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BackgroundIt is known that rheumatologic patients often present a course of COVID-19 similar to that of the general population. Some factors are linked to a worse COVID-19 outcome, such as moderate glucocorticoid (GC) dose, high body mass index (BMI), and comorbidities.ObjectivesTo describe the outcome of COVID-19 in patients with rheumatoid arthritis (RA) in terms of symptoms, therapy and need for hospitalization compared to a control group. Also, to evaluate the variation in disease activity before and after COVID-19.MethodsIn this monocentric prospective study, we recruited consecutive adult patients with RA classified according to ACR-EULAR 2010 criteria who received a diagnosis of COVID-19 through molecular or rapid antigen swab tests between September 2020 and December 2022. Demographic and clinical data, including age, BMI, smoking habit, comorbidities, treatment at the diagnosis of COVID-19, duration of COVID-19, symptoms related to the infection and therapy required, together with the vaccination status were collected through a self-administered questionnaire. We compared DAS28-CRP before the infection and at the first visit after the resolution. As controls (Cs), individuals with COVID-19 but with no referred diagnosis of rheumatic/autoimmune disease were recruited.ResultsWe enrolled 111 patients affected by RA (males 15%, median age 56 years, IQR 25) and 89 Cs (males 44%, median age 47 years, IQR 43), whose demographic and clinical characteristics are reported in Table 1. The median RA disease duration was 108 months (IQR 201). At the COVID-19 diagnosis, 62 patients (56%) were assuming csDMARDs, 67 (60%) bDMARDs, and 18 (16%) GC with a median prednisone equivalent dose of 4 mg/day (IQR 1). DAS28-CRP was available for 62 patients, with a median value of 1.67 (IQR 2.71);42 patients (60%) were in remission (Figure 1). Before developing COVID-19, only 35 (32%) RA patients and 42 (47%) Cs had completed the vaccinal cycle, which was performed by mRNA vaccine in all the patients and 87% of Cs. The median COVID-19 duration was 18 days (IQR 18) for RA patients and 14 days (IQR 13.5) for Cs (p>0.7). Cs reported a significantly higher frequency of constitutional symptoms (headache and asthenia) compared to RA patients (p<0.00001). When hospitalization was required, RA patients received heparin more frequently than Cs (p<0.039). Once COVID-19 was resolved, RA patients were evaluated after a median of 2 months (IQR 2). DAS28-CRP was available for 68 patients, with a median value of 1.61 (IQR 1.77);42 patients (68%) were in remission (Figure 1).No differences in terms of COVID-19 duration, clinical manifestations, and therapy emerged comparing RA patients in remission (40;58%) with patients with the active disease before COVID-19 (29;42%). Also, in vaccinated subjects, the outcome of COVID-19 was similar in RA patients and Cs, irrespective of RA activity.ConclusionCOVID-19's impact on patients with RA was not significantly different from the general population, even for patients with active RA. Patients did not suffer from reactivation of RA because of COVID-19. In our opinion, these positive results could be ascribed to the massive vaccination campaign.References[1]Conway R et al, Ir J Med Sci. 2023[2]Andersen KM et al, Lancet Rheumatol. 2022Table 1.Clinical characteristics, COVID-19 symptoms, and therapy of the two groups. Values in brackets are expressed as percentages unless specified. Musculoskeletal diseases: osteoarthritis and osteoporosis.Rheumatoid arthritis N=111Controls N=89P value*ACTIVE SMOKERS13 (12)20 (22)BMI (IQR)24 (7)23(6)COMORBIDITIES64 (58)44 (49)Cardiovascular26 (23)18 (20)Endocrine24 (22)14 (16)Musculoskeletal11 (10)6 (7)Neoplastic12 (11)3 (3)CLINICAL MANIFESTATIONS96 (86)74 (83)Fever50 (45)47 (53)Constitutional symptoms52 (47)75 (84)p <0.00001Respiratory symptoms100 (90)86 (97)Gastrointestinal symptoms12 (11)13 (15)THERAPY88 (79)74 (67)NSAIDs41 (37)31 (35)Glucocorticoids24 (22)21 (30)Antibiotics33 (30)27 (24)Oxygen6 (5)5 (6)Heparin8 (7)0 (0)p <0.039HOSPITALIZATION10 (9)6 (9)*Where not indi ated, p value >0.5Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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BackgroundThe World Health Organization defined long-COVID or post-COVID-19 condition as "the continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation” [1]. Data on long-COVID in patients with inflammatory arthritis are very limited. The prevalence of this condition is 45% in the general population affected by COVID-19 who still experience symptoms after 4 months from the infection [2].ObjectivesTo investigate the persistence of symptoms after SARS-CoV-2 infection in a cohort of patients with inflammatory arthritis and the most common clinical manifestations.MethodsWe enrolled adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) classified according to standard criteria that received a diagnosis of COVID-19 through molecular, rapid or quantitative antigen swab tests between September 2020 and September 2022. Demographic and clinical data including age, body mass index (BMI), smoking habit, comorbidities, rheumatic treatment at diagnosis of COVID-19, date of COVID-19 diagnosis and clinical manifestations were collected through a questionnaire and recorded in a database.ResultsThirty-eight (40%) patients with RA, 49 (51.6%) with PsA, and 8 (8.4%) with AS [total: 95 patients;F:M=65:30, median