RESUMEN
In pharmacoepidemiology, robust data are needed to judge the impact of drug treatment on pregnancy, pregnancy outcomes and breast-fed infants. As pregnant and breastfeeding women are usually excluded from randomised clinical trials, observational studies are required. One of those data sources are pregnancy registers specifically developed to focus on certain diseases or disease groups. The German Rhekiss register investigates pregnancies in women with chronic inflammatory rheumatic diseases (IRD). Rhekiss is a nationwide, multicentre, longitudinal study, in which women aged 18 years or older with an underlying IRD can be enrolled by a rheumatologist either when planning a pregnancy or in the first half of pregnancy. Data are collected prospectively at regular follow-up visits. Rheumatologists and patients provide information in a web-based system before conception (if enrolment was at the time of pregnancy planning), during and after pregnancy. A smartphone app is available for patients. Maternal and clinical information, general laboratory markers, treatment with antirheumatic and other drugs, adverse events, items related to course and outcome of pregnancy and the health of the child are uniformly assessed for all diseases. Individual information on the IRD includes classification criteria, diagnosis-specific laboratory parameters, clinical parameters and validated instruments to measure disease activity or damage. Furthermore, patient-reported outcome measures are captured. A total of 2013 individual patients have been enrolled in the register, and data on 1801 completed pregnancies are available. In summary, Rhekiss is a comprehensive and complex register that can answer various research questions about pregnancy in women with chronic IRDs.
Asunto(s)
Antirreumáticos , Complicaciones del Embarazo , Resultado del Embarazo , Sistema de Registros , Enfermedades Reumáticas , Humanos , Embarazo , Femenino , Enfermedades Reumáticas/tratamiento farmacológico , Enfermedades Reumáticas/epidemiología , Alemania/epidemiología , Complicaciones del Embarazo/epidemiología , Complicaciones del Embarazo/tratamiento farmacológico , Resultado del Embarazo/epidemiología , Antirreumáticos/uso terapéutico , Antirreumáticos/efectos adversos , Estudios Longitudinales , Adulto , Farmacoepidemiología/métodos , Adolescente , Adulto JovenRESUMEN
OBJECTIVES: To investigate the impact of disease activity and treatment with disease-modifying antirheumatic drugs (DMARDs) on all-cause mortality in patients with rheumatoid arthritis and prevalent interstitial lung disease (RA-ILD). METHODS: Patients with RA-ILD were selected from the biologics register Rheumatoid Arthritis: Observation of Biologic Therapy (RABBIT). Using time-varying Cox regression, the association between clinical measures and mortality was investigated. The impact of DMARDs was analysed by (1) Cox regression considering cumulative exposure (ie, treatment months divided by total months) and (2) time-varying Cox regression as main approach (treatment exposures at monthly level). RESULTS: Out of 15 566 participants, 381 were identified as RA-ILD cases with 1258 person-years of observation and 2.6 years median length of follow-up. Ninety-seven patients (25.5%) died and 34 (35.1%) of these were not receiving DMARD therapy at the time of death. Higher inflammatory biomarkers but not swollen and tender joint count were significantly associated with mortality. Compared with tumour necrosis factor inhibitors (TNFi), non-TNFi biologic DMARDs (bDMARDs) exhibited adjusted HRs (aHRs) for mortality below 1, lacking statistical significance. This finding was stable in various sensitivity analyses. Joint aHR for non-TNFi biologics and JAKi versus TNFi was 0.56 (95% CI 0.33 to 0.97). Receiving no DMARD treatment was associated with a twofold higher mortality risk compared with receiving any DMARD treatment, aHR 2.03 (95% CI 1.23 to 3.35). CONCLUSIONS: Inflammatory biomarkers and absence of DMARD treatment were associated with increased risk of mortality in patients with RA-ILD. Non-TNFi bDMARDs may confer enhanced therapeutic benefits in patients with RA-ILD.
