Abbott) assay Results: One hundred fifty-six consecutive patients (76% females) treated at a single rheumatology center (mean age (range) 59.1 (21-83) years), mean (range) disease duration 10.8 (1-55) years), were recruited to the study. Thirty-five percents of patients received conventional synthetic (cs)DMARDs only, 64% biological/targeted synthetic (b/ts) DMARDs, 34% received combined treatment with csDMARDs and b/tsDMARDs and 32% corticosteroids (mean dose(range) 5.8mg(2.5-20mg) prednisone). One hundred thirty-seven patients (88%) were seropositive for IgG Ab against SARS CoV2 virus (median 2832.5 AU/ml, range 58-29499). Nineteen (12%) patients had negative tests, 11/19 were treated with B cell depleting agents. The reported side effects of the vaccine were minor (muscle sore, headache, low grade fever). The rheumatic disease remained stable in all patients. Conclusions: The vast majority of AIRD patients developed a significant humoral response following the administration of the second dose of the Pfeizer mRNA vaccine against SARS CoV2 virus. Only minor side effects were reported and no apparent impact on AIRD activity was noted.

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Comorbidities of rheumatic disease

10.1093/med/9780199642489.003.0032 ◽

2013 ◽

Cited By ~ 1

Author(s):

Tuulikki Sokka ◽

Kari Puolakka ◽

Carl Turesson

Keyword(s):

Rheumatic Disease ◽

Rheumatic Diseases ◽

Health Professionals ◽

Physical Inactivity ◽

Organ Damage ◽

Inflammatory Rheumatic Diseases ◽

Rheumatology Clinic ◽

Cholesterol Levels ◽

Lifestyle Choices ◽

The Impact

All other diseases that coexist with a disease of interest are called comorbidities. Comorbidities in inflammatory rheumatic diseases may be associated with persistent inflammatory activity or disease-related organ damage, or may be related to medications. Lifestyle choices such as smoking or physical inactivity contribute to comorbidity. Patients with rheumatic diseases meet health professionals regularly and are more often tested for osteoporosis or cholesterol levels than individuals without rheumatic disease, which may contribute to a higher prevalence of some comorbidities. Comorbidities can also be unrelated to rheumatic diseases or their treatments. In this chapter, we discuss the impact of comorbidities to the patient. We emphasize the importance to review and manage comorbidities in usual daily rheumatology clinic, to improve outcomes of patients with rheumatic diseases.

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Comorbidities of rheumatic disease

10.1093/med/9780199642489.003.0032_update_001 ◽

2015 ◽

Author(s):

Tuulikki Sokka ◽

Kari Puolakka ◽

Carl Turesson

Keyword(s):

Rheumatic Disease ◽

Rheumatic Diseases ◽

Health Professionals ◽

Physical Inactivity ◽

Organ Damage ◽

Inflammatory Rheumatic Diseases ◽

Rheumatology Clinic ◽

Cholesterol Levels ◽

Lifestyle Choices ◽

The Impact

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AB0336 IMPACT OF SUBJECTIVE INTOLERANCE TO METHOTREXATE ON THE QUALITY OF LIFE OF PATIENTS WITH RHEUMATOID ARTHRITIS: SIDE EFFECTS AND AVOIDANCE COPING STRATEGIES THROUGH SELF-ADMINISTRATION IN THE EVENING OR DURING THE WEEKEND

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.4242 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1466.1-1467

Author(s):

G. Cavalli ◽

M. Biggioggero ◽

A. Cariddi ◽

G. De Luca ◽

E. Agape ◽

...