age 56 years (IQR 15), median BMI 25.54 kg/m2 (IQR 5.58), active smokers 21 (22.1%), median rheumatic disease duration 96 months (IQR 120), median COVID-19 duration 13 days (IQR 7)] were recruited. Eighteen (19%) were only treated with csDMARDs, 38 (40%) only with bDMARDs, 29 (30.5%) with csDMARDs and bDMARDs, 8 (8.4%) were not taking any treatment and 2 (1%) were only taking glucocorticoids.Six (6.3%) patients were hospitalized (either in Day Hospital facilities for monoclonal antibodies infusion or in the emergency room). Twenty-six (27.3%) and 7 (7.3%) patients reported pre-existing cardiovascular or respiratory comorbidities, respectively. Ninety patients (94.7%) had a symptomatic SARS-CoV-2 infection. Seventy-five (79%) patients reported the persistence of symptoms after the end of the infection (negative swab), while 20 (21%) patients reported no symptoms. Among the former, 38 (50.7%) patients were symptomatic for ≤3 months and 37 (49.3%) were symptomatic for >3 months. In the hospitalized subgroup, 6 (100%) patients reported the persistence of COVID-19 symptoms, while this was reported by 69 (77.5%) patients in the non-hospitalized subgroup (p=ns).The clinical manifestations and their persistence after the infection are reported inFigure 1. The most common were cough and fatigue, which both lasted ≤3 months in 38 (42.2%) patients and >3 months in 3 (3.33%) and 21 (23.3%) patients, respectively. Headache (32 patients - 35.5%), arthralgias (28 patients - 31.1%), myalgias (27 patients - 30%) and shortness of breath (25 patients - 27.7%) were the most common symptoms that persisted in the first 3 months after the infection. Symptoms that persisted for >3 months in more than 20% of the patients were arthralgias (24 patients - 26.6%) and sleep disturbances (19 patients - 21.1%). However, it is difficult to assess whether arthralgias and myalgias were consequences of COVID-19 or secondary to the rheumatic disease. No COVID-19-related deaths were recorded.ConclusionOur data show the persistence of symptoms of COVID-19 after recovery in 79% of patients with chronic inflammatory arthritis. 49.3% of patients were symptomatic for >3 months. Cough, fatigue, headache, arthralgias, myalgias and shortness of breath were the most represented symptoms in the first 3 months after the infection, while arthralgias, fatigue, and sleep disturbances were the most reported after 3 months from SARS-CoV-2 infection.References[1]https://www.who.int/europe/news-room/fact-sheets/item/post-covid-19-condition updated: 7 Dec 2022[2]O'Mahoney LL et al. Lancet 2022Figure 1.Persistence of symptoms and signs after the end of SARS-CoV-2 infection.Data are represented as percentagesAcknowl dgements:NIL.Disclosure of InterestsNone Declared.
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PurposeA pandemic emergency could represent a source of concern for Systemic Lupus Erythematosus (SLE) patients and their rheumatologists;the unexpected arrival of the COVID-19 emergency could determine the loss of health status control, with anxiety and stress development. Here, we performed a descriptive and explanatory study to describe the expectations and potential concerns related to COVID-19 vaccination in SLE subjects, by using a narrative approach and thus providing the patients’ perspectives.MethodsSLE patients filled out an anonymous self-administered web-based questionnaire consisting of four questions regarding their experience with SLE over the past year and with vaccination, as reported below:1. How have you experienced your condition as a Lupus patient in the last year?2. How did you feel when you were called for the vaccination? What did it mean for you to be called for the vaccination?;3. Describe the day of vaccination;4. Do you think anything will change in your life now that you have been vaccinated? (If so, what)?).Furthermore, the Positive and Negative Affect Schedule (PANAS) and the Generic Risk Perception (GRP) were performed in all the patients.ResultsThirty-one patients were recruited [M/F 29/2;mean age 45.2 years (SD 8.9)]. The experience during the last year was described with a predominantly negative connotation, referring to the fear of infection, feelings of fear or anxiety, concern for own frailty or for contracting the virus. Concerning the question on vaccination, people basically answered in two ways, referring either to the fear or concern related to the risk to their health and possible side effects, or to the feeling of relief, opportunity/freedom/health protection and gratitude for having received the vaccine.The application of PANAS questionnaire referring to the period before and after vaccination demonstrated a significant improvement in the majority of investigated positive items and the reduction of those negative. In detail, we observed the significant improvement in the following positive items: determined (p=0.03), active (p=0.001), enthusiastic (p=0.0005), alert (p=0.01), and strong (p=0.02). Finally, a substantial change in the risk perception was observed: in particular the proportion of patients perceiving high risk of being infected with SARS-Cov2 decreased from 29.4% to 2.9%.ConclusionThe present descriptive and explanatory study provides information about the experience with vaccination against COVID-19 of SLE patients. Our results indicated that vaccination substantially changed the patients’ perspective, with a positive direction towards the future.
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Background. Hearing dysfunction, caused by the involvement of the vestibulocochlear nerve or by direct damage on inner ear structures has been described in patients with Sjogren's Syndrome (SS). Previous studies evaluating the prevalence and incidence of hearing dysfunction in SS showed conflicting results, therefore, to date, the exact prevalence has not been extensively evaluated. Objectives. The aim of this study is to evaluate the prevalence of hearing involvement in patients with primary SS (pSS). Materials and methods. Patients with pSS (AECC criteria) with >=18 years of age attending a dedicated Sjogren's syndrome clinic were consecutively enrolled Auditory function was investigated by pure tone audiometry (PTA), It-Matrix test (Speech Reception Threshold in noise leading to 50% correct sentences-SRT) and the Hearing Handicap Inventory (HHI) during a baseline visit and at a follow up visit. A questionnaire of auto-evaluation of hearing loss impact on life was also administered to the patients. Results. Twenty-five patients with pSS (24 females) were enrolled in the study. The median age was 56.2 years (IQR 49-64) The mean disease duration was 3.7 years, 8 were treated with hydroxychloroquine (HCQ) and 1 with methotrexate. At baseline evaluation PTA revealed hearing loss in 17 patients (68%) with severity ranging from mild to severe. Fifteen patients (60%) presented mild hearing loss, 1(4%) moderate e 1 (4%) severe. The It-Matrix score ranged from -9.9 to 0.9 (median - 3.50). Median HHI score was 12.17 (min 0, max 68, SD 177.9). For Covid restrictions, a follow-up evaluation was available for 10 patients only. In these patients, a worsening of PTA and HHI was observed. Interestingly, the it-Matrix scores of patients with a stable disease showed an improvement. Conclusions. These preliminary findings suggest that hearing involvement is common in patients with SS and that it progresses over time. If confirmed on larger cohorts, these data will be useful for physicians in counseling patients about their disease and, in case of suspicious symptoms, an early evaluation by an otolaryngologist may prevent delay in diagnosis and allow an appropriate diagnostic evaluation and therapeutic intervention.
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Not available.
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COVID-19 , Lupus Erythematosus, Systemic , COVID-19/prevention & control , Humans , VaccinationABSTRACT
Background: Vaccinations against SARS-CoV-2 represent a fundamental tool in controlling the pandemic. To date, data on the safety of anti-SARS-CoV-2 vaccines in patients with rare rheumatic diseases, such as systemic vasculitis, are limited. Objectives: In this study we aimed at evaluating the safety of anti-SARS-CoV-2 vaccines in a multicentric cohort of patients with systemic vasculitis. Methods: Patients with systemic vasculitis from two Rheumatology centres who had received anti-SARS-CoV-2 vaccine were retrospectively examined. The primary outcome was to evaluate, in this multi-centric cohort, the occurence of a disease fare after the administration of the vaccine, defned as development of clinical manifestations related to vasculitis with a concomitant increase in serum infammatory markers. As a secondary outcome we aimed at evaluating, in a monocentric cohort of patients with vasculitis, the occurrence of adverse events (AEs) following vaccine administration compared to healthy controls (HC). Results: We examined 111 patients with systemic vasculitis (n=69 female, n=42 male), with a mean age of 64.3 (± 13) years. Sixty had ANCA-associated vas-culitis (AAV), fourty-two had Giant-Cell Arterities (GCA), five had Periarteritis Nodosa, four had Takayasu's arteritis. One-hundred and five patients received a mRNA vaccine and six a viral vector one. A disease fare occurred in only 2 patients (1.8%) after the frst dose of a mRNA vaccine: both had AAV (microscopic poliangioitis) and developed a pulmunary disease fare (respiratory failure requiring hospitalization and treatment with high-dose glucocorticoids). Of note, one of these patients had multiple previous comorbidities, including a severe COPD. Multivaried analysis, adjusted for age and sex, performed in a single monocentric cohort of patients with systemic vasculitis [n=60 (39 AAV, 21 GCA), 37 female, 23 male, mean age 71 (± 12.5) years] demonstrated a statistically sig-nifcant higher frequency of AEs in vasculitis patients compared to HC (p=0.015) after the frst dose of vaccination. No signifcant differences in the frequency of AEs in vasculitis patients compared to HC after the second dose were detected. All the AEs were mild in both groups (malaise was the most frequently reported);no serious AEs were reported. Conclusion: Our data show a very low incidence of disease fares after the administration of anti-SARS-CoV-2 vaccines in patients with systemic vasculitis. Patients with systemic vasculitis seem more prone to develop mild AEs after the frst dose of the vaccine. Taken together, this data suggest a good risk profile for anti-SARS-CoV-2 vaccine in patients with systemic vasculitis.
