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.

Mortality Trends Among Patients with Rheumatoid Arthritis in Western Australia.

INTRODUCTION: With scarce comparative data on mortality in Australian patients with rheumatoid arthritis (RA), we investigated temporal changes in standardized mortality rates for patients with RA using longitudinal linked population-wide health data in Western Australia (WA) over the period 1980 to 2015. METHODS: The study included 17,125 patients with a first-time hospital contact for RA (ICD-10-AM M05.00-M06.99 and ICD-9-AM 714.00-714.99) in the study period. Standardized mortality rate ratios (SMRRs) for the RA cohort versus the WA general population was estimated using direct age standardization. We analyzed temporal trends over with dates and causes provided by the WA Death Registry. RESULTS: During 356,069 patient-years of follow-up, a total of 8955 (52%) deaths occurred in the RA cohort. The SMRR was 2.24 (95% CI 2.15-2.34) in males and 3.09 (95% CI 3.00-3.19) in females over the study period. SMRR decreased since 2000 to 1.59 (95% CI 1.39-1.81) for the period 2011-2015. Median survival was 26.80 years (95% CI 26.30-27.30), where age and comorbidity independently increased the risk of death. The leading causes of deaths were cardiovascular diseases (26.60%), cancer (16.80%), rheumatic diseases (5.80%), chronic pulmonary disease 491 (5.50%), dementia (3.00%), and diabetes 235 (2.6%). CONCLUSIONS: The mortality rate in patients with RA in WA has decreased but remains 1.59-times higher than in community counterparts, suggesting that there is room for further improvement. Comorbidity is the main modifiable risk factor to further reduce mortality in patients with RA.

Total Hip Replacement in Patients with Rheumatoid Arthritis: Trends in Incidence and Complication Rates Over 35 Years.

INTRODUCTION: Advances in rheumatoid arthritis (RA) management have made disease remission achievable. We evaluated trends in total hip replacement (THR) and postoperative outcomes in patients with RA in Western Australia (WA) over more than three decades. METHODS: This was a retrospective analysis of routinely collected prospective data from a state-wide registry containing longitudinally linked administrative health data based on International Classification of Diseases (ICD) diagnostic and procedural codes. We included patients with two or more diagnostic codes for RA (between 1980 and 2015) and studied THR incidence rates (THR IR) and complication rates (revision, peri-prosthetic fracture, infection, venous thrombosis, and mechanical loosening). Survival rates were estimated by Kaplan-Meier method and predictors analyzed by Cox regression. RESULTS: We followed 9201 RA patients over 111,625 person-years, during which 1560 patients (16.9%) underwent THR. From 1985 to 2015, THR IR (per 1000 RA patient-years) decreased from 20.8 (95% CI 20.1-21.5) to 7.3 (95% CI 7.2-7.5), and 5-year THR-free survival increased from 84.3 to 95.3% (1980-2015). Ten-year prosthetic survival was 91.2%. Complication rates in the first 5 years post-THR decreased significantly from 13.1 to 3.7% (p < 0.001). Mechanical complications such as loosening and periprosthetic fracture rates decreased significantly (> 35%, P < 0.05), while infection and revision did not change over the observation period (p > 0.05). CONCLUSIONS: Over the last 30 years in RA patients, THR IR and mechanical complication rates decreased significantly, but the medical complication of infection has not changed significantly.

The Prevalence of Rheumatoid Arthritis: A Systematic Review of Population-based Studies.

OBJECTIVE: To estimate the prevalence of rheumatoid arthritis (RA) from international population-based studies and investigate the influence of prevalence definition, data sources, classification criteria, and geographical area on RA prevalence. METHODS: A search of ProQuest, MEDLINE, Web of Science, and EMBASE was undertaken to identify population-based studies investigating RA prevalence between 1980 and 2019. Studies were reviewed using the Joanna Briggs Institute approach for the systematic review and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: Sixty studies met the inclusion criteria. There was a wide range of point prevalence reported (0.00-2.70%) with a mean of 0.56% (SD 0.51) between 1986 and 2014, and a mean period prevalence of 0.51% (SD 0.35) between 1955 and 2015. RA point and period prevalence was higher in urban settings (0.69% vs 0.48%) than in rural settings (0.54% vs 0.25%). An RA diagnosis validated by rheumatologists yielded the highest period prevalence of RA and was observed in linked databases (0.80%, SD 0.1). CONCLUSION: The literature reports a wide range of point and period prevalence based on population and method of data collection, but average point and period prevalence of RA were 51 in 10,000 and 56 in 10,000, respectively. Higher urban vs rural prevalence may be biased due to poor case findings in areas with less healthcare or differences in risk environment. The population database studies were more consistent than sampling studies, and linked databases in different continents appeared to provide a consistent estimate of RA period prevalence, confirming the high value of rheumatologist diagnosis as classification criteria.

Color stability and degree of conversion of a novel dibenzoyl germanium derivative containing photo-polymerized resin luting cement.

AIM: To compare the color stability and degree of conversion (DC) of a resin cement containing a dibenzoyl germanium derivative photo-initiator (Variolink Esthetic) to resin cements containing conventional luting agents. MATERIALS AND METHOD: Spectrophotometry and Fourier transform infrared spectroscopy (FTIR) were used to compare the color stability and DC, respectively, of Variolink Esthetic compared to Calibra, Variolink-N, and NX3 resin cements. Ten specimens (1 × 2 mm2) of each resin cement were photo-polymerized and then subjected to color stability assessments. In addition, 30 samples of each of the four resin cements were prepared and then immersed in three staining solutions (tea, coffee, and distilled water) for two weeks. Changes in color for the immersed versus non-immersed specimens (control specimens) were determined by comparing ΔL (lightness), Δa, and Δb (color components), and an overall ΔE (color difference) obtained from spectrophotometry assays. One-way analysis of variance and a multiple comparison test (Tukey's test) were used to analyze color stability and DC data. NX3 and Variolink Esthetic resin cements exhibited significantly lower values compared to the dual cured resin cements (Variolink-N and Calibra). RESULTS: The highest DC values were observed among the photo-polymerized samples of Variolink Esthetic (87.18 ± 2.90%), while the lowest DC values were observed among the Variolink-N samples (44.55 ± 4.33%). CONCLUSION: The resin cement, Variolink Esthetic, containing a novel dibenzoyl germanium derivative photo-initiator exhibited superior color stability (p < 0.05) and a higher DC than other resin cements containing conventional luting agents in an in vitro setting.