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  • 1
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 79, No. Suppl 1 ( 2020-06), p. 661.1-661
    Abstract: SLE onset is preceded by a preclinical phase evidenced by the presence of anti-nuclear and other autoantibodies (autoAbs), which however, have low predictive value for development of clinical SLE. Objectives: To define the subgroup of autoAbs-positive individuals who are at high risk for progression into SLE by integrating environmental, clinical/serological, genetic and transcriptome data. Methods: A multicenter, across five European countries, inception cohort of autoAbs-positive individuals or first-degree relatives (FDRs) of SLE patients who are monitored prospectively over five years for possible transition to SLE according to the classification criteria. Structured data collection on demographics, family and medical history, clinical (criteria and selected non-criteria manifestations) and serological parameters, use of medications, hydroxyvitamin D levels and lifestyle (tobacco, alcohol use, physical activity, adherence to Mediterranean diet). Blood samples are stored for RNA-sequencing and genotyping. Results: A total 254 at-risk individuals (93% women, 99% Caucasians, aged [mean ± standard deviation] 36 ± 12 years) have been included and enrolment/monitoring is still ongoing. Forty individuals (16%) have FDR with SLE and 88 individuals (35%) have FDR with another autoimmune disorder. The frequency of active and past use of tobacco was 28% and 20%, respectively. Sedentary lifestyle (moving only for necessary chores or outdoor activity 1-2 times/week) was reported by 54% and adherence to the Mediterranean diet was low (3.4 ± 2.3, maximum score: 9). At enrolment, individuals had 1.9 ± 1.1 ACR-1997 classification criteria, with anti-nuclear antibodies (ANA) being the most frequent (88%), followed by synovitis (39%), photosensitivity (33%) and immunologic disorder (30%) (Table 1). During follow-up of 15.2 ± 7.2 months, a total 15 individuals (5.9%) have progressed into classified SLE, including cases with severe hematological and neurological disease. Table 1. Baseline characteristics of the at-risk for SLE cohort N (%) or mean ± SD ACR 1997 classification criteria 1.9 ± 1.1  Malar rash 68 (27%)  Discoid rash 29 (11%)  Photosensitivity 83 (33%)  Mucosal ulcers 49 (19%)  Synovitis 100 (39%)  Serositis 30 (12%)  Renal disorder 28 (11%)  Neurologic disorder 31 (12%)  Hematologic disorder 58 (23%)  Immunologic disorder 77 (30%)  ANA 222 (88%) SLICC 2012 classification criteria  Clinical criteria 1.0 ± 0.9  Immunological criteria 1.3 ± 0.9 Conclusion: Among individuals with positive autoAbs or FDRs with SLE, the short-term risk for transition into clinical SLE is low. Following the study completion, clinical and lifestyle data will be combined with blood transcriptome to define a high-risk subgroup of individuals for progression into SLE. Acknowledgments: The study is supported by the Foundation for Research in Rheumatology (FOREUM; preclin016) Disclosure of Interests: Christina Adamichou: None declared, Dionysis Nikolopoulos: None declared, Myrto Nikoloudaki: None declared, Zahra Rahme: None declared, Micaela Fredi: None declared, Antigoni Pieta: None declared, ARGYRO REPA: None declared, Alice Parma: None declared, Eleni Kalogiannaki: None declared, Nestor Avgustidis: None declared, Nikolaos Kougkas: None declared, Aggelos Banos: None declared, Anastasios Eskitzis: None declared, Alessandra Bortoluzzi: None declared, Søren Jacobsen: None declared, Prodromos Sidiropoulos: None declared, Emmanouil Dermitzakis: None declared, Marta Mosca: None declared, Luís Inês: None declared, Laura Andreoli: None declared, Angela Tincani: None declared, Antonis Fanouriakis Paid instructor for: Paid instructor for Enorasis, Amgen, Speakers bureau: Paid speaker for Roche, Genesis Pharma, Mylan, George Bertsias Grant/research support from: GSK, Consultant of: Novartis
