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  • 1
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 79, No. Suppl 1 ( 2020-06), p. 1551.2-1551
    Abstract: Recommendations to collect the most relevant information on disease course, treatment and outcomes in giant cell arteritis (GCA) has been proposed by EULAR to facilitate clinical research and to improve clinical care. Objectives: To assess the quality of data collection in routine clinical practice according to EULAR recommendations and to describe baseline and follow-up characteristics of a retrospective cohort of patients with GCA. Methods: We reviewed medical records of patients diagnosed with GCA in a tertiary academic center between 2004-2018. We included patients with available data at diagnosis and one year of follow-up. Data extraction included: demographics, diagnosis, GCA-related signs and symptoms, laboratory, imaging modalities, comorbidities and treatment. Data in the chart was then compared with the core set of parameters proposed for GCA registries and databases by EULAR. Major relapse, according to the EULAR 2018 definition, was independently assessed by two rheumatologists. Results: 58 patients were identified, 39 met predefined inclusion criteria with 151 visits during first-year follow-up. Headache (100%; 80.4%), ocular symptoms (89.7%; 81.2%), constitutional symptoms (89.7%; 80.4%), polymyalgia rheumatica (89.7%; 82%) and jaw claudication (87%; 81.2%) were the most frequently collected items at baseline and follow-up. Weight and height (2.6%; 2.6%), peripheral pulses (8%; 4.5%), smoking status (41%; 21%), and blood pressure (61.5%; 4.5%) were the less frequently collected. Most patients lacked differential pressure measurement. Myocardial infarction, malignancy, serious infections, arterial hypertension, diabetes and osteoporosis were collected in every patient (39, 100%). Only 2 mayor relapses were identified (5%). Two (2) patients died during the one-year follow-up period. Table 1 provides information on GCA-related signs and symptoms, laboratory and therapeutic data. Table 1. GCA-related signs and symptoms, laboratory and therapeutic data. Item Performed Baseline Baseline n=39 Performed Follow-up Follow-up n=112 Ocular symptoms 35/39 (89.7%) 15/35 (42.9%) 91/112 (81.2%) 29/91 (31.9%) Permanent ocular symptoms 34/39 (87%) 9/34 (26.5%) 92/112 (82%) 28/92 (30.4%) Headache 39 (100%) 30/39 (77%) 90/112 (80.4%) 13/90 (14.4%) Scalp tenderness 31/39 (79.5%) 9/31 (29.8%) 88/112 (78.6%) 4/88 (4.5%) Jaw claudication 34/39 (87%) 19/34 (55.85) 91/112 (81.2%) 6/91 (6.6%) Cranial artery abnormality 27/39 (69.2%) 17/27 (63%) 69/112 (61.6%) 3/69 (4.3%) Constitutional symptoms 35/39 (89.7%) 19/35 (54.3%) 90/112 (80.4%) 11/90 (12.2%) PMR 35/39 (89.7%) 18/35 (51.4%) 92/112 (82%) 9/92 (9.8%) ESR mean (SD ) 33/39 (84.6%) 58.7 (32.1) 83/112 (74%) 14.6 (18.8) CRP mean (SD ) 31/39 (79.5%) 8.4 (7.9) 70/112 (62.5%) 1.3 (3.3) Haemoglobin mean (SD ) 38/39 (97.4%) 12.0 (1.7) 90/112 (80.4%) 12.9 (1.5) Peripheral pulses 9/39 (8%) 3/9 (33.3%) 5/112 (4.5%) 2/5 (40%) Large vessel involvement 8/39 (20.5%) 5/8 (62.5%) 7/112 (6.25%) 3/7 (42.8%) Glucocorticoids median (IQR ) 39 (100%) 102.5 (50-250) 112 (100%) 10.0 (5-15) Synthetic DMARD 39 (100%) 8/39 (20.5%) 111/112 (99%) 17/39 (43.6%) Biological DMARD 39 (100%) 0/39 (0%) 111/112 (99%) 3/39 (7.7%) Antiplatelet agents 39 (100%) 6/39 (15.4%) 110/112 (98%) 25/110 (22.7%) PMR: polymyalgia rheumatica, ESR: erythrocyte sedimentation rate, CRP: C-reactive protein, SD: standard deviation, IQR: interquartile range, DMARD: disease modifying antirheumatic drugs Conclusion: Although data collection in routine care is usually comprehensive enough according to EULAR proposed data set, key components in physical exam mostly those aiming to detect large vessel involvement, should be addressed more carefully. References: [1]Ehlers L, et al. Ann Rheum Dis. 2019;78(9):1160–6. [2]Hellmich B, et al. Ann Rheum Dis. 2019;1–12. Disclosure of Interests: Julia Martínez-Barrio Consultant of: UCB Pharma, Belén Serrano Benavente: None declared, Tamara Del Río Blasco: None declared, Alfonso Ariza: None declared, Juan Ovalles: None declared, Juan Molina Collada: None declared, Teresa González: None declared, Carlos Gonzalez Consultant of: Gilead, Janssen, Novartis,, Speakers bureau: Abbvie, Celgene, Gilead, Janssen, Novartis, Pfizer, Roche, Isabel Castrejon: None declared, Jose Maria Alvaro Gracia: None declared
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
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    Publisher: BMJ
    Publication Date: 2020
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  • 2
