Background: We recently created PORTRESS, the Portuguese registry of Sjögren’s Disease (SjD), as a specific module embedded within the Portuguese Registry of Rheumatic Diseases (Reuma.pt). Objectives: To characterise the largest nationwide cohort of SjD patients. Methods: We included patients with a clinical diagnosis of SjD, registered in PORTRESS up to November 2023. Demographic, clinical, treatment and patient-reported outcomes (PROs) data were collected. Variables were compared according to parametric or non-parametric tests, as applicable. Results: 1375 patients were included. Patients fulfilled AECG 2002 or ACR/EULAR 2016 classification criteria in 62.1% and 57.4% of cases, respectively. However, a large percentage of patients (n=769/1375, 55.9%) did not have a complete assessment of all criteria, which translates common clinical practice reality. Importantly, the vast majority of patients had both sicca symptoms (or extraglandular involvement) and a positive anti-Ro and/or minor salivary gland biopsy (n=1130/1210, 93.4%).Most patients were anti-Ro positive and almost half had circulating rheumatoid factor. Hypergammaglobulinemia (49%) and raised immunoglobulin G (40%) were common, unlike cryoglobulinemia (6%). Although Schirmer’s test, SG ultrasound and minor SG biopsy were positive in 52-59% of patients, only 22% had reduced unstimulated whole salivary flow.Most patients (88%) had at least one active ESSDAI domain over the course of the disease. Around half had laboratorial features of B cell hyperactivity (52%), whereas articular, hematologic and glandular involvements were seen in 31-43% of patients (Table 1). Excluding biological and hematological involvement, both involvements that poorly correlate with disease impact, systemic involvement was still observed in almost two thirds of patients (64%).Hydroxychloroquine and corticosteroids were used in 65% and 29% of patients, whereas 1 in 5 was treated with pilocarpine. Of note, up to 12% of patients were treated with other immunosuppressants.The mean ESSDAI was 3.0±4.4 (range 0-42), corresponding to 77.0% (n=800/1039) of patients with low systemic disease activity (ESSDAI<5). At the last follow-up, the mean ESSDAI was 2.1±3.7 (range 0-31), corresponding to a significant decrease from baseline (Figure 1A). Around 24% of patients experienced disease activity worsening, whereas 46% improved (Figure 1B).Finally, dryness, pain and fatigue PROs were high, and more importantly, had a significant increase from baseline to follow-up (Figure 1C). Conclusion: In the PORTRESS registry, a considerable number of patients do not have a full assessment of classification criteria, reflecting clinical practice. Systemic involvement was seen in most patients, although reduced salivary flow was present in only 1/5 of cases. Although systemic activity improved over follow-up, symptom burden worsened when compared to baseline, underlining a major unmet need in treating SjD. REFERENCES: NIL. Acknowledgements: This project was funded by SPCare; PORTRESS Reuma.pt Task Force: Sara P Dinis, Filipe Vinagre, Maria H Lourenço, Ana B Silva, Alexandra Daniel, Paula Valente, Inês Almeida, Joana Dinis, Lígia Silva, Lídia Teixeira, Filipe Araújo, Carlos M Gomes, Patrícia Pinto, Filipa Farinha, Teresa Nóvoa, Ana Rodrigues, Sara Cortes. Disclosure of Interests: Matilde Bandeira Research grant for this work: SPCare, Manuel Silvério-António Menarini; Theramex, Roberto Pereira da Costa: None declared, Ana Rita Lopes: None declared, Margarida Silva: None declared, Filipe Cunha Santos: None declared, Paulo Pereira: None declared, Diana B Raimundo: None declared, Anita Cunha: None declared, Cláudia Pinto Oliveira: None declared, Ana Catarina Duarte Boehringher Ingelheim, João Madruga Dias: None declared, Mariana Emília Santos: None declared, Maria João Gonçalves: None declared, Ana Catarina Moniz: None declared, Ana Maduro: None declared, Mariana Luis: None declared, Ana Valido: None declared, Margarida Oliveira: None declared, Luísa Brites: None declared, Catarina Tenazinha: None declared, Nikita Khmelinskii Paid instructor: GSKPaid speaker: Astrazeneca, GSK, Vifor PharmaPaid consultant: Abbvie, Astrazeneca, GSK, Novartis., Filipe Barcelos: None declared, Joao Eurico Fonseca: None declared, Vasco C Romão Speaking fees: Astrazeneca, Abbvie, GSK, Janssen, Lilly, Pfizer, SobiResearch Grants: MSD, SPCareTravel grants and scientific support: Abbvie, Lilly, Medac, MSD, Novartis, Pfizer, Roche.Figure 1Disease activity (A); ESSDAI variation between baseline and follow-up (B); Symptom burden (C) Table 1PORTRESS cohortPORTRESS cohort (n=1375)Age at diagnosis, y52.7±14.7Age at symptom onset, y47.9±14.8Diagnosis delay, y4.6±5.9Disease duration, y13.2±8.9Female1300 (95)AECG 2002747 (62)ACR/EULAR 2016758 (57)ANA1060 (91)Anti-Ro1061 (84)Anti-La541 (45)RF531 (48)Baseline ESSDAI3.0±4.4Baseline ESSPRI5.0±2.9USF <0.1ml/min161 (22)Schirmer’s ≤5mm/5min577 (59)Focus score1.6±2.1InvolvementConstitutionalLymphadenopathicGlandularArticularCutaneousPulmonaryRenalMuscularPNSCNSHematologicBiologicHepato/GastrointestinalOther228 (18)138 (11)387 (31)540 (43)223 (18)105 (8)34 (3)18 (2)49 (4)20 (2)429 (35)646 (52)36 (3)177 (16)TreatmentHydroxicloroquineCorticosteroidsPilocarpineMethotrexateAzathioprineRituximabLeflunomideMMFIVIGCyclophosphamide596 (65)265 (29)177 (19)110 (12)76 (8)29 (3)26 (3)19 (2)1 (0)1 (0)Results presented as mean±sd or n (%); USF – unstimulated saliva flow rate, PNS – peripheral nervous system, CNS – central nervous system; MMF – mycophenolate mofetil, IVIG – intravenous Immunoglobulin therapy
AIMS:To characterise the idiopathic inflammatory myopathies (IIM) module of the Rheumatic Diseases Portuguese Register (Reuma.pt/myositis) and the patients in its cohort.METHODS:Reuma.pt is a web-based system with standardised patient files gathered in a registry. This was a multicentre open cohort study, including patients registered in Reuma.pt/myositis up to January 2022.RESULTS:Reuma.pt/myositis was designed to record all relevant data in clinical practice and includes disease-specific diagnosis and classification criteria, clinical manifestations, immunological data, and disease activity scores. Two hundred eighty patients were included, 71.4% female, 89.4% Caucasian, with a median age at diagnosis and disease duration of 48.9 (33.6-59.3) and 5.3 (3.0-9.8) years. Patients were classified as having definite (N=57/118, 48.3%), likely (N=23/118, 19.5%), or possible (N=2/118, 1.7%) IIM by 2017 EULAR/ACR criteria. The most common disease subtypes were dermatomyositis (DM, N=122/280, 43.6%), polymyositis (N=59/280, 21.1%), and myositis in overlap syndromes (N=41/280, 14.6%). The most common symptoms were proximal muscle weakness (N=180/215, 83.7%) and arthralgia (N=127/249, 52.9%), and the most common clinical signs were Gottron's sign (N=75/184, 40.8%) and heliotrope rash (N=101/252, 40.1%). Organ involvement included lung (N=78/230, 33.9%) and heart (N=11/229, 4.8%) involvements. Most patients expressed myositis-specific (MSA, N=158/242, 65.3%) or myositis-associated (MAA, 112/242, 46.3%) antibodies. The most frequent were anti-SSA/SSB (N=70/231, 30.3%), anti-Jo1 (N=56/236, 23.7%), and anti-Mi2 (N=31/212, 14.6%). Most patients had a myopathic pattern on electromyogram (N=101/138, 73.2%), muscle oedema in magnetic resonance (N=33/62, 53.2%), and high CK (N=154/200, 55.0%) and aldolase levels (N=74/135, 54.8%). Cancer was found in 11/127 patients (8.7%), most commonly breast cancer (N=3/11, 27.3%). Most patients with cancer-associated myositis had DM (N=8/11, 72.7%) and expressed MSA (N=6/11) and/or MAA (N=3/11). The most used drugs were glucocorticoids (N=201/280, 71.8%), methotrexate (N=117/280, 41.8%), hydroxychloroquine (N=87/280, 31.1%), azathioprine (N=85/280, 30.4%), and mycophenolate mofetil (N=56/280, 20.0%). At the last follow-up, there was a median MMT8 of 150 (142-150), modified DAS skin of 0 (0-1), global VAS of 10 (0-50) mm, and HAQ of 0.125 (0.000-1.125).CONCLUSIONS:Reuma.pt/myositis adequately captures the main features of inflammatory myopathies' patients, depicting, in this first report, a heterogeneous population with frequent muscle, joint, skin, and lung involvements.
