Background/Purpose: The Biologic Treatment Registry Across Canada (BioTRAC) was a prospective, observational registry that enrolled ankylosing spondylitis (AS) (radiographic axial SpA) patients treated with subcutaneous golimumab (GLM) 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, enrollment period, concomitant medication, smoking and employment. 

Results: A total of 421 patients were enrolled and followed for a mean duration of 1.6 years. The proportion of male gender was 59.1% and the mean disease duration at baseline was 6.0 years (SD=10.1 years). Most patients were bio-naive ( >82%). 

ASDAS clinically important improvement was more likely to be achieved with higher baseline ASDAS-CRP score [OR (95%): 2.28 (1.51–3.45); p< 0.001], however less likely in patients with baseline concomitant DMARD use [0.31 (0.12–0.80); p=0.015]. ASDAS major improvement was more likely to be achieved with lower age [OR (95%): 0.94 (0.91–0.97); p< 0.001], higher baseline ASDAS-CRP score [OR (95%): 2.93 (1.80–4.75); p< 0.001], and higher baseline CRP levels [1.04 (1.00–1.07); p=0.025]. ASAS partial remission was more likely to be achieved with lower age [OR (95%): 0.97 (0.94–0.99); p=0.013], male vs. female gender [OR (95%): 2.22 (1.10–4.48); p=0.025], lower baseline ASDAS-CRP [0.67 (0.48–0.94); p=0.020], and higher baseline CRP levels [1.01 (1.00–1.02); p=0.048]. 

AEs were more likely to occur with older age [1.02 (1.00–1.05); p=0.024] and concomitant DMARD use [3.03 (1.17–7.85); p=0.022], yet less likely in patients who enrolled later [2016–2017 vs. 2010–2012: 0.36 (0.15–0.85); p=0.019]. SAEs were also less likely to occur in patients who enrolled later [2013–2015 vs. 2010–2012: 0.29 (0.10–0.84); p=0.023 and 2016–2017 vs. 2010–2012: 0.15 (0.03–0.64); p=0.010]. 

Increased treatment retention for AS patients treated with GLM were significantly associated with earlier enrollment period (2010-2012 vs. 2016-2017: HR [95% CI]: 0.51 [0.29–0.89], p=0.017; 2013-2015 vs. 2016-2017: 0.65 [0.44–0.95], p=0.027), and male gender [0.49 (0.35–0.68); p< 0.001].

Conclusion: In this real world, long-term prospective cohort of AS patients treated with GLM, male patients were more likely to achieve a positive treatment response and sustained treatment persistence. Baseline concomitant DMARDs was associated with a lower treatment response, possibly through its association with more complex non-axial disease. Later enrollment period was associated with a lower risk of experiencing an AE but with a higher risk of early treatment discontinuation, possibly driven by the greater availability of alternative therapies. 

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