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    RVK:
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 1481557-6
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  • 2
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 79, No. Suppl 1 ( 2020-06), p. 1892.3-1892
    Abstract: Despite the increased incidence of influenza infection in rheumatoid arthritis (RA) patients, vaccination coverage has been shown to be suboptimal. Prospective data regarding the current rate and predictors of influenza vaccination adherence in RA patients are limited. Objectives: To calculate the current rate and predictors of influenza vaccination in a real-life, prospective, longitudinal RA cohort. Methods: Data regarding demographics, disease characteristics, treatments and co-morbidities from a multi-center, longitudinal cohort of Greek RA patients were collected at baseline and ~ 3 years later. Disease and patient characteristics were compared between patients with at least one influenza vaccine administration and non-vaccinated ones, during the 3 year follow-up period. Results: From a cohort of 1,569 RA patients, 1,406 with available vaccination data at baseline and 3 years later (mean interval: 2.9 years) were included; (women: 80.4%, mean age: 61.8 years, mean disease duration: 9.7 years, RF and/or anti-CCP positive: 50.4%, mean DAS-28 = 3.33, mean HAQ: 0.44, bDMARD use: 44.8%). At baseline, 54.2% of patients reported influenza vaccination in the past (31.8% during the previous season), while during the 3 year follow-up period, 81% had ≥1 influenza vaccinations (p= 〈 0.001). Patients who received ≥1 influenza vaccine were older (63.5 vs. 54.7 years, p 〈 0.001), were more likely to be seropositive (59.2% vs. 45.2%, p 〈 0.001), had higher HAQ (0.46 vs. 0.36, p=0.02) and BMI (27.7 vs. 26.9, p=0.02) at baseline, more likely to be treated with bDMARDs (46.8% vs. 36.4%, p 〈 0.001) and more likely to have chronic lung disease (9.7% vs. 5.3%, p=0.02), dyslipidemia (36.4% vs. 24.2%, p 〈 0.001), hypertension (46.1% vs. 29.2%, p 〈 0.001) and to report vaccination against influenza the previous season before baseline evaluation (34.9% vs. 18.2%, p 〈 0.001). By multivariate analysis, history of influenza vaccination during the last season before baseline (OR=1.87, CI: 1.27-2.74, p=0.001), bDMARD treatment (OR=1.51, CI: 1.07-2.13, p=0.018) and age (OR=1.05, CI: 1.04-1.06, p 〈 0.001) were independent predictors of influenza vaccination. Conclusion: In this ongoing, longitudinal, prospective, real-life RA cohort study, a significant increase in the influenza vaccination coverage was noted (from 53% to 81%). Influenza vaccination was independently associated with recent history of influenza vaccination, older age, and bDMARD treatment. Acknowledgments: Supported by grants from the Greek Rheumatology Society and Professional Association of Rheumatologists. Disclosure of Interests: Konstantinos Thomas: None declared, Argyro Lazarini: None declared, Evripidis Kaltsonoudis: None declared, Alexandros Drosos: None declared, ARGYRO REPA: None declared, Prodromos Sidiropoulos: None declared, Kalliopi Fragkiadaki: None declared, Maria Tektonidou Grant/research support from: AbbVie, MSD, Novartis and Pfizer, Consultant of: AbbVie, MSD, Novartis and Pfizer, Petros Sfikakis Grant/research support from: Grant/research support from Abvie, Novartis, MSD, Actelion, Amgen, Pfizer, Janssen Pharmaceutical, UCB, Panagiota