Asunto(s)
Antirreumáticos , Artritis Reumatoide , Productos Biológicos , Enfermedades Pulmonares Intersticiales , Humanos , Antirreumáticos/efectos adversos , Estudios de Cohortes , Factor de Necrosis Tumoral alfa , Artritis Reumatoide/complicaciones , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/inducido químicamente , Enfermedades Pulmonares Intersticiales/complicaciones , Enfermedades Pulmonares Intersticiales/tratamiento farmacológico , Inflamación/tratamiento farmacológico , Factores Biológicos/uso terapéutico , Productos Biológicos/uso terapéutico , BiomarcadoresRESUMEN
OBJECTIVE: The Assessment of Spondyloarthritis international Society Health Index (ASAS HI) measures global functioning and health in patients with axial spondyloarthritis (axSpA) covering domains of physical, emotional, and social functioning. The main aim of this study was to investigate the sensitivity to change of ASAS HI in comparison with established variables of disease activity, function, and mental health. METHODS: Patients with axSpA from the disease register RABBIT-SpA with follow-up time of at least 12 months and available ASAS HI questionnaires were included. Patients received questionnaires addressing disease activity (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], Ankylosing Spondylitis Disease Activity Score [ASDAS]), physical function (Bath Ankylosing Spondylitis Functional Index [BASFI]), mental health (5-item World Health Organization Well-Being Index [WHO-5]), and global functioning (ASAS HI). Standardized response means (SRMs) were calculated to compare the sensitivity to change of different variables. RESULTS: Six hundred and sixty-seven patients were included, 552 treated with biologic disease-modifying antirheumatic drugs (bDMARDs) and 115 with conventional synthetic DMARDs and/or nonsteroidal antiinflammatory drugs (control group). Between baseline and month 12, the mean ASAS HI declined from 6.9 to 5.1 in the bDMARD group and from 5.9 to 5.6 in the conventionally treated group. In the bDMARD group, the SRM of ASAS HI was 0.52, compared to 0.59 for BASFI, 0.65 for WHO-5, 0.73 for BASDAI, and 0.90 for ASDAS. The following ASAS HI domains were most frequently affected: pain (78% agreed), maintaining body position (75%), and energy/drive (73%). In the patients receiving bDMARDs, there was an improvement in all items. In the control group, the largest improvement was seen in pain. CONCLUSION: As expected, ASDAS and BASDAI as disease activity scores showed high sensitivity to change, whereas changes in physical function (BASFI), mental health (WHO-5), and the broader concept of functioning and health (ASAS HI) were moderate.
Asunto(s)
Espondiloartritis , Espondilitis Anquilosante , Humanos , Estudios de Cohortes , Dolor , Calidad de Vida , Reproducibilidad de los Resultados , Índice de Severidad de la EnfermedadRESUMEN
OBJECTIVES: To investigate pregnancy outcomes in women with axial spondyloarthritis (axSpA) under different pharmacological treatments in comparison with matched controls. METHODS: Using health insurance data from 2006 to 2019, pregnancy outcomes of women with axSpA were compared with those of age-matched and calendar year-matched controls without axSpA. Women with axSpA were further stratified by treatment prior to delivery and pregnancy outcomes compared. Adjusted ORs (aORs) with 95% CIs were calculated using generalised estimating equation analyses. RESULTS: A total of 1021 pregnancy outcomes in patients with axSpA were identified (928 deliveries, 80 abortions, 13 ectopic pregnancies) and compared with 10 210 pregnancy outcomes in controls (9488 deliveries, 615 abortions, 147 ectopic pregnancies). Compared with controls, women with axSpA showed higher odds of elective caesarean section (aOR 1.52; 1.25 to 1.85).Among women with axSpA, the risk of preterm birth was higher under non-steroidal anti-inflammatory drugs (NSAIDs) treatment (aOR 2.22; 1.09 to 4.52) than without any anti-inflammatory treatment. The risks of preterm birth (aOR 4.01; 1.93 to 8.34) and small-for-gestational-age (aOR 3.22; 1.34 to 7.73) were increased under NSAIDs treatment in combination with conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs), steroids or analgesics. Non-significant increased risks of small-for-gestational-age (aOR 1.68; 0.43 to 6.57) and preterm birth (aOR 1.56; 0.51 to 4.83) were found under biological DMARDs. CONCLUSIONS: Women with axSpA have significantly increased odds of caesarean section compared with matched controls. Risks of preterm birth and small-for-gestational-age vary by type of anti-inflammatory treatment.