Background The Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) has been recently developed and validated, providing improved accuracy and sensitivity for changes in SLE disease activity in comparison to SLE Disease Activity Index 2000 (SLEDAI-2K) [1]. New recommendations to standardize the Physician Global Assessment (PGA) scoring may improve its reliability [2]. Objectives To assess the intra- and interrater reliability of SLE-DAS, SLEDAI-2K and PGA for measuring SLE disease activity. Methods A set of 24 clinical vignettes were abstracted, each from a real clinical visit of patients followed at an academic lupus clinic. These vignettes were selected to include a wide spectrum of SLE manifestations, organ-system involvements, and global severity of disease activity. Abstracted data were presented in a standardized format, including demographic, past medical history, current clinical picture and treatment, laboratory, and other workup assessments. A group of 19 raters were recruited as a random multicenter sample of Rheumatologists. All raters completed a preliminary training session on scoring rules for SLE-DAS, SLEDAI-2K and PGA. Each rater scored each clinical vignette with SLE-DAS, SLEDAI-2K, and PGA through an online survey. The scoring was repeated in a second round 7-14 days after the first one. The clinical vignettes were randomly ordered for each round. Inter and intra-rater reliability of each instrument was estimated using the intraclass correlation coefficient (ICC) with 95% confidence intervals (95%CI), based on single-measurement, absolute agreement, with a two-way random effect or two-way mixed-effects model, respectively. Results The 19 raters included 8 rheumatologists and 11 rheumatology trainees from 11 hospitals, with a mean of 12.1±7.1 and 3.6±0.5 years of rheumatology practice, respectively, and 78.9% of the participants assess ≤5 SLE patients per week in their regular clinical practice. The 24 clinical vignettes included 83.3% female patients, with a mean of 36.5±17.9 years of age. Active SLE organ involvement included: skin rashes (20.8%); arthritis (12.5%); nephritis (12.5%); thrombocytopenia (12.5%); cardiac/pulmonary involvement (12.5%); mucocutaneous vasculitis (8.3%); serositis (8.3%); neuropsychiatric lupus (8.3%). Systemic vasculitis, myositis, alopecia, hemolytic anemia, and leukopenia were each present in 4.2% of the vignettes. Hypocomplementemia and/or high anti-dsDNA were present in 75.0%. Twenty-one percent of the cases were in remission.All raters completed the survey, totaling 912 case assessments. Scores attributed by the raters ranged from 0.37 to 49.53 in SLE-DAS, 0 to 24 in SLEDAI-2K, and 0.0 to 3.0 in PGA. The interrater reliability was good for SLE-DAS and SLEDAI-2K, and moderate for PGA. The intra-rater reliability was excellent for SLE-DAS, and good for SLEDAI-2K and PGA (Table 1). Conclusion SLE-DAS presents high intra- and interrater reliability for measuring SLE disease activity. The high reliability of SLE-DAS is an important quality both in clinical practice and research, allowing consistent scoring among different clinicians including those who are not SLE experts. References [1] Jesus D, Matos A, Henriques C, et al. Derivation and validation of the SLE Disease Activity Score (SLE-DAS): a new SLE continuous measure with high sensitivity for changes in disease activity. Ann Rheum Dis 2019;78:365-71.[2] Piga M, Chessa E, Morand EF, et al. Physician Global Assessment International Standardisation Consensus in Systemic Lupus Erythematosus: the PISCOS study. Lancet Rheumatol 2022;4:e441-e449. Acknowledgements Beatriz Mendes and Carolina Mazeda contributed equally and share first authorship. Disclosure of Interests None Declared.Table 1:Interrater and intra-rater reliability of SLE-DAS, SLEDAI-2K and PGA.ICC (95%CI)Interrater reliabilityIntra-rater reliabilitySLE-DAS0.877 (0.807-0.934)0.908 (0.891-0.923)SLEDAI-2K0.812 (0.717-0.896)0.892 (0.871-0.909)PGA0.704 (0.578-0.828)0.900 (0.881-0.916)CI: confidence interval; ICC: intraclass correlation coefficient.
INTRODUCTIONDespite years of experience with biological disease modifying anti-rheumatic drugs (bDMARD) in rheumatoid arthritis (RA), little is known about differences in infectious risk among bDMARDs. The aim of this study was to assess the incidence and type of infections in RA patients on bDMARDs and to determine possible predictors.METHODSA retrospective multicenter cohort study that included patients registered in the Rheumatic Diseases Portuguese Registry (Reuma.pt) with RA, and exposed to at least one bDMARD until April 2021. RA patients under bDMARD and with at least one episode of severe infection (SI), defined as infection that requires hospitalization, use of parenteral antibiotics or that resulted in death, were compared to patients with no report of SI. Demographic and clinical data at baseline and at the time of each SI were collected to establish comparisons between different groups of bDMARDs. Comparisons between different bDMARDs were assessed and logistic regression was performed to identify predictors of SI.RESULTSWe included 3394 patients, 2833 (83.5%) female, with a mean age at RA diagnosis of 45.5±13.7 years. SI was diagnosed in 142 of the 3394 patients evaluated (4.2%), totaling 151 episodes of SI. At baseline, patients with SI had a significantly higher proportion of prior orthopedic surgery, asthma, interstitial lung disease, chronic kidney disease and corticosteroid use, higher mean age and longer median disease duration at first bDMARD. Nine patients died (6.0%). Ninety-two SI (60.9%) occurred with the first bDMARD, the majority leading to discontinuation of the bDMARD within 6 months (n=75, 49.7%), while 65 (43.0%) restarted the same bDMARD and 11 (7.3%) switched to another bDMARD (6 of them to a different mechanism of action). In the multivariate analysis, we found that chronic kidney disease, asthma, infliximab, corticosteroid use, interstitial lung disease, previous orthopedic surgery, higher Health Assessment Questionnaire and DAS284V-ESR are independent predictors of SI.CONCLUSIONThis study described the incidence and types of SI among Portuguese RA patients on biologics, identifying several predictors of SI, both globally and with different bDMARDs. Physicians should be aware of the real-word infectious risk in RA patients on bDMARDs when making treatment decisions.
