RESUMO
OBJECTIVE: To compare the response to nonsteroidal antiinflammatory drugs (NSAIDs) in patients with longstanding axial spondyloarthritis (axSpA) and controls with back pain (nonspondyloarthritis [non-SpA]). METHODS: Consecutive outpatients with chronic back pain (axSpA or non-SpA), were prospectively recruited. Any previous NSAIDs were withdrawn 2 days before study start (baseline). Back pain was assessed using a numerical rating scale (NRS; range 0-10) starting at 2 hours after baseline and several times thereafter up to 4 weeks. "Any response" to NSAIDs was defined as improvement of back pain on the NRS > 2 units, and "good response" as improvement > 50%, compared to baseline. RESULTS: Among 233 patients included, 68 had axSpA (29.2%) and 165 had non-SpA back pain (70.8%). The mean age was 42.7 (SD 10.7) vs 49.3 (SD 11.1) years, symptom duration 15.1 (SD 11.1) years vs 14.6 (SD 11.9) years, and pain score 5.9 (SD 2.3) vs 6.3 (SD 2.0), respectively. Overall, of patients with axSpA or non-SpA back pain, 30.9% vs 29.1% of patients showed any response and 23.5% vs 16.4% of patients showed a good response after 4 weeks, respectively (P value not significant). No differences were found in the rapidity of response or between subgroups of patients based on demographics, including different stages of axSpA. CONCLUSION: No major differences in the response to NSAIDs were found between patients with axSpA and those with non-SpA with longstanding chronic back pain. The item in the Assessment of SpondyloArthritis international Society classification criteria on "response to NSAIDs" needs more study.
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Espondiloartrite Axial , Espondilartrite , Humanos , Adulto , Pacientes Ambulatoriais , Dor nas Costas/diagnóstico , Dor nas Costas/tratamento farmacológico , Espondilartrite/complicações , Espondilartrite/diagnóstico , Espondilartrite/tratamento farmacológico , Anti-Inflamatórios não Esteroides/uso terapêuticoRESUMO
OBJECTIVES: We aimed to study remission rates in patients with RA in a tertiary care centre over a long-term observation period. METHODS: In a monocentric cohort study with a prospective and a retrospective part, adult RA patients were included. Patient's characteristics and outcome parameters were documented prospectively (clinical visit). Data of the initial visit (index visit) and date of first occurrence of remission were taken retrospectively from the hospital information system. Remission was defined as DAS28 <2.6 and sustained remission (SR) was defined as remission lasting >6 months. Logistic regression analysis was used to analyse factors associated with remission and SR. RESULTS: A total of 136 RA patients were included with retrospective data available over a period of 47.9 (18.9) months. One third already had erosions and severe limitations in physical function at baseline. The vast majority (n=109) of patients achieved a state of remission at least once over time (80.1%). At the clinical visit, 40 patients (29.4%) were in remission. Remission was achieved 14.9 months (13.8) after the index visit and by 54.1%, 23.9%, 13.8%, and 8.3% of patients within the first, second, third, and fourth year, respectively. SR was achieved by 65 patients (47.8%) within the observation period. CONCLUSIONS: Most patients achieved remission at least once within the observation period and almost 50% of patients also achieved SR. This study shows that the target of achieving remission should be constantly pursued, as we were able to show that even in the fourth year of treatment, patients still achieved remission.
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Antirreumáticos , Artrite Reumatoide , Indução de Remissão , Centros de Atenção Terciária , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/fisiopatologia , Estudos Retrospectivos , Idoso , Antirreumáticos/uso terapêutico , Resultado do Tratamento , Adulto , Estudos Prospectivos , Fatores de Tempo , Índice de Gravidade de Doença , Modelos LogísticosRESUMO
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.
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Anticorpos Monoclonais Humanizados/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Herpes Zoster/epidemiologia , Inibidores de Janus Quinases/uso terapêutico , Adulto , Idoso , Feminino , Humanos , Incidência , Interleucina-6/antagonistas & inibidores , Masculino , Pessoa de Meia-Idade , Terapia de Alvo Molecular , Sistema de Registros , Fatores de Risco , Fator de Necrose Tumoral alfa/antagonistas & inibidoresRESUMO
OBJECTIVE: To evaluate the diagnostic value of SpA parameters and their combination for the diagnosis of axial SpA in patients with an a priori different probability of the diagnosis. METHODS: A total of 361 patients with chronic back pain and suspicion of axial SpA (181 referred by primary care physicians or orthopaedists, 180 recruited via an online screening tool) received a structured rheumatologic examination, which resulted into a diagnosis or exclusion of axial SpA. The prevalence of axial SpA indicating the pre-test probability was 40% in the physician-referred subgroup and 20% in the online screening subgroup. Sensitivities, specificities and likelihood ratios for SpA features were determined in both subgroups and the respective post-test probabilities of axial SpA were calculated. RESULTS: The relative diagnostic value of single SpA features varied substantially between the groups with different referral pathways. For instance, HLA-B27 positivity increased the probability of the presence of axial SpA by 35% to 55% in online-screened patients and by 22% to 62% in physician-referred patients. The absence of HLA-B27 resulted in a sharp decrease in the probability of the presence of axial SpA in physician-referred patients (from 40% to 6%). This decrease was less sharp in the online screening group (from 20% to 10%). These differences were especially relevant in patients with a small number (one to two) of positive SpA features. CONCLUSION: The diagnostic value of SpA features varies in different patient populations, which should be considered in the diagnostic approach.
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Espondiloartrite Axial/diagnóstico , Espondiloartrite Axial/epidemiologia , Estudos de Coortes , Sistemas de Apoio a Decisões Clínicas , Alemanha/epidemiologia , HumanosRESUMO
OBJECTIVE: Chronic inflammatory back pain (IBP) is frequently reported in axial SpA (axSpA) but also in the general population. We evaluated a recently proposed two-step referral system for early recognition of axSpA in primary care and compare it with other combinations of symptoms and SpA-related items. METHODS: Consecutive chronic back pain patients ≤45 years of age answered a questionnaire and were seen by a primary care physician who decided whether HLA-B27 needed to be determined. They were then referred to a rheumatologist who made the diagnosis. Generally sticking to the two-step system with HLA-B27 as an additional option, combinations with a sensitivity ≥90% and a likelihood ratio >4 were compared. RESULTS: A total of 326 patients were included, 46 of whom were diagnosed with axSpA (14.1%). The sensitivity of the strategy was 87%, the specificity was 56.8% and the positive and negative predictive values were 24.8% and 96.4%, respectively. A 'good response to NSAIDs', 'morning stiffness >30 min' and 'elevated C-reactive protein' performed best, with a sensitivity of 91%, specificity of 67%, positive predictive value of 31% and negative predictive value of 98%. On that basis, only three patients had to be seen by a rheumatologist to diagnose one. CONCLUSION: The earlier proposed referral system worked well but was outperformed by other combinations with high sensitivity and better specificity, which deserve to be prospectively studied.
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Dor nas Costas/etiologia , Dor Crônica/etiologia , Atenção Primária à Saúde/métodos , Encaminhamento e Consulta/normas , Espondilartrite/diagnóstico , Adulto , Diagnóstico Precoce , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Encaminhamento e Consulta/estatística & dados numéricos , ReumatologiaRESUMO
OBJECTIVES: Osteitis condensans ilii (OCI) has become an important differential diagnosis for axial spondyloarthritis (axSpA). The objective of this matched case-control study was to investigate demographic, clinical, laboratory and MRI characteristics of OCI as compared with axial spondyloarthritis (axSpA). METHODS: A total of 60 patients diagnosed with OCI were included in the final analysis. From 27 of these patients, MRIs of the sacroiliac joints were available. OCI patients were matched with a 1:1 ratio by back pain duration to patients with definite axSpA in order to compare clinical, laboratory and MRI characteristics. RESULTS: The OCI patients were nearly all females (96.7 vs 46.7%), had a significantly lower prevalence of inflammatory back pain (39.5 vs 88.9%), a significantly lower percentage of HLA-B27 positives (35.2 vs 80.0%) and a lower prevalence of the majority of other SpA features as compared with axSpA patients. Interestingly, there was no difference in the prevalence of osteitis in the sacroiliac joints (92.6 vs 85.2% in OCI and axSpA, respectively, P = 0.44), but there was a difference in the prevalence of erosions (7.4 vs 66.7%, respectively, P = 0.0001). In addition, in OCI nearly all lesions were localized in the anterior part of the sacroiliac joints while in axSpA lesions were localized predominantly in the middle part of the joint (for osteitis: 96 vs 4% in OCI and 28.6 vs 71.4% in axSpA; P = 0.0002 for the inter-group difference). CONCLUSION: Clinical and imaging features of OCI compared with axSpA are described that should help in differential diagnosis.
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Dor nas Costas/diagnóstico por imagem , Espondilartrite/diagnóstico por imagem , Adulto , Dor nas Costas/etiologia , Diagnóstico Diferencial , Feminino , Humanos , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Estudos RetrospectivosRESUMO
OBJECTIVES: To capture comorbidity and medication of persons with Sjögren's syndrome (SS) in a population-based cohort in comparison to matched controls. METHODS: Individuals with an outpatient diagnosis of M35.0 (ICD-10) in ≥2 quarters of a year or an inpatient diagnosis of M35.0 were identified in a German statutory health insurance fund covering 7.2 million people. Persons in rheumatologic care were grouped by incident or prevalent diagnosis and by co-existing autoimmune disease (sSS) or primary (p)SS and compared to age- and sex-matched controls regarding comorbidity (ICD-10), medical prescriptions, hospitalisation and inability to work in the previous year. RESULTS: In 2018, 7,283 persons (0.10%) had incident and 54,273 persons (0.75%) prevalent SS diagnosis, and 5,961 (11%) were in rheumatologic care. Of these (90% female, mean age 66 years), 3,457 (58%) had further autoimmune disease (sSS), mostly rheumatoid arthritis (80%) and systemic lupus erythematosus (13%). Compared to controls, frequent comorbid conditions in SS were hypertension (controls: 52%, pSS: 55%, sSS: 63%), osteoarthritis (22%/40%/47%), osteoporosis (10%/26%/38%) and depression (21%/34%/36%). Systemic antirheumatic drugs were prescribed in 31% (pSS) and 66% (sSS) while < 5% received topical therapies. Glucocorticoids (8%/34%/59%), NSAIDs (28%/41%/45%), opioids (8%/15%/21%), analgesics (19%/30%/36%) and antidepressants (14%/21%/21%) were frequently prescribed. Compared to controls, hospitalisation (21%/32%/39%) and inability to work in persons <65 years (41%/48%/44%, median days 17/24/30) were more frequent in pSS and sSS than in controls. CONCLUSIONS: SS claims diagnosis is associated with substantial comorbidity and frequent prescription of anti-inflammatory drugs, analgesics and antidepressants. The individual and societal burden of SS shows that, in addition to effective treatment strategies, intensive attention to comorbidities is important in this disease.
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Artrite Reumatoide , Doenças Autoimunes , Síndrome de Sjogren , Idoso , Comorbidade , Análise de Dados , Feminino , Humanos , Masculino , Síndrome de Sjogren/diagnóstico , Síndrome de Sjogren/tratamento farmacológico , Síndrome de Sjogren/epidemiologiaRESUMO
BACKGROUND: A great heterogeneity in total joint replacement (TJR) rates has been reported for osteoarthritis (OA), most likely arising from a gap between patients' and physicians' views on the need for TJR. The purpose of this study therefore was to analyze potential cofactors which might influence the desire of patients to undergo TJR and physicians' willingness to discuss surgery with their patients. METHODS: A total of 8995 patients in Germany with a claims data diagnosis of hip or knee OA or polyarthrosis were asked to complete a questionnaire for this cross-sectional study of sociodemographic factors, indicators of current joint function (WOMAC score), willingness to undergo TJR and whether they had already discussed TJR with a physician. The overall response rate was 40%. Responders with polyarthrosis and individuals without current or chronic symptoms in the corresponding joints, pain in already replaced joints or simultaneous symptomatic hip and knee OA were excluded. We linked the survey results to claims data. Separate logistic regression models were used to assess which parameters were associated with patients' willingness to undergo TJR and physicians' discussion of surgery. RESULTS: We analyzed 478 hip OA and 932 knee OA patients. Just 17% with hip OA and 14% with knee OA were willing to undergo TJR, although 44 and 45% had already discussed surgery with their physicians. Patients' willingness was associated with higher WOMAC scores, a deterioration of symptoms over the last 2 years, and previous TJR for another joint. The discussion with a physician was influenced by the impact on personal life and previous arthroplasty. Older age (odds Ratio (OR) 1.2 per 10 years), male sex (OR 0.69 vs female), longer symptom duration (OR 1.08 per 5 years), deterioration of symptoms (OR 2.0 vs no change/improvement), a higher WOMAC score (OR 1.3 per 10% deterioration) and reduced well-being (OR 1.1 per 10% deterioration) were associated with physician discussion in knee OA patients. CONCLUSIONS: The proportion of patients willing to undergo TJR is lower than the proportion in whom physicians discuss surgery. While previous TJR seems to enhance patients' and surgeons' willingness, the influence of other cofactors is heterogeneous.
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Artroplastia de Quadril/estatística & dados numéricos , Artroplastia do Joelho/estatística & dados numéricos , Osteoartrite do Quadril/cirurgia , Osteoartrite do Joelho/cirurgia , Preferência do Paciente/psicologia , Idoso , Estudos Transversais , Tomada de Decisões , Feminino , Alemanha , Necessidades e Demandas de Serviços de Saúde , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Quadril/diagnóstico , Osteoartrite do Joelho/diagnóstico , Índice de Gravidade de Doença , Inquéritos e QuestionáriosRESUMO
OBJECTIVES: The objective of this study was to assess the current diagnostic delay in axial SpA (axSpA) and to analyse factors associated with it. METHODS: A stratified sample of subjects with a diagnosis of axSpA (International Classification of Diseases, 10th Revision code M45) was drawn from health insurance data in Germany and was questioned on disease-related, lifestyle and socio-economic characteristics. The diagnostic delay was calculated as the time from back pain onset until a diagnosis of axSpA. A multivariable linear regression analysis was performed to explore factors associated with the diagnostic delay. RESULTS: Among 1677 patients with axSpA included in the analysis, the mean diagnostic delay was 5.7 years (median 2.3). Of those, 407 patients were diagnosed in 1996-2005 and 484 patients in 2006-2015. The mean diagnostic delay was not substantially different in both periods: 6.3 years (median 2.6) and 7.4 (2.7), respectively. Multivariable linear regression revealed that female sex [ß = 1.85 (95% CI 1.06, 2.65)], negative HLA-B27 status [ß = 3.61 (95% CI 2.07, 5.14)], presence of psoriasis [ß = 1.40 (95% CI 0.08, 2.73)] and younger age at symptom onset [ß = 1.91 (95% CI 1.53, 2.29)] were factors associated with a longer diagnostic delay. CONCLUSION: The diagnostic delay in axSpA is still unacceptably long. Patients who are female, young at symptom onset, HLA-B27 negative or have psoriasis have a longer diagnostic delay. Specific referral strategies might be necessary in order to decrease the diagnostic delay in patients presenting with these characteristics.
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Espondilartrite/diagnóstico , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Dor nas Costas/etiologia , Criança , Diagnóstico Tardio , Escolaridade , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Fatores de Risco , Fatores Sexuais , Espondilartrite/complicações , Espondilite Anquilosante/complicações , Espondilite Anquilosante/diagnóstico , Fatores de Tempo , Adulto JovemRESUMO
OBJECTIVES: The aim of this study was to assess the psychological well-being and to analyse factors associated with depressive symptoms in axial spondyloarthritis (axSpA). METHODS: A stratified random sample of subjects with a diagnosis of axSpA (International Classification of Diseases, Tenth Revision, German Modification M45) was drawn from health insurance data in Germany. These persons received a postal questionnaire on disease-related, psychological and lifestyle factors as well as socioeconomic status. Additional information to verify the axSpA diagnosis was also collected. The psychological well-being was assessed by means of the 5-item WHO Well-Being Index (WHO-5), which is considered a screening tool for depression. The following established cut-offs on the WHO-5 were applied: >50: good well-being, no depressive symptoms; 29-50: mild depressive symptoms; ≤28: moderate-to-severe depressive symptoms. Information on comorbidities, drug prescriptions and non-pharmacological treatment was retrieved from claims data and linked to the questionnaire data. RESULTS: A total of 1736 persons with a confirmed axSpA diagnosis were included. Using the cut-offs on the WHO-5, 533 persons (31%) were found to have moderate-to-severe depressive symptoms, 479 (28%) had mild depressive symptoms and 724 (42%) had a good well-being. Multivariable logistic regression revealed that higher disease activity, higher level of functional impairment, lower income, self-reported stress and lack of exercise, and younger age represent factors associated with moderate-to-severe depressive symptoms. CONCLUSIONS: The prevalence of depressive symptoms in axSpA subjects is high and associated with disease-related parameters, socioeconomic status and lifestyle factors. These findings highlight the need for the careful evaluation of depressive symptoms as a part of the management strategy for axSpA.
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Depressão/epidemiologia , Depressão/etiologia , Qualidade de Vida , Espondilartrite/diagnóstico , Espondilartrite/psicologia , Adulto , Fatores Etários , Idoso , Estudos de Coortes , Depressão/fisiopatologia , Avaliação da Deficiência , Feminino , Alemanha , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Medidas de Resultados Relatados pelo Paciente , Prognóstico , Medição de Risco , Articulação Sacroilíaca , Índice de Gravidade de Doença , Fatores Sexuais , Perfil de Impacto da Doença , Espondilite Anquilosante/diagnóstico , Espondilite Anquilosante/psicologia , Inquéritos e QuestionáriosRESUMO
Objectives: To investigate the prevalence of diabetes in patients with RA and the impact of diabetes on self-reported outcomes and health care. Methods: RA patients between the ages of 18 and 79 years were randomly selected from a nationwide statutory health insurance fund and were surveyed about rheumatological care and disease burden. Comorbid diabetes (E10-14) was analysed regarding age, sex, BMI and socioeconomic status. Disease burden, comorbidity and prescriptions were compared in RA patients with and without diabetes. Predictors of rheumatological care were identified by multivariate regression. Results: Of the 2535 RA patients, 498 (20%) had diabetes. Diabetes was more frequent in males, in older patients, in patients with a higher BMI and in those with a lower socioeconomic status. All disease outcomes were poorer in RA-diabetes patients and were mainly attributable to a higher BMI. RA-diabetes patients received less DMARDs (40% vs 48%) and had more hospital stays (41% vs 30%) than patients without diabetes (all P < 0.05). Rates of cardiovascular disease (35% vs 15%), depression (39% vs 26%) and renal failure (23% vs 8%) were higher in RA-diabetes patients (all P < 0.0001). They were less frequently treated by rheumatology specialists: 57% vs 67%; odds ratio = 0.64 (95% CI: 0.45, 0.92), after controlling for confounders. Conclusion: The prevalence of diabetes in patients with RA is high and is associated with known sociodemographic factors. More than 40% of patients with RA and diabetes were not under rheumatological care even though they reported a high disease burden, were frequently hospitalized and often presented with further comorbidities.
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Artrite Reumatoide/epidemiologia , Diabetes Mellitus/epidemiologia , Adolescente , Adulto , Fatores Etários , Idoso , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Índice de Massa Corporal , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/etiologia , Comorbidade , Depressão/epidemiologia , Depressão/etiologia , Complicações do Diabetes , Feminino , Inquéritos Epidemiológicos , Hospitalização/estatística & dados numéricos , Humanos , Seguro Saúde , Masculino , Pessoa de Meia-Idade , Razão de Chances , Prevalência , Insuficiência Renal/epidemiologia , Insuficiência Renal/etiologia , Fatores de Risco , Fatores Sexuais , Classe Social , Adulto JovemRESUMO
INTRODUCTION: To identify facilitators and barriers towards vaccination in general and specifically against pneumococci, influenza and SARS-CoV-2 in patients with rheumatic musculoskeletal diseases (RMD). METHODS: Between February and April 2021, consecutive patients with RMD were asked to complete a structured questionnaire on general knowledge about vaccination, personal attitudes and perceived facilitators and barriers towards vaccination. General facilitators (n=12) and barriers (n=15) and more specific ones for vaccination against pneumococci, influenza and SARS-CoV-2 were assessed. Likert scales had four response options: from 1 (completely disagree) to 4 (completely agree). Patient and disease characteristics, their vaccination records and attitudes towards vaccination against SARS-CoV-2 were assessed. RESULTS: 441 patients responded to the questionnaire. Knowledge about vaccination was decent in ≥70% of patients, but <10% of patients doubted its effectiveness. Statements on facilitators were generally more favourable than on barriers. Facilitators for SARS-CoV-2 vaccination were not different from vaccination in general. Societal and organisational facilitators were more often named than interpersonal or intrapersonal facilitators. Most patients indicated that recommendations of their healthcare professional would encourage them to be vaccinated-without preference for general practitioner or rheumatologists. There were more barriers towards SARS-CoV-2 vaccination than to vaccination in general. Intrapersonal issues were most frequently reported as a barrier. Statistically significant differences in response patterns to nearly all barriers between patients classified as definitely willing, probably willing and unwilling to receive SARS-CoV-2 vaccines were noted. DISCUSSION: Facilitators towards vaccination were more important than barriers. Most barriers against vaccination were intrapersonal issues. Societal facilitators identified support strategies in that direction.
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COVID-19 , Vacinas contra Influenza , Influenza Humana , Doenças Musculoesqueléticas , Humanos , Vacinas contra COVID-19/uso terapêutico , Influenza Humana/epidemiologia , Influenza Humana/prevenção & controle , SARS-CoV-2 , COVID-19/epidemiologia , COVID-19/prevenção & controle , Estudos Prospectivos , Vacinas contra Influenza/uso terapêutico , Vacinação , Doenças Musculoesqueléticas/epidemiologia , Doenças Musculoesqueléticas/etiologiaRESUMO
Background: Previous experiences with non-medical switching of adalimumab (ADA) in patients with chronic inflammatory rheumatic diseases (CIRD) come mainly from phase III extension of randomised clinical trials and little from routine care. Objectives: To analyse treatment trajectories over 2 years in patients with CIRD conducting a non-medical switch from originator to biosimilar ADA. Design: A retrospective observational cohort study was conducted with data from a third-level rheumatology centre in Germany. CIRD patients on originator ADA who switched to ADA biosimilar from October 2018 onwards were identified and followed until September 2020. Methods: Patients' characteristics were compared between the four a priori defined treatment trajectories 'continued biosimilar ADA therapy', 'back-switch to originator ADA therapy', 'switch to another biological disease-modifying anti-rheumatic drug (bDMARD) therapy' and 'stopped bDMARD therapy/death/drop out'. Factors associated with continuing biosimilar ADA therapy were analysed using Cox proportional hazards regression analyses. Results: A total of 121 CIRD patients were included. Most patients (66.9%) continued therapy with biosimilar ADA over 2 years, with a treatment retention rate of 73.1%. Whereas 21 patients (17.4%) switched back to originator ADA, mainly due to adverse events, and 8 patients (6.6%) switched to a different bDMARD, mainly due to lack of effect. The estimated risk of withdrawal was lower for longer prior duration on originator ADA [hazard ratio (HR): 0.82; 95% CI: 0.69-0.97] and higher for higher C-reactive protein levels at baseline (HR: 1.18; 95% CI: 1.00-1.39). Male patients, older patients and those for whom originator ADA was their first bDMARD tended to have a lower risk of withdrawal. Conclusion: Our results indicated that three of four patients continue biosimilar ADA over 2 years with lower risks of withdrawal for male sex, older age, longer prior duration on originator ADA and originator ADA as first bDMARD.
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OBJECTIVE: The objective of this study is to build a structural model visualising and quantifying the interrelationships of different disease outcomes with the Assessment of SpondyloArthritis International Society Health Index (ASAS HI) in patients with axial spondyloarthritis (axSpA). METHODS: Cross-sectional data collected at month 72 of the Devenir des Spondylarthropathies Indifferénciées Récentes cohort was analysed. Combining prior knowledge and observed data, probabilistic Bayesian network modelling was used to study how the interplay of different disease outcomes affects the ASAS HI, which measures disease-specific overall functioning and health. Disease outcomes comprised, among others, the Ankylosing Spondylitis (AS) Disease Activity Score (ASDAS) and the Bath AS Functional Index (BASFI). RESULTS: Data of 384 patients were analysed. The obtained structure suggests that ASAS HI is determined by both patient-reported physical function (BASFI) and disease activity (ASDAS). The parameters of the structural model show that an increase of ASDAS or BASFI by 1 unit corresponds to an increase of ASAS HI by 0.70 or 1.25 units, respectively. Moreover, the model suggests that disease activity has an indirect impact on ASAS HI via BASFI. No relationship between spinal mobility or structural damage and ASAS HI was found. CONCLUSIONS: This is the first structural model developed to better understand the construct and the interplay between clinically relevant outcomes related to ASAS HI in axSpA patients. It shows that disease activity and physical function have a strong impact on ASAS HI, confirming it to be a valid construct of overall functioning and health in axSpA patients.
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Espondilartrite , Espondiloartropatias , Espondilite Anquilosante , Humanos , Estudos Transversais , Teorema de Bayes , Espondilartrite/diagnóstico , Espondilartrite/epidemiologia , Espondilite Anquilosante/diagnóstico , Espondilite Anquilosante/epidemiologiaRESUMO
Background: Recent surveys in chronic inflammatory rheumatic diseases (CIRD) showed a high degree of vaccine hesitancy. Current knowledge about patients' attitudes toward vaccination against SARS-CoV-2 is limited. Objectives: To assess the willingness of CIRD patients to be vaccinated against SARS-CoV-2 and to identify the influencing factors compared with non-CIRD patients. Methods: In this cross-sectional study, two cohorts of consecutive patients with and without CIRD were recruited in parallel when presenting to our tertiary hospital and asked to answer questions of a structured interview to assess vaccination willingness to SARS-CoV-2 their experience with SARS-CoV-2 and their personal history of infections and vaccinations. Vaccination willingness was assessed using a numerical rating scale (0: fully disagree; 10: fully agree). Arbitrarily defined cut-offs were used to define definite (score ⩾7) and probable willingness (score of 5 or 6) to be vaccinated. Factors associated with willingness were assessed using Kendall's tau-b correlation measure and linear regression analysis. Results: A total of 514 CIRD and 100 non-CIRD patients, mean age of 54.7 ± 12.8 and 55.6 ± 9.8 years, respectively, were included. Definite and probable willingness to be vaccinated against SARS-CoV-2 was declared by 79.6% and 90.7% versus 76.0% and 85.0% of CIRD and non-CIRD patients, respectively. Only 60% of CIRD patients believed that the vaccines against SARS-CoV-2 were safe, and 42% indicated to be afraid of side effects. Vaccination willingness was significantly correlated with being in a risk group for COVID-19 (tau-b = -0.149), hypertension (tau-b = 0.14), and information about disease prevention (tau-b = 0.19), while a history of infections or immunosuppressive therapy was not. Vaccination willingness was significantly associated with higher education (b = 0.65) and age (b = 0.06). Conclusion: This survey highlights several predictors of relevance for the vaccination willingness of patients with CIRD and controls including appropriate information about its relevance. The good news, however, is that the vast majority of CIRD patients indicated their willingness to be vaccinated. However, there was some uncertainty regarding the safety and efficacy of the vaccines. Since the major influencing factors were education and information about SARS-CoV-2 Vaccine and COVID-19 Disease, patient education should be improved soon.
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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.
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Antirreumáticos , Espondiloartrite Axial , Gravidez Ectópica , Nascimento Prematuro , Anti-Inflamatórios não Esteroides/uso terapêutico , Antirreumáticos/uso terapêutico , Cesárea/efeitos adversos , Feminino , Humanos , Recém-Nascido , Seguro Saúde , Gravidez , Resultado da Gravidez/epidemiologia , Gravidez Ectópica/tratamento farmacológico , Nascimento Prematuro/tratamento farmacológico , Nascimento Prematuro/epidemiologia , Nascimento Prematuro/etiologiaRESUMO
BACKGROUND: The ASAS Health Index (ASAS HI) was developed to assess global functioning in patients with axial spondyloarthritis (axSpA). Influencing factors have not been studied to date, especially the influence of inflammation and structural changes in the spine has remained unclear to date. OBJECTIVE: To find out whether and to what degree do axial inflammation, radiographic damage and other clinical features influence global functioning of patients with axSpA. METHODS: Patient reported outcomes (ASAS HI, pain, BASDAI, BASFI, EQ-5D and SF-36) were assessed, spinal mobility by BASMI and depression by SF-36 scores. Axial inflammation was quantified using the MRI Berlin score and structural damage as detected by conventional radiographs by the modified Stokes AS Spinal Score (mSASSS). Correlation and regression analyses were performed to analyze the association between global functioning and other variables. RESULTS: A total of 191 axSpA patients with different degrees of global functioning and disease activity was included, 60.2% had r-axSpA. Syndesmophytes were found in 38.5% of patients - with a median mSASSS score of 3.8 (IQR 1.0-18.7) in r-axSpA and 0.0 (IQR 0.0-1.2) in nr-axSpA patients. The mean MRI score was 2.3 (IQR 0.5-7.6). ASAS HI values correlated significantly with BASMI, BASDAI, BASFI, BMI and MRI scores. However, no significant correlation was found for mSASSS and CRP. Regression analyses revealed that global functioning was significantly influenced by disease activity, physical function, obesity and depression but not by structural damage or spinal inflammation as detected MRI. CONCLUSIONS: Our study shows that global functioning is strongly associated with physical function, body weight and depression in patients with axSpA but not with spinal inflammation and structural damage. This may be explained by the relatively low mSASSS of these well treated patients.
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Espondiloartrite Axial , Espondilartrite , Espondiloartropatias , Espondilite Anquilosante , Humanos , Inflamação/diagnóstico por imagem , Índice de Gravidade de Doença , Coluna Vertebral/diagnóstico por imagem , Espondilartrite/diagnóstico por imagem , Espondilartrite/tratamento farmacológico , Espondilite Anquilosante/tratamento farmacológicoRESUMO
OBJECTIVE: To analyse comorbidity and healthcare utilisation in individuals with SLE. METHODS: A cohort of individuals with incident SLE diagnosis in 2016 were investigated using claims data from a German statutory health insurance fund. Concomitant diagnoses, medical prescriptions, hospitalisation and sick leave were analysed in the year prior to diagnosis and during a 3-year follow-up in comparison with age-matched and sex-matched controls (1) without autoimmune diseases and (2) with incident diabetes mellitus. Sensitivity analyses were performed excluding cases with additional autoimmune diagnoses and without prescription of antimalarials. RESULTS: Among 571 individuals with SLE, hypertension (48%), depression (30%), hyperlipidaemia (25%), osteoarthritis (25%) and osteoporosis (20%) were the most frequent comorbidities in 2016. Cerebrovascular disease was documented in 9.6%. The number of drugs (mean 9.6, ∆+6.2), hospitalisation (40%, ∆+27%) and days on sick leave (median 46 days, ∆+27 days) increased significantly in the first year with SLE diagnosis. Individuals with SLE were more frequently hospitalised and had more medications compared with both control groups (all p<0.001). The increase in comorbidity diagnoses was low in controls without autoimmune diseases, while controls with diabetes showed a more pronounced increase in cardiovascular risk factors, but less in osteoporosis and cerebrovascular disease. Sensitivity analyses showed comparable results. CONCLUSION: Comorbidities are frequently detected at the time of diagnosis of SLE. High numbers of drug prescriptions and hospitalisation following SLE diagnosis reflect the comprehensive disease burden. The comparison with incident diabetes shows that differences with controls without autoimmune disease are overestimated by detection bias.
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Doenças Autoimunes , Lúpus Eritematoso Sistêmico , Estudos de Coortes , Comorbidade , Humanos , Lúpus Eritematoso Sistêmico/complicações , Aceitação pelo Paciente de Cuidados de SaúdeRESUMO
OBJECTIVE: Osteoarthritis (OA) is a major reason for chronic pain, stiffness, and functional limitation. This study was undertaken to analyze factors associated with the burden of OA, taking the pattern of joint involvement into account. METHODS: From a random sample of 8,995 patients with OA (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, German Modification codes M15 [polyarticular], M16 [hip], or M17 [knee]) from a German statutory health insurance database, 3,564 patients completed a survey including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Patients with knee, hip, concomitant hip and knee, or polyarticular manifestation were compared concerning pain, stiffness, function, and impact on work and personal life. Data were linked to dispensation records. The association of age, sex, body mass index (BMI), symptom duration, and the World Health Organization-5 Well-Being Index (WHO-5) with WOMAC results was assessed in multiple linear regression models. RESULTS: Patients with knee (n = 1,448), hip (n = 959), hip and knee (n = 399), or polyarthritic (n = 758) OA were included. Concomitant hip and knee OA was accompanied by the highest WOMAC values (mean 44), frequent impairment of personal life (75%), and the highest use of analgesics (52% nonsteroidal antiinflammatory drugs, 22% opioids, and 37% others). In the regression analyses, BMI per 5 units and WHO-5 per 10% worsening were associated with an increase in WOMAC values of 4-5 points, irrespective of the joint manifestations. CONCLUSION: Disease burden is high in patients with concomitant hip and knee OA and is connected with frequent prescription of analgesics. Involvement of several joints, BMI, and depressive symptoms need to be considered when using the WOMAC as an outcome instrument.