Asunto(s)
Antirreumáticos , Espondiloartritis Axial , Embarazo Ectópico , Nacimiento Prematuro , Antiinflamatorios no Esteroideos/uso terapéutico , Antirreumáticos/uso terapéutico , Cesárea/efectos adversos , Femenino , Humanos , Recién Nacido , Seguro de Salud , Embarazo , Resultado del Embarazo/epidemiología , Embarazo Ectópico/tratamiento farmacológico , Nacimiento Prematuro/tratamiento farmacológico , Nacimiento Prematuro/epidemiología , Nacimiento Prematuro/etiologíaRESUMEN
ObjectiveTo analyse the performance of the rheumatoid arthritis impact of disease (RAID) score in patients with ankylosing spondylitis, polymyalgia rheumatica, systemic lupus erythematosus, primary Sjögren's syndrome, idiopathic inflammatory myositis and systemic sclerosis, as compared with rheumatoid arthritis (RA).MethodsA total of 12 398 patients from the German National Database were included. For each diagnosis, we calculated age-adjusted/sex-adjusted partial correlation coefficients between RAID and patient global (PtGl) health, PtGl disease activity, physician global (PhGl) disease activity, Well-Being Index (WHO-5) and EuroQoL-5 Dimensions (EQ-5D). As a measure of agreement, the mean differences between the RAID and other outcomes were compared with the respective differences for RA. The effect of each diagnosis on the difference between RAID and the other scores was assessed with linear regression, with RA as the reference.ResultsAcross all diagnoses, RAID correlated strongly with PtGl health (0.71-0.83), moderately to strongly with PtGl disease activity (0.59-0.79), WHO-5 (0.65-0.81) and EQ-5D (0.68-0.73) and weakly with PhGl disease activity (0.23-0.38). Mean differences were calculated for RAID and PtGl disease activity (0 to -0.6), PtGl health (-0.4 to -0.9), WHO-5 (-0.7 to -1.3), EQ-5D (1.1 to 1.7) and PhGl disease activity (1.4 to 2.2). Discrepancies between other scores and RAID were comparable to RA. Linear regression revealed no clinically relevant effect of any of the diagnoses on the difference between RAID and the other outcomes.ConclusionThe RAID score performs comparably across all diagnoses investigated. This supports the use of RAID for measuring the impact also of other rheumatic diseases.
Asunto(s)
Artritis Reumatoide , Enfermedades Reumáticas , Espondilitis Anquilosante , Artritis Reumatoide/diagnóstico , Artritis Reumatoide/epidemiología , Estudios Transversales , Bases de Datos Factuales , Humanos , Enfermedades Reumáticas/diagnóstico , Enfermedades Reumáticas/epidemiología , Espondilitis Anquilosante/diagnóstico , Espondilitis Anquilosante/epidemiologíaRESUMEN
The scientific focus of the DRFZ's Programme Area Epidemiology and Health Services Research is, on the one hand, investigating the health care situation of people with rheumatic diseases in Germany, including its deficits, progress and trends. On the other hand, an essential goal is to uncover risk factors for unfavourable disease trajectories, but also protective factors, through the long-term observation of disease courses in large cohorts. With the approval of innovative, targeted therapies at the beginning of this millennium, the question of the real-world safety and effectiveness of the various anti-rheumatic therapies became a key issue for doctors and patients. The biologics registers have developed into central instruments of the programme area, which enable questions on comparative drug safety, but also on therapy effectiveness and risk reduction through effective therapy, to be answered in a robust manner.In this article, selected results of epidemiological research at the DRFZ are presented. The overall goal of the research was and is to contribute to improving the quality of life of children and adults with rheumatic and musculoskeletal diseases. This is the purpose of clinical-evaluative health services research as well as the acquisition of knowledge that supports effective, individualised therapy. Large, long-term patient cohorts and a stable network with clinical rheumatologists and those affected have proven to be indispensable instruments.
