OPAL Year in Review 2021

This article outlines the 2021 research outputs of OPAL Rheumatology, highlighting the collaborative efforts of OPAL's researchers, rheumatologists and their patients

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This article, by OPAL Rheumatology’s Dr Catherine O’Sullivan (Director of Operations) and Dr Tegan Smith (CEO), highlights the collaborative efforts of OPAL’s researchers, rheumatologists and their patients.

OPAL Overview

OPAL Rheumatology is a collaboration of 112 Australian rheumatologists contributing their de-identified clinical records for research to increase our understanding of rheumatic diseases and optimise patient outcomes.

Founded in 2009 as a quality use of medicines initiative, the OPAL dataset contains clinical data from more than 220,000 patients captured during 1.3 million clinical consultations. The OPAL dataset is one of the largest collections of data on rheumatic diseases globally, providing extraordinary power for research.

Rheumatologists contributing data to OPAL use an electronic medical record (Audit4, Software4Specialists) in their daily clinical practice that is specifically customised for comprehensive data capture relevant to the routine management of rheumatic diseases, with clinical efficiency at the forefront of the design.

Any rheumatologist practising in Australia is welcome to become a member of OPAL and contribute their clinical data for research while benefiting from rheumatologist-driven digital innovation in clinical data management and value-based care initiatives. The Audit4 software is provided to OPAL members at no cost.

Expressions of interest: info@opalrheumatology.com.au

Research outputs in 2021

• 12 abstracts presented at the four major conferences: ARA, APLAR, EULAR and ACR
• Six study manuscripts (three published, three submitted/in press)

Summary of major findings:

Real-world evaluation of effectiveness, persistence, and usage patterns of monotherapy and combination therapy tofacitinib in treatment of rheumatoid arthritis in Australia. Bird et al 2021

The impact of monotherapy and combination-therapy treatment was investigated in a post-hoc analysis of 1300 bDMARD and 650 tofacitinib treated patients with rheumatoid arthritis (RA). A higher percentage of patients were treated with tofacitinib monotherapy (43.3%) compared with bDMARD monotherapy (33.4%). Patients treated with combination therapy (regardless of bDMARD or tofacitinib) were found to have higher disease activity at time of starting treatment. Similar treatment effectiveness and persistence was found for monotherapy bDMARD and tofacitinib treatments as well as for combination bDMARD and tofacitinib therapy.

Persistence to Biologic Therapy Among Patients With Ankylosing Spondylitis: An Observational Study Using the OPAL Dataset. Griffiths et al 2021.

Treatment persistence is an important consideration when selecting a bDMARD therapy for chronic conditions such as ankylosing spondylitis (AS). Of 5,048 eligible patients with AS, 2,597 had initiated on a bDMARD during the study window. Persistence to first-line bDMARD therapy was 96 months, 19 months for second-line therapy and 15 months for third-line therapy. Median persistence was longest for patients treated with golimumab in all lines of therapy and shortest for patients treated with etanercept. Interestingly, differences in persistence were observed depending on when treatment was initiated. Patients initiated on adalimumab and etanercept as first-line bDMARD therapy prior to 2012 remained on treatment longer than patients initiated on these same agents after 2012.

Prevalence of sleep disturbance and the association between poor disease control in people with ankylosing spondylitis within the Australian clinical setting (ASLEEP study): a real-world observational study using the OPAL dataset. Tymms et al 2021.

Sleep disturbance and fatigue are common in patients with AS and screening for insomnia, sleep apnoea and fatigue in routine clinical care may provide a more holistic view of the burden of this disease.

This study aimed to assess the prevalence of sleep disturbances in patients with AS receiving routine care in Australia. Of the 5000+ OPAL database patients with AS, 629 patients received validated PROs to assess self-reported insomnia, apnoea and fatigue, and 495 patients responded (79% response rate). Overall, self-reported sleep apnoea was reported in one-third of patients and one in five patients reported moderate to severe insomnia. Those with poor disease control (BASDAI ≥ 4), were seven times more likely to experience greater sleep disturbance than patients with good disease control. No significant differences in the incidence of insomnia or sleep apnoea were found for propensity score matched patients treated with TNFi or IL-17Ai, except for self-reported sleep apnoea score, which was significantly higher in those treated with IL-17Ai.

Modelling of disease activity in patients with inflammatory arthropathies treated with etanercept originator or biosimilar as first-line biologic in an Australian real-world dataset. Deakin et al (manuscript in press, poster presented at EULAR 2021 and ACR 2021).

This study aimed to model change in clinical disease activity measured using DAS28CRP in patients prescribed etanercept originator or biosimilar as first-line bDMARD therapy in patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA). This study found that both brands reduced DAS28CRP over time, and an additional modest improvement for patients on the originator. No difference in treatment persistence was observed between the originator or biosimilar. Median time to treatment discontinuation was 24.6 months for the originator and 24.1 months for the biosimilar (p=0.72). An adverse event was the reason for discontinuing treatment for 11.4% of patients on the originator and 13.4% of patients on the biosimilar.

The demographics, burden of disease and real-world treatment patterns of patients with systemic lupus erythematosus in Australia: an analysis from the OPAL-QUMI dataset. Littlejohn et al. (Submitted)

The OPAL dataset provides unique insight into the real-world clinical management, burden of disease and outcomes of patients in the private community setting, which is representative of the practice of rheumatology in Australia. This study described the demographics, basic clinical features and prescribed medications of patients with a physician diagnosis of systemic lupus erythematosus in the OPAL dataset. Results will be available soon.

A novel electronic patient-reported outcome delivery system to implement health-related quality of life measures in routine clinical care: An analysis of 5 years of experience. Tymms et al (Manuscript submitted, presented at EULAR 2021).

OPAL and S4S have successfully developed a simple and secure electronic PRO delivery system within the electronic medical record, Audit4, to incorporate validated PROs into routine clinical care. Since the implementation of the ePRO system in April 2016 to December 2020, 221,352 fatigue (FACIT-Fatigue), mood and general heath (PHQ-2), function (RAPID3), and healthcare resource utilisation (HCRU) questionnaires have been delivered to patients via email on a quarterly basis or completed on a tablet in the waiting room. Overall, the engagement and completion rate among patients was very high (85% of patients completed at least one questionnaire, and of all questionnaires sent, 73% were completed) and these rates have been sustained over time. Age was not found to be a barrier to completion, with older patients (>80 years) more likely to complete questionnaires on all instances they were delivered.

This simple and secure digital solution has been well received by patients and is an efficient and convenient way to understand the full burden of the disease experienced by the patient, with the potential to elevate the standard of routine clinical care.   

ABSTRACTS 2021

ARA

1. Changing patterns of use of b/tsDMARDs in rheumatoid arthritis: an analysis of the OPAL Dataset. Hedley Griffiths et al.
2. Renal function in patients with rheumatoid arthritis receiving biologic or targeted synthetic disease modifying antirheumatic drugs within the Australian OPAL dataset. Geoff Littlejohn et al.
3. Biological treatment of ankylosing spondylitis in Australia: An analysis of real-world treatment patterns from the OPAL Dataset. David Mathers et al.
4. Biosimilar uptake for the treatment of inflammatory arthritis in Australia: Analysis of the OPAL Dataset. Peter Youssef et al.
5. Treatment patterns of b/tsDMARDs for the management of psoriatic arthritis in Australia: An analysis of the OPAL Dataset. Sabina Ciciriello et al.

EULAR

1. Patterns of Janus Kinase inhibitor cycling for the management of rheumatoid arthritis in real-world clinical practice: an analysis of the OPAL Dataset. Sabina Ciciriello et al.
2. Prevalence of sleep disturbance in patients with ankylosing spondylitis within the Australian Clinical Setting (ASLEEP study): A Real-World Observational Study using the OPAL Dataset. Kathleen Tymms et al.
3. The development of a novel ePRO delivery system to measure patient quality of life in routine clinical care: An analysis of 5 years of experience. Kathleen Tymms et al.
4. Modelling of disease activity in patients with inflammatory arthropathies treated with etanercept originator or biosimilar as first-line biologic in an Australian real-world dataset. Claire T. Deakin et al.

APLAR

1. Changing Patterns of use of b/tsDMARDs in rheumatoid arthritis: An analysis of the OPAL Dataset. Geoffrey Littlejohn et al.

2. Optimising patient outcomes in Australian rheumatology (OPAL): using real-world clinical data to enhance clinical care and research. Geoffrey Littlejohn et al.

ACR

1. Modelling of disease activity in patients with inflammatory arthropathies treated with etanercept originator or biosimilar as first-line biologic in an Australian real-world dataset. Claire T. Deakin et al.

PUBLICATIONS 2021

1. Bird et al. Real-world evaluation of effectiveness, persistence, and usage patterns of monotherapy and combination therapy tofacitinib in treatment of rheumatoid arthritis in Australia. Clin Rheumatol. Aug 2021. Link: https://link.springer.com/article/10.1007%2Fs10067-021-05853-x
2. Griffiths et al. Persistence to biologic therapy among patients with spondyloarthritis: An observational study using the OPAL Dataset. J Rheumatol. 2021. 48(11) Link: https://www.jrheum.org/content/early/2021/10/27/jrheum.201551.long
3. Tymms et al. Prevalence of sleep disturbance in patients with ankylosing spondylitis treated with biological DMARDs: An observational study using the OPAL dataset. Clin Rheumatol. 2021 Nov 26. doi: 10.1007/s10067-021-05953-8. Link: https://link.springer.com/article/10.1007%2Fs10067-021-05953-8
4. Deakin et al. Modelling of disease activity in patients with inflammatory arthropathies treated with etanercept originator or biosimilar as first-line biologic in an Australian real-world dataset. In press.
5. Littlejohn et al. The demographics, burden of disease and real-world treatment patterns of patients with systemic lupus erythematosus in Australia: an analysis from the OPAL-QUMI dataset. Submitted.
6. Tymms et al. A novel electronic patient-reported outcome delivery system to implement health-related quality of life measures in routine clinical care: An analysis of 5 years of experience. Submitted.