Background/Purpose: Long-term registries are essential to evaluate new therapies in a patient population that differs from clinical trial and usually varies over time.  The purpose was to describe the profile of ankylosing spondylitis (AS) patients treated with infliximab (IFX) or golimumab (GLM) treatment in Canadian routine care along with its long-term effectiveness and safety.

Methods: 810 AS patients treated with IFX or GLM were enrolled into the Biologic Treatment Registry Across Canada (BioTRAC) registry between 2005-2015 and 2010-2017, respectively. Study visits occurred at baseline and every 6 months thereafter, as needed per routine care. Effectiveness was assessed with changes in ASDAS, BASDAI, BASFI, MDGA, HAQ-DI, PtGA, back pain and acute phase reactants. Safety was evaluated with the incidence of adverse events (AEs) and drug survival rates.

Results: Of the 389 IFX- and 421 GLM-treated patients, the proportion of males were 62.7% and 59.1%, the mean age were 45.6 and 45.7 years and the mean disease duration were 8.6 and 6.0 years, respectively. Most patients were bio-naive ( >82.7%). Interestingly, we observed a significant decrease in disease duration in the IFX cohort from a median of 8.0 to 3.5 and 1.0 years in 2005-2008, 2009-2012 and 2013-2015, respectively (p< 0.001). A reduction in baseline BASFI score (6.3 vs. 5.9 vs 5.1; P=0.011) and in the proportion of patient in ASDAS very high disease activity (48.4%, 43.8%, 30.3%; p=0.004) were also observed. As for the GLM cohort, most disease parameters including median disease duration (1.6 years), mean baseline BASFI (5.3) and the proportion of patients in ASDAS very high disease activity (48%) remained similar from 2010-2017.   

Treatment with both IFX and GLM significantly improved all disease parameters over time (P< 0.001) from baseline up to 120 and 84 months, respectively, with similar efficacy between agents.   AEs were reported for 67.9% and 70.5% (136 and 131 events/100 PYs) and SAEs for 15.4% and 8.1% (10.5 and 8.45 events/100 PYs) covering 1251.3 and 674.8 years of exposure for IFX- and GLM-treated patients, respectively. The most frequently occurring AEs ( >7% of patient in either group) were upper respiratory tract infection, arthralgia and back pain. Two deaths occurred in IFX-treated patients (myocardial infarct, drowning) and two among GLM-treated patients (oropharyngeal cancer; neutropenia, staphylococcal/pseudomonas infections, septic shock).   

The proportion of patients who discontinued treatment were 65.8% over a mean 3.2 years of exposure in the IFX cohort and 56.8% over 1.6 years in the GLM cohort.

Conclusion:

Both IFX and GLM treatment significantly reduced disease activity and improved functionality in a similar fashion and were well tolerated in patients with AS. Differences in baseline characteristics over time demonstrate improvement in early diagnosis of AS and earlier access to biologic therapies. 

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-effectiveness-and-safety-of-infliximab-and-golimumab-in-ankylosing-spondylitis-patients-from-a-prospective-observational-registry/