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OBJECTIVES: The ASSIST study investigated prescribing in routine psoriatic arthritis (PsA) care and whether the patient reported outcome: PsA Impact of Disease questionnaire (PsAID-12), impacted treatment. This study also assessed a range of patient and clinician factors and their relationship to PsAID-12 scoring and treatment modification. METHODS: Patients with PsA were selected across the UK and Europe between July 2021-March 2022. Patients completed the PsAID questionnaire, with the results shared with their physician. Patient characteristics, disease activity, current treatment methods, treatment strategies, medication changes and patient satisfaction scores were recorded. RESULTS: 503 patients recruited. 36.2% had changes made to treatment, 88.8% of this had treatment escalation. Overall, the mean PsAID-12 score was higher for patients with treatment escalation; the PsAID-12 score was associated with odds of treatment escalation (OR: 1.58; p< 0.0001). However, most clinicians reported PsAID-12 did not impact their decision to escalate treatment, instead supporting treatment reduction decisions. Physician's assessment of disease activity had the most statistically significant effect on likelihood of treatment escalation, (OR = 2.68, per 1-point score increase). Escalation was more likely in patients not treated with biologic therapies. Additional factors associated with treatment escalation included: patient characteristics, physician characteristics, disease activity and disease impact. CONCLUSION: This study highlights multiple factors impacting treatment decision making for individuals with PsA. PsAID-12 scoring correlates with multiple measures of disease severity and odds of treatment escalation. However, most clinicians reported the PsAID-12 did not influence treatment escalation decisions. PsAID scoring could be used to increase confidence in treatment de-escalation.
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INTRODUCTION: Diagnosis of axial spondyloarthritis (axSpA) is frequently delayed for years after symptom onset. However, little is known about patient and healthcare professional (HCP) perspectives on barriers and facilitators in axSpA diagnosis. This study explored the experiences and perceptions of both groups regarding the factors affecting the timely diagnosis of axSpA. METHOD: Semi-structured interviews with patients with axSpA and axSpA-interested HCPs from the United Kingdom (UK) were performed by telephone or Microsoft Teams and focussed on the individuals' perspective of the diagnostic journey for axSpA. Interview transcripts were thematically analysed. RESULTS: Fourteen patients with axSpA (10 female, 4 male) and 14 UK based HCPs were recruited, the latter comprising of 5 physiotherapists, 4 General Practitioners, 3 rheumatologists, a nurse, and an occupational therapist. Barriers to diagnosis identified by patients and HCPs were: difficult to diagnose, a lack of awareness, unclear referral pathways, patient behaviour and patient/HCP communication. Patient-identified facilitators of diagnosis were patient advocacy, clear referral processes and pathways, increased awareness, and serendipity. HCPs identified promoting awareness as a facilitator of diagnosis, along with symptom recognition, improvements to healthcare practice and patient/HCP communications. CONCLUSION: Poor communication and a lack of understanding of axSpA in the professional and public spheres undermine progress towards timely diagnosis of axSpA. Improving communication and awareness for patients and HCPs, along with systemic changes in healthcare (such as improved referral pathways) could reduce diagnostic delay.
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Espondiloartrite Axial , Espondilartrite , Espondilite Anquilosante , Humanos , Masculino , Feminino , Espondilartrite/diagnóstico , Espondilite Anquilosante/diagnóstico , Diagnóstico Tardio , Pesquisa QualitativaRESUMO
OBJECTIVES: To identify and prioritize the top 10 research questions for PsA. METHODS: The British Psoriatic Arthritis Consortium (BritPACT) formed a Priority Setting Partnership (PSP) comprising of people living with PsA, carers and clinicians, supported by the James Lind Alliance (JLA). This PSP followed the established three-stage JLA process: first, an online survey of people living with PsA, carers and clinicians to identify PsA questions, asking, 'What do you think are the most important unanswered questions in psoriatic arthritis research?' The questions were checked against existing evidence to establish 'true uncertainties' and grouped as 'indicative questions' reflecting the overarching themes. Then a second online survey ranked the 'true uncertainties' by importance. Finally, a workshop including people living with PsA and clinician stakeholders finalized the top 10 research priorities. RESULTS: The initial survey attracted 317 respondents (69% people living with PsA, 15% carers), with 988 questions. This generated 46 indicative questions. In the second survey, 422 respondents (78% people living with PsA, 4% carers) prioritized these. Eighteen questions were taken forward to the final online workshop. The top unanswered PsA research question was 'What is the best strategy for managing patients with psoriatic arthritis including non-drug and drug treatments?' Other top 10 priorities covered diagnosis, prognosis, outcome assessment, flares, comorbidities and other aspects of treatment (https://www.jla.nihr.ac.uk). CONCLUSION: The top 10 priorities will guide PsA research and enable PsA researchers and those who fund research to know the most important questions for people living with PsA.