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    BMJ ; 2020
    In:  Annals of the Rheumatic Diseases Vol. 79, No. Suppl 1 ( 2020-06), p. 1514.1-1515
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 79, No. Suppl 1 ( 2020-06), p. 1514.1-1515
    Abstract: Sjogren’s syndrome (SS) is characterized by lymphocytic infiltration of the exocrine glands and marked B-lymphocytic cell hyperreactivity involving a variety of serum autoantibodies. 1 Salivary Gland Ultrasound (SGU) is a simple, fast, and well- tolerated examination, wich provides information about glandular structure and has proven to be very useful in the Sjögren Syndrome diagnosis 2 . A prognostic value has also been proposed due to its posible relationship with lymphomas and extra-glandular manifestations. Objectives: The objective of our study is to evaluate ultrasound results in patients who went through an SGU in clinical practice, its usefulness in the diagnosis of Sjögren’s syndrome and the presence of complications (lymphomas, extra-glandular manifestations or factors related to increased lymphoma risk). Methods: We conducted a retrospective cross-sectional study with review of clinical records that included all those patients coded as SGU in the Ultrasound unit of Rheumatology Department from 2016 to December 2019. Information collected included final diagnosis, laboratory results, clinical manifestations and ultrasound results. We performed an analysis on the frequency of pathological SGU and on the relationship between this lesions in patients with final SS diagnosis and the presence of lymphoma, extra-glandular manifestations and the laboratory values related with increased lymphoma risk (low complement levels, cryoglobulinemia, positive autoimmunity). Results: SGU was performed in 171 patients in four years, 162 women (94.7%). The previous diagnoses, reason for the request and final diagnosis are shown in Table 1. The vast majority of the SGU were normal, only 28 (16,3%) were pathological, 13 with a grade II and 8 with a grade III. In the other 7 patients grading was not available. Of the 28 patients with pathological SGU, none had lymphoma, only 3 had recurrent parotitis and 15 had had extra-glandular manifestations, mainly arthralgia / arthritis (12). Only 1 patient, with rheumatoid arthritis, had had a lymphoma and the SGU was normal. Antibody positivity was frequent in pathological SGU, 16/23 antinuclear antibodies, 13/22 anti-Ro and 9/23 rheumatoid factor. Of the 86 patients without previous diagnosis, 18 were diagnosed with Sjogren syndrome, 9 with pathological SGU and the rest were normal. No patient diagnosed with a dry non-autoimmune syndrome presented pathological SGU. Table 1. Previous diagnoses, reason for request and final diagnoses. Previous diagnoses (n: 171) Reason for request (n: 171) Final diagnosis (n: 78) Without prior diagnosis (n: 86) Dry non- autoinmune syndrome (n: 127) Dry non-autoimmune syndrome (n: 60) Primary Sjögren’s syndrome (n: 11) Primary Sjögren’s syndrome (n: 12) Primary Sjögren’s syndrome (n: 18) Systemic Lupus Erythematosus (n: 9) Lymphoma (n: 0) Secondary Sjögren’s syndrome (n: 0) Rheumatoid arthritis (n: 24) Control (n: 13) Other diagnoses (n: 7) Other diagnoses (n: 18) Other reasons (n: 11) Conclusion: The impact of the SGU is low and its use cannot, for now, displace other methods (e.g. salivary gland biopsy) in the diagnosis of SS. Also our low number of patients with pathological SGU together with the low prevalence of the complications studied (e.g. lymphomas = 1) prevents the expected comparisons. References: [1]Ramos-Casals M, Solans R, Rosas J, et al. Primary Sjogren syndrome in Spain: clinical and immunologic expression in 1010 patients. Medicine (Baltimore) 2008; 87: 210–219. [2]Damjanov N, Milic V, Nieto-Gonzalez JC, et al. Multiobserver Reliability of Ultrasound Assessment of Salivary Glands in Patients with Established Primary Sjogren Syndrome. J Rheumatology 2016; 43: 1858–1863. Disclosure of Interests: Fernando Montero: None declared, Karen Carpio: None declared, Iustina Janta: None declared, Juan Molina Collada: None declared, Belén Serrano Benavente: None declared, Julia Martínez-Barrio Consultant of: UCB Pharma, Alfonso Ariza: None declared, Javier Rivera: None declared, Carlos Gonzalez Consultant of: Gilead, Janssen, Novartis,, Speakers bureau: Abbvie, Celgene, Gilead, Janssen, Novartis, Pfizer, Roche, Indalecio Monteagudo: None declared, Juan Carlos Nieto Speakers bureau: Pfizer, Abbvie, MSD, Novartis, Janssen, Lilly, Nordic Pharma, BMS, Gebro, FAES Farma, Roche, Sanofi
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
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    Language: English
    Publisher: BMJ
    Publication Date: 2020
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  • 3
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 80, No. Suppl 1 ( 2021-06), p. 658.2-659
    Abstract: EULAR recommendations propose temporal and axillary arteries ultrasound (US) as first-line investigation when predominantly cranial giant cell arteritis (GCA) is suspected. Recently, two novel US scoring systems, the halo count and the Southend Halo Score, have been developed to quantify the extent of inflammation by US in GCA. Objectives: To assess whether adding the subclavian arteries examination into the ultrasound (US) Southend Halo Score, as proposed in the modified Halo Score, improves the diagnostic accuracy of GCA and its relationship with systemic inflammation. Methods: Retrospective observational study of patients referred to a GCA fast track pathway (FTP) over a 1-year period. Patients underwent US exam of temporal and large vessel (LV) (carotid, subclavian and axillary) arteries. The extent of inflammation was measured by the halo count, the Southend Halo Score and the modified Halo Score (Image 1). The gold standard for GCA diagnosis was clinical confirmation after 6 months follow-up. Results: 64 patients were evaluated in the FTP, 17(26.5%) had GCA. Subclavian arteries involvement was present only in patients with GCA (29.4% versus 0%,p 〈 0.001) (Table 1). Overall, the three scores showed excellent diagnostic accuracy for GCA (ROC AUC 0.906, 0.930 and 0.928, respectively) and moderate correlations with acute phase reactants (0.35-0.51, p 〈 0.01). However, in the subgroup of patients presenting LV involvement, moderate correlations were found between the modified Halo Score and ESR (rho 0.712, p 〈 0.05), haemoglobin (rho 0.703, p 〈 0.05) and platelets (rho 0.734, p 〈 0.05), but not with the other two US scores. Figure 1. Proposed scores to quantify the extent of vascular inflammation by ultrasound in giant cell arteritis. A. Halo count, B. Halo Score, C: Modified Halo Score Table 1. Clinical, laboratory and ultrasound findings of patients included in the fast track pathway with or without GCA clinical confirmation. Total n=64 Patients with GCA n=17 Patients without GCA n=47 p Age, median (IQR ) 78 (69.3-83) 78 (72.5-83) 78 (66-83) 0.5 Female, n (% ) 42 (65.6%) 10 (58.8%) 32 (68.1%) 0.491 Temporal artery biopsy positive n=13, no. of patients 5 (38.5%) 5 (50%) 0 (0%) 0.231 18 F-FDG-PET/CT positive n=14, no. of patients 7 (50%) 5 (62.5%) 2 (33.3%) 0.592 Fulfilling 1990 GCA criteria, no. of patients 16 (25%) 8 (47.1%) 8 (17%) 0.022 PMR diagnosis before US examination, no. of patients 21 (32.8%) 4 (23,5%) 17 (36,2%) 0.386 Headache, no. of patients 31 (48.4%) 12 (70.6%) 19 (40.4%) 0.033 Jaw claudication, no. of patients 12 (18.8%) 9 (52.9%) 3 (6.4%) 〈 0.001 Ocular ischaemia, no. of patients 4 (6.3%) 2 (11.8%) 2 (4.3%) 0.285 Abnormal TA clinical examination, no. of patients 5 (7.8%) 3 (17.6%) 2 (4.3%) 0.112 CRP (mg/dL), median (IQR ) 1.7(0-6.5) 7 (2.1-14) 1.1 (0-5.1) 0.001 ESR (mm/h), mean (SD ) 52.8 (34.6) 68.3 (33.3) 46.8 (33.3) 0.044 Haemoglobin (g/dL), mean (SD ) 12.5 (1.7) 11.8 (1.6) 12.7 (1.7) 0.059 Platelets 10 9 /L, mean (SD ) 276.1 (105.8) 323.4 (116.3) 258.7 (97.3) 0.52 Positive US findings, no. of patients 17 (26.6%) 15 (88.2%) 2 (4.3%) 〈 0.001 Temporal artery positive US findings, no. of patients 13 (20.3%) 12 (70.6%) 1 (2.1%) 〈 0.001 Axillary positive US findings, no. of patients 9 (14.1%) 8 (47.1%) 1 (2.1%) 〈 0.001 Subclavian positive US findings, no. of patients 5 (7.8%) 5 (29.4%) 0 (0%) 〈 0.001 Temporal artery + axillary or subclavian positive US findings, no. of patients 5 (7.9%) 5 (29.4%) 0 (0%) 0.003 Halo Count, median (IQR ) 0 (0-0.75) 2 (1-4.5) 0 (0-0) 〈 0.001 Halo Score, median (IQR ) 0 (0-4.5) 18 (7-22.5)) 0 (0-0) 〈 0.001 Modified Halo Score, median (IQR ) 0 (0-2.75) 8 (3-13.5) 0 (0-0) 〈 0.001 Conclusion: The inclusion of subclavian arteries examination in the modified Halo Score does not improve the diagnostic accuracy of GCA. Nevertheless, it correlates better with markers of systemic inflammation in LV-GCA Disclosure of Interests: None declared
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
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    Language: English
    Publisher: BMJ
    Publication Date: 2021
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  • 4
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 79, No. Suppl 1 ( 2020-06), p. 1402.2-1403