Asunto(s)
Productos Biológicos , Enfermedades Reumáticas , Adulto , Productos Biológicos/uso terapéutico , Niño , Alemania/epidemiología , Investigación sobre Servicios de Salud , Humanos , Calidad de Vida , Enfermedades Reumáticas/tratamiento farmacológico , Enfermedades Reumáticas/terapiaRESUMEN
OBJECTIVE: To investigate the frequency of outpatient physical therapy (PT) in persons with rheumatoid arthritis (RA), axial spondylarthritis (axSpA), psoriatic arthritis (PsA) or systemic lupus erythematosus (SLE) between 2005 and 2020. METHODS: Adult insured persons of the BARMER health insurance fund with a diagnosis of RA (ICD-10: M05, M06), axSpA (M45), PsA (M07.0-3) or SLE (M32.1,8,9) were included. The prescription of PT was identified via the national item number index for therapeutic products. The proportion of persons with at least 1 prescription in the years 2005 to 2020 is reported as well as PT prescriptions by age and gender groups. In addition, the number and duration of prescriptions were compared and it was analyzed whether persons in specialist care received PT more frequently. RESULTS: In 2020, 43% (SLE), 46% (RA, PsA) and 49% (axSpA) received at least 1 PT prescription. Physiotherapy was prescribed most frequently (37%), followed by manual therapy (14%) and thermotherapy (10%). Since 2005 the number of insured persons receiving PT has not changed. Manual therapy is increasingly prescribed (+7%), while massage (-10%), thermotherapy (-7%) and electrotherapy (3% in 2005, 2% in 2020) have been decreasing (data relating to RA). The number of prescriptions has not relevantly changed since 2010. Persons in orthopedic care received PT more frequently than persons in general or rheumatological care. Female patients 61-80 years old were most frequently treated with PT. CONCLUSION: Slightly less than half of all persons with an RA, axSpA, PsA or SLE diagnosis received outpatient PT. This proportion has hardly changed in the last 15 years.
Asunto(s)
Artritis Psoriásica , Artritis Reumatoide , Lupus Eritematoso Sistémico , Fiebre Reumática , Adulto , Anciano , Anciano de 80 o más Años , Artritis Psoriásica/diagnóstico , Artritis Psoriásica/epidemiología , Artritis Psoriásica/terapia , Artritis Reumatoide/diagnóstico , Artritis Reumatoide/epidemiología , Artritis Reumatoide/terapia , Femenino , Humanos , Persona de Mediana Edad , Modalidades de Fisioterapia , PrescripcionesRESUMEN
OBJECTIVE: To develop evidence-based European Alliance of Associations for Rheumatology (EULAR) points to consider (PtCs) for the management of difficult-to-treat rheumatoid arthritis (D2T RA). METHODS: An EULAR Task Force was established comprising 34 individuals: 26 rheumatologists, patient partners and rheumatology experienced health professionals. Two systematic literature reviews addressed clinical questions around diagnostic challenges, and pharmacological and non-pharmacological therapeutic strategies in D2T RA. PtCs were formulated based on the identified evidence and expert opinion. Strength of recommendations (SoR, scale A-D: A typically consistent level 1 studies and D level 5 evidence or inconsistent studies) and level of agreement (LoA, scale 0-10: 0 completely disagree and 10 completely agree) of the PtCs were determined by the Task Force members. RESULTS: Two overarching principles and 11 PtCs were defined concerning diagnostic confirmation of RA, evaluation of inflammatory disease activity, pharmacological and non-pharmacological interventions, treatment adherence, functional disability, pain, fatigue, goal setting and self-efficacy and the impact of comorbidities. The SoR varied from level C to level D. The mean LoA with the overarching principles and PtCs was generally high (8.4-9.6). CONCLUSIONS: These PtCs for D2T RA can serve as a clinical roadmap to support healthcare professionals and patients to deliver holistic management and more personalised pharmacological and non-pharmacological therapeutic strategies. High-quality evidence was scarce. A research agenda was created to guide future research.