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Artrite Psoriásica , Pesquisa Biomédica , Humanos , Artrite Psoriásica/terapia , Prioridades em Saúde , Avaliação de Resultados em Cuidados de Saúde , Inquéritos e Questionários , CuidadoresRESUMO
OBJECTIVES: Shared decision-making (SDM) is advocated to improve patient outcomes in Psoriatic arthritis (PsA). We analysed current prescribing practices and the extent of SDM in PsA across Europe. METHODS: The ASSIST study was a cross-sectional observational study of PsA patients aged ≥18 years attending face-to-face appointments between July 2021-March 2022. Patient demographics, current treatment and treatment decisions were recorded. SDM was measured by the clinician's effort to collaborate (CollaboRATE questionnaire) and patient communication confidence (PEPPI-5 tool). RESULTS: 503 patients were included from 24 centres across the UK, France, Germany, Italy and Spain. Physician- and patient-reported measures of disease activity were highest in the UK. Conventional synthetic DMARDs constituted a higher percentage of current PsA treatment in UK than continental Europe (66.4% vs 44.9%), which differed from biologic DMARDs (36.4% vs 64.4%). Implementing treatment escalation was most common in the UK. CollaboRATE and PEPPI-5 scores were high across centres. Of 31 patients with low CollaboRATE scores (<4.5), no patients with low PsAID-12 scores (<5) had treatment escalation. However, of 465 patients with CollaboRATE scores ≥4.5, 59 patients with low PsAID-12 scores received treatment escalation. CONCLUSIONS: Higher rates of treatment escalation seen in the UK may be explained by higher disease activity and a younger cohort. High levels of collaboration in face-to-face PsA consultations suggests effective implementation of the SDM approach. Our data indicate that, in patients with mild disease activity, only those with higher perceived collaboration underwent treatment escalation. Prospective studies should examine the impact of SDM on PsA patient outcomes. TRIAL REGISTRATION: clinicaltrials.gov, NCT05171270.
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OBJECTIVES: We aimed to estimate what proportion of people with SLE attending UK rheumatology clinics would be categorized as being at high risk from coronavirus disease 2019 (COVID-19) and therefore asked to shield, and explore what implications this has for rheumatology clinical practice. METHODS: We used data from the British Society for Rheumatology multicentre audit of SLE, which included a large, representative cross-sectional sample of patients attending UK Rheumatology clinics with SLE. We calculated who would receive shielding advice using the British Society for Rheumatology's risk stratification guidance and accompanying scoring grid, and assessed whether ethnicity and history of nephritis were over-represented in the shielding group. RESULTS: The audit included 1003 patients from 51 centres across all 4 nations of the UK. Overall 344 (34.3%) patients had a shielding score ≥3 and would have been advised to shield. People with previous or current LN were 2.6 (1.9-3.4) times more likely to be in the shielding group than people with no previous LN (P < 0.001). Ethnicity was not evenly distributed between the groups (chi-squared P < 0.001). Compared with White people, people of Black ethnicity were 1.9 (1.3-2.8) and Asian 1.9 (1.3-2.7) times more likely to be in the shielding group. Increased risk persisted after controlling for LN. CONCLUSION: Our study demonstrates the large number of people with SLE who are likely to be shielding. Implications for clinical practice include considering communication across language and cultural differences, and ways to conduct renal assessment including urinalysis, during telephone and video consultations for patients who are shielding.