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Background: With the outbreak of the SARS-CoV-2 pandemic, the rheumatol-ogists' attention was directed at understanding whether infected patients could have a less favorable outcome. Available data seem to indicate that the course in rheumatic patients is not dissimilar from that in the general population. However, data on the outcome of COVID-19 in patients with spondyloarthritis (SpA) are scant. Objectives: To describe the outcome of COVID-19 in patients with SpA in terms of hospitalization, need of oxygen therapy, and symptoms compared to a control group. The variation in disease activity before and after COVID-19 was also assessed. Methods: We enrolled adult patients with psoriatic arthritis (PsA) and ankylosing spondylitis (AS) classifed according to standard criteria, that received a diagnosis of COVID-19 through molecular or rapid antigen swab tests between September 2020 and January 2022. Demographic and clinical data, including age, body mass index (BMI), smoking habit, comorbidities, rheumatic treatment at diagnosis of COVID-19, date of COVID-19 diagnosis, symptoms and additional therapy during the infection and vaccination status were collected through a questionnaire and recorded on an electronic database. Disease activity, assessed by DAPSA in PsA patients and by BASDAI and ASDAS in AS patients, was evaluated before and at the frst visit after the infection. As controls, individuals with COVID-19 but with no known diagnosis of rheumatic/autoimmune disease were recruited using the 'best friend' system. Results: Sixty-two patients were enrolled [43 with PsA and 19 with AS;F:M=40:22;median age 51 years, 25th-75th percentile 39.5-61;median BMI 25.5, 25th-75th percentile 21.75-28;median disease duration 90 months, 25th-75th per-centile 36-192;6 (9.7%) smokers, 37 (59.7%) non-smokers, 19 (30.6%) past smokers;15 (24.2%) only treated with one conventional DMARD, 27 (43.5%) with bDMARDs and 20 (32.3%) with both;44 (71%) had received no vaccine, 18 (29%) one or more doses of vaccine]. Forty-eight controls were also recruited [F:M=29:19;median age 48 years, 25th-75th percentile 41.5-57;median BMI 23.86, 25th-75th percentile 20.69-28.03;10 (20.83%) smokers, 28 (58.33%) non-smokers, 10 (20.83%) past smokers;43 (89.6%) had received no vaccine, 5 (10.4%) one or more doses of vaccine]. Among patients, 10 (16.1%) were hospitalized, of whom 8 (80%) required noninvasive oxygen therapy. Among controls, 7 (14.5%) were hospitalized, of whom 5 (71.4%) required noninvasive oxygen therapy. No differences were observed compared to the control group in terms of hospitalization and need for oxygen support. Likewise, the two groups did not bear any statistically signifcant difference in terms of symptoms (fever, dys-geusia, dyspnoea) and cardiovascular and respiratory comorbidities. BMI and smoking habit did not influence the outcome of COVID-19 in SpA patients, while a BMI of 25 or above was associated with hospitalization in the control group (p=0.0004, RR 3.417). Baseline treatment with immunosuppressants did not influence the disease outcome. DAPSA, ASDAS, and BASDAI did not signif-cantly change after the infection (Table 1). We did not record any COVID-19-re-lated death in either group. Conclusion: Our data show that patients with SpA do not face a worse prognosis of COVID-19 than subjects without rheumatic/autoimmune diseases and that demographic and clinical features did not influence the course of the disease.
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Background: Rheumatoid arthritis (RA) is the most common systemic autoimmune disease that primarily affects joints but is also often characterized by extra-articular involvement1. Cardiovascular diseases are the most important causes of sudden death in these patients, which present a risk of developing cardiovascular events increased by 48%2. The causes of increased cardiovascular risk are several and not completely understood, but recent evidence supports the key role of endothelial dysfunction in pathogenesis. In this complex scenario, it is known that IL-6 receptors are present at the endothelial level and can be activated leading to endothelial dysfunction. SARS-Cov-2 is a coronavirus responsible for the disease called 'coronavirus disease 2019' (CoViD-19) characterized by clinical manifestations ranging from a flu-like syndrome up to severe lung damage associated with systemic hyper cytokine syndrome that can lead to multiple organ failure and death. Therefore, both RA and Covid-19 are associated with an increased pro-thrombotic and cardiovascular risk and IL-6 might be crucial in the patho-physiological mechanisms of both diseases. Objectives: The main hypothesis of this study was to evaluate the possible role of IL-6 as a promoter of endothelial dysfunction in RA and CoViD-19. Methods: In vitro experiments were conducted on the endothelial cell line EA. hy926. Cells were treated for 24 h with fetal bovine serum (FBS), a pool of RA patients' sera or a pool of CoViD-19 patients' sera. The expression levels of adhesion molecules (V-CAM1/CD-106, I-CAM/CD-54, p-selectine/CD-62, tissue factor/CD-142) and apoptosis were analyzed using cytofuorimetric technique. In addition, the autophagy level, using the autophagy markers p62 and LC3II, were evaluated through a western-blot analysis. The same experiments were conducted co-treating cells with the same pool of sera in addition to tocilizumab (TCZ), an anti-IL-6 drug, to verify the reversibility of the process and test the role of the aforementioned cytokine. Data are reported as interquartile median values. The Kruskal Wallis test was used for unpaired samples and the Mann-Whitney test for paired samples. P<0.05 values were considered statistically signifcant. Results: EA. hy926 cells, when treated with both RA and CoViD-19 patients' sera, showed increased levels of activation molecules and apoptosis compared to FBS treated cells. In addition, we observed increased levels of both p62 and LC3 proteins after both rheumatoid arthritis and CoViD-19 patients' sera treatment. All these fndings were reversible in the presence of TCZ. The results are presented in Figure 1. Conclusion: Our data showed that treatment with RA and CoViD-19 patients' sera increase the activation and death of endothelial cells in vitro. The increased level of cells death is possibly due to a block of autophagy. The reversibility of the process after blocking IL-6 with TCZ co-treatment confrms the hypothesis that IL-6 can play a key role in the pathogenesis of endothelial damage in patients with RA and CoViD-19.
