Luciana Assis Costa

Pacto pela saúde: aproximações e colisões na arena federativa

Resumo O artigo analisa o processo de construcao institucional do Pacto pela Saude consolidado em 2006, e que expressa uma evolucao incremental do arcabouco regulatorio das relacoes federativas no SUS. Ainda que considerando que tal processo se desenvolveu de forma privilegiada, numa arena federativa paritaria – a CIT –, assume-se a hipotese geral da literatura brasileira sobre federalismo que sugere um papel dominante da Uniao na formulacao das politicas sociais. Utilizando a abordagem institucionalista, com foco na relacao entre federalismo e politicas publicas, realizou- se um estudo qualitativo a partir de entrevistas com gestores e consultores que participaram do processo, e analise das atas de reunioes da CIT (2004-2012). Os resultados apontam: a Uniao foi detentora da iniciativa de formulacao, mas houve razoavel influencia dos governos subnacionais; o longo periodo de discussoes refletiu alto grau de dissenso entre os entes federados; na ausencia de consenso, a questao do financiamento foi transferida para um compromisso politico pela ampliacao das fontes de financiamento a ser assumido pelas tres esferas de governo; o Pacto nao modificou a dinâmica das relacoes federativas quanto a conformacao das redes regionais de atencao a saude.This article analyze the institutional construction process of the Health Pact, consolidated in 2006 and that expresses an incremental evolution of the regulatory framework of federative relationships in Brazilian National Health System. Even considering that such process has developed in a federative parity arena ( CIT) it is assumed the general hypothesis of Brazilian literature about federalism that suggests the Federal Government dominant role in the formulation of social policies. Using an institutionalist approach, focusing on the relationship between Federalism and Public Policy it was done a qualitative study starting from semi-structured interviews with managers and consultants who participated in the process and analyzing the minutes of meetings from CIT between 2004-2012. The results indicate: the federal government held the formulation initiative, but there was reasonable influence of sub national governments; the long discussions period reflected a high degree of dissent between the federated entities; as a result, the question of financing was transferred to a political commitment for expansion of funding sources to be assumed by the three spheres of government; the Health Pact did not change the dynamics federative relations regarding the frame of regional health care networks.

AB0581 Two years existence of reuma.pt/vasculitis – the portuguese registry of vasculitis

Background The vasculitides are a group of relatively rare diseases with different manifestations and outcomes. New therapeutic options have led to the need for long-term registries. The Rheumatic Diseases Portuguese Register, Reuma.pt, is an electronic clinical record, created in 2008, which currently includes specific protocols for 11 diseases and >16000 patients registered from 79 national and international rheumatology centres. Since October 2014, a dedicated protocol to vasculitis has been created as part of the European Vasculitis Society initiative of having compatible European registries. Objectives To describe the structure of Reuma.pt/Vasculitis and characterize the patients registered over the last two years. Methods We developed a dedicated web-based software to enable prospective collection and central storage of anonymised data from patients with vasculitis. All Portuguese rheumatology centres were invited to participate. Data regarding demographics, diagnosis, classification criteria, imaging and laboratory tests, outcome measures of prognosis, damage, disease activity and quality of life, and treatment were collected. We performed a cross-sectional descriptive analysis of all patients registered up to January 2017. Results A total of 492 patients, with 1114 visits, from 11 centres were registered in Reuma.pt/Vasculitis. The mean age was 53±20 years at last visit; 68% were females. The diagnoses followed the 2012 Chapel Hill Consensus nomenclature (Table 1). The most common diagnoses were Behçets disease (BD) (39%) and giant cell arteritis (GCA) (20%). Patients with BD met the International Study Group 1990 criteria, the International Criteria for BD 2006 and 2013 in 84%, 95% and 95% of cases, respectively. Patients with GCA met the 1990 American College of Rheumatology criteria in 95% of cases. Data on vascular ultrasound was available in 74% of patients; 73% compatible with the diagnosis. Assessment of the Birmingham Vasculitis Activity Score (BVAS) and Vasculitis Damage Index (VDI) was available for all vasculitides and the Five Factor Score calculation of survival rate for ANCA associated vasculitis (AAV) and polyarteritis nodosa (PAN). The mean BVAS at first visit was 18±7 for AAV and 15±9 for PAN; the mean VDI at last visit was 3±2 for AAV and 2±2 for PAN. Health related quality of life assessments (SF-36, EQD5, FACIT and HADS) were also collected. Treatment registry with the disease assessment variables shown in graphics was available for all patients; only 6% were under biologic treatment. Conclusions Reuma.pt/Vasculitis is a registry adapted for routine care, allowing an efficient data repository at a national level with the potential to link with other international databases. It facilitates research, trials recruitment, service planning and benchmarking. Disclosure of Interest None declared