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COVID-19/prevenção & controle , Lúpus Eritematoso Sistêmico/terapia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Quarentena/estatística & dados numéricos , Reumatologia/estatística & dados numéricos , Adulto , Estudos Transversais , Feminino , Humanos , Lúpus Eritematoso Sistêmico/virologia , Nefrite Lúpica/terapia , Nefrite Lúpica/virologia , Masculino , Auditoria Médica , Pessoa de Meia-Idade , Análise de Regressão , SARS-CoV-2 , Telemedicina/estatística & dados numéricos , Reino Unido/epidemiologiaRESUMO
OBJECTIVES: To assess the baseline care provided to patients with SLE attending UK Rheumatology units, audited against standards derived from the recently published BSR guideline for the management of adults with SLE, the NICE technology appraisal for belimumab, and NHS England's clinical commissioning policy for rituximab. METHODS: SLE cases attending outpatient clinics during any 4-week period between February and June 2018 were retrospectively audited to assess care at the preceding visit. The effect of clinical environment (general vs dedicated CTD/vasculitis clinic and specialized vs non-specialized centre) were tested. Bonferroni's correction was applied to the significance level. RESULTS: Fifty-one units participated. We audited 1021 episodes of care in 1003 patients (median age 48 years, 74% diagnosed >5 years ago). Despite this disease duration, 286 (28.5%) patients had active disease. Overall in 497 (49%) clinic visits, it was recorded that the patient was receiving prednisolone, including in 28.5% of visits where disease was assessed as inactive. Low documented compliance (<60% clinic visits) was identified for audit standards relating to formal disease-activity assessment, reduction of drug-related toxicity and protection against comorbidities and damage. Compared with general clinics, dedicated clinics had higher compliance with standards for appropriate urine protein quantification (85.1% vs 78.1%, P ≤ 0.001). Specialized centres had higher compliance with BILAG Biologics Register recruitment (89.4% vs 44.4%, P ≤ 0.001) and blood pressure recording (95.3% vs 84.1%). CONCLUSIONS: This audit highlights significant unmet need for better disease control and reduction in corticosteroid toxicity and is an opportunity to improve compliance with national guidelines. Higher performance with nephritis screening in dedicated clinics supports wider adoption of this service-delivery model.
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Fidelidade a Diretrizes/estatística & dados numéricos , Lúpus Eritematoso Sistêmico/terapia , Guias de Prática Clínica como Assunto , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antirreumáticos/uso terapêutico , Feminino , Humanos , Lúpus Eritematoso Sistêmico/diagnóstico , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Masculino , Auditoria Médica , Pessoa de Meia-Idade , Qualidade da Assistência à Saúde/normas , Qualidade da Assistência à Saúde/estatística & dados numéricos , Estudos Retrospectivos , Reino Unido , Adulto JovemRESUMO
OBJECTIVE: To test the addition of pain and fatigue to the Composite Psoriatic Arthritis Disease Activity (CPDAI) and the Group for Research and Assessment of Psoriasis and PsA (GRAPPA) Composite Exercise (GRACE) composite measures of psoriatic arthritis (PsA). METHODS: Clinical and patient-reported outcome measures were assessed in patients with PsA at 3 consecutive follow-up visits over 6 months in a UK multicenter observational study. A pain visual analog scale and Functional Assessment of Chronic Illness Therapy Fatigue scale were added as modifications to the CPDAI and GRACE composite measures. Original and modified versions were tested against the PsA Disease Activity Score (PASDAS) and the Disease Activity Index for PsA (DAPSA). Discrimination between disease states and responsiveness were tested with t-scores, standardized response means (SRMs), and effect sizes. Data were presented to members at the 2020 annual meeting who then voted on the GRAPPA-recommended composite and treatment targets for clinical trials. RESULTS: One hundred forty-one patients were recruited with a mean PsA disease duration of 6.1 years (range 0-41 yrs). The SRMs for the GRACE and modified GRACE (mGRACE) were 0.67 and 0.64, respectively, and 0.54 and 0.46, respectively, for the CPDAI and modified CPDAI (mCPDAI). The t-scores for the GRACE and mGRACE were unchanged at 7.8 for both, and 6.8 and 7.0 for the CPDAI and mCPDAI, respectively. The PASDAS demonstrated the best responsiveness (SRM 0.84) and discrimination (t-scores 8.3). Most members (82%) agreed the composites should not be modified and 77% voted for the PASDAS as the GRAPPA-recommended composite for clinical trials, with 90% minimal disease activity (MDA) as the target. CONCLUSION: Modifying the CPDAI and GRACE with the addition of pain and fatigue does not enhance responsiveness nor the measures' ability to detect disease status in terms of requiring treatment escalation. GRAPPA members voted for the PASDAS as the composite measure in clinical trials and MDA as the target.
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Artrite Psoriásica , Artrite Psoriásica/diagnóstico , Artrite Psoriásica/terapia , Fadiga/diagnóstico , Fadiga/etiologia , Humanos , Dor , Índice de Gravidade de Doença , Reino UnidoRESUMO
OBJECTIVE: To test shortened versions of the psoriatic arthritis (PsA) composite measures for use in routine clinical practice. METHODS: Clinical and patient-reported outcome measures (PROMs) were assessed in patients with PsA at 3 consecutive follow-up visits in a UK multicenter observational study. Shortened versions of the Composite Psoriatic Arthritis Disease Activity Index (CPDAI) and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Exercise (GRACE) measures were developed using PROMs and tested against the Disease Activity Score in 28 joints (DAS28), composite Disease Activity in Psoriatic Arthritis, and Routine Assessment of Patient Index Data (RAPID3). Discrimination between disease states and responsiveness were tested with the t-score, standardized response mean (SRM), and effect size (ES). Data were presented to members at the GRAPPA 2020 annual meeting and members voted on the recommended composite routine practice. RESULTS: The SRM for the GRACE, 3 visual analog scale (VAS), and 4VAS were 0.67, 0.77, and 0.63, respectively, and for CPDAI and shortened CPDAI (sCPDAI) were 0.54 and 0.55, respectively. Shortened versions of the GRACE increased the t-score from 7.8 to 8.7 (3VAS) and 9.0 (4VAS), but reduced the t-score in the CPDAI/sCPDAI from 6.8 and 6.1. The 3VAS and 4VAS had superior performance characteristics to the sCPDAI, DAS28, Disease Activity in Psoriatic Arthritis, and RAPID3 in all tests. Of the members, 60% agreed that the VAS scales contained enough information to assess disease and response to treatment, 53% recommended the 4VAS for use in routine care, and 26% the 3VAS, while leaving 21% undecided. Conclusion. Shortening the GRACE to VAS scores alone enhances the ability to detect status and responsiveness and has the best performance characteristics of the tested composite measures. GRAPPA members recommend further testing of the 3VAS and 4VAS in observational and trial datasets.
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Artrite Psoriásica , Psoríase , Artrite Psoriásica/diagnóstico , Artrite Psoriásica/terapia , Humanos , Medição da Dor , Índice de Gravidade de Doença , Reino UnidoRESUMO
OBJECTIVE: Improving the assessment of psoriatic arthritis (PsA) is a key purpose of the Group for Research and Assessment of Psoriasis and PsA (GRAPPA). Herein, we report the proceedings of the GRAPPA composites workshop at the 2019 GRAPPA annual meeting and the membership's recommended next steps. METHODS: A review of continuous composite measures was conducted in an introductory workshop, followed by 10 breakout group sessions and a final plenary session for feedback and voting. RESULTS: Participants included 154 members: 87 rheumatologists, 18 dermatologists, 2 rheumatologist/dermatologists, 12 patient research partners, 14 academics, 1 methodologist, and 20 industry members. Of voting members, 88.8% agreed a need exists for a continuous composite measure for routine practice, but only 62% were currently using a composite measure. Of these, 27% were using the 28-joint count Disease Activity Score (DAS), which is not a PsA-specific measure; 20% were using a PsA-specific measure such as PsA DAS (PASDAS), Composite Psoriatic Disease Activity Index (CPDAI), or Disease Activity Index for PsA (DAPSA). Members agreed that the existing measures were not feasible in their current forms (CPDAI 83%, PASDAS 82%, and DAPSA 47%) and that modification should be tested. The majority (76%) agreed that disease effect should be measured separately from disease activity. CONCLUSION: The GRAPPA membership supports the need for a continuous composite measure of disease activity for use in routine clinical care, the separate measurement of disease effect and activity, and the testing of modifications to candidate instruments rather than the development of new measures.
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Artrite Psoriásica , Psoríase , Artrite Psoriásica/diagnóstico , Artrite Psoriásica/terapia , Dermatologia , Humanos , Psoríase/diagnóstico , Psoríase/terapia , ReumatologiaRESUMO
Objective: The aim of this study was to compare the incidence of cancer and all-cause and cause-specific mortality rates among a cohort of patients with severe PsA receiving TNF inhibitor (TNFi) with those of the general UK population. Methods: Cancers and deaths were identified from the national cancer and the national death registers in patients with PsA included in the British Society for Rheumatology Biologics Register from start of TNFi until 31 December 2012. Standardized incidence ratios (SIRs) and standardized mortality ratios (SMRs) were calculated using published cancer and death rates for the general population. SIRs were calculated for both overall cancer risk and non-melanoma skin cancer. SMRs were calculated for (1) all-cause mortality, (2) death from malignancy and (3) death from circulatory disease. Gender-specific analyses were also performed. Results: Thirty-four cancers and 41 deaths among 709 patients were observed. The risk of malignancy overall was not increased (SIR 0.94; 95% CI: 0.65, 1.34). However, there was a significantly increased incidence of non-melanoma skin cancer (SIR 2.12; 95% CI: 1.19, 3.50). The all-cause mortality rate in our cohort was increased (SMR 1.56; CI: 1.12, 2.11). Death from malignancy was not increased, but death from coronary heart disease was increased (SMR 2.42; 95% CI: 1.11, 4.59). Conclusion: In our cohort of patients with severe PsA, the overall incidence of malignancy was similar to that of the general population, although the incidence of non-melanoma skin cancer was increased. All-cause mortality was significantly increased, in part due to excess of deaths attributed to coronary heart disease.
