CHARACTERISTICS and OUTCOMES of SARS-COV-2 BREAKTHROUGH INFECTIONS among DOUBLE and TRIPLE VACCINATED PATIENTS with INFLAMMATORY RHEUMATIC DISEASES

Background: SARS-CoV-2 vaccines offer the most effective way to reduce the risk of severe COVID-19. Recent data indicate sufficient immune response after vaccination in most patients with infammatory rheumatic diseases (IRD) on immunomodulatory treatments. Objectives: To investigate the clinical profile of SARS-CoV-2 breakthrough infections among double and triple vaccinated patients with IRD. Methods: Data from the German COVID-19-IRD registry, collected by treating rheumatologists between February 2021 and January 2022 were analysed. Patients double or triple vaccinated against COVID-19 ≥14 days prior to proven SARS-CoV-2 infection were identifed, and type of IRD, vaccine, immunomodulation, comorbidities and outcome of the infection were compared with 737 unvac-cinated IRD-patients with COVID-19. Results: In total, 271 cases of breakthrough infections were reported, 250 patients (91%) had received two doses of vaccines, 21 (9%) patients three. More than 70% of the patients received Pfzer/Biontech vaccine for the frst, second and third vaccination. The median time from second/third vaccine dose to infection was 148 days (range 14-302) days. Most of the patients were diagnosed with infamma-tory joint diseases (Table 1). Most of the patients were treated with methotrexate (Table 1). The use of Januskinase inhibitors(i) was more frequently reported in double vaccinated patients (10.4% vs 4.8%), whereas tumor necrosis (TNF)i were reported more often in triple vaccinated patients (33.3% vs. 22.8). Hospitalisation rate was higher in unvaccinated IRD-patients than in vaccinated ones, while fatality rate was similar in unvaccinated and double vaccinated patients. Although the rate of comorbidities and median age were higher in triple-vaccinated patients, infected patients showed a lower rate of hospitalisation, neither COVID-19 related complications, nor the need of oxygen treatment or death. Conclusion: In this cohort of triple-vaccinated IRD patients no fatal courses and no COVID-19 related complications were reported, although median age and rate of comorbidities were higher compared to double-vaccinated and unvacci-nated patients. These results support the general recommendations to reduce the risk of severe COVID-19 disease by administering three doses of vaccine, especially in patients with older age, presence of comorbidities, and on immuno-modulatory treatment.

COVID-19 in RITUXIMAB TREATED PATIENTS with INFLAMMATORY RHEUMATIC DISEASES

Background: At the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease 2019 (COVID-19) pandemic, the influence of anti-infammatory therapy on the course of SARS-CoV-2 infection in patients with infammatory rheumatic diseases (IRD) was unknown. In the meantime, several data indicate an association of severe courses of COVID-19 with the use of ritux-imab (RTX). Objectives: To gather further knowledge about SARS-CoV-2 infections in RTX-treated IRD patients, data from the German COVID-19-IRD-registry were analysed. Methods: Hospitalisation was used as a surrogate of COVID-19 severity. Baseline characteristics, disease features, medication and outcome of COVID-19 were compared in RTX-treated inpatients and outpatients. Results: In total, 3592 cases were reported in the registry, which included 130 RTX patients (3.6%) for our analysis. RTX-treated inpatients were older than RTX-treated outpatients (median age 63 y vs 56 y, p=0.007). Patients with granulomatosis with polyangiitis treated with RTX (n=32) showed a significant higher COVID-19 related hospitalisation rate (33% vs 11%, p=0.005), which was not the case for patients with rheumatoid arthritis (49% vs 50%). Cardiovascular comorbidities were reported more frequently in hospitalised RTX-treated patients (20% vs. 6%, p=0.032). More than 50% of the RTX-treated inpatients developed COVID-19 related complications, e.g. acute respiratory distress syndrome. The median time period between the last RTX treatment and SARS-CoV-2 infection was shorter in inpatients than in non-hospitalised patients (3 (range 0-17) vs. 4 months (range-29), p=0.039). The COVID-19 related mortality rate was 14% (n=19) in RTX-treated IRD patients. In RTX-treated inpatients and outpatients, there were no relevant differences with respect to the use of concomitant glucocor-ticoids or other disease modifying anti-rheumatic drugs, disease activity, median last RTX dose or median number of immunomodulatory drugs prior to RTX treatment. Conclusion: In addition to general risk factors, such as age and comorbidities, it is already known that IRD patients treated with RTX show a higher rate of severe COVID-19. In our registry, RTX-treated patients with granulomatosis with polyangiitis appear to be at even higher risk to develop severe COVID-19 compared to other IRD. Moreover, the shorter the time since the last RTX treatment, the higher seems to be the risk of developing severe COVID-19. This might be explained by a more profound B-cell depletion in the frst weeks after RTX treatment warranting further studies.