Asunto(s)
Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Antirreumáticos/administración & dosificación , Artritis Reumatoide/complicaciones , Artritis Reumatoide/diagnóstico , Artritis Reumatoide/terapia , Terapia Cognitivo-Conductual , Comorbilidad , Ejercicio Físico , Hepatitis B/complicaciones , Hepatitis B/tratamiento farmacológico , Hepatitis C/complicaciones , Hepatitis C/tratamiento farmacológico , Humanos , Cumplimiento de la Medicación , Educación del Paciente como Asunto , Evaluación de SíntomasRESUMEN
OBJECTIVE: To compare event and incidence rates of herpes zoster (HZ), also known as shingles, in patients with rheumatoid arthritis under treatment with conventional synthetic (cs), targeted synthetic (ts) or biologic (b) disease-modifying antirheumatic drugs (DMARDs). METHODS: Patients were prospectively enrolled from 2007 until October 2020. Reported HZ events were assigned to ongoing treatments or those terminated within 1 month prior to the HZ event. Exposure-adjusted event rates (EAERs) of HZ were calculated per 1000 patient years (py) and adjusted HRs with 95% CIs computed. Inverse probability weights (IPW) were used to adjust for confounding by indication. RESULTS: Data of 13 991 patients (62 958 py) were analysed, with 559 HZ events reported in 533 patients. The EAER of HZ was highest for tsDMARDs (21.5, 95% CI 16.4 to 27.9), followed by B cell targeted therapy (10.3, 95% CI 8.0 to 13.0), monoclonal antitumour necrosis factor (anti-TNF) antibodies (9.3, 95% CI 7.7 to 11.2), interleukin 6 inhibitors (8.8, 95% CI 6.9 to 11.0), soluble TNF receptor fusion protein (8.6, 95% CI 6.8 to 10.8), T cell costimulation modulator (8.4, 95% CI 5.9 to 11.8) and csDMARDs (7.1, 95% CI 6.0 to 8.3). Adjusted for age, sex and glucocorticoids and weighted with IPW, tsDMARDs (HR 3.66, 95% CI 2.38 to 5.63), monoclonal anti-TNF antibodies (HR 1.63, 95% CI 1.17 to 2.28) and B cell targeted therapy (HR 1.57, 95% CI 1.03 to 2.40) showed a significantly higher risk compared with csDMARDs. CONCLUSION: Our results provide evidence for a 3.6-fold increased risk of HZ associated with tsDMARDs and an increased risk of HZ under bDMARDs compared with csDMARDs.
Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Productos Biológicos/uso terapéutico , Herpes Zóster/epidemiología , Inhibidores de las Cinasas Janus/uso terapéutico , Adulto , Anciano , Femenino , Humanos , Incidencia , Interleucina-6/antagonistas & inhibidores , Masculino , Persona de Mediana Edad , Terapia Molecular Dirigida , Sistema de Registros , Factores de Riesgo , Factor de Necrosis Tumoral alfa/antagonistas & inhibidoresRESUMEN
OBJECTIVE: To analyze the effect of tooth loss/periodontitis on disease activity in early and established rheumatoid arthritis (RA). METHODS: Participants of the Course And Prognosis of Early Arthritis (CAPEA) early arthritis cohort reported their number of teeth at baseline. The number of teeth had been validated as a predictor of periodontitis. Clinical end points, including disease activity score (Disease Activity Score in 28 joints using the erythrocyte sedimentation rate [ESR]), swollen joint count (SJC), ESR, and C-reactive protein level were collected at baseline, 3, 6, 12, 18, and 24 months. We used linear mixed regression models to estimate the association between tooth loss and clinical end points over time in early arthritis. For established RA, we analyzed cross-sectional data from the German National Database (NDB). All models accounted for age, sex, smoking, seropositivity, education level, and disease duration (only NDB). RESULTS: Among 1,124 CAPEA participants with early arthritis, those with higher tooth loss were older, more often male, smokers, and seropositive, and they had higher disease activity and inflammation markers at baseline. Tooth loss was associated with higher disease activity and ESR values over time. Inflammatory markers decreased comparably across tooth loss categories. Glucocorticoid use was higher among those with more tooth loss, whereas dose reduction was similar across tooth loss categories. Among 7,179 NDB participants with longstanding RA, disease activity and inflammation markers but not SJC were significantly higher in patients with more tooth loss. CONCLUSION: Although we observed an association between tooth loss and disease activity scores and inflammation markers in early and established RA, longitudinal results suggest that tooth loss does not hamper treatment response.
RESUMEN
Background: The German pregnancy register Rhekiss is designed as a nationwide, web-based longitudinal observational cohort established in 2015. The register follows women with inflammatory rheumatic disease prospectively from child wish or early pregnancy until 2 years post-partum. Information on clinical and laboratory parameters, drug treatment, and (adverse) pregnancy outcomes are documented in pre-specified intervals. Physicians and patients report data for the same time periods via separated accounts and forms into a web-based application (app). As data entry on mobile devices might improve response rates of patients, a responsive app as a further convenient documentation option was developed. Methods: The Rhekiss-app is available for self-reported data retrieval since August 2017 from the App stores. For the current analysis, Rhekiss register data were used from the start of the register until 30 September 2020. The analyses were performed for forms containing information on devices. Outcome parameters were compared for mobile and desktop users for the quantity and quality of filled forms. Results: In total, 5,048 forms were received and submitted by 966 patients. About 57% of forms were sent from mobile devices with the highest numbers in patients with child wishes (63%). Users of mobile devices were slightly younger and often had less high-education level (62 vs. 79%) compared with desktop users. The proportion of forms submitted via mobile devices increased steadily from 48% in the fourth quarter of 2018 to 64% in the third quarter of 2020. The proportion of forms received before and after the Rhekiss-app implementation increased with the highest increase of 12% for forms filled at time point 12 months post-partum. Mobile users submitted significantly more forms than desktop users (2.9 vs. 2.1), data sent via desktops were more often complete (88 vs. 86%). Conclusion: The responsive app is a valuable additional tool for data collection and is well-accepted by patients as indicated by its increasing use in Rhekiss. Apart from desktop/browser developments, the technological adoptions within observational cohorts and registries should take smartphone requirements and developments into account, especially when patient-reported data in young, mobile patients are collected, bearing in mind that data quality could be compromised and concepts for improving data quality should be implemented.
RESUMEN
BACKGROUND AND OBJECTIVE: There is an urgent need for robust data on the trajectories and outcomes of pregnancies in women with inflammatory rheumatic diseases (IRD). In particular when rare outcomes or rare diseases are to be investigated, collaborative approaches are required. However, joint data analyses are often limited by the heterogeneity of the different data sources.To facilitate future research collaboration, a European League Against Rheumatism (EULAR) Task Force defined a core data set with a minimum of items to be collected by pregnancy registries in rheumatology covering the period of pregnancy and the 28-day neonatal phase in women with any underlying IRD. METHODS: A stepwise process included a two-round Delphi survey and a face-to-face meeting to achieve consensus about relevant items. RESULTS: A total of 64 multidisciplinary stakeholders from 14 different countries participated in the two rounds of the Delphi process. During the following face-to-face meeting of the EULAR Task Force, consensus was reached on 51 main items covering 'maternal information', 'pregnancy' and 'treatment'. Generic instruments for assessment are recommended for every item. Furthermore, for the five most frequent IRDs rheumatoid arthritis, spondyloarthritis, juvenile idiopathic arthritis, systemic lupus erythematosus and other connective tissue diseases, disease-specific laboratory markers and disease activity measurements are proposed. CONCLUSION: This is the first consensus-based core data set for prospective pregnancy registries in rheumatology. Its purpose is to stimulate and facilitate multinational collaborations that aim to increase the knowledge about pregnancy course and safety of treatment in women with IRDs during pregnancy.
