Abstract
Scanty information on clustering longitudinal real-world data is available in the medical literature about the adherence implementation phase in rheumatoid arthritis (RA). To identify and characterize trajectories by analyzing the implementation phase of adherence to biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), we conducted a retrospective cohort drug-utilization study using Tuscan administrative databases. RA patients were identified by a validated algorithm, including the first biologic DMARD supply from 2010 to 2015, RA specialist visit in the year before or after the first supply date and RA diagnosis in the five years before or in the year after the first supply date. We observed users for three years or until death, neoplasia, or pregnancy. We evaluated adherence quarterly through the Medication Possession Ratio. Firstly, we identified adherence trajectories and described the baseline characteristics; then, we focused on the trajectory most populated to distinguish the related sub-trajectories. We identified 952 first ever-biologic DMARD users in RA (712 females, mean age 52.7 years old, standard deviation 18.8). The biologic DMARD mostly supplied was etanercept (387 users) followed by adalimumab (233). Among 935 users with at least 3 adherence values, we identified 49 fully-adherent users, 829 continuous users, and 57 early-discontinuing users. Significant differences were observed among the index drugs. After focusing on the continuous users, three sub-trajectories were identified: continuous-steady users (556), continuous-alternate users (207), and continuous-declining users (66). No relevant differences emerged at the baseline. The majority of first ever-biologic DMARD users showed a continuous adherence behavior in RA. The role of adherence potential predictors and the association with effectiveness and safety outcomes should be explored by further studies.
Highlights
Rheumatoid arthritis (RA) is an immune-mediated inflammatory disease (IMID) resulting in joint deformation and disability [1], with negative impact on quality of life [2,3].Poor rheumatoid arthritis (RA) control can promote other diseases [4], including cardiovascular ones [5], which add to pre-existing comorbidities [6] and increase mortality [7]
We considered the following categories of variables as baseline characteristics of patients: time invariant, and single event
We identified 11,100 first users of biologic DiseaseModifying Anti-Rheumatic Drugs (DMARDs) between 2010 and 2015 in Tuscany
Summary
Rheumatoid arthritis (RA) is an immune-mediated inflammatory disease (IMID) resulting in joint deformation and disability [1], with negative impact on quality of life [2,3]. Poor RA control can promote other diseases [4], including cardiovascular ones [5], which add to pre-existing comorbidities [6] and increase mortality [7]. The first-line pharmacological approach includes glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), opioids, as well as conventional disease-modifying anti-rheumatic drugs (DMARDs) [8,9,10]. Rheumatologists must continuously monitor the disease activity and adjust the treatment [10]. In this regard, monitoring drug utilization and adherence are crucial for verifying the appropriateness of use
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