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. 2021 Dec 8;10(24):5743.
doi: 10.3390/jcm10245743.

Trajectories of Adherence to Biologic Disease-Modifying Anti-Rheumatic Drugs in Tuscan Administrative Databases: The Pathfinder Study

Irma Convertino  1 , Sabrina Giometto  2 , Rosa Gini  3 , Massimiliano Cazzato  4 , Marco Fornili  2 , Giulia Valdiserra  1 , Emiliano Cappello  1 , Sara Ferraro  1 , Claudia Bartolini  3 , Olga Paoletti  3 , Silvia Tillati  2 , Laura Baglietto  2 , Giuseppe Turchetti  5 , Leopoldo Trieste  5 , Valentina Lorenzoni  5 , Corrado Blandizzi  1   6 , Marta Mosca  4 , Marco Tuccori  1   6 , Ersilia Lucenteforte  2
Affiliations

Trajectories of Adherence to Biologic Disease-Modifying Anti-Rheumatic Drugs in Tuscan Administrative Databases: The Pathfinder Study

Irma Convertino et al. J Clin Med. .

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.

Keywords: DMARD; adherence; biologic; real world evidence; rheumatoid arthritis.

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Conflict of interest statement

R.G., V.L., G.T., C.B., M.T. and E.L. were involved as investigators of observational study funded by the pharmaceutical company Galapagos in compliance with the ENCEPP Code of Conduct. R.G., C.B. and O.P. are employed by Agenzia Regionale di Sanità (ARS) Toscana, a public health agency that conducts or participates in pharmacoepidemiology studies compliant with the ENCePP Code of Conduct; the budget of ARS is partially sustained by such studies. M.M. has carried out consultancy/conference presentations for ABBVIE, LILLY, UCB, GSK, BMS. E.L. has carried out consultancy for Angelini. I.C., S.G., M.C., M.F., G.V., E.C., S.F., S.T. and L.B. have no relevant financial or non-financial interests to disclose.

Figures

Figure 1
Figure 1
Study flow chart. DMARDs: Disease-modifying Anti-Rheumatic Drugs; RA: rheumatoid arthritis.
Figure 2
Figure 2
Adherence behavior to biologic DMARDs over three years of observation in the first-phase analysis.
Figure 3
Figure 3
Spaghetti plots of random samples of 50 patients selected from each of the three adherence trajectories. Individual and mean trajectories are displayed in grey and black, respectively.
Figure 4
Figure 4
Sub-trajectories of adherence to biologic DMARDs in the second-phase analysis.
Figure 5
Figure 5
Spaghetti plot of random samples of 50 patients selected from each of the 3 adherence sub-trajectories identified in the second-phase analysis. Individual and mean sub-trajectories are displayed in grey and black, respectively.
See this image and copyright information in PMC

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