    Abstract: Patients with inflammatory arthralgia (IA) are considered to be at increased risk for progression to RA. US has shown high sensitivity to detect synovitis compared with physical examination. Thus, US is recommended to identify subclinical synovitis in patients without clinical signs of inflammation. Objectives: The objective of our study is to determine the frequency and pattern of US detected inflammatory findings in patients with IA and investigate factors contributing to predict these findings. Methods: An US clinic is scheduled in an academic center running three days every week. A retrospective analysis of our US unit cohort during a period of 6 months was undertaken. Patients with IA and no previous diagnosis of inflammatory arthropathies were included for analysis. Inclusion criteria of IA definition included: severe symptoms presenting in the morning, duration of morning stiffness ≥60 min, symptoms predominantly located in MCP joints and abscense of clinically detected synovitis by the referral rheumatologist. The following routinely collected variables were included in the analysis: demographics, clinical features and laboratory tests. Patients underwent bilateral US examination in GS and PD mode of hands and/or feet according to the European League Against Rheumatism (EULAR) guidelines. The presence of synovitis, tenosynovitis and enthesitis was assessed on a semi quantitative scale (0–3) for Grey Scale(GS)/Power Doppler(PD) or using enthesitis OMERACT definition, respectively. Patients were stratified in two groups based on the presence of US inflammatory findings (synovitis, tenosynovitis or enthesitis with PD signal). First, differences between groups were tested using chi-squared and Student-t tests in the univariate analysis. Second, multivariate logistic regression models were employed to investigate the association between possible predictive factors of US detected inflammatory findings. Results: A total of 57 patients were included in the analysis. Mean age was 55.8±15.2 years, 41 (71.9%) were females, and mean symptoms duration was 11.4±10.4 months (Table 1). A total of 42 (73.7%) patients presented with a polyarticular arthralgia pattern. US inflammatory findings were present in 20 (35.1%) patients (26.3% PD synovitis, 21.1% PD tenosynovitis and 3.5% PD enthesitis). Hands were most commonly involved with PD synovitis at wrists in 19.3% and at MCP in 12.3% of patients (Table 2). For PD tenosynovitis, the flexor MCP 2-5 (5.3%) and compartment IV tenosynovitis (1.8 %) were the most frequent affected locations. Only two patients had PD enthesitis at feet and 6 (10.5%) had erosions in hands or feet at baseline examination. In the univariate analysis, the higher ESR values and the shorter time from symptoms onset were significantly associated with US detected inflammatory findings (p=0.044 and 0.049, respectively). In the multivariate analysis, only ESR values (OR=1,04; 95%CI 1,002-1,078), remained significantly associated with the presence of US inflammatory findings (Table 3). Table 3. Independent predictors of US detected inflammatory findings p Odds ratio 95% C.I. Lower Upper ESR (mm/h) 0.039 1.04 1.002 1.078 Time (months) from symptoms onset 0.1 0.924 0.841 1.015 Conclusion: PD US inflammatory findings are found in 1 over 3 patients with IA being PD synovitis the most common finding, specially at the wrists and MCP joints. Higher ESR values were significantly associated with the presence of US inflammatory findings. Our data highlights how the use of PD US may be useful to detect subclinical synovitis in patients with IA. Disclosure of Interests: Katerine López Gloria: None declared, Isabel Castrejon: None declared, Laura Trives Folguera Speakers bureau: ROCHE, Juan Carlos Nieto Speakers bureau: Pfizer, Abbvie, MSD, Novartis, Janssen, Lilly, Nordic Pharma, BMS, Gebro, FAES Farma, Roche, Sanofi, Belén Serrano Benavente: None declared, Julia Martínez-Barrio Consultant of: UCB Pharma, Javier Rivera: None declared, Carlos Gonzalez Consultant of: Gilead, Janssen, Novartis,, Speakers bureau: Abbvie, Celgene, Gilead, Janssen, Novartis, Pfizer, Roche, Indalecio Monteagudo: None declared, Jose-Maria Alvaro-Gracia Grant/research support from: Abbvie, Elli-Lilly, MSD, Novartis, Pfizer, Consultant of: Abbvie, BMS, Janssen-Cilag, Elli-Lilly, MSD, Novartis, Pfizer, Sanofi, Tigenix, Roche, UCB, Paid instructor for: Elli-Lilly, Pfizer, Roche, Speakers bureau: Abbvie, BMS, Janssen-Cilag, Elli-Lilly, Gedeon Richter, MSD, Novartis, Pfizer, Sanofi, Tigenix, Roche, UCB, Juan Molina Collada: None declared
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
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    Language: English
    Publisher: BMJ
    Publication Date: 2020
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  • 5
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 79, No. Suppl 1 ( 2020-06), p. 1465.2-1465