OBJECTIVES:To compare the effectiveness of the infliximab biosimilar CT-P13 with originator infliximab over 24 months of follow-up in biological-naïve patients with rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA).METHODS:Biological-naïve patients from the Rheumatic Diseases Portuguese Register (Reuma.pt), with a clinical diagnosis of RA or axSpA, who were starting either the infliximab biosimilar CT-P13 or the originator infliximab after 2014 (date of market entry of CT-P13 in Portugal), were included. Patients on biosimilar and originator were compared regarding different response outcomes at 3 and 6 months, adjusting for age, sex and baseline C-reactive protein (CRP). The main outcome was the change in DAS28-erytrocyte sedimentation rate (ESR) for RA and the ASDAS-CRP for axSpA. Additionally, the effect of infliximab biosimilar vs originator on different response outcomes over 24 months of follow-up was tested with longitudinal generalized estimating equations (GEE) models.RESULTS:In total, 140 patients were included, 66 (47%) of which with RA. The distribution of patients starting the infliximab biosimilar and the originator was the same between the two diseases (approximately 60% and 40%, respectively). From the 66 patients with RA, 82% were females, mean age was 56 years (SD 11) and mean DAS28-ESR 4.9 (1.3) at baseline. As for the patients with axSpA, 53% were males, mean age was 46 years (13) and mean ASDAS-CRP 3.7 (0.9) at baseline. There were no differences in efficacy between RA patients treated with the infliximab biosimilar and the originator, either at 3 months (∆DAS28-ESR: -0.6 (95% CI -1.3; 0.1) vs -1.2 (-2.0; -0.4)), or at 6 months (∆DAS28-ESR: -0.7 (-1.5; 0.0) vs -1.5 (-2.4; -0.7)). This was also true for patients with axSpA (∆ASDAS-CRP at 3 months: -1.6 (-2.0; -1.1) vs -1.4 (-1.8; -0.9) and at 6 months: -1.5 (-2.0; -1.1) vs -1.1 (-1.5; -0.7)). Results were similar with the longitudinal models over 24 months.CONCLUSION:There are no differences in effectiveness between the infliximab biosimilar CT-P13 and the infliximab originator in the treatment of biological-naïve patients with active RA and axSpA in clinical practice.
Background The idiopathic inflammatory myopathies (IMM) module of the Rheumatic Diseases Portuguese Register (Reuma.pt/Myositis) is a tool used to systematically evaluate IIM patients. Objectives To clinically characterise the Reuma.pt/Myositis cohort. Methods Multicentre open cohort study, including IIM patients registered in Reuma.pt up to January 2022. Data collected included demographic, clinical, and treatment data and patient-reported outcomes. Data were presented as frequencies and median (interquartile range) for categorical and continuous variables, respectively. Results 280 patients were included, 71.4% female, 89.4% Caucasian, with a median age at diagnosis and disease duration of 48.9 (33.6-59.3) and 5.3 (3.0-9.8) years, respectively. Patients were classified as having definite (N=57/118, 48.3%; N=35/224, 15.6%), likely (N=23/118, 19.5%; N=50/224, 22.3%), or possible (N=2/118, 1.7%; N=46/224, 20.5%) IIM by 2017 EULAR/ACR and Bohan-Peter criteria, respectively. Disease subtypes included dermatomyositis (DM, N=122/280, 43.6%), polymyositis (N=59/280, 21.1%), myositis in overlap syndromes (N=41/280, 14.6%), clinically amyopathic DM (N=17/280, 6.1%), nonspecific myositis (N=13/280, 4.6%), mixed connective tissue disease (N=12/280, 4.3%), immune-mediated necrotizing myositis (N=9/280, 3.2%), and inclusion bodies myopathy (N=7/280, 2.5%). Over the course of the disease, the most common symptoms were proximal muscle weakness (N=180/215, 83.7%), arthralgia (N=127/249, 52.9%), erythema (N=63/166, 38.0%), fatigue (N=47/127, 37.0%), Raynaud’s phenomenon (N=76/234, 32.5%), and dysphagia (N=33/121, 27.3%), and the most common clinical signs were Gottron’s sign (N=75/184, 40.8%), heliotrope rash (N=101/252, 40.1%), Gottron’s papules (N=93/237, 39.2%), and arthritis (N=38/98, 38.8%). Organ involvement included lung (N=78/230, 33.9%), oesophageal (N=40/221, 18.1%), and heart (N=11/229, 4.8%) involvements. Most patients expressed myositis-specific (MSA, N=158/242, 65.3%) and/or myositis-associated (MAA, 112/242, 46.3%) antibodies. The most frequent antibodies were anti-SSA/SSB (N=70/231, 30.3%), anti-Jo1 (N=56/236, 23.7%), and anti-Mi2 (N=31/212, 14.6%). Most patients had a myopathic pattern on electromyogram (N=101/138, 73.2%), muscle oedema in magnetic resonance (N=33/62, 53.2%), and high CK (N=154/200, 55.0%) and aldolase levels (N=74/135, 54.8%) at diagnosis, with median highest CK levels of 1308 (518-3172) and aldolase of 42 (12-121) mg/dL. Neoplasia was found in 11/127 patients (8.7%), most commonly breast (N=3/11, 27.3%), non-melanoma skin (N=2/11, 18.2%), and colorectal (N=2/11, 18.2%) cancer (Table 1). Most patients with cancer-associated myositis had DM (N=8/11, 72.7%) and expressed MSA (N=6/11) and/or MAA (N=3/11). The most used drugs over the course of disease were glucocorticoids (N=201/280, 71.8%), methotrexate (N=117/280, 41.8%), hydroxychloroquine (N=87/280, 31.1%), azathioprine (N=85/280, 30.4%), mycophenolate mofetil (N=56/280, 20.0%), intravenous immunoglobulin (N=55/280, 19.6%), and rituximab (N=45/280, 16.1%). At the last follow-up, there was a median MMT8 of 150 (142-150), modified DAS skin of 0 (0-1), global VAS of 10 (0-50) mm, and HAQ of 0.125 (0.000-1.125). Table 1. Autoantibodies in cancer-associated myositis Cancer IIM Autoantibodies Breast DM (3) Mi2, SRP (+ SSA/SSB), Pm/Scl Skin (non-melanoma) Clinically amyopathic DM, PM Jo1, SAE1 (+SSA/SSB) Colorectal DM (2) Mi2 (2) Kidney DM - Lung DM - Lymphoma Inclusion bodies myopathy - Unknown DM - Conclusion Reuma.pt/Myositis adequately captures the main features of inflammatory myopathies’ patients, depicting in this first report a heterogeneous population, with frequent muscle, joint, skin and lung involvements. Of interest, most patients reached low disease activity at the last follow-up appointment. Disclosure of Interests None declared
