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Background: 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 of golimumab treatment in patients with rheumatic diseases and the factors associated with persistence up to 7 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 Dec 2019 on all the patients aged 18 years or older who had initiated golimumab for rheumatoid arthritis (RA),psoriatic arthritis (PsA) and axial spondyloarthritis (SpA).The probability of persistence was calculated with a Kaplan-Meier test.Factors related to persistence were analyzed with a Cox-regression model
Results: There were 685 patients included (195 [28.5%] RA, 294 [42.9%] axial SpA and 196 [28.6%] PsA) in the analysis (Mean age 51.3 [12.6] years, 53.7% women). Median duration of disease at the onset of golimumab therapy was 7.6 (3.0-14.5) years. Golimumab was prescribed as first biological drug in 36.4%, as second in 31.7% and as third or further in 31.9% of the patients. Concomitant medication at golimumab initiation included methotrexate (40.0%), corticosteroids (34.2%), leflunomide (17.8%) and sulphasalazine (8.1%). The probability of persistence with golimumab treatment was 71.7% (95% CI 68.1–74.9) at year 1,60.5% (56.5–64.2) at year 2, 55.6% (51.5–59.5) at year 3, 50.6% (46.2–54.8) at year 4, 45.1% (40.1–50.0) at year 5, 44.2% (39.0–49.3) at year 6 and 39.5% (32.8–46.2) at year 7. As the first biological agent the probability of persistence was 83.2% at year 1 and 60.0% at year 5. As a second biological drug persistence was 70.4% and 39.9% (year 1 and 7). Cox-regression analysis (table) showed that the probability of persistence with golimumab treatment was higher in first vs second or third biological line (Hazard Ratio[HR] for discontinuation: 1.45 for second and 3.04 for third or further vs first line), in SpA and PsA patients (HR discontinuation vs RA:0.56 and 0.49 respectively) and in patients with methotrexate (HR:0.61) and lower in those needing corticosteroids(HR:1.71) or DMARDs different to methotrexate (HR:1.88) and in patients with higher disease activity at golimumab onset (HR:1.45)
Conclusion: The probability of persistence on golimumab therapy was high and remained relatively stable up to 7 years of follow-up. A lower risk of treatment discontinuation was observed in patients who received golimumab as first biological agent and in PsA and SpA patients. Persistence was lower in patients needing corticosteroids, DMARDs different to methotrexate and in those with higher disease activity at golimumab onset
Cox-regression analysis.HR for discontinuation of golimumab
| HR | 95% CI | p | |
|---|---|---|---|
| Age at golimumab initiation | 1.01 | (0.99-1.02) | 0.480 |
| Gender (women vs men) | 1.15 | (0.69-1.90) | 0.595 |
| Smoking habit (smoker vs non-smoker) | 1.46 | (0.90-2.37) | 0.128 |
| Smoking habit (past smoker vs non-smoker) | 0.94 | (0.48-1.84) | 0.859 |
| Overweight (vs normal) | 1.10 | (0.63-1.93) | 0.728 |
| Obesity (vs normal) | 0.90 | (0.51-1.59) | 0.708 |
| SpA vs RA | 0.56 | (0.31-1.00) | 0.050 |
| PsA vs RA | 0.49 | (0.28-0.87) | 0.015 |
| Second vs first biological drug | 1.45 | (0.85-2.46) | 0.171 |
| Third or further vs first biological drug | 3.04 | (1.86-4.98) | 0.001 |
| MTX | 0.61 | (0.38-0.97) | 0.037 |
| Other DMARD | 1.88 | (0.90-3.93) | 0.091 |
| Corticosteroids | 1.71 | (1.04-2.83) | 0.036 |
| Activity higher than median | 1.45 | (0.96-2.19) | 0.078 |
Acknowledgments: BIOBADASER is a multi-funded registry of The Spanish Society of Rheumatology (SER) and this specific analysis was funded by MSD Spain.
Disclosure of Interests: Manuel Pombo: None declared, Carlos Sánchez-Piedra: None declared, Luis Cea-Calvo Employee of: MSD Spain, Sara Manrique Arija: None declared, Blanca Garcia-Magallon Consultant of: MSD, Speakers bureau: Pfizer, Amgen, Celgene, MSD, Cristina Campos Fernández: None declared, Irene Notario: None declared, Federico Diaz-Gonzalez: None declared, Juan Jesus Gomez-Reino: None declared