Background The COVID-19 pandemic has raised numerous questions among patients with immune-mediated inflammatory diseases regarding potential reciprocal effects of COVID-19 and their underlying disease, and potential effects of immunomodulatory therapy on outcomes related to COVID-19. The seroprevalence of SARS-CoV-2 and factors associated with symptomatic COVID-19 in patients with immune-mediated inflammatory diseases are still unclear. The Euro-COVIMID study aimed to determine the serological and clinical prevalence of COVID-19 among patients with immune-mediated inflammatory diseases, as well as factors associated with COVID-19 occurrence and the impact of the pandemic in its management. Methods In this multicentre cross-sectional study, patients aged 18 years or older with a clinical diagnosis of rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Sjögren's syndrome, or giant cell arteritis were recruited from six tertiary referral centres in France, Germany, Italy, Portugal, Spain, and the UK. Demographics, comorbidities, treatments, and recent disease flares, as well as information on COVID-19 symptoms, were collected through a questionnaire completed by participants. SARS-CoV-2 serology was systematically tested. The main outcome was the serological and clinical prevalence of COVID-19. Factors associated with symptomatic COVID-19 were assessed by multivariable logistic regression, and incidence of recent disease flares, changes in treatments for underlying disease, and the reasons for treatment changes were also assessed. This study is registered with ClinicalTrials.gov , NCT04397237 . Findings Between June 7 and Dec 8, 2020, 3136 patients with an immune-mediated inflammatory disease answered the questionnaire. 3028 patients (median age 58 years [IQR 46–67]; 2239 [73·9%] women and 789 [26·1%] men) with symptomatic COVID-19, serological data, or both were included in analyses. SARS-CoV-2 antibodies were detected in 166 (5·5% [95% CI 4·7–6·4]) of 3018 patients who had serology tests. Symptomatic COVID-19 occurred in 122 (4·0% [95% CI 3·4–4·8]) of 3028 patients, of whom 24 (19·7%) were admitted to hospital and four (3·3%) died. Factors associated with symptomatic COVID-19 were higher concentrations of C-reactive protein (odds ratio 1·18, 95% CI 1·05–1·33; p=0·0063), and higher numbers of recent disease flares (1·27, 1·02–1·58; p=0·030), whereas use of biological therapy was associated with reduced risk (0·51, 0·32–0·82; p=0·0057). At least one disease flare occurred in 654 (21·6%) of 3028 patients. Over the study period, 519 (20·6%) of 2514 patients had treatment changes, of which 125 (24·1%) were due to the pandemic. Interpretation This study provides key insights into the epidemiology and risk factors of COVID-19 among patients with immune-mediated inflammatory diseases. Overall, immunosuppressants do not seem to be deleterious...
ObjectivesThis post hoc analysis assessed speed, magnitude and maintenance of pain improvement in patients with early rheumatoid arthritis (RA) receiving baricitinib, baricitinib and methotrexate (MTX), or MTX over 1 year. Cumulative pain and quality of life benefits were also assessed.MethodsRandomised, double-blind, phase 3 study RA-BEGIN (NCT01711359) compared baricitinib 4 mg (N=159), baricitinib 4 mg +MTX (N=215) and MTX (N=210) in patients with RA who had no or limited prior disease-modifying antirheumatic drug treatment. Pain was assessed on a 0–100 mm Visual Analogue Scale (VAS). Proportion of patients with ≥30%, ≥50% and ≥70% pain improvement from baseline; ≤20 mm and ≤10 mm on the pain VAS; and time to achieve pain improvement thresholds were assessed over 52 weeks, as were Patient Global Assessment (PtGA) and 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS) outcomes.ResultsBaricitinib monotherapy or combination with MTX provides greater (least square mean changes (LSM) from baseline −40 mm and −43 mm, respectively) and more rapid (median 12 and 8 weeks to ≥70% improvement, respectively) pain relief than MTX alone (LSM −31 mm, median 20 weeks to ≥70% improvement) over 52 weeks. Baricitinib, alone or combination, provides 9–10 additional weeks of limited to no pain, similar gain in achievable wellness measured through PtGA, and 5–7 additional weeks with change in SF-36 PCS ≥5 vs MTX over 1 year.ConclusionsPatients treated with baricitinib reported significantly greater and more rapid pain relief, more weeks with limited to no pain, and clinically meaningful improvements in physical health than patients treated with MTX alone over 1 year.
