Psoriatic disease (Psoriasis and Psoriatic Arthritis, PsD) is a condition that affects the skin, the musculoskeletal system, and beyond, impairing patients' quality of life. A multidisciplinary approach of combined dermatology-rheumatology clinics is recommended and valuable to respond to PsD diagnosis, management, and treatment challenges. In Portugal, five Hospitals have implemented a multidisciplinary clinic for PsD assessment. This report aims to describe how these multidisciplinary clinics were developed, their characteristics, and the main obstacles to their implementation. Although the different hospitals adopted distinct functional models, a consensus respecting the minimal core set assessment for PsD in Multidisciplinary Dermatology/Rheumatology Clinics should comprise all disease manifestations and, if possible, quality of life. The main objective of these clinics is to achieve remission/minimal disease activity. Limitations to these multidisciplinary approaches are discussed, namely financial, time management, and human resources obstacles that can be a handicap in their implementation, despite the benefits of PsD integrated care.
The Portuguese Rheumatology Society (SPR) embraced quality as a major goal and launched, in early 2015, a program to aim for excellence in global clinical care: Rheuma SPACE - Standard Practice Aiming Clinical Excellence. Evaluating daily reality is the first step in a quality development timeline, ultimately contributing for health gains. Herein we describe the results of the evaluation of the quality indicators defined for this project and the improvement strategies identified. The Rheuma SPACE project included three phases: 1) establishing a set of quality indicators and an excellence quality model; 2) assessment of the current care at Rheumatology departments concerning the defined quality indicators in the scope of the excellence model; and 3) elaboration of global and customized reports for each participating Rheumatology department, resulting in the identification of improvement opportunities. Ten Rheumatology departments, countrywide, including larger and smaller institutions, were asked to participate in Rheuma SPACE. This resulted in an individual report for each department along with global benchmarking practices analysis. Furthermore, a list of improvement initiatives was developed. We concluded that departments lack physicians and need exclusively dedicated nurses. Time dedicated to research and audit activities should be specifically allocated. Internal contracting is well established, and professionals are committed to targets. Processes are still suboptimal, needing standardization of triage criteria, more frequent follow-up, as well as better medical records and multidisciplinary coverage. Regarding outcomes, patients are satisfied with the provided care and professionals with the working environment. However, department facilities for the former, and career related aspects, for the latter should improve. With this innovative study conducted in Portugal we expect to have enlightened tailored opportunities for improvement, ensure patient-focused practices and be able to define the indispensable quality requirements for excellence.
To describe the baseline characteristics of psoriatic arthritis (PsA) patients who initiated secukinumab in Portugal. This registry-based analysis included all Portuguese patients diagnosed with PsA, aged ≥ 18 years, registered in the rheumatic diseases Portuguese registry - Reuma.pt (Jan 2018-May 2020). We collected and analyzed patients' characteristics at baseline including demographic variables, disease scores and previous treatments We identified a total of 111 PsA patients treated with secukinumab. In 36.9%, secukinumab was the first biologic (naïve) and 63.1% was non-naïve (24.3% had one previous biologic and 38.7% had two or more). Overall, 41.4% of patients were male and mean age was 50.9(SD:12.3) years, but naïve patients were younger [naïve 47.5(13.8) years, non-naïve 52.8(11.0) years; p=0.039]. Mean age at diagnosis was 43.7(11.9) and mean delay to diagnosis was 3.6 years, with no differences between the two groups. Among non-naïve, etanercept was the most used first biologic (47.1%). The higher dosage of secukinumab (300mg) was given in 73.9% of PsA patients. The mean disease activity measured by the Disease Activity in PsA (DAPSA) was 27.7(14.2), while the patient's assessment of PsA (100 mm visual analogue scale) was 64.0(23.3). None of these scores was statistically different between naïve versus non-naïve patients. The function, measured by the Health Assessment Questionnaire, was 1.3(0.7). The quality of life measured by EQ-5D was 0.37(0.22), which is less than half the average score of the Portuguese Population (0.76). Our results provide insightful information about PsA patients initiating secukinumab in a real-life setting, showing some differences in baseline characteristics comparing to pivotal trials, namely fewer naive patients, but similar levels of function and disease activity. Quality of life is highly impaired, highlighting the importance of providing patients with an effective treatment.