Asunto(s)
Antirreumáticos/uso terapéutico , Recolección de Datos , Complicaciones del Embarazo/terapia , Resultado del Embarazo , Sistema de Registros , Enfermedades Reumáticas/terapia , Comités Consultivos , Artritis Juvenil/fisiopatología , Artritis Juvenil/terapia , Artritis Reumatoide/fisiopatología , Artritis Reumatoide/terapia , Enfermedades del Tejido Conjuntivo/fisiopatología , Enfermedades del Tejido Conjuntivo/terapia , Técnica Delphi , Europa (Continente) , Femenino , Humanos , Lupus Eritematoso Sistémico/fisiopatología , Lupus Eritematoso Sistémico/terapia , Atención Posnatal , Atención Preconceptiva , Embarazo , Complicaciones del Embarazo/fisiopatología , Enfermedades Reumáticas/fisiopatología , Reumatología , Índice de Severidad de la Enfermedad , Espondiloartropatías/fisiopatología , Espondiloartropatías/terapiaRESUMEN
BACKGROUND: Despite treatment according to the current management recommendations, a significant proportion of patients with rheumatoid arthritis (RA) remain symptomatic. These patients can be considered to have 'difficult-to-treat RA'. However, uniform terminology and an appropriate definition are lacking. OBJECTIVE: The Task Force in charge of the "Development of EULAR recommendations for the comprehensive management of difficult-to-treat rheumatoid arthritis" aims to create recommendations for this underserved patient group. Herein, we present the definition of difficult-to-treat RA, as the first step. METHODS: The Steering Committee drafted a definition with suggested terminology based on an international survey among rheumatologists. This was discussed and amended by the Task Force, including rheumatologists, nurses, health professionals and patients, at a face-to-face meeting until sufficient agreement was reached (assessed through voting). RESULTS: The following three criteria were agreed by all Task Force members as mandatory elements of the definition of difficult-to-treat RA: (1) Treatment according to European League Against Rheumatism (EULAR) recommendation and failure of ≥2 biological disease-modifying antirheumatic drugs (DMARDs)/targeted synthetic DMARDs (with different mechanisms of action) after failing conventional synthetic DMARD therapy (unless contraindicated); (2) presence of at least one of the following: at least moderate disease activity; signs and/or symptoms suggestive of active disease; inability to taper glucocorticoid treatment; rapid radiographic progression; RA symptoms that are causing a reduction in quality of life; and (3) the management of signs and/or symptoms is perceived as problematic by the rheumatologist and/or the patient. CONCLUSIONS: The proposed EULAR definition for difficult-to-treat RA can be used in clinical practice, clinical trials and can form a basis for future research.
Asunto(s)
Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Productos Biológicos/uso terapéutico , Glucocorticoides/uso terapéutico , Comités Consultivos , Artritis Reumatoide/diagnóstico por imagen , Artritis Reumatoide/fisiopatología , Progresión de la Enfermedad , Resistencia a Medicamentos , Quimioterapia Combinada , Europa (Continente) , Humanos , Guías de Práctica Clínica como Asunto , Reumatología , Participación de los Interesados , Terminología como Asunto , Insuficiencia del TratamientoRESUMEN
OBJECTIVE: The aim of this study was to investigate the association of extra-musculoskeletal manifestations (EMMs) with disease activity, functional status, and treatment patterns in a large population-based cohort of patients with axial spondyloarthritis (axSpA). METHODS: A stratified random sample of patients with axSpA, drawn from health insurance data, received a survey on disease-related characteristics including history (ever presence) of the following EMMs: inflammatory bowel disease (IBD), psoriasis (PSO), and anterior uveitis (AU). Survey data were linked to health insurance data, gathering additional information on current occurrence (within one year) of EMMs and drug prescriptions. Separate multivariable linear regression models were calculated to determine the association of EMMs with disease activity (Bath Ankylosing Spondylitis Disease Activity Index), and functional status (Bath Ankylosing Spondylitis Functional Index) after adjustment for relevant parameters, including treatment. RESULTS: A total of 1729 patients with axSpA were included in the analyses (response: 47%; mean age: 56 years; 46% female) of whom 6% (9%) had current (ever) IBD, 10% (15%) had current (ever) PSO, and 9% (27%) had current (ever) AU. Ever presence of IBD and history of PSO were significantly associated with higher level of disease activity. Ever presence of PSO was also associated with higher level of functional impairment, whereas current AU was significantly associated with lower disease activity. Patients with current IBD or PSO received more frequently biological and conventional synthetic disease-modifying anti-rheumatic drugs as well as systemic steroids. AU was associated with a higher use of conventional synthetic disease-modifying anti-rheumatic drugs only. CONCLUSION: Disease activity is higher in patients with axSpA with history of IBD or history of PSO. Functional impairment is also higher in patients with axSpA with history of PSO. The presence of different EMMs was associated with different treatment patterns in axSpA.
RESUMEN
Non-response in surveys can lead to bias, which is often difficult to investigate. The aim of this analysis was to compare factors available from claims data associated with survey non-response and to compare them among two samples. A stratified sample of 4471 persons with a diagnosis of axial spondyloarthritis (axSpA) and a sample of 8995 persons with an osteoarthritis (OA) diagnosis from a German statutory health insurance were randomly selected and sent a postal survey. The association of age, sex, medical prescriptions, specialist physician contact, influenza vaccination, hospitalization, and Elixhauser comorbidity index with the survey response was assessed. Multiple logistic regression models were used with response as the outcome. A total of 47% of the axSpA sample and 40% of the OA sample responded to the survey. In both samples, the response was highest in the 70-79-year-olds. Women in all age groups responded more often, except for the 70-79-year-olds. Rheumatologist/orthopedist contact, physical therapy prescription, and influenza vaccination were more frequent among responders. In the logistic regression models, rheumatologist/orthopedist treatment, influenza vaccination, and physical therapy were associated with a higher odds ratio for response in both samples. The prescription of biologic drugs was associated with higher response in axSpA. A high Elixhauser comorbidity index and opioid use were not relevantly associated with response. Being reimbursed for long-term care was associated with lower response-this was only significant in the OA sample. The number of quarters with a diagnosis in the survey year was associated with higher response. Similar factors were associated with non-response in the two samples. The results can help other investigators to plan sample sizes of their surveys in similar settings.
Asunto(s)
Revisión de Utilización de Seguros , Osteoartritis , Espondiloartritis , Encuestas y Cuestionarios , Anciano , Sesgo , Productos Biológicos , Estudios Transversales , Femenino , Humanos , Revisión de Utilización de Seguros/estadística & datos numéricos , Masculino , Osteoartritis/tratamiento farmacológico , Osteoartritis/epidemiología , Espondiloartritis/tratamiento farmacológico , Espondiloartritis/epidemiología , Encuestas y Cuestionarios/estadística & datos numéricosRESUMEN
The original article can be found online.
RESUMEN
OBJECTIVE: To assess satisfaction with the effectiveness and tolerability of treatments in patients with rheumatoid arthritis (RA). METHODS: Patients from the RABBIT register, starting a biological (b) or targeted synthetic (ts) disease-modifying antirheumatic drug (DMARD), or a conventional synthetic (cs)DMARD treatment after ≥1 csDMARD failure, were included. Treatment satisfaction was measured after 1 year of treatment in four categories and binarised for analysis. Logistic regression models were performed to calculate ORs for factors associated with treatment satisfaction. RESULTS: Data of 10 646 patients (74% women, mean 58 years) were analysed. At baseline, 55% of the patients were satisfied with the efficacy and 68% with the tolerability of their previously given treatments. After 1 year, 85% of the patients were satisfied with treatment effectiveness and 90% with tolerability. Baseline satisfaction (OR 2.98, 95% CI 2.58 to 3.44), seropositivity (OR 1.36, 95% CI 1.17 to 1.57), reduction of DAS28 (OR 1.38, 95% CI 1.31 to 1.46) and pain (OR 1.26, 95% CI 1.22 to 1.31), and the improvement of physical capacity (OR 1.22, 95% CI 1.17 to 1.29) were positively associated with treatment satisfaction at follow-up while glucocorticoids (GCs) >5 mg/day, depression, fibromyalgia, obesity, prior bDMARDs and therapy changes were negatively associated. The impact of GC on satisfaction was dose-dependent, becoming strongest for GC >15 mg (OR 0.24, 95% CI 0.16 to 0.34). A 5 mg/day reduction within 12 months was positively associated with satisfaction regarding efficacy (OR 1.19, 95% CI 1.11 to 1.27) and tolerability (OR 1.11, 95% CI 1.03 to 1.21). CONCLUSION: Most patients were satisfied with their treatment's effectiveness and tolerability after 1 year of treatment. Tapering GCs was positively associated with the improvement of patients' satisfaction.