ObjectivesTo analyse the effect of targeted therapies, either biological (b) disease-modifying antirheumatic drugs (DMARDs), targeted synthetic (ts) DMARDs and other factors (demographics, comorbidities or COVID-19 symptoms) on the risk of COVID-19 related hospitalisation in patients with inflammatory rheumatic diseases.MethodsThe COVIDSER study is an observational cohort including 7782 patients with inflammatory rheumatic diseases. Multivariable logistic regression was used to estimate ORs and 95% CIs of hospitalisation. Antirheumatic medication taken immediately prior to infection, demographic characteristics, rheumatic disease diagnosis, comorbidities and COVID-19 symptoms were analysed.ResultsA total of 426 cases of symptomatic COVID-19 from 1 March 2020 to 13 April 2021 were included in the analyses: 106 (24.9%) were hospitalised and 19 (4.4%) died. In multivariate-adjusted models, bDMARDs and tsDMARDs in combination were not associated with hospitalisation compared with conventional synthetic DMARDs (OR 0.55, 95% CI 0.24 to 1.25 of b/tsDMARDs, p=0.15). Tumour necrosis factor inhibitors (TNF-i) were associated with a reduced likelihood of hospitalisation (OR 0.32, 95% CI 0.12 to 0.82, p=0.018), whereas rituximab showed a tendency to an increased risk of hospitalisation (OR 4.85, 95% CI 0.86 to 27.2). Glucocorticoid use was not associated with hospitalisation (OR 1.69, 95% CI 0.81 to 3.55). A mix of sociodemographic factors, comorbidities and COVID-19 symptoms contribute to patients’ hospitalisation.ConclusionsThe use of targeted therapies as a group is not associated with COVID-19 severity, except for rituximab, which shows a trend towards an increased risk of hospitalisation, while TNF-i was associated with decreased odds of hospitalisation in patients with rheumatic disease. Other factors like age, male gender, comorbidities and COVID-19 symptoms do play a role.
Objectives:To analyze the risk of admission for COVID19 infection and outcome of patients treated with bDMARD or tsDMARD from our biologic therapy center, to compare with all patients admitted for COVID-19 infection in our hospital.Methods:Records of the patients from our center admitted for COVID-19 infection between March 8 and May 8, 2020 were analyzed retrospectively. Age, gender, and outcome of all patients admitted for COVID19 infection to our hospital on the same dates were collected. Chi-square, Student’s t and Man-Whitney U tests were used for comparisons when appropriate.Results:1,668 patients with inflammatory diseases treated with bDMARD or tsDMARD were included. Median age 53.0 years (range 17-91), 52.4% women. Diagnoses and DMARD distribution are shown in tables 1 and 2. 19/1668 (1.1%; 6.8 patient-years) were admitted for severe COVID19 infection. Mortality ratio: 4/19 (21.1%). Median age of the admitted patients was higher: 61.0y (SD 14.2) vs 53.0y (SD 15.0); p <0.009. Median age of deceased patients was also higher 69.5y (SD 20.3) vs 53.0y (SD 15.0); p: NS. Female gender had a worse prognosis trend: 52.4% of all group, 68.4% of those hospitalized, 75.0% of those who died. Females had a higher median age than men: 55.0y (SD 14.9) vs. 50.0y (SD 14.9); p <0.001.When comparing patients treated with DMARD admitted for COVID19 infection with all patients hospitalized for the same reason (4,601patients), no differences were found neither in age (61.0y [SD 14.2] vs 58.3y [SD 18.1]; NS) nor gender (female: 68.4% vs 54.7%; NS). However, DMARD group seemed to have higher mortality: 