Background Carpal tunnel syndrome (CTS) is a focal neuropathy caused by compression of the median nerve (MN) at the wrist. Electromyography (EMG) is the gold standard for the diagnosis of CTS. Currently, the ultrasound (US) is frequently used as an initial screening exam by measuring the cross-sectional area (CSA) of the MN. The cut-off point of the CSA at the pisiform bone level to define CTS remains controversial with previous studies reporting values between 6.5mm 2 and 15mm 2 (1). Objectives The aim of this study is to determine the best cut-off point of the CSA for the diagnosis of CTS. Methods Cross-sectional study at a Tertiary Rheumatology Department including patients aged ≥ 18 years with symptoms compatible with CTS. Sociodemographic and clinical data, visual analogue scale for pain (VAS), Boston Questionnaire (BQ), and the results of EMG and US performed in each patient were collected. The EMG was performed according to the standardized protocol (sensory conduction velocity, sensory amplitude, distal sensory and motor latency), and the patients were categorized in 4 groups: normal, mild, moderate, and severe. A rheumatologist with expertise in imaging performed all the US evaluations by means of a 6–18-MHz (Siemens ACUSON S 2000) linear array transducer. The largest CSA of the MN was measured at the level of the pisiform bone. Receiver operating characteristic (ROC) curve was used to determine optimal cut-off values of the CSA taking the EMG result as the gold-standard. One-way ANOVA test was used to compare CSA between the 4 EMG groups. Results Fifty patients were included, 90% were female, mean age was 52.1 ± 10.8 years and median duration of symptoms was 28.0 (IQR 23.0-31.0) months. The mean VAS was 4.2 ± 2.9. In the BQ there was a mean symptom severity score of 2.4 ± 0.6 and a mean functional status score of 2.0 ± 0.9. One-way ANOVA showed that mean CSA values were significantly different in the 4 groups of patients. The Ryan-Einot-Gabriel-Welsch post hoc analysis showed that only the mean CSA of patients with severe STC is different from the remaining groups defined by EMG results. The best cut-off point for CSA at the pisiforme bone level for CTS diagnosis was 6.6 mm 2 with a sensitivity and specificity of 92.9% and 75.0% (AUC=0.9, P <0.001). The positive and negative predictive values were 95.1% and 66.7%, respectively. For severe CTS diagnosis the best cut-off point for CSA was 12.3mm 2 with a sensitivity of 82.4% and a specificity of 72.7% (AUC=0.8, P <0.001). The positive and negative predictive values were 60.9% and 88.9%, respectively. Conclusion In our study we found that the best cut-off point of the CSA was 6.6mm 2 for distinguishing patients with/without CTS based on EMG alterations, with a high sensitivity and moderate specificity. This is a lower cut-off value than usually used in clinical practice and could be explained by small sample and the greater number of patients with mild and moderate STC on EMG. References [1]McDonagh C, Alexander M, Kane D. The role of ultrasound in the diagnosis and management of carpal tunnel syndrome: A new paradigm. Rheumatology (Oxford, England). 2014;54. Disclosure of Interests None declared
Background:Rheumatoid Arthritis (RA) is a chronic inflammatory arthropathy that potentially leads to loss of function and disability early in the disease course. (1) Optimizing physical function is one of the primary goals of RA treatment (2). Several demographic, psychosocial and clinical factors may influence the impact of RA upon physical capacity, and understanding their relative contribution to disability at disease diagnosis is key to an effective treatment approach.Objectives:To evaluate functional disability at the time of disease diagnosis and identify its demographic and clinical correlates in an early RA cohort.Methods:We conducted a cross-sectional study based on a Rheumatology centre early arthritis cohort. Consecutive patients with early RA – less than 12 months duration– fulfilling ACR/EULAR 2010 and/or ACR 1987 RA classification criteria, were included. Variables were collected from patients’ registries at the first rheumatology appointment after symptom’s onset. Functional disability was assessed using the Health Assessment Questionnaire- Disability Index (HAQ-DI) (range 0 to 3, higher values indicating greater disability). Independent t-test, one way-ANOVA and Pearson’s correlation coefficient were performed to evaluate differences between groups. Variables with p<0.1 were included in a stepwise multiple linear regression analysis to assess the independent association of variables with the HAQ-DI at baseline.Results:We included 71 patients (63.4% female, mean age 57.2 ±2.01 years). Mean HAQ-DI score was 1.42±0.08. Sociodemographic and clinical variables are described in Table 1. There was a significant difference in HAQ-DI scores between rheumatoid factor (RF) positive (mean 1.24±0.11) and RF negative (1.61±0.113) patients. HAQ-DI was positively weakly correlated with age (r=0.48; p<0.001), CDAI (r=0.43; p=0.038), SDAI (r=0.49; p=0.015), and moderately with DAS28-3V (r=0.60; p<0.001) and DAS28-3V-CRP (r=0.60; p<0.001). The number of tender (r=0.35; p=0.024) and swollen joints (r=0.42; p= 0.005), ESR (r=0.46; p=0.001), CRP (r=0.35; p=0.018), HADS-depression (r=0.46; p=0.023) and educational level (r= -0.48; p=0.002) were also associated with HAQ-DI in univariate analyses. After multivariate regression analysis, age at disease diagnosis (β= 0.022 [95 CI 0.010 to 0.034]; p= 0.001) was the only independent predictor of HAQ-DI (R2= 0.46, p=0.001).Table 1.Patients’ baseline sociodemographic and clinical characteristics.Age at diagnosis (years), mean (SD)57.2±2.01Educational level (years), mean (SD)7.37±0.59Employment: full-time, %42.4Employment: partial-time, %3.00Employment: retired, %48.4Employment: absenteeism in the last month, %1.50Unemployed, %4.50Disease duration at presentation (weeks), mean (SD)20.4±1.70Morning stiffness >30 minutes, %83.0RF positivity, %47.9ACPA positivity, %53.5Fibromyalgia, %6.60DAS28-3V, mean (SD)4.72±0.17CDAI, mean (SD)29.2±2.28SDAI, mean (SD)32.4±2.42PtGA, mean (SD)66.8±3.73PhGA, mean (SD)54.7±3.08Pain intensity (VAS), mean (SD)67.7±3.75EQ-5D score, mean (SD)0.26±0.039HADS-depression, mean (SD)7.17±0.87Legend: ACPA- anti-citrullinated protein antibodies; ESR- erythrocyte sedimentation rate; CRP- c-reactive protein; DAS- disease activity score; CDAI- clinical disease activity score; SDAI-simplified disease activity score; PtGA/ PhGA – patient’s/physician’s global assessment of general health; VAS- visual analogic scale; EQ-5D- EuroQoL 5-Dimensional Descriptive System; HADS-Hospital Anxiety and Depression Scale.Conclusion:Older age at disease onset is associated with greater functional impairment at diagnosis, assessed by HAQ-DI, in this cohort of early RA patients, irrespective of disease activity and other clinical variables. This result suggests that older newly diagnosed RA patients may deserve special attention regarding physical function.References:[1]Wolfe F et al. Arthritis Res Ther. 2010; 12(2): R35.[2]Smolen JS et al. Ann Rheum Dis. 2010; 69:631-637.Disclosure of Interests:None declared
