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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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BackgroundHuman SARS-CoV-2 infection is responsible for a large variety of clinical manifestations related to Coronavirus disease-19 (COVID-19) [1]. SARS-CoV-2 can induce microvascular damage, that can be safely detected by nailfold videocapillaroscopy (NVC), as recently demonstrated [2-4]. Virus-induced endothelial dysfunction has been implicated in the pathogenesis of both active infection and long-COVID clinical manifestations (the last as persistence of disease symptoms after at least three months from onset) [5]. The study group on capillaroscopy and microcirculation in rheumatic diseases of the Italian Society of Rheumatology (CAPSIR) carried out an internal survey on the interest of the Italian Centers that perform NVC in participating in a detailed capillaroscopic and clinical data collection in long-COVID patients.ObjectivesTo carry out an Italian multicenter cognitive survey on the interest in collecting NVC and clinical data of patients affected by long-COVID with or without previous rheumatological diseases.MethodsThe steering committee of the CAPSIR study group formulated a cognitive questionnaire, entitled "Study on the role of capillaroscopy in patients with long-COVID” (CAPSIR_2 Study), consisting of 27 open or multiple-choice questions. A Google Form of the questionnaire was emailed to all the member of the study group between September and October 2022. Data are reported with a descriptive analysis.ResultsThe online questionnaire was completed by 41 CAPSIR members, belonging to 33 different Italian centers. Of note, 63% of participants had already experienced NVC in patients with long-COVID. The primary indication to perform the NVC was the onset of a new Raynaud's phenomenon (46% of cases) and the requests come mainly from General Practitioners (33% of cases). In 2/3 of the cases, patients with long-COVID and previous rheumatic diseases, who underwent NVC examination, represented less than 20% of the total. It should be noted that always in 2/3 of the cases there was no preferential channel for the study of the microcirculation in patients affected by long-COVID nor a NVC investigation prior to the SARS-CoV-2 infection. According to the previous experience of the participants in the interview, the most important NVC parameters considered to be evaluated in long-COVID patients were number of capillaries per linear millimeter (24% of cases), presence of hemorrhages (34% of cases) and giant capillaries (22% of capillaries). All participants (100%) therefore agreed to participate in a further collection of NVC and clinical data in this cohort of patients.ConclusionThis survey highlighted the interest of Italian Rheumatologists in assessing by NVC the COVID-related microvascular involvement. A consensus has emerged that future research is needed. After this pilot survey, the second part of the CAPSIR_2 Study will concern the collection/analysis before and after the SARS-CoV-2 infection of NVC and clinical data in patients with primary and secondary (to rheumatic diseases) Raynaud's phenomenon and affected by long-COVID versus adequate controls. The aim is to investigate if the presence/severity of the microvascular damage might be involved in the pathogenesis of the clinical manifestations observed in COVID-19 patients after the active infection. CAPSIR_2 Study will be open to all Italian rheumatological centers that participated in the previous national CAPSIR_1 Project [6].References[1]Fernandes Q et al. Ann Med. 2022;54:524-540.[2]Cutolo M et al. Nat Rev Rheumatol. 2021;17:665-677.[3]Sulli A et al. Microvasc Res 2022;142:104361.[4]Natalello G et al. Microvasc Res. 2021;133:104071.[5]Charfeddine S et al. Front Cardiovasc Med. 2021;8:745758.[6]Ingegnoli F et al. Reumatismo. 2022;74.AcknowledgementsAuthors wrote the on behalf of the study group on capillaroscopy and microcirculation in rheumatic diseases of the Italian Society of Rheumatology (SIR) - CAPSIR.CAPSIR Study Group thanks the EULAR Study Group of Microcirculation in Rheumatic Diseases for the continuous cultural support.Dis losure 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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Background: Patients with autoimmune systemic diseases (ASDs) can be counted among frail populations as regards the predisposition to COVID-19 due to the frequent visceral organ involvement and comorbidities, as well as the ongoing immunomodulating treatments. Objectives: Our long-term multicenter telephone survey prospectively investigated the prevalence, prognostic factors, and outcomes of COVID-19 in Italian ASD patients during the frst 3 pandemic waves. Methods: A large series of 3,918 ASD patients (815 M, 3103 F;mean age 59±12SD years) was consecutively recruited at the 36 referral centers of COVID-19 & ASD Italian Study Group. In particular, ASD series encompassed the following conditions: rheumatoid arthritis (n: 981), psoriatic arthritis (n: 471), ankylosing spondylitis (n: 159), systemic sclerosis (n: 1,738), systemic lupus (172), systemic vasculitis (n: 219), and a miscellany of other ASDs (n: 178). The development of COVID-19 was recorded by means of telephone survey using standardized symptom-assessment questionnaire (1). Results: A signifcantly increased prevalence of COVID-19 (8.37% vs 6.49%;p<0.0001) was observed in our ASD patients, while the cumulative death rate revealed statistically comparable to the Italian general population (3.65% vs 2.95%;p: ns). In particular, among the 328 ASD patients complicated by COVID-19, 57 (17%) needed hospitalization, while mild-moderate manifestations were observed in the large majority of individuals (83%). In addition, 12/57 hospitalized patients died due to severe interstitial pneumonia and/or cardiovascular manifestations. Interestingly, a signifcantly higher COVID-19-related death rate was observed in systemic sclerosis patients compared to the Italian general population (6.29% vs 2.95%;p=0.018). Other adverse prognostic factors to develop COVID-19 were the patients' older age, male gender, pre-existing ASD-related interstitial lung involvement, and chronic steroid treatment. Conversely, patients treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) showed a signifcantly lower prevalence of COVID-19 compared to those without (3.58% vs 46.99%;p=0.000), as well as the chronic administration of low dose aspirin in a subgroup of SSc patients (with 5.57% vs without 27.84%;p=0.000). Conclusion: The cumulative impact of COVID-19 on ASD patients after the frst 3 pandemic waves revealed less severe than that observed during the frst phase of pandemic (1), especially with regards to the death rate that was comparable to the Italian general population in spite of the increased prevalence of complicating COVID-19 in the same ASD series. Ongoing long-term treatments, mainly csDMARDs, might usefully contribute to generally positive outcomes of in this frail patients' population. Of note, a signifcantly increased COVID-19-related mortality was recorded in only SSc patients' subgroup, possibly favored by pre-existing lung fbrosis. Among different ASD, SSc deserves special attention, since it shares the main pathological alterations with COVID-19, namely the interstitial lung involvement and the endothelial injury responsible for diffuse microangiopathy. Besides SSc, the patients' subgroups characterized by older age, chronic steroid treatment, pre-existing interstitial lung disease, and/or impaired COVID-19 vaccine response (1-3), may deserve well-designed prevention and management strategies.
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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: SARS-CoV-2 infection poses a serious challenge for patients with rheumatic autoimmune systemic diseases (ASD), characterized by marked immune-system dysregulation and frequent visceral organ involvement. Objectives: To evaluate the impact of COVID-19 pandemic in a large series of Italian patients with ASD. Methods: Our multicenter telephone survey (8-week period, March-April 2020) included a large series of 2,994 patients (584 M, 2,410 F, mean age 58.9±13.4SD years) with ASD followed at 34 tertiary referral centers of 14 regions of northern, central, and southern Italian macro areas, characterized by different prevalence of SARS-CoV-2 infection. According to currently used criteria, COVID-19 was classified as definite COVID-19 (signs or symptoms of COVID-19 confirmed by positive oral/nasopharyngeal swabs at PCR testing) or highly suspected COVID-19 (signs or symptoms highly suggestive of Covid-19, but not confirmed by PCR testing due to limited availability of virological tests in that period). The results were analyzed performing the Odds Ratio by Java-Stat 2-way Contingency Table Analysis. Results: The main findings of the survey study revealed a significantly increased prevalence of COVID-19 in: a.the whole series of ASD patients (definite Covid-19: 22/2994, 0.73%;p=0.0007;definite COVID-19 plus highly suspected Covid-19: 74/2,994, 2.47%;p<0.0001) when compared to Italian general population of COVID-19 infected individuals (349/100000 = 0.34%;data from Italian Superior Institute of Health;h t t p s : / / w w w . e p i c e n t r o . i s s . i t / e n / c o r o n a v i r u s / sars-cov-2-national-surveillance-system). b.the subgroup of patients with connective tissue diseases or systemic vasculitis (n = 1,901) compared to the subgroup of inflammatory arthritis (n = 1,093), namely rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (definite Covid-19: 19/1,901, 0.99%, vs 3/1,093, 0.27%;p=0.036;definite COVID-19 plus highly suspected Covid-19: 69/1,901, 3.6%, vs 5/1,093, 0.45%;p<0.0001) c.the subgroup of patients with pre-existing interstitial lung involvement (n = 526) compared to those without (n = 2,468) (definite Covid-19: 10/526, 1.90%, vs 12/2,468, 0.48%;p=0.0015;definite COVID-19 plus highly suspected Covid-19: 33/526, 6.27%, vs 41/2,468, 1.66%;p<0.0001). Of interest, the prevalence of COVID-19 did not correlate with presence/absence of different comorbidities, mainly diabetes, cardio-vascular and/or renal disorders, as well as of ongoing treatments with biological DMARDs;while patients treated with conventional DMARDs showed a significantly lower prevalence of COVID-19 compared to those without. COVID-19 was more frequently observed in the patients' populations from northern and central compared to southern Italian macro area with lower diffusion of pandemic. Clinical manifestations of Covid-19, observed in 74 patients, were generally mild or moderate;4/9 individuals requiring hospital admission died for severe pneumonia. Conclusion: The prevalence of COVID-19 observed in ASD patients during the first wave of pandemic was significantly higher than that observed in Italian general population;moreover, the actual prevalence of COVID-19 might be underestimated due to the high number of mild variants as well as the possible clinical overlapping between these two conditions. Patients with ASD should be invariably regarded as 'frail patients' during the pandemic course, considering the risk of worse outcome in the acute phase of Covid-19, as well as the potential long-term effects of viral infection. The statistically significant association of COVID-19 with connective tissue diseases/ systemic vasculitis, as well as with pre-existing interstitial lung involvement, suggests the presence of distinct clinico-pathological ASD subsets, characterized by markedly different patients' vulnerability to SARS-CoV-2 infection.
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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.
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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.
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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.