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Annals of the Rheumatic Diseases | 2014

SAT0484 Bsmi VDR Gene Polymorphism is Associated with Bone Mineral Density and Bone Metabolism in Established Rheumatoid Arthritis Patients

M. Bernardes; J.C. Machado; T. Vieira; D. Gonçalves; R. Vieira; R. Fonseca; P. Madureira; J. Abelha-Aleixo; A. Bernardo; J.G. Pereira; M.J. Martins; L. Costa; F. Simões-Ventura

Background Rheumatoid arthritis (RA) is characterized by a localized bone resorption at the hands, namely, as well as a generalized osteoporosis. BsmI vitamin D receptor (VDR) gene polymorphism is a well known genetic determinant of bone mineral density (BMD) in healthy populations. Objectives Determine the degree of association of BsmI VDR gene polymorphism with BMD and bone metabolism in patients with established RA. Methods Clinical features and peripheral blood samples were collected from a monitoring visit. HAQ and DAS28 (4v) were obtained. We measured the following laboratory parameters: ESR, CRP, serum β-CTX1, osteocalcin, Dkk-1, sclerostin, RANKL and OPG. Genomic DNA was extracted from blood and genotyped for the BsmI (A/G) (rs1544410) SNP by PCR-RFLPs analysis. BMD was assessed by Dual energy X-ray Absorptiometry (Lunar Expert ® 1320) at the lumbar spine, total hip, femoral neck, hands and second proximal phalanges. A multivariate analysis model was used for statistical analysis (IBM SPSS Statistics 21). Results We evaluated 208 RA patients, 166 (80%) women, 65 (31%) premenopausal women, age 54±12 years, disease duration 14±10 years, mean DAS28 (4v) of 4.25±1.33 and a mean HAQ of 1.254±0.709. In our sample, 107 (51%) were under biologics, 87 (42%) under anti-TNFalpha agents, 69 (33%) under bisphosphonates and 42 (20%) under vitamin D supplements, Genotype frequencies were determined for BsmI VDR gene polymorphism: GG 37%, AG 44%, AA 19%. AA genotype was associated with higher BMD at femoral neck, lumbar spine, hands and second proximal phalanges (p<0.001). In the subgroup of patients without vitamin D supplements, AA genotype was also associated with higher BMD at the hip (p<0.001). These associations were found after adjusting for age, disease duration, body mass index, DAS28 (4v), current HAQ, time under DMARDs therapy, years of corticosteroid use and years of bisphosphonates use. In terms of bone metabolism, AA genotype was associated with higher values of Dkk-1 (p<0.05) and sclerostin (p<0.001). The presence of A allele was associated with higher RANKL levels (p<0.05). In the subgroup of patients without vitamin D supplements, AA genotype was only associated with higher sclerostin levels (p<0.001). These later associations were found after adjusting for age, age at diagnosis, disease duration, body mass index, DAS28 (4v), current HAQ, current average daily dose of prednisolone and years of bisphosphonates use. Conclusions BsmI VDR gene polymorphism may serve as a genetic marker of both, localized and generalized, bone loss in RA population since it is associated with BMD in several anatomic sites. The link of this polymorphism to high serum levels of sclerostin reinforce a possible role for this bone marker in coupling bone resorption to bone formation. There is recent evidence that zoledronic acid increases sclerostin serum levels in treated postmenopausal women and that sclerostin serum levels correlate positively with BMD in haemodialysis patients. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.3868


Annals of the Rheumatic Diseases | 2014

AB0547 Prevalence of Osteopenia and Osteoporosis in A Cohort of 160 Patients with Systemic Lupus Erythematosus