    Abstract: Metotrexate (MTX) is usually the first line therapy for Rheumatoid Arthritis (RA) because of its favorable efficacy-toxicity ratio. However the exact mechanism and treatment response time in both a clinical and ultrasonographic setting are still uncertain. Objectives: To describe the clinical and ultrasound response to MTX during the first 6 months of treatment in early RA patients who started subcutaneous methotrexate as the first disease-modifying drug (DMARD). Methods: Ongoing prospective cohort of patients with early RA (ACR-EULAR 2010 criteria), over 18 years and starting MTX-SC. Patients had a clinical and ultrasonographic evaluation at baseline, 1, 3 and 6 months. We collected demographic data, C-reactive protein [CRP], erythrocyte sedimentation rate [ESR] , rheumatoid factor [FR], anti-citrullinated protein antibody [ACPA] ), inflammatory activity indexes (DAS28esr and DAS28crp) and EULAR’s response to treatment (delta value of -1.2 in DAS28 scores). Joints explored with ultrasound were elbows and wrists (radio-carpal and inter-carpal joint) counted as a single joint, 1st-5th metacarpophalangeal (MCF), proximal interphalangeal (IFP), knees, tibio-talar and subtalar joints and 2nd-5th metatarsophalangeal (MTF) joints. Bone erosions were evaluated in 2nd and 5th MCF, styloid, distal ulna and 5th MTF. Synovitis was graduated semi-quantitatively from 0 to 3 (OMERACT) and calculated on B mode and Doppler. Results: 35 patients were included (mean age 61.2 years, 65.7% women) with a median of 0.8 (+/-8) months delay to diagnosis. 34 patients (97.1%) started 15mg MTX-SC/weekly. A higher DAS28esr was found in baseline data for the group that had a response by month 1 (DAS28esr baseline 5.5 vs 4.2 p=0.01), no other significant differences were found. During the first month, a significant response was achieved in 13 (41%) patients and remission in 11 (35%) (Table 1). 17 patients have 6 th month data. 11 (64.7%) have achieved EULAR response compared to baseline(P=0.0005) out of which 7 (54.5%) had already reached it by month 1. A difference in MTX dose (month1 14.8 vs month6 17.1 p=0.003) was found between month 1 and 6, with no differences in disease activity. In the ultrasonographic baseline data; 8 patients (22.9%) had erosions, with a mean of 2,75 erosions/patient (22 of the 280 locations). During the follow up the global rating lowered, with no differences in B mode but significant differences in Doppler at the 6 month mark (Table 2). As of this report, 10 patients (28.5%) had stopped MTX treatment due to lack on response or adverse effects and 8 (22.9%) are waiting 6 th month evaluation. Table 2. Ultrasound synovitis global rating. Baseline Month 1 P Value EULAR response 0 13 (41) 0.00005 MTX Dose mg (SD) 14.8 (+/-0.8) 14.8 (+/-1.6) 1 Prednisone Dose mg(SD) 5.9 (+/-6.5) 2.9 (+/-3) 0.02 DAS28crp (SD) 4.3 (+/-1.5) 3,4 (+/-1.4) 0.02 DAS28esr (SD) (4.8 (+/-1.5) 3.7 (+/-1.4) 0.006 Remission (DAS28 〈 1.2) 3(9.6) 11(35.5) 0.04 Table 1. Baseline characteristics of the patients with RA (n=102). Baseline N=35 1 month N=31 3 months N=25 6 months N=17 B Mode: Median (interquartile range) 8 (3.5-12) 8 (3-12.5) 6 (4-11) 5 (2-11) p 0,16 Doppler Mode : Median (interquartile range) 2 (0.5-6) 2 (0-6) 2 (0-6) 0 (0-2) p 0,005 Conclusion: In this cohort half of the patients that responded to treatment had achieved this by month 1. A higher baseline inflammatory profile was related to the response. Little difference is found between month 1 and 6 on clinical data, however ultrasonographic results suggest that at least 6 months are needed for Doppler improvement. Perhaps MTX has a faster effect over joint pain and lowers DAS28 scores requiring longer to completely suppress inflammatory activity. References: [1]Braun, J. et al. Comparison of the clinical efficacy and safety of subcutaneous versus oral administration of methotrexate in patients with active rheumatoid arthritis. Arthritis Rheum 2008 Disclosure of Interests: Liz R. Caballero Motta: None declared, Ana Melissa Anzola Alfaro: None declared, Luis A Torrens Cid: None declared, Christian Y Soleto: None declared, Belén Serrano Benavente: None declared, Iustina Janta: None declared, Juan Molina Collada: None declared, Carlos Gonzalez Consultant of: Gilead, Janssen, Novartis,, Speakers bureau: Abbvie, Celgene, Gilead, Janssen, Novartis, Pfizer, Roche, Indalecio Monteagudo: None declared, Jose Maria Alvaro Gracia: None declared, Juan Carlos Nieto Speakers bureau: Pfizer, Abbvie, MSD, Novartis, Janssen, Lilly, Nordic Pharma, BMS, Gebro, FAES Farma, Roche, Sanofi
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    ISSN: 0003-4967 , 1468-2060
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    Language: English
    Publisher: BMJ
    Publication Date: 2020
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  • 6
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 81, No. Suppl 1 ( 2022-06), p. 1423-1424
    Abstract: Ultrasound (US) is a valid imaging tool to detect signs of giant cell arteritis (GCA). Although the halo sign has always been considered the most useful finding for GCA diagnosis, modern high frequency transducers are able to precisely measure the intima-media thickness (IMT) of cranial and extracranial arteries. However, data on optimal cut-off values for IMT to differentiate patients and controls in clinical practice are limited. Objectives To determine the optimal cut-off value for IMT of cranial and extracranial arteries in patients with suspected GCA. Methods This is a retrospective observational study of patients referred to our US fast-track clinic with suspected GCA. All patients underwent bilateral US examination of the cranial and extracranial (carotid, subclavian and axillary) arteries within 24 hours per protocol. The exam was performed using an EsaoteMyLab8 with a 12-18 MHz frequency transducer for cranial arteries and an 8-14 frequency transducer for extracranial arteries. The IMT was measured in gray scale mode and the presence of a non-compressible halo sign was checked in all arteries. The gold standard for GCA diagnosis was clinical confirmation by the referring rheumatologist after 6 months follow-up. Mean IMT values of each artery were compared between patients with and without GCA by independent samples T-test. Receiver operating characteristics analysis was performed and the Youden index was used to determine the optimal cut-off value for IMT of each artery. Results Of the 157 patients with suspected GCA (67.5% female, mean age 73.7 years) referred to the fast-track clinic, 47 (29.9%) had GCA clinical confirmation after 6 months. 41 (87.2%) patients with GCA had positive US findings (61.7% had cranial involvement, 44.7% extracranial involvement and 19.1% a mixed pattern of cranial and extracranial arteries). The following IMT cut-off values showed the highest diagnostic accuracy: 0.44mm for the common superficial temporal artery; 0.34 mm for the frontal branch; 0.36 mm for the parietal branch; 1.1 mm for the carotid artery: 1 mm for the subclavian and axillary arteries. The area under the ROC curve of the IMT for a clinical diagnosis of GCA was 0.984 (95% CI 0.959 - 1) for common superficial temporal artery, 0.989 (95% CI 0.976 -1) for frontal branch, 0.991 (95% CI 0.980 - 1) for parietal branch, 0.977 (95% CI 0.961 – 0.993) for carotid, 0.99 (95% CI 0.979 - 1) for subclavian and 0.996 (95% CI 0.991 -1) for axillary arteries (Table 1). Table 1. Optimal IMT cut-off values for cranial and extracranial arteries Artery Side Patients without GCA Patients with GCA Cut-off (mm) AUC (CI 95%) Sensitivity (%) Specificity (%) Common superficialtemporal artery mm, mean (SD) Right 0.33 (0.06) 0.68 (0.28) 0.43 0.997 (0.988 -1) 100 97.1 Left 0.35 (0.11) 0.57 (0.21) 0.45 0.966 (0.905 -1) 100 92.3 Both 0.34 (0.08) 0.63 (0.25) 0.44 0.984 (0.959 -1) 94.7 95.1 Frontal branch mm, mean (SD) Right 0.26 (0.05) 0.4 (0.18) 0.34 0.994 (0.983 -1) 100 97.1 Left 0.27 (0.05) 0.4 (0.18) 0.34 0.985 (0.962 -1) 100 96.1 Both 0.26 (0.05) 0.4 (0.18) 0.34 0.989 (0.976 -1) 100 96.6 Parietal branch mm, mean (SD) Right 0.27 (0.05) 0.43 (0.18) 0.36 0.994 (0.981 -1) 100 98.9 Left 0.27 (0.05) 0.41 (0.16) 0.36 0.987 (0.967 -1) 100 97.6 Both 0.27 (0.05) 0.42 (0.17) 0.36 0.991 (0.980 -1) 100 98.3 Carotid mm, mean (SD) Right 0.8 (0.17) 0.88 (0.29) 1 0.974 (0.949 – 0.999) 100 92.6 Left 0.82 (0.15) 1 (0.42) 1.2 0.982 (0.961 - 1) 90.9 96.2 Both 0.81 (0.16) 0.96 (0.36) 1.1 0.977 (0.961 – 0.993) 90 94 Subclavian mm, mean (SD) Right 0.74 (0.18) 0.99 (0.44) 1 0.987 (0.97 - 1) 100 93.4 Left 0.67 (0.17) 0.9 (0.35) 1.1 0.991 (0.975 - 1) 100 98.3 Both 0.7 (0.18) 0.94 (0.4) 1 0.99 (0.979 - 1) 100 96 Axillary mm, mean (SD) Right 0.69 (0.16) 0.99 (0.5) 1 0.992 (0.982 - 1) 100 96 Left 0.67 (0.17) 0.99(0.49) 1 0.998 (0.995 -1) 100 98.3 Both 0.68 (0.17) 0.99 (0.49) 1 0.996 (0.991 -1) 100 97.1 Conclusion Different IMT cut-off values for each artery are necessary to establish a correct US diagnosis of GCA. These proposed IMT cut-off values may help to improve the diagnostic accuracy of US in clinical practice. Disclosure of Interests None declared
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    ISSN: 0003-4967 , 1468-2060
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  • 7
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 79, No. Suppl 1 ( 2020-06), p. 1478.2-1479
    Abstract: Tofacitinib is an oral JAK 1 and 3 inhibitor for the treatment of moderate to severe active rheumatoid arthritis (RA) or psoriatic arthritis (PsA) in adults with inadequate response or intolerant to one or more conventional disease-modifying antirheumatic drugs (cDMARDs). Since its approval by the European Medicines Agency (EMA), there is limited data about its use in daily practice in Europe. Objectives: To describe rates and reasons for discontinuation of Tofacitinib in patients with RA and other inflammatory conditions Methods: We identified patients with a prescription for tofacitinib at our academic center from January 2017 to January 2020. Patients were treated according to their rheumatologist evaluation following standards of care. The following variables were retrospectively collected from the electronic medical chart: age, gender, diagnosis, date of treatment initiation, date and reasons for treatment discontinuation, the use of concomitant or previous cDMARDs and of biologics. A comparison between patients continuing and stopping tofacitinib was performed through chi 2 or t-test for qualitative and quantitative variables, respectively. Survival analysis was done by Kaplan-Meier method Results: Ninety patients receiving tofacitinib were identified, 81 with RA, 6 with PsA, 1 with Dermatomyositis, 1 with Sjögren´s and 1 with juvenile idiopathic arthritis. Table 1 shows the baseline characteristics. 84% percent patients were women and the mean (SD) age was 58.5 (14.2) years. 51% patients started tofacitinib in monotherapy. When used, methotrexate was the most frequent cDMARD (61.3%); 10% patients used tofacitinib as first line after cDMARD and the majority used it after 1 or 2 previous biologics (46.7%). Table 2. Clinical coutcome of patients who developed HZ at initiation of baricitinib All patients (n=90, 100%) Continue Tofacitinib (n=58; 64%) Not continue Tofacitinib (n=32; 35.5%) p-value Female (%) 76 (84.4) 48 (82.7) 28 (87.5) 0.55 Age (year) – mean (SD) 58.5 (14.2) 58 (12.9) 59.5 (16.5) 0.63 Diagnosis 0.66 Rheumatoid arthritis 81 (90) 52 (89.6) 29 (90.6) Psoriatic arthritis 6 (6.7) 4 (6.8) 2 (6.2) Other 3 (3.3) 2 (3.4) 1 (3.1) Treatment duration (months) – mean (SD) 10.6 (6.9) 11.9 (7.3) 8.2 (5.5) 0.02 Prednisone (mg) – mean (SD) 1.75 (3.2) 1.20 (2.5) 2.73 (4.1) 0.03 Monotherapy (%) 46 (51.1) 28 (48.2) 18 (56.2) 0.244 Concomitant csDMARDs (%) 44 (48.8) 30 (51.7) 14 (43.7) 0.62 Methotrexate (%) 27 (30) 17 (29.3) 10 (31.2) Leflunomide (%) 10 (11.1) 8 (13.7) 2 (6.2) Other (%) 7 (7.7) 5 (8.6) 2 (6.2) Prior biologic treatment 0.13 None (%) 9 (10) 6 (10.3) 3 (9.3) 1-2 (%) 42 (46.6) 28 (48.2) 14 (43.7) ≥3 (%) 39 (43.3) 24 (41.3) 15 (46.8) Survival rates when used as first or second line were 85% at 6 months and 70% at 12 months; when used as third line or further, 76% and 70%, respectively (graphic 1). Factors associated to tofacitinib discontinuation were treatment duration and baseline prednisone dose. In contrast concomitant csDMARD and number of previous biologics were not. Reasons for tofacitinib discontinuation were: lack/loss of efficacy 46.9%, adverse events 50% (including intolerance -22%- herpes zoster -16%-, other infections 12%) and others. Conclusion: Tofacitinib in our experience is mostly used in RA patients after biologic failure. Overall survival rate at 12 months was good regardless line of therapy. Adverse event rates were similar to other biologic treatments. Herpes zoster was the most common infectious AE. Graphic 1: References: [1]Wollenhaupt J, Lee EB, Curtis JR, et al. Safety and efficacy of tofacitinib for up to 9.5 years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study. Arthritis Res Ther. 2019;21(1):89. Disclosure of Interests: Christian Y Soleto: None declared, Belén Serrano Benavente: None declared, Luis A Torrens Cid: None declared, Julia Martínez-Barrio Consultant of: UCB Pharma, Juan Molina Collada: None declared, Javier Rivera: None declared, Teresa González: None declared, Indalecio Monteagudo: None declared, Carlos Gonzalez Consultant of: Gilead, Janssen, Novartis,, Speakers bureau: Abbvie, Celgene, Gilead, Janssen, Novartis, Pfizer, Roche, Isabel Castrejon: None declared, Jose-Maria Alvaro-Gracia Grant/research support from: Abbvie, Elli-Lilly, MSD, Novartis, Pfizer, Consultant of: Abbvie, BMS, Janssen-Cilag, Elli-Lilly, MSD, Novartis, Pfizer, Sanofi, Tigenix, Roche, UCB, Paid instructor for: Elli-Lilly, Pfizer, Roche, Speakers bureau: Abbvie, BMS, Janssen-Cilag, Elli-Lilly, Gedeon Richter, MSD, Novartis, Pfizer, Sanofi, Tigenix, Roche, UCB
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    ISSN: 0003-4967 , 1468-2060
