Probiotic Supplementation in the Neonatal Age Group and the Risk of Hospitalisation in the First Two Years: A Data Linkage Study from Western Australia.

BACKGROUND: Probiotic supplementation in preterm neonates is standard practice in many centres across the globe. The impact of probiotic supplementation in the neonatal age group on the risk of hospitalisation in infancy has not been reported previously. METHODS: Infants born < 32 + 6 weeks of gestation in Western Australia were eligible for inclusion. We conducted a retrospective cohort study comparing data from before probiotic supplementation (Epoch 1: 1 December 2008-30 November 2010, n = 1238) versus after (Epoch 2: 1 June 2012-30 May 2014, n = 1422) on the risks of respiratory- and gastrointestinal infection-related hospitalisation. A subgroup analysis of infants born < 28 weeks of gestation was analysed separately for similar outcomes. RESULTS: Compared to Epoch 1, an 8% reduction in incidence of hospitalisation up to 2 years after birth was observed in Epoch 2 (adjusted incidence rate ratio (IRR) of 0.92; 95% confidence interval (CI); 0.87-0.98), adjusted for gestational age, smoking, socioeconomic status, and maternal age. The rate of hospitalisation for infants born < 28 weeks of gestation was comparable in epochs 1 and 2. CONCLUSION: Infants exposed to probiotic supplementation in the neonatal period experience a reduced risk of hospitalisation in the first two years after discharge from the neonatal unit.

Clinical profile of paediatric acute rheumatic fever and rheumatic heart disease in Western Australia: 1987 to 2020.

AIM: To describe the clinical profile of acute rheumatic fever (ARF) presentations to paediatric cardiology tertiary services in Western Australia (WA). METHODS: A retrospective clinical audit of individuals with confirmed ARF referred to the only paediatric tertiary cardiac service in WA (1 January 1987 to 31 December 2020). Comparisons between inpatient, outpatient, remote and non-remote groups were assessed. RESULTS: Four hundred seventy-one episodes of ARF in 457 individuals (235 male; median age = 8 years) met clinical criteria. The majority were Aboriginal and Torres Strait Islander children (91.2%), with 62.1% living in remote areas. The number of ARF and rheumatic heart disease (RHD) diagnoses per year increased from 1987 to 2017 with notable peaks in 2013 and 2017. The average annual incidence of tertiary-referred ARF in WA of 4-15-year-olds from 1987 to 2020 was 4.96 per 100 000. ARF features included carditis (59.9%), chorea (31%), polyarthritis (30%) and polyarthralgia (24.2%). RHD was evident in 61.8% of cases and predominantly manifested as mitral regurgitation (55.7%). Thirty-four children (7.4%) with severe RHD underwent valvular surgery. 12% had at least one recurrent ARF episode. Remote individuals had more than double the rate of recurrence compared to non-remote individuals (P = 0.0058). Compared to non-remote episodes, remote presentations had less polyarthritis (P = 0.0022) but greater proportions of raised ESR (P = 0.01), ASOT titres (P = 0.0073), erythema marginatum (P = 0.0218) and severe RHD (P = 0.0133). CONCLUSION: The high proportion of Aboriginal and Torres Strait Islander Australians affected by ARF/RHD in WA reflects the significant burden of disease within this population. Children from remote communities were more likely to present with concurrent severe RHD. Our study reinforces the persisting need to improve primary and secondary ARF initiatives in rural and remote communities.

Ocular TB in Western Australia.

This was a retrospective chart review in Western Australia, Australia.To describe the diagnosis, management, and treatment outcomes of ocular TB in Western Australia (WA).This was a retrospective review of ocular TB cases in WA from 2007 to 2018 with a minimum 2-year follow-up upon completion of anti-TB therapy (ATT).A total of 44 patients were referred to WA TB clinic. Ten were excluded from the analysis of treatment response; 34 met the inclusion criteria, of whom 97.1% were born overseas. No patients had symptomatic extraocular TB. Chest X-ray showed prior pulmonary TB in 11.7% of patients (n = 4). All patients were treated with three or four ATT drugs. The most common ocular TB manifestation was retinal vasculitis (23.5%). Full resolution of ocular inflammation following ATT occurred in 66.7% (n = 22), and reduced ocular inflammation requiring only topical steroid treatment was seen in 21.2% (n = 7). Treatment failure occurred in 12.1% (n = 4). Side effects were reported in 45.6% of patients, with gastrointestinal symptoms most common (27.2%).Our study is the first Australian study examining the management of ocular TB. Our study highlights the challenges in diagnosing TB ocular disease in a low-endemicity setting and the importance of the collaboration between uveitis and TB subspecialists..