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Introduction: After viral or bacterial sepsis, most intensive care unit (ICU) patients enter a state of profound immunosuppression contributing to patients' worsening. Transgene has developed an immunotherapy based on a viral vector encoding human interleukin-7 (hIL-7) to restore both innate and adaptive immune responses. Here, we assessed the capacity of hIL-7 to improve ex vivo T lymphocyte function from septic shock and COVID-19 patients. Methods: Primary human hepatocytes were transduced with MVAhIL- 7-Fc, a recombinant Modified Vaccinia virus Ankara (MVA) encoding the hIL-7 fused to the human IgG2 Fc fragment, or with empty MVA as control. Cell culture supernatants were harvested for further assays. T cells were collected from ICU patients (septic shock = 11, COVID- 19 = 29) and healthy donors (n = 21). STAT5 phosphorylation, cytokine production (ELISpot and intracellular staining) and cell proliferation were assessed upon TCR stimulation with supernatants containing or not hIL-7 produced after MVA transduction or with the counterpart recombinant hIL-7 (rhIL-7). Results: Patients with viral and bacterial sepsis display T lymphocyte alterations compared to healthy donors with a decreased production of cytokines and a decreased proliferation capacity. Supernatant containing hIL-7 induces STAT5 phosphorylation in CD3 lymphocytes of all patients. With 90% of responders, hIL-7 boosts cytokines production (single and double IFN-TNF) and T lymphocytes proliferation capacity at the same level as rhIL-7 in both cohorts whereas empty MVA has no effect. Conclusions: This study indicates that hIL-7-Fc produced after MVA transduction initiates IL-7 signaling through the phosphorylation of STAT5 and restores ex vivo human lymphocyte functions in cells from septic patients with acquired immunosuppression. This proof-of-concept study, along with experimental results in animal models, supports the clinical development of the MVA-hIL-7-Fc in sepsis immunosuppressed patients.
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Background and aim: Infections in cirrhotic patients are associated with an increased risk of liver-related complications (LRC) and mortality. Limited data regarding the prevalence of Coronavirus disease (COVID-19) in cirrhotic patients’ awaiting liver transplantation (LT) are available. The aim of this study was to evaluate the prevalence of SARS-CoV2 in a cohort of cirrhotic patients and its impact on LRC rate and on LT.Materials and methods: We retrospectively included 187 waitlist patients for LT from 24-January-2020 (2020-cohort) and 123 patients from 24-January-2019 (2019-cohort). All 2020-cohort patients were screened for COVID-19 symptoms with a survey. COVID-19 infection was defined by a positive PCR assay for SARS-CoV-2 on nasopharyngeal swab or the positivity for specific antibodies or typical lung lesions on CT scan. We also assessed the indirect impact of SARSCoV2 infection on LRC and LT rate, estimated by competitive risk survival analyses in 2020-cohort vs. 2019-cohort (Fine and Gray method).Results: In 2020-cohort, 72.7% (n=136) of patients were male with mean age of 55.5±12, 47.2% (n=85) patients have alcohol and/or NASH related cirrhosis, with a median MELD score of 14.1±7.4. 45.5% (n=71), 38.5% (n=60) and 14.8% (n=23) of patients were A, B and C for Child-Pugh-score, respectively. 172 patients responded to survey and 22% (n= 38) had symptoms. 20/38 patients were tested for SARS-CoV2 and 4 patients were positive. 3/4 patients with COVID-19 disease needed hospitalization and 1 intensive care support. No death was reported and 1 patient was LT. The 2020-cohort and 2019-cohort were comparable for sex (p=0,6), age (p=0.7), comorbidities (p=0.2) and Child-Pugh-score (p=0.2). The cumulative incidence of LRC was not significantly higher in the 2020-cohort vs. 2019-cohort (SHR 0.65, 95% CI 0.36-1.15, p=0.138). The cumulative incidence of LT was significantly lower in the 2020-cohort than in the 2019-cohort (SHR0.21, 95% CI 0.13-0.33, p<0.001). Conclusions: Our study reported a low prevalence rate of SARSCoV2 infection in a cohort of cirrhotic patients waiting for LT. No SARS-CoV2 infection direct or indirect impact on mortality and LRC rate was reported. However, a significant shortage of LT was found in 2020 cohort.
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Purpose: Infections in cirrhotic patients are associated with an increased risk of liverrelated complications (LRC) and mortality. Limited data regarding the prevalence of Coronavirus disease (COVID-19) in cirrhotic patients' awaiting liver transplantation (LT) are available. The aim of this study was to evaluate the prevalence of Sars-cov2 in a cohort of cirrhotic patients and its impact on LRC rate and on LT. Methods: We retrospectively included 187 waitlist patients for LT from 24-January-2020 (2020-cohort) and 123 patients from 24-January-2019 (2019-cohort). All 2020-cohort patients were screened for COVID-19 symptoms with a survey. COVID-19 infection was defined by a positive PCR assay for SARS-CoV-2 on nasopharyngeal swab or the positivity for specific antibodies or typical lung lesions on CT scan. We also assessed the indirect impact of Sars-Cov2 infection on LRC and LT rate, estimated by competitive risk survival analyses in 2020-cohort vs. 2019-cohort (Fine and Gray method). Results: In 2020-cohort, 72.7% (n=136) of patients were male with mean age of 55.5±12, 47.2% (n=85) patients have alcohol and/or NASH related cirrhosis, with a median MELD score of 14.1±7.4. 45.5% (n=71), 38.5% (n=60) and 14.8% (n=23) of patients were A, B and C for Child-Pugh-score, respectively. 172 patients responded to survey and 22% (n= 38) had symptoms. 20/38 patients were tested for Sars-Cov2 and 4 patients were positive. 3/4 patients with COVID-19 disease needed hospitalization and 1 intensive care support. No death was reported and 1 patient was LT. The 2020-cohort and 2019-cohort were comparable for sex (p=0,6), age (p=0.7), comorbidities (p=0.2) and Child-Pugh-score (p=0.2). The cumulative incidence of LRC was not significantly higher in the 2020-cohort vs. 2019-cohort (SHR 0.65, 95% CI 0.36-1.15, p=0.138). The cumulative incidence of LT was significantly lower in the 2020-cohort than in the 2019-cohort (SHR0.21, 95% CI 0.13-0.33, p<0.001). Conclusions: Our study reported a low prevalence rate of Sars-Cov2 infection in a cohort of cirrhotic patients waiting for LT. No Sars-Cov2 infection direct or indirect impact on mortality and LRC rate was reported. However, a significant shortage of LT was found in 2020 cohort.