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Antirreumáticos/efeitos adversos , Artrite Psoriásica/mortalidade , Produtos Biológicos/efeitos adversos , Neoplasias/mortalidade , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adulto , Idoso , Artrite Psoriásica/tratamento farmacológico , Causas de Morte , Doença das Coronárias/induzido quimicamente , Doença das Coronárias/mortalidade , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Neoplasias/induzido quimicamente , Sistema de Registros , Neoplasias Cutâneas/induzido quimicamente , Neoplasias Cutâneas/mortalidade , Reino Unido/epidemiologiaRESUMO
Objectives: To assess the concordance of gout management by UK rheumatologists with evidence-based best-practice recommendations. Methods: Data were collected on patients newly referred to UK rheumatology out-patient departments over an 8-week period. Baseline data included demographics, method of diagnosis, clinical features, comorbidities, urate-lowering therapy (ULT), prophylaxis and blood tests. Twelve months later, the most recent serum uric acid level was collected. Management was compared with audit standards derived from the 2006 EULAR recommendations, 2007 British Society for Rheumatology/British Health Professionals in Rheumatology guideline and the National Institute for Health and Care Excellence febuxostat technology appraisal. Results: Data were collected for 434 patients from 91 rheumatology departments (mean age 59.8 years, 82% male). Diagnosis was crystal-proven in 13%. Of 106 taking a diuretic, this was reduced/stopped in 29%. ULT was continued/initiated in 76% of those with one or more indication for ULT. One hundred and fifty-eight patients started allopurinol: the starting dose was most commonly 100 mg daily (82%); in those with estimated glomerular filtration rate <60 ml/min the highest starting dose was 100 mg daily. Of 199 who started ULT, prophylaxis was co-prescribed for 94%. Fifty patients started a uricosuric or febuxostat: 84% had taken allopurinol previously. Of 44 commenced on febuxostat, 18% had a history of heart disease. By 12 months, serum uric acid levels ⩽360 and <300 µmol/l were achieved by 45 and 25%, respectively. Conclusion: Gout management by UK rheumatologists concords well with guidelines for most audit standards. However, fewer than half of patients achieved a target serum uric level over 12 months. Rheumatologists should help ensure that ULT is optimized to achieve target serum uric acid levels to benefit patients.
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Auditoria Clínica , Gerenciamento Clínico , Gota/tratamento farmacológico , Pacientes Ambulatoriais , Guias de Prática Clínica como Assunto , Sociedades Médicas , Ácido Úrico/metabolismo , Feminino , Gota/metabolismo , Supressores da Gota/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Reumatologia/normas , Reino UnidoRESUMO
Objective: To quantify the extent to which co-morbid FM is associated with higher disease activity, worse quality of life (QoL) and poorer response to TNF inhibitors (TNFis) in patients with axial SpA. Methods: A prospective study recruiting across 83 centres in the UK. Clinical information and patient-reported measures were available, including 2011 criteria for FM. Multivariable linear regression was used to model the effect of meeting the FM criteria on disease activity, QoL and response to TNFis. Results: A total of 1757 participants were eligible for analyses, of whom 22.1% met criteria for FM. Those with co-morbid FM criteria had higher disease activity [BASDAI average difference FM+ - FM- 1.04 (95% CI 0.75, 1.33)] and worse QoL [Ankylosing Spondylitis Quality of Life score difference 1.42 (95% CI 0.88, 1.96)] after adjusting for demographic, clinical and lifestyle factors. Among 291 participants who commenced biologic therapy, BASDAI scores in those with co-morbid FM were 2.0 higher at baseline but decreased to 1.1 higher at 12 months. There was no significant difference in the likelihood of meeting Assessment of SpondyloArthritis international Society 20 criteria at 12 months. Less improvement in disease activity and QoL over 3 months of TNFi therapy was most strongly related to high scores on the FM criteria symptom severity scale component. Conclusion: Fulfilling criteria for FM has a modest impact on the assessment of axial SpA disease activity and QoL and does not significantly influence response to biologic therapy. Those with a high symptom severity scale on FM assessment may benefit from additional specific management for FM.