LONG-TERM OUTCOMES of COVID-19 VACCINATION in PATIENTS with RARE and COMPLEX CONNECTIVE TISSUE DISEASES: AN AD-INTERIM ANALYSIS of ERN-RECONNET VACCINATE STUDY

Background: Since the COVID-19 vaccination campaign was launched all over Europe, there has been general agreement on how benefts of SARS-CoV2 vaccines outweigh the risks in patients with rare connective tissue diseases (rCTDs). Yet, there is still limited evidence regarding safety and efficacy of such vaccines in these patients, especially in the long-term. For this reason, in the framework of ERN-ReCONNET, an observational long-term study (VACCINATE) was designed in order to explore the long-term outcome of COVID-19 vaccination in rCTDs patients. The consent form was developed thanks to the involvement of the ERN ReCONNET ePAG Advocates (European Patients Advocacy Group). Objectives: To evaluate the safety profile of COVID-19 vaccination in rCTDs patients and the potential impact on disease activity. Primary endpoints were the prevalence of adverse events (AEs) and of disease exacerbations post-vaccination. Secondary endpoints were the proportion of serious adverse events (SAEs) and adverse events of special interest for COVID-19 (adapted from https://bright-oncollaboration.us/wp-content/uploads/2021/01/SO2-D2.1.2-V1.2-COVID-19- AESI-update-23Dec2020-review-fnal.pdf) Methods: The frst ad-interim analysis of the VACCINATE study involved 9 ERN-ReCONNET Network centres. Patients over 18 years of age with a known rCTD and who received vaccine against COVID-19 were eligible for recruitment. Demographic data and diagnoses were collected at the time of enrolment, while the appearance of AEs and potential disease exacerbations were monitored after one week from each vaccination dose, and then after 4, 12 and 24 weeks from the second dose. A disease exacerbation was defned as at least one of the following: new manifestations attributable to disease activity, hospital-ization, increase in PGA from previous evaluation, addition of corticosteroids or immunosuppressants. Results: A cohort of 300 patients (261 females, mean age 52, range 18-85) was recruited. Systemic lupus erythematosus (44%) and systemic sclerosis (16%) were the most frequent diagnoses, followed by Sjogren's syndrome (SS,12%), idiopathic infammatory myositis (IMM,10%), undifferentiated connective tissue disease (UCTD,8%), mixed connective tissue disease (MCTD,4%), Ehlers-Dan-los's syndrome (EDS,4%), antiphospholipid syndrome (APS,2%). AEs appearing 7 days after the frst and second doses were reported in 93 (31%) and 96 (32%) patients respectively, mainly represented by fatigue, injection site reaction, headache, fever and myalgia. Otitis, urticaria, Herpes Simplex-related rash, stomatitis, migraine with aura, vertigo, tinnitus and sleepiness were reported with very low frequency. Less than 2% of patients experienced AEs within 24 weeks from the second dose. No SAEs or AEs of special interest were observed in the study period. There were 25 disease exacerbations (8%), 7 of which severe. The highest number of exacerbations was observed after 4 weeks from the second dose (12 within week 4, 6 within week 12 and 7 within week 24). Disease exacerbation was most frequent in patients with EDS (33%) and MCTD (25%). Conclusion: This preliminary analysis shows that COVID-19 vaccination is safe in rCTDs patients. AEs appear most often early after vaccination and are usually mild. Disease exacerbations are not frequent, but can be potentially severe and tend to occur most frequently within the frst month after vaccination. Exacerbations can also occur 3-6 months after vaccination, although a causal relationship with the vaccination remains to be established. Our present data underline the importance of long-term observational studies.