The Youth Daily Life Before Fulfilling Socio-educational Measures of Deprivation of Liberty in Brazil: Ordinary Experiences That Are Tangent to the Inclusion in Drug Trafficking.

The aim of this paper is to demonstrate some understanding of the daily lives of young people facing socio-educational measures of incarceration, especially regarding the predisposing factors that may explain their involvement in criminal occupations and activities (Although the socio-educational measures applicable to adolescents configures as a response to committing of an offence, it has a mostly educational and not punitive character.). This is an exploratory study with a qualitative approach. The data collection instrument used was semi-structured interviews with 22 young men aged between 12 and 17 years, on condition of deprivation of freedom in four youth centres in Belo Horizonte, Minas Gerais, Brazil. The results showed that these adolescents had a way of life associated with a scarcity of resources owned by households (including little control over them, despite the efforts of their mothers); low adherence to school; limited institutional access to activities in their free time; exposure to predisposing factors to crime, such as early contact with crime through neighbourhood and family relationships; and profiting from crime. Copyright

AB0608 Greater Organ Involvement and Disease Activity in Childhood-Onset than Adult-Onset With SLE (DATA from Reuma.Pt/Les)

Background Systemic lupus erythematosus (SLE) is a multi-organ immune-mediated disease that affects predominantly women at reproductive age but may present itself at any age. Age at disease onset has a strong modulating effect on clinical presentation and course of disease. Although young patients may have a more aggressive disease, controversies persist regarding the impact of age at disease onset on SLE outcome. Objectives Characterize childhood-onset, adult-onset and late-onset SLE and assess whether disease outcome differs in these three patient groups. Methods Patients with childhood-onset (diagnosis ≤18 years) SLE fulfilling ACR 1997 criteria were identified in the Portuguese registry Reuma.pt/SLE and compared with adult-onset (≥19y and ≤49 years) and late-onset (≥50 years) SLE patients paired for disease duration. Results Two hundred and sixty seven SLE patients with mean disease duration of 11.9±9.3 years were analyzed (Table 1). The number of fulfilled ACR criteria was significantly higher in childhood-onset SLE. A greater proportion of women, higher prevalence of arthritis and anti-SSA antibodies were noted in the adult-onset group. Hypertension, diabetes and thyroid disease were significantly more prevalent in late-onset SLE. Disease activity at last visit evaluated using the SLEDAI-2K was significantly higher in childhood-onset group than in the late-onset counterparts. SLICC/ACR damage index was numerically higher in late-onset SLE and significantly more patients in this group had irreversible damage. Cyclophosphamide and mycophenolate mophetil were used more frequently in childhood-onset SLE patients.Table 1. Demographic and clinical characteristics of childhood-onset, adult-onset and late-onset SLE Childhood-onset Adult-onset Late-onset P N=89 N=89 N=89 Female n (%) 77 (87) 85 (96) 78 (88) 0.039 Current mean age (years) 25.1±9.1 40.0±13.1 68.3±7.3 <0.001 Number of ACR criteria fulfilled 5.8±1.3 5.3±1.3 5.2±1.1 0.005  Malar rash (%) 55 (62) 32 (36) 33 (37) <0.001  Arthritis (%) 62 (70) 79 (89) 71 (80) 0.005  Renal involvement (%) 52 (58) 28 (31) 14 (16) <0.001  Neurologic disorder (%) 10 (11) 5 (6) 2 (2) 0.039  Hematologic disorder (%) 68 (76) 53 (62) 67 (75) 0.029 Anti-SSA positivity (%) 13 (15) 30 (34) 19 (21) 0.006 Low complement (%) 74 (83) 60 (67) 46 (52) <0.001 SLEDAI-2K at last visit 3.4±3.8 2.2±2.7 1.6±2.8 0.004 SLICC-DI 0.5±0.9 0.7±1.3 0.9±1.3 0.116 SLICC-DI ≥1 (%) 18 (20) 23 (26) 36 (40) <0.001 Hypertension (%) 17 (19) 16 (18) 43 (48) <0.001 Diabetes (%) 0 (0) 7 (8) 15 (17) 0.008 Thyroid disease (%) 3 (3) 13 (26) 20 (23) 0.004 Conclusions The skin, kidney and neurological involvement are most common in childhood-onset, as well as the use of immunosuppressants, supporting the concept of a more severe disease. In contrast, patients with late-onset SLE have more comorbidities and irreversible damage. The age of SLE onset has a significant impact not only on the clinical characteristics and disease activity, but is also important for disease outcome. Disclosure of Interest None declared