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Antirreumáticos/uso terapêutico , Fibromialgia/complicações , Espondilartrite/complicações , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Índice de Gravidade de Doença , Espondilartrite/diagnóstico , Espondilartrite/tratamento farmacológico , Resultado do Tratamento , Nações UnidasRESUMO
BACKGROUND: Tumour necrosis factor (TNF) inhibition and B-cell depletion are highly effective treatments for active rheumatoid arthritis, but so far no randomised controlled trials have directly compared their safety, efficacy, and cost-effectiveness. This study was done to test the hypothesis that using rituximab would be clinically non-inferior and cheaper compared with TNF inhibitor treatment in biological-treatment naive patients with rheumatoid arthritis. METHODS: This open-label, randomised controlled, non-inferiority trial enrolled patients with active, seropositive rheumatoid arthritis and an inadequate response to synthetic disease modifying anti-rheumatic drugs (DMARDs) from 35 rheumatology departments in the UK. Patients were randomly assigned 1:1 to the rituximab or TNF inhibitor groups with minimisation to account for methotrexate intolerance using a web-based randomisation system. Patients were given intravenous rituximab 1 g on days 1 and 15, and after 26 weeks if they responded to treatment but had persistent disease activity (28 joint count disease activity score [DAS28-ESR] >3.2; rituximab group) or a TNF inhibitor-adalimumab (40 mg subcutaneously every other week) or etanercept (50 mg per week subcutaneously) according to the patient's and rheumatologist's choice (TNF inhibitor group). Patients could switch treatment in the case of drug-related toxic effects or absence or loss of response. The primary outcome measure was the change in DAS28-ESR between 0 and 12 months in the per-protocol population of patients who were assigned to treatment and remained in follow-up to 1 year. We assessed safety in all patients who received at least one dose of study drug. We also assessed the cost-effectiveness of each strategy. The non-inferiority margin was specified as 0.6 DAS28-ESR units. This study is registered with ClinicalTrials.gov, number NCT01021735. FINDINGS: Between April 6, 2009, and Nov 11, 2013, 295 patients were randomly assigned and given either rituximab (n=144) or TNF inhibitor (n=151) treatment. After 12 months, the change in DAS28-ESR for patients assigned to rituximab was -2.6 (SD 1.4) and TNF inhibitor was -2.4 (SD 1.5), with a difference within the prespecified non-inferiority margin of -0.19 (95% CI -0.51 to 0.13; p=0.24). The health-related costs associated with the rituximab strategy were lower than the TNF inhibitor strategy (£9,405 vs £11,523 per patient, p<0.0001). 137 (95%) of 144 patients in the rituximab group and 143 (95%) of 151 patients in the TNF inhibitor group had adverse events. 37 serious adverse events occurred in patients receiving rituximab compared with 26 in patients receiving TNF inhibitors, of which 27 were deemed to be possibly, probably, or definitely related to the treatment (15 vs 12, p=0.5462). One patient in each group died during the study. INTERPRETATION: Initial treatment with rituximab is non-inferior to initial TNF inhibitor treatment in patients seropositive for rheumatoid arthritis and naive to treatment with biologicals, and is cost saving over 12 months. FUNDING: Arthritis Research UK, Roche.
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Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Rituximab/uso terapêutico , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adalimumab/administração & dosagem , Adalimumab/uso terapêutico , Antirreumáticos/administração & dosagem , Análise Custo-Benefício , Etanercepte/administração & dosagem , Etanercepte/uso terapêutico , Feminino , Humanos , Injeções Intravenosas , Masculino , Pessoa de Meia-Idade , Rituximab/administração & dosagem , Resultado do TratamentoRESUMO
BACKGROUND: Biologic drugs are expensive treatments used in rheumatoid arthritis (RA). Switching among them is common practice in patients who have had an inadequate response or intolerable adverse events. The National Institute of Health and Clinical Excellence (NICE) UK, which aims to curtail postcode prescribing, has provided guidance on the sequential prescription of these drugs. This study sought to evaluate the extent to which rheumatology centres across the Midlands were complying with NICE guidance on the switching of biologic drugs in RA, as well as analyse the various prescribing patterns of these drugs. METHODS: Data was collected via a web-based tool on RA patients who had undergone at least one switch of a biologic drug during 2011. The standards specified in NICE technology appraisals (TA130, TA186, TA195, TA198, and TA225) were used to assess compliance with NICE guidance. Descriptive statistical analysis was performed. RESULTS: There were 335 biologic drug switches in 317 patients. The most common reason given for switching to a drug was NICE guidelines (242, 72.2%), followed by Physician's choice (122, 33.4%). Lack of effect was the most common reason for discontinuing a drug (224, 67%). For patients on Rituximab, Methotrexate was used in 133 switches (76.9% of the time). Overall NICE compliance for all units was 65% (range 50 to 100%), with anti-TNFα to anti-TNFα switches for inefficacy making up the majority of non-compliant switches. CONCLUSION: This study draws attention to the enigma and disparity of commissioning and prescribing of biologic drugs in RA. Currently the evidence would not support switching of a biologic drug for non-clinical purposes such as economic pressures. Flexibility in prescribing should be encouraged: biologic therapy should be individualised based on the mode of action and likely tolerability of these drugs. Further work should focus on the evidence for using particular sequences of biologic drugs.
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Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/epidemiologia , Produtos Biológicos/uso terapêutico , Substituição de Medicamentos/normas , Auditoria Médica/normas , Padrões de Prática Médica/normas , Idoso , Produtos Biológicos/economia , Coleta de Dados/métodos , Substituição de Medicamentos/economia , Feminino , Humanos , Masculino , Auditoria Médica/economia , Pessoa de Meia-Idade , Padrões de Prática Médica/economia , Reino Unido/epidemiologiaRESUMO
BACKGROUND: Anti-tumour necrosis factor (anti-TNF) therapies are an important recent development in the treatment of autoimmune disease. Despite important side effects relating to immune suppression, there is lack of research into patient experiences, attitudes and expectations about the information they receive prior to starting anti-TNF therapy. METHODS: In May 2011 participants were purposively sampled to form two focus groups varying in age, anti-TNF agent and pre-therapy disease activity. A semi-structured topic guide was used to explore patients' experiences regarding the information they received prior to commencing anti-TNF therapy. The focus groups were audio-taped and transcribed verbatim. Data were analysed using content analysis. RESULTS: Four key themes were identified.Firstly, weighing the risks and benefits of anti-TNF therapy. However, most participants attached limited importance to side effects, saying their strong desire for RA symptom control was overriding. Two reported deliberately concealing illness in order to continue their medication. Secondly, the desire for information. They suggested that counselling should occur at an early stage and not during a severe RA flare-up. Thirdly, the process of starting anti-TNF. Many identified that their biggest worry was whether they would be eligible for the new medication. They remembered little about the investigations they underwent, and none said they would have objected to being tested for blood borne viruses. Finally, the experience of being on anti-TNF. Most were positive, describing effects on quality of life as well as symptoms. CONCLUSIONS: The use of qualitative methodology in this study has enabled an understanding of patients' attitudes towards receiving information about anti-TNF therapy. The results may be useful to health professionals in terms of the timing and content of the information given to patients prior to commencing anti-TNF therapy.
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Antirreumáticos/uso terapêutico , Doenças Autoimunes , Conhecimentos, Atitudes e Prática em Saúde , Satisfação do Paciente , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Doenças Autoimunes/tratamento farmacológico , Doenças Autoimunes/psicologia , Aconselhamento/métodos , Aconselhamento/organização & administração , Feminino , Grupos Focais , Humanos , Disseminação de Informação , Masculino , Pessoa de Meia-Idade , Reumatologia/educação , Reumatologia/métodos , Medição de Risco , Percepção SocialRESUMO
OBJECTIVE: To determine the responsiveness and minimal important change (MIC) of Evaluation of Ankylosing Spondylitis Quality of Life (EASi-QoL), a reliable and valid patient-reported measure of AS-specific quality of life with four domains: physical function (PF), disease activity (DA), emotional well-being (EWB) and social participation (SP). METHODS: A total of 1000 UK AS patients received a postal questionnaire including EASi-QoL. Comparative responsiveness of EASi-QoL was assessed against measures reflecting similar health domains in patients self-reporting an improvement in their AS-specific health at 6 months on a health transition question. Effect size (ES) statistics were calculated for all measures and MIC was determined for EASi-QoL. Comparative responsiveness was determined in a randomized trial of AS patients receiving etanercept (ETN) 50 mg weekly or SSZ 3 g daily. RESULTS: Of 470 patients, 80 responding at 6 months reported health improvement. Responsiveness (ES) for EASi-QoL domains was superior or similar to comparator measures: DA 0.72 vs BASDAI 0.58; SP 0.52 vs SF-36 social functioning 0.29; PF 0.32 vs BASFI 0.28 and SF-36 PF 0.24; EWB 0.40 vs HADS-anxiety 0.13, HADS-depression 0.21 and SF-36 mental health 0.35. ES for the ASQoL was 0.40. Superior ES was seen in those improving somewhat. In the randomized trial, all EASi-QoL domains had superior responsiveness to comparator measures following ETN treatment. Following SSZ treatment, all EASi-QoL domains were highly responsive, but BASDAI and BASFI was more responsive than EASi-QoL(DA) and (PF), respectively. CONCLUSION: In patients reporting improvement during routine clinical practice or following treatment with ETN or SSZ, EASi-QoL domains have superior or comparable responsiveness than comparable measures.