Tsatsani: None declared, Sousana Gazi: None declared, Pelagia Katsimbri: None declared, Dimitrios Boumpas: None declared, Evangelia Argyriou: None declared, Kyriaki Boki: None declared, Gerasimos Evangelatos: None declared, Alexios Iliopoulos: None declared, Konstantina Karagianni: None declared, Lazaros Sakkas: None declared, Konstantinos Melissaropoulos: None declared, Panagiotis Georgiou: None declared, Eleftheria Grika: None declared, PANAYIOTIS VLACHOYIANNOPOULOS: None declared, Theodoros Dimitroulas: None declared, Alexandros Garyfallos Grant/research support from: MSD, Aenorasis SA, Speakers bureau: MSD, Novartis, gsk, Constantinos Georganas: None declared, Periklis Vounotrypidis: None declared, Konstantinos Ntelis: None declared, Maria Areti: None declared, George D Kitas: None declared, Dimitrios Vassilopoulos: None declared
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    RVK:
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 1481557-6
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  • 3
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 81, No. Suppl 1 ( 2022-06), p. 1314.2-1315
    Abstract: Comparative data among rheumatoid arthritis (RA), spondylarthritis (SpA) and psoriatic arthritis (PsA) patients regarding long-term survival of etanercept (ETN) in clinical practice are limited. Objectives The first aim of this study was to analyze the long-term ( 〉 3 years) ETN survival comparatively between its three main indications. We also aimed to analyze for predictors of long term ETN survival. Methods We analyzed data from the University of Crete Rheumatology Clinic Registry (UCRCR), a single center prospective cohort study. All patients with a diagnosis of RA, SpA or PsA starting treatment with a biologic DMARD are recorded prospectively based on a common follow-up protocol. For the first aim, ETN survival 〉 3 years was compared among the 3 diseases. For the 2nd aim patients on ETN 〉 3 years were compared to those stopping ETN during the first 2 years. We analyzed baseline and early on treatment (first 6 months) characteristics, comedications, comorbidities as predictors for long term survival applying univariate and multivariate models. Results A total of 711 patients who were started on ETN were analyzed (RA: 450, SpA: 177, PsA: 84). As expected, patients’ and disease characteristics at baseline differed significantly between the 3 diagnoses (Table 1). Patients’ function was compromised irrespective of the diagnosis, while inflammatory activity was significant across diseases. Table 1. Baseline parameters [Medians (IQR) unless otherwise specified] RA (n=450 ) SpA (n=177 ) PsA (n=84 ) p Women N (%) 370 (82) 66 (37) 46 (55) 〈 0.001 Age 61.5 (53-70) 44.5 (35-54) 51 (41-62) 〈 0.001 Disease duration 2.6 (0.9-6.5) 0.8 (0.1-5.1) 1.7 (0.6-4.9) 〈 0.001 Follow-up years 1.0 (0.5-2.1) 1.0 (0.4-3.1) 1.1 (0.4-3.6) 0.649 Total comorbidities nr. 3 (1-4) 1 (0-3) 2 (1-4) 〈 0.001 RDCI 1 (1-2) 0 (0-1) 1 (0-1) 〈 0.001 Ever smokers N(%) 124 (39) 82 (67) 30 (61) 〈 0.001 BMI 31 (26-35) 27 (25-32) 29 (23-32) 0.015 Treatment line N (%): 1st 264 (59) 87 (49) 43 (51) 0.012   2nd 119 (26) 70 (39.5) 24 (29)   ≥ 3rd 67 (15) 20 (11) 17 (20) Nr of previous csDMARDs 2 (1-3) 1 (0-2) 1 (1-2) 〈 0.001 Co-administered MTX N(%) 284 (63) 65 (37) 50 (60) 〈 0.001 Monotherapy, N (%) 60 (13) 100 (56.5) 25 (30) 〈 0.001 Ongoing corticosteroids N(%) 153 (34) 25 (14) 17 (20) 〈 0.001 DAS28 - ESR 5.8 (5.0-6.5) 3.7 (2.9-4.7) 5.3 (4.5-6.4) 〈 0.001 ASDAS-ESR - 3.4 (2.8-4.1) 3.6 (3.2-4.7) 0.067 CRP (mg/dl) 0.4 (0.3-1.1) 1.1 (0.3-2.4) 0.8 (0.4-2.0) 〈 0.001 During a follow-up of 1371 patient-years, 466 (65.5%) patients stopped therapy. The estimated percentage of patients