Keyword(s):

Quality Of Life ◽

Rheumatoid Arthritis ◽

Side Effects ◽

Social Participation ◽

Disease Duration ◽

P Value ◽

Self Administration ◽

Cross Sectional ◽

The Impact

Background:Methotrexate (MTX) represents theanchor drugfor the treatment of rheumatoid arthritis (RA), as well as other rheumatological diseases such as psoriatic arthritis (PsA) and spondyloarthritides (SpA). Despite consolidated clinical efficacy, the use of MTX suffers from relevant limitations. Common issues include subjective intolerance, nausea, malaise, and fatigue, which negatively impact on quality of life and work/social participation.Objectives:In this study, we evaluated the frequency with which patients on MTX therapy opt for self-administration over the weekend or in the evening hours, in order to minimize interference with daily activities, work productivity, and social participation.Methods:A cross-sectional, prospective study was performed in two tertiary referral Rheumatology clinics, which included consecutive patients with RA, PsA, or SpA on MTX therapy. Enrolled patients had not previously received instructions by their healthcare provider as to when during the week or day MTX ought to be administered, and were free to choose or change the weekday and time for self-administration. Data on the route and timing of MTX self-administration was collected using dedicated questionnaires, which included queries on the dose and route of administration, day of the week and time of self-administration, reasons for the patient’s choice, use of folic acid supplementation, and concomitant therapies. Statistical analyses were conducted using a chi-square test; a p-value <0.05 was considered significant.Results:A total of 275 consecutive patients treated with MTX were included, mostly with RA (86%). Patients had an average age of 59.8 years (SD 14.0) and an average disease duration of 134.5 months (SD 127.3). The average MTX dose was 15 mg/wk (SD 4.4); MTX was administered subcutaneously in 68.2% of cases, orally in 17.8%, and intramuscularly in 5%. Regarding the timing of MTX self-administration, 157 patients (57.1%) took MTX in the evening and 119 patients (44.3%) took it during the weekend; even among patients taking MTX in the evening, weekend administration was preferred (93/157, 59.2%, p <0.001). The most frequent reasons leading to MTX self-administration during the evening or weekend were gastrointestinal side effects/nausea (85% of cases), fatigue (63%), interference with work activities (36%) and interference with social activities (29%). Patients who opted for MTX self-administration in the evening or over the weekend were significantly younger (p <0.001), with no significant gender differences or disease duration.Conclusion:The majority of patients with inflammatory arthritis opt for self-administration of MTX in the evening (absolute majority) or during the weekend (relative majority). This choice is dictated by the need to avoid side effects and detrimental repercussions on the individual’s social or working life. The adoption of these strategies for minimizing the adverse effects of MTX is more frequent among younger patients, and provides an indirect, yet powerful indicator of the impact of MTX therapy on patients’ quality of life.Disclosure of Interests:Giulio Cavalli Consultant of: SOBI, Pfizer, Sanofi, Novartis, Paid instructor for: SOBI, Novartis, Speakers bureau: SOBI, Novartis, Martina Biggioggero: None declared, adriana cariddi: None declared, Giacomo De Luca Speakers bureau: SOBI, Novartis, Celgene, Pfizer, MSD, Elena Agape: None declared, nicola boffini: None declared, Elena Baldissera Speakers bureau: Novartis, Pfizer, Roche, Alpha Sigma, Sanofi, Lorenzo Dagna: None declared, Ennio Giulio Favalli Consultant of: Consultant and/or speaker for BMS, Eli-Lilly, MSD, UCB, Pfizer, Sanofi-Genzyme, Novartis, and Abbvie, Speakers bureau: Consultant and/or speaker for BMS, Eli-Lilly, MSD, UCB, Pfizer, Sanofi-Genzyme, Novartis, and Abbvie

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Comorbidities of rheumatic disease

Oxford Textbook of Rheumatology ◽

10.1093/med/9780199642489.003.0032_update_002 ◽

2013 ◽

pp. 243-250

Author(s):

Tuulikki Sokka ◽

Kari Puolakka ◽

Carl Turesson

Keyword(s):