Microbiological screening of corneas stored in organ culture medium at Lions Eye Bank of Western Australia from 2011 to 2022.

PURPOSE: The purpose of this study was to analyse the contamination rate of corneal samples stored in OCM at Lions Eye Bank of Western Australia over a 12-year period. METHODS: All OCM samples used to preserve corneas from 2011 to 2022 (inclusive) underwent microbiological testing. Samples were collected into aerobic and anaerobic culture bottles on day 3-5 of corneal preservation and 24 h after transfer to thinning medium. Samples were tested for 7 days using the BACTEC FX system. Corneas remained in quarantine until clearance was obtained. RESULTS: From 2011 to 2022, 3009 corneas were retrieved and 2756 corneas were stored in OCM. Thirty one (1.1%) positive samples were reported, with 20 growths of bacterial origin and 11 fungal. Microbial contamination was mostly identified on day 1 of culture (77.5%). Donors of contaminated samples had a mean age of 55 years, with 17 male and 14 female donors. The highest incidence of contamination came from donors whose cause of death was cancer. Death to enucleation times of contaminated samples ranged from 3.5 to 25.5 h (mean = 13.5 ± 7.3) and death to preservation time ranged from 4.1 to 27.5 h (mean = 14.8 ± 7.2). These did not significantly differ from the average time from death to enucleation (mean = 13.9 ± 3) and death to preservation (mean = 16.3 ± 4.2) of non-contaminated samples. CONCLUSION: Microbiological screening of corneas stored in OCM at LEBWA showed a very low rate of positive cultures with no predictive donor characteristics.

Collecting routine and timely cancer stage at diagnosis by implementing a cancer staging tiered framework: the Western Australian Cancer Registry experience.

BACKGROUND: Current processes collecting cancer stage data in population-based cancer registries (PBCRs) lack standardisation, resulting in difficulty utilising diverse data sources and incomplete, low-quality data. Implementing a cancer staging tiered framework aims to improve stage collection and facilitate inter-PBCR benchmarking. OBJECTIVE: Demonstrate the application of a cancer staging tiered framework in the Western Australian Cancer Staging Project to establish a standardised method for collecting cancer stage at diagnosis data in PBCRs. METHODS: The tiered framework, developed in collaboration with a Project Advisory Group and applied to breast, colorectal, and melanoma cancers, provides business rules - procedures for stage collection. Tier 1 represents the highest staging level, involving complete American Joint Committee on Cancer (AJCC) tumour-node-metastasis (TNM) data collection and other critical staging information. Tier 2 (registry-derived stage) relies on supplementary data, including hospital admission data, to make assumptions based on data availability. Tier 3 (pathology stage) solely uses pathology reports. FINDINGS: The tiered framework promotes flexible utilisation of staging data, recognising various levels of data completeness. Tier 1 is suitable for all purposes, including clinical and epidemiological applications. Tiers 2 and 3 are recommended for epidemiological analysis alone. Lower tiers provide valuable insights into disease patterns, risk factors, and overall disease burden for public health planning and policy decisions. Capture of staging at each tier depends on data availability, with potential shifts to higher tiers as new data sources are acquired. CONCLUSIONS: The tiered framework offers a dynamic approach for PBCRs to record stage at diagnosis, promoting consistency in population-level staging data and enabling practical use for benchmarking across jurisdictions, public health planning, policy development, epidemiological analyses, and assessing cancer outcomes. Evolution with staging classifications and data variable changes will futureproof the tiered framework. Its adaptability fosters continuous refinement of data collection processes and encourages improvements in data quality.

Low-level elevations in high-sensitivity cardiac troponin predict obstructive coronary artery disease and revascularisation in rural patients with non-ST-elevation myocardial infarction referred for coronary angiography.

Rural patients with non-ST-elevation myocardial infarction (NSTEMI) are transferred to metropolitan hospitals for invasive coronary angiography (ICA). Yet, many do not have obstructive coronary artery disease (CAD). In this analysis of rural Western Australian patients transferred for ICA for NSTEMI, low-level elevations in high-sensitivity cardiac troponin (≤5× upper reference limit) were associated with less obstructive CAD and revascularisation. Along with other factors, this may help identify rural patients not requiring transfer for ICA.

Behavioural and neuropsychological outcomes in children exposed in utero to maternal labour epidural analgesia.

BACKGROUND: Recent studies report conflicting results regarding the relationship between labour epidural analgesia (LEA) in mothers and neurodevelopmental disorders in their offspring. We evaluated behavioural and neuropsychological test scores in children of mothers who used LEA. METHODS: Children enrolled in the Raine Study from Western Australia and delivered vaginally from a singleton pregnancy between 1989 and 1992 were evaluated. Children exposed to LEA were compared with unexposed children. The primary outcome was the parent-reported Child Behaviour Checklist (CBCL) reporting total, internalising, and externalising behavioural problem scores at age 10 yr. Score differences, an increased risk of clinical deficit, and a dose-response based on the duration of LEA exposure were assessed. Secondary outcomes included language, motor function, cognition, and autistic traits. RESULTS: Of 2180 children, 850 (39.0%) were exposed to LEA. After adjustment for covariates, exposed children had minimally increased CBCL total scores (+1.41 points; 95% confidence interval [CI] 0.09 to 2.73; P=0.037), but not internalising (+1.13 points; 95% CI -0.08 to 2.34; P=0.066) or externalising (+1.08 points; 95% CI -0.08 to 2.24; P=0.068) subscale subscores. Increased risk of clinical deficit was not observed for any CBCL score. For secondary outcomes, score differences were inconsistently observed in motor function and cognition. Increased exposure duration was not associated with worse scores in any outcomes. CONCLUSIONS: Although LEA exposure was associated with slightly higher total behavioural scores, there was no difference in subscores, increased risk of clinical deficits, or dose-response relationship. These results argue against LEA exposure being associated with consistent, clinically significant neurodevelopmental deficits in children.

Postoperative hypothermia is associated with reduced length of stay in adult acute burn survivors.

BACKGROUND: The hypermetabolic response after a burn predisposes patients to hypothermia due to dysfunction of thermoregulation. Traditionally, hypothermia is avoided actively in burn care due to reported complications associated with low body temperature. The likelihood of hypothermia with acute burn surgery is compounded by general anesthesia, exposure of wound areas and prolonged operation times. However, we find limited studies exploring the effects of perioperative hypothermia on length of stay in the adult burn population. OBJECTIVE: To determine associations between postoperative hypothermia and hospital length of stay in adult burns patients. METHOD: This retrospective cohort study involved patients admitted to the State Adult Burn Unit in Western Australia between 1st January 2015 to 28th February 2021. All adults who underwent surgery for acute burn, and had postoperative recovery room body temperature recorded, were included in the study. In this study, we defined normothermia as >36.5C and hypothermia as < 36.0 °C with mild, moderate, and severe hypothermia being 35.0-35.9 °C, 34.0-34.9 °C and < 34.0 °C, respectively. Patients with hyperthermia were excluded. Multivariable general linear models explored if hypothermia was independently associated with length of stay. RESULTS: Among 1486 adult patients, 1338 (90%) were normothermic postoperatively, with temperatures >36.0C. We included 148 (10%) patients with hypothermia (temperature <36.0 °C) postoperatively. Most burns in the study population were minor: 96% had burns < 15% TBSA. Data modelling demonstrated that hypothermia was associated with a shorter length of hospital stay (coefficient = -0.129, p = 0.041). CONCLUSION: In adult acute burn patients, postoperative hypothermia was associated with reduced length of stay after surgery. The positive results of this study indicate that a review of the core temperature targets with acute burn surgery, and timing of burn patient cooling practices in general is warranted.

The Changing Detection Rate of Respiratory Syncytial Virus in Adults in Western Australia between 2017 and 2023.

The incidence of respiratory syncytial virus (RSV) in adults is inadequately defined and the impact of SARS-CoV-2-related non-pharmaceutical interventions (NPIs) is underexplored. Using laboratory data, we described the detection rate of RSV in adults ≥16 years in Western Australia (WA) between 2017 and 2023. With the exception of 2020, RSV detections rose annually between 2017 and 2023, reaching 50.7 per 100,000 in 2023 (95% confidence interval [CI], 47.9-53.8). RSV testing expanded considerably across the study period, with the testing in 2023 more than five times the 2017 total. The detection rate was highest in adults ≥60 years between 2017 and 2019, particularly those ≥75 years. Following 2020, the detections in all age groups increased, with the highest detection rate in 2023 in those ≥75-years (199.5 per 100,000; 95% CI, 180.5-220). NPIs significantly impacted RSV seasonality; the preceding winter pattern was disrupted, resulting in an absent 2020 winter season and two major summer seasons in 2020/21 and 2021/22. The RSV season began to realign in 2022, reverting to a winter seasonal pattern in 2023 and the largest season in the study period. Ongoing surveillance will be required to understand the stability of these increases and to delineate the impact of new immunisation strategies.

Aggregation of melanoma tumour site within Western Australian families.

BACKGROUND: Evidence is emerging that melanoma has distinct aetiologic pathways and subtypes, characterized by factors like anatomic site of the tumour. To explore genetic influences on anatomic subtypes, we examined the extent to which melanomas in first-degree relatives shared the same body site of occurrence. METHODS: Population-level linked data was used to identify the study population of over 1.5 million individuals born in Western Australia between 1945 and 2014, and their first-degree relatives. There were 1009 pairs of invasive tumours from 677 family pairs, each categorised by anatomic site. Greater than expected representation of site-concordant pairs would suggest the presence of genetic factors that predispose individuals to site-specific melanoma. RESULTS: Comparing observed versus expected totals, we observed a modest increase in site concordance for invasive head/neck and truncal tumours (P=0.02). A corresponding analysis including in situ tumours showed a similar concordance (P=0.05). No further evidence of concordance was observed when stratified by sex. CONCLUSION: In conclusion, modest evidence of aggregation was observed but with inconsistent patterns between sites. Results suggest that further investigation into the familial aggregation of melanoma by tumour site is warranted, with the inclusion of genetic data in order to disentangle the relative contributions of genetic and environmental factors.

Modelling respiratory syncytial virus age-specific risk of hospitalisation in term and preterm infants.

BACKGROUND: Respiratory syncytial virus (RSV) is the most common cause of acute lower respiratory infections in children worldwide. The highest incidence of severe disease is in the first 6 months of life, with infants born preterm at greatest risk for severe RSV infections. The licensure of new RSV therapeutics (a long-acting monoclonal antibody and a maternal vaccine) in Europe, USA, UK and most recently in Australia, has driven the need for strategic decision making on the implementation of RSV immunisation programs. Data driven approaches, considering the local RSV epidemiology, are critical to advise on the optimal use of these therapeutics for effective RSV control. METHODS: We developed a dynamic compartmental model of RSV transmission fitted to individually-linked population-based laboratory, perinatal and hospitalisation data for 2000-2012 from metropolitan Western Australia (WA), stratified by age and prior exposure. We account for the differential risk of RSV-hospitalisation in full-term and preterm infants (defined as < 37 weeks gestation). We formulated a function relating age, RSV exposure history, and preterm status to the risk of RSV-hospitalisation given infection. RESULTS: The age-to-risk function shows that risk of hospitalisation, given RSV infection, declines quickly in the first 12 months of life for all infants and is 2.6 times higher in preterm compared with term infants. The hospitalisation risk, given infection, declines to < 10% of the risk at birth by age 7 months for term infants and by 9 months for preterm infants. CONCLUSIONS: The dynamic model, using the age-to-risk function, characterises RSV epidemiology for metropolitan WA and can now be extended to predict the impact of prevention measures. The stratification of the model by preterm status will enable the comparative assessment of potential strategies in the extended model that target this RSV risk group relative to all-population approaches. Furthermore, the age-to-risk function developed in this work has wider relevance to the epidemiological characterisation of RSV.

A two-year retrospective cohort study investigating the occurrence and short-term outcomes of dog-bite injures in regional Western Australia.

BACKGROUND: Dog bite injuries are a preventable yet common cause of animal related hospitalisation. Dog bites in metropolitan areas have been well characterised however there is limited information regarding dog bites in regional areas. This study sought to describe the demographics, clinical presentation and short-term outcomes of patients presenting with dog bite related injuries to Broome Regional Hospital (BRH). METHODS: A retrospective cohort study examined all dog bite related injuries presenting to BRH Emergency Department (ED) between July 1st 2021 - June 30th 2023, with the terms "dog" AND "bitten OR bite" in ED triage note. Chart review was performed to extract demographics, clinical presentation and short-term outcomes of dog bite related injuries. RESULTS: After exclusions, 207 patients were identified during the 2-year study period; approximately four dog-bites per week. Median age was 32 (IQR: 32, range 1-97 years old) with 46 % of patients being female. Residents of the Kimberley represented 78 % of presentations for dog bites. Dogs that belonged to or were known to patients were involved in 74 % of cases. The lower limb below the knee (42 %) was most commonly bitten, followed by the distal upper limb (30.5 %) and then face (13 %). Most patients presented on the same-day (67 %), were treated with antibiotics (79 %) and 83 % were discharged on the day of presentation. There were 43 (23 %) patients who required repair in the ED or operating theatre. Thirty-three patients were admitted to BRH. Seven patients required transfer for subspecialty tertiary level care. CONCLUSION: Dog-bite trauma is common and consumes significant health resources associated with ED presentations, hospital admissions, theatre usage and transfer in severe cases. A multifaceted approach encompassing education, engineering, and enforcement is required to prevent dog bites.

Characterization of invasive Group B Streptococcus isolates from Western Australian infants, 2004-2020.

Background. Invasive Group B Streptococcus (GBS; Streptococcus agalactiae) remains a leading cause of infant morbidity and mortality. Intrapartum antibiotic prophylaxis (IAP) has been implemented in many countries with a reduction in early-onset disease, but an effective vaccine may further reduce the disease burden. Candidate vaccines targeting capsular polysaccharides and surface proteins are now in clinical trials.Methods. Using whole-genome sequencing and phenotypic antimicrobial susceptibility testing, we characterized sterile-site GBS isolates recovered from Western Australian infants between 2004 and 2020. Characteristics were compared between three time periods: 2004-2008, 2009-2015 and 2016-2020.Results. A total of 135 isolates were identified. The proportion of serotype III (22.7 % in Period 1 to 47.9 % in Period 3, P=0.04) and clonal complex 17 (13.6-39.6 %, P=0.01) isolates increased over time. Overall coverage of vaccines currently being trialled was >95 %. No isolates were penicillin resistant (MIC>0.25 mg l-1), but 21.5 % of isolates had reduced penicillin susceptibility (MIC>0.12 mg l-1) and penicillin MIC increased significantly over time (P=0.04). Clindamycin resistance increased over time to 45.8 % in the latest period.Conclusions. Based on comprehensive characterization of invasive infant GBS in Western Australia, we found that coverage for leading capsular polysaccharide and surface protein vaccine candidates was high. The demonstrated changes in serotype and molecular type highlight the need for ongoing surveillance, particularly with regard to future GBS vaccination programmes. The reduced susceptibility to IAP agents over time should inform changes to antibiotic guidelines.

COVID-19 outcomes in haemopoietic stem cell transplant recipients in Western Australia: the value of vaccination and antiviral therapy.

Coronavirus-19 (COVID-19) mortality rates among haemopoietic stem cell transplant (HSCT) patients are high, ranging between 20% and 40%. We prospectively evaluated the mortality outcomes of COVID-19 in Western Australian HSCT patients. A total of 32/492 (6.5%) HSCT recipients contracted COVID-19 during the study, of whom 30/32 (94%) developed mild or asymptomatic disease. Two allogeneic HSCT patients were hospitalised for severe COVID-19; one patient died. Stringent healthcare, social isolation practices, aggressive vaccination programmes and rapid access to COVID-19 antivirals may have promoted mild COVID-19 illness in Western Australian HSCT patients, resulting in one of the lowest COVID-19 mortality rates in HSCT recipients worldwide.

Epidemiology and assessment of Hepatitis B positive children in Western Australia.

AIM: To describe the characteristics of patients with chronic hepatitis B (CHB) presenting to a tertiary paediatric hospital in Perth, Western Australia. Review of implementation of previous follow-up recommendations for the cohort was also undertaken. METHOD: A retrospective data analysis of all individuals aged between 0 and 17 years presenting to the tertiary children's hospital who were hepatitis B surface antigen (HBsAg) positive over 8 years (2013-2020). Demographic features, clinical progress and follow up are described, including proportion transferred to adult services. RESULTS: Seventy-four patients were identified to have CHB; mean age at diagnosis 11 years; standard deviation 4 years; 41 (55%) male. Cultural and ethnolinguistic diversity was high; 74% (n = 55) were from refugee-like backgrounds. Many did not demonstrate English proficiency (23/40; 75%) and 7 (10%) Australian born including 4 patients who were Aboriginal. Most patients (58%) with CHB were in the hepatitis B e antigen-positive chronic infection phase with no intervention provided. Seventeen children had undergone liver ultrasonography and one underwent liver biopsy; none received antiviral treatment. Follow up was concerning; 28 (38%) had at least one clinic non-attendance, 24 (32%) lost to follow-up and interpreter utilisation was poorly documented. Thirty-nine (53%) were transferred to adult services with only 56% attending follow-up. CONCLUSION: CHB burden is higher in those from culturally and ethnolinguistically diverse backgrounds. There is a significant loss to follow-up and suboptimal transfer to adult services. Improved recall, education and referral processes are necessary to overcome language, socioeconomic and cultural barriers. Although childhood complications are infrequent, longitudinal monitoring is crucial to prevent long-term complications and adult morbidity.

Long-term incidence, risk factors and complications for venous thromboembolism in patients with systemic lupus erythematosus.

AIM: To compare frequency, incidence rates (IR), risk factors and outcomes of a first venous thromboembolic event (VTE) between patients with systemic lupus erythematosus (SLE) and controls. METHODS: Using state-wide longitudinal hospital data from Western Australia (WA), we recorded venous thrombosis (VT) and pulmonary embolism (PE) in patients with SLE (n = 1854, median age 40, 86% female) and matched hospitalised controls (n = 12,107, median age 40 years, females 88.6%) in the period 1985-2015. Results presented are medians, frequency, IR per 1000 person years (PY) and odds, rate, or adjusted hazard ratios (OR/RR/a-HR) with 95% confidence intervals (CI). RESULTS: Patients with SLE had significantly higher odds (12.8 vs 3.3%; OR 4.26, CI 3.60-5.05) and IR for a first VTE (10.09 vs 1.52; RR 6.64; CI 5.56-7.79). Over the three study decades, the IR for PE declined in patients with SLE from 7.74 to 3.75/1000 PY (p < .01) with no changes observed for VT or in controls. VTE recurred more frequently in patients with SLE (24.1% vs 10.2 %) (p < .01). Antiphospholipid antibodies (aPL) (a-HR 4.24, CI 2.50-7.19), serositis (a-HR 2.70, CI 1.86-3.91), lupus nephritis (a-HR 1.75 CI 1.25-2.33) and thrombocytopenia (a-HR 1.65 (1.10-2.49) were the strongest disease risk factors for VTE only in patients with SLE, while arterial hypertension, smoking and obesity were independent VTE risk factors for both groups. VTE was not associated with an increased risk for arterial events, but PE increased the risk for pulmonary hypertension (PH) in both patients with SLE (a-HR 6.47, CI 3.73-11.23) and controls (a-HR 9.09, CI 3.50-23.63). VTE increased the risk of death in both patients with SLE (a-HR 2.02, CI 1.50-2.70) and controls (a-HR 6.63, CI 5.21-8.42) after 10 years of follow-up. CONCLUSIONS: VTE affected 12.8% of patients with SLE at six times the VTE rate in controls with aPL as the strongest, but not the only risk factor in SLE. The risk of PH was increased in both groups following PE, but VTE did not associate with an increased risk of arterial events.

The temporal association between adverse drug reactions and antirheumatic drugs utilisation in Western Australia: a retrospective study from real-world data (1995-2015).

BACKGROUND/OBJECTIVES: Adverse drug reactions (ADRs) can result in morbidity, mortality, and higher healthcare costs. Given the limited information available on ADRs associated with antirheumatic medications, this study aims to analyse and compare ADR reporting for these drugs in the pharmacovigilance datasets of Western Australia (WA) and the United States (US). METHODS: Therapeutic Goods Administration provided WA pharmacovigilance data of selected antirheumatic drugs to from 1995 to 2015. The proportional reporting ratio (PRR) for WA case reports was compared to corresponding USA pharmacovigilance data by assessing the disproportionality of each ADR. clinically significant or true ADRs were determined using the Evans 2001 criteria (n > 2, chi-square > 4, PRR > 2). RESULTS: A total of 232 reports were found in WA, mostly on sixty-nine women aged 45 to 69. Methotrexate, leflunomide, azathioprine, sulfasalazine, and infliximab had the highest reported ADRs, related to gastrointestinal disorders. Patients who used biological agents in WA had 2.7 times the likelihood of reporting true ADRs compared to conventional antirheumatic drugs. The ADR rates in the two datasets were comparable over the study period. CONCLUSIONS: The PRR values of ADRs were consistent between WA and US databases. Methotrexate and infliximab use were commonly associated with ADR reports in WA females, with incidence rates comparable to the US; while patients using biological agents were more likely to report true ADRs than those on conventional antirheumatic drugs in WA.