persisting on ETN therapy for 〉 3 years was 28.4%, 42.8% and 44% of RA, SpA and PsA respectively. The main reason for therapy discontinuation was inefficacy (75% of stop reasons in RA vs. 58% in SpA vs. 69% in PsA). In multivariable Cox regression analyses the most important predictor for ETN survival was the achievement of LDA/remission at 6 months based on DAS28 for RA or ASDAS for SpA [Odds Ratio (OR) 1.98, p=0.008 and 3.02, p=0.001 respectively]. Prognostic factors for ETN discontinuation specifically due to inefficacy were comorbidities number and csDMARDs coadministration (p 〈 0.05 for both), while older age and no co-therapy with MTX predicted ETN stop due to adverse events (p 〈 0.05 for both). Logistic regression analysis indicated that male sex [OR: 2.08, p=0.004], calendar year of treatment start [OR per 3 years: 0.74, p=0.001] , comorbidities’ number [OR: 0.82, p=0.045] and monotherapy [OR: 1.81, p=0.027] predict persistence on ETN therapy beyond 3 years, while the clinical diagnosis or other baseline parameters are not significant predictors. Conclusion In this prospective cohort study, we found that ETN survival was higher for patients with SpA/PsA as compared to RA. Male sex, absence of comorbidities and no csDMARDs co-administration are independent predictors of long-term persistence to therapy, irrespectively of the clinical diagnosis. Notably, both in RA and SpA, 6-month response predicted ETN survival in the long term. Acknowledgements This study was funded by the Pancretan Health Association and Pfizer Global Medical Grants. Disclosure of Interests None declared
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    RVK:
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 1481557-6
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  • 4
    In: Klinische Pädiatrie, Georg Thieme Verlag KG, Vol. 222, No. S 01 ( 2010-6)
    Type of Medium: Online Resource
    ISSN: 0300-8630 , 1439-3824
    Language: German
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2010
    detail.hit.zdb_id: 2039110-9
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  • 5
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 81, No. Suppl 1 ( 2022-06), p. 437-438
    Abstract: Belimumab has been introduced in the management of SLE for more than 10 years, however long-term efficacy and safety data are still limited and mostly derive from the extended phase of randomized clinical trials. Objectives To evaluate the long-term survival of belimumab treatment, reasons for treatment cessation and associated predictors in routine care setting. Methods Multicentre observational study of adult SLE patients who were treated with belimumab according to physician discretion and in line with the EULAR recommendations. Disease activity (Physician Global Assessment [PGA]: scale 0-3; SLE disease activity index-2000 [S2K] ), flares (SELENA-SLEDAI Flare Index), organ damage (SLICC damage index [SDI]), co-administered treatments and dosage, adverse events and causes of belimumab discontinuation were monitored prospectively at 3–6-month intervals. Cox-regression analysis was performed to identify factors associated with reduced drug survival. Results A total 184 patients treated with belimumab for at least 3 months were included (women 95.6%; mean ± SD age 48.8 ± 13.4 years; disease duration 9.2 ± 11.3 years). Baseline S2K and PGA were 7.5 ± 3.0 and 1.64 ± 0.42, respectively, both demonstrating significant improvement at 6 months (4.5 ± 3.5 and 1.02 ± 0.69, respectively; p 〈 0.001) and 12 months (3.5 ± 3.1 and 0.68 ± 0.55, respectively; p 〈 0.001). Of patients receiving glucocorticoids at onset, 49.0% tapered the dose and 17.6% completely withdrew them. After a median (interquartile range) follow-up of 15.1 (16.9) months, 44.0% of patients discontinued belimumab due to suboptimal efficacy as judged by the treating physician (28.3%), adverse events (including infections) (9.8%) or other causes (e.g., pregnancy, patient decision). Accordingly, efficacy-related drug survival rates at 1 and 2 years were 70% and 61%, respectively, with corresponding safety-related survival rates of 94% and 87%, respectively. Baseline factors associated with belimumab discontinuation due to suboptimal efficacy included PGA 〉 1.50 (hazard ratio [HR] 3.66; 95% confidence interval [95% CI] 1.14–11.73; p=0.029) and severe (RA-like) arthritis (HR 2.56; 95% CI 1.16–5.68; p=0.020) but not disease duration, use of glucocorticoids, active serology or organ damage. Notably, patients with early (3 months) improvement (i.e., any decrease in PGA) showed significantly lower risk for treatment cessation (HR 0.38; 95% CI 0.22–0.67; p=0.001) (Figure 1) and this effect was independent of the initial PGA level. Baseline use of hydroxychloroquine was associated with prolonged safety-related belimumab survival (HR 0.32; 95% CI 0.12–0.88; p=0.028). Figure 1. Efficacy-related survival of belimumab according to improvement or not of PGA at 3 months since treatment initiation. Conclusion In real-life setting, about 28% of SLE patients discontinue belimumab due to suboptimal treatment response per physician judgement, especially those with moderate-to-high activity and severe arthritis. Improvement in PGA at 3 months predicts long-term drug maintenance, therefore suggesting its value for patient monitoring. Our data confirm the very good tolerability of belimumab and identify hydroxychloroquine co-administration as a predictor for prolonged safety-related drug survival. Acknowledgements The study was partly funded by the Greek Rheumatology Society and the Greek Association of Professional Rheumatologists (ERE-EPERE) and by Pfizer Global Medical Grants Disclosure of Interests Myrto Nikoloudaki: None declared, Dionysis Nikolopoulos: None declared, SOFIA KOUTSOVITI: None declared, Irini Flouri: None declared, Noemin Kapsala: None declared, ARGYRO REPA: None declared, PELAGIA KATSIMPRI: None declared, EVANGELOS THEOTIKOS: None declared, Sofia Pitsigavdaki: None declared, Katerina Pateromichelaki: None declared, Anastasios Eskitzis: None declared, ANTONIA ELEZOGLOU: None declared, Prodromos Sidiropoulos: None declared, Antonis Fanouriakis: None declared, Dimitrios Boumpas: None declared, George Bertsias Speakers bureau: GSK, AstraZeneca, Pfizer, SOBI, UCB, Novartis, AENORASIS, Abbvie, Grant/research support from: GSK, Pfizer
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    RVK:
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 1481557-6
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  • 6
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 79, No. Suppl 1 ( 2020-06), p. 1811.1-1812
    Abstract: Adult-onset Still’s disease (AOSD) is a rare systemic inflammatory disorder. In recent years biological disease modifying antirheumatic drugs (bDMARDs) are becoming increasingly important for its treatment. Objectives: To evaluate disease outcomes, treatment strategies and their long-term safety in a cohort of AOSD patients treated with bDMARDs. Methods: A single-center retrospective study of patients diagnosed with AOSD until 2019 was conducted. Patients were included if they: a) were 16 years old or older, b) met the Yamaguchi criteria and c) had received a bDMARD Demographics, clinical and laboratory parameters were collected at the time of diagnosis. Data regarding treatment lines included: the previous and concomitant conventional disease modifying