THE PROPER STUDY: A 48-WEEK ANALYSIS of A PAN-EU REAL-WORLD STUDY of SB5 BIOSIMILAR FOLLOWING TRANSITION from REFERENCE ADALIMUMAB in PATIENTS with RHEUMATOID ARTHRITIS, AXIAL SPONDYLOARTHRITIS or PSORIATIC ARTHRITIS

Background: SB5, a biosimilar to reference adalimumab (ADL), received EU marketing authorisation in 2017, based on pre-clinical and clinical phase I and III studies that demonstrated bioequivalence and comparable efficacy, safety and immunogenicity to ADL. Objectives: The real-world study 'PROPER' is designed to provide insights into outcomes of the transition from ADL to SB5 outside the randomised, controlled, clinical trial setting. Methods: Under an umbrella design, 1000 patients with immune-mediated infammatory disease were enrolled at centres in Belgium, Germany, Ireland, Italy, Spain and the UK, and followed for 48 weeks post-transition. Eligible patients with a diagnosis of rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), ulcerative colitis or Crohn's disease had been transitioned to SB5 as part of routine treatment following a minimum of 16 weeks' treatment with ADL. Data were captured from patient charts retrospectively for 24 weeks prior to and prospectively and/or retrospectively up to 48 weeks after SB5 initiation. This analysis of the rheumatology cohort reports clinical characteristics, disease scores, persistence on SB5, clinical management and safety up to the closing date of November 30th, 2021. Results: Of the 496 patients included in this analysis, the majority were enrolled in UK (n=174), Germany (n=145) and Spain (n=73);Italy, Ireland and Belgium enrolled 45, 44 and 15 patients respectively. At study close, 487 patients had completed 48 weeks of follow-up;397 of those remained on SB5 throughout. Methotrexate was received as concomitant therapy by 37% of patients and 20% had received a biologic therapy prior to reference ADL. Most patients (89.3% of RA, 92.1% of axSpA, 97.3% of PsA) transitioned to SB5 at the same dose regimen received for ADL. Clinical characteristics, SB5 dose and fare are detailed in Table 1, disease scores in Figure 1. Fifteen patients each experienced one unrelated Serious Adverse Event (SAE): 2 in the axSpA cohort [tachycardia, intracranial haemorrhage];6 in the PsA cohort [myocardial infarct (2), breast carcinoma, COVID-19, gallbladder calculus, dyspnoea];7 in the RA cohort [facial numbness, depression, COVID-19, pneumonia, diverticulitis, parvovirus, coronary occlusion]. Tw o patients reported SAEs considered causally related to SB5: Herpes zoster and pneumonia (RA cohort), and ALS with worsening (PsA cohort). Conclusion: This analysis of a large, contemporary cohort of EU patients with established RA, axSpA or PsA shows treatment effectiveness maintained at 48 weeks after switching from ADL to SB5, with most patients continuing on SB5 Q2W throughout. Episodes of fare were uncommon, and the importance of patient-reported symptoms in recognition of fare is evident. No new safety signals were observed.

The added value of a European Reference Network on rare and complex connective tissue and musculoskeletal diseases: insights after the first 5 years of the ERN ReCONNET

In order to address the main challenges related to the rare diseases (RDs) the European Commission launched the European Reference Networks (ERNs), virtual networks involving healthcare providers (HCPs) across Europe. The mission of the ERNs is to tackle low prevalence and RDs that require highly specialised treatment and a concentration of knowledge and resources. In fact, ERNs offer the potential to give patients and healthcare professionals across the EU access to the best expertise and timely exchange of lifesaving knowledge, trying to make the knowledge travelling more than patients. For this reason, ERNs were established as concrete European infrastructures, and this is particularly crucial in the framework of rare and complex diseases in which no country alone has the whole knowledge and capacity to treat all types of patients. It has been five years since their kick-off launch in Vilnius in 2017. The 24 ERNs have been intensively working on different transversal areas, including patient management, education, clinical practice guidelines, patients' care pathways and many other fundamental topics. The present work is therefore aimed not only at reporting a summary of the main activities and milestones reached so far, but also at celebrating the first 5 years of the ERN on Rare and Complex Connective Tissue and Musculo-skeletal Diseases (ReCONNET), in which the members of the network built together one of the 24 infrastructures that are hopefully going to change the scenario of rare diseases across the EU.

