Hedley Griffiths - Academia.edu (original) (raw)
Papers by Hedley Griffiths
Clinical rheumatology, Apr 18, 2024
Objective To describe the trends in remission rates among RA patients in the OPAL dataset, spanni... more Objective To describe the trends in remission rates among RA patients in the OPAL dataset, spanning from 2009 to 2022, and provide insights into the effectiveness of evolving RA management approaches in real-world clinical settings. Methods Patients with a physician diagnosis of RA and at least 3 visits between 1 January 2009 and December 2022 were identified in the OPAL dataset, an aggregated collection of data extracted from the electronic medical records of patients managed by 117 Australian rheumatologists. Demographics, disease history, prescribed medications and proportions of patients in Disease Activity Score 28-joint count C-reactive protein (DAS28CRP)) categories (remission, low disease activity (LDA), moderate disease activity (MDA) and high disease activity (HDA)) were described. Results A large population (n = 48,388) of eligible patients with RA were identified in the OPAL dataset. A consistent and substantial improvement in DAS28CRP remission rates were found in (i) all patients, (ii) patients managed on conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and (iii) patients treated with biological or targeted synthetic (b/ts)DMARD therapy, increasing from approximately 50% in 2009 to over 70% by 2022. The increase in DAS28CRP remission was accompanied by reduced proportions of patients in MDA and HDA states. Conclusion This study highlights a consistent improvement in disease activity and rising remission rates among Australian RA patients within the OPAL dataset, offering the potential for enhanced patient outcomes and reduced disease burden. Key Points • The treat-to-target (T2T) approach, with the treatment goal of remission or, as an alternative, a state of LDA, has been widely adopted for the management of RA in Australia. • This study demonstrates an encouraging trend of improved disease activity over time, with remission rates of Australian patients with RA steadily increasing year on year.
The Journal of Rheumatology, May 15, 2022
Annals of the Rheumatic Diseases, May 19, 2021
Annals of the Rheumatic Diseases, May 19, 2021
Conclusion: The gradient-boosting model previously identified predictors of abatacept retention f... more Conclusion: The gradient-boosting model previously identified predictors of abatacept retention from ACTION; 2 the addition of SHAP in this analysis has provided information on the importance and directionality of those predictors. The most important predictor of abatacept retention was no previous corticosteroid use, which was associated with lower retention. The models and predictors identified could be further refined by using additional datasets from clinical trials. Machine learning offers an innovative and complementary approach to biostatistics and could be used to identify treatment response predictors at an individual patient level, leading to a more personalised treatment approach.
AB0460-Figure 1. Survival of First-Line Anti-TNF Therapies in Patients with Rheumatoid Arthritis ... more AB0460-Figure 1. Survival of First-Line Anti-TNF Therapies in Patients with Rheumatoid Arthritis Conclusions: Long-term survival rates for ADA, ETN, and IFX were similar and relatively high for treatment periods up to 36 months. After 36 months, there was a noticeable decline in drug survival for all three TNFa inhibitors. Heterogeneity in study size and design may contribute to the range of survival data for each agent.
Revue du Rhumatisme, Dec 1, 2021
Internal Medicine Journal, 2018
Annals of the Rheumatic Diseases, 2021
Background:There are currently eleven biologic and targeted synthetic (b/ts)DMARDs acting via fiv... more Background:There are currently eleven biologic and targeted synthetic (b/ts)DMARDs acting via five different modes of action available for the treatment of RA in Australia. The cost of b/tsDMARDs is subsidized by government for patients that have active RA despite six months of combination csDMARD therapy. Once a patient is eligible, the clinician can prescribe the b/tsDMARD they deem to be the most clinically appropriate for the patient. In Oct 2015 the first JAK inhibitor (JAKi) became available in Australia (tofacitinib, TOF), baricitinib (BARI) became available in Sept 2018, and upadacitinib (UPA) in May 2020. Each of these oral tsDMARDs possess different selectivity profiles towards different members of the JAK family (JAK1–3 and Tyk2).Objectives:The aim of this analysis was to determine the patterns of JAKi cycling in real-world practice in Australia.Methods:Deidentified clinical data were sourced from the OPAL dataset, which is collected in a custom-built electronic medical r...