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COVID-19 , Chilblains , Biopsy , Chilblains/diagnosis , Child , Family , Humans , SARS-CoV-2ABSTRACT
Background: The spread of COVID-19, the lockdown, the limited access to care reevaluated the role of tele-consultation and self-assessment. Objectives: Our aim was to evaluate in a cohort of Rheumatoid Arthritis (RA) patients treated with JAK-inhibitors (JAKi): the self-assessed disease activity during lockdown, the lockdown impact on fatigue, anxiety, depression and the prevalence of Covid-19. Methods: We enrolled RA patients treated with baricitinib or tofacitinib. At baseline (BL) and follow-up we collected: patients' demographic data, composite disease activity indices (CDAI, DAS28CRP), global assessment (PGA), pain visual analogue scale (VAS), FACIT (functional assessment of chronic illness therapy) and a self-rating scale for disease impact on anxiety and depression (Zung-A/D). Patients were instructed on how to perform self-assessment through video-material and fulfilled the online form of Rheumatoid Arthritis Impact of Disease (RAID)1 and RA Disease Activity Index (RADAI). To capture the pandemic effect, we compared patients in different status (remission, low, moderate and high-disease activity) at the last in-person visit (preCoV) through the DAS28CRP and CDAI, to the tele-health visit (THV), measured by the RAID. BL and pre-CoV ZUNG-A, ZUNG-D, FACIT questionnaires were compared with the online results during the pandemic. Exposure, tests and symptoms of Covid-19 were recorded. Data were expressed as mean±standard deviation or median(IQR) according to distribution. Results: Twenty patients (median age 58.2±11.9 and mean disease duration 153.5 ± 112.7 months) were treated with tofacitinib and 27 with baricitinib. The median time-lapse between the pre-CoV visit and the THV was 12 (IQR 4) weeks. DAS28CRP and CDAI significantly decreased from BL to pre-CoV visit. During the last in-person visit, 21 patients (48.83%) were in remission, 9 (20.93%) in low disease activity;according to the RAID, 15 (31.91%) and 7 (14.89%) patients were respectively in remission and low disease activity during the THV (Table A). PGA and pain significantly decreased from BL to pre-Cov visit but worsened during the lockdown (Table A). FACIT remaining stable during THV. At THV, we detected a significant improvement of anxiety from BL (Zung-A) and a tendency to lower depression scores compared to BL (Table A). JAKi showed a good safety profile considering Covid-19 symptoms, none of the patients was diagnosed with SarsCoV2 infection. Conclusion: This is the first study on virtual assessment in RA patients treated with JAKi. The unique social experiment of the pandemic impaired the clinical response already achieved before the lockdown, without a collateral worseling of FACIT, anxiety and depression.
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Background: The severe measures of lockdown imposed in Italy to limit the SARS coronavirus 2 disease (COVID-19) spread caused an increase of reported anxiety, depression and suicidal rate among general population. Patients affected by rheumatic disorders feature an increased risk of mood disorders for the chronic course of the disease itself and for the related disability. Objectives: Aim of this study was to investigate the impact of COVID-19 lockdown on emotional well-being of a large cohort of rheumatic patients through a telemedicine approach. Methods: Patients in follow-up in rheumatologic out-patient clinics of our hospital were invited to participate to an online survey. They were asked also to invite their best friend, matched for age and sex, to participate the survey, as control group. The online survey included demographic questions and validated, psychometric scales for stress vulnerability (Stress Vulnerability Scale-SVS), resilience (Resilience Scale-RS), depression (Zung's depression questionnaire-Zung-D) and anxiety (Zung's anxiety questionnaire-Zung-A) evaluation. Results: The cohort was composed by 484 subjects (84,1% F, 15,9% M). The number of subjects and the frequency of various diagnosis are shown in Table 1. According to the psychometric scales, 55,5% and 43,3% of subject showed respectively an increased stress vulnerability and a reduced resiliency. Moreover, 64% and 40,5% of the enrolled subjects reported respectively anxiety and depressive symptoms worthy of psychiatric attention. There was a significant different distribution of scores for SVS (p<0,0001), Zung-A (p<0,0001) and Zung-D (p<0,0001) among the various diagnosis. In comparison with controls, higher scores of SVS were present in connective tissue diseases (CTD) (p=0,007), Sjogren's Syndrome (SSJ) (p=0,0029) and fibromyalgia (FM) (p<0,0001) patients, higher scores of Zung-A were present in SSJ (p=0,006) and FM (p<0,0001) patients and higher scores of Zung-D were present in FM (p<0,0001) patients (Figure 1). Ordinal regression analysis showed that higher classes of anxiety were independently predicted by the Tension (β=0,32;CI=0,13-0,52;p=0,003) and Demoralization (β=0,22;CI=0,04-0,44;p=0,046) components of SVS and by the Zung-D score (β=0,09;CI=0,05-0,1;p<0,001), while higher classes of depression were independently predicted by SVS total (β=0,17;CI=0,03-0,30;p=0,012), by its subcomponent Demoralization (β=0,22;CI=0,01-0,43;p=0,038), by a lower absolute RS score (β=-0,083;CI=-0,1-0,06;p<0,001) and by the Zung-A score (β=0,11;CI=0,06-0,15;p<0,001). In both cases, a specific diagnosis was not associated to a higher risk of advanced anxiety and depression classes. Conclusion: Rheumatic patients developed a high frequency of anxiety and depressive symptoms following COVID-19 lockdown, of which a large part should be referred for specialist attention according to their severity. There was a large variability of the symptoms reported among the various diagnosis. CTD, SSJ and FM patients were the most susceptible to the development of anxiety, depression and stress vulnerability. The application of psycometric scales through a telemedicine approach represents a useful tool to identify patients with higher levels of anxiety and depression.