Assuntos
Qualidade de Vida , Índice de Gravidade de Doença , Espondilite Anquilosante/reabilitação , Inquéritos e Questionários , Adulto , Idoso , Antirreumáticos/uso terapêutico , Método Duplo-Cego , Etanercepte , Feminino , Humanos , Imunoglobulina G/uso terapêutico , Relações Interpessoais , Masculino , Saúde Mental , Pessoa de Meia-Idade , Satisfação do Paciente , Receptores do Fator de Necrose Tumoral/uso terapêutico , Espondilite Anquilosante/tratamento farmacológico , Espondilite Anquilosante/fisiopatologia , Espondilite Anquilosante/psicologia , Resultado do TratamentoRESUMO
OBJECTIVES: To describe the healthcare resource use and productivity losses associated with patients with ankylosing spondylitis (AS) and explore the relationship between disease severity and total costs. METHODS: A cross-sectional postal survey was conducted on a sample of 1,000 patients with AS randomly selected from registries at 10 secondary care rheumatology centres in the UK. Information on demographic characteristics, disease and functional activity, healthcare use and work status (presenteeism and absenteeism) during the previous three months was collected. The relationship between disease severity and total costs was explored using a two-part regression model, controlling for age, gender and disease duration and validated on respondents (n=470) of the second round of the survey. RESULTS: Respondents at baseline (n=612) covered the full spectrum of AS, had a mean BASDAI of 4.6 and 55.3% of individuals scored at least 4 on the BASDAI scale. The mean (median) three month total cost was £2,802 (£1,160). Both physical function and disease activity were significant predictors of total costs. Mean (median) three month total costs for patients with BASDAI <4, 4-6 and >6 were £1,331 (£502), £2,790 (£1,281) and £4,840 (£5,017) respectively. Direct National Health Service funded healthcare costs contributed to just 15% of total costs while unemployment, absenteeism from work and reduced productivity at work accounted for 63.2%, 1.4% and 19.0% of total costs, respectively. CONCLUSIONS: This study shows that direct healthcare costs alone do not describe the total costs associated with AS and that productivity losses associated with AS are considerable.
Assuntos
Absenteísmo , Custos de Cuidados de Saúde , Licença Médica/economia , Espondilite Anquilosante/economia , Medicina Estatal/economia , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Distribuição de Qui-Quadrado , Efeitos Psicossociais da Doença , Estudos Transversais , Avaliação da Deficiência , Eficiência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Sistema de Registros , Análise de Regressão , Índice de Gravidade de Doença , Espondilite Anquilosante/diagnóstico , Espondilite Anquilosante/terapia , Inquéritos e Questionários , Fatores de Tempo , Reino Unido , Adulto JovemRESUMO
Identification of axial spondyloarthritis (axSpA) remains challenging, frequently resulting in a diagnostic delay for patients. Current benchmarks of delay are usually reported as mean data, which are typically skewed and therefore may be overestimating delay. Our aim was to determine the extent of median delay patients' experience in receiving a diagnosis of axSpA and examine whether specific factors are associated with the presence of such delay. We conducted a systematic review across five literature databases (from inception to November 2021), with studies reporting the average time period of diagnostic delay in patients with axSpA being included. Any additional information examining associations between specific factors and delay were also extracted. A narrative synthesis was used to report the median range of diagnostic delay experienced by patients with axSpA and summarise which factors have a role in the delay. From an initial 11,995 articles, 69 reported an average time period of diagnostic delay, with 25 of these providing a median delay from symptom onset to diagnosis. Across these studies, delay ranged from 0.67 to 8 years, with over three-quarters reporting a median of between 2 years and 6 years. A third of all studies reported median delay data ranging from just 2 to 2.3 years. Of seven variables reported with sufficient frequency to evaluate, only 'gender' and 'family history of axSpA' had sufficient concordant data to draw any conclusion on their role, neither influenced the extent of the delay. Despite improvements in recent decades, patients with axSpA frequently experience years of diagnostic delay and this remains an extensive worldwide problem. This is further compounded by a mixed picture of the disease, patient and healthcare-related factors influencing delay. Key points ⢠Despite improvements in recent decades, patients with axSpA frequently experience years of diagnostic delay. ⢠Median diagnostic delay typically ranges from 2 to 6 years globally. ⢠Neither 'gender' nor 'family history of axSpA' influenced the extent of diagnostic delay experienced. ⢠Diagnostic delay based on mean, rather than median, data influences the interpretation of the delay time period and consistently reports a longer delay period.