Objective
To estimate the effect of denosumab compared with oral bisphosphonates on reducing the risk of type 2 diabetes in adults with osteoporosis.
Design
Population based study involving emulation of a randomized target trial using electronic health records.
Setting
IQVIA Medical Research Data primary care database in the United Kingdom, 1995-2021.
Participants
Adults aged 45 years or older who used denosumab or an oral bisphosphonate for osteoporosis.
Main outcome measures
The primary outcome was incident type 2 diabetes, as defined by diagnostic codes. Cox proportional hazards models were used to estimate adjusted hazard ratios and 95% confidence intervals, comparing denosumab with oral bisphosphonates using an as treated approach.
Results
4301 new users of denosumab were matched on propensity score to 21 038 users of an oral bisphosphonate and followed for a mean of 2.2 years. The incidence rate of type 2 diabetes in denosumab users was 5.7 (95% confidence interval 4.3 to 7.3) per 1000 person years and in oral bisphosphonate users was 8.3 (7.4 to 9.2) per 1000 person years. Initiation of denosumab was associated with a reduced risk of type 2 diabetes (hazard ratio 0.68, 95% confidence interval 0.52 to 0.89). Participants with prediabetes appeared to benefit more from denosumab compared with an oral bisphosphonate (hazard ratio 0.54, 0.35 to 0.82), as did those with a body mass index ≥30 (0.65, 0.40 to 1.06).
Conclusions
In this population based study, denosumab use was associated with a lower risk of incident type 2 diabetes compared with oral bisphosphonate use in adults with osteoporosis. This study provides evidence at a population level that denosumab may have added benefits for glucose metabolism compared with oral bisphosphonates.
In daily clinical practice, the DAS28 and RAPID3 definitions identified remission about twice as often as the ACR/EULAR Boolean, SDAI, and CDAI. Predictors of remission were similar across remission definitions. These findings provide additional evidence to follow treatment recommendations and treat RA early with a DMARD.
ObjectiveThe objective of this study was to compare achievement of remission in 2 early rheumatoid arthritis (RA) treat‐to‐target (TTT) cohorts, a tight control cohort with a target of stringent remission in a randomized controlled trial and an observational cohort targeting a looser definition of remission in clinical practice.MethodsWe analyzed data from the Aiming for Remission in Rheumatoid Arthritis: a randomised trial examining the benefit of ultrasound in a Clinical Tight Control regimen (ARCTIC) trial and the Norwegian Very Early Arthritis Clinic (NOR‐VEAC) observational study. Both were Norwegian multicenter studies that included disease‐modifying antirheumatic drug (DMARD)–naive RA patients and implemented TTT. The target in the ARCTIC trial was remission defined as a Disease Activity Score (DAS) of <1.6 plus 0 swollen joints on a 44‐joint count, while the target in the NOR‐VEAC study was the less stringent remission target of a DAS28 of <2.6. We assessed achievement of the study‐specific targets and compared the odds of achieving the American College of Rheumatology(ACR)/European League Against Rheumatism (EULAR) Boolean remission during 2 years of follow‐up.ResultsWe included 189 patients from the ARCTIC trial and 330 patients from the NOR‐VEAC study. The study‐specific target had been achieved in more than half of the patients in each cohort at 6 months, increasing to >60% at 12 and 24 months. The odds of achieving ACR/EULAR Boolean remission during follow‐up were higher in the ARCTIC trial than in the NOR‐VEAC study, with significant differences at 3 months (odds ratio 1.73 [95% confidence interval 1.03–2.89]), 12 months (odds ratio 1.97 [95% confidence interval 1.21–3.20]), and 24 months (odds ratio 1.82 [95% confidence interval 1.05–3.16]).ConclusionA majority of patients in both cohorts reached the study‐specific treatment targets. More patients in the ARCTIC trial than in the NOR‐VEAC study achieved ACR/EULAR Boolean remission during follow‐up, suggesting that targeting a more stringent definition of remission provides further potential for favorable outcomes of a TTT strategy.
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