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    Publisher: BMJ
    Publication Date: 2020
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  • 8
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 80, No. Suppl 1 ( 2021-06), p. 1117.2-1117
    Abstract: Patients with inflammatory arthralgia (IA) are considered to be at increased risk for progression to RA. Ultrasound (US) has shown high sensitivity to detect synovitis compared with physical examination. Thus, US is recommended to identify subclinical synovitis in patients without clinical signs of inflammation. Objectives: To determine the frequency and pattern of US detected active inflammation in patients with IA and investigate factors contributing to predict this outcome. Methods: An US clinic is scheduled in an academic center running twice every week. A retrospective analysis of our US unit cohort during a period of 12 months was undertaken. Patients with IA and no previous diagnosis of inflammatory arthropathies were included for analysis. Inclusion criteria of IA definition included: severe symptoms presenting in the morning, duration of morning stiffness ≥60 min, symptoms predominantly located in MCP joints and absence of clinically detected synovitis by the referral rheumatologist. The following routinely collected variables were included in the analysis: demographics, clinical features and laboratory tests. Patients underwent bilateral US examination of hands and/or feet according to the European League Against Rheumatism (EULAR) guidelines. The presence of synovitis and tenosynovitis was assessed on a semi quantitative scale (0–3) for Grey Scale(GS)/Power Doppler(PD). Active inflammation was defined as PD synovitis and/or tenosynovitis 〉 1 at any location. First, differences between groups were tested using chi-squared/Fisher and Student-t tests in the univariate analysis. Second, multivariate logistic regression models were employed to investigate the association between possible predictive factors of US active inflammation. Results: A total of 110 patients were included in the analysis. Mean age was 53.6±15.6 years, 80 (72.7%) were females, and mean symptoms duration was 11.7±9.9 months (Table1). A total of 76 (69.1%) patients presented with a polyarticular arthralgia pattern. US active inflammation were present in 38 (34.5%) patients (28.2% showed PD synovitis and 19.1% PD tenosynovitis). Hands were most commonly involved with PD synovitis at wrists in 18.2% and at MCP in 14.5% of patients. For PD tenosynovitis, the flexor MCP 2-5 (4.5%) and 6 th extensor tenosynovitis (5.5 %) were the most frequent affected locations. Only 9 (8.2%) patients had erosions in hands and/or feet at baseline examination. In the univariate analysis, the higher ESR values, the shorter time from symptoms onset and the presence of ACPA were significantly associated with the presence of US active inflammation (p 〈 0.001, p=0.035 and p=0.01, respectively). In the multivariate analysis, only ACPA and ESR values (OR=1,0003; 95%CI 1,000-1,006 and OR=1.054; 95%CI 1.016-1.094), remained significantly associated with the detection of US active inflammation. Conclusion: US features of active inflammation are found in 1 over 3 patients with IA being PD synovitis the most common finding, specially at the wrists and MCP joints. Higher ESR and ACPA values are significantly associated with the presence of US active inflammation. Thus, we strongly recommend the use of PD US to detect subclinical inflammation in at-risk patients with IA with no sign of inflammation on clinical examination, especially those with high ESR and ACPA values. Table 1. Baseline characteristics of patients with IA Total n= 110 US inflammatory findings n= 38 (34.5%) Non-US inflammatory findings n=72 (65.5%) p Age 53.6 ± 15.6 57.2±16.2 51.6±13.4 0.071 Sex Female 80 (72.7%) 26 (68.4%) 54 (75%) 0.461 Smoking n= 87 Non smoker 45 (51.7%) 12 (44.4%) 33 (55%) 0.412 Smoker 34 (39.1%) 11 (40.7%) 23 (38.3%) Former smoker 8 (9.2%) 4 (14.8%) 4 (6.7%) Extension Monoarticular 12 (10.9%) 6 (15.8%) 6 (8.3%) 0.176 Oligoarticular 22 (20%) 10 (26.3%) 12 (16.7%) Polyarticular 76 (69.1%) 22 (57.9%) 54 (75%) Time (months) from symptoms onset 11.7 ± 9.9 9.1±8.1 13±10.5 0.035 ESR (mm/h) n=45 24.7 ± 18.2 33.1±21.8 20.3 ±14.4 〈 0.001 RF (IU/mL) n=53 39.1 ± 230.5 28.5±56 45.1±286.1 0.647 ACPA (IU/mL) n=56 98.1 ± 331.2 209.4±488.4 26±125.2 0.01 Disclosure of Interests: None declared
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    ISSN: 0003-4967 , 1468-2060
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    Language: English
    Publisher: BMJ
    Publication Date: 2021
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