Background: Quality of care is a key component of the right to health, and the route to equity and dignity. The aim of the project Rheuma SPACE - Standard Practice Aiming Clinical Excellence was to develop a set of quality indicators focused in rheumatoid arthritis care and apply them to rheumatology departments of the Portuguese National Health Service in order to benchmark the care for these patients. This article details the methodology that was applied. Methodology: This was a single country, three-phase project, each phase comprising multiple steps. The first step defined quality indicators and the excellence quality model to be used. It involved a literature search for international benchmarking of quality of care initiatives and indicators, followed by a pre-selection of an initial set of indicators. The set of indicators was latter on narrowed after an online Delphi round with all Portuguese rheumatologists and two consensus meetings involving the study task force. A set of 26 quality indicators was defined, within the three classic Donabedian dimensions of healthcare quality: Structure (9), Processes (11), and Outcomes (6). These indicators cover eleven domains of quality of care: personnel and organizational structure, training and research, facilities, equipment and information technology, budgeting and financial resources, access to care, clinical records, patient communication, multidisciplinary management, clinical outcomes, and patient and personnel satisfaction. Decision on quality and excellence thresholds for each of the 26 quality indicators was agreed upon a consensus meeting gathering principal investigators of the eight Rheumatology Departments that decided to participate, task force core set members and invited representatives of all Portuguese Departments/Units. Rheumatoid arthritis was the chosen disease model of the project based on the reliability of the outcomes to be measured in the context of this condition. The second step was the assessment of the participating Rheumatology Departments. During eighteen months, research teams applied the 26 quality indicators to their own Departments. The third step comprised data analysis and the elaboration of individual Rheumatology Department reports and of a global public report. Results: Eight Departments, comprising 80 specialists, 20 residents and 30 nurses, covering 5.904.080 inhabitants, underwent quality evaluation. More than one thousand patients (1.325) and 113 health professionals' surveys were analysed, as well as data from 570 clinical records and 3.927 medical appointments on rheumatoid arthritis patients. Discussion: 26 quality indicators were used for the first evaluation of Portuguese Rheumatology Departments, turning Rheuma SPACE into a pioneer project. Data analysis and benchmarking will be the subject of a further publication.
Background Tumour necrosis factor inhibitors (TNFi) lead to a dramatic improvement in the management of psoriatic arthritis (PsA). Nevertheless, a significant proportion of patients still do not respond and/or are intolerant to TNFis, requiring treatment switch for an adequate control of disease activity. Objectives To assess TNFis drug retention and the main reasons for TNFi discontinuation in PsA patients. Methods This was a non-interventional study of PsA patients registered at the Rheumatic Diseases Portuguese Registry (Reuma.pt), with at least one TNFi prescription. Drug retention for a first, second and third line TNFi was assessed by Kaplan-Meier survival analysis. The reasons for discontinuation were described as frequencies. Results 750 PsA patients were included, with a mean age of 47.6 years (±11.6); 50.3% (n=377) female. 200 patients (26.7%) treated with adalimumab, 335 (44.7%) with etanercept, 114 (12.2%) with golimumab and 101 (13.5%) with infliximab, as first line TNFi. The majority (67.6%) were receiving concomitantly conventional synthetic disease modifying anti-rheumatic drugs (62.3% MTX) and 33.9% corticosteroids. The mean duration of TNFi retention was of 48.5±40.1 months, when treated with a 1st TNFi, decreasing to 35.5±33 months for the 2nd TNFi, and to 22.7±22.9 months for the 3rd TNFi (figure 1). After being treated with a 1st TNFi, the majority of discontinuers (35,8% of the total population), withdraw due to lack or loss of effectiveness (53.5%) and due to adverse events (24.4%). The rates of discontinuation for the 2nd and 3rd TNFi were of 39% and 54%, respectively. Lack or loss of effectiveness and adverse events were maintained the two main reasons of withdrawal for the 2nd (62.3%; 21.6%) and 3rd TNFi (63%; 22.2%). Conclusions