Rheumatic Disease ◽

Rheumatic Diseases ◽

Health Professionals ◽

Organ Damage ◽

Inflammatory Rheumatic Diseases ◽

Rheumatology Clinic ◽

Cholesterol Levels ◽

Lifestyle Choices ◽

The Impact ◽

Index Disease

All other diseases that coexist with a disease of interest are called comorbidities. Comorbidities in inflammatory rheumatic diseases may be associated with persistent inflammatory activity or disease-related organ damage, or may be related to medications. Lifestyle choices such as smoking or physical inactivity contribute to comorbidity. Patients with rheumatic diseases meet health professionals regularly and are more often tested for osteoporosis or cholesterol levels than individuals without rheumatic disease, which may contribute to a higher prevalence of some comorbidities. Comorbidities can also be unrelated to rheumatic diseases or their treatments. The concept of ‘multimorbidity’ is being used increasingly, shifting the focus from the index disease to two or more chronic diseases that exist in the same individual. In this chapter, we discuss the impact of multi/comorbidities. We emphasize the importance to review and manage comorbidities in usual daily rheumatology clinic, to improve outcomes of patients with rheumatic diseases.

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AB0899-HPR THE IMPACT OF CORONAVIRUS (COVID-19) PANDEMIC ON THERAPEUTIC MAINTENANCE IN PATIENTS WITH CHRONIC INFLAMMATORY RHEUMATIC DISEASES

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.4151 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1472.3-1473

Author(s):

T. El Joumani ◽

H. Rkain ◽

T. Fatima Zahrae ◽

H. Kenza ◽

A. Radouan ◽

...

Keyword(s):

Rheumatic Diseases ◽

Well Being ◽

Therapeutic Education ◽

Inflammatory Rheumatic Diseases ◽

Rheumatic Arthritis ◽

Health Crisis ◽

Disease Evolution ◽

Chronic Inflammatory Rheumatic Diseases ◽

Disease Modifying ◽

The Impact

Background:The Coronavirus pandemic caused many consequences on well being, access to care and therapeutic maintenance in patients with chronic diseases.Objectives:To assess the impact of COVID-19 on therapeutic maintenance of patients with Chronic Inflammatory Rheumatic Diseases (CIRD) and to identify related factors to difficulties in access to rheumatologist care during the COVID-19 pandemic.Methods:A cross-sectional study was conducted among patients with rheumatic diseases using a questionnaire providing information on patients and disease characteristics, impact of COVID-19 on access to rheumatologist care and therapeutic maintenance during the confinement. Reasons of therapeutic interruption and of diificulties in access to healthcare were precised.Results:We received answers from 350 patients (female sex of 68%, mean age of 46,1 ± 14,4 years) suffering from Chronic Inflammatory Rheumatic Diseases (CIRD):rheumatic arthritis (RA) (62.3%), spondyloarthropathies (34.3%), and undifferentiated CIRD (3.4%). The global average disease evolution was 12,1 ± 9,7 years.The patients were treated with conventional Disease-modifying anti-rheumatic drugs (cDMARDs) and biologic Disease-modifying anti-rheumatic drugs (bDMARDs) in respectively 67.4% and 30.6% of cases. Corticosteroids and Nonsteroidal Anti-Inflammatories (NSAIDs) intake was noted in 39.1 and 33.7% of patients.Difficulties to access to rheumatologist care appointments were reported in 82.9% of the participants. Reasons of thoses difficulties are summurized in Figure 1.Figure 1.Causes of difficulties of access to Rheumatologist care during COVID-19 pandemic.Half of patients declared that the pandemic had affected their therapeutic compliance. Discontinued drugs were in decreasing order: Synthetic antimalarials (68.4%), NSAIDs (45.8%), Methotrexate (43.8%), bDMARDs (25.2%), Sulfasalazine (18.2%) and Corticosteroids (10,2%).Causes of treatments interruption are summarized in Table I.Table 1.Causes of treatments interuption in patients with CIRDDrugsNot found in pharmaciesThe pharmacy refuses to give me the treatment without a recent prescriptionTo avoid the decrease in immunity and therefore to avoid catching Covid-19I stopped the follow-up, and so I stopped the treatment...Other reasonsNSAIDS027.874.144.427.8Corticosteroids014.392.957.150Methotrexate70.1310.416.422.4Sulfasalazine012.52575100Synthetic antimalarial69.20023.161.5Leflunomide00000bDMARDs07.440.744.451.9Conclusion:The COVID-19 pandemic impacted heavly on therapeutic maintenance in CIRD patients in our country. Patients expressed many difficulties in access to appropiate management. Facing to all thoses consequences, we need to devolopp as soon as possible adequate solutions adapted in such health crisis, especially therapeutic education and telemedecine.Disclosure of Interests:None declared

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Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-220647 ◽

2021 ◽

pp. annrheumdis-2021-220647

Author(s):

Victoria Furer ◽

Tali Eviatar ◽

Devy Zisman ◽

Hagit Peleg ◽

Daphna Paran ◽

...

Keyword(s):

General Population ◽

Disease Activity ◽

Rheumatic Diseases ◽

Messenger Rna ◽

Vaccine Dose ◽

Adult Patients ◽

Control Group ◽

Inflammatory Rheumatic Diseases ◽

Igg Antibody ◽

Antibody Levels

IntroductionVaccination represents a cornerstone in mastering the COVID-19 pandemic. Data on immunogenicity and safety of messenger RNA (mRNA) vaccines in patients with autoimmune inflammatory rheumatic diseases (AIIRD) are limited.MethodsA multicentre observational study evaluated the immunogenicity and safety of the two-dose regimen BNT162b2 mRNA vaccine in adult patients with AIIRD (n=686) compared with the general population (n=121). Serum IgG antibody levels against SARS-CoV-2 spike S1/S2 proteins were measured 2–6 weeks after the second vaccine dose. Seropositivity was defined as IgG ≥15 binding antibody units (BAU)/mL. Vaccination efficacy, safety, and disease activity were assessed within 6 weeks after the second vaccine dose.ResultsFollowing vaccination, the seropositivity rate and S1/S2 IgG levels were significantly lower among patients with AIIRD versus controls (86% (n=590) vs 100%, p<0.0001 and 132.9±91.7 vs 218.6±82.06 BAU/mL, p<0.0001, respectively). Risk factors for reduced immunogenicity included older age and treatment with glucocorticoids, rituximab, mycophenolate mofetil (MMF), and abatacept. Rituximab was the main cause of a seronegative response (39% seropositivity). There were no postvaccination symptomatic cases of COVID-19 among patients with AIIRD and one mild case in the control group. Major adverse events in patients with AIIRD included death (n=2) several weeks after the second vaccine dose, non-disseminated herpes zoster (n=6), uveitis (n=2), and pericarditis (n=1). Postvaccination disease activity remained stable in the majority of patients.ConclusionmRNA BNTb262 vaccine was immunogenic in the majority of patients with AIIRD, with an acceptable safety profile. Treatment with glucocorticoids, rituximab, MMF, and abatacept was associated with a significantly reduced BNT162b2-induced immunogenicity.

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Predictors of an Immunogenic Response to the BNT162b2 mRNA COVID-19 Vaccination in Patients with Autoimmune Inflammatory Rheumatic Diseases Treated with Rituximab: A Multicenter Study

10.21203/rs.3.rs-1189980/v1 ◽

2021 ◽

Author(s):

Victoria Furer ◽

Tali Eviatar ◽

Devy Zisman ◽

Hagit Peleg ◽

Yolanda Braun-Moscovici ◽

...

Keyword(s):