antirheumatic drugs (cDMARDs), the type of initial bDMARD, switches, survival and corticosteroids discontinuation. Adverse events related to treatment and disease outcomes including death and amyloidosis were also recorded. Results: Sixteen patients with AOSD (Table 1) refractory to cDMARDs were administered biologics. The median duration of follow-up was 14 years (range 1-24). Consistent with recent literature 1 , two distinct disease patterns were recognized: the systemic form (SF) and the chronic articular form (CAF). In the SF the leading clinical symptoms were fever, pericarditis and pleuritis. In CAF the leading clinical symptom was persistent RA-like arthritis. Table 1. Some clinical and laboratory features of patients with FMF or MEFV mutations accompanied by demyelination disease Cases Age/Sex Diseases MEFV mutations The onset age/diagnostic age for FMF The onset age for DD/MS/Presenting manifestations/MRI findings Treatment for FMF /DD/MS Case 1 (F1) 17/F FMF+DD M694V homozygous 3/5 15 OB (-) Fusiform plaques in the cingulate gyrus; plaques in T4-6 Colchicine IL-1 RA Glatiramer acetate Case 2 (F1) 46/F FMF+MS M694V homozygous 8/9 28 Optic nerve involvement OB(+) Plaques (+) Colchicine Glatiramer acetate Case 3 (F1) 17/F FMF+MS M694V heterozygous 3/5 15 Loss of the right eye, vertigo OB(+) Plaques Colchicine Pulse steroid Beta-interferon Teriflunomide Case 4 (F2) 36/F MS+MEFV mutation M694V/R202Q - 27 Headache, blurred vision, optic nerve atrophy OB(+) Plaques (+) Glatiramer acetate Case 5 (F2) 16/F MS?+FMF+Cutaneous vasculitis M694V/R202Q 16/16 11 Headache, blurred vision No LP (denied by pt) Plaques - F: Female, F1: Family 1, F2: Family 2; DD: Demyelination disease;MS: Multiple sclerosis;MRI: Magnetic resonance imaging; OB:Oligoclonal band; LP: Lumbar punction Table 1. Summary of patient characteristics at the time of diagnosis Characteristics Results Age at the time of diagnosis median, (range) years 32.5 (18-64) Sex (N) 11 female, 5 male Fever 14 (87.5%) Rash 8 (50%) Lymphadenopathy 2 (12.5%) Arthritis 15 (93.75%) Pleuritis 7 (43.7%) Pericarditis 9 (56.25%) Hepatosplenomegaly 2 (12.5%) Elevated liver enzymes 2 (12.5%) Hyperferritinaemia 4 (25%) Patients with the SF were treated with anakinra (n=4), tocilizumab (TCZ; n=3), canakinumab (n=1) and anti-TNFa (1 adalimumab, 1 etanercept) (n=2). Patients with the CAF received anti-TNFa (3 infliximab, 1 etanercept) (n=4) and TCZ (n=2). The median time from biologic initiation to corticosteroids discontinuation was 6.5 months, (range 2-32), (Table 2). 9 patients (56.25%) remained on treatment with the initial bDMARD, 4 patients (25%) received treatment with two and 3 patients (18.75%) with ≥ 3 bDMARDs. All patients with the CAF were on bDMARD at the end of follow-up, while 4/10 patients (40%) with the SF discontinued it. During follow-up only one serious adverse event was attributed to bDMARD (allergic reaction to infliximab infusion). There were no cases of amyloidosis or deaths Conclusion: Dichotomous phenotype in AOSD can determine treatment strategy for initial biologic treatment. Inhibition of IL-1 and IL-6 was the preferred therapeutic option for systemic form while inhibition of TNF and IL-6 was the preferred option for the chronic articular form. All of the above bDMARDs have favorable long-term safety profile in patients with AOSD. References: [1]François Vercruysse et al. Adult-onset Still’s disease biological treatment strategy may depend on the phenotypic dichotomy Arthritis Research & Therapy. 2019 Disclosure of Interests: Nikolaos Kougkas: None declared, Nestor Avgustidis: None declared, Sofia Pitsigavdaki: None declared, Katerina Pateromichelaki: None declared, ARGYRO REPA: None declared, Ainour Molla Ismail Sali: None declared, Anastasios Eskitzis: None declared, George Bertsias Grant/research support from: GSK, Consultant of: Novartis
