Long-term effectiveness and safety of infliximab and golimumab in ankylosing spondylitis patients from a Canadian prospective observational registry

Proton Rahman, Michael Starr, Derek Haaland, Louis Bessette, Michelle Teo, Emmanouil Rampakakis, Allen J Lehman, Francois Nantel, Proton Rahman, Michael Starr, Derek Haaland, Louis Bessette, Michelle Teo, Emmanouil Rampakakis, Allen J Lehman, Francois Nantel

Abstract

Background: The objectives of this study were to describe the profile of ankylosing spondylitis (AS) patients treated with either infliximab (IFX) or subcutaneous golimumab (GLM) treatment in Canadian routine care setting along with assessing long-term effectiveness and safety.

Methods: AS patients who were eligible for treatment with IFX or subcutaneous GLM as per their respective Canadian product monographs were enrolled into the BioTRAC registry from 2005 to 2017. The study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in clinical outcomes and acute phase reactants. Safety was evaluated by assessing the incidence of adverse events (AEs) and drug survival rates.

Results: A total of 389 IFX- and 421 GLM-treated patients were enrolled. A significant decrease in disease duration at baseline was observed in the IFX cohort, from a median of 8.0 in 2005-2008 to 1.0 years in 2009-2015 (p < 0.001). A reduction in baseline BASFI score (p = 0.011) and proportion of patients in ASDAS very high disease activity (p = 0.004) was also observed over time. Meanwhile, in the GLM cohort, most disease parameters remained similar from 2010 to 2017. Treatment with both agents significantly improved all disease parameters over time with similar efficacy between the two agents. The incidence of AEs and SAEs were 136 and 131 events/100 PYs and 10.5 and 8.45 events/100 PYs for IFX- and GLM-treated patients, respectively.

Conclusion: Both IFX and GLM treatment in AS significantly reduced disease activity in most outcome measures in a similar fashion and were well tolerated in Canadian routine care.

Trial registration: NCT00741793 .

Keywords: Ankylosing spondylitis; Axial spondyloarthritis; Effectiveness; Golimumab; Infliximab; Registry; Safety.

Conflict of interest statement

Proton Rahman has received consulting fees for Abbott, AbbVie, Amgen, BMS, Celgene, Janssen, Novartis, Pfizer and Roche; and received research grant from Janssen. Michael Starr received consultant fees from Janssen, AbbVie, Novartis, Sanofi, Pfizer, BMS and Lilly. Derek Haaland received grant/research support, sponsored study funding and speaker fees from Janssen. Louis Bessette received speaker fees from Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly and Novartis; consultant fees from Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Celgene, Lilly and Novartis and research grants from Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly and Novartis. Michelle Teo received research support and consulting fees from Janssen. Allen Lehman and Francois Nantel are employees of Janssen Inc. and are JNJ stockholders.

Figures

Fig. 1
Fig. 1
Evolution of baseline characteristics over time
Fig. 2
Fig. 2
Effect of treatment with IFX and GLM on disease parameters over time. P-value vs baseline
Fig. 3
Fig. 3
Kaplan-Meier drug survival analysis

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