Australian Rheumatology Association Database Research Articles

Interpersonal Process of Dyadic Coping in Rheumatoid Arthritis: A Perspective From the Australian Rheumatology Association Database.

Dyadic coping, the process of coping that transpires between couples challenged by one partner's illness, is an important predictor of disease adjustment and patient well-being. However, the extent of dyadic coping in rheumatoid arthritis (RA) remains unclear. This study examines the effect of dyadic coping on psychological distress and relationship quality from the perspectives of both participants with RA and their spouses. Participants and their spouses were invited to participate in an online survey study if they were aged ≥ 18 years and had lived together for more than a year. The survey included the Chronic Pain Grade Scale, Dyadic Coping Inventory, Depression Anxiety Stress Scale, and Dyadic Adjustment Scale. Participants and spouses completed the survey independently. The actor-partner interdependence model was used to analyze the dyadic data. One hundred sixty-three couples participated. Our findings showed that participants who reported higher supportive dyadic coping reported lower depression, anxiety, and stress, and higher relationship quality, whereas participants who reported higher negative dyadic coping reported higher depression, anxiety, and stress, and lower relationship quality. Spouses who reported higher supportive dyadic coping reported higher relationship quality, but no effect on depression, anxiety, and stress was observed. In contrast, spouses who reported higher negative dyadic coping reported higher levels of depression, anxiety, and stress, and lower relationship quality. Participants' and spouses' perceptions of supportive and negative dyadic coping closely influenced their psychological distress and relationship quality. Further, having a partner with RA also seemed to affect the spouse, especially when there was a negative dyadic coping pattern.

Trajectories of self-reported pain-related health outcomes and longitudinal effects on medication use in rheumatoid arthritis: a prospective cohort analysis using the Australian Rheumatology Association Database (ARAD)

ObjectiveTo determine distinct trajectories of self-reported pain-related health status in rheumatoid arthritis (RA), their relationship with sociodemographic factors and medication use.Methods988 Australian Rheumatology Association Database participants with RA (71% female,...

Mortality Estimates and Excess Mortality in Rheumatoid Arthritis.

To determine long-term (20 year) survival in RA patients enrolled in the Australian Rheumatology Association Database (ARAD). ARAD patients with RA and data linkage consent who were diagnosed from 1995 onwards were included. Death data were obtained through linkage to the Australian National Death Index. Results were compared with age, gender and calendar year matched Australian population mortality rates.Analysis included both the standardised mortality ratio (SMR) and relative survival models. Restricted mean survival time (RMST) at 20 years was calculated as a measure of life lost. Cause-specific SMRs (CS-SMRs) were estimated for ICD-10 chapter cause of death classifications. 1895 RA patients were included, 74% female, baseline median age 50 years (IQR 41-58), with 204 deaths. There was no increase in mortality over the first 10 years of follow up, but at 20 years the SMR was 1.49 (95%CI 1.30,1.71) and the relative survival was 94% (95% CI 91,97). The difference between observed (18.41 years) and expected (18.68 years) RMST was 4 months.Respiratory conditions were an important underlying cause of death in RA, primarily attributable to pneumonia (CS-SMR 5.2, 95% CI 2.3, 10.3) and interstitial lung disease (CS-SMR 7.6, 95% CI 3.0, 14.7), however coronary heart disease (CS-SMR 0.82, 95% CI 0.42, 1.4) and neoplasms (CS-SMR 1.2 (0.89, 1.5) were not. Mortality risk in this RA cohort accrues over time and is moderately increased at 20 years follow-up. Respiratory diseases may have supplanted cardiovascular diseases as a major contributor to this mortality gap.

Vaccination Rates, Perceptions, and Information Sources Used by People With Inflammatory Arthritis.

To determine vaccination rates, perceptions, and information sources in people with inflammatory arthritis. Participants enrolled in the Australian Rheumatology Association Database were invited to participate in an online questionnaire, conducted in January 2020, prior to the COVID-19 pandemic. Included questions were about vaccination history, modified World Health Organization Vaccination Hesitancy Scale, views of the information sources consulted, the Beliefs About Medicines Questionnaire, education, and the Single-Item Health Literacy Screener. Response rate was 994 of 1498 (66%). The median age of participants was 62 years, with 67% female. Self-reported adherence was 83% for the influenza vaccine. Participants generally expressed positive vaccination views, particularly regarding safety, efficacy, and access. However, only 43% knew which vaccines were recommended for them. Vaccine hesitancy was primarily attributable to uncertainty and a perceived lack of information about which vaccines were recommended. Participants consulted multiple vaccination information sources (median 3, interquartile range 2-7). General practitioners (89%) and rheumatologists (76%) were the most frequently used information sources and were most likely to yield positive views. Negative views of vaccination were most often from internet chatrooms, social media, and mainstream media. Factors of younger age, male gender, and having more concerns about the harms and overuse of medicines in general were associated with lower adherence and greater uncertainty about vaccinations, whereas education and self-reported literacy were not. Participants with inflammatory arthritis generally held positive views about vaccination, although there was considerable uncertainty as to which vaccinations were recommended for them. This study highlights the need for improved consumer information about vaccination recommendations for people with inflammatory arthritis.

COVID-19 vaccine hesitancy in inflammatory arthritis patients: serial surveys from a large longitudinal national Australian cohort.

ObjectivesTo determine COVID-19 vaccine hesitancy rates in inflammatory arthritis patients and identify factors associated with changing vaccine hesitancy over time.MethodsProspective cohort study of inflammatory arthritis patients from community and public hospital outpatient rheumatology clinics enrolled in the Australian Rheumatology Association Database (ARAD). Two surveys were conducted, one immediately prior to (pre-pandemic) and then approximately one year after the start of the pandemic (follow-up). COVID-19 vaccine hesitancy was measured at follow-up and general vaccine hesitancy was inferred pre-pandemic; these were used to identify factors associated with fixed and changing vaccine beliefs, including sources of information and broader beliefs about medication.ResultsOf the 594 participants who completed both surveys, 74 (12%) were COVID-19 vaccine hesitant. This was associated with pre-pandemic beliefs about medications being harmful (p< 0.001) and overused (p= 0.002), with stronger beliefs resulting in vaccine hesitancy persistent over two time points (p= 0.008, p= 0.005). For those not vaccine hesitant pre-pandemic, the development of COVID-19 vaccine hesitancy was associated with a lower likelihood of seeking out vaccine information from healthcare professionals (p< 0.001). COVID-19 vaccine hesitancy was not associated with new influenza vaccine hesitancy (p= 0.138).ConclusionIn this study of vaccine beliefs before and during the COVID-19 pandemic, factors associated with COVID-19 vaccine hesitancy in inflammatory arthritis patients varied, depending on vaccine attitudes immediately prior to the start of the pandemic. Fixed beliefs reflected broader views about medications, while fluid beliefs were highly influenced by whether they sought out information from healthcare professionals, including rheumatologists.

Patterns of biologic and targeted-synthetic disease-modifying antirheumatic drug use in rheumatoid arthritis in Australia.

ObjectiveThe aim of this study was to describe treatment patterns in RA, including the frequency and reasons for switching or stopping biologic and targeted synthetic DMARDs (b/tsDMARDs).MethodsThe reasons for switching or stopping b/tsDMARDs were extracted from the Australian Rheumatology Association Database (ARAD) from 2003 to 2018 for RA participants. Switching patterns for each b/tsDMARD and time on first-, second- and third-line b/tsDMARDs were evaluated using Sankey diagrams and survival methods.ResultsA total of 2839 participants were included in the analysis. The first-line b/tsDMARDs were etanercept (n = 1414), adalimumab (n = 1024), infliximab (n = 155), golimumab (n = 98), abatacept (n = 66), certolizumab (n = 38), tocilizumab (n = 21) and tofacitinib (n = 23). Of those starting first-, second- and third-line biologic therapy, 24.0%, 31.8% and 24.4% switched to another b/tsDMARD within 12 months, respectively. Inefficacy or adverse effects were the most common reasons for stopping therapy, irrespective of line of treatment. Compared with first-line etanercept, participants were more likely to stop adalimumab [Hazard ratio (HR) 1.16, 95% CI: 1.04, 1.29] and infliximab (HR 1.77, 95% CI: 1.46, 2.16). No differences were seen for other b/tsDMARDs. For second-line therapies compared with etanercept, the risk of stopping was lower for tocilizumab (HR 0.41, 95% CI: 0.25, 0.70), rituximab (HR 0.51, 95% CI: 0.30, 0.85) and tofacitinib (HR 0.29, 95% CI: 0.15, 0.57). Participants taking rituximab, tocilizumab and tofacitinib were also less likely to stop third-line therapy in comparison with participants taking etanercept.ConclusionsSwitching between b/tsDMARDs was common among ARAD participants with RA, most commonly due to inefficacy or adverse effects. Durability of exposure and reasons for switching varied between b/tsDMARDs.

Attitudes of Australians with inflammatory arthritis to biologic therapy and biosimilars.

To investigate the knowledge and beliefs of Australian patients with inflammatory arthritis regarding biologic/targeted synthetic DMARDs (b/tsDMARDs) and biosimilars and their sources of information. Participants enrolled in the Australian Rheumatology Association Database (ARAD) with RA, PsA and axial SpA were sent an online survey. They were asked about information sources for b/tsDMARDs and how positive or negative this information was. The Beliefs about Medicine Questionnaire (BMQ) was used to measure beliefs about b/tsDMARDs with scores ranging from 1 (strongly disagree) to 5 (strongly agree). Participants were asked about their knowledge of biosimilars and willingness to switch to biosimilar. There was a response rate of 66% (994/1498; 67% female, median age 62 years). Participants currently taking b/tsDMARDs (n = 794) had a high b/tsDMARD-specific BMQ 'necessity' score {median 4.2 [interquartile range (IQR) 3.6-4.8]}, with a lower specific 'concerns' score [median 2.4 (IQR 2.0- 3.0)]. Participants consulted multiple information sources [median 3 (IQR 2-5)]. Positive sources were rheumatologists and educational websites and negative were chat rooms and social media. Only 18% were familiar with biosimilars, with half knowing of availability in Australia. Following a short paragraph describing biosimilars, 75% (744) of participants indicated they would consider switching if recommended by their rheumatologist, with nearly half identifying safety and efficacy of biosimilars as an important concern. Australian patients have positive attitudes towards b/tsDMARDs overall, although little knowledge of biosimilars specifically. They have a high degree of trust in their rheumatologist regarding treatment decisions, even if they are unfamiliar with the medication recommended.

Dyadic Coping with Rheumatoid Arthritis: A Couple Perspective from the Australian Rheumatology Association Database Registry

Dyadic Coping with Rheumatoid Arthritis: A Couple Perspective from the Australian Rheumatology Association Database Registry

Perspectives of Glucocorticoid Use in Patients with Rheumatoid Arthritis.

ObjectivePrednisolone is an effective oral glucocorticoid for managing symptoms of rheumatoid arthritis (RA) but has predictable and common adverse effects. We explored patient perspectives of prednisolone use in RA.MethodsPatients with RA registered with the Australian Rheumatology Association Database (ARAD) who had completed an ARAD questionnaire in the preceding 12 months were invited to participate in an online survey. Responses were linked to already collected respondent demographics, medication use, and patient‐reported outcome measures. The Beliefs about Medicine Questionnaire (BMQ) measured patient beliefs on medication necessity and concerns. Free‐text responses outlining reasons for stopping or declining prednisolone underwent thematic analysis using NVivo 12.ResultsThe survey response rate was 79.6% (804/1010), including 251 (31.2%) reporting current prednisolone use and 432 (53.7%) reporting previous use. Compared with previous users, current users were older (P = 0.0002) and had worse self‐reported pain, disease activity, health‐related quality of life, and function (all P < 0.001). Current users had higher BMQ scores for prednisolone‐specific necessity (3.6 versus 1.7; P <0.001) and concerns (2.7 versus 2.3; P <0.001). In previous prednisolone users (n = 432), the most frequent themes identified in free‐text responses for cessation were adequate disease control (30.3%), adverse effects (25.2%), and predetermined short courses (21.3%). Of respondents citing adverse effects for cessation (n = 131), weight gain (27.5%), osteoporosis (14.7%), and neuropsychiatric issues (13.8%) were most frequent.ConclusionsIn our cohort, patients with RA taking prednisolone believed it was necessary yet remained concerned about its use. Adequate disease control and adverse effects were important considerations for patients using prednisolone.

Oral Complementary Medicine Use among People with Inflammatory Arthritis: An Australian Rheumatology Association Database Analysis.

Objectives To describe oral complementary medicine (CM) use in people with inflammatory arthritis, associations with use, and changes in use over time. Methods Demographic, clinical, and patient-reported outcome data from 5,630 participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), and juvenile idiopathic arthritis (JIA) were extracted from the Australian Rheumatology Association Database (ARAD), a national observational database. CM use at entry into ARAD was ascertained for participants recruited between 2002 and 2018. CM was categorised according to the NIH/Cochrane schema (fatty acids, herbs, or supplements). Logistic regression was used to assess associations between demographic characteristics and CM use. Change in CM use between 2006 and 2016 was investigated using a nonparametric test for trend of rate by year. Results 2,156 (38.3%) ARAD participants were taking CM at enrolment (RA: 1,502/3,960 (37.9%), AS: 281/736 (38.2%), PsA: 334/749 (44.6%), and JIA: 39/185 (21.1%)). CM use was more prevalent in women (OR 1.3; 95% CI: 1.13-1.50), those with tertiary education (OR 1.32; 95% CI: 1.13-1.55), private health insurance (OR 1.26; (95% CI: 1.10-1.44), drinking alcohol sometimes (OR 1.22; 95% CI: 1.05-1.43), poorer function (HAQ) (OR 1.13; 95% CI: 1.02-1.24), use of NSAID (OR 1.32; 95% CI 1.17-1.50), weak (OR 1.21; 95% CI 1.05-1.41) but not strong opioids, and less prevalent in current smokers (OR 0.76; 95%: CI 0.63-0.91). CM use was not associated with pain, disease activity, or quality of life. The most common CMs were fish oils (N = 1,489 users) followed by glucosamine (N = 605). Both declined in use over time between 2006 and 2016 (27.5% to 21.4%, trend p = 0.85 and 15.5% to 6.4%, trend p < 0.01), respectively. Conclusion Oral CM use is common among Australians with inflammatory arthritis. Its use is greater among women and those with tertiary education. Fish oil and glucosamine, the most common CMs, both declined in use over time.

Factors associated with commencing and ceasing opioid therapy in patients with rheumatoid arthritis

ObjectiveTo determine factors associated with opioid use in rheumatoid arthritis (RA) patients. MethodsAdult RA patients (n = 3225, 73% female, mean age 57 years, median follow-up 54 months) were recruited into the Australian Rheumatology Association Database (ARAD) between 2001–2015. A logistic regression examining both within- and between-patient effect sizes for time-varying covariates, and transition-state analysis for covariates associated with opioid commencement or cessation were used to examine determinants of current opioid use. ResultsThe population-averaged prevalence of any opioid use was 33% (95%CI 32–34), 9% (95% CI 8, 10) for high potency opioid use, and 62% (95% 60, 64) of patients reported opioid ever-use after five years of follow-up. Opioid use was higher in females and decreased with older baseline age. Within-patients opioid use was associated with higher self-reported pain and HAQ scores (p < 0.001), and NSAID (OR 1.88; 1.67–2.10), oral glucocorticoid (2.23;1.93–2.58), csDMARD (2.08;1.78–2.44) and bDMARD (1.22;1.06–1.40) treatment. Younger baseline age, higher pain scores, HAQ scores and oral GC use were important determinants of change in opioid use, associated with both a higher probability of commencing opioid use, and a lower probability of cessation. Paradoxically, NSAID and DMARD treatments were associated with both a lower probability of commencing opioids, and a lower probability of cessation. ConclusionsThere was a high prevalence of opioid use among RA patients, which was associated with pain, function and GC treatment. NSAID, and DMARD treatments obviate the need for opioids in some, but not all, patients.

Investigating Dimensions of Stiffness in Rheumatoid and Psoriatic Arthritis: The Australian Rheumatology Association Database Registry and OMERACT Collaboration.

It is not known how the experience of stiffness varies between diagnoses or how best to measure stiffness. The aims of our study were to (1) compare stiffness in psoriatic arthritis (PsA) and rheumatoid arthritis (RA) using patient-reported outcomes, (2) investigate how dimensions of stiffness are associated with each other and reflect the patient experience, and (3) analyze how different dimensions of stiffness are associated with physical function. An online survey was sent to Australian Rheumatology Association Database participants (158 PsA, and 158 age- and sex-matched RA), assessing stiffness severity, duration, impact, importance, coping, and physical function [modified Health Assessment Questionnaire (mHAQ)]. Scores were compared between diagnoses and correlations among stiffness dimensions calculated. Multivariate regression was performed for stiffness severity, impact, and duration on mHAQ, adjusting for age, sex, disease duration, obesity, and pain. Cognitive debriefing was conducted through semistructured telephone interviews. Overall, 240/316 (75.9%) responded [124/158 RA (78.5%) and 116/158 PsA (73.4%)], with no significant difference in stiffness ratings between diagnoses. Scores for all stiffness dimensions were strongly correlated (r = 0.52-0.89), and severity and impact were associated with mHAQ in both diagnoses. Stiffness duration was not associated with mHAQ in RA. In cognitive debriefing, participants described stiffness severity and impact by their effect on daily activities (10/16 and 14/16 participants, respectively). Stiffness ratings were similar between PsA and RA. Different dimensions of stiffness were strongly correlated. Stiffness severity and impact both independently predicted mHAQ. Stiffness was important to participants; however, measuring multiple dimensions of stiffness may have minimal additive value.

Malignancy risk in Australian rheumatoid arthritis patients treated with anti-tumour necrosis factor therapy: an update from the Australian Rheumatology Association Database (ARAD) prospective cohort study

BackgroundTumour necrosis factor inhibitor (TNFi) therapy has been available for rheumatoid arthritis (RA) patients for several decades but data on the long-term risk of malignancy associated with its use is limited. Our aims were to assess malignancy risk in a cohort of Australian RA patients relative to the Australian population and to compare cancer risk for patients exposed to TNFi therapy versus a biologic-naïve group.MethodsDemographic data for RA participants enrolled in the Australian Rheumatology Association Database (ARAD) before 31 Dec 2012 were matched to national cancer records in May 2016 (linkage complete to 2012). Standardised incidence ratios (SIRs) were used to compare malignancy incidence in TNFi-exposed and biologic-naïve ARAD participants with the Australian general population using site-, age- and sex-specific rates by calendar year. Malignancy incidence in TNFi-exposed participants and biologic-naïve RA patients, were compared using rate ratios (RRs), adjusted for age, sex, smoking, methotrexate use and prior malignancy.ResultsThere were 107 malignancies reported after 10,120 person-years in the TNFi-exposed group (N = 2451) and 49 malignancies after 2232 person-years in the biologic-naïve group (N = 574). Compared with the general population, biologic-naïve RA patients showed an increased risk for overall malignancy (SIR 1.52 (95% confidence interval (CI) 1.16, 2.02) prostate cancer (SIR 2.10, 95% CI 1.18, 4.12). The risk of lung cancer was increased for both biologic naïve and TNFi-exposed patients compared with the general population (SIR 2.69 (95% CI 1.43 to 5.68) and SIR 1.69 (95% CI 1.05 to 2.90) respectively). For the TNFi-exposed patients there was an increased risk of lymphoid cancers (SIR 1.82, 95% CI 1.12, 3.18). There were no differences between the exposure groups in the risk of cancer for any of the specific sites examined.ConclusionsOverall malignancy incidence was elevated for biologic-naïve RA patients but not for those exposed to TNFi. TNFi exposure did not increase malignancy risk beyond that experienced by biologic-naïve patients. Lung cancer risk was increased for both TNFi-treated and biologic-naïve RA patients compared with the general population suggesting that RA status or RA treatments other than TNFi may be responsible in some way.

Cardiovascular risk management in rheumatoid and psoriatic arthritis: online survey results from a national cohort study

BackgroundChronic inflammatory arthritis is associated with increased cardiovascular (CV) morbidity and mortality. Pharmacological management and healthy lifestyle modification is recommended to manage these risks, but it is not known how often these are utilised and whether there is any difference in their use between patients with different types of arthritis. The aim of this study was to determine and compare the proportion of participants with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) receiving pharmacological or lifestyle management strategies for CV risk factors. The secondary objective was to identify factors associated with use of management strategies.MethodsA survey was sent to online participants in the Australian Rheumatology Association Database, a voluntary national registry for inflammatory arthritis. Participants were asked whether they took medications for hypertension, hyperlipidaemia and diabetes, and to report their height, weight, level of physical activity, and dietary changes made. The use of management strategies was compared between participants with RA and PsA. Logistic regression analyses were performed to identify factors associated with physical activity and dietary changes.ResultsThere were 858 respondents with RA and 161 with PsA (response rate 64.5%). Pharmacological treatment was reported by 93% of participants with hypertension and 70% with hyperlipidaemia. All participants with diabetes reported being managed with dietary modification, pharmacological treatment, or a combination of both. Adequate physical activity was reported by 50.8%. Only 27% of overweight or obese participants reported making any dietary change for their health in the past year. There was no difference between RA and PsA in reported utilisation of management strategies. Hyperlipidaemia and being overweight were associated with making dietary change. Obesity and arthritis disease activity were negatively associated with physical activity.ConclusionsMost participants with RA and PsA reported using pharmacological treatment for CV risk factors. Relatively few reported using lifestyle modifications. Targeted lifestyle interventions should be implemented for RA and PsA patients.

Biologics and cardiovascular events in inflammatory arthritis: a prospective national cohort study

BackgroundInflammatory arthritides including rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) are associated with increased risk of cardiovascular disease. This process may be driven by systemic inflammation, and the use of tumour necrosis factor (TNF) inhibitors could therefore potentially reduce cardiovascular risk by reducing this inflammatory burden. The aims of this study were to evaluate whether the risk of cardiovascular events (CVEs) in patients with inflammatory arthritis is associated with treatment with anti-TNF therapy, compared with other biologics or non-biologic therapy, and to compare the CVE risk between participants with RA, PsA and AS.MethodsData from consecutive participants in the Australian Rheumatology Association Database with RA, PsA and AS from September 2001 to January 2015 were included in the study. The Cox proportional hazards model using the counting process with time-varying covariates tested for risk of having CVEs, defined as angina, myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention, other heart disease, stroke/transient ischaemic attack or death from cardiovascular causes. The model was adjusted for age, sex, diagnosis, methotrexate use, prednisone use, non-steroidal anti-inflammatory use, smoking, alcohol consumption, hypertension, hyperlipidaemia, diabetes and functional status (Health Assessment Questionnaire Disability Score).ResultsThere were 4140 patients included in the analysis, totalling 19,627 patient-years. After multivariate adjustment, the CVE risk was reduced with anti-TNF use (HR 0.85, 95% CI 0.76–0.95) or other biologic therapies (HR 0.81, 95% CI 0.70–0.95), but not in those who had ceased biologic therapy (HR 0.96, 95% CI 0.83–1.11). After adjustment, no significant difference in CVE risk was observed between participants with RA and PsA (HR 0.92, 95% CI 0.77–1.10) or AS (HR 1.14, 95% CI 0.96–1.36).ConclusionsCurrent biologic use was associated with a reduction in major CVEs. No reduction in CVE risk was seen in those who had ceased biologic therapy. After adjustment, the CVE risk was not significantly different between RA, AS or PsA.

Factors associated with oral glucocorticoid use in patients with rheumatoid arthritis: a drug use study from a prospective national biologics registry

BackgroundGlucocorticoids (GCs) are used in ~ 60% of patients with rheumatoid arthritis (RA). Although disease-modifying, they also have significant adverse effects. Understanding factors associated with GC use may help minimise exposure. The aims of the present study were to describe oral GC use in RA; determine any change in use over time; and determine factors associated with oral GC use, commencement or cessation.MethodsAdult patients with RA were identified in the Australian Rheumatology Association Database (ARAD), a national Australian registry that collects long-term outcome data from patients with inflammatory arthritis. Patients were categorised by their ARAD date of entry (DOE), with population-averaged logistic regression and transition state analysis used to determine any change in GC use over time. Fixed-effects panel regression was used to examine whether GC current use was associated with pain/arthritis activity/Health Assessment Questionnaire (HAQ) scores or medication use. Transition state analysis was used to assess whether these factors influenced the commencement or cessation of GCs.ResultsA total of 3699 patients with RA completed a baseline ARAD questionnaire (73% female, mean age 57 years). The probability of GC use decreased over time according to ARAD DOE: September 2001 to March 2005, 55% (95% CI 52–58%); March 2005 to September 2008, 47% (45–49%); September 2008 to March 2012, 42% (39–45%); and March 2012 to October 2015, 39% (34–43%) (p < 0.001). Conventional synthetic disease-modifying anti-rheumatic drugs (OR 10.13; 95% CI 8.22–12.47), non-steroidal anti-inflammatory drugs (1.18; 1.02–1.37) and opioids (2.14; 1.84–2.48) were associated with GC current use, as were lower pain scores (0.94; 0.90–0.98), higher arthritis activity scores (1.09; 1.05–1.14) and poorer HAQ scores (1.52; 1.30–1.79). Use of biologic disease-modifying anti-rheumatic drugs (bDMARDs) was not associated with GC current use (0.98; 0.83–1.15) or GC cessation (HR 0.87; 95% CI 0.75–1.01), but it was associated with GC commencement (0.54; 0.47–0.62).ConclusionsThe probability of oral GC use decreased over time, with reduced commencement and increased cessation of GCs. The modest effect of bDMARDs on GC cessation was not statistically significant.

Malignancy risk in Australian rheumatoid arthritis patients treated with anti-tumour necrosis factor therapy: analysis of the Australian Rheumatology Association Database (ARAD) prospective cohort study.

BackgroundMalignancy risk with tumour necrosis factor inhibitor (TNFi) therapy remains unclear. Our primary aim was to assess malignancy risk with TNFi therapy in a cohort of Australian patients with rheumatoid arthritis (RA). We also assessed risk in a biologic-naïve group.MethodsDemographic data of all RA patients enrolled in the Australian Rheumatology Association Database before 25 October 2010 were matched to national cancer records in July 2010 (linkage complete to 2007). Verified self-reported malignancies occurring between 1 January 2008 and 25 October 2010 were also included in the analysis. Standardised incidence ratios (SIRs) were used to compare malignancy incidence in biologic-naïve and TNFi-exposed ARAD participants to the general population using site-, age- and sex-specific rates by calendar year. Rate ratios (RRs) were used to compare malignancy incidence in TNFi-exposed participants to biologic-naïve RA patients, and a composite RA cohort that included pre-TNFi person years, both adjusted for age, gender, smoking, methotrexate use and prior malignancy.ResultsForty-four malignancies were reported after 5752 person-years in the TNFi-exposed group (N = 2145) and 32 malignancies were reported after 1682 person-years in the biologic-naïve group (N = 803). No overall increased risk of malignancy in TNFi-treated RA patients was found when compared with the general population or with biologic-naïve RA patients. Compared to the biologic naïve group, without the inclusion of pre-TNFi years in the comparator group, the relative risk of female breast cancer was reduced in TNFi-treated patients (RR 0.17 (95 % CI 0.03 to 0.95)). It was no longer significant when adding pre-TNFi years in the comparator group. The risk of melanoma was increased for both biologic naïve and TNFi-treated patients when compared with the general population (SIR 2.72 (95 % CI 1.13 to 6.53) and SIR 2.03 (95 % CI 1.09 to 3.78) respectively). The relative risk of melanoma was not increased in the TNFi-exposed group compared with biologic naïve patients (RR 0.54, 95 % CI 0.12, 2.40). Inclusion of pre-TNFi person years in the comparator group did not change these results.ConclusionsMalignancy incidence was low in this RA cohort and biologic exposure did not increase the risk of malignancy. Melanoma risk was increased in both TNFi-treated and biologic-naïve RA patients compared with the general population suggesting that RA status, and possibly methotrexate exposure, may be responsible.

Risk factors for herpes zoster in rheumatoid arthritis patients: the role of tumour necrosis factor-α inhibitors.

To determine whether exposure to tumour necrosis factor (TNF)-α inhibitors increases the risk of herpes zoster (HZ) among people with rheumatoid arthritis (RA). We performed a cohort study of people with RA participating in the Australian Rheumatology Association Database. We identified self-reported cases of HZ and verified using medical records. For the primary analysis, we only included doctor-verified cases. For TNF-α inhibitor exposed groups, we excluded HZ episodes that occurred before TNF-α inhibitor initiation, and for the control group we excluded HZ episodes that occurred prior to 2000 or RA diagnosis. The risk of HZ among participants exposed versus not exposed to TNF-α inhibitors was compared using Cox proportional hazards models including significant covariates affecting the risk. Adjusted hazard ratios (HR) were calculated for TNF inhibitors as a class and for individual agents. Among 2157 active RA participants, there were 442 self-reported cases of HZ. From 346 responses from doctors, 249 cases were verified and four were false positives (false positive rate 1.6%). Crude incidence of verified HZ in the entire RA cohort was 15.9/1000 person-years (95% confidence interval (CI): 13.5-18.8). An increased risk of HZ was found for all TNF-α inhibitors combined (fully adjusted HR 1.71; 95% CI: 1.00-2.92) and adalimumab (fully adjusted HR 2.33; 95% CI: 1.22-4.45), but in the fully adjusted model was not increased with etanercept (fully adjusted HR 1.65; 95% CI: 0.90-3.03). No increased risk was found with infliximab (HR 1.29; 95% CI: 0.37-4.47). TNF-α inhibitors are associated with an increased risk of HZ in people with RA compared with those who have not been exposed.

Strategy support for the Post‐Market Monitoring (PMM) of GM plants: Review of existing PMM strategies developed for the safety assessment of human and animal health

Strategy support for the Post‐Market Monitoring (PMM) of GM plants: Review of existing PMM strategies developed for the safety assessment of human and animal health

Smoking did not modify the effects of anti-TNF treatment on health-related quality of life among Australian ankylosing spondylitis patients.

The aim of this study was to examine the impact of smoking on health-related quality of life (HRQoL) among AS patients who were taking biologic DMARDS. This is a longitudinal cohort study of AS patients with anti-TNF treatment in the Australian Rheumatology Association Database (2003-11). They were assessed using the 36-item Short Form Health Survey (SF-36), Assessment of Quality of Life (AQoL) and HAQ for spondylitis (HAQ-S) on a biannual basis. Linear mixed models were used to assess the impact of smoking on HRQoL outcomes over the first 2 years of treatment. Four hundred and twenty-two patients [73% male, mean age 44.9 years (s.d. 12.7) provided 1189 assessments for the study. Current smokers (n = 79) were slightly younger, more likely to be male, less likely to use or to have previously used prednisolone and had a slightly shorter disease duration than past smokers (n = 138) or non-smokers (n = 205). After adjusting for smoking, gender, age, education, employment, co-morbidities and medication use, including DMARDs, anti-inflammatories and analgesics, all the HRQoL measures improved significantly over the study period and the improvements were not modified by smoking status (all P-values >0.36). Current smokers tended to have a poorer HRQoL on the SF-36 physical score [-1.93 (95% CI -3.94, 0.09), P = 0.06] and the HAQ-S score [0.10 (95% CI -0.01, 0.20), P = 0.07] compared with non-smokers. Among AS patients, active smoking did not diminish or modify the improvements in HRQoL from anti-TNF treatment, even though current smokers compared with non-smokers tended to have poorer scores in some HRQoL measures.