ABSTRACT
Background: Antimalarials have been associated with QT prolongation in COVID19 patients but are generally safe in patients with rheumatologic disease. Objectives: Aim of the study was to compare the prevalence of QTc prolongation between COVID19 and Systemic Lupus Erythematosus (SLE) patients treated with hydroxychloroquine (HCQ). Methods: We included consecutive patients with SARS-CoV-2 infection confirmed by nasopharyngeal swab and patients taking HCQ for SLE. A prolonged QTc was defined as an increase in QTc intervals ≥60 ms (compared with baseline) or as a QTc of ≥500 ms. Results: We enrolled 58 COVID19 patients (median age 70.5 years, IQR 25). HCQ, without or with azithromycin, was given to 26 (44.8%) and 15 patients (25.9%), respectively;17 (29.3%) had not received either drug. The median baseline QTc was 432 (IQR 36) and prolonged QTc was observed in 15 (26%) patients (12 QTc≥500 ms and 3 patients ΔQTc≥60 ms). We didn't find significant differences in QTc prolongation among the three treatment groups. Baseline QTc (OR 111.5) and D-dimer (OR 78.3) were independently associated to QTc prolongation. Compared to the 50 SLE patients (median age of 38.5 years, IQR 22), chronically treated with HCQ, patients with COVID19 showed significantly longer QTc (p < 0.001) (Table 1). Conclusion: This is the first study demonstrating that, differently from COVID19 patients, patients with SLE are not susceptible to HCQ-induced long QT syndrome and arrhythmia. The combined arrhythmogenic effect of SARS-CoV-2 infection and HCQ could account for the excess of QTc prolongation and fatal arrhythmias described in patients with COVID19.
ABSTRACT
Background: Since the beginning of the SARS-CoV-2 outbreak, antiphospholipid antibodies (aPL), a known thrombotic risk factor, have been studied in COVID-19 patients, in whom thromboembolic events have been associated with poor prognosis. To date, the pathogenetic role of aPL and the trend over time is still unknown. Objectives: Aim of the study was to investigate whether aPL positivity was correlated with thrombosis in COVID-19 patients and whether it was a transient or persistent. Methods: We included all consecutive COVID-19 patients hospitalized at Policlinico Umberto I, Sapienza University of Rome from April 1, 2020 to June 7, 2020. In these patients, serum levels of anti-cardiolipin (aCL) IgM, IgG, IgA, anti-β2glycoprotein I (aβ2GPI) IgM, IgG were measured by enzyme-linked immunosorbent assay (ELISA) and Lupus Anticoagulant (LA) was detected with coagulatory tests in patients not in treatment with anticoagulant drugs. Results: Five out of 73 (6.8%) patients resulted positive for aCL IgM, 3 of them also tested positive for aβ2GPI IgM. aCL IgA were tested positive in 14 out of 46 patients (30.4%). Overall 18 patients resulted positive for at least one test. Seven (9.6%) patients developed thrombotic events during hospitalization, 3 of them resulting positive for aPL (Table 1. below). We observed that patients showing double positivity for aCL IgM and aβ2GPI IgM had a likelihood positive ratio of 6.3 for thrombotic events (p=0.012) and a likelihood positive ratio of 4.9 for increased D-dimer levels (p=0.027). aCL IgA, the most prevalent aPL in this cohort, was not associated with thrombosis. Of the 18 aPL positive patients, 5 died, 3 were lost to follow-up, and 10 were tested on a second occasion at least 12 weeks, two patients confirmed positivity without clinical signs suggestive of APS. Conclusion: These results suggest that double positivity for aCL and aβ2GPI IgM increases the risk of thrombosis in COVID-19 patients, unlike aCL IgA. APL positivity may be persistent and it is advisable to monitor it over time.