The influence of the SARS-CoV-2 lockdown on patients with inflammatory rheumatic diseases on their adherence to immunomodulatory medication: a cross sectional study over 3 months in Germany.

OBJECTIVES: To evaluate the influence of the SARS-CoV-2 pandemic on the adherence of patients with inflammatory rheumatic diseases (IRD) to their immunomodulatory medication during the three-month lockdown in Germany. METHODS: From 16th March until 15th June 2020, IRD patients from private practices and rheumatology departments were asked to answer a questionnaire addressing their behaviour with respect to their immunomodulating therapy. Eight private practices and nine rheumatology departments that included rheumatology primary care centres and university hospitals participated. A total of 4252 questionnaires were collected and evaluated. RESULTS: The majority of patients (54%) were diagnosed with RA, followed by psoriatic arthritis (14%), ankylosing spondylitis (10%), connective tissue diseases (12%) and vasculitides (6%). Most of the patients (84%) reported to continue their immunomodulatory therapy. Termination of therapy was reported by only 3% of the patients. The results were independent from the type of IRD, the respective immunomodulatory therapy and by whom the patients were treated (private practices vs rheumatology departments). Younger patients (<60 years) reported just as often as older patients to discontinue their therapy. CONCLUSION: The data show that most of the patients continued their therapy in spite of the pandemic. A significant change in behaviour with regard to their immunomodulatory therapy was not observed during the three months of observation. The results support the idea that the immediate release of recommendations of the German Society of Rheumatology were well received, supporting the well-established physician-patient relationship in times of a crisis.

Does tnf-inhibition decrease the risk of severe COVID-19 in rmd-patients

Background: Patients with rheumatic and musculoskeletal diseases (RMD) might have an increased risk for infection due to their immunomodulatory treatment, secondary to their disease and comorbidities. Recent studies suggest a decreased risk of severe COVID-19 in RMD-patients treated with biologics. Objectives: The aim of this study was to assess courses of RMD patients treated with TNF-inhibitors (TNF-I) included in the German COVID-19 registry. Methods: In the German physician-reported COVID-19-RMD registry, patients with an RMD and confirmed SARS-CoV-2-infection were documented (data entered between March 30, 2020 and January 30, 2021). We analysed TNF-I treated patients, their course and outcome of the infection. Data were compared to RMD-patients treated with other immunomodulatory drugs (OID) than TNF-I. Results: A total of 269 patients were treated with a TNF-I (57% female) compared to 874 patients who were treated with OID (68% female). Median age was 52 years (range: 19-87) in the TNF-I-group versus 58 years (range: 18-91) in the OID-group. Rheumatoid arthritis was the most common diagnosis (38% in TNF-I-group vs. 52% in the OID-group), followed by ankylosing spondylitis (32% vs. 6%), psoriatic arthritis (22% vs. 11%) and other RMD (9% vs. 31%). Adalimumab (35%) and etanercept (35%) were the most frequently used TNF-I (tab. 1). Glucocorticoids (GC) were used in 22% of TNF-I-treated patients and in 42% of the OID-group. Under TNF-I, stable disease was reported prior to the SARS-CoV-2-infection in 53% of the patients (OID-group: 47%), followed by low disease activity in 35% (OID: 34%), moderate disease activity in 6% (OID: 12%) and high disease activity in 4% (OID: 3%). Most frequent comorbidities were arterial hypertension (29% under TNF-I vs. 35% under OID), diabetes (8% vs. 11%) and cardiovascular diseases (7% vs. 12%). The most common reported COVID-19 symptoms were dry cough (57% vs. 55%), fever (53% vs. 61%) and fatigue (50% vs. 49%). Hospitalization due to SARSCoV infection was required in only 12% of the TNF-I-treated cases vs. in 29% in the OID-group. Oxygen treatment was necessary in 5% of the patients under TNF-I compared to 22% under OID and invasive ventilation in 2% in the TNF-Igroup compared to 6% under OID. Most notably, no fatal courses of COVID-19 were reported among the 269 RMD-patients treated with TNF-I versus 49 deaths in the 874 cases (5.6%) treated with OID. Focussing on the hospitalizated TNF-I patients, the rate of concomitant GC use (p<0.001) and higher disease activity (p=0.005) was significant higher (tab.1). Conclusion: High or moderate RMD-disease activity is an important factor associated with severity of COVID-19 including mortality. In this large cohort RMD patients treated with TNF-I show a low hospitalisation rate and no fatal course. This is reassuring for patients and treating rheumatologists to use TNF-I to control RMD disease activity. The use of glucocorticoids and high disease activity seem to counteract possible protective effects of TNF-I.

Disease activity and pain levels are not influenced by the current COVID19 pandemic in patients with rheumatic diseases in germany-data from the german COVID-19 patient survey

Background: The current pandemic constitutes an entirely new situation for patients as well as physicians. The insecurity of the early phase, shutdowns, increasing infection rate and appearing SARS-CoV2 mutations have created a situation that makes live difficult especially for chronic diseases i.e. patients with rheumatic and musculoskeletal diseases (RMD) and their treating physicians. The psychosocial burden that is created by this special situation is completely unknown and is estimated to be higher in patients than in the general population. Objectives: In order to measure the impact on our patients, the German COVID19-Rheuma patient survey was set up in April 2020, during Germany's first shut down. Methods: The German COVID19-Rheuma patient survey is a patient reported longitudinal online survey where patients with RMD who registered between April and July 2020 are asked on a monthly base using an online survey on social, personal, medical factors, whether a COVID19 infection occurred, isolation measures were changed and scores regarding stress and anxiety are recorded. Between April and July 2020, 637 patients registered and completed a first survey. Up to January 2021, about 400 patients are still enrolled. Here we present an interim analysis of the first 6 months regarding patients that were enrolled in April and May during the first shut-down. This first analysis compares the situation in the first lockdown to July, a phase with very low infection numbers in Germany, and to November, the beginning of the second lockdown. Results: 150 patients (87% female) were enrolled in April/early May 2020. Mean age was 48 years (range 11-89). The majority of patients suffered from rheumatoid arthritis (51%), followed by psoriatic arthritis (17%), other spondyloarthropathies (10%) and connective tissue diseases (10%). The majority of patients received antirheumatic therapies: 32% glucocorticoids (GC), 31% cDMARDs, 21% TNF inhibitors, 7% Jak inhibitors, and 9% other biologicals. Of the patients treated with GC, 25% were on GC monotherapy. In the first lockdown, 26% of patients were working remotely and 24% were self-isolating (doubles included). Additionally, 48% were using masks that were not mandatory at that time and 41% were using disinfection in a regular manner. The rates for remote work and self-isolation did not change significantly over time while the mask use increased to 98% with the official obligation to do so. The use of disinfectants increased to 88% in November. Regarding disease activity, no change in patient global assessment could be observed over time (4.3 ± 2.5 vs. 4.0 ±2.6 and 4.0 ± 2.5). Self-reported pain was also stable over time as were sleep disturbances. While 48.2% of patients who were receiving physiotherapy paused in April, only 10 and 14% did so in July and November, respectively. 11% of the patients paused their medication in the first lockdown, whereas only 2.75% did so in July and 3.4% in November. Contact with the treating rheumatologist was maintained over time in the majority of cases. Conclusion: While in the beginning of the pandemic the insecurity was considerable and the concern that the fear for infection would lead to inadequately treated patients with RMDs, we here show for the first time that on the one hand our patients were timely in taking adequate measures to keep themselves safe (e.g. self-isolating, mask use) and adapted to the clinical situation in not pausing their medication. Altogether, in this alert cohort, the pandemic did not lead to an increase of patient-reported disease activity in the first six months.

Evaluation of a virtual reality teaching concept for medical students during the SARS-CoV-2 pandemic

Background: The ongoing COVID-19 pandemic has disrupted face-to-face teaching of medical students and forced efforts in finding alternative approaches. In order to help maintain high-quality education, a new virtual reality (VR)-based concept for training medical students in rheumatic and musculoskeletal diseases (RMD) has been developed. This VR training concept is based on the integration of real patient data with two-and three-dimensional visualized pathological joints from X-ray and computed tomography generated images. Objectives: To evaluate the practicability and acceptance of the VR training application in the digital curricular education of medical students during the COVID-19 pandemic. Methods: A short refresher lecture on rheumatic diseases (duration 60 minutes) was followed by presenting the VR training concept to the students. The VR training concept included the demonstration of three virtual patients with early rheumatoid arthritis, rheumatoid arthritis psoriatic arthritis regarding the symptoms, current medical problems, disease patterns at the imaging (conventional radiographs and high-resolution computed tomography) and therapy options. The practicability and acceptance of the VR was evaluated by medical students using a survey. Results: The study encompassed 237 medical students (163 female, 73 male, one diverse, age range 20 to 40 years). 72 % of the participants rated the virtual teaching as good or very good. 87 % presented an expanded knowledge for rheumatoid arthritis and psoriatic arthritis through the VR. Moreover, 91 % reported that the lecture provided a deeper understanding of RMD. Furthermore, 60 % of the students asked for additional courses by VR. Conclusion: The study highlighted the usefulness of innovative VR tools for teaching medical students digitally about RMD. VR applications can be a complementary educational modality for medical students, especially during the COVID-19 pandemic, to provide students with the best possible clinical experience while ensuring that patient, student, and staff safety is not compromised.

The proper study: Interim analysis of a pan-eu real-world study of sb5 biosimilar following transition from reference adalimumab in patients with rheumatoid arthritis, axial spondyloarthritis, or psoriatic arthritis

Background: SB5, a biosimilar to reference adalimumab (ADL), received EU marketing authorisation in August 2017, based on the totality of evidence from pre-clinical and clinical Phase I and III studies that demonstrated bioequivalence, similar efficacy, and comparable safety and immunogenicity to the reference. This real-world study provides data on outcomes of the transition from reference to biosimilar ADL outside the controlled, randomised, clinical trial setting. Objectives: To evaluate candidate predictors of persistence on SB5 in EU patients (pts) across multiple indications. Methods: This ongoing observational study enrolled 1000 pts with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), ulcerative colitis, or Crohn's disease who initiated SB5 as part of routine clinical practice following a minimum of 16 weeks' treatment with reference ADL, at clinics in Belgium, Germany, Ireland, Italy, Spain, and the UK. Data are captured from clinic records retrospectively for the 24 weeks prior to transition, and prospectively and/or retrospectively for 48 weeks following transition. Primary outcome measures include baseline clinical characteristics, disease activity scores and clinical management over time;data on COVID-19 infection has recently been captured. This interim analysis (IA) provides an overview of baseline characteristics, disease scores and dose regimen up to 48 weeks post-initiation of SB5, and COVID-19 infection reported to date, in subjects with RA, axSpA, or PsA enrolled at 35 specialist sites and followed up to the data extract date of 18th December 2020. Results: Of the 504 pts included in this IA, 201 have RA, 169 have PsA, and 134 axSpA. At time of data extract, 216 pts had completed 48 weeks on SB5, 73 pts had discontinued SB5, and 8 had discontinued the study. Conclusion: This IA provides a first insight into clinical management of pts over 48 weeks, in a contemporary cohort of EU pts with established RA, axSpA and PsA, switched from reference to biosimilar ADL SB5 in clinical practice. The majority of pts showed no meaningful difference in disease score or dose regimen of SB5 by Week 48 post-transition. As of data extract date, the proportion of pts with a known positive COVID-19 test was low (1.3%) and a small minority (1.3%) had SB5 treatment changed or interrupted as a result of the COVID-19 pandemic. With follow-up of pts ongoing to Q4 2021, the study will continue to provide pertinent information about clinical outcomes of transition from reference to biosimilar ADL in real-world practice and in indications not investigated in controlled studies.

Do patients with rheumatoid arthritis show a different course of COVID-19 compared to patients with spondyloarthritis?

OBJECTIVES: Rheumatoid arthritis (RA) and spondyloarthritis (SpA) are the most common inflammatory rheumatic diseases (IRD). The aim of this study was to elucidate differences in the outcome of SARS-CoV-2 infection in RA- and SpA-patients. METHODS: Data from the German COVID-19 registry for IRD patients from 30th March to 16th November 2020 were analysed. 208 RA and SpA patients were included in the study, matched for gender and age. RESULTS: 104 SpA patients (40% patients with ankylosing spondylitis, 54% with psoriatic arthritis and 6% with enteropathic arthritis) were compared to 104 RA patients. For both groups, median age was 56 years. TNF-i treatment was reported in 45% of the SpA and in 19% of RA patients (p=0.001). Glucocorticoids were used in 13% of the SpA and in 40% of the RA patients (p=0.001). In both groups, the majority of the patients (97% SpA, 95% RA) recovered from COVID-19. Hospitalisation was needed in 16% of the SpA and in 30% of the RA patients (p=0.05), and oxygen treatment in 10% and 18% respectively (p=ns). Three versus six (p=ns) fatal courses were reported in the SpA versus the RA group. CONCLUSIONS: The study revealed that the hospitalisation rate during COVID-19 infection, but not the mortality, was significantly higher in RA as compared to SpA patients. This could be explained either by different treatment strategies or by different susceptibilities of the two diseases.

OLDER AGE, CARDIOVASCULAR COMORBIDITY AND GLUCOCORTICOSTEROIDS ARE RISK FACTORS FOR COVID-19 HOSPITALISATION IN PATIENTS WITH INFLAMMATORY RHEUMATIC DISEASES: FIRST RESULTS OF THE GERMAN COVID-19-IRD REGISTRY

Background:Patients with inflammatory rheumatic diseases (IRD) and infection with SARS-CoV-2 may be at risk to develop a severe course of COVID-19. To gather knowledge about SARS-CoV-2 infections in IRD patients, a national registry was established to elucidate IRD specific profiles of COVID-19.Objectives:To identify risk factors for hospitalisation.Methods:Patients from the German registry on SARS-CoV-2 infection in IRD were analysed. Patients are enrolled with a pre-existing IRD and a positive lab-result for a SARS-CoV-2 infection. The main outcome parameter was hospitalisation versus non-hospitalisation. Multivariable logistic regression was used to estimate odds ratios (OR) and 95% confidence intervals (CI). Covariates included in the model were age group, gender, key comorbidities (cardiovascular, lung diseases, chronic renal insufficiency), prior and/or current use of glucocorticosteroids (GC) or NSAIDs and remission.Results:Until May 17th, 2020, data from 192 IRD patients with SARS-CoV-2 infection were reported (67 males;124 females;1 diverse). 64 patients were hospitalised, 21 patients were ventilated non-invasively/invasively and 15 patients died.Baseline characteristics are shown in table 1, stratified into the patient groups non-hospitalisation, hospitalisation without ventilation, and hospitalisation with ventilation. Non-hospitalised patients were younger, had less comorbidities and were less often treated with GC. In the group of hospitalised patients compared to non-hospitalised patients more patients were male (42% vs 32% male) with an even higher proportion in the ventilated patient group (57% male).In the multivariable logistic regression model, age65 years (OR 5.1;95%CI 2.3-11.4), cardiovascular comorbidity (OR 2.3;95%CI 1.0-5.0), and prior and/or current treatment with GC (OR 2.6;95%CI 1.2-5.4) were independently associated with hospitalisation.Parameter, N (%)Non-hospitalisation 128 (66.7)Hosp. without ventilation 42 (22.4)Hosp. with ventilation 21 (10.9)Age [years], mean (SD)53.8 (13.4)65.2 (15.5)69.7 (9.9)Female87 (68.5)28 (65.1)9 (42.9)RA60 (46.9)24 (55.8)12 (57.1)Psoriasis23 (18)3 (7)3 (14.3)Axial spondyloarthritis14 (10.9)2 (4.7)0Lupus7 (5.5)1 (2.3)0Remission of IRD67 (52.3)23 (53.5)4 (19)Number of comorbidities, mean (SD)1 (1.2)1.8 (1.4)2.4 (1.5)Cardiovascular disease42 (32.8)25 (58.1)16 (76.2)Pulmonary disease16 (12.5)8 (18.6)8 (38.1)Chronic renal insufficiency5 (3.9)7 (16.3)4 (19)Cancer2 (1.6)4 (9.3)2 (9.5)Obesity (BMI30)23 (18)5 (11.6)3 (14.3)Diabetes3 (2.3)7 (16.3)4 (19)Other comorbidities20 (15.6)9 (20.9)6 (28.6)csDMARD (without HCQ)59 (46.1)25 (58.1)8 (38.1)HCQ13 (10.2)1 (2.3)2 (9.5)bDMARD48 (37.5)15 (34.9)8 (38.1)tsDMARD5 (3.9)1 (2.3)1 (4.8)Glucocorticosteroids47 (37)29 (67.4)13 (61.9)NSAIDs21 (16.4)5 (11.6)1 (4.8)Conclusion:As has been described for COVID-19 in general, also in IRD male gender may be associated with a more severe course of the infection as the descriptive analysis of data shows. Risk factors for SARS-CoV-2 infection-dependent hospitalisation in IRD patients include age (65 years), cardiovascular comorbidities, and prior and/or current treatment with GC.Disclosure of Interests:Anne Regierer Speakers bureau: Novartis, Celgene, Janssen-Cilag, Rebecca Hasseli Grant/research support from: Pfizer, Consultant of: Pfizer, Gilead, Novartis, Celgene, Abbvie, Medac, Bimba Hoyer: None declared, Andreas Krause: None declared, Hanns-Martin Lorenz Grant/research support from: Consultancy and/or speaker fees and/or travel reimbursements: Abbvie, MSD, BMS, Pfizer, Celgene, Medac, GSK, Roche, Chugai, Novartis, UCB, Janssen-Cilag, Astra-Zeneca, Lilly. Scientific support and/or educational seminars and/or clinical studies: Abbvie, MSD, BMS, Pfizer, Celgene, Medac, GSK, Roche, Chugai, Novartis, UCB, Janssen-Cilag, Astra-Zeneca, Lilly, Baxter, SOBI, Biogen, Actelion, Bayer Vital, Shire, Octapharm, Sanofi, Hexal, Mundipharm, Thermo Fisher., Consultant of: see above, Alexander Pfeil Grant/research support from: This study Investigator Initiated Study “Automatic assessment of jo nt space narrowing in rheumatoid arthritis based on the Post-hoc analysis” (number: IIS-2016-110818) is a part of the of the Investigator Initiated Study “The quantification of inflammatory related periarticular bone loss in certolizumab pegol treated patients with rheumatoid arthritis” (number: IIS-2014-101458) which is supported by UCB Pharma GmbH, Monheim, Germany., Jutta Richter Grant/research support from: Grant/research support from: GlaxoSmithKline and UCB Pharma for performing the LuLa-study., Tim Schmeiser Speakers bureau: Actelion, UCB, Pfizer, Christof Specker Consultant of: Abbvie, Boehringer Ingelheim, Chugai, Lilly, Novartis, Sobi, UCB, Celgene, Janssen-Cilag, MSD, Pfizer, Roche, UCB, Toshiba, Anja Strangfeld Speakers bureau: AbbVie, BMS, Pfizer, Roche, Sanofi-Aventis, Reinhard Voll: None declared, Hendrik Schulze-Koops: None declared, Ulf Müller-Ladner Speakers bureau: Biogen