Rheumatic Diseases ◽

Vaccine Dose ◽

Humoral Response ◽

Optimal Timing ◽

Inflammatory Rheumatic Diseases ◽

Inflammatory Myositis ◽

Predicting Factors ◽

Igg Level ◽

Immunogenic Response ◽

Independent Cohort

Abstract BackgroundTreatment with rituximab (RTX) blunts SARS-CoV-2 vaccination-induced humoral response. We sought to identify predictors of a positive immunogenic response to the BNT162b2 mRNA vaccine in patients with autoimmune inflammatory rheumatic diseases (AIIRD) treated with RTX (AIIRD-RTX).MethodsWe analyzed 108 AIIRD-RTX patients and 122 immunocompetent controls immunized with BNT162b2 mRNA vaccine participating in a multicenter vaccination study. Immunogenicity was defined by positive anti-SARS-CoV-2 S1/S2 IgG measured at 2 to 6 weeks after the second vaccine dose. We used a stepwise backward multiple logistic regression to identify predicting factors for a positive immunogenic response to vaccination and develop a predicting calculator, further validated in an independent cohort of AIIRD-RTX patients (n=48) immunized with the BNT162b2 mRNA vaccine.Results AIIRD-RTX patients who mounted a seropositive immunogenic response significantly differed from non-responders by lower number of RTX courses (median (range) 3 (1-10) vs 5 (1-15), p=0.007; lower cumulative RTX dose 6943.11±5975.74 vs 9780.95±7240.12 mg, p=0.033; higher IgG level prior to last RTX course (mean ± SD), 1189.78±576.28 vs. 884.33±302.31 mg/dL, p=0.002, and extended interval between RTX treatment and vaccination, 469.82±570.39 vs 162.08±160.12 days, p=0.0009, respectively. Patients with ANCA-associated vasculitis and inflammatory myositis had a low likelihood of a seropositive immunogenic response compared to patients with rheumatoid arthritis, odds ratio (OR) 0.209, 95% confidence interval (CI) 0.046-0.96, p=0.044 and OR 0.189, 95% CI 0.036-0.987, p=0.048, respectively. Based on these findings, we constructed a calculator predicting the probability of a seropositive immunogenic response following BNT162b2 mRNA vaccination which performed with 90.5% sensitivity, 59.3% specificity, 63.3% positive and 88.9% negative predictive values.ConclusionsThe predicting calculator might guide clinicians for optimal timing of BNT162b2 mRNA vaccination in AIIRD-RTX patients.

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Protocol for a multicentre randomised controlled parallel-group trial to compare the effectiveness of remotely delivered cognitive-behavioural and graded exercise interventions with usual care alone to lessen the impact of fatigue in inflammatory rheumatic diseases (LIFT)

BMJ Open ◽

10.1136/bmjopen-2018-026793 ◽

2019 ◽

Vol 9 (1) ◽

pp. e026793 ◽

Cited By ~ 1

Author(s):

Kathryn R Martin ◽

Eva-Maria Bachmair ◽

Lorna Aucott ◽

Emma Dures ◽

Richard Emsley ◽

...

Keyword(s):

Rheumatic Diseases ◽

Controlled Trial ◽

Scientific Journal ◽

Randomised Trial ◽

Inflammatory Rheumatic Diseases ◽

Exercise Interventions ◽

Cognitive Behavioural ◽

Graded Exercise ◽

Randomised Controlled ◽

The Impact

IntroductionFatigue remains pervasive, disabling and challenging to manage across all inflammatory rheumatic diseases (IRDs). Non-pharmacological interventions, specifically cognitive-behavioural approaches (CBAs) and graded exercise programmes designed to support and increase exercise, are valuable treatments which help patients with IRD to manage their fatigue. Yet, healthcare systems have encountered substantial barriers to the implementation of these therapeutic options. Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: a Randomised Trial (LIFT) is designed to give insights into the effectiveness of a remotely delivered standardised intervention for a range of patients with IRD. It will also enable the exploration of putative moderating factors which may allow for the future triage of patients and to investigate the precise mediators of treatment effect in IRD-related fatigue.Methods and analysisLIFT is a pragmatic, multicentre, three-arm randomised, controlled trial, which will test whether adapted CBA and personalised exercise programme interventions can individually reduce the impact and severity of fatigue. This will be conducted with up to 375 eligible patients diagnosed with IRD and interventions will be delivered by rheumatology healthcare professionals, using the telephone or internet-based audio/video calls.Ethics approval and disseminationEthical approval has been granted by Wales REC 7 (17/WA/0065). Results of this study will be disseminated through presentation at scientific conferences and in scientific journal. A lay summary of the results will be sent to participants.Trial registration numberNCT03248518; Pre-results.

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