PsA patients registered at Reuma.pt treated with a 1st TNFi had an overall drug retention of 49 months. We observed a decrease in the average retention of TNFi therapy of 13.0 months in PsA patients who switched to a 2nd TNFi or a 3rd TNFi. Lack or loss of response were the main reason for TNFi discontinuation, independently of TNFi position, responsible for more than half of the discontinuations. The observed short survival of TNFis in PsA, and the inability to regain drug expectancy when switching to another TNFi, highlights the limitations from recycling between TNFi when aiming at long-term disease remission. Acknowledgements Financial support for statistics and report writing was provided by Novartis, Produtos Farmacêuticos S.A. Disclosure of Interest None declared
Background Pharmacological treatment for systemic lupus erythematosus (SLE) is aimed at reducing disease activity, preventing flares and minimising the damage. The use of medication varies widely and therapeutic strategies are well defined only for certain organ manifestations. Hydroxychloroquine is the standard treatment for most SLE patients during the entire disease course, while immunosuppressants are recommended for those with severe organ involvement. Belimumab is the only biological currently licensed for SLE, although others are used off-label in clinical practice. Objectives To describe the real-world patterns of drug use in SLE patients, and their relationship with disease phenotype. Methods Observational study of adult SLE patients registered in the Rheumatic Diseases Portuguese Registry, who have clinical diagnosis of SLE, followed for at least 1 year and with available data on medication, which was retrieved. Sociodemographic and clinical characteristics were compared among treatment groups defined as: group 1 antimalarials and/or glucocorticoids; group 2 immunosuppressants (azathioprine (AZA)/mycophenolate mofetil (MM)/methotrexate (MTX))±antimalarials and/or glucocorticoids; group 3 biologics±immunosuppressants and/or antimalarials and/or glucocorticoids. To assess possible differences between the groups, univariate regression analyses were made. In all analyses significance level was set at 0.05. Results A total of 824 SLE patients were included, mean age of 47.3±14.4 years, 92.3% female. The mean age at first symptoms was 31.6±14.1 and at SLE diagnosis of 34.1±14.3 years. On their last assessment, 678 (82.3%) were being treated with antimalarials, 463 (56.2%) glucocorticoids, 343 (41.6%) immunosuppressants (149 AZA, 99 MM, 67 MTX, 14 cyclosporine, 11 cyclophosphamide, 3 leflunomide), 53 (6.4%) biologics (32 rituximab, 21 belimumab) and 26 (3.2%) were off medication. The sociodemographic and clinical characteristics according to treatment groups are shown in table 1. Gender distribution was similar across groups. A high prevalence of women, Caucasians, non-smokers, acute cutaneous lupus and arthritis was found in all groups. Patients in group 1 had lower disease activity measured by SLEDAI, less organ damage measured by SLICC and lower physician’s global assessment. In group 2 patients were younger and had higher prevalence of renal involvement. Patients in group 3 had higher SLEDAI score and damage, higher prevalence of mucocutaneous, articular, neurologic and hematologic involvement and more use of glucocorticoids. Conclusions Almost all SLE patient with established disease were chronically medicated, most with antimalarials and/or glucocorticoids. As expected, group 1 had less severe disease. Patients under immunosuppressants had a higher frequency of renal involvement, which denotes a targeted therapeutic strategy. In routine clinical settings biologics are rarely used, being restricted to patients with very active SLE and multiple clinical manifestations. Disclosure of Interest None declared
We present the clinical case of a 38 year old woman diagnosed with rheumatoid arthritis at the age of 32. She went into remission of her disease during treatment with subcutaneous methotrexate (25 mg/week) for 2 years. She decided to become pregnant and stoped treatment. RA relapses 4 months later and she has no response to classic DMARD9s (sulphassalazine and hydroxychloroquine) and starts etanercept (50mg/week). She gets pregnant and achieves remission at week 16 of her pregnancy. At week 36 she is still in remission and stops etanercept. 2 months after giving birth the disease relapses but she wants to breastfeed and would like to restart etanercept. We agreed and 3 months after restarting anti-TNF RA is again in remission. In January 2017 her RA is inremission for 15 months and keeps her medication with etanercept every other week because she plans another pregnancy.Disclosure of InterestNone declared