Annals of the Rheumatic Diseases, 2021
RF and anti-citrullinated protein antibodies (ACPAs) are associated with a severe and aggressive ... more RF and anti-citrullinated protein antibodies (ACPAs) are associated with a severe and aggressive disease course in patients with RA.1 Abatacept is a selective co-stimulation modulator for the treatment of RA.2 ASCORE (Abatacept SubCutaneOus in Routine Clinical PracticE; NCT02090556) was a 2-year, observational, prospective, multicentre study of SC abatacept for the treatment of RA in routine clinical practice.3To determine if serostatus and treatment line impacted disease activity in patients enrolled in the ASCORE study.Eligible patients, aged ≥18 years, with active moderate-to-severe RA (ACR/EULAR 2010 criteria) who were IV abatacept-naive and initiated SC abatacept 125 mg once weekly, were enrolled into two cohorts: biologic (b)DMARD-naive patients and those with ≥1 prior bDMARD treatment failure. This post hoc analysis assessed the mean change in disease activity (CDAI, SDAI and DAS28 [ESR]) from baseline (BL) at 6, 12, 18 and 24 months in response to treatment with abatacept. P...
Annals of the Rheumatic Diseases, 2021
Background:Up to 50% of patients with RA discontinue DMARD treatment within 18 months.1 However, ... more Background:Up to 50% of patients with RA discontinue DMARD treatment within 18 months.1 However, up to 20% of patients who fail multiple treatments may have a good treatment response to another therapy.1 Predictive biomarkers, such as RF and anti-citrullinated protein antibodies (ACPAs), may be useful to stratify patients with RA to the most appropriate treatment.1 ASCORE (Abatacept SubCutaneOus in Routine Clinical PracticE; NCT02090556) was a 2-year, observational, prospective, multicentre study of SC abatacept for the treatment of RA in routine clinical practice.2Objectives:To determine if RF/ACPA serostatus and treatment line impact abatacept retention in patients with RA in a post hoc analysis of ASCORE.Methods:Eligible patients, aged ≥18 years, with active moderate-to-severe RA (ACR/EULAR 2010 criteria) who were IV abatacept-naive and initiated SC abatacept 125 mg once weekly, were enrolled into two cohorts: biologic (b)DMARD-naive patients and those with ≥1 prior bDMARD treatm...
Annals of the Rheumatic Diseases, 2021
Background:Registry studies and clinical trials are increasingly incorporating patient reported o... more Background:Registry studies and clinical trials are increasingly incorporating patient reported outcomes (PROs) to measure the full burden of disease and better measure the efficacy and value of medicines; however, the burden of paper-based surveys, time constraints, and privacy concerns impede the widespread use of PROs in routine clinical care.Objectives:To develop a simple and secure technological solution to incorporate validated PROs into routine clinical care for patients with rheumatic diseases, and to assess the patient response to functional assessment of chronic illness therapy fatigue (FACIT-F), patient health questionnaire-2 (PHQ-2), and healthcare resource utilization (HCRU) questionnaires delivered using this ePRO method.Methods:A novel ePRO questionnaire delivery system was developed by Software4Specialists in partnership with OPAL Rheumatology. Validated PRO questionnaires were sent from the patient’s electronic medical record (Audit4, Software4Specialists) and deliv...
Annals of the Rheumatic Diseases, 2016
Annals of the Rheumatic Diseases, 2013
Annals of the Rheumatic Diseases, 2021
Sleep disorders are more prevalent in patients with ankylosing spondylitis (AS) compared to the g... more Sleep disorders are more prevalent in patients with ankylosing spondylitis (AS) compared to the general population. Sleep disturbance in AS, in addition to pain and fatigue, can lead to impaired physical function and reduced quality of life.The primary objective was to determine the prevalence of sleep disturbance in patients with AS in a real-world Australian cohort using the Insomnia Severity Index (ISI) and Multivariate Apnoea Prediction Index (MAPI). ISI score of ≥ 15 is considered clinical insomnia. MAPI values below 0.05 are suggestive of clinical apnoea.Routinely collected, de-identified clinical data were sourced from the OPAL dataset. Patients aged between 18 and 95 years with a diagnosis of AS and who had completed at least one ISI or MAPI questionnaire between Jan-2019 and Sept-2020 were included. ISI and MAPI questionnaires were emailed to patients using OPAL’s electronic patient reported outcome (ePRO) delivery method or completed in the clinic using a smart device and ...
JAMA Network Open
ImportanceThere is a need for observational studies to supplement evidence from clinical trials, ... more ImportanceThere is a need for observational studies to supplement evidence from clinical trials, and the target trial emulation (TTE) framework can help avoid biases that can be introduced when treatments are compared crudely using observational data by applying design principles for randomized clinical trials. Adalimumab (ADA) and tofacitinib (TOF) were shown to be equivalent in patients with rheumatoid arthritis (RA) in a randomized clinical trial, but to our knowledge, these drugs have not been compared head-to-head using routinely collected clinical data and the TTE framework.ObjectiveTo emulate a randomized clinical trial comparing ADA vs TOF in patients with RA who were new users of a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD).Design, Setting, and ParticipantsThis comparative effectiveness study emulating a randomized clinical trial of ADA vs TOF included Australian adults aged 18 years or older with RA in the Optimising Patient Outcomes in...
Frontiers in Digital Health
ObjectiveTo develop a simple and secure technological solution to incorporate electronic patient-... more ObjectiveTo develop a simple and secure technological solution to incorporate electronic patient-reported outcomes (ePROs) into routine clinical care.MethodsA novel ePRO questionnaire delivery system was developed by Software for Specialists (S4S) in partnership with OPAL Rheumatology Australia. Validated questionnaires were sent from the electronic medical record (EMR) (Audit4) of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), lupus or giant cell arteritis (GCA) and delivered to the patient's email address or completed in the clinic waiting room using a smart device (in-practice). Completed questionnaires were encrypted and returned to the patient's Audit4. Deidentified clinical data was extracted and aggregated across all sites. Data collected between April 2016-Dec 2020 were analysed descriptively.ResultsBetween April 2016 to Dec 2020, 221,352 Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F), Patient Heal...
Internal Medicine Journal, 2012
Background: ASCORE (NCT02090556) is an ongoing, prospective, non-interventional, multicentre stud... more Background: ASCORE (NCT02090556) is an ongoing, prospective, non-interventional, multicentre study of SC abatacept in patients with RA across ten countries. To provide a local perspective, this analysis presents the 6-month (6M) interim retention rates and clinical outcomes by biologic (b)DMARD treatment[for full text, please go to the a.m. URL]
Journal of Pharmacovigilance, 2014
Methotrexate is the mainstay of treatment in rheumatoid arthritis (RA). Used for over 40 years as... more Methotrexate is the mainstay of treatment in rheumatoid arthritis (RA). Used for over 40 years as an anchor treatment in a number of rheumatic diseases, it remains a gold standard of therapy for RA. This review will provide a concise discussion of the efficacy and safety of methotrexate in rheumatic disease, with a focus on Rheumatoid Arthritis.
Clinical rheumatology, Apr 18, 2024
Objective To describe the trends in remission rates among RA patients in the OPAL dataset, spanni... more Objective To describe the trends in remission rates among RA patients in the OPAL dataset, spanning from 2009 to 2022, and provide insights into the effectiveness of evolving RA management approaches in real-world clinical settings. Methods Patients with a physician diagnosis of RA and at least 3 visits between 1 January 2009 and December 2022 were identified in the OPAL dataset, an aggregated collection of data extracted from the electronic medical records of patients managed by 117 Australian rheumatologists. Demographics, disease history, prescribed medications and proportions of patients in Disease Activity Score 28-joint count C-reactive protein (DAS28CRP)) categories (remission, low disease activity (LDA), moderate disease activity (MDA) and high disease activity (HDA)) were described. Results A large population (n = 48,388) of eligible patients with RA were identified in the OPAL dataset. A consistent and substantial improvement in DAS28CRP remission rates were found in (i) all patients, (ii) patients managed on conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and (iii) patients treated with biological or targeted synthetic (b/ts)DMARD therapy, increasing from approximately 50% in 2009 to over 70% by 2022. The increase in DAS28CRP remission was accompanied by reduced proportions of patients in MDA and HDA states. Conclusion This study highlights a consistent improvement in disease activity and rising remission rates among Australian RA patients within the OPAL dataset, offering the potential for enhanced patient outcomes and reduced disease burden. Key Points • The treat-to-target (T2T) approach, with the treatment goal of remission or, as an alternative, a state of LDA, has been widely adopted for the management of RA in Australia. • This study demonstrates an encouraging trend of improved disease activity over time, with remission rates of Australian patients with RA steadily increasing year on year.
The Journal of Rheumatology, May 15, 2022
Annals of the Rheumatic Diseases, May 19, 2021
Annals of the Rheumatic Diseases, May 19, 2021
Conclusion: The gradient-boosting model previously identified predictors of abatacept retention f... more Conclusion: The gradient-boosting model previously identified predictors of abatacept retention from ACTION; 2 the addition of SHAP in this analysis has provided information on the importance and directionality of those predictors. The most important predictor of abatacept retention was no previous corticosteroid use, which was associated with lower retention. The models and predictors identified could be further refined by using additional datasets from clinical trials. Machine learning offers an innovative and complementary approach to biostatistics and could be used to identify treatment response predictors at an individual patient level, leading to a more personalised treatment approach.
AB0460-Figure 1. Survival of First-Line Anti-TNF Therapies in Patients with Rheumatoid Arthritis ... more AB0460-Figure 1. Survival of First-Line Anti-TNF Therapies in Patients with Rheumatoid Arthritis Conclusions: Long-term survival rates for ADA, ETN, and IFX were similar and relatively high for treatment periods up to 36 months. After 36 months, there was a noticeable decline in drug survival for all three TNFa inhibitors. Heterogeneity in study size and design may contribute to the range of survival data for each agent.
Revue du Rhumatisme, Dec 1, 2021
Internal Medicine Journal, 2018
Annals of the Rheumatic Diseases, 2021
Background:There are currently eleven biologic and targeted synthetic (b/ts)DMARDs acting via fiv... more Background:There are currently eleven biologic and targeted synthetic (b/ts)DMARDs acting via five different modes of action available for the treatment of RA in Australia. The cost of b/tsDMARDs is subsidized by government for patients that have active RA despite six months of combination csDMARD therapy. Once a patient is eligible, the clinician can prescribe the b/tsDMARD they deem to be the most clinically appropriate for the patient. In Oct 2015 the first JAK inhibitor (JAKi) became available in Australia (tofacitinib, TOF), baricitinib (BARI) became available in Sept 2018, and upadacitinib (UPA) in May 2020. Each of these oral tsDMARDs possess different selectivity profiles towards different members of the JAK family (JAK1–3 and Tyk2).Objectives:The aim of this analysis was to determine the patterns of JAKi cycling in real-world practice in Australia.Methods:Deidentified clinical data were sourced from the OPAL dataset, which is collected in a custom-built electronic medical r...
Annals of the Rheumatic Diseases, 2021
RF and anti-citrullinated protein antibodies (ACPAs) are associated with a severe and aggressive ... more RF and anti-citrullinated protein antibodies (ACPAs) are associated with a severe and aggressive disease course in patients with RA.1 Abatacept is a selective co-stimulation modulator for the treatment of RA.2 ASCORE (Abatacept SubCutaneOus in Routine Clinical PracticE; NCT02090556) was a 2-year, observational, prospective, multicentre study of SC abatacept for the treatment of RA in routine clinical practice.3To determine if serostatus and treatment line impacted disease activity in patients enrolled in the ASCORE study.Eligible patients, aged ≥18 years, with active moderate-to-severe RA (ACR/EULAR 2010 criteria) who were IV abatacept-naive and initiated SC abatacept 125 mg once weekly, were enrolled into two cohorts: biologic (b)DMARD-naive patients and those with ≥1 prior bDMARD treatment failure. This post hoc analysis assessed the mean change in disease activity (CDAI, SDAI and DAS28 [ESR]) from baseline (BL) at 6, 12, 18 and 24 months in response to treatment with abatacept. P...
Annals of the Rheumatic Diseases, 2021
Background:Up to 50% of patients with RA discontinue DMARD treatment within 18 months.1 However, ... more Background:Up to 50% of patients with RA discontinue DMARD treatment within 18 months.1 However, up to 20% of patients who fail multiple treatments may have a good treatment response to another therapy.1 Predictive biomarkers, such as RF and anti-citrullinated protein antibodies (ACPAs), may be useful to stratify patients with RA to the most appropriate treatment.1 ASCORE (Abatacept SubCutaneOus in Routine Clinical PracticE; NCT02090556) was a 2-year, observational, prospective, multicentre study of SC abatacept for the treatment of RA in routine clinical practice.2Objectives:To determine if RF/ACPA serostatus and treatment line impact abatacept retention in patients with RA in a post hoc analysis of ASCORE.Methods:Eligible patients, aged ≥18 years, with active moderate-to-severe RA (ACR/EULAR 2010 criteria) who were IV abatacept-naive and initiated SC abatacept 125 mg once weekly, were enrolled into two cohorts: biologic (b)DMARD-naive patients and those with ≥1 prior bDMARD treatm...
Annals of the Rheumatic Diseases, 2021
Background:Registry studies and clinical trials are increasingly incorporating patient reported o... more Background:Registry studies and clinical trials are increasingly incorporating patient reported outcomes (PROs) to measure the full burden of disease and better measure the efficacy and value of medicines; however, the burden of paper-based surveys, time constraints, and privacy concerns impede the widespread use of PROs in routine clinical care.Objectives:To develop a simple and secure technological solution to incorporate validated PROs into routine clinical care for patients with rheumatic diseases, and to assess the patient response to functional assessment of chronic illness therapy fatigue (FACIT-F), patient health questionnaire-2 (PHQ-2), and healthcare resource utilization (HCRU) questionnaires delivered using this ePRO method.Methods:A novel ePRO questionnaire delivery system was developed by Software4Specialists in partnership with OPAL Rheumatology. Validated PRO questionnaires were sent from the patient’s electronic medical record (Audit4, Software4Specialists) and deliv...
Annals of the Rheumatic Diseases, 2016
Annals of the Rheumatic Diseases, 2013
Annals of the Rheumatic Diseases, 2021
Sleep disorders are more prevalent in patients with ankylosing spondylitis (AS) compared to the g... more Sleep disorders are more prevalent in patients with ankylosing spondylitis (AS) compared to the general population. Sleep disturbance in AS, in addition to pain and fatigue, can lead to impaired physical function and reduced quality of life.The primary objective was to determine the prevalence of sleep disturbance in patients with AS in a real-world Australian cohort using the Insomnia Severity Index (ISI) and Multivariate Apnoea Prediction Index (MAPI). ISI score of ≥ 15 is considered clinical insomnia. MAPI values below 0.05 are suggestive of clinical apnoea.Routinely collected, de-identified clinical data were sourced from the OPAL dataset. Patients aged between 18 and 95 years with a diagnosis of AS and who had completed at least one ISI or MAPI questionnaire between Jan-2019 and Sept-2020 were included. ISI and MAPI questionnaires were emailed to patients using OPAL’s electronic patient reported outcome (ePRO) delivery method or completed in the clinic using a smart device and ...
JAMA Network Open
ImportanceThere is a need for observational studies to supplement evidence from clinical trials, ... more ImportanceThere is a need for observational studies to supplement evidence from clinical trials, and the target trial emulation (TTE) framework can help avoid biases that can be introduced when treatments are compared crudely using observational data by applying design principles for randomized clinical trials. Adalimumab (ADA) and tofacitinib (TOF) were shown to be equivalent in patients with rheumatoid arthritis (RA) in a randomized clinical trial, but to our knowledge, these drugs have not been compared head-to-head using routinely collected clinical data and the TTE framework.ObjectiveTo emulate a randomized clinical trial comparing ADA vs TOF in patients with RA who were new users of a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD).Design, Setting, and ParticipantsThis comparative effectiveness study emulating a randomized clinical trial of ADA vs TOF included Australian adults aged 18 years or older with RA in the Optimising Patient Outcomes in...
Frontiers in Digital Health
ObjectiveTo develop a simple and secure technological solution to incorporate electronic patient-... more ObjectiveTo develop a simple and secure technological solution to incorporate electronic patient-reported outcomes (ePROs) into routine clinical care.MethodsA novel ePRO questionnaire delivery system was developed by Software for Specialists (S4S) in partnership with OPAL Rheumatology Australia. Validated questionnaires were sent from the electronic medical record (EMR) (Audit4) of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), lupus or giant cell arteritis (GCA) and delivered to the patient's email address or completed in the clinic waiting room using a smart device (in-practice). Completed questionnaires were encrypted and returned to the patient's Audit4. Deidentified clinical data was extracted and aggregated across all sites. Data collected between April 2016-Dec 2020 were analysed descriptively.ResultsBetween April 2016 to Dec 2020, 221,352 Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F), Patient Heal...
Internal Medicine Journal, 2012
Background: ASCORE (NCT02090556) is an ongoing, prospective, non-interventional, multicentre stud... more Background: ASCORE (NCT02090556) is an ongoing, prospective, non-interventional, multicentre study of SC abatacept in patients with RA across ten countries. To provide a local perspective, this analysis presents the 6-month (6M) interim retention rates and clinical outcomes by biologic (b)DMARD treatment[for full text, please go to the a.m. URL]
Journal of Pharmacovigilance, 2014
Methotrexate is the mainstay of treatment in rheumatoid arthritis (RA). Used for over 40 years as... more Methotrexate is the mainstay of treatment in rheumatoid arthritis (RA). Used for over 40 years as an anchor treatment in a number of rheumatic diseases, it remains a gold standard of therapy for RA. This review will provide a concise discussion of the efficacy and safety of methotrexate in rheumatic disease, with a focus on Rheumatoid Arthritis.