Factors associated to persistence of treatment with golimumab in the biobadaser registry, with up to 6 years of follow-up

Abstract

Background: Survival, or persistence in treatment with a biological drug can be considered an indirect measure of efficacy, safety and tolerability

Objectives: We assessed the probability of persistence (survival) of treatment with golimumab in patients with rheumatic diseases and the factors associated to persistence with up to 6 years of follow-up.

Methods: BIOBADASER is the Spanish registry of biological drugs of the Spanish Society of Rheumatology and the Spanish Medicines Agency. A data-base analysis was done in December 2018 on all the patients aged 18 years or more who had initiated golimumab for one of the approved indications (rheumatoid arthritis [RA], axial spondyloarthritis [SpA] or psoriatic arthritis [PsA]). The probability of persistence was calculated with a Kaplan-Meier test. Factors related to persistence were analyzed with a Cox-regression model.

Results: 581 patients were included (165 [28.4%] RA, 249 [42.9%] axial SpA and 167 [28.7%] PsA), mean age 51 [12] years, 53% women). Median duration of disease at the onset of golimumab was 8.0 (3.0-14.7) years. Golimumab was prescribed as first biological drug in 37.9% of the patients, as second in 32.1% and as third or further in 30.0%. Concomitant medications at golimumab initiation included steroids (28.2%), methotrexate (MTX) (35.5%), sulphasalazine (7.2%) and leflunomide (13.9%). The probability of persistence of treatment with golimumab since treatment initiation was 74.3% at year 1 (95% CI 70.3 – 77.8), 63.5% at year 2 (59.0 – 67.6), 60.5% at year 3 (55.9 – 65.8), 54.5% (49.1 – 59.7) at year 4 and 5, and 52.1% (44.9 – 57.7) at year 6. Persistence was higher when golimumab was used as first biological agent (p log-rank <0.001) and for the treatment of axial SpA or PsA compared to RA (p log-rank <0.001). As first biological drug the probability of persistence was 82.8% (year 1) and 66.5% at year 4. At year 5, survival rates (all lines of therapy) were 59.7%, 63.4% and 37.3% for axial SpA, PsA and RA respectively. Cox-regression analysis (table) showed that the probability of persistence in treatment with golimumab therapy was higher in first vs second or third biological line patients (Hazard Ratio [HR] for discontinuation: 1.78 for second and 2.41 for third or further line versus first line), in SpA and PsA patients (HR discontinuation of RA patients: 1.94 versus PsA), and lower in women (HR: 1.62), in those needing steroids (HR: 1.47) or DMARDs different to MTX (HR: 2.17). Patients treated with MTX had higher but non-significant persistence rate (HR discontinuation 0.79, table).

Conclusion: The probability of persistence (survival) on therapy with golimumab was high up to 6 years of follow-up and was higher in patients treated with golimumab as first biological drug or for PsA and SpA, and lower in those needing steroids, DMARDs different to MTX and in women.