Clinical factors associated with discontinuation of ts/bDMARDs in rheumatic patients from the BIOBADASER III registry

Abstract

Biologic and targeted synthetic disease-modifying antirheumatic drugs (ts/bDMARDs) play a pivotal role in the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Persistence of therapy provides an index of a drug’s overall effectiveness. The objective of the study was to identify factors associated with discontinuation of ts/bDMARDs in a real-world dataset. The study population comprised patients diagnosed with RA, PsA, and AS included in the BIOBADASER registry for whom follow-up data were available until November 2019. Patient features and treatment data were included in the analysis. The Kaplan–Meier method was used to study survival of the different drugs according to the reason for discontinuation. Factors associated with discontinuation were studied using Cox regression models and bivariate and multivariate analyses. P values of less than 0.05 were regarded as statistically significant. The study population comprised 4,752 patients who received a total of 8,377 drugs, of which 4,411 (52.65%) were discontinued. The Kaplan–Meier curves showed that survival for first-line treatment was greater in all 3 groups (p < 0.001). Patients with RA had a greater risk of discontinuation if they were younger (HR, 0.99; 95% CI 0.99–1.00), if they were receiving anti-TNFα agents (HR, 0.61; 95% CI 0.54–0.70), and if they had more comorbid conditions (HR, 1.09; 95% CI 1.00–1.17). Patients with PsA had a higher risk if they were women (HR, 1.36; 95% CI 1.15–1.62) and if they were receiving other ts/bDMARDs (HR, 1.29; 95% CI 1.05–1.59). In patients with AS, risk increased with age (HR, 1.01; 95% CI 1.00–1.02), as did the number of comorbid conditions (HR, 1.27; 95% CI 1.12–1.45). The factors that most affected discontinuation of ts/bDMARDs were line of treatment, age, type of drug, sex, comorbidity and the year of initiation of treatment. The association with these factors differed with each disease, except for first-line treatment, which was associated with a lower risk of discontinuation in all 3 diseases.

Long‐term retention of golimumab treatment in clinical practice in a large cohort of patients with rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis

“…Different studies have reported 3-, 4-, or 5-year retention rates for golimumab ranging from 35% to 65% (Aaltonen et al, 2017;Alegre-Sancho et al, 2021;Chimenti et al, 2022;Michelsen et al, 2020;Serrano_Benavente et al, 2022;Thomas et al, 2018), and a systematic review reported 3-year golimumab retention rates of 32%-67% (Svedbom, Storck et al, 2017). To the best of our knowledge, the Navarini et al, 2020;Prior-Español et al, 2021) appears to be greatest when they are used as first-line biological DMARD therapy, an observation which is consistent with our findings in the current analysis. The probability of retention at year 1 was 81.7% when golimumab was administered as first-line therapy compared with 69.9% when it was given as second-line therapy.…”

“…Retention of golimumab (Hernandez et al., 2019; Pombo‐Suarez et al., 2021) and other biological DMARDs (González‐Fernández et al., 2019; Navarini et al., 2020; Prior‐Español et al., 2021) appears to be greatest when they are used as first‐line biological DMARD therapy, an observation which is consistent with our findings in the current analysis. The probability of retention at year 1 was 81.7% when golimumab was administered as first‐line therapy compared with 69.9% when it was given as second‐line therapy.…”

“…Long‐term persistence with treatment is needed to achieve the greatest benefit from bDMARDs; however, many patients discontinue treatment after receiving one or more lines of therapy (Dalén et al., 2016; Ebina et al., 2020). Retention tends to decrease with each subsequent line of therapy (Prior‐Español et al., 2021; Svedbom, Dalén et al., 2017), and such changes are associated with increased healthcare costs (Carballo et al., 2021; Svedbom, Dalén et al., 2017). Therefore, treatment decisions should take into account the probability of persisting with the same bDMARDs over time.…”

Cardiovascular Risk Factors and the Risk of Discontinuation of Advanced Therapies Due to Treatment Failure in Rheumatoid Arthritis: Results From the Ontario Best Practices Research Initiative

“…Moreover, we found no significant correlation between the number of CVD risk factors and treatment discontinuation specifically attributed to adverse events. This outcome contradicts the findings from the BIOBADSER registry, which found an association between higher comorbidity index (including CVD) and discontinuation of b/tsDMARDs due to adverse events 15 . These differences may be attributed to variations in cohort characteristics or strategies employed to mitigate the risk of adverse events across different countries or regions.…”

Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study

“…In fact, patients stratified for the presence of comorbid disease had a significantly lower retention rate (60% vs. 90%, p < 0.0007), up to 3 years. The presence of comorbidities would be expected to negatively impact upon drug adherence since these patients tend to have a higher rate of treatment interruption due to complications [31][32][33].…”