OP0031 Tocilizumab is Associated with Higher CDai/Sdai Remission in Biologic-Naïve Rheumatoid Arthritis Patients – Data from Reuma.Pt

Background Tocilizumab (TCZ), an interleukin-6 receptor blocker, and anti-tumor necrosis factor (TNF) biologic agents are key therapies in the management of rheumatoid arthritis (RA). They are considered to be equally effective and very few head-to-head comparisons have been published. Objectives To compare remission rates in RA patients treated with anti-TNF agents and TCZ and assess the impact of previous biologic therapies in treatment response. Methods We included RA patients registered in the Rheumatic Diseases Portuguese Register, Reuma.pt, who started anti-TNF or TCZ after January 1, 2008, were treated for at least 6 months and had available DAS28 scores at baseline and at 6 months. Our primary outcome was the proportion of patients who achieved remission at 6 months by DAS28, CDAI, SDAI and Boolean remission criteria. Logistic regressions were performed to compare the groups and subgroup analyses of biologic-naïve patients were conducted. Results 524 RA patients were enrolled, (106 adalimumab, 202 etanercept, 43 golimumab, 78 infliximab, 95 TCZ). At baseline, the groups were similar except for proportion of biologic-naïve patients (lower in TCZ group, p<0.0001) and mean DAS28, CDAI and swollen joint count, all higher in the TCZ group (respectively: p=0.0005, p=0.037 and p<0.0001). At 6 months, more TCZ-treated patients were in DAS28 remission, with no differences for CDAI, SDAI or Boolean remission. Considering only naïve patients, DAS28, CDAI and SDAI remission were significantly higher in the TCZ group compared to anti-TNF, with similar rates of Boolean remission. This was confirmed in the multivariate logistic regression, adjusting for age, gender, number of previous biologics and baseline disease activity: DAS28 OR 10.8 (5.9-19.7), CDAI OR 2.9 (1.3-6.5), SDAI OR 4.1 (1.8-9.5), Boolean OR 1.9 (0.88-4.3). Table 1. Proportion of patients in remission according to different criteria and biologic class Anti-TNF Tocilizumab OR (95% CI) Overall Population  DAS28 (n=524) 102/429 (23.8) 55/95 (57.9) 4.4 (2.8–7.0)  CDAI (n=327) 36/260 (13.9) 14/67 (20.9) 1.6 (0.8–3.2)  SDAI (n=298) 33/239 (13.8) 14/59 (23.7) 1.9 (0.97–3.9)  Boolean (n=468) 42/358 (11.7) 11/83 (13.3) 1.1 (0.6–2.3) Biologic-naïve patients  DAS28 (n=417) 89/365 (24.4) 37/52 (71.2) 7.7 (4.0–14.5)  CDAI (n=258) 33/223 (14.8) 11/35 (31.4) 2.6 (1.2–5.8)  SDAI (n=237) 32/206 (15.5) 11/31 (35.5) 2.99 (1.33–6.76)  Boolean (n=348) 36/302 (11.9) 8/46 (17.4) 1.6 (0.7–3.5) Conclusions TCZ treatment was associated with higher rate of DAS28 remission at 6 months and previous biologic therapy significantly affected CDAI/SDAI remission. Naïve patients treated with TCZ had better DAS28, CDAI and SDAI remission rates compared to those treated with TNF inhibitors, whereas the more stringent Boolean remission was similar among all groups. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.2668

AB0451 Changes in DAS28, CDAI and SDAI are Associated with Biologic Class, Gender, Previous Biologic Therapy and ACPA/RF Status – Results from Reuma.PT

Background Tocilizumab (TCZ) and anti-tumor necrosis factor (TNF) biologic agents are key therapies in the management of rheumatoid arthritis (RA). They are considered to be equally effective and very few head-to-head comparisons have been published. Objectives To compare response to therapy in RA patients treated with anti-TNF agents and TCZ according to different response measures and determine the factors influencing it. Methods We included RA patients registered in the Rheumatic Diseases Portuguese Register, Reuma.pt, who started anti-TNF or TCZ after January 1, 2008, were treated for at least 6 months and had available DAS28 scores at baseline and at 6 months. Our primary outcome was the change in DAS28, CDAI and SDAI at 6 months. We performed linear regressions to compare the groups and determined the best model predicting change in disease activity for each index. Results 524 RA patients were enrolled, (106 adalimumab, 202 etanercept, 43 golimumab, 78 infliximab, 95 TCZ). At baseline, TCZ users were less frequently naïve to biologic therapies (54.7% vs. 85%, p<0.0001), had more swollen and tender joint counts (p<0.0001 and p=0.02, respectively) and higher disease activity according to all indexes: DAS28 6.1±1.1 vs. 5.4±1.3 (n=524, p<0.0001), CDAI 33.3±13.2 vs. 28.1±13.6 (n=376, p=0.005), SDAI.35.6±13.1 vs. 29.1±30.4 (n=361, p=0.004). At 6 months, change in DAS28, CDAI, SDAI and joint counts was significantly higher in the TCZ group (Table 1). Multivariate linear regression models best predicting change in disease activity included biologic class, number of previous biologics, baseline activity, gender and ACPA/RF status (Table 2). Compared to anti-TNF, TCZ was associated with a larger difference in ΔDAS28, ΔCDAI and ΔSDAI of, respectively, 1.45, 4.25 and 5.41. Table 1. Baseline and change in disease activity according to biologic class (Mann-Whitney test) Change at 6 months Anti-TNF (n=429) Tocilizumab (n=95) p-value ΔDAS28 1.8 (1.4) 3.3 (1.6) <0.0001 ΔCDAI (n=327) 16.0 (13.6) 22.7 (15.7) 0.0003 ΔSDAI (n=298) 17.1 (14.8) 25.2 (16.5) 0.0001 ΔSJC 4.7 (4.8) 7.8 (6.6) <0.0001 ΔTJC 6.4 (7.2) 8.7 (7.7) 0.005 Table 2. Multivariate linear regression models predicting 6-months change in disease activity ΔDAS28 (n=524) ΔCDAI (n=286) ΔSDAI (n=260) Adjusted-R2 0.391 0.613 0.559 Covariables β-coefficient (p) β-coefficient (p) β-coefficient (p) Biologic class (TCZ) 1.45 (<0.0001) 4.25 (0.004) 5.41 (0.003) No. previous biologics −0.41 (<0.0001) −2.47 (0.002) −2.78 (0.004) Baseline activity 0.54 (<0.0001) 0.79 (<0.0001) 0.77 (<0.0001) Female gender −0.40 (0.02) −1.74 (0.29) −1.64 (0.41) ACPA/RF positivity −0.45 (0.004) −3.65 (0.01) −4.77 (0.008) Conclusions TCZ treatment was associated with greater change in DAS28, CDAI, SDAI and joint counts at 6 months. Biologic class, number of previous biologics, baseline activity, gender and ACPA/RF status predicted change in disease activity. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.3414