R. Fonseca; G. Terroso; D. Gonçalves; J. Abelha-Aleixo; F. Aguiar; P. Madureira; R. Vieira; M. Bernardes; L. Costa

Background Low bone mineral density (BMD) is highly prevalent in patients with systemic lupus erythematosus (SLE). However, determinants of BMD changes in SLE are still largely unknown. Objectives The aim of this study was to describe the clinical characteristics of SLE patients submitted to a dual energy X-ray absorptiometry (DEXA), evaluating the prevalence of osteopenia/osteoporosis and searching for possible predictors of bone loss in these patients. Methods Retrospective observational study of 160 SLE patients of our Rheumatology department, was performed. Demographic, clinical data and BMD measurements (g/cm2) of the lumbar spine (LS) and total hip (TH) were collected. The DEXA results were classified according to WHO criteria for osteoporosis. Statistical analyses was performed using t-test, Mann-Whitney U-test, and Spearman correlation (SPSS 21.0). Results Out of 160 SLE patients, 148 (92,5%) were female with a mean age 44,23±12,5 years. The median SLEDAI was 2 [0-23], median SLICC was 0,2 [0-5]. 74 (56%) patients were taking vitamin D supplements, 56 (35%) were taking calcium supplements and 24 (15%) received bisphosphonate therapy. Only 81 (50,6%) had a DEXA done. Patients with DEXA were older (47.28±12.7 vs 41.09±11.8 years, p<0.01), had a longer disease duration (13.8±9 vs. 10.6±8 years, p=0.02), high SLICC score (2,0 vs 0,0 p=0,04) and were taking a higher dose of steroids (7 vs 5; p=0,01). No significant differences were found between gender, SLEDAI, serum vitamin D, complement levels, erythrocyte sedimentation rate or c-reactive protein. Of the 81 patients with DEXA, 34 (42%) had osteopenia, 13 (16%) had osteoporosis and 34 (42%) had normal BMD. The mean lumbar spine BMD was 0.96±0.12 g/cm2 and the mean total hip BMD was 0.87±0.13 g/cm2. Statistically significantly correlation was found between age and lumbar spine BMD (r=-0,256; p=0,02), age and total hip BMD (r=-0,262; p=0,02), SLICC score and lumbar spine DMO (r=-0,230; p=0,04) and SLICC score and total hip BMD (r=-0,279; p=0,04). Conclusions In our cohort, SLE patients referred for a DEXA have more traditional risk factors, take a higher dose of corticosteroids and have a higher disease damage access by SLICC score. The prevalence of osteopenia and osteoporosis in our SLE-patients was greater than in general population. In addition to age, disease damage access by SLICC score was associated with low BMD. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.4635


Annals of the Rheumatic Diseases | 2017

SAT0211 Real world data of rituximab effectiveness in rheumatoid arthritis: differences between biologic-naive patients and previously exposed to biologics

Rm Ferreira; R. Fonseca; Gonçalves; F. Aguiar; T. Rocha; A. Bernardo; S. Pimenta; M. Bernardes; L. Costa