Background: Rheumatoid Arthritis (RA) is a chronic inflammatory arthropathy that can present at any age. Data regarding differences in the clinical course and outcome in Late-Onset Rheumatoid Arthritis (LORA) comparing to Young-Onset RA (YORA) are conflicting. Some studies suggested that LORA may represent a more benign form of RA (1), while others have shown a poorer prognosis in these patients (2,3). Only a few publications have included patients with early disease (3). Objectives: To compare demographic and clinical features between LORA and YORA patients, and clinical activity at baseline and after 12 months of initial therapy, in patients with early disease. Methods: We conducted a prospective cohort study of 12 months of follow-up based on an early arthritis clinic. Consecutive patients with early RA – less than 12 months duration – fulfilling ACR/EULAR 2010 and/or ACR 1987 RA classification criteria, were included and classified in LORA (disease onset ≥60 years) and YORA groups. Variables were collected from patients’ registries at first appointment after symptoms onset and after 12 months of treatment, according to a treat-to-target strategy. Independent t-test and chi-square test were performed to compare variables between groups. Results: We included 72 patients (40 (55.6%) YORA; 32 (44.4%) LORA), mean age at diagnosis 44.9±1.78 and 72.5± 1.34 years, respectively. In LORA group, the symptoms duration at first observation was shorter (17.0±2.26 vs. 23.8±2.45 weeks; p=0.046) and rheumatoid factor (RF)/ anti-citrullinated protein antibodies (ACPA) positivity was lower (28.1% vs 65.0%; p= 0.002; 31.3% vs 72.5%; p<0.001). At baseline, LORA had higher mean number of tender joints (9.76±1.29 vs 6.50±0.67; p=0.021), erythrocyte sedimentation rate (ESR) (45.7±4.98 vs. 29.3±3.74; p=0.011), C-reactive protein (CRP) (4.63±0.91 vs 2.22±0.46; p=0.022) and disease activity using DAS28-3V (5.11±0.28 vs 4.42±0.19; p=0.046), CDAI (33.7±3.39 vs 23.6±2.18; p=0.015) and SDAI (37.4±3.43 vs 26.3±2.57; p=0.015). At the end of follow-up, there were no statistically significant differences between LORA and YORA groups regarding treatment, disease activity and patient-reported outcomes at 12 months (Table 1). Table 1. Clinical variables assessment at 12 months of follow-up. EORA YORA p -value Treatment, % users Corticosteroids 93.3 97.4 p= 0.576 Methotrexate 76.7 74.4 p=0.825 Hydroxychloroquine 43.3 46.2 p= 0.815 Sulfasalazine 10.0 15.4 p=0.722 Leflunomide 3.30 5.10 p=1.000 TNF blockers 3.30 5.10 p=0.717 DAS28-3V, mean (SD) 1.99±0.15 2.22±0.15 p=0.286 SDAI, mean (SD) 4.64±1.35 7.68±1.39 p=0.128 CDAI, mean (SD) 4.15±1.17 6.56±1.32 p=0.180 Swollen joints, mean (SD) 1.29±0.49 1.03±0.25 p=0.613 Tender joints, mean (SD) 0.32±0.13 1.28±0.53 p=0.084 ESR, mean (SD) 10.6±1.79 9.43±1.14 p=0.585 CRP, mean (SD) 0.44±0.09 0.50±0.15 p=0.730 PtGA, mean (SD) 21.8±5.90 29.2±6.11 p=0.387 PhGA, mean (SD) 10.6±3.26 13.1±3.11 p= 0.593 Pain intensity (VAS), mean (SD) 20.7±5.82 32.7±6.30 p=0.169 HAQ, mean (SD) 0.23±0.089 0.54±0.13 p=0.060 Legend: DMARD- disease-modifying anti-rheumatic drug; TNF- tumoral necrosis factor; SDAI-simplified disease activity score; CDAI- clinical disease activity score; PtGA/ PhGA – patient’s/ physician’s global assessment of general health; VAS- visual analogic scale; HAQ- health assessment questionnaire. Conclusion: LORA patients presented with higher disease activity manifested by higher joint counts and laboratory inflammatory markers but lower RF and ACPA positivity proportion. Despite the more aggressive clinical presentation, the clinical and functional outcomes at 12 months were similar between LORA and YORA patients. References: [1]Deal et al. Arthritis Rheum 1985;28(9):987-94. [2]Arnold et al. Rheumatology (Oxford) 2014; 53:10751086. [3]Romão et al. Semin Arthritis Rheum 2020;0(4):735-743. Disclosure of Interests: None declared
BACKGROUND In rheumatoid arthritis (RA), global disease activity is commonly evaluated, from the patient's and the physician's perspective, through a 100mm visual analogue scale (VAS) and plays an important role in the assessment of diseases activity and treatment decisions. Our aim was to determine patient-physician discordance in the assessment of disease activity and to explore its determinants. METHODS Cross sectional study including RA patients (ACR/EULAR 2010 classification criteria). The discrepancy between patients-physicians (∆PPhGA) was defined as PGA minus PhGA, and a difference > |20mm| was considered as "discordant". Correlation between ∆PPhGA and other variables was assessed through Pearson's correlation and comparison between groups through t-test. Variables with p < 0.05 or considered clinically relevant were included in multivariable linear regression analysis to identify determinants for ∆PPhGA. A p < 0.05 was considered statistically significant. RESULTS In total, 467 patients with RA were included (81.2% female; mean age 63.9% ± 12.2 years). PGA and PhGA were discordant in 61.7% of the cases. The proportion of concordance increased (p < 0.01) when considering only patients in remission (DAS 28 3V < 2.6). In multivariable analysis (R2adjusted=0.27), VAS-pain-patient (β 0.74, 95% CI 0.62-0.88, p=0.00) and TJC (β 0.16, 95% CI 0.45-0.48, p=0.02) remained associated with a higher ∆PPhGA. CONCLUSION Our study confirmed that a significant discrepancy between patients and physicians in the assessment of global disease activity is frequent in clinical practice, and is probably due to valorization of different parameters by the two groups.