Tumor necrosis factor inhibitors (TNFi) dramaticaly improved the management of psoriatic arthritis (PsA). Nevertheless, a significant proportion of patients do not respond and/or are intolerant to TNFis. The objective of this work was to assess the effectiveness, measured by response rates and drug survival, and the main reasons for TNFi discontinuation, in PsA patients. This was a retrospective non-interventional study of PsA patients registered at the Rheumatic Diseases Portuguese Registry, with at least 1 TNFi prescription. Data was analyzed at 0, 3, 6, 12, 24, 36 and 48 months after starting a first TNFi. Response was measured by composite disease activity (DAS, ACR, PsARC, BASDAI, ASDAS, MDA) and functional (HAQ) indices. Drug survival was assessed by Kaplan-Meier survival analysis. In all analyses significance level was set at 0.05. 705 PsA patients were included, with a mean age of 52.5 years (±13.3); 50.8% (n=358) female. 185 patients (26.24%) treated with adalimumab, 322 (45.67%) etanercept, 100 (14.18%) golimumab and 98 (13.90%) with infliximab. The average response rates, measured by composite disease activity and functional indices, are shown in Table 1. The average drug persistence was of 31.79±17.03 months for TNFi as a group, with 205 (29.08%) of discontinuations during a period of 4 years of follow-up. The main reasons for discontinuation of the first TNFi were: non-response/loss of response 111 (54.15%), adverse event 48 (23.41%), surgery 6 (2.93%), refusal to continue treatment, 4 (1.95%), loss to follow-up 3 (1.46%), pregnancy 4 (1.95%), death 2 (0.98%), remission 2 (0.98%), and others 10 (4.88%). PsA patients receiving a first TNFi will persist on treatment for an average of 2.6 years with treatment discontinuations rates of 29.08%. Non-response/loss of response constitutes the major reason for treatment discontinuation in this population.
Psoriatic arthritis (PsA) is a chronic inflammatory rheumatic disease with a broad clinical spectrum. PsA can affect the axial skeleton, peripheral joints, entheses, synovial sheaths of tendons, skin, nails and extra-articular organs. Tumour necrosis factor alpha blockers (TNF blockers) were a breakthrough development in the treatment of PsA. Identifying predictors of response to biological therapies in patients with PsA is of utmost importance, especially in view of the costs and potential side effects of these agents. The aims of the present study were to determine baseline predictive factors of response to biological therapies, at 3 and 6 months, in PsA patients with polyarticular involvement (with or without axial involvement). Data were collected from the Rheumatic Diseases Portuguese Register (Reuma.pt). Eligible patients had to be anti-TNF-naive at baseline and to have at least 3 months of follow-up after the beginning of TNF blocker therapy. Only patients with information on at least one of the response measures (at 3 or 6 months of follow-up) were included in the analysis. Univariable logistic regression analysis of potential baseline predictors of European League Against Rheumatism (EULAR) good clinical response, EULAR good/moderate response, 28-joint Disease Activity Score with three variables including the erythrocyte sedimentation rate (DAS28-3V-ESR) remission and Health Assessment Questionnaire (HAQ) response were performed. Multivariable logistic regression using a forward selection procedure was used until the best-fit model was obtained, taking confounding effects into account. A total of 180 patients were eligible for the study (mean age 52 years, 54% women). In multivariable analysis at 3 months, females were less likely to attain a good EULAR response [OR=0.082 (95% CI=0.024, 0.278)], a DAS28-3V-ESR remission [OR=0.083 (95% CI=0.017, 0.416)], a moderate or good EULAR response [OR=0.091 (95% CI=0.011, 0.091)] and a HAQ response [OR=0.074 (95% CI=0.009, 0.608)]. At 6 months, female gender was also less likely to achieve a good EULAR response [OR=0.060 (95% CI=0.011, 0.325)], DAS28-3V-ESR remission [OR=0.060 (95% CI=0.012, 0.297)], and a HAQ response [OR=0.138 (95% CI= 0.029, 0.654)]. In this study we found that gender was the most consistent predictor of response to TNF blocker therapy in patients with polyarticular PsA, with females having a lower probability of response compared to males. These findings suggest that gender-related biochemical, hormonal and psychological factors could play an important role in the response to TNF blocker therapy in PsA.