Background Rituximab is only approved for rheumatoid arthritis (RA) treatment in patients with an incomplete response or intolerance to others DMARDs, including TNF alfa inhibitors. It represents a significant advance in RA biologics arsenal due to its safety and efficacy profiles. Objectives To evaluate the effectiveness of rituximab in RA patients and to compare the response between first-line rituximab patients and those previously exposed to other biologics. Methods An observational retrospective study was conducted, including all the consecutive patients with diagnosis of RA under rituximab, followed at our Rheumatology department until December 2016. Demographic and clinical data were obtained by consulting the national database (Reuma.pt). DAS28 variations and EULAR response were measured at 6, 12 and 18 months. Parametric and non parametric tests were used for statistics (SPSS 20.0). Results We included 63 RA patients (81% of women), with a mean (SD) age of 61 (10) years and a mean disease duration of 19 (10) years; 86% rheumatoid factor positive and 87% anti- citrullinated peptide antibody (ACPA) positive. Bone erosions and extra-articular manifestations were present in 85,7% and 58,7% of the patients, respectively. At baseline, the mean DAS28 was 5.79 (65% and 29% of patients with severe and moderate disease activity, respectively, and 6% in clinical remission). Thirty patients were treated with rituximab as first-line therapy and 33 patients were previously exposed to other biologics. Combination therapy with methotrexate (MTX) was observed in 48% and with others classic DMARDs in 30%, while 22,3% received rituximab monotherapy. First-line rituximab option was justified by lung involvement in 21%, past malignancy in 13%, recurrent infections in 5%, congestive cardiac failure in 3%, vascular involvement in 3% and untreated latent tuberculosis in 3%. In the group previously exposed to biologics, 13% switched therapy due to ineffectiveness and 87% due to adverse events. No significant differences were found between the 2 groups in terms of age, gender, concomitant use of MTX and baseline DAS28. The group previously exposed to biologics had a longer disease duration (mean 23 vs 15 years, p=0.001) and fewer patients with ACPA seropositivity (79% vs 97%, p=0.035). There was a significant reduction of DAS28 at 6, 12 and 18 months (p<0.001 for all). Fifty six percent of the patients achieved a EULAR response at 6 months, 46% at 12 months and 59% at 18 months. DAS28 variation at 6 months differed significantly between groups, with a better clinical response in naive biological patients comparing to those previously exposed to biologics (median 1.173 vs 0.477; p=0.038). There were no differences in terms of DAS28 variation at 12 and 18 months (p=0.642 and p=0.135, respectively) and in EULAR responses at 6, 12 and 18 months between the groups (p=0.289, p=0.523 and p=1.000, respectively). Conclusions Our study confirms the effectiveness of rituximab in RA patients and suggests a higher magnitude of response in naive biological patients at 6 months of RTX therapy. These findings put in perspective an extension of rituximab as a first-line biologic for RA treatment. Disclosure of Interest None declared


Annals of the Rheumatic Diseases | 2016

AB0633 Performance of The EULAR/ACR 2013 Classification Criteria in A Portuguese Systemic Sclerosis Population

R. Fonseca; D. Rosa-Gonçalves; F. Aguiar; T. Meirinhos; T. Martins-Rocha; E. Mariz; M. Bernardes; L. Costa

Background The 1980s ACR classification criteria for systemic sclerosis (SSc) show low sensitivity, especially in early or mild forms. A new set of classification criteria has been developed by ACR/EULAR in 2013. Applicability of the new criteria in clinical practice remains to be shown. Objectives To evaluate the performance of both set of classification criteria for SSc in a Portuguese SSc population. Methods Cross-sectional study including consecutive patients with clinical diagnose of SSc (based on expert opinion) followed in our rheumatology department. Clinical and demographic characteristics were collected by consulting the clinical files and national data base – Reuma.pt. The two sets of criteria were applied to all patients, sensitivity was calculated and Kappa coefficient was used to evaluate the agreement between them. Patients not fulfilling the old but fulfilling the new criteria were compared with those that fulfilled ACR criteria using Mann-Whitney, qui-square and fisher test (SPSS 23.0). Significance level was set as <0.05. Results 108 patients were included, 96 (88.9%) were female with mean age of 58.21 (±12.8) years and a median disease duration of 6 years (0–38). 96 (88.9%) had localized and 12 (11.1%) had diffuse disease form. The most prevalent criteria items were: Raynauds phenomenon (93.5%), sclerodactyly of the fingers (85.2%) and antinuclear antibodies (94.4%). For overall cohort, 53 patients (49.1%) fulfilled the old ACR criteria. These 53 patients and more 44 patients (97) fulfilled the new ACR/EULAR criteria, showing a sensitivity of 89.9% compared to 49.1% of the old ones. Kappa coefficient was 0.197 (p=0.01). In patients with localized forms, the sensitive of ACR/EULAR criteria was 88.5% compared with 43.8% of ACR 1980 criteria and Kappa coefficient was 0.183 (p=0.02). In diffuse forms, all 12 patients fulfilled both criteria set, showing an almost perfect agreement. Patients not fulfilling the old but fulfilling the new criteria presented more frequently with capillaroscopic abnormalities (p=0.04) and anticentromere antiboy (p=0.01), but low incidence of anti-Scl70 antibodies (p<0.001) and interstitial lung disease (p<0.001). Conclusions Our study confirmed a greater sensibility of the new ACR/EULAR 2013 criteria compared with ACR 1980 criteria, especially in mild and localized SSc disease forms. In our patients with SSc not fulfilling the old criteria, the presence of capillaroscopic abnormalities and anticentromere antibodies among the new set of classification criteria were of the utmost importance in their reclassification as SSc patients. The application of the new criteria in clinical scenario allows an early classification and timely management of more SSc patients, ensuring a better prognosis. Disclosure of Interest None declared