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    RVK:
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 1481557-6
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  • 7
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 80, No. Suppl 1 ( 2021-06), p. 523.2-523
    Abstract: There is limited information on the burden of comorbidities in patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA) in real-world clinical practice and its impact on the incidence of serious adverse events (SAE) during biologic disease-modifying anti-rheumatic drug (bDMARD) therapy. Objectives: To evaluate the number of comorbidities in patients with RA and SpA initiating a bDMARD in everyday clinical practice and to explore its association with the occurrence of a SAE during therapy. Methods: Prospective study of all patients who start any bDMARD treatment in a tertiary centre University Hospital. All comorbidities and SAEs (AEs necessitating hospitalization or resulting in significant incapacity/death) are registered by treating physicians. Comorbidities’ number was evaluated using two different indices: total comorbidities count (CC) and Rheumatic Disease Comorbidity Index (RDCI). Statistical analysis was performed using multinomial logistic and Cox regression models. Results: A total of 799 patients were analysed, of which 428 (54%) had ≥3 comorbidities (Table 1). Comorbidity burden was higher in RA, however in multivariable analyses, comorbidities were not significantly associated with diagnosis, but mainly with increasing patient age. Patients received 1701 bDMARD treatments. During a follow-up of 4019 patient-years, 198 patients (RA:134, SpA:64) had a total of 295 SAE (RA: 217, SpA:78). Each one additional comorbidity in CC index was resulting in 16% increased adjusted risk for the first SAE [HR (95%CI) = 1.16 (1.12-1.20), p 〈 0.001], and each additional comorbidity of the RDCI index was resulting in 28% increased risk [HR (95%CI) = 1.28 (1.20-1.37), p 〈 0.001]. Other baseline independent predictors of the first SAE were greater age [HR=1.04, p 〈 0.001] and use of corticosteroids [HR=1.42, p=0.006] . Table 1. Biologic treatments and clinical characteristics at baseline Patients, Ν Total RA SpA p 799 501 298 Females, Ν (%) 535 (67) 404 (81) 131 (44) 〈 0.001 Age, median (IQR) έτη 55 (45-65) 60 (51-68) 46 (36-54) 〈 0.001 Disease duration, median (IQR) έτη 6.0 (2.5-13) 5.4 (3-11) 7.4 (2.0-15) 〈 0.001 Comorbidities count, median (IQR) 3 (1-5) 3 (2-6) 2 (1-4) 〈 0.001 Patients with no comorbidities, Ν (%) 103 (13) 43 (9) 60 (20) 〈 0.001 Patients with 1 comorbidity, Ν (%) 134 (17) 77 (15) 57 (19) 0.172 Patients with 2 comorbidities, Ν (%) 134 (17) 76 (15) 58 (19,5) 0.118 Patients with ≥3 comorbidities, Ν (%) 428 (54) 305 (61) 123 (41) 〈 0.001 RDCI, median (IQR) 1 (0-2) 2 (0-3) 1 (0-2) 〈 0.001 Patients with RDCI = 0, Ν (%) 267 (33) 128 (25.5) 139 (47) 〈 0.001 Patients with RDCI = 1, Ν (%) 185 (23) 119 (24) 66 (22) 0.665 Patients with RDCI = 2, Ν (%) 163 (20) 113 (23) 50 (17) 0.057 Patients with RDCI ≥ 3, Ν (%) 184 (23) 141 (28) 43 (14) 〈 0.001 Total bDMARDs initiated by patients, Ν 1701 1098 603 Co-administered methotrexate, Ν(%) 946 (56) 674 (61) 272 (45) 〈 0.001 Co-administered corticosteroids, Ν (%) 493 (29) 397 (36) 96 (16) 〈 0.001 DAS28, median (IQR) (in RA and perSpA) 5.8 (4.9-6.6) 5.8 (5.0-6.6) 5.4 (4.2-6.3) 〈 0.001 BASDAI, median (IQR) (in axSpA) - - 5.6 (4.5-7.0) Conclusion: Patients with RA and SpA initiating a bDMARD treatment in real-world clinical practice have a significant comorbidity burden which increases with age and is an independent predictor for an SAE during therapy. Acknowledgements: This research is co-financed by Greece and the European Union (European Social Fund- ESF) through the Operational Programme «Human Resources Development, Education and Lifelong Learning» in the context of the project “Reinforcement of Postdoctoral Researchers - 2nd Cycle” (MIS-5033021), implemented by the State Scholarships Foundation (ΙΚΥ). Disclosure of Interests: None declared