ABSTRACT
Background: Conflicting results have been published regarding the risk of infection with SARS-CoV-2 and development of severe COVID-19 among patients affected by rheumatic musculoskeletal diseases (RMDs). [1-4] Taking into account the lack of effective drugs to treat the COVID-19 and despite the burdensome and costly lockdown measures adopted to counteract the spread of SARS-CoV-2, effective and safe vaccines appear reasonably to be the best strategy for fighting the virus. [6] Before vaccines availability, several reports showed that a non-negligible proportion of subjects, among the general population or within specific categories, would have refused vaccination against COVID-19 once possible;[6, 7] data on vaccination hesitation among patients with RMD are not available yet. Objectives: This study aimed to evaluate the attitude of patients with RMDs to vaccination against SARS-CoV-2 and explore the factors which may influence it. Methods: During the first weeks of Europe vaccination campaign, we proposed an online survey to Italian adult patients with RMDs followed up in the Rheumatology Unit. All patients fulfilled the most recent classification criteria for each disease. HCs were recruited using a “best friend” system. The informed consent was collected for all participants. The questionnaires included the following items: demographic features, presence of comorbidities, educational level, and ongoing therapy. The individual's perception of the COVID-19 vaccination, as well as the willingness to receive a COVID-19 vaccination with targeted questions was properly assessed. For the statistical analyses, Mann-Whitney and Chi-square tests were used. To account for baseline clinical differences among RMD-patients and controls, multivariable logistic regression analysis was used;covariates were selected according to a clinical criterion. The hypothesis that willingness for COVID-19 vaccine varied in specific subgroups of patients was tested using interaction terms at logistic regression analysis. All statistical tests were performed using the RStudio graphical interface and all tests were two-sided with a significance level set at p<0.05. Results: We provided an online survey to 830 adult RMD-patients and 370 healthy controls (HCs). Overall, 626 RMD-patients and 345 HCs completed the survey. Patients with RMDs were less willing to receive a COVID-19 vaccination compared to HCs (Odds Ratio (OR) 0.24, 95% CI 0.17 -0.34, p<0.0001) despite they perceived themselves as at higher risk both to get infected (OR 11.3, 95% CI 8 -15.9, p<0.0001) and develop a severe COVID-19 (OR 11.06, 95% CI 7.8 -15.6, p<0.0001) and even if they had been vaccinated for influenza and pneumococcus more frequently than controls (OR 1.60 95% CI 1.18 -2.16, p=0.002;OR 2.23, 95% CI 1.34 -3.73, p=0.002). However, our results reveal that RMD-patients are more willing to change their minds if properly informed by the rheumatologist (OR 3.08, 95% CI 2.19 -4.34, p<0.0001) in comparison to controls. Conclusion: The results of our study indicate for the first time that patients with RMDs are less willing to receive COVID-19 vaccination compared to the general population, despite perceiving themselves as at higher risk of getting infected with SARS-CoV-2 and develop severe COVID-19. However, our data underscored a meaningful aspect: patients with RMDs may change their attitude to COVID-19 vaccination if properly informed about risks and benefits by their trusted specialist. The results of this study encourage the entire rheumatologist community to become more committed to patient education, increasing their willingness to COVID-19 vaccine, which is the most promising strategy to protect them from the virus.
ABSTRACT
Background: Social distancing due to COVID-19 pandemic had a major impact on the mental health of general population, with a high prevalence of post-traumatic stress disorder (PTSD) related symptoms1, 2. Psychological repercussions were notably found in people with chronic diseases, including systemic sclerosis (SSc) patients, where an increasing of anxiety symptoms, related also to low financial resources, emerged3. Objectives: To evaluate the impact of COVID-19 lockdown on the onset of PTSD in patients with SSc, firstly during the total confinement period (March-April 2020) and then at the time of less restrictive government measures, following the RT index lowering (June-July 2020)4. Methods: We carried out a case-control study on 57 SSc patients, according to the ACR/EULAR 2013 criteria, and on 57 healthy subjects as control group (HC), matched by sex and age. At T0 (March-April) and T1 (June-July) both populations received the “Impact of Event Scale Revised” questionnaire (IES-R) by e-mail, with a cut-off of ≥ 33 defining probable diagnosis of PTSD5. A multivariate analysis of possible factors influencing IES-R score, such as age, number of cohabitating people and weekly outings count, was performed in SSc patients at both times of the survey. Results: At T0 we found a significantly greater number of SSc patients with IES-R score ≥ 33 compared to HC (26/45.6% vs 13/22.8%;median value [quartiles] 31 [19.5;42.5] vs 24 [15.5;32];p-value 0.046). At T1, we obtained data from 44 SSc patients and 35 HC but no significant difference was noticed (18 / 40.9% vs 8 / 23.5%;26 [15.25;38] vs 26.5 [20.75;32.5];p≥ 0.05). SSc patients also had significantly fewer weekly outings than HC, both at T0 (p <0.001) and T1 (p <0.001) (Table 1). The multivariate analysis performed at T0 on SSc patients showed a significant association of IES-R ≥33 score with age (p 0.025) and with a lower count of weekly outings (p 0.002). The latter data negatively correlated with an IES-R ≥33 score in SSc patients (r -0.267, p 0.004). Conclusion: We found a significantly higher prevalence of PTSD in SSc patients compared to HC at the strictest lockdown time, turning into comparable when government measures were less restrictive, due to the minimum RT index values recorded in Italy. Older age and lower count of weekly outings were associated with PTSD in SSc patients during the lockdown, whereas the count of weekly outings was lower than in HC during both the examined periods. The results of this study indicate that COVID-19 lockdown had a worse impact in SSc patients, where the fewer weekly outings may depend on their clinical condition and on a greater concern about their health6. These findings strengthen the World Scleroderma Foundation recommendations regarding care to the psychological frailty of SSc patients7.