Annals of the Rheumatic Diseases | 2016

AB0446 Contraceptive Practices and Knowledge among Women with Systemic Lupus Erythematosus in A Portuguese Terciary Care Hospital

F. Aguiar; R. Fonseca; Iva Brito

Background Systemic Lupus Erythematosus (SLE) is a disease that primarily affects women of reproductive ages. Unplanned pregnancy in women with SLE can have various complications both for the child and the woman, due to the disease itself or to eventual exposure to teratogenic medications. Most of these patients are candidates for extremely effective contraceptive methods, including implants, intrauterine devices (IUD) or permanent sterilization. However, some of these patients do not receive proper counseling and these methods are often underutilized. Objectives To determine contraceptive use, knowledge and counseling among patients with SLE attending a portuguese terciary care hospital. Methods Cross-sectional study in which women aged 15–50 followed in our Rheumatology Department with a diagnosis of SLE were approached to complete a researcher-administered survey. Results 74 women were included, median age 34 years (range 15–50), with median disease duration of 9.0 years (range 0.50–30.0). 8 patients were in menopause, 2 were pregnant at the time of the survey, and 18 had not been sexually active with a man in the 3 months prior to the survey. 46 women (62.1%) were sexually active and were considered to be at risk for unintended pregnancy. 41.3% (n=19) of these patients were using extremely effective contraceptive methods with a typical use failure rate of ≤3% (10 of them using (IUD), 7 permanent sterilization, and 2 implants), 32.6% (n=15) were using highly effective contraceptive methods with a typical use failure rate of ≥3% but ≤10% (combined oral contraceptive in 7 and progestatin-only oral contraceptive in 8) and 26.1% (n=12) were using either no method, or low effective methods with a typical use failure rate of >10% (masculine condom in 11 and one patient was not using any method). 52.2% (n=24) of the sexually active women were taking one or more of methotrexate, mycophenolate mofetil, cyclophosphamide or warfarin. Amongst these soubgroup of patients one third was using extremely effective contraceptive methods, one third was using highly effective methods and another third was using low effective methods either or no method. Among women at risk for unintended pregnancy 13% (n=6) were not aware of the complications associated with pregnancy in their medical condition, and in patients using teratogenic medications 8.3% (n=2) were not aware of the the risks and 37.5% (n=9) had never been counseled about contraception. In women using teratogenic medications and low effective methods, 87.5% (n=7) were aware of the risks of pregnancy but 87.5% (n=7) had never been counseled about contraception. Conclusions In this study, most women with SLE who are at risk for unintended pregnancy were aware that their medical condition increases the health risks for themselves and their fetuses. However a significant number of patients, especially those under potencially teratogenic medications did not receive any contraceptive counseling. It is essential to educate these women about their reproductive health and contraceptive options and risks. Disclosure of Interest None declared


Annals of the Rheumatic Diseases | 2016

SAT0278 Association between Mucocutaneous Manifestations and Clinical and Immunological Characteristics in Juvenile-Onset Systemic Lupus

R. Fonseca; F. Aguiar; Marcos V. Rodrigues; Iva Brito

Background Patients diagnosed with juvenile-onset systemic lupus erythematosus (jSLE) often have skin and oral lesions as part of their presentation. It is suggested, in literature, that mucocutaneous involvement in jSLE may be associated with some antibodies and systemic disease and often require treatment with systemic immunosuppressive drugs in order to achieve adequate disease control. Objectives To assess mucocutaneous manifestations in jSLE and to study its associations with clinical and immunological characteristics. Methods Retrospective observational study was performed including consecutive patients with jSLE (disease onset before 16 years of age) followed in our Paediatric Rheumatology Unit. Clinical, demographic and laboratory characteristics were retrospectively collected by consulting the medical records. All patients fulfilled the clinical and laboratory criteria of the American College of Rheumatology (ACR). Patients with mucocutaneous manifestations were compared with others using Student t-test, Mann-Whitney test, Chi-square or Fisher test. (SPSS 23.0). Significance level was set as <0.05. Results 38 patients were included, 92.1% (35) were female, with a mean age at diagnosis of 12.9 ± 3 years. Median period between onset of symptoms and diagnosis of SLE was 0.3 [0–1.2] years and median duration of follow-up was 14 [0.75–26]. 84.3% had mucocutaneous manifestations, (78.9% malar rash, 5.2% discoid rash, 70.3% photossensibility and 39.5% ulcers). 78.9% of the patients also had musculoskeletal symptoms, 63.2% haematological manifestations, 50% had renal involvement, 21% serositis and 13.2% neuropsychiatric involvement. Patients with mucocutaneous involvement had more frequently renal involvement (58% vs 14.2%, p=0.001), haematological manifestations (70.9% vs 28.5%, p=0.02), positive lupus anticoagulant (13.8% vs 4.3%, p=0.012), positive coombs test (59% vs 14.2%, p=0.04) and positive anti-SSa (35.4% vs 3.3%, p=0.04). SLEDAI and SLICC scores were comparable between the two groups. Analysing by type of skin involvement, patients with malar rash had also more frequently haematological involvement (76.7% vs 12.5%, p=0.002) and it was associated with the presence of anti-SSa (33.3% vs 12.5%, p=0.04). Patients with photossensibility had more frequently positive anti-SSa (34.5% vs 11.1%, p=0.029). Two patients (5.2%) had discoid lupus and 15 (39.5%) had ulcers but it was not associated with any other clinical or immunological manifestation. Conclusions Mucocutaneous are frequent manifestations in jSLE, and they are associated with active disease occurring frequently in patients with also haematological and renal manifestations. Anti-Ssa antibody is important in these patients as we have demonstrated its association with some particularly skin manifestations. Disclosure of Interest None declared


Annals of the Rheumatic Diseases | 2016

SAT0221 Determinants Associated with Interstitial Pulmonar Involvement in Patients with Systemic Sclerosis – A Cross-Sectional Study

D. Gonçalves; R. Fonseca; F. Aguiar; T. Martins-Rocha; M. Bernardes; L. Costa

Background Interstitial lung disease (ILD) is one of the major types of lung involvement in systemic sclerosis (SSc). Affected patients have a worse prognosis than patients with SSc who are free of pulmonary involvement. Therefore, it is important to explore determinants of this organ complication. Objectives To found possible determinants of ILD in SSc patients. Methods A cross-sectional study was conducted in 104 SSc patients (2013 ACR/EULAR criteria) from a university hospital of Portugal. The analyzed variables were: age, sex, age at disease onset, disease duration, antinuclear antibodies (ANA), topoisomerase I DNA (Scl70) and anticentromere antibodies (ACAs) status, Raynaud phenomenon, areas of skin sclerosis (limited was divided into sclerodactyly or proximal to the metacarpophalangeal (MCP) joints), digital ulcers (DU), digital pitting scar and telangiectasia status, diffusion capacity of carbon monoxide transfer/alveolar volume (DLCO/VA, % of the predicted value) at diagnosis and esophagus involvement. Descriptive statistics were calculated for several demographic and clinical characteristics. Pearson or Spearman correlation and chi-square or Fishers exact test was used for the assessment of the correlation between ILD and the different continuous and categorical variables. Subsequently, binary logistic regression analysis (method enter) was carried out using the ILD as the dependent variable. As independent variables, were included variables that had clinical or statistical significance. Results Most (89.4%) of patients were women; mean (SD) age was 59 (±13) years. Mean age at diagnosis was 51 (±13) years with disease duration median (min;max) of 6 (0;38) years. Ninety-three (89.4%) patients had limited (lcSSc) scleroderma. Most (98.1%) patients had ANA positive (mainly centromere (n=61) followed by nucleolar pattern (n=15)), 61 (58.7%) patients were ACAs positive and 21 (20.2%) positive for Scl70 antibodies. DLCO/VA mean at SSc diagnosis was 74.8% (±13.6). Twenty-three (22.1%) patients had ILD (most NSIP pattern) and 64 (61.5%) had esophagus involvement. Correlation coefficients with statistical significance were noted for disease duration and age however, these were weak (rô=0.22, p=0.03 and r=0.29, p=0.004; respectively). For categorical variables we observed statistical significance for SSc subgroups (ILD prevalence of 15.1% in lcSSc vs 72.7% in diffuse SSc; p<0.001), ACAs and Scl70 serology (6.6% in ACAs vs 57.1% in Scl70 positive patients; p<0.001) and DU (33.3% if history vs 15.5% if without history of DU, p=0.02). Correlation of ILD with DLCO/VA at SSc diagnosis and sex had not statistical significance (p=0.064). In logistic regression the following variables were introduced: age, disease duration, SSc subgroups, ACAs and Scl70 serology, skin sclerosis proximal to the MCP joints, DU status and DLCO/VA at SSc diagnosis. The analysis showed that the age (OR=1.13,p=0.003), SSc subgroups (OR=22.95,p<0.001) and ACAs status (OR=0.08,p=0.001) influence the ILD in the model. Conclusions Our results suggest that higher age and diffuse sclerosis increased ILD risk and ACAs decreases. A prospective longitudinal study with a larger sample is desirable to confirm these results. Disclosure of Interest None declared


Annals of the Rheumatic Diseases | 2016

FRI0415 Serum Amyloid A Protein in Spondyloarthritis Patients under Anti-Tumour Necrosis Factor-Alpha: An Useful Biomarker?

F. Aguiar; T. Martins-Rocha; D. Rosa-Gonçalves; R. Fonseca; Iva Brito; A. Bernardo; M. Bernardes

Background Inflammation is known to play a major role in rheumatologic disorders. Hence quantitating the degree of inflammation has become essential to tailor the treatment strategy. Traditionally used measures to assess disease activity in spondyloarthritis (SpA) are ESR, CRP, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS). Serum amyloid A (SAA) is an acute-phase reactant predominantly synthesized in the liver by hepatocytes in response to proinflammatory cytokines. Some studies have shown that SAA correlates with disease activity in SpA and suggest it as a valuable indicator of disease activity, however it has not been extensively used in clinical practice. Objectives To investigate if SAA levels have better correlation with conventional clinical and serological assessments in SpA than CRP and ESR. Methods Cross-sectional study, including SpA patients under anti-TNFα treatment at a Rheumatology Department of a Portuguese Universitary Hospital. We compared the correlation between SAA, CRP and ESR levels with BASDAI, ASDAS-CRP, ASDAS-ESR, BASFI, BASMI, swollen and tender joints counts (SJC and TJC), MASES, SPARCC, and patient global assessment, physician global assessment, total back pain, nocturnal back pain rated on a visual analogue scale (VAS). The statistical analysis was performed using SPSS 21.0 software, and p<0.05 was taken to indicate statistical significance. Correlation was calculated using the Spearman rank correlation (r). Results 88 patients were included, 61.4% (n=54) were male. The median age was 44,0 years (range 21.0–74.6). Median disease duration was 19.0 years (2- 51.6). According to ASDAS criteria, 23 patients (26.1%) had inactive disease, 21.7% moderate disease activity, 40.9% high disease activity and 11.4% very high disease activity. SAA levels were moderately correlated with CRP levels (r=0.51, p<0.001) and had lower correlation with ESR (r=0.36, p=0.001). There was no statistically significant correlation between SAA levels and the following parameters: physician global assessment-VAS, total back pain-VAS, nocturnal back pain-VAS, MASES, SJC and TJC. SAA levels correlated with patient global assessment-VAS (r=0.218, p=0.04) but also did ESR (r=0.277, p=0.01). There was no significant correlation between SAA and BASDAI (r=0.161, p=0.134), however CRP levels and ESR showed little correlation (r=0.232, p<0.03 and r=0.366, p<0.001). We found statistically significant correlation between SAA levels and ASDAS-ESR (r=0.298, p=0.005), ASDAS-CRP (r=0.330, p=0.002), SPARCC (r=0.221, p=0.034), BASFI (r=0.327, p=0.002) and BASMI (r=0.262, p=0.014). CRP and ESR also showed significant correlation with BASFI, but it was weaker than that observed with SAA (r=0.285, p=0.007 and 0.310, p=0.004, respectively). ESR and CRP did not correlate with BASMI. Conclusions This study suggests that SAA can be a valuable indicator not only of disease activity but also of damage and functional impairment, that could be introduced in clinical pratice. However more studies, with larger sample sizes, and prospective ones should be undertaken to better assess this subject. Disclosure of Interest None declared


Annals of the Rheumatic Diseases | 2016

SAT0105 Inflammatory Markers in Rheumatoid Arthritis – What Is The Role of Serum Amyloid A Protein?

D. Gonçalves; R. Fonseca; F. Aguiar; T. Martins-Rocha; M. Bernardes; L. Costa

Background Dissociation between the responses of a number of acute-phase proteins (APP) is well known. C reactive protein (CRP) levels have been used extensively to model disease activity in rheumatoid arthritis (RA). However, biologic therapy reduce CRP levels, even without associated reductions in RA disease activity. Serum amyloid A (SAA) also models RA disease activity and has been suggested as a better biomarker for RA disease activity. Objectives To determine if SAA levels had better correlation with conventional clinical and serological assessments in RA than CRP and ESR. Methods A cross-sectional study was performed. Samples were analyzed from RA patients under biologic therapy of a reference hospital in northern Portugal. We compared the correlation between SAA, CRP and ESR levels with swollen and tender joints counts (SJC and TJC), DAS28-4v, SDAI, CDAI, HAQ and visual analogue scale for pain (VAS-P). Correlation was calculated using the Spearman rank correlation (r). P-values <0.05 were regarded as significant. Results 173 patients were evaluated, 86.7% (n=150) were women. The mean (SD) age was 56 years (10.75). Mean disease duration was 16.31 years (8.87). Most of patients had positive serology (rheumatoid factor and/or anti-CCP antibody) (n=146, 84.4%). Ninety eight patients (56.6%) were under TNF antagonists, 23.7% (n=41) were under rituximab and the remaining under tocilizumab (TCZ). SAA levels were moderately correlated with CRP levels (r=0.49, p<0.001) but there was no statistically significant correlation with ESR (r=0.03, p=0.75). Correlation analysis of SAA and CRP levels with several conventional assessments showed (SAA and CRP, respectively): SJC - 0.17 vs 0.08, TJC - 0.18 vs 0.09, DAS28-4v - 0.32 vs 0.41, SDAI - 0.23 vs 0.18, CDAI - 0.18 vs 0.11, ESR – 0.32 vs 0.55; all p values <0.05 except SJC, TJC and SDAI for CRP values. There was no statistically significant correlation of these acute-phase protein with HAQ and VAS-P. ESR levels showed very weak correlation with all parameters (p>0.05), except with DAS28-4v (r=0.58, p<0.001). We also noted that SAA levels were raised (>6.4mg/L) in 37.6% (n=65) of patients in which the CRP concentration was normal (<0.3mg/dL). However, only 6% (n=11) with normal SAA levels had raised concentrations of CRP. When evaluated SAA and CRP levels in patients with active disease (DAS28-4v 32.6, SDAI>3.3 and CDAI>2.8) we found more patients with normal CRP values than SAA (62 vs 26, 82 vs 32, 84 vs 33, respectively). Interestingly, when comparing the effects of biological therapy on APP we noted that in TCZ group the CRP, ESR and SAA levels were lower than in group under TNF antagonists and rituximab (p<0.001 for all, Mann-Whitney test). Conclusions The lack of a strong correlation between SAA and CRP or ESR levels coupled with their better correlation with markers of RA activity suggests that changes in their levels may provide a more sensitive indicator of disease activity, especially during treatment with biologic therapy. Disclosure of Interest None declared


Annals of the Rheumatic Diseases | 2016

FRI0569 Remission and Low Disease Activity Matrix Tool: Results in Real-World Rheumatoid Arthritis Patients under Golimumab

D. Rosa-Gonçalves; R. Fonseca; F. Aguiar; T. Martins-Rocha; M. Bernardes; L. Costa

Background Cost-effectiveness of treatments in rheumatoid arthritis (RA) is of growing importance thus, the ideal is to have a tool that help us to select patients most likely to respond to biotechnological drugs. Objectives To assess the relationship between predicted disease states and the observed amount of improvement applying the remission and low disease activity (LDA) matrix tool presented by MSD as a poster at EULAR 20151 to our patients receiving golimumab (GLM). Methods We identified RA patients who had done GLM as first biological therapy in our hospital. Demographic and clinical data at baseline and at 6 months were collected. The calculation of remission or LDA rates at 6 months of GLM treatment was made based on the proposed prediction matrix tool. Patients were divided into 2 groups by their predicted remission rate at 6 months: lowest chance if <30% and greatest if ≥30%. Thereafter, we compared the amount of improvement in DAS28-4v, tender joint count (TJC), HAQ and Patient Global Assessment of Disease Activity Visual Analog Scale (PGA-VAS) scores observed in each group during 6 months of treatment with GLM. Results At our hospital, 239 patients with RA are under biological therapy. Of these, 20 had GLM as the first biological agent. Most patients were females (n=16, 80%) and mean age (SD) at start of biological therapy was 50 (11.8) years. Most were non-smoking (n=15, 78.9%). Only 2 patients had rheumatoid factor and anti–citrullinated protein antibodies negative and mean disease duration was 9.5 (5.6) years. The mean of DAS28 4v was 5.71 (1.16). At 6 months we found that only one patient had inactive disease, the remaining showed moderate (n=12) or high (n=4) disease activity; 6 patients did not have EULAR response. When we applied the matrix tool, we found that in these cases only three and one case had less than 20% predicted rate of remission and LDA, respectively. We observe that patients with lowest chance of remission had greater improvement in DAS28-4v, TJC, HAQ, and PGA-VAS scores than those with highest chance, during 6 months of treatment: 1.80 vs 0.54, 8.13 vs 0.27, 0.44 vs 0.26 and 19.63 vs 15.91, respectively (p<0.05 only for DAS28-4v and TJC). We found 9 cases (45%) of drug discontinuations at 6 months, 8 of which for primary failure and 1 for adverse event (at 1 month). Of the patients that remained under GLM at 6 months, 9 remained beyond 12 months of treatment, 4 of which have achieved remission. Conclusions The application of the remission and LDA matrix tool in our sample showed contradictory results with regard to the predictive ability of remission or LDA rate at 6 months. On the other hand, our results reinforce that EULAR response may be a more appropriate goal of treatment than LDA or remission in a subgroup of patients. References Vastesaeger N, et al. EULAR 2015 (SAT0360) Disclosure of Interest None declared

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