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    RVK:
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 1481557-6
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  • 8
    In: Allergy, Wiley, Vol. 61, No. 7 ( 2006-07), p. 812-819
    Abstract: Background:  Probiotic lactic acid bacteria (LAB) are able to modulate the host immune system and clinical trials have demonstrated that specific strains have the capacity to reduce allergic symptoms. Therefore, we aimed to evaluate the potential of recombinant LAB producing the major birch pollen allergen Bet v 1 for mucosal vaccination against birch pollen allergy. Methods:  Recombinant Bet v 1‐producing Lactobacillus plantarum and Lactococcus lactis strains were constructed. Their immunogenicity was compared with purified Bet v 1 by subcutaneous immunization of mice. Intranasal application of the live recombinant strains was performed to test their immunomodulatory potency in a mouse model of birch pollen allergy. Results:  Bet v 1 produced by the LAB was recognized by monoclonal anti‐Bet v 1 and IgE antibodies from birch pollen‐allergic patients. Systemic immunization with the recombinant strains induced significantly lower IgG1/IgG2a ratios compared with purified Bet v 1. Intranasal pretreatment led to reduced allergen‐specific IgE vs enhanced IgG2a levels and reduced interleukin (IL)‐5 production of splenocytes in vitro , indicating a shift towards non‐allergic T‐helper‐1 (Th1) responses. Airway inflammation, i.e. eosinophils and IL‐5 in lung lavages, was reduced using either Bet v 1‐producing or control strains. Allergen‐specific secretory IgA responses were enhanced in lungs and intestines after pretreatment with only the Bet v 1‐producing strains. Conclusions:  Mucosal vaccination with live recombinant LAB, leading to a shift towards non‐allergic immune responses along with enhanced allergen‐specific mucosal IgA levels offers a promising approach to prevent systemic and local allergic immune responses.
    Type of Medium: Online Resource
    ISSN: 0105-4538 , 1398-9995
    URL: Issue
    RVK:
    Language: English
    Publisher: Wiley
    Publication Date: 2006
    detail.hit.zdb_id: 2003114-2
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    Online Resource
    Online Resource
    Georg Thieme Verlag KG ; 2014
    In:  Klinische Pädiatrie Vol. 226, No. 01 ( 2014-1-16), p. 3-7
    In: Klinische Pädiatrie, Georg Thieme Verlag KG, Vol. 226, No. 01 ( 2014-1-16), p. 3-7
    Type of Medium: Online Resource
    ISSN: 0300-8630 , 1439-3824
    URL: Issue
    Language: German
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2014
    detail.hit.zdb_id: 2039110-9
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  • 10
    Online Resource
    Online Resource
    Georg Thieme Verlag KG ; 2013
    In:  Klinische Pädiatrie Vol. 225, No. 07 ( 2013-10-24), p. 379-382
    In: Klinische Pädiatrie, Georg Thieme Verlag KG, Vol. 225, No. 07 ( 2013-10-24), p. 379-382
    Type of Medium: Online Resource
    ISSN: 0300-8630 , 1439-3824
    URL: Issue
    Language: German
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2013
    detail.hit.zdb_id: 2039110-9
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