4/19 (21.1%) vs 551/4601 (12.0%); p: NS, at a younger age: 69.5y (SD 20.3) vs 82.4 (SD 11.4); p: NS.Rheumatoid arthritis patients were admitted more frequently: (9/392 (2.3%) vs 10/1276 (0.8%); p <0.025. And were older: median 62y (SD 13.5) vs 50.0y (SD 14.4); p <0.001.Patients treated with anti-TNF suffered less admissions: 6/1055 (0.6%) vs 13/613 (2.1%); p<0.001 and were younger: median 51.0y (SD 15.0) vs 55.0y (SD 14.7); p <0.001. Anti-TNF were less used in patients with rheumatoid arthritis 188/392 (48.0%) vs 867/1276 (67.9%); p<0.001.DiseaseN (%)AdmitteddeathsRheumatoid arthritisSpondylarthritisPsoriatic arthritisJIACTDVasculitisIBDPsoriasisOthers392 (23.5%)277 (16.6%)124 (7.4%)30 (1.8%)31 (1.9%)20 (1.2%)582 (34.9%)202 (12.1%)10 (0.6%)9/392 (2.3%)2/277 (0.7%)1/124 (0.8%)0/30 (0.0%)1/31 (3.2%)0/20 (0.0%)4/578 (0.7%)2/202 (1.0%)0/10 (0.0%)110010100TOTAL1,668 (100%)19/1668 (1.1%)4/19 (21.1%)JIA: Juvenile Idiopathic Arthritis; CTD: Connective Tissue Disease; IBD: Inflammatory Bowel DiseaseTreatmentN (%)AdmitteddeathsAnti-TNFAnti-CD20Anti-IL6CTLA4-IgAnti-IL17Anti-IL12/23Anti-integrinJAK inhibitorPDE4 inhibitorAnti-IL231055 (63.2%)79 (4.7%)96 (5.8%)44 (2.6%)92 (5.5%)143 (8.6%)79 (4.7%)34 (2.0%)32 (1.9%)14 (0.8%)6/1055 (0.6%)3/79 (3.8%)3/96 (3.1%)3/44 (6.8%)2/92 (2,2%)1/143 (0.7%)0/79 (0.0%)1/34 (2.9%)0/32 (0.0%)0/14 (0.0%)2101000000TOTAL1,668 (100%)19/1668 (1.1%)4/19 (21.1%)Conclusion:It seems reasonable that patients with inflammatory diseases treated with bDMARD or tsDMARD continue their treatment during the COVID19 epidemic. The different rates of hospitalization based on the diagnosis or DMARD may be due to comorbidity, confounding by indication and other bias. The study is not powerful enough to study these confounders.Disclosure of Interests:Carlos Gonzalez Consultant of: Gilead, Janssen, Novartis, Speakers bureau: Abbvie, Celgene, Gilead, Janssen, Novartis, Pfizer, Roche, Luis Alberto Menchén Viso Grant/research support from: Abbvie, Janssen, MSD, Takeda, Consultant of: Abbvie, Janssen, Takeda, MSD, Medtronic, Tillotts, Pfizer, Dr. Falk Pharma, Speakers bureau: Abbvie, Janssen, Takeda, MSD, General Electric, Tillotts, Pfizer, Ferring, General Electric, Fresenius, Ofelia Baniandrés Rodríguez: None declared, Ana Herranz Alonso: None declared, Carmen Lobo Rodríguez: None declared, Juan Carlos Nieto Speakers bureau: Pfizer, Abbvie, MSD, Novartis, Janssen, Lilly, Nordic Pharma, BMS, Gebro, FAES Farma, Roche, Sanofi, Indalecio Monteagudo Sáez: None declared, Ignacio Marín Jiménez: None declared, Amparo López: None declared, Ana López: None declared, Arantza Ais Larisgoitia: None declared, Esther Chamorro de Vega: None declared, Paloma Morales de los Ríos: None declared, Maria Jesus Lizcano: None declared, Jose Maria Alvaro Gracia: None declared, Sonia García de San José: None declared
Background:Radiosynovectomy (RS) is a useful for treating inflammatory arthritis that fail conventional treatments. The main isotope used is Yttrium-90 on large joints as knees, whereas Erbium-169 and Renium-186 are more common in small and medium sized joints respectively.RS is a safe procedure since the isotopes cannot escape the synovial capsule or be absorbed into circulation. It is, however, lethal against cells within the inflamed joint.The most common rheumatic disease treated with RS is rheumatoid arthritis (RA), followed by axial spondyloarthritis (SpA) and idiopathic juvenile arthritis (JIA). It has also been used on persistent synovitis after joint replacements, pigmented villonodular synovitis (PVNS) and undifferentiated arthritis.Objectives:To describe the experience in RS of a tertiary rheumatology center and compare patients with and without clinical response to treatment in the following 12 months.Methods:Observational retrospective study between May 31st 2013 and October 31st 2019. We collected demographic variables, data about the disease of the patient, the joints affected, isotope utilized, presence of Baker’s cyst, systemic treatment received, need of additional infiltrations (before and after), complications and any changes in medication up to a year after the procedure.All the RS were performed ambulatory and the radioisotope infiltration was guided by ultrasound, with 40mg of triamcinolone infiltrated after.SPSS v23 was used for statistical analysis; with Chi2 for qualitative variables and Student’s T distribution for quantitative variables.Results:We evaluated 67 joints in 49 patients in total. All of them were refractory to conventional treatment. 44 patients (65.7%) were women, median of 53.4 years of age (IQ 43.4-67.1).The median disease duration was 12.5 years and RS seemed to fare better the longer the patient had the disease (median of 13.5 years vs 6.5 years p<0.001).The joints infiltrated where 46 (68.6%) knees, 14 (20.9%) wrists and 7 (15.2%) elbows. Out of the knees, 16 (34.8%) belonged to RA patients with effective response in 14 (87,5%). 100% of elbows had an effective response, of them 6 (85.7%) had RA. However, even when 9 (64.2%) wrists also had RA as diagnosis, only 3 (21.4%) were effective.Of the PVNS, 6 out of 8 (75%) had no clinical response, as shown in Table 1.Table 1.RS response compared to clinical diagnosis.TOTALEFFECTIVEINEFFECTIVEp 67 (100%)46 (68.6%)21 (31.3%)Inflammatory Arthritides(RA + PsA + SpA + sJIA), (%)52 (77.6)39 (75%)13 (25%)<0.0001RA (%)30 (44.7)22 (73.3)8 (26.6)<0.001RA positive ACPA/FR21 (70)15 (71.4)6 (28.6)<0.0001Psoriasic arthritis (PsA) (%)6 (9)4 (66.6)2 (33.3)0.42SpA (%)10 (14.9)8 (80)2 (20)0.45sJIA (%)6 (9)5 (83.3)1 (16.6)0.55PVNS (%)8 (11.9)2 (25)6 (75)<0.001Inespecific monoarthritis (%)3 (4.4)3 (100)0 (0)0.23OA + Calcium Pyrophosphate Deposition (CPPD) (%)4 (5.9)2 (50)2 (50)0.33Intra articular corticosteroids were needed before RS, with no differences in effective and ineffective joints; however after RS it was significantly lower in effective joints in the first six months (0% vs 43% p<0.0001) and remained so in the following 6 months (0% vs 19% p<0.0001)Only 13 (28%) patients with effective RS needed to change systemic treatment compared to 10 (43%) of those ineffective (p<0.0001). None of the patients with RS had any complication after the procedure during follow up.Conclusion:Our study showed that knees were the main joint infiltrated and they had an overall good response to treatment, especially if the diagnosis was RA.Patients with effective procedures needed leest treatment changes and significantly less corticosteroids infiltrations.In our study, RS in PVNS was significantly less effective than in inflammatory arthritis (25% vs 75% p<0.0001) and RA seemed to have the best response overall.References:[1]Liepe K. Efficacy of radiosynovectomy in rheumatoid arthritis. Rheumatol Int. 2012 Oct; 32(10):3219-24.[2]Ćwikła JB, Żbikowski P, Kwiatkowska B, Buscombe JR, Sudoł-Szopińska I. Radiosynovectomy in rheumatic diseases. J Ultrason. 2014 Sep; 14(58):241-51.Disclosure of Interests:None declared
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