INTRODUCTIONConcerns about the side effects and interactions of biologic drugs with reproduction and pregnancy have been always an issue between experts. The safety of these therapies during conception and/or pregnancy is not fully understood. The aim of this study was to assess the exposure to biologic drugs before and/or during conception/pregnancy and the risk of adverse pregnancy outcomes in women with rheumatic diseases.METHODSWe conducted a cohort study of pregnancies reported in women with immune-mediated rheumatic diseases registered at the Rheumatic Diseases Portuguese Registry (Reuma.pt) and exposed to biologic drugs. Data concerning fetal and maternal outcomes (live birth, spontaneous abortion, neonatal and intrauterine death, intrauterine growth restriction, premature delivery, congenital malformations, neonatal lupus, voluntary or medical interruption of pregnancy, disease flares and need for treatment with other drugs) was extracted.RESULTSIn total, 69 pregnancies from 56 females were analysed, the majority with the diagnosis of spondyloarthritis or rheumatoid arthritis. In almost half of the cases (n=32, 46.4%) the biologic was stopped for pregnancy planning, in 31 cases (44.9%) it was stopped when pregnancy was diagnosed and in 6 pregnancies (8.7%) biologic therapy was maintained, at least until the 2nd trimester. There were 76.8% of live births and 22% of spontaneous abortions. Congenital anomalies were reported in 2 newborns.CONCLUSIONSIn half cases, it was decided to stop biologic therapy in the family planning period. Using biologic disease-modifying anti-rheumatic drugs before and/or during pregnancy doesn't seem to affect the overall maternal and fetal outcomes. Pregnancy planning and treatment options should be discussed and a shared decision should be established between physician and patient.
Background:Physician’s global assessment of disease activity (PhGA) is highly influential upon treatment decisions taken by rheumatologists, surpassing the impact of DAS28. [1, 2]. However, data regarding its psychometric properties are scarce.Objectives:To evaluate the reliability and responsiveness of PhGA.Methods:We included two consecutive visits of RA patients followed in a Tertiary Rheumatology Department. Socio-demographic (age and gender) and clinical data were collected including tender (TJ28) and swollen (SJC28) joints in 28 count, C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Disease activity Score (DAS28-3v-CRP, DAS28-3v-ESR, DAS28-4v-CRP, DAS28-4v-ESR), PhGA and Patient Global Assessment of disease Activity (PGA) through a Visual Analogic Scale (VAS) 0-100mm. Changes (Δ) between the two visits were calculated. Only patients without missing data were included. Correlations between ΔPhGA and change of other variables were assessed using Pearson’s correlations. Reliability was evaluated through Intraclass Correlation Coefficient (ICC) between two consecutive appointments in a subgroup of patients with stable disease activity (Δ DAS28-4vESR [-0.6 to 0.6]. An ICC above 0.8 was considered indicative of excellent reliability. Sensitivity to change was assessed in the subgroup of patients who improved their disease activity at least 0.6 on DAS28-4V-ESR, through Standardized Response Mean (SRM). The respective intervals of confidence were obtained through bootstrapping procedures. SRM above 0.8 were considered large. Independent factors associated with ΔPhGA were identified through multivariate linear regression analysis. p<0.05 was considered statistically significantResults:121 RA patients (84.3% female and 64.0±12.6 years) were included. Δ PhGA was weakly correlated with ΔCRP (r=0.23), Δ PGA (r=0.31) and Δ pain (r=0.37). Moderate to strong correlations were observed with Δ DAS28-3V-ESR (r=0.55), Δ SJC28 (r=0.56), Δ DAS28-3V-CRP (r=0.58), Δ DAS28-3V-CRP (r=0.60), Δ TJ28 (r=0.62) and Δ DAS28-4V-CRP (r=0.63). ICC between two consecutive visits was 0.7, [95%CI:0.47-0.83] and SRM was -1.01 [95%CI:-1.26-(-0.73)]. In the multivariate regression analysis, ΔSJC28 (β=4.01; 95% CI:3.07 to 4.96) and Δ Pain (β=0.18; 95%CI: 0.07 to 0.28) remained as independent factors associated with ΔPhGA (R2:0.49, p<0.01)Conclusion:In this study, PhGA showed a high reliability and sensitivity to change regarding disease activity, in clinical practice. Changes in SJC had the strongest association with change in PhGA scoring, but Δ Pain was also significantly correlated (graph 1).Figure 1.Graph 1 – Explicative model to variations on PhGAReferences:[1]Choy T et al. Rheum (Oxford, England). 2014;53(3):482-90.[2]Rohekar G et al. Jour Rheum. 2009;36(10):2178.Disclosure of Interests:LILIANA SARAIVA: None declared, Luisa Brites: None declared, Ana Rita Cunha: None declared, Helena Assunção: None declared, Ana Rita Prata: None declared, Mariana Luis: None declared, Flavio Costa: None declared, Pedro Freitas: None declared, Marlene Sousa: None declared, José Antonio P. da Silva Grant/research support from: Pfizer, Abbvie, Consultant of: Pfizer, AbbVie, Roche, Lilly, Novartis, Catia Duarte: None declared
Background:Patient global Assessment (PGA) of disease activity is considered a key patient reported outcome in Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA), both being included in combined indices of disease activity. However, patients and physicians frequently disagree in their assessment.Objectives:This study aimed at comparing the degree of this discrepancy and its determinants in RA and PsA.Methods:Cross sectional study including 100 patients with RA (ACR/EULAR 2010 criteria) and 100 patients with PsA with predominant peripheral joint involvement (CASPAR criteria), aged ≥18 years, randomly selected from the electronic registry Reuma.pt. Data were collected from the most recent rheumatology visit during the last year: sociodemographic data, disease duration (years), tender and swollen joint counts 0-28 (TJC and SJC), disease activity (DAS28 3V-PCR), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), patient’s pain assessment, PGA and physician global assessment (PhGA). The discrepancy between patients and physicians (ΔPPhGA) was defined as PGA minus PhGA, and a difference > |20mm| was taken as “discordance”. Categorical variables are presented as proportions and continuous variables as mean (±SD). Patient and clinical characteristics were compared between patients with RA and PsA using t- test and χ2 test, as adequate. Variables with p<0.05 or clinically relevant were included in multivariable logistic regression analysis to identify correlates for ΔPPhGA in the whole sample. A p≤0.05 was considered statistically significant.Results:Compared to PsA, patients with RA were more often female (90% Vs 49%,p< 0.05), older (66.7 ± 10.7 Vs 58.3 ± 12.2 years,p< 0.05) and had a shorter disease duration (18.2 ± 9.8 Vs 19.9 ± 9.7 years,p= 0.202). Regarding disease activity, the RA and PsA groups were comparable: DAS28 3V-PCR (2.3 ± 0.9 Vs 2.4 ± 1.0,p= 0.34). Patients with RA had a higher mean ΔPPhGA (30.4 ± 30.6 Vs 25.4 ± 27.5,p< 0.05), and were more frequently discordant to the physician (69% Vs 51%,p< 0.05). In univariable analysis, having RA, higher patient’s pain assessment and higher ESR were associated to patient-physician discordance. In multivariable analysis, only patient’s pain assessment (OR 1.04 [95% CI 1.03-1.06], p = 0.00) and TJC (OR 0.82 [95% CI 0.68-0.97], p = 0.02) remained as predictors of discordance.Conclusion:Despite comparable disease activity scores in RA and PsA patients, RA patients tend to have a worst self-perception of their disease activity compared to their physician´s. Patient’s pain assessment and TJC were the only predictors of patient-physician discordance, irrespective of the disease.Disclosure of Interests:Luisa Brites: None declared, LILIANA SARAIVA: None declared, Flavio Costa: None declared, João Dinis de Freitas: None declared, Mariana Luis: None declared, Ana Rita Prata: None declared, Helena Assunção: None declared, José Antonio P. da Silva Grant/research support from: Pfizer, Abbvie, Consultant of: Pfizer, AbbVie, Roche, Lilly, Novartis, João Rovisco: None declared, Catia Duarte: None declared
