FRI0109 EFFECTIVENESS AND SAFETY OF INFLIXIMAB, GOLIMUMAB AND GOLIMUMAB-IV IN RHEUMATOID ARTHRITIS PATIENTS FROM A PROSPECTIVE OBSERVATIONAL REGISTRY
Authors: Proton Rahman, Philip Baer, Denis Choquette, Rafat Faraawi, Louis Bessette, Milton Baker, Raman Rai, John Kelsall, Larissa Lisnevskaia, Jodie Reis, Keltie Anderson, Wojciech Olszynski, Emmanouil Rampakakis, Odalis Asin Miilan, Allen Lehman, Meagan Rachich, Francois Nantel
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> Long-term registries are essential to evaluate new therapies in a patient population that differs from clinical trials and usually varies over time. <h3>Objectives</h3> To describe the profile of rheumatoid arthritis (RA) patients treated with infliximab (IFX), golimumab subcutaneous (GLM) or intravenous (GLM-IV) in Canadian routine care, along with its effectiveness and safety. <h3>Methods</h3> 1577 RA patients treated with IFX, GLM or GLM-IV were enrolled into the Biologic Treatment Registry Across Canada (BioTRAC) between 2006-2015, 2010-2017 and 2014-2017, respectively. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed with changes in TJC28, SJC28, MDGA, PtGA, pain, HAQ, and acute phase reactants. Safety was evaluated with the incidence of adverse events (AEs) and drug survival. <h3>Results</h3> Of the 890 IFX-, 530 GLM- and 157 GLM-IV-treated patients, the proportion of females were 75.7%- 77.1%, the mean age were 55.8-57.7 and the mean disease duration were 6.5-8.6 years. Most patients were bio-naive (&gt; 80%). A significant decrease in disease duration and disease activity scores (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) were observed in the IFX cohort over time (p&lt;0.001). Interestingly, baseline disease duration and disease activity scores for the GLM cohort (DAