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Objectives: BIOBADAGUAY is the Paraguayan/Uruguayan registry of adverse events in patients with inflammatory rheumatic conditions under biologic therapy (BT). Three years have elapsed from the first case of coronavirus and data about South American patients with COVID are still scarce. In this study we analyzed the frequency and clinical outcomes of COVID-19 in a cohort of patients with rheumatic diseases from Paraguay. Method(s): A cross sectional study of Paraguayan patients with rheumatic diseases from BIOBADAGUAY and controls without BT. Clinical, epidemiological, and COVID-19 data were analyzed. Only cases confirmed by SARSCoV-2 positive PCR test were included. Descriptive analysis were performed for this study. Result(s): 832 patients were included (696 under BT and 136 controls). 116 (13.9%) had COVID-19. 22 had a second infection and 9 a third reinfection. Table 1 shows characteristic of COVID-19 patients. The most frequent diagnosis was rheumatoid arthritis (n = 93, 80.2%) followed by ankylosing spondylitis (n = 6, 5.2%), undifferentiated spondylarthritis (n = 5, 4.3%), psoriatic arthritis (n = 4, 3.4%), juvenile onset arthritis (n = 2, 1.7%), vasculitis (n = 2, 1.7%). Only 1 case (0.8%) were registered for Still's disease, enteropathic spondylarthritis, systemic sclerosis and seronegative polyarthritis, respectively. When comorbidities were analyzed, 46 (39.6%) patients had at least one (Table 1). Of the total treatments received: 65 (56.0%) had methotrexate, 53 (45.7%) leflunomide, 3 (2.5%) sulfasalazine, 15 (12.9%) hydroxychloroquine, 25 (21.5%) glucocorticoid, 52 (44.8%) anti-TNF and 20 (17.2%) non-anti-TNF. COVID-19 severity outcomes were: 101(87%) non severe, 31 (26.7%) severe and 1 fatal(0.8%). 189 (90.9%) patients received vaccination and the mean number of doses were 2.5 doses. 55 (26.4%) had COVID prior to vaccination Conclusion(s): In this study we examined the frequency of COVID-19 in Paraguayan patients with rheumatic diseases. In this cohort of rheumatologic patients, COVID 19 severity was similar to the one in the 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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Objectives: To investigate the risk of flare-ups after COVID-19 vaccination in patients with rheumatic disease. Method(s): A total of 1,617 patients with rheumatic diseases were identified from three rheumatology clinics. Patients were interviewed for demographic data, disease activity, and vaccination status. Disease flare-up was determined clinically by independent rheumatologists. Change of serum markers and medications were retrieved from medical records. The risk of exacerbation of rheumatic disease, change in serum markers, and escalation of rheumatic medications between vaccinated and nonvaccinated patients were determined using Cox, linear, and logistic regression models, respectively. Possible confounding factors were also taken into consideration. Result(s): Among 562 (34.76%) patients who received COVID-19 vaccination, rheumatic disease (HR = 2.10, P < 0.001), inflammatory arthritis (HR = 2.71, P < 0.001), rheumatoid arthritis (RA) (HR = 2.03, P = 0.002), spondyloarthritis (SpA) (HR = 4.78, P < 0.001), autoimmune disease (HR = 1.77, P = 0.01), and systemic lupus erythematosus (SLE) (HR = 1.99, P = 0.02) were associated with postvaccination clinical flare-up. Adult Still's disease (B = 12.76, P = 0.03) was associated with increased serum C-reactive protein (CRP). No association was found between vaccination and escalation of rheumatic medication. Subgroup analyses showed that only the mRNA vaccine was associated with flare-ups. Conclusion(s): COVID-19 vaccination was associated with minor disease flare-up but not escalation of rheumatic medications. In the absence of absolute contraindications, COVID-19 vaccination is recommended in patients with rheumatic disease. KEY MESSAGES 1. Vaccination is effective in the prevention of morbidity due to COVID-19 in patients with autoimmune diseases. 2. The mRNA vaccine was associated with mild rheumatic disease flare-up. 3. Inactivated virus vaccine is preferable to mRNA vaccine in patients with active autoimmune disease. Copyright © 2023 The Author(s).
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Seasonal influenza is a frequent cause of hospitalization and mortality among patients with systemic autoimmune diseases. Despite this evidence, vaccination coverage is generally much lower than the minimum 75% target proposed by the WHO. Therefore, an active campaign was implemented in the years 2019/2020 and 2020/2021 within the Rheumatology Department of the Niguarda Hospital (Milan, Italy) to improve the vaccination coverage in patients with inflammatory arthritis. This study aims to evaluate the vaccination coverage in the 2019/2020 and 2020/2021 (active campaigns) seasons and to compare these results with the 2018/2019 season. A monocenter observational study was conducted among adult patients with rheumatoid arthritis, spondylarthritis, or psoriatic arthropathy, who were referred to the Rheumatology Department of the Niguarda Hospital. Patients were given a questionnaire to investigate previous years' vaccination coverage and to propose an influenza vaccine for the 2020/2021 season. Compared with 2018/2019, a trend for increase in vaccination coverage was reported in 2019/2020 season (+ 10.7%, p = 0.055; 45.5% of coverage) and a statistically significant increase was reported in 2020/2021 (+ 31.2%, p < 0.001; 65.9% of coverage). The increase was also significant when comparing the 2020/2021 and 2019/2020 seasons (+ 20.5%, p < 0.001). The greatest increase in vaccination coverage was observed among under-65-year-old patients. Obtained results support the implementation of active vaccination campaigns to increase vaccination coverage among patients with systemic autoimmune diseases and highlight the importance of external factors (such as the COVID-19 pandemic) in directing the patient to adopt preventive measures to avoid infections and related complications.
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Background: Vaccinations are of paramount importance in eradicating various diseases. Currently, there have been numerous reports on the development of new-onset autoimmune phenomena and disease flares following COVID-19 vaccination. The etiology and vaccine trigger mechanism of autoimmune disease still remains unclear. Molecular mimicry, by-stander activation and role of vaccine adjuvants are the main pathogenic mechanisms linked to an autoimmune phenomenon. However, vaccines as inducers of an autoimmunity is still an arguable subject. Case: We report a case series of six patients who developed new onset autoimmune reaction and disease flares following SARS-COV 2 vaccine. The patients received viral vector vaccine, inactivated vaccine and mRNA vaccine who developed symptoms in an average of 7-28 days following inoculation. A 27 year old male, previously healthy developed new onset of clinical amyopathic dermatomyositis after a week of 1st and 2nd dose of a viral vector vaccine. Two patients with systemic lupus erythematous developed severe cutaneous, hematologic and renal flare 14 and 28 days following vaccination. Two rheumatoid arthritis patients in long remission, developed atypical arthritis and disease flares after 10 and 14 days of inactivated and mRNA vaccine inoculation. One patient with spondylarthritis in remission experienced disease flare 7 days following inactivated SARS-COV- 2 vaccination. The patient age ranges from 19-72 years old of whom two are males and four are females. The management was individualized which includes oral corticosteroid and disease modifying anti-rheumatic drugs which showed improvement of symptoms. Conclusion: Development of an autoimmune reaction following SARS-COV 2 vaccination is of scientific and public importance. Vaccination might potentially trigger an autoimmune disease, however further investigations need to be established. The causative link between vaccination and autoimmunity needs to be studied. Susceptibility to a vaccine-induced autoimmunity might be triggered by the individual's genetic predisposition and several pathomechanisms.
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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 Sjögren'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.
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Objectives: To investigate the risk of flare-ups after COVID-19 vaccination in patients with rheumatic disease. Method(s): A total of 1617 patients with rheumatic diseases were identified from three rheumatology clinics. Patients were interviewed for demographic data, disease activity, and vaccination status. Clinical disease flare up was determined independently by expert opinion by managing rheumatologists. Change of serum markers and medications were retrieved from medical records. The risk of exacerbation of rheumatic disease, change in serum markers, and escalation of rheumatic medications between vaccinated and non-vaccinated patients were determined using cox, linear and logistic regression models respectively. Possible confounding factors were also taken into consideration. Result(s): There were 562 (34.76%) patients received COVID-19 vaccine. After vaccination, rheumatic disease (HR = 2.10, P < 0.001), inflammatory arthritis (HR = 2.71, P < 0.001), rheumatoid arthritis (RA) (HR = 2.03, P = 0.002), spondyloarthritis (SpA) (HR = 4.78, P < 0.001), autoimmune disease (HR = 1.77, P = 0.01), and systemic lupus erythematosus (SLE) (HR = 1.99, P = 0.02) were associated with clinical flare up. Adult still's disease (B = 12.76, P = 0.03) was associated with an increase in CRP level. Escalation of rheumatic medications were not associated with COVID-19 vaccination in all diseases. Subgroup analyses showed only mRNA vaccine was associated with disease flare ups. Conclusion(s): COVID-19 vaccine was associated with minor disease flare up but not escalation of rheumatic medications. In the absence of absolute contraindications, full COVID-19 vaccination in patients with rheumatic disease should be encouraged by managing rheumatologists.
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The proceedings contain 539 papers. The topics discussed include: advances in the understanding and management of atherosclerosis in inflammatory arthritis;long-term safety and efficacy of voclosporin in Asian patients with lupus nephritis;clinical profile of four children with juvenile dermatomyositis and anti-SAE antibody positivity: a single center experience from north India;the MMP degraded and citrullinated vimentin (VICM) is a diagnostic and treatment response biomarker;incidence and outcome of covid-19 in AIRD patients on concomitant treatment with tofacitinib- results from KRA covid cohort (KRACC) subset;are we treating-to-target in spondyloarthritis (SPA)? a cross-sectional analysis from the Asia Pacific league of associations for rheumatology (APLAR) SPA registry;utilities of low-dose computed tomography (LDCT) on identifying patient with axial psoriatic arthritis (AXPSA) a cross-sectional study;age-related genes USP2 and ARG2 are involved in the reduction of immune cell infiltration in elderly patients with rheumatoid arthritis;and MICRORNA-27a-3p inhibits lung and skin fibrosis of systemic sclerosis by negatively regulating SPP1.
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Background: Autoimmune inflammatory rheumatic diseases (AIRD) were associated with an increased risk for COVID-19 infection, worse clinical outcomes, and COVID-19- related deaths. Vaccines carry the potential benefit of reducing disease transmission and disease severity. Issues on vaccine safety, trigger of an autoimmune reaction or disease flares has been a long issue. Thus this study describes the COVID-19 vaccination status and adverse events following SARS-COV 2 vaccine in a tertiary hospital in Manila, Philippines. Method(s): This retrospective cross-sectional study included patients diagnosed with AIRD and seen in the clinics over 12 months (March 2021-March 2022).We collected data from patients' clinic records and analyzed the clinicodemographic profile, vaccination status, adverse events and development of new onset autoimmune reaction and disease flares post vaccination and those who developed COVID-19 infection even after vaccination. Result(s): There were 204 respondents included in this study: 174 (85%) were female and 30 (14%) were male;63.2 % with SLE, 10.8% rheumatoid arthritis, 8.3% psoriatic arthritis, 6.4% ankylosing spondylitis and other systemic autoimmune disease. Others included were scleroderma and inflammatory arthritis and myopathies. The median age is 38.4 years. 100% of the respondents were fully vaccinated;87 (42.6%) received inactivated vaccine, 63 (30.8%) viral vector vaccine and 54 (26.4%) mRNA vaccine. 133 (65.2%) reported no adverse events while 71 (34.8%) experienced constitutional symptoms, musculoskeletal, cutaneous, respiratory, gastrointestinal and cardiovascular symptoms after vaccination. There were 9 (4.4%) of the respondents who developed new onset autoimmune reaction and disease flares 7-28 days post vaccination;1 patient had new onset amyopathic dermatomyositis;3 SLE patients developed severe hematologic, cutaneous and renal flare;2 rheumatoid arthritis, 1 spondyloarthritis, and 1 inflammatory arthritis patients in long remission had disease flares and 1 patient with henoch schonlein purpura developed flare. Twenty two (10.8%)of the respondents developed COVID-19 infection after 30-120 days post vaccination;19 (86.4%) had mild symptoms, 2 (9.1%) moderate infection and 1 (4.5%) had severe infection and all of the patients recovered. Conclusion(s): This study showed that patients with AIRD experienced varied organ system adverse events following vaccination ranging from mild side effects, disease flares and new onset autoimmune reactions. The development of an autoimmune reaction following SARS-COV 2 vaccination is of scientific and public importance and still needs to be investigated. Even after a complete vaccination, some patients still had COVID-19 infection, however preventing them from worse complications, hospitalization and mortality.
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Introduction/Background: Primary bone marrow oedema syndrome is an elusive and less well-defined entity. Whether Rheumatologists should consider it as a stand alone diagnosis, is debatable. It possibly would be best described as an MRI feature which could be a finding in a number of diseases which would include the initial phases of Osteonecrosis of the bone, Rheumatoid Arthritis, Spondyloarthritis, Enthesitis related, Post traumatic, OA, Infections and Cancers. The treatment options become constricted due to the paucity of evidence. Rheumatologists need to consider this as an area of unmet need with development of consensus classification criteria and treatment approaches. Description/Method: 27-year-old male, Height 174 cms Weight 90 Kgs BMI 29 Kg/m2, became symptomatic in Jan 2022 with complains of pain in the both hip joints & groin regions, pain became excruciating and he became bed-bound, with early morning stiffness lasting approximately 45 mins. Had received steroids for COVID infection in August 2020. Investigations Hb 13.5gm/dl TLC 7000/mm3 Platelet 400 x 103/mm3 Sr Bil 0.8mg/dl AST 16 IU/L. ALT 24 IU/L Sr Creatininine 1.1mg/dl Blood Sugar Levels, Fasting 89 mg/dl Post Prandial 102 mg/dl ESR 10mm in 1st hour by Wintrobes method CRP Quantitative 29.38mg/L HLA B27 by PCR Negative, RF Negative, ACCP Negative Serum, IgG, Beta2 Glycoprotein 1.44 SGU Serum, IgM, Beta2 Glycoprotein 3.44 SGU Serum, IgG, Cardiolipin antibody 8.4 GPL Serum, IgG, Cardiolipin antibody 17.45 GPL Lupus anticoagulant by DRVVT Negative Sr Cholesterol 211mg/dl HDL 29 mg/dl LDL 156mg/dl TGs 130 mg/dl MRI Hips & SI joints Transient bone marrow oedema/osteopenia of bilateral hip. PET CT Increased metabolic activity in both hip joints Bone Scan (99mTcMDP) Increased vascularity in perfusion phase, increased accumulation in soft tissue in blood pool phase and increased uptake in bilateral Hip joints in skeletal phase scan, suggestive of CRPS Type-I. Management Was initially managed with Tab Etoricoxib 90mg BD, also started on Tab Sulphaslazine and Tab Methotrexate. However, when he had no symptomatic relief he was administered Inj Infliximab on 12 May 2022 and a second dose on 9 June 2022. He had excellent pain relief after the 1st dose, however after 10 days of the administration, he again began experiencing pain especially after walking. He also had pain in the knees on this occasion. He was also administered Inj Zoledronic 4mg on 23 May 2022. He is at present not requiring any NSAIDs over the last 1 month. Discussion/Results: The patient having presented with excruciating and debilitating pain was worked up and evaluation revealed features of bone marrow oedema on MRI which was corroborated with bone scan and PET CT imaging. The acute phase reactant CRP was also significantly elevated. The patient also gave history of early morning stiffness lasting approximately 45 mins. Hence an underlying Inflammatory process such as Spondyloarthritis(Peripheral) with enthesitis was considered. The confounding factors were the pain which worsened on mobilization, HLA B27 negative status, Rheumatoid Factor and ACCP negative status and past history of having received IV Corticosteroids for COVID infection in August 2020. In view of the debilitating pain and aworking diagnosis of Spondyloarthritis, hewas started onNSAIDs alongwith rest, initially, followed by conventional synthetic disease modifying agents in Rheumatic disease followed by biologic synthetic diseasemodifying agent - Inj Infliximab. The thought process was to avoid prolonged NSAID use to prevent the associated side effects. However, since Avascular Necrosis of the Femoral head is a very likely possibility, the patient is planned to be kept under close follow up. Key learning points/Conclusion: Collaborative efforts between the Departments of Nuclear Medicine, Radiology, Orthopaedics and Rheumatology are crucial in the early detection and approach to cases of Bone Marrow oedema. Avascular necrosis of head of Femur is a far more common entity and must be kept in ind even when a diagnosis of Bone Marrow oedema syndrome is being entertained. Diagnosis of Bone Marrow oedema syndrome must be entertained only as a diagnosis of exclusion. Continued follow up and regular imaging must be pursued rigorously in patients diagnosed with Bone Marrow oedema syndromes. There is a requirement to document acute phase reactants such as CRP and ESR in patients diagnosed with Avascular necrosis of bone as this data could help us differentiate AVN from Primary Bone marrow oedema in the early stages.
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Background: We recently reported an attenuate immunogenicity in patients with autoimmune rheumatic diseases. However, the effect of spondyloarthritis (SpA) and its treatment on COVID-19 vaccine immunogenicity remains to be determined for this group of patients. We therefore aimed to evaluate humoral immune responses to inactivated SARS-CoV-2 vaccine (CoronaVac) in patients with SpA (axial spondyloarthritis and psoriatic arthritis) taking DMARDs and commonly used targeted biological therapies, compared with a control group(CG). Objectives: Evaluate immunogenicity and safety of CORONAVAC (Sninovac, Beijing) in Spondyloarthritis (SpA) patients. Methods: Prospective observational cohort patients diagnosed with 194 SpA and 183 CG were vaccinated with CoronaVac in two doses with a 28-days interval. 194 patients completed the study and could be paired with CG for immunogenicity analysis. Blood samples were collected in the days 0, 28 and 69 (D69) to evaluate anti-SARS-CoV-2 IgG seroconversion(SC) and presence of neutralizing antibodies (NAb) in participants with negative IgG and NAb at baseline. Results: Patients and GC were comparable regarding age (p=0.93) and sex (p=1.00). Immunogenicity at D69 showed a moderate/high SC (80.2% vs. 95.7%, p<0.0001) and Nab positivity (61.6% vs. 82.7%, p<0.0001) in SpA but lower than CG. Factors associated with lower immunogenicity were older age (56.8 vs. 51.4;p=0.03318) and higher frequencies of prednisone (25.7% vs 4.2%;p=0.0004), methotrexate (51.4% vs 40.1%, p=0.0016) and TNF inhibitor (TNFi) (62.9% vs 34.5%, p=0.0035). Likewise, prednisone (17.6% vs. 2.8%, p=0.0013) and TNFi (50% vs 33.9%;p=0.0408) were associated with diminished NAb positivity. Sulfasalazine was associated with higher SC rates (8.6% vs. 26.8%, p=0.0246) and NAb positivity (13.2% vs. 29.4%, p=0.0168). The multivariate analysis revealed that older age (p=0.037), prednisone (p=0.001), TNFi (p=0.016), and methotrex-ate(p=0.017) were independently associated with lower SC while prednisone (p=0.006) and TNFi (p=0.027) were also associated with reduced NAb response. Conclusion: Our fnding of an excellent safety and moderate/high SC rate in SpA supports the recommendation of CoronaVac vaccination. The impaired immune response in the minority of patients under immunosuppressive and biological therapy requires novel strategies to enhance antibody response in this subgroup of patients.
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Background: Patients with autoimmune infammatory diseases (AID) have been prioritized for urgent vaccination to mitigate COVID-19 risk. However, few studies in the literature assessed the immunogenicity and safety of the COVID-19 vaccine in patients with AID. Objectives: In this context, the present study aims to evaluate the immunogenic-ity and safety of the vaccine against COVID-19 in patients with AID. Methods: These data are from 'Safety and efficacy on COVID-19 Vaccine in Rheumatic Disease'-SAFER study, a Brazilian multicentric prospective phase IV study to evaluate COVID-19 Vaccine in AID, in the real-life, in Brazil. Immunogenicity and adverse events (AE) from a single center were assessed, after 2 doses of ChAdOx1 (Oxford/AstraZeneca), 8 weeks of interval, in patients with AID and healthy controls (HC). Inclusion criteria were age ≥ 18 years and fulflling criteria according to international classifcation for AID. Exclusion criteria: pregnancy, previous severe AE to any vaccine, other immunosuppression causes. Stratifcation of post-vaccination AE was performed using a diary, flled out daily and returned at the end of 28 days for each dose. Participants were followed up through blood collection for measurement of IgG antibodies against SARS-CoV-2 spike receptor-binding domain by chemiluminescence (SARS-CoV-2 IgG II Quant assay, Abbott Laboratories, Abbott Park, IL, USA) at baseline and 28 days after the second dose. The seropositivity was defned for titers ≥50 AU/mL. Quantitative analyses were presented as observed frequency, percentage, central tendency, and variability measurements. The sample's normal distribution was verifed through the Shapiro-Wilk test. The Kruskal-Wallis test and the post-hoc Dwass-Steel-Critchlow-Fligner pairwise comparisons test were used to compare the IgG-S titers between the groups through the evaluation period. Categorical data were addressed using the Fisheŕs exact or Chi-squared (χ2) test. An alpha level of 5% signifcance was used in all analyses. Results: A total of 377 volunteers with AID and 50 HC were included in the study. Patients with spondyloarthritis (N=64), systemic lupus erythematosus (N=63), rheumatoid arthritis (N=61), primary Sjögren's syndrome (N=61), vasculitis (N=31), systemic sclerosis (N=14), inflammatory myopathy (N=9), Crohńs disease (N=49), ulcerative colitis (N=11) and other systemics AID (N=12) were evaluated. Both groups had female predominance (73.5% vs. 74.0%, p=0.937) and were homogeneous for age (43.5 vs. 41.7,p=0.308). The seroconversion among those not reactive (IgG-S negative at baseline) (46 HC and 191 AID), 28 days after second dose was 97.1% for spondyloar-thritis (p=0.425), systemic lupus erythematosus 88.2% (0.006), rheumatoid arthritis 93.5% (0.158), primary Sjögren's syndrome 92.6% (0.133), systemic sclerosis or inflammatory myopathy 47.1% (0.001), inflammatory bowel disease 100% (0.999) and vasculitis 80% (0.006), while in healthy control was 100%. In comparison with HC, there was a statistically significant difference in IgG-S titles only in systemic sclerosis or inflammatory myopathy (1.694 AU/ml vs. 3.719 AU/ml;p=0.006). Both groups only presented mild AE. Pain at the injection (85.7% vs. 78.4%, p=0.239), headache (67.3% vs. 53.8, p=0.074) and fatigue (59.2% Vs. 46.2%, p=0.089) were more common in HC than AID. Overall, reactions like arthralgia (52.6 vs. 22.4%, p<0.001), hematoma (14.1 vs. 4.1%, p=0.05), cutaneous rash (9.5 vs. 0%, p=0.024) were more frequent in AID. Most participants related that they felt safer after receiving a COVID-19 vaccination, and 52.4% did not reported a worse patient global assessment (PGA) index. Conclusion: In conclusion, our data indicated that ChAdOx1 vaccine is safe and induced high titers and seroconversion rate in AID. More severe AID, such as vasculitis, systemic lupus erythematosous, and systemic sclerosis and myositis showed a lower seroconversion rate. Further analysis will explore the association between immunossupressant and reactivity, and booster dose.
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Background: Coronavirus 19 disease (COVID-19) represents the most important pandemic of the last century. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection has produced more than 170 million cases and more than 3 million deaths. Due to the easy spread of the infection and the possibility of serious clinical manifestations, the role of anti-COVID 19 vaccination is essential. Vaccines with different mechanisms of action have been developed: mRNA-based, such as Biontech-Pfzer and Moderna, and viral vectored, such as AstraZeneca and Janssen. Despite possible adverse events, benefts afforded by these vaccines signifcantly outweigh potential risks associated with their administration in the general population. Objectives: This study aimed to evaluate incidence and severity of adverse events (AEs), secondary to vaccination, in patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Spondyloarthritis (SpA), immune-mediated diseases treated with immunomodulating drugs, by administering a questionnaire. Methods: 294 patients (201 f and 93 m) were enrolled with a diagnosis of arthritis (RA 28%, PsA 43%, SpA 28%). Results: Of the 294 enrolled patients, 107 underwent COVID vaccination, 73% with Biontech-Pfzer vaccine, 20% Astrazeneca and 6% Moderna. 50% of patients completed the entire vaccination cycle. 46% of patients presented AEs after the frst dose of vaccine (45% of vaccinated with Biontech-Pfzer;48% of vaccinated with Astrazeneca, 33% of vaccinated with Moderna). The most frequently observed AEs are: pain at the injection site (17%), fever (13%), headache (12%), myalgia (12%), fatigue (7.5%). Only 2.9% of patients had arthritis fares. The greatest trend of AEs was observed in patients with PsA (48%), and RA (26%). 32% of patients receiving the second dose of vaccine presented AEs (40% Moderna, 32% Biontech-Pfzer). The most frequently observed AEs after the second dose are: pain at the injection site (4.7%), fever (9%), headache (2.8%), myalgia (6%). No patient had arthritis fare after the second dose. The greatest trend of AEs was observed in patients with SpA (66%). Only 11% of patients presented AEs after the administration of both doses. Thirteen percent of patients did not follow the clinician's recommendations for immunomodulatory drug management, provided as per ACR or SIR recommendations. Conclusion: The incidence of adverse events in arthritis patients was in line with that of the general population, without presenting serious manifestations, such as thrombosis, and without indicating a preference on the type of vaccine.
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Background: Over the past few decades there have been an increasing debate around the use of telemedicine. Despite this, there is still a slow rate of adoption of telemedicine services. According to a recent scoping review this may be due to a piecemeal approach to the change process, and a lack of understanding of how to plan, manage and reinforce change when implementing telemedicine service1. A virtuous example of implementation of telemedicine services can be found within the rheumatology unit of Niguarda Hospital in Milan (Italy), where the whole staff has been involved in experimenting with new multichannel interactions to communicate with patients for more than a decade. Developed in 2011 with the introduction of the iAr Plus app for the collection of Patient Reported Outcomes (PROs), the project was first targeted to patients with Rheumatoid arthritis, Pso-riatic arthritis and Spondylarthritis. In 2019 the project consolidated and added the home delivery of biological drugs for the stable patients. During spring 2020, this experience was further enhanced and extended to all patients treated with biological drugs to facilitate patient interaction during Covid-19 and was characterized by three elements: remote monitoring, triage through phone calls and home delivery of medication. What contextual factors and mechanisms adopted to plan, manage, and reinforce change where more successful? Objectives: This study aimed to highlight what were the distinctive and successful elements of this implementation experience, what we could learn from it, and which managerial implications we could derive for future implementations. Methods: We adopted a realist evaluation approach2 to identify the underlying generative mechanisms that explain 'how' the outcomes were caused and the influence of context. Thus, we deepened how the change management process has been managed by conducting semi-structured interviews with the unit director, and the staff members involved in the phases of the project (i.e., clinicians, nurses, and administrative staff). The interviews were recorded and analyzed through an ad-hoc framework1 for the analysis of change management practices. This framework identifes 10 change steps divided into 13 strategic practices and 6 operational practices that are important during the preparatory phase of the change process, for managing the change, and to sustain and reinforce longterm change. Results: Our study identifed the most relevant actions put in place by the rheumatology unit during the three major steps of preparing for change (e.g., developed telemedicine App, assigned coordinating role, identifed champions), managing change (e.g., developed and articulated a clear vision, provided training, developed ownership), and reinforcing change (e.g., continued to engage partners). The analysis highlighted four main lessons learned: frst the characteristics of the context and a strong managerial structure were a prerequisite for success. The generative mechanisms that explain how these successful outcomes were caused are: a leadership role able to defne a clear vision and a clear specialization of tasks and roles;the involvement of all team members;regular meetings and interactions. Second, patients should be involved as central actors in the defnition of the care pathway. The fnal decision on the kind of services to be used was made by the patient. Third, the relevant stakeholders should be involved since the co-design of the app. Finally, change should be incremental. The Rheumatic unit introduced one change at a time, and this brought to constant improvements. Conclusion: The framework adopted can be used either to retrospectively analyze the experiences developed but may also act as a tool to guide future tele-medicine service implementation and research. As well as the lessons learned can guide the implementation of future telemedicine experiences.
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Background: The lockdown and mobility restrictions in early COVID19 pandemic had a great impact in chronic patient care due to limited access and scheduled visits. In our hospital, coordinated non-pharmacological interventions (NPI) were designed in Rheumatology and Pharmacy services to maintain the accessibility and continuity of care for patients with IMID. Objectives: To evaluate the patient reported experience (PRE), health status and quality of life in Rheumatology outpatient IMID subjects since March 14, 2020 when lockdown was imposed and during subsequent restrictions, related to the healthcare team and medications accessibility, and continuity of care. Methods: Observational study, using a patient survey. Adult patients attending the rheumatology outpatient clinic between Nov 2, 2020 to Feb 13, 2021, with rheumatoid arthritis (RA), psoriatic arthritis (PsA), spondylarthritis (SpA) or systemic autoimmune diseases (SAD), with at least 1 year from diagnosis and 1 month of treatment with conventional synthetic (cs) targeted synthetic (ts) or biological (b) disease modifying antirheumatic drugs (DMARD). Face to face or phone interviews were conducted using an ad hoc designed questionnaire that included COVID19 related questions, the 11 IEXPAC scale items (5 point Likert scale ranging from never to always) (www.iexpac.org), and 4 items (5 points, very good to very bad) of the global scale PROMIS 10 (Patient-Reported Outcomes, PRO). All questions refer to the patient's experience during the 6 months prior to data collection. Results: From 174 screening patients, 158 completed the survey, mainly woman (66.5%) with a median age of 60 (IQR 47-69,3) years. The most frequent diagnosis was RA (43%) followed by ESAP (35%), EAS (22%) and PsA (13%). 46.8% of the patients have been prescribed b or ts DMARD and 53.2% sc DMARD, 32.9% in combination. From 158, 39 persons requested healthcare for COVID-19 related symptoms and diagnosis was confrmed in 17 (10,8%). Just 2 patients required hospital admission. Clinical control and continuity of care for COVID19+ patients were carried out from their primary care center and by phone consultation. Some key results of the survey are displayed in Table 1. Conclusion: Lessons have learned during the COVID19 lockdown and restrictions by assessing patients' health status and patients-reported experience. Coordinated NPI such as medication monitoring and home delivery, appointment reorganization and protocolized phone visits can result in a good patient perception and medication adherence whilst receiving care in a challenging situation.
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Background: Multimodal rheumatologic complex treatment (MRCT) is a treatment concept for patients with rheumatologic diseases requiring acute inpatient care suffering from exacerbated pain and/or functional impairment. A rheumatol-ogist directs the treatment program including multimodal assessments and treatment from three of the following: ergotherapy, physiotherapy, pain medicine and cognitive behavioural treatment. Most studies evaluated data from a two-week inpatient MRCT program.1 Available data on the effectiveness of a one-week inpatient multimodal treatment program are scarce. However, whether a shorter program might also be effective has not been studied so far. Objectives: To evaluate the effectiveness of a one-week inpatient multimodal and interprofessional treatment program on musculoskeletal pain and function of patients with rheumatologic disorders. Methods: 59 consecutive patients were entered into a program of multimodal treatment courses (MRCT) from January 2021 until December 2021. All patients completed a total of 11 hours of therapy in one week. Two patients were excluded for evaluation (one patient acquired COVID 19 during hospitalization and one patient was excluded due to missing data). Pain was assessed via visual analogue scale (VAS) and functional impairment via the 'Funktionsfragebogen Hanover (FFbH)' and the 'Health Assessment Questionnaire (HAQ)' at admission, at discharge and at 12 weeks of follow up. Paired t-test analyses for all treatment episodes were performed. Results: The mean treatment duration (days, ±SD) was 8.1 ± 0.8. Mean age (years, ±SD) of the 57 patients treated in the MRCT program was 57.2 ± 12.5, with 72% female and 28% male patients. Of all patients, 40% had an underlying infammatory disorder, 60% a non-infammatory rheumatic disease. 23% of all patients had 'back pain', 14% 'spondyloarthritis' and 11 % 'rheumatoid arthritis'. Overall, VAS (pain) mean at admission was 6.9 ± 1.0 (SD), HAQ mean 0.57 ± 0.23 (SD) and FFbH mean 81.44 ± 7.95 (SD), respectively. Signifcant improvements in VAS, HAQ and FFbH were demonstrated at discharge (day 8), with a mean improvement of VAS of-2.86 (95% CI:-3.07 to-2.64, P value: <0.0001), a mean improvement of HAQ of-0.24 (95% CI:-0.28 to-0.20, P value: <0.0001) and a mean improvement of FFbH of 5.38 (95% CI: 3.78 to 6.98, P value: <0.0001). Follow up assessment at week 12 was recorded in 22 patients (39%) with a signifcant mean improvement in VAS of-2.23 (95% CI:-2.98 to-1.48), P value < 0.0001) (Table 1 and Figure 1). Conclusion: Signifcant improvement of pain and function was demonstrated at discharge and at week 12 in patients with rheumatologic diseases and mus-culoskeletal pain completing a one-week inpatient multimodal interprofessional treatment program. A multimodal therapeutic approach may provide an effective treatment strategy superior to unimodal standard management.
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Background: The preselection of patients with suspicion of an infammatory rheumatic disease is not easy for general practitioners and orthopedists. In countries with a limited number of practicing rheumatologists waiting lists are often long, since a full rheumatologic examination often needs a long consultation time. Objectives: To test the performance of an early triage strategy for early identif-cation of patients with infammatory rheumatic diseases. Methods: Prior to the SARS-CoV 2 pandemic, physicians caring for patients contacting a tertiary rheumatologic cente were frst contacted by a health-care professional (HPR) who offered an appointment the timing of which was based on the symptoms reported (Step 1). Patients were then seen by a rheumatolo-gist who, within a 10-minute consultation (Step 2), shortly examined the patient to determine the urgency of a planned full work up. The main outcome of the study was the comparison between the initial assessment and the fnal expert diagnosis (Step 3). Results: Within 9 months, physicians caring for 1.180 patients contacted the hospital, 972 of whom kept their appointment (82.4%). Most patients were transferred by GPs (73.1%) and orthopedists (22.1%). The mean time between Step 1 and Step 2 was 10.4 days, while 6.2% of patients were seen within 4 days, 24.4% within 7 days and 69.3% within 12 weeks. Only 36 patients (3.7%) of patients had an already established rheumatic disease. Complaints lasting between 0-4 weeks were reported by 69 (7.1%), of > 4-12 weeks by 100 (10.3%), and of > 12 weeks by 973 (82.6%) patients. Almost 90% of patients reported a pain intensity >4/10 (NRS) for < 2 weeks. An elevated CRP was found in 207 patients (24.5%). Prior treatment with glucocorticoids was reported in 163 (16.8%) and with NSAIDs in 730 (75.1% of) patients. The confirmed diagnosis at Step 3 was rheumatoid arthritis in 127 (13.1%), spondyloarthritis including pso-riatic arthritis in 72 (7.4%), systemic diseases including connective tissue diseases in 112 (11.5%), vasculitides in 41 (4.2%), and crystal arthropathy in 38 (3.9%) patients, while 38 (3.9%) had an infection, a malignancy or a differential diagnosis such as Raynaud's phenomenon or sicca syndrome. Degenerative joint diseases (n=254;26.1%) and non-inflammatory soft tissue syndromes such as fibromyalgia (n=369;38%) accounted for more than half of the patients. Conclusion: This study describes the performance of a standardized triage system hereby confrming the need for an early identifcation and preselection of patients with rheumatic musculoskeletal symptoms, including involvement of HPRs in the initial phase of contact. Based on the results, three patients with musculoskeletal complaints had to be examined in order to identify one patient with an infammatory rheumatic disease.
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Background: Although there have been expansion of knowledge about the course of COVID-19 in rheumatologic diseases, it still remains unclear the effect of vaccination status and variants on the disease course. Objectives: We aimed to investigate the general clinical characteristics of our patients with infammatory rheumatic disease (IRD) who had COVID-19 disease, their vaccination status and the time periods in which different variants were dominant during the disease. Methods: During the routine follow-up of our patient's with IRD, whether the patients had COVID-19 disease, when they were vaccinated (Pfzer/Biontech or Sinovac in our Country) and main clinical characteristics and their comor-bid diseases were recorded. The last patient was included in the study on January 25, 2022. They were divided into those who received insufficient or no vaccine and those who received a full dose of vaccine. The patients were divided into 3 groups according to the period they had the disease: Those who had the disease between March 2020 and June 2021accepted as '1st period patietns', the period when the Alpha and Beta variants, the initial forms of the disease, were dominant variants in populations;those who had the disease between July 2021 and November 2021, when the Delta variant dominated the World and in our country accepted as '2nd period patients';and those who had the disease in December 2021 and later, when the Omicron variant was dominant throughout the world and in our country, was accepted as ' 3rd period' patients. Results: Total 463 (294 woman) IRD patients enrolled to the study. Distrubution of these patients included Behcet's syndrome:15;familial mediterranean fever: 5 7, rheumatoid arthritis:134, Sjogren's syndrome:24, systemic lupus erythema-tosus:26, Spondyloarthritis:141, necrotising vasculitis:6 and Others:50 cases. Mean age of patients were 46±13,2 (18-83) years. 354 (77%) of our patients got sick in the 1st period, 80 (17%) in the 2nd period and 28 (6%) in the 3rd period. When patients were compared in terms of their clinical complaints in these periods, dyspnea was signifcantly higher in patients in the 1st period (1st. period 36% vs 3rd period 18%;p:0.039), but there was no difference between other complaints including lung involvement and the frequency of hospitalization (p>0.05). 53% of patients had received at least 2 doses of mRNA vaccine. 84% of the patient has had COVID19 before full vaccination with any valid vaccine. When the patients who were full vaccinated and those who were not vaccinated or inadequately vaccinated at the time of illness were compared in terms of clinical features, lung involvement frequency and hospitalization frequency, no difference was found between them. (p>0.05, for all). However, hospitalization and lung involvement were less in those who received a booster dose of any valid vaccine (p: 0.03). While the average hospitalization rate was 17% for all groups, this rate was 50% for necrotizing vasculitis and was signifcantly higher (p:0,005). The probability of lung involvement and hospitalization were found to be sig-nifcantly higher in patients using prednisolone 5mg (or equivalents) or more;(p:0.008 and p:0.000, respectively). Pulmonary involvement was signifcantly higher among patients receiving sulphasalasine (p:0.008). Among the patients on Rituximab, the probability of hospitalization was higher than those who did not (p: 0.01). There was no statistical difference in terms of hospitalization and pulmonary involvement between patients who took other drugs (p>0.05, for all). A total of 5 cases died, including 2 GPA, 1 EGPA, 1 RA and 1 FMF patients. Only 8 patients had a second history of COVID19. Conclusion: The frequency of COVID-19 among IRD cases seems to decrease over time. Full vaccination seems effective for the prevention of COVID-19. It should be recommended that IRD patients have the full dose of vaccines and boosters. The risk of lung involvement and hospitalization increases in patients using certain drugs, such as corticosteroids, sulphasalasine and ituximab. These patients should be followed more closely.
ABSTRACT
Background: During the COVID-19 pandemic telemedicine has become an important and safe means for patients suffering from chronic diseases to control their condition with the assistance of a physician [1]. In order to ensure that treatment of chronic rheumatic diseases is effective, it is important that patients develop a favorable attitude towards telerheumatology [2] as well as disease-related individual behavior, which signifcantly depends on the patients' health locus of control [3]. Objectives: To analyze the attitude of patients suffering from chronic rheumatic diseases towards peculiarities of remote consultations by a rheumatologist and their correlation with health locus of control. Methods: To reveal the patients' attitude towards remote consultations by a rheumatologist, an original questionnaire has been prepared, which contains: reasons for choosing remote consultations, fears about such consultations and their advantages. Health locus of control was evaluated using a Multidimensional Health Locus of Control (MHLC) scale, which consists of three subscales: Internal, Chance, and Powerful Others. Demographical questions and questions related to health are also included in the questionnaire. 207 subjects participated in the study: 177 (85.5 %) women and 30 (14.5 %) men, (Mage=39.4, SD=11.76). The majority of subjects were diagnosed with spondyloarthritis (n=83), connective tissue diseases (n=53), rheumatoid arthritis (n=49), and osteoarthritis (n=20), 42 subjects were diagnosed with some other rheumatic diseases. 111 (53.6%) patients had the previous experience of remote consulting by a rheumatologist. Results: It has been determined that the attitude of patients with rheumatic diseases is related to various demographic characteristics of patients, e.g., gender, etc., and the peculiarities of the disease, e.g., strength of the symptoms, etc. It has been found that patients without experience of remote consultations have more fears about such consultations (p=0.024). When comparing the average of statements revealing a positive attitude M=66.4% with the average of statements revealing a negative attitude M=27.3%, it becomes clear that the overall attitude of subjects toward remote consultations of a rheumatologist is favorable. To assess correlations between positive or negative attitude of patients with rheumatic diseases and health locus of control correlational analysis was performed. The results did not confrm the expected correlations between the positive attitude of patients with the internal locus of control. However, it has been obtained that negative attitude towards remote consultations by a rheumatologist positively correlates with two indicators of health locus of control-Chance (r=0.203, p≤0.0001) and Powerful Others (r=0.194, p=0.01), although the said correlation is not strong, but statistically signifcant. Conclusion: The study has revealed the major fears and satisfaction sources related to remote consultations of Lithuanian patients with rheumatic diseases. In addition, it has shown that personal convictions of a patient that health depends on the circumstances and the influence of other people exacerbates the attitude towards remote consultations.
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Background: Rheumatological disease fares may be seen after many infections. However, our knowledge for the post-COVID axial spondyloarthritis (SpA) fares and its related factors is limited. Objectives: We aimed to evaluate disease activity and factors that may be associated with disease activity in axial SpA patients in post-COVID period. Methods: We retrospectively assessed the axial SpA patients who have had COVID-19 disease confrmed by a positive SARS-CoV-2 polymerized chain reaction (PCR) test result. Demographics, comorbid diseases, active medical treatments for SpA and information regarding COVID-19 clinical courses were collected from medical records. PCR positive patients were reached via telephone and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scored for pre-and post-COVID SpA symptoms. An increase of ≥2 points in the BASDAI score was defned as fare, and SpA groups with and without fare were compared. Factors predicting SpA fare were also analyzed by the logistic regression analysis. Results: A total of 48 axial SpA patients were included in our study, 65% of them male and the mean±SD age was 42.3±8.6 years. Post-COVID SpA fare was seen in 38% patients. Demographic, clinical, medical features of the SpA patients and COVID-19 disease severity were similar between Flare and No fare groups. In comparison of the COVID-19 symptoms, although most of the COVID-19 related symptoms were similar between two groups, the frequency of the back pain and diarrhea were higher in the Flare group than No fare group. But in multivariate analysis, only history of the infammatory bowel disease had an increased risk for post-COVID SpA fare (Table 1). Conclusion: The presence of infammatory bowel disease statistically signifcant related post-COVID SpA fares. In addition, diarrhea and back pain symptoms in COVID-19 disease may be stimulating factors for SpA fares but we found no effect of rheumatological therapies.