Background:Patients with rheumatoid arthritis (RA) suffer from joint pain, stiffness and fatigue and are therefore limited in their physical activities. Since functional disability is a major determinant of quality of life in patients with RA, an optimized approach should focus on the maintenance of functional ability.Objectives:To evaluate self-reported disability in RA patients and to identify its influencing clinical and demographic factors in a real-life cohort of patients with RA.Methods:Cross-sectional study of consecutive patients with RA fulfilling the ACR/EULAR 2010 and/or ACR 1987 RA classification criteria, followed in a Portuguese tertiary care centre. Variables collected included socio-demographic and clinical variables (disease duration; time from symptoms onset to diagnosis, classified as short (≤ 2 years) and long (> 2 years); time of diagnosis, categorised as <2000, 2000-2009, ≥2010); DAS28-CRP-3V and its individual components; pain assessed through visual analogue scale (0-100 mm) and self-perception of anxiety/ depression through EQ5D dimension 5. Disability was assessed through Health Assessment Questionnaire (HAQ) score and categorised as none-to-mild (<1) or moderate-to-severe (1-3). Comparison between groups was assessed through chi-square or T-student test, as adequate. Variables with p<0.1 and others clinically relevant in the researcher’s perspective were included in a multivariable logistic regression model. Previously to the analysis, all the assumptions were verified. Given the implementation of new strategies regarding diagnosis and treatment of RA in the last decade, a subgroup analysis was performed for patients with diagnosis performed after 2010).Results:A total of 251 patients were included (78.9% female, aged 62.0±12.1 years, disease duration 16.7±11.2 years), with a mean DAS28-CRP-3V of 2.24 ±0.87, with 65.3% being in remission or low disease activity. The mean HAQ score was 1.2±0.8. Over half of the patients (56.2%) reported moderate-to-severe disability. In the univariate analysis, moderate-to-severe disability was more frequent in female patients (60.6% vs 39.6%, p<0,006), in patients with moderate-to-severe self-perception of anxiety/depressive symptoms (67.2% vs 44.2%, p<0.001) and in patients with diagnosis before the year 2000, 2000-2009 than ≥2010 (71.4% vs 63.1% vs 36.7%; p< 0.001). In addition, patients with moderate-to-severe disability tended to be older (65.05 vs 57.98, p<0,001), to have longer disease duration (20.07 vs 12.39, p <0.001), to report more pain (VAS 58.08 vs 28.62, p<0.001) and to have higher disease activity (2.48 vs 1.95, p=0.001). In the multivariable analysis, pain (OR=1.04; 95%CI 1.03-1.06, p<0.001), disease activity (OR=1.51; 95%CI 1.01-2.26, p=0.049), and time of diagnosis (OR=0.553, 95%CI 0.38 -0.81, p=0.002) remained as independent factors associated with moderate-to-severe disability (R2: 0.40, p<0,001). In the subgroup of patients diagnosed after 2010, a longer time to diagnosis (>2 years) (OR=7.97, 95%CI 1.88-34.06; p=0.005) and pain (OR=1.05, 95%CI 1.03-1.08; p<0,001) remained as independent factors (R2= 0.44, p=<0.001).Conclusion:Functional disability remains a major problem in our patients with RA, despite clinical remission. Beyond non-modifiable factors, disease activity and pain are associated with higher disability. Moreover, in the subgroup of patients diagnosed after 2010 a long time to diagnosis was the major predictor of disability. However, a large variance of the reported functional disability remains unexplained. Hence, other factors should be properly evaluated in our patients in order to achieve a more holistic approach aiming at reducing functional disability.Disclosure of Interests:Helena Assunção: None declared, Ana Rita Prata: None declared, Mariana Luis: None declared, Luisa Brites: None declared, João Dinis de Freitas: None declared, Flavio Costa: None declared, Stefanie Silva: None declared, José Antonio P. da Silva Grant/research support from: Pfizer, Abbvie, Consultant of: Pfizer, AbbVie, Roche, Lilly, Novartis, Catia Duarte: None declared
Background: Satisfaction with body image has a major impact in quality of life. Systemic sclerosis (SSc) is a can result in disfiguring physical changes. Objectives: Our aim was to determine the impact of systemic sclerosis on body image using the Satisfaction with Appearance Scale (SWAP). (1) Methods: Cross-sectional study including patients satisfying the 2013 American College of Rheumatology criteria for SSc diagnosis, aged ≥ 18 years, treated in a tertiary Rheumatology Department. Demographic and clinical data were collected from Reuma.pt and clinical records. All patients provided informed consent and fulfilled SWAP questionnaire, which consists of 14 questions in 4 subscales: satisfaction with facial appearance, satisfaction with non-facial appearance, social discomfort due to appearance and perceived social impact of appearance. Patients rate each item on a numerical rating scale from 1 (strongly disagree) to 7 (strongly agree). Scores for the facial and non-facial appearance range from 0-24 and scores for the social discomfort and perceived social impact subscales range from 0-18. Total SWAP score can range from 0-84 and higher values indicate greater dissatisfaction with appearance and poorer body image. A descriptive analysis was used to summarize demographic and clinical data; categorical variables were described using frequencies; and continuous data using mean and standard deviation. Correlation between variables [Rodnan, age, disease duration, Hospital Anxiety and Depression Scale (HADS) and Short Form Health Survey (SF36)] and SWAP score was tested with Pearson or Spearman coefficient, as appropriated. Scores of SWAP and its subscales in preclinical, limited and diffuse forms of SSc were compared using ANOVA test. Analyses were performed with SPSS Statistics, V.21 and p <0.05 was considered statistically significant. Results: We enrolled 38 patients, 84.2% (n=32) female, with mean age 60.3±14.5 years and mean disease duration 13.3±6.5 years. All but one were caucasian. Fifty percent (n=19) had a limited form, 26.3% (n=10) had preclinical scleroderma and 23.7% (n=9) had a diffuse form of SSc. Regarding the autoantibody profile: 63.2% (n=24) had anti-centromere antibodies, 28.9% (n=11) had anti-Scl-70 antibodies, 5.3% (n=2) had anti-PM antibodies and 2.6% (n=1) had no positive antibodies. The median of Rodnan scores was 4 (IQR 0-9). The total mean SWAP score was 44.8±12.5 with worse results at “Satisfaction with facial appearance” subscale (mean score 14.4±6.1). There is no statistically significant difference in the SWAP score (or its subscales) between the three diagnosis subtypes. No statistically significant correlation was found between the total and subscale SWAP scores and any of the continuous variables considered and no statistically significant difference was found between the different forms of SSc. Conclusion: We found no significant differences between preclinical, limited or diffused SS. SWAP scores were not significantly correlated with the total Rodnan score, age or disease duration. Contrary to our expectations SWAP did not show any relationship with depression, anxiety (HADS) or quality of Life (SF-36) However, our sample is too small to support definite conclusions. Further studies assessing body image in SSc and its impact in quality of life are warranted to support the holistic care of these patients. References: [1]doi:10.3899/jrheum.141482.; [2]10.1037/0278-6133.22.2.130; [3]10.3899/jrheum.141482. Disclosure of Interests: Luisa Brites: None declared, Flavio Costa: None declared, LILIANA SARAIVA: None declared, Ana Rita Cunha: None declared, José Antonio P. da Silva Grant/research support from: Pfizer, Abbvie, Consultant of: Pfizer, AbbVie, Roche, Lilly, Novartis, Tânia Santiago: None declared, Maria Joao Salvador: None declared