Systemic lupus erythematosus (SLE) affects predominantly women at reproductive age but may present at any age. Age at disease onset has a modulating effect on presentation and course of disease, but controversies persist regarding its impact on long-term outcome. Our aims were to characterize clinical features, co-morbidities and cumulative damage in childhood-onset, adult-onset and late-onset SLE. Patients with childhood-onset SLE fulfilling ACR 1997 criteria were identified in a nationwide register-Reuma.pt/SLE (N = 89) and compared with adult-onset and late-onset counterparts matched 1:1:1 for disease duration. 267 SLE patients with mean disease duration of 11.9 ± 9.3 years were analyzed. Skin (62 %), kidney (58 %), neurological (11 %) and hematologic involvement (76 %) were significantly more common in childhood-onset SLE and disease activity was higher in this subset than in adult- and late-onset disease (SLEDAI-2K 3.4 ± 3.8 vs. 2.2 ± 2.7 vs. 1.6 ± 2.8, respectively; p = 0.004). Also, more childhood-onset patients received cyclophosphamide (10 %) and mycophenolate mofetil (34 %). A greater proportion of women (96 %), prevalence of arthritis (89 %) and anti-SSA antibodies (34 %) were noted in the adult-onset group. There was a significant delay in the diagnosis of SLE in older ages. Co-morbidities such as hypertension, diabetes and thyroid disease were significantly more frequent in late-onset SLE, as well as the presence of irreversible damage evaluated by the SLICC/ACR damage index (20 vs. 26 vs. 40 %; p < 0.001). Greater organ involvement as well as the frequent need for immunosuppressants supports the concept of childhood-onset being a more severe disease. In contrast, disease onset is more indolent but co-morbidity burden and irreversible damage are greater in late-onset SLE, which may have implications for patients' management.
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. 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
Background Approximately one-third of patients with ankylosing spondylitis (AS) treated with tumor necrosis factor inhibitors (TNFi) need to switch their biological therapy. However, a significant clinical response only occurs in half of switcher patients. Objectives To determine predictive factors of treatment response at 12 weeks in AS patients switching treatment to a second TNFi. Methods Patients with AS (1984 modified New York classification criteria) switching treatment to a second TNFi were identified in the Rheumatic Diseases Portuguese Register, Reuma.pt. Data was extracted at baseline (at second TNFi start) and at 12 weeks of follow-up. Variables included in the analysis were age, race, gender, BMI, education level, work status, tobacco and alcohol consumption, disease duration, time to diagnosis, peripheral arthritis, extra-articular manifestations, ESR, CRP, HLA-B27 positivity, previous DMARD and steroid therapy, BASDAI, ASDAS, BASFI, BASMI, first TNFi used, reason and time to switch. Univariable logistic regression analysis of baseline predictors of BASDAI response (improvement ≥2 units or ≥50%) was performed and variables with a p-value<0.25 were re-tested in multivariable regression models. Results Of the 334 AS patients treated with biologicals, 85 (25.4%) switched to a second TNFi. Reasons for switch included treatment failure (16; 18.8%), adverse events (25; 29.4%) and other reasons (44; 51.8%) like refractory extra-articular manifestations, surgery or patient preferences. Patients were included in the analysis if they stayed in therapy at least for 3 months and have BASDAI at baseline and at 3 months available. Forty-nine patients were analyzed, 22 responders (44.9%) and 27 non-responders (55.1%). BASDAI clinical response at 12 weeks was predicted by BASMI (p=0.04; OR 3.8 [95% CI 1.0, 14.1]) adjusting for gender, erythrocyte sedimentation rate and age at biological treatment onset. No other statistical significant demographical, clinical or laboratorial predictors were found. Conclusions We found 44.9% switchers who responded to the second TNFi. An increased BASMI score was an independent predictor of BASDAI clinical response to a second TNFi in AS patients. The inclusion of a greater number of patients in future studies may allow the determination of further predictive factors. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.5590