Comparative effectiveness of first-line biological monotherapy use in rheumatoid arthritis: a retrospective analysis of the RECord-linkage On Rheumatic Diseases study on health care administrative databases

Silvagni, Ettore; Bortoluzzi, Alessandra; Carrara, Greta; Zanetti, Anna; Govoni, Marcello; Scirè, Carlo Alberto

doi:10.1136/bmjopen-2017-021447

Cited by 34 publications

(32 citation statements)

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“…In observational studies, survival on drug is considered a good indirect and composite measure of effectiveness, safety, and tolerability of a given treatment [23]. While a significant amount of data regarding survival on drug exists for TNF inhibitors, the lack of studies on abatacept has been recognized [24].…”

Section: Discussionmentioning

confidence: 99%

Abatacept in rheumatoid arthritis: survival on drug, clinical outcomes, and their predictors—data from a large national quality register

et al. 2020

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Background: There are limited data regarding efficacy of abatacept treatment for rheumatoid arthritis (RA) outside clinical trials. Quality registers have been useful for observational studies on tumor necrosis factor inhibition in clinical practice. The aim of this study was to investigate clinical efficacy and tolerability of abatacept in RA, using a national register. Methods: RA patients that started abatacept between 2006 and 2017 and were included in the Swedish Rheumatology Quality register (N = 2716) were investigated. Survival on drug was estimated using Kaplan-Meier analysis. The European League Against Rheumatism (EULAR) good response and Health Assessment Questionnaire (HAQ) response (improvement of ≥ 0.3) rates (LUNDEX corrected for drug survival) at 6 and at 12 months were assessed. Predictors of discontinuation were investigated by Cox regression analyses, and predictors of clinical response by logistic regression. Significance-based backward stepwise selection of variables was used for the final multivariate models. Results: There was a significant difference in drug survival by previous biologic disease-modifying antirheumatic drug (bDMARD) exposure (p < 0.001), with longer survival in bionaïve patients. Men (hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.74-0.98) and methotrexate users (HR 0.85, 95% CI 0.76-0.95) were less likely to discontinue abatacept, whereas a high pain score predicted discontinuation (HR 1.14 per standard deviation, 95% CI 1.07-1.20). The absence of previous bDMARD exposure, male sex, and a low HAQ score were independently associated with LUNDEX-corrected EULAR good response. The absence of previous bDMARD exposure also predicted LUNDEXcorrected HAQ response. Conclusions: In this population-based study of RA, bDMARD naïve patients and male patients were more likely to remain on abatacept with a major clinical response.

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Section: Discussionmentioning

confidence: 99%

Abatacept in rheumatoid arthritis: survival on drug, clinical outcomes, and their predictors—data from a large national quality register

et al. 2020

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“…This is a retrospective cohort study performed using data of the Record Linkage of Rheumatic Disease (RECORD) study (promoted by the Italian Society for Rheumatology), [19][20][21][22][23][24] an observational study aimed both to measure prevalence, incidence and mortality of RA and to implement an algorithm which can identify patients with RA using administrative healthcare database (AHD) information.…”

Section: Patients and Methods Study Design And Settingmentioning

confidence: 99%

Can the adherence to quality of care indicators for early rheumatoid arthritis in clinical practice reduce risk of hospitalisation? Retrospective cohort study based on the Record Linkage of Rheumatic Disease study of the Italian Society for Rheumatology

et al. 2020

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ObjectiveTo describe the adherence to quality of care indicators in early rheumatoid arthritis (RA) and to evaluate its impact on the risk of hospitalisation in a real-world setting.DesignRetrospective cohort study.SettingPatients with early-onset RA identified from healthcare regional administrative databases by means of a validated algorithm between 2006 and 2012 in the Lombardy region (Italy).ParticipantsThe study cohort included 14 203 early-onset RA (71% female, mean age 60 years).Outcome measuresFor each patient, a summary adherence score was calculated starting from the compliance to six quality indicators: (1–2) methotrexate or sulfasalazine or leflunomide with/without glucocorticoids, (3–4) other disease-modifying antirheumatic drugs (DMARDs) with/without glucocorticoids, (5) early interruption of glucocorticoids, (6) early clinical assessment.The relationship between low, intermediate and high categories of the summary score and the 12-month risk of hospitalisation for all causes and for RA was assessed.ResultsDuring a follow-up of 1 year, 2609 hospitalisations occurred, of which 704 were for RA (main or secondary diagnosis) and 252 primarily for RA. In a 7-year period (2006–2012), early DMARDs and timely clinical monitoring treatment increased (from 52% to 62% p trend <0.001 and from 25% to 30% p trend 0.009, respectively).Intermediate and high summary adherence score categories (compared with the low category) were related significantly with a lower risk of hospitalisation (adjusted HR 0.85 (95% CI 0.77 to 0.93), p<0.001 and HR 0.76 (95% CI 0.69 to 0.84), p<0.001, respectively). Among the indicators of the adherence score, early DMARD prescription showed the strongest positive impact, while long-term use of glucocorticoids was the worst negative one.ConclusionIn early RA, adherence to quality standards of care is associated with a lower risk of hospitalisation. Future interventions to improve the adherence to quality standards of care in this setting should decrease the risk of hospitalisation with a significant impact on individual and population health.

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“…We will assess any biosimilars of adalimumab, etanercept and in iximab. We chose these three main biologics because they are the most prescribed rst-line biologics DMARDs in RA (24). Also, these three DMARDS have the highest numbers of approved biosimilars for RA in the market (13,25).…”

Section: Types Of Biosimilarsmentioning

confidence: 99%

Equivalence and switching between biosimilars and reference molecules in rheumatoid arthritis: protocol for two systematic reviews and meta-analyses

Ascef

Almeida

Ribeiro

et al. 2020

Preprint

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Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-line and second-line treatments for rheumatoid arthritis (RA) patients. However, their high cost poses a massive burden on healthcare systems worldwide. The expiration of patents for these biologics has driven to the production of biosimilar drugs, which are potentially less costly and remarkably similar, albeit not identical to the reference molecules. These two systematic reviews aim to investigate the efficacy and safety profile of biosimilars compared to biologics (systematic review 1) and the impact of switching between biosimilar drugs and reference biologics on the management of RA patients (systematic review 2).Methods Electronic searches will be performed through MEDLINE (via Pubmed), EMBASE, LILACS, and CENTRAL (from inception to September 2020). Risk of bias assessments will be carried out with the Cochrane risk of bias tool, supplemented with specific domains from equivalence trials. Random-effects models will be fitted to obtain summary estimates using either relative risk or standardized mean difference as a metric. Between-trial heterogeneity will be tested and quantified with the Q-test and I2 metric, respectively, whereas assessment of small-study bias will be examined through contour-enhanced funnel plots and Egger and Harbord's tests. Meta-regression models will be fitted when appropriate. The primary outcome will be the rate of treatment success according to the American College of Rheumatology 20 (ACR20) and the co-primary outcome will be the Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index). Conclusions will be based on equivalence hypothesis testing using predefined margins of equivalence elicited from a group of experienced rheumatologists and prior studies. The overall certainty of evidence will be assessed based on the GRADE system.Discussion The two systematic reviews described here, to the best of our knowledge, are the first ones proposing a comprehensive, clinician-oriented approach to assess the equivalence and the impact of switching between biosimilars and biologics on the management of patients with RA. The results will elucidate the efficacy, safety, immunogenicity of biosimilars, and the clinical consequences of substituting biologics with biosimilars in the management of RA. Systematic Review Registration Protocol synopses were previously registered on PROSPERO (CRD42019137152 and CRD42019137155).

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Comparative effectiveness of first-line biological monotherapy use in rheumatoid arthritis: a retrospective analysis of the RECord-linkage On Rheumatic Diseases study on health care administrative databases

Cited by 34 publications

References 49 publications

Abatacept in rheumatoid arthritis: survival on drug, clinical outcomes, and their predictors—data from a large national quality register

Abatacept in rheumatoid arthritis: survival on drug, clinical outcomes, and their predictors—data from a large national quality register

Can the adherence to quality of care indicators for early rheumatoid arthritis in clinical practice reduce risk of hospitalisation? Retrospective cohort study based on the Record Linkage of Rheumatic Disease study of the Italian Society for Rheumatology

Equivalence and switching between biosimilars and reference molecules in rheumatoid arthritis: protocol for two systematic reviews and meta-analyses

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