Background:Physician’s global assessment of disease activity (PhGA) is included in some scores of disease activity and, demonstrably, plays a major role upon treatment decisions in rheumatoid arthritis (RA) [1, 2, 3]. Therefore, understanding the reasons underlying the physician´s assessment is crucial.Objectives:To understand the reasons underlying the physician´s assessment.Methods:Cross-sectional study, including consecutive RA patients followed in a Tertiary Rheumatology Department. Socio-demographic (age and gender) and clinical data were collected through a standardized protocol, including 28 tender (TJ28) and swollen (SJC28) joints count, C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Disease activity Score (DAS28-4v-CRP and DAS28-4v-ESR), PhGA and Patient Global Assessment of disease Activity (PGA) through a Visual Analogic Scale (VAS) 0-100mm, Health Assessment Questionnaire (HAQ), European Quality of Life-5 Dimensions (EQ-5D) and Hospital Anxiety and Depression Scale (HADS). Correlation between PhGA and other continuous variables was evaluated through Pearson´s Correlation Coefficient and variables with p<0.05 in univariate analysis were included in multivariable linear regression (stepwise model).Results:392 RA patients (80.6% female, 65.3±12.6 years) were included. PhGA was weakly correlated with CRP (r=0.23), TJC28 (r=0.35), PGA (r=0.26), HAQ (r=0.31) and EQ5D (r=-0.21). Moderate correlations were observed with SJC28 (r=0.45) and DAS-4V-CRP (r=0.48). In multivariable analysis, SJC28 (β=4.14, 95%CI:3.16-5.12), CRP (β=0.22; 95%CI: 0.02-0.03), HAQ (β=4.46, 95%CI:1.50-7.42) and PGA (β=0.08; 95%CI:0.00-0.16) remained as independent correlates of PhGA (R2=0.27, p<0,05).Conclusion:In this study, PhGA was associated with SJC28, CRP, HAQ and PGA, suggesting that physicians adopt a comprehensive reading of the disease into account. However, a large proportion of the variance of PhGA remains unexplained. Given its driving role in treatment decisions, the need to standardize and better understand PhGA seems to deserve a closer attention.References:[1]Ward MM, et al. Art Car Res. 2017;69(8):1260-5.[2]Desthieux C, et al. Art Car Res (Hoboken). 2016;68(12):1767-73.[3]Kaneko Y, et al. Mod Rheumatol. 2018;28(6):960-7.Disclosure of Interests:LILIANA SARAIVA: None declared, Luisa Brites: None declared, Ana Rita Cunha: None declared, Helena Assunção: None declared, Ana Rita Prata: None declared, Mariana Luis: None declared, Flavio Costa: None declared, Pedro Freitas: None declared, Marlene Sousa: None declared, José Antonio P. da Silva Grant/research support from: Pfizer, Abbvie, Consultant of: Pfizer, AbbVie, Roche, Lilly, Novartis, Catia Duarte: None declared
Background: Early recognition of patients with arthritis is a crucial opportunity for optimal outcome. The Early Arthritis Clinic (EAC) of our department was created in 2012 to ensure a prompt access of these patients to efficient medical care. Patients may be referred based on a set of clinical criteria with less than 12 months duration and laboratory parameters: arthritis, inflammatory arthralgias, squeeze test, morning stiffness > 30 minutes, rheumatoid factor (RF), erythrocyte sedimentation rate (ESR)>30mm/h and C-reactive-protein>0.5mg/dL (CRP). Objectives: To assess the level of agreement between the referring physician and the rheumatologist, regarding the presence of each of the six referral criteria and to identify predictors of inflammatory arthritis. Methods: Cross sectional study including patients aged ≥ 18-year-old observed in the EAC between January 2012 and October 2019. Subjects who were referred to the EAC by a rheumatologist and those without available referral letter/medical records from the first visit to the EAC were excluded. Demographic data, provenience, referral criteria (presence/absence) and the final diagnosis [presence or not of an inflammatory rheumatic disease (IRD)] were collected from medical records. For the six referral criteria, the agreement between the referring physician and the rheumatologist was assessed using the Cohen’s Kappa. The presence of each referral criteria was compared between patients with and without an IRD using χ2 tests. Variables with p<0.1 or clinically relevant were included in forward stepwise multivariable logistic regression analysis to identify possible predictors for IRD. The statistical analysis was performed using SPSS® v21 and p <0.05 was considered statistically significant. Results: 376 patients (70% female; mean age (±SD) 56.3±16.2 years) were included. Most patients were referred from primary care (84%); the remaining 16% include those referred from emergency department and other hospital specialties. We diagnosed an inflammatory arthritis in 62% (n = 232) of the patients. Table 1 shows the level of agreement between the referring physician and the rheumatologist, regarding the presence of the referral criteria. Table 1. Agreement between the referring physician and the rheumatologist, regarding the presence of the referral criteria. Referral criteria Kappa p Arthritis 0.23 0.05 Squeeze test 0.09 0.04 Inflammatory arthralgias 0.11 0.04 Morning stiffness 0.18 0.04 RF 0.27 0.04 ESR 0.26 0.04 CRP 0.25 0.04 ANA 0.02 0.47 ANA- antinuclear antibodies; CRP- C-reactive-protein; ESR-erythrocyte sedimentation rate; RF-Rheumatoid factor In univariable analysis (IRD Vs non-IRD), inflammatory arthralgias (74% Vs 93%, p=0.01), squeeze test (24% Vs 55%, p=0.01), morning stiffness (49% Vs 63%, p=0.05), ESR (63% Vs 46%, p=0.01), CRP (62% Vs 48%, p=0.04) were associated to IRD. In multivariable analysis, only ESR (OR 5.0 [95% CI 1.9-13.0], p < 0.05) and inflammatory arthralgias (OR 0.15 [95% CI 0.04-0.52], p < 0.05) remained as predictors of IRD. Conclusion: Agreement between the referring physicians and the rheumatologist regarding then presence/absence of the referral criteria was poor in all clinical criteria and fair in laboratory criteria. Elevated ESR was an independent predictor of IRD and the description of inflammatory arthralgias was negatively correlated with IRD. These findings suggest the need to clarify the referral criteria used and to improve education among the physicians referring patients to the EAC. Disclosure of Interests: Luisa Brites: None declared, LILIANA SARAIVA: None declared, Ana Rita Cunha: None declared, Helena Assunção: None declared, Tânia Santiago: None declared, José Antonio P. da Silva Grant/research support from: Pfizer, Abbvie, Consultant of: Pfizer, AbbVie, Roche, Lilly, Novartis, Catia Duarte: None declared