FRI0428 The Weaker Sex: Characterization of Gender Disparities in A Nationwide Lupus Registry (REUMA.PT LES): Table 1.

Background Systemic lupus erythematosus (SLE) is characterized by female predominance with male to female ratio around 1:10. Differences regarding clinical manifestations, disease activity, damage and mortality between men and women with SLE have been reported. Overall it is recognized that gender may affect SLE phenotype, but results concerning disease severity and prognosis are still a matter of debate. Objectives Characterization of Portuguese SLE male patients, focusing demographic, clinical, and laboratorial features. Methods All SLE patients from the Portuguese Lupus Register, Reuma.pt/LES were included. Demographic, clinical and therapeutic data were analyzed upon records from the last visit. Student t-tests, chi-square tests and Fishers exact tests were used to compare male and female patients. Analyses were further adjusted to age and disease duration. Results Of the 1510 SLE patients registered in Reuma.pt/LES, 122 (8%) are men. Male patients had later onset (39.4±20.6y vs 35.6±14.1y; p=0.005) and shorter disease duration (10.7±7.6y vs 14.1±9.0 y; p=0.0001). Mean current age, racial distribution and education level was similar in the two groups. Serositis, renal involvement and hemolytic anemia were more prevalent in men while, photosensitivity, alopecia, oral ulcers and arthritis were more commonly found in women (Table 1). Thyroid disease was more frequent in women (11.4 vs 2.3%). Cardiovascular risk factors had a similar distribution between these groups. Accumulated damage assessed by the SLICC damage index (SDI) and disease activity, assessed by SLEDAI-2K at last visit were similar in the two groups, with adjustment to age and disease duration. Antimalarial drugs and steroids were used more frequently in women. Table 1. Characteristics of SLE in male and female patients Men (n=122) Women (n=1389) P Photosensitivity 36 (32.4) 620 (49.9) <0.001* Alopecia 7 (6.7) 310 (26.8) <0.001* Oral ulcers 20 (17.7) 395 (31.9) 0.008* Arthritis 65 (57.0) 906 (72.5) <0.001* Serositis 36 (32.1) 236 (18.9) 0.001* Renal Involvement 49 (44.1) 344 (28.1) <0.001* Neurologic disorder 6 (5.4) 59 (4.8) 0.448 Hemolytic anemia 18 (16.4) 122 (9.8) 0.031* Anti-dsDNA positivity 96 (84.96) 929 (74.7) 0.020 Anti-SSA positivity 15 (27.8) 688 (39.1) 0.064 SLEDAI-2K 2.3±3.0 2.6±3.1 0.650 SLICC 0.82±1.3 0.71±1.22 0.126 * Statistically significant differences, adjusted to age and disease duration. Conclusions Male patients with SLE are older at disease onset and present a distinct phenotype with less cutaneous, mucous membranes and articular manifestations. However, disease outcome evaluated by the SDI is comparable in men and women, which is in line with observations from other European cohorts. The acknowledgement of the effect of gender on disease manifestations may help physicians in the timely introduction of an appropriate care. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.4615