Background/Purpose: The Biologic Treatment Registry Across Canada (BioTRAC) was a prospective, observational registry that enrolled rheumatoid arthritis (RA) patients treated with either subcutaneous golimumab (GLM-SC) or intravenous golimumab (GLM-IV) between 2010 and 2017. The registry was closed in June 2018. 

Methods: Patient visits occurred at baseline and every 6 months thereafter. Multivariate logistic regression was used to identify independent predictors of achieving specific efficacy and safety endpoints and included the following covariates: age, gender, disease duration, enrolment period, concomitant medication, smoking and employment. 

Results: A total of 687 Golimumab treated patients (530 GLM-SC and 157 GLM-IV) were enrolled and followed for a mean of 2.0 and 1.6 years, respectively. Most patients were bio-naive ( > 80%). 

DAS28-CRP low disease activity was more likely to be achieved with lower baseline DAS28-CRP [OR (95% CI): 0.73 (0.57–0.92); p=0.009], among those with concomitant DMARD use [2.86 (1.35–6.08); p=0.006], and in patients who were employed [2.26 (1.18–4.33); p=0.014]. However, it was less likely among those with baseline concomitant corticosteroid (CS) use [0.55 (0.30–0.99); p=0.047]. DAS28-CRP remission was more likely to be achieved in males [OR (95% CI): 2.06 (1.10–3.86); p=0.023], later enrolment [2013–2015 vs. 2010–2012: 1.91 (1.02–3.59); p=0.045], and among those with concomitant DMARD use [3.15 (1.53–6.51); p=0.002] and less likely in patients with baseline concomitant CS use [0.37 (0.22–0.62); p< 0.001]. A HAQ-DI < 0.5 was more likely to be achieved with lower age [OR (95% CI): 0.98 (0.96–1.00); p=0.023), in males [2.00 (1.10–3.67); p=0.024], lower baseline HAQ-DI scores [0.13 (0.08–0.20); p< 0.001], higher baseline CRP levels [1.01 (1.00–1.02); p=0.009], in patients who were employed [2.0 (1.09–3.53); p=0.026], and among those with GLM-SC vs. GLM-IV treatment [2.19 (1.12–4.31); p=0.023]. 

AEs were more likely to occur with lower baseline CDAI [OR (95% CI): 0.98 (0.97–1.00); p=0.023], and in patients with baseline concomitant CS [1.62 (1.04–2.52); p=0.032] or NSAID use [1.79 (1.19–2.70); p=0.005], whereas SAEs were less likely to occur in patients enrolled later [2013–2015 vs. 2010–2012: 0.42 (0.23–0.79); p=0.007 and 2016–2017 vs. 2010–2012: 0.18 (0.08–0.44); p< 0.001], and in those with baseline DMARD use [0.37 (0.18–0.79); p=0.009].  

Early treatment period (2013–2015 vs. 2016–2017: 0.58 [0.39–0.87], p=0.008) and concomitant DMARD use [0.58 (0.37–0.90); p=0.016] increased the likelihood of treatment continuation.

Conclusion: In this real-world, long-term prospective cohort of RA patients treated with golimumab, concomitant DMARD use at baseline appears to be a positive predictor of achieving treatment targets, avoiding SAEs and treatment retention.  Patients with concomitant CS at baseline, however, were less likely to meet efficacy endpoints and at higher risk of AEs. Finally, patients enrolled later had a lower likelihood of experiencing an SAE but a higher likelihood of discontinuation, possibly driven by the larger availability of treatment options and/or more rigorous adherence to treat to target guidelines.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/predictors-of-response-adverse-events-and-treatment-retention-in-ra-patients-treated-with-either-subcutaneous-or-intravenous-golimumab-in-a-prospective-observational-registry/