Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 21
Filtrar
1.
Artigo em Inglês | MEDLINE | ID: mdl-33493321

RESUMO

OBJECTIVES: The definition of an accurate target for a treat to target (T2T) approach in systemic lupus erythematosus (SLE) has been challenging over the past years and recently the DORIS definitions of remission were presented by the international DORIS task force. It was our aim to assess the frequency of DORIS remission and LLDAS in our SLE-cohort and their agreement with the treating physician's (DORIS-) independent remission judgment. Patient characteristics leading to lack of agreement and incoherence ought to be identified. METHODS: In this monocentric cross-sectional study patients with SLE were enrolled and assessed between September 2016 and December 2017. DORIS remission definitions were applied and after the clinical consultation, the treating physicians gave his opinion if his/her patient was in remission. Regression analyses were performed to identify parameters influencing physician remission. RESULTS: A total of 233 patients were included (87.6% female). 99 (42.5%) patients fulfilled any of the four DORIS remission definitions, while 126 patients were in remission according to their physician's judgement. We observed discordance in the assessment of remission in 53 patients (22.7%). Physician remission was influenced by both disease activity (OR 0.76 CI 0.63-9.90), disease and/or treatment related damage (OR 0.78, 0.62-0.98 and the presence of ds-DNA-antibodies 2.47 (1.06-6.04). CONCLUSIONS: DORIS remission proved an achievable target in our outpatient clinic. Still we found discordance regarding DORIS remission and the treating physician's judgement with a greater number of patients considered in remission by their physicians.

2.
Lupus ; : 961203320983445, 2021 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-33402036

RESUMO

OBJECTIVE: Despite increased physician's awareness and improved diagnostic and serological testing in the recent years, the interval between the initial symptoms and the diagnosis of Systemic lupus erythematosus (SLE) is still very long. Our aim was to study this delay and its association to the outcome of the disease. METHODS: Information on demographics, onset of first symptoms, first physicians visit and time of diagnosis was assessed by self-reported questionnaires among SLE patients in Germany (LuLa cohort, n = 585) in the year 2012. Disease activity (Systemic Lupus Activity Questionnaire; SLAQ), disease related damage (Brief Index of Lupus Damage; BILD), health related quality of life (Short Form 12) and fatigue (FSS) were chosen as proxies for outcome. Linear regression analysis was used to analyze the association of the delay in diagnosis to the outcome, adjusted for age, disease duration and sex. RESULTS: Mean duration between the onset of symptoms and the diagnosis of SLE was 47 months (SD 73). The longer the time to diagnosis, the higher the disease activity (ß = 0.199, p < 0.0001), the disease-related damage (ß = 0.137, p = 0.002) and fatigue (ß 0.145, p = 0.003) and the lower the health-related quality of life (physical ß = -0.136, p = 0.004, mental ß = -0.143, p = 0.004). CONCLUSION: In systemic lupus erythematosus, longer time to diagnosis was associated with worse outcome. Concepts in care with the intention to shorten the time to diagnosis are needed to improve the long-term outcome of the disease.

3.
Rheumatology (Oxford) ; 59(Supplement_5): v63-v68, 2020 Dec 05.
Artigo em Inglês | MEDLINE | ID: mdl-33280017

RESUMO

A few decades ago, the therapy goal of patients with systemic lupus erythematosus (SLE) was survival and the prevention of organ failure. Today, clinical remission and low disease activity are believed to be the optimal therapeutic targets. These aims are difficult to reach for many patients, but they still do not address the health-related quality of life (QoL) that is significantly impaired in SLE patients. Even in the state of remission, QoL and fatigue are insufficient controlled. Thus, patient-oriented research is essential to design new strategies for the management of lupus patients. The INTEGRATE project analyses the patients' and physicians' perspectives to pave the way to design an innovative therapeutic strategy for lupus and focuses on the multifaceted dimensions of the disease burden. Shared decision making (SDM) could include the patient's perspective of SLE to treatment strategy and consider QoL and the burden of lupus into the process of therapy decision.

4.
Lupus ; : 961203320965690, 2020 Oct 20.
Artigo em Inglês | MEDLINE | ID: mdl-33081589

RESUMO

OBJECTIVE: To comprehensively assess associations of site-specific CD4+-T-cell hypomethylation of the CD40-Ligand gene (CD40L) with disease activity of women with systemic lupus erythematosus (SLE). METHODS: CpG-sites within the DNA of the promotor and two enhancer regions (n = 22) of CD40L were identified and numbered consecutively. The rate of methylated DNA in isolated CD4+-T-cells of women with SLE were quantified for each methylation site by MALDI-TOF. Disease activity was assessed by SLE Disease Activity Index (SLEDAI). Associations of site-specific methylation rates with the SLEDAI scores were assessed by linear regression modelling. P values were adjusted according to Bonferroni-Holm as indicated. RESULTS: 60 female SLE patients participated in the study (age 45.7 ± 11.1 years, disease duration 17.0 ± 8.3 years). Significant associations to the SLEDAI were noted for CpG22 hypomethylation of the promotor (ß = -40.1, p = 0.017, adjusted p = 0.027), trends were noted for CpG17 hypomethylation of the promotor (ß = -30.5, p = 0.032, adjusted p = 0.6), and for CpG11 hypermethylation of the second enhancer (ß = 15.0, p = 0.046, adjusted p = 0.8). CONCLUSION: Site-specific hypomethylation of the CD40L promotor in CD4+-T-cells show associations with disease activity in female SLE patients.

7.
Patient Prefer Adherence ; 13: 1889-1894, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31806937

RESUMO

Purpose: Since the launch of belimumab in 2011, the BLyS antibody has been increasingly used in the therapy of systemic Lupus erythematosus (SLE). Comparative studies showed that the intravenous (i.v.) and subcutaneous (s.c.) administration forms do not differ in their efficacy. Since the approval of the s.c. therapy, many patients have been switched from i.v. to s.c. administration. The clinical course of these patients and their satisfaction regarding the drug have not yet been investigated. Methods: A total of 9 patients with SLE were switched from i.v. to s.c. belimumab between 12/2017 and 03/2018. We assessed a self-developed questionnaire on drug satisfaction, disease activity (SLEDAI-2k), serological activity (leukocytes, DNA antibodies, complement), disease damage (SLICC/ACR damage index) and functional status (health-assessment questionnaire) at switching (T0) and after 6 months (T1). Association of the questionnaires with the form of administration (i.v. vs s.c.) was analyzed for each variable separately by linear regression analyses, adjusted for age, gender and disease duration. Results: At switching, disease activity of all patients was well controlled (median SLEDAI-2k = 2 [Interquartile range 0-4]) and the patients were mainly satisfied with their therapy. No evidence for any difference in disease activity, disease damage or patient satisfaction 6 months after switching was found. In tendency, patients were more satisfied with the s.c. administration. Conclusion: The switch from i.v. to s.c. belimumab was successful in all cases and had no effect on disease activity or patient satisfaction. Despite the small sample size, s.c. belimumab seems to offer a good alternative to i.v. application.

9.
Dtsch Med Wochenschr ; 144(7): 464-469, 2019 04.
Artigo em Alemão | MEDLINE | ID: mdl-30925601

RESUMO

STATE OF THE ART: Innovations in information and communication technology have been used in rheumatology for many years. In 2018 the German Society for Rheumatology established the Commission "Digital Rheumatology". DIGITAL APPLICATIONS IN GERMAN RHEUMATOLOGY: Mobile data acquisition in rheumatological patients is feasible. It offers innovative possibilities in the implementation of modern treatment strategies. Digital applications such as the "Rheuma Check" and the "Bechterew Check" are available to the public at any time to screen for inflammatory rheumatic diseases. Other digital services and modern networks allow a triage of patients. Rhekiss and RABBIT SpA are the first fully digitalised registries to provide short-term data on issues that are not covered by clinical trials of pharmaceutical companies. OUTLOOK: Digitalization in Rheumatology will provide much faster answers to important questions in healthcare research in the future.


Assuntos
Informática Médica , Reumatologia , Telemedicina , Alemanha , Humanos
11.
Rheumatology (Oxford) ; 57(8): 1439-1447, 2018 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-29757414

RESUMO

Objectives: Vaccinations are an important measure to prevent infections in immunocompromised patients. The knowledge of vaccination coverage and reasons for non-vaccination in patients with SLE is scarce. The aim of this study was to assess coverage rates of selected vaccinations in a representative sample of SLE patients and to identify predictors for non-vaccination. Methods: In 2013, information on selected vaccinations (coverage, application and reservations) and on demographics, clinical parameters and health beliefs was assessed by means of a self-reported questionnaire among a representative sample of SLE patients in Germany (LuLa cohort). Results: Five hundred and seventy-nine patients participated. Vaccination status was primarily checked by their general practitioner (57.3%). Of all the patients, 24.9% did not get their vaccination status checked at all, 16.1% had generally been advised against the use of vaccinations by a physician, and 37.5% stated that they had rejected vaccinations themselves. Their main reasons were fears of developing a lupus flare (21.8%) or adverse events (13.5%). A greater belief by patients in the doctor controlling one's health and the general benefit of medication prevented the rejection of vaccines. Vaccination coverage was low for all recorded vaccinations (tetanus 65.8%, influenza 45.2%, pneumococcus 32.2% and meningococcus 6.1%). Older age was predictive of receiving influenza and pneumococcal vaccination. The same applies for CSs >7.5 mg for receiving influenza vaccination. Conclusion: Vaccination coverage in SLE patients is poor and reflects insufficient implementation of national and international recommendations. Rheumatologists need to recognize patients' reservations against vaccinations, to communicate their importance and safety and to give individual recommendations to patients and their health-care providers. Trial registration: German Clinical Trials Register, www.germanctr.de, DRKS00011052.


Assuntos
Imunocompetência , Influenza Humana/prevenção & controle , Lúpus Eritematoso Sistêmico/complicações , Infecções Pneumocócicas/prevenção & controle , Cobertura Vacinal/estatística & dados numéricos , Vacinação/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Feminino , Seguimentos , Alemanha/epidemiologia , Humanos , Incidência , Vacinas contra Influenza , Influenza Humana/epidemiologia , Influenza Humana/etiologia , Lúpus Eritematoso Sistêmico/epidemiologia , Lúpus Eritematoso Sistêmico/imunologia , Masculino , Pessoa de Meia-Idade , Infecções Pneumocócicas/epidemiologia , Vacinas Pneumocócicas , Estudos Retrospectivos , Inquéritos e Questionários , Fatores de Tempo , Adulto Jovem
12.
J Rheumatol ; 45(2): 227-234, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29142037

RESUMO

OBJECTIVE: Psychosocial stress at work not only affects the healthy working population, but also workers with chronic diseases. We aimed to investigate the psychosocial work stress levels in patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). METHODS: A cross-sectional study applied the Effort-Reward Imbalance (ERI) questionnaire - an internationally established instrument that measures work stress - to patients with SLE and RA who were capable of work and to a group of controls without these diseases. Participants were recruited through rheumatologists in private practices, hospitals, and from self-help groups by personal communication, paper-based flyers, and online advertisements. Because very few studies tested the ERI's applicability in patient groups, with a lack of evidence in patients with inflammatory rheumatic diseases, internal consistency and construct validity of the ERI measure were evaluated. RESULTS: Data came from 270 patients with RA and 247 with SLE, and 178 controls. Patients showed elevated psychosocial stress at work compared to controls. Across the total sample and all groups, satisfactory internal consistencies of the scales effort, reward, and overcommitment were obtained (Cronbach's alpha coefficients > 0.70), and confirmatory factor analysis replicated the theoretical structure of the ERI model (goodness-of-fit index > 0.80). CONCLUSION: We found elevated psychosocial stress at work in patients with SLE and RA compared to controls by applying the ERI model. Despite some heterogeneity in the sample, we achieved satisfactory psychometric properties of the ERI questionnaire. Our results suggest that the ERI questionnaire is a psychometrically useful tool to be implemented in epidemiological studies of employed patients with SLE and RA.


Assuntos
Artrite Reumatoide/psicologia , Lúpus Eritematoso Sistêmico/psicologia , Estresse Ocupacional/psicologia , Estresse Psicológico/psicologia , Adulto , Estudos Transversais , Disciplina no Trabalho , Emprego/psicologia , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Psicometria/métodos , Recompensa , Autorrelato , Estatísticas não Paramétricas , Carga de Trabalho/psicologia
13.
Autoimmun Rev ; 16(11): 1119-1124, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28899802

RESUMO

Biologic therapy is still limited in lupus, where chronic steroid exposure and wide-spectrum immunosuppression are major triggers of organ damage. In this viewpoint, the authors summarize their views for a "half-full or half-empty" glass on targeted therapy in SLE. The are several reasons for seeing the glass half-empty and in this section the authors propose a critical reflection on scarceness of novel targeted lupus therapies. They show how hard it is to identify suitable biological and clinical targets and to choose the patients that may best fit those targets, as well as to stratify patients according to disease subtype and response, all contributing to the final outcome. On the other hand, reasons are emerging to see the glass half-full, including the growing evidence that disease activity and damage can both be hindered by the proper use of novel drugs and that promising molecules are upcoming. In this section, the authors contextualize potentials and failures of new drugs, providing a critical reading of disappointing results and underlining the concrete benefits obtainable through a wise use of available treatments. Indeed, combining medications with new therapeutic strategies such as the treat-to-target seems the right approach to add some water to a filling glass.


Assuntos
Produtos Biológicos/uso terapêutico , Imunossupressores/uso terapêutico , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Terapia de Alvo Molecular , Medicina de Precisão , Humanos
14.
Lupus Sci Med ; 3(1): e000181, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27933200

RESUMO

OBJECTIVE: To provide an estimate of age-specific incidence rate of physician-diagnosed systemic lupus erythematosus (SLE) for German men and women. METHODS: The age-specific and sex-specific prevalence of diagnosed SLE in claims data is used to estimate the incidence in the German male and female population. The claims data set stems from a representative sample of the statutory health insurance in 2002 and comprises 2.3 million people. The statutory health insurance covers >85% of the German population. RESULTS: The estimated incidence rates are 0.9 (95% CI 0.7 to 1.1) per 100 000 person-years for men and 1.9 (95% CI 1.7 to 2.2) per 100 000 person-years for women. The age-specific incidence rate of SLE in the male population has a maximum of 2.2 (95% CI 1.0 to 3.4) per 100 000 person-years at the age of 65-70 years. In women, the incidence is peaking at the rate of 3.6 (95% CI 2.9 to 4.3) cases per 100 000 person-years at the age of 20-25 years, but has a second local maximum (2.6, 95% CI 1.5 to 3.8) at menopausal age. CONCLUSIONS: For the first time, representative data on the incidence of SLE in Germany are provided. The estimated incidence rates of SLE for men and women in Germany are at the lower end of other estimates from comparable European countries.

15.
Clin Exp Rheumatol ; 34(5 Suppl 101): S62-S68, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27762191

RESUMO

Electronic health records are increasingly used and frequently required from various regulatory authorities. Apart from their day-to-day use by health care professionals for routine clinical practice and/or the improvement of quality of care processes, patients with chronic inflammatory disease may become increasingly involved in the data retrieval process by self-monitoring and providing patient-reported (outcome) data. Among key features of electronic health records are automated scoring, visualisation of validated measures, and long-term systematic patient-centered data collection in a structured and standardised manner. Data derived from electronic health records are increasingly incorporated into patient-centered research, registries, and other secondary uses. Thus, electronic health records offer opportunities to improve knowledge and to create new process flows in rheumatology health care. The article summarises some of these opportunities in patient care, as well as an overview of secondary use scenarios. In addition, the article focuses on patients' active involvement in the disease management process via health information applications, reports on patients' perspectives, as well as some legal and regulatory matters concerning electronic health records.


Assuntos
Registros Eletrônicos de Saúde , Indicadores Básicos de Saúde , Informática Médica , Medidas de Resultados Relatados pelo Paciente , Doenças Reumáticas/diagnóstico , Reumatologia/métodos , Automação , Mineração de Dados , Avaliação da Deficiência , Registros Eletrônicos de Saúde/legislação & jurisprudência , Regulamentação Governamental , Política de Saúde , Pesquisa sobre Serviços de Saúde , Nível de Saúde , Humanos , Informática Médica/legislação & jurisprudência , Participação do Paciente , Formulação de Políticas , Valor Preditivo dos Testes , Prognóstico , Reprodutibilidade dos Testes , Doenças Reumáticas/fisiopatologia , Doenças Reumáticas/psicologia , Doenças Reumáticas/terapia , Reumatologia/legislação & jurisprudência , Índice de Gravidade de Doença , Fatores de Tempo
16.
Lupus Sci Med ; 2(1): e000113, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26629351

RESUMO

OBJECTIVE: The aim of this study was to identify factors associated with pain coping and catastrophising in patients with systemic lupus erythematosus. METHODS: All patients were participants of the lupus erythematosus long-term study, which is based on patient-reported data assessed among members of the German Lupus Erythematosus Self-Help Organization. Assessments were performed by means of a questionnaire. Among self-reported clinical data the Pain-Related Self Statements Scale (PRSS) was included. To depict significant differences univariable analyses were carried out using non-parametrical rank tests. To examine factors influencing our outcome variables, we performed a multivariable stepwise regression model including variables that presented significantly in the univariable analysis. RESULTS: 447 cases (94.9% female) were analysed showing a mean catastrophising score of 1.1 (SD 0.8) and a mean coping score of 2.8 (SD 0.9) in the PRSS subscales. Higher catastrophising quartiles went along with higher experienced pain, lupus activity, fatigue, damage and decreased health related quality of life, whereas they presented inversely for coping. In our multivariable model, factors associated with catastrophising were: number of lupus-specific drugs (p value 0.004), pain in the last 7 days (p value 0.034), the Short Form 12 Health Survey Mental Component Summary (p value <0.001) and disease activity measured by the Systemic Lupus Activity Questionnaire (p value 0.042). Social participation reflected by performed leisure activities such as dancing or bowling had a positive association with coping (p value 0.006). In contrast, other health related physical activities and their extent had no impact on coping. A direct association between the amount of pain coping and catastrophising, as well as a great impact of the catastrophising, respectively, coping level on physical and mental functioning could be shown. CONCLUSIONS: Reduction or increase of detected factors might lead to a modification of pain coping and catastrophising and offer an approach to more effective care in patients with SLE.

17.
Clin Exp Rheumatol ; 33(3): 354-9, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25797042

RESUMO

OBJECTIVES: Disease activity accounts for damage, overall mortality and co-morbidities in SLE and should frequently be assessed to adapt therapeutic patient management. The Systemic Lupus Activity Questionnaire (SLAQ) is a patient-reported instrument for the assessment of disease activity derived from the Systemic Lupus Erythematosus Activity Measure (SLAM) and was originally developed in English. Our aim was to validate the SLAQ in German and evaluate its use in a large cohort. METHODS: We translated and adapted the SLAQ questionnaire in German. It was applied to SLE outpatients at a tertiary centre (n=328) and compared to the SLAMnolab and other SLE outcome parameters. Internal consistency, criterion validity, inter-rater and test-retest reliability as well as construct validity were examined. Correlation, Cronbach's alpha, Mann-Whitney U-test or the Kruskal-Wallis one-way analysis of variance test were ascertained where appropriate. Levels of statistical significance were defined at 5% (p<0.05). All reported p-values are two-tailed. RESULTS: The German SLAQ showed a comparable strong correlation with the SLAMnolab (r=0.632, p<0.0001) as the original version of the SLAQ and presented a good to excellent internal consistency reliability (Cronbach's alpha=0.89). Accrued damage as well as low disease activity are factors possibly influencing the score. Amongst others, scores were higher in patients with more reported flares, lower self-reported overall health, lower functional status and higher daily doses of prednisolone. CONCLUSIONS: Our German version of the SLAQ shows a comparable validity as the original SLAQ and is a promising instrument to survey disease activity in clinical routine as well as in clinical and epidemiological studies. Possible interacting factors need to be considered when applying.


Assuntos
Lúpus Eritematoso Sistêmico/diagnóstico , Inquéritos e Questionários , Alemanha , Glucocorticoides/administração & dosagem , Nível de Saúde , Humanos , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Lúpus Eritematoso Sistêmico/fisiopatologia , Lúpus Eritematoso Sistêmico/psicologia , Variações Dependentes do Observador , Valor Preditivo dos Testes , Prednisolona/administração & dosagem , Recidiva , Indução de Remissão , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , Fatores de Tempo , Tradução , Resultado do Tratamento
19.
J Rheumatol ; 39(11): 2111-7, 2012 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-22984276

RESUMO

OBJECTIVE: Intravenous cyclophosphamide (IV CYC) in combination with high doses of corticosteroids is considered the "gold standard" of therapy for lupus nephritis (LN). However, the optimal dose of corticosteroids needed has not been defined. We evaluated the efficacy of a monotherapy with IV CYC in patients with a first episode of LN (duration ≤ 6 months). METHODS: Forty patients with LN received IV CYC (12 pulses). Prednisone alone was administered and dose-adjusted to control extrarenal manifestations. Response after 24 months was defined as normalization of creatinine level, inactive urinary sediment, and proteinuria ≤ 0.2 g/day [complete response (CR)] or ≤ 0.5 g/day [partial response (PR)]. RESULTS: CR was achieved in 25 (62.5%) and PR in 8 (20%) patients. Mean starting dose of prednisone was 23.9 ± 23.8 mg/day. In a posthoc analysis, we separately analyzed patients initially treated with prednisone doses ≥ 20 mg/day (Group A, n = 19) or < 20 mg/day (Group B, n = 21). CR was achieved in 52.6% (Group A) versus 71.4% (Group B; p = 0.37); and PR in 26.3% versus 14.3%, respectively (p = 0.58). During longterm followup (10.4 ± 3.1 yrs), 37.8% experienced a renal flare. Thirty patients (81%) still have normal renal function. Renal outcome was irrespective of initial prednisone doses (p = 0.46, Pearson chi-square test of independence). CONCLUSION: Our rates of CR and PR and longterm outcomes were comparable with rates after treatment with a combination of IV CYC with high doses of corticosteroids. These data warrant randomized controlled trials evaluating different doses of corticosteroids in LN.


Assuntos
Ciclofosfamida/administração & dosagem , Ciclofosfamida/uso terapêutico , Imunossupressores/administração & dosagem , Imunossupressores/uso terapêutico , Nefrite Lúpica/tratamento farmacológico , Administração Intravenosa , Corticosteroides/uso terapêutico , Adulto , Creatinina/metabolismo , Ciclofosfamida/farmacologia , Relação Dose-Resposta a Droga , Quimioterapia Combinada , Feminino , Seguimentos , Humanos , Imunossupressores/farmacologia , Incidência , Rim/efeitos dos fármacos , Rim/metabolismo , Rim/fisiopatologia , Nefrite Lúpica/complicações , Nefrite Lúpica/metabolismo , Masculino , Prednisona/uso terapêutico , Estudos Prospectivos , Proteinúria/epidemiologia , Proteinúria/etiologia , Resultado do Tratamento
20.
Arthritis Res Ther ; 13(3): R75, 2011 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-21569519

RESUMO

INTRODUCTION: Evidence from a number of open-label, uncontrolled studies has suggested that rituximab may benefit patients with autoimmune diseases who are refractory to standard-of-care. The objective of this study was to evaluate the safety and clinical outcomes of rituximab in several standard-of-care-refractory autoimmune diseases (within rheumatology, nephrology, dermatology and neurology) other than rheumatoid arthritis or non-Hodgkin's lymphoma in a real-life clinical setting. METHODS: Patients who received rituximab having shown an inadequate response to standard-of-care had their safety and clinical outcomes data retrospectively analysed as part of the German Registry of Autoimmune Diseases. The main outcome measures were safety and clinical response, as judged at the discretion of the investigators. RESULTS: A total of 370 patients (299 patient-years) with various autoimmune diseases (23.0% with systemic lupus erythematosus, 15.7% antineutrophil cytoplasmic antibody-associated granulomatous vasculitides, 15.1% multiple sclerosis and 10.0% pemphigus) from 42 centres received a mean dose of 2,440 mg of rituximab over a median (range) of 194 (180 to 1,407) days. The overall rate of serious infections was 5.3 per 100 patient-years during rituximab therapy. Opportunistic infections were infrequent across the whole study population, and mostly occurred in patients with systemic lupus erythematosus. There were 11 deaths (3.0% of patients) after rituximab treatment (mean 11.6 months after first infusion, range 0.8 to 31.3 months), with most of the deaths caused by infections. Overall (n = 293), 13.3% of patients showed no response, 45.1% showed a partial response and 41.6% showed a complete response. Responses were also reflected by reduced use of glucocorticoids and various immunosuppressives during rituximab therapy and follow-up compared with before rituximab. Rituximab generally had a positive effect on patient well-being (physician's visual analogue scale; mean improvement from baseline of 12.1 mm). CONCLUSIONS: Data from this registry indicate that rituximab is a commonly employed, well-tolerated therapy with potential beneficial effects in standard of care-refractory autoimmune diseases, and support the results from other open-label, uncontrolled studies.


Assuntos
Anticorpos Monoclonais Murinos/administração & dosagem , Anticorpos Monoclonais Murinos/efeitos adversos , Antirreumáticos/administração & dosagem , Antirreumáticos/efeitos adversos , Doenças Autoimunes/tratamento farmacológico , Adulto , Doenças Autoimunes/mortalidade , Hipersensibilidade a Drogas/epidemiologia , Resistência a Medicamentos/imunologia , Seguimentos , Alemanha/epidemiologia , Nível de Saúde , Humanos , Imunossupressores/administração & dosagem , Satisfação do Paciente , Sistema de Registros/estatística & dados numéricos , Estudos Retrospectivos , Rituximab , Resultado do Tratamento
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA