RESUMO
BACKGROUND: For cost-saving purposes, children and young people with juvenile idiopathic arthritis (JIA) are being switched (for non-medical reasons) from biological originators to biosimilars. Here, we aimed to investigate those who switched from an anti-tumour necrosis factor (TNF) originator to a biosimilar, regarding drug survival and disease activity, compared with a matched cohort who continued the originator. METHODS: This analysis included all patients in the UK JIA Biologics Register switching directly from an anti-TNF originator to a biosimilar of the same product. All patients were matched (age, sex, disease duration, calendar year of when patients started originator therapy, line of therapy, and International League of Associations for Rheumatology [ILAR] category) to patients continuing the originator. For those matched successfully, a Cox proportional hazard model assessed whether drug persistence differed between those who switched compared with those who continued the originator. Overall change in the 71-joint juvenile arthritis disease activity score and the proportion of patients with a clinically important worsening score (by ≥1·7 units) after 6 months was compared between cohorts. This analysis was designed to address a priority research area set by our patient partners. FINDINGS: There were 224 children and young people with non-systemic JIA (139 [62%] were female, and 85 [38%] were male) identified as switching from a biological originator to a biosimilar of the same product from Jan 1, 2017, to July 7, 2023. 143 (64%) patients were originally on adalimumab, 56 (25%) on etanercept, and 25 (11%) on infliximab. Of these, 164 patients were matched successfully to those continuing the originator. There was no evidence that patients switching were more likely to stop treatment compared with those continuing the originator, with a hazard ratio of 1·46 (95% CI 0·93-2·30). Of the 51 patients in the biosimilar group who stopped treatment, 18 (35%) switched back to the originator (14 in the first year), 28 (55%) started a different biological drug, and five (10%) discontinued all treatment by the last follow-up. Of the 87 matched patients with available disease activity, there was no evidence that JADAS-71 worsened more after 6 months, with an odds ratio of 0·71 (95% CI 0·34-1·51; p=0·38). INTERPRETATION: In this matched comparative effectiveness analysis, children and young people with JIA switched from originators to biosimilars. Disease activity was similar between patients switching compared with those continuing the originator. Three quarters of patients were still receiving their biosimilar after 1 year, with switching back to originator uncommon, at only 9% after 1 year, suggesting good tolerability of non-medical switching in this patient population. This information is reassuring to clinicians and patients regarding the effect of non-medical biological switching. FUNDING: British Society for Rheumatology, Versus Arthritis, and National Institutes for Health Research Manchester Biomedical Research Centre.
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Antirreumáticos , Artrite Juvenil , Medicamentos Biossimilares , Substituição de Medicamentos , Humanos , Artrite Juvenil/tratamento farmacológico , Masculino , Feminino , Medicamentos Biossimilares/uso terapêutico , Medicamentos Biossimilares/economia , Medicamentos Biossimilares/efeitos adversos , Criança , Adolescente , Antirreumáticos/uso terapêutico , Reino Unido , Estudos de Coortes , Resultado do Tratamento , Pré-Escolar , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Infliximab/uso terapêutico , Adalimumab/uso terapêutico , Etanercepte/uso terapêutico , Produtos Biológicos/uso terapêuticoRESUMO
OBJECTIVE: To investigate how social support, financial status, and lifestyle influence the development of excess disability in rheumatoid arthritis (RA). METHODS: Data were obtained from the Étude et Suivi des Polyarthrites Indifférenciées Récentes (ESPOIR) cohort study of people with RA. A previous analysis identified groups with similar inflammation trajectories but markedly different disability over 10 years; those in the higher disability trajectory groups were defined as having "excess disability." Self-reported data regarding contextual factors (social support, financial situation, lifestyle) were obtained from participants, and they completed patient-reported outcome measures (pain, fatigue, anxiety, depression) at baseline. The direct effect of the contextual factors on excess disability and the effect mediated by patient-reported outcome measures were assessed using structural equation models. Findings were validated in 2 independent data sets (Norfolk Arthritis Register [NOAR], Early Rheumatoid Arthritis Network [ERAN]). RESULTS: Of 538 included ESPOIR participants (mean age ± SD 48.3 ± 12.2 years; 79.2% women), 200 participants (37.2%) were in the excess disability group. Less social support (ß = 0.17 [95% confidence interval (95% CI) 0.08, 0.26]), worse financial situation (ß = 0.24 [95% CI 0.14, 0.34]), less exercise (ß = 0.17 [95% CI 0.09-0.25]), and less education (ß = 0.15 [95% CI 0.06, 0.23]) were associated with excess disability group membership; smoking, alcohol consumption, and body mass index were not. Fatigue and depression mediated a small proportion of these effects. Similar results were seen in NOAR and ERAN. CONCLUSION: Greater emphasis is needed on the economic and social contexts of individuals with RA at presentation; these factors might influence disability over the following decade.
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Artrite Reumatoide , Humanos , Feminino , Masculino , Estudos de Coortes , Inflamação , Estilo de Vida , Apoio Social , Apoio FinanceiroRESUMO
OBJECTIVE: MTX remains the cornerstone for therapy for RA, yet research shows that non-adherence is significant and correlates with response to therapy. This study aimed to halve self-reported non-adherence to MTX at the Kellgren Centre for Rheumatology. METHODS: An anonymous self-report adherence questionnaire was developed and data collected for 3 months prior to the introduction of interventions, and then regularly for the subsequent 2.5 years. A series of interventions were implemented, including motivational interviewing training, consistent information about MTX and development of a summary bookmark. Information on clinic times was collected for consultations with and without motivational interviewing. Surveys were conducted to ascertain consistency of messages about MTX. A biochemical assay was used to test MTX serum levels in patients at two time points: before and 2.8 years following introduction of the changes. Remission rates at 6 and 12 months post-MTX initiation were retrieved from patient notes and cost savings estimated by comparing actual numbers of new biologic starters compared with expected numbers based on the numbers of consultants employed at the two time points. RESULTS: Between June and August 2016, self-reported non-adherence to MTX was 24.7%. Following introduction of the interventions, self-reported non-adherence rates reduced to an average of 7.4% between April 2018 and August 2019. Clinic times were not significantly increased when motivational interviewing was employed. Consistency of messages by staff across three key areas (benefits of MTX, alcohol guidance and importance of adherence) improved from 64% in September 2016 to 94% in January 2018. Biochemical non-adherence reduced from 56% (September 2016) to 17% (June 2019), whilst remission rates 6 months post-initiation of MTX improved from 13% in 2014/15 to 37% in 2017/18, resulting is estimated cost savings of £30 000 per year. CONCLUSION: Non-adherence to MTX can be improved using simple measures including focussing on the adherence and the benefits of treatment, and providing consistent information across departments.
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Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Adesão à Medicação/estatística & dados numéricos , Metotrexato/uso terapêutico , Entrevista Motivacional , Melhoria de Qualidade , Antirreumáticos/sangue , Artrite Reumatoide/sangue , Produtos Biológicos/uso terapêutico , Consultores/estatística & dados numéricos , Redução de Custos , Humanos , Metotrexato/sangue , Educação de Pacientes como Assunto , Indução de Remissão , Autorrelato/estatística & dados numéricos , Inquéritos e Questionários/estatística & dados numéricos , Fatores de TempoRESUMO
Rheumatoid arthritis (RA) is a chronic inflammatory condition that can result in pain and functional disability. It is also associated with an increased occurrence of comorbidities, including an increased risk of certain cancers such as lung cancer and lymphoma. The aetiopathogenesis of this increased cancer risk is likely multifactorial and includes shared risk factors as well as chronic inflammation. There is also a concern that the treatment for RA itself may increase this risk further, particularly treatment with biologic disease-modifying anti-rheumatic drugs (DMARDs). This paper aims to review the evidence for the increased risk of cancer in RA as well as the latest evidence for the association between DMARDs and tumorigenesis. It also discusses the evidence for the management of patients with biologic DMARDs in the setting of existing cancer.
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Antirreumáticos/uso terapêutico , Artrite Reumatoide/epidemiologia , Artrite Reumatoide/terapia , Neoplasias/etiologia , Antirreumáticos/farmacologia , Artrite Reumatoide/patologia , Humanos , Neoplasias/patologia , Fatores de RiscoRESUMO
Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. Patient global assessment (PGA) is one of the most widely used PROs in RA practice and research and is included in several composite scores such as the 28-joint Disease Activity Score (DAS28). PGA is often assessed by a single question with a 0-10 or 0-100 response. The content can vary and relates either to global health (e.g., how is your health overall) or to disease activity (e.g., how active is your arthritis). The wordings used as anchors, i.e., for the score of 0, 10, or 100 according to the scale used, and the timing (i.e., this day or this week) also vary. The different possible ways of measuring PGA translate into variations in its interpretation and reporting and may impact on measures of disease activity and consequently achievement of treat-to-target goals. Furthermore, although PGA is associated with objective measures of disease activity, it is also associated with other aspects of health, such as psychological distress or comorbidities, which leads to situations of discordance between objective RA assessments and PGA. Focusing on the role of PGA, its use and interpretation in RA, this review explores its validity and correlations with other disease measures and its overall value for research and routine clinical practice.
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Artrite Reumatoide , Psicometria , Autorrelato , Avaliação da Deficiência , Humanos , Psicometria/métodos , Psicometria/normas , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
OBJECTIVE: Under the auspices of the European League Against Rheumatism (EULAR), a study group of investigators representing European biologic DMARD (bDMARD) registers was convened. The purpose of this initial assessment was to collect and compare a cross section of patient characteristics and collate information on the availability of potential confounders within these registers. METHODS: Baseline characteristics of patients starting their first bDMARD in an arbitrary year (2008) for the treatment of RA, including demographic and disease characteristics, bDMARD drug details and co-morbidities, were collected and compared across 14 European bDMARD registers. RESULTS: A total of 5320 patients were included. Half the registers had restricted recruitment to certain bDMARDs during the study year. All registers` collected data on age, gender, disease duration, seropositivity for IgM-RF and 28-joint DAS (DAS28). The mean DAS28 ranged from 4.2 to 6.6 and the mean HAQ from 0.8 to 1.9. Current smoking ranged from 9% to 34%. Nine registers reported co-morbidities with varying prevalence. CONCLUSION: In addition to demonstrating European-wide collaboration across rheumatology bDMARD registers, this assessment identified differences in prescribing patterns, recruitment strategies and data items collected. These differences need to be considered when applying strategies for combined analysis. The lack of a common data model across Europe calls for further work to harmonize data collection across registers.
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Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Grupos Diagnósticos Relacionados , Sistema de Registros/estatística & dados numéricos , Adulto , Estudos Transversais , Europa (Continente) , Humanos , Estatística como AssuntoRESUMO
OBJECTIVE: To examine the association between socioeconomic status (SES) and delay to a pediatric rheumatology clinic, disease severity, and illness perception in patients with juvenile idiopathic arthritis in England. METHODS: Using the Index of Multiple Deprivation, 923 consecutive children from the Childhood Arthritis Prospective Study were assigned to SES groups: high-SES (19.1%), middle-SES (44.5%), or low-SES (36.4%). At baseline, disease activity was assessed, and the Childhood Health Assessment Questionnaire (C-HAQ), the Illness Perception Questionnaire, and the Child Health Questionnaire, version Parent Form 50, were completed. Linear median regression analyses or zero-inflated negative binominal (ZINB) regression analyses were used. RESULTS: Delay to first pediatric rheumatology consultation was the same between the 3 SES groups. Although disease activity scores assessed by the pediatric rheumatologist did not differ between the 3 SES groups, persons in the low-SES group recorded higher C-HAQ scores compared to the high-SES group (zero-inflated part of ZINB odds ratio 0.28 [95% confidence interval (95% CI) 0.14, 0.55], count part of ZINB ß 0.26 [95% CI 0.05, 0.48]). Parents with low SES also reported more often that their children's school work or activities with friends had been limited. Furthermore, the low-SES group had a worse perception about the consequences of the disease and the effect of treatment than those in the high-SES group. CONCLUSION: Patients from a low-SES background report more problems with daily activities and have a lower perception of the consequences of the disease than patients from a high-SES background, warranting special attention from a multidisciplinary team.
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Artrite Juvenil/diagnóstico , Artrite Juvenil/economia , Avaliação da Deficiência , Disparidades nos Níveis de Saúde , Atividade Motora , Reumatologia/métodos , Autoimagem , Classe Social , Inquéritos e Questionários , Atividades Cotidianas , Adolescente , Artrite Juvenil/fisiopatologia , Artrite Juvenil/psicologia , Artrite Juvenil/terapia , Criança , Pré-Escolar , Efeitos Psicossociais da Doença , Estudos Transversais , Inglaterra , Feminino , Acessibilidade aos Serviços de Saúde/economia , Humanos , Modelos Lineares , Masculino , Razão de Chances , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Encaminhamento e Consulta , Índice de Gravidade de DoençaRESUMO
INTRODUCTION: Anti-TNF therapies have been introduced for the management of psoriatic arthritis (PsA). There is a need to assess their effectiveness and safety in clinical practice. AREAS COVERED: This review examines the emerging evidence of effectiveness, safety and drug persistence of anti-TNF therapies in PsA. It also assesses their impact on quality of life and physical functioning in patients with PsA, as well as potential predictors associated with changes in these domains. Several studies from different countries have demonstrated the effectiveness of the anti-TNF therapies in the management of PsA. These therapies have also been shown to be safe and well tolerated over a median usage of 3 years when compared to conventional disease modifying antirheumatic drugs. They also improved quality of life and physical functioning of patients suffering from PsA. EXPERT OPINION: Anti-TNF therapies are effective and safe in the management of PsA. Improvements in disease activity have been shown to be associated with improvements in quality of life of PsA patients receiving anti-TNF therapies.
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Artrite Psoriásica/tratamento farmacológico , Fatores Imunológicos/uso terapêutico , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Antirreumáticos/administração & dosagem , Antirreumáticos/efeitos adversos , Antirreumáticos/uso terapêutico , Artrite Psoriásica/fisiopatologia , Humanos , Fatores Imunológicos/administração & dosagem , Fatores Imunológicos/efeitos adversos , Adesão à Medicação , Qualidade de Vida , Resultado do TratamentoRESUMO
OBJECTIVES: Adolescents with juvenile idiopathic arthritis have demonstrated substantial disagreement with their proxy's assessment of their disability, pain, and well-being. Our objective was to describe the clinical and psychological factors associated with discordance. STUDY DESIGN: This analysis included 204 proxy-adolescent (median age, 13 years) dyads that completed a Childhood Health Assessment Questionnaire for disability with 100-mm visual analogue scales for pain and well-being. Depressive symptoms in adolescents were measured by the Mood and Feelings Questionnaire and in proxies the General Health Questionnaire. Disagreement was assessed using Bland-Altman plots. Associations with discordance were identified using logistic regression analyses. RESULTS: There was higher agreement for disability (84%) than for pain (71%) and well-being (66%). Regression analyses found no association between age, sex, or disease duration and disagreement. However, relationships between disease activity and disagreement in outcomes were identified. Independent associations were found between increasing Mood and Feelings Questionnaire scores and disagreement in pain and well-being. CONCLUSIONS: Proxy and adolescent reports of pain and well-being are more likely to disagree in those with severe disease. Adolescents who report depressive symptoms are also more likely to disagree with their proxy. The reasons for these are multifactorial, and considerations of both reports are important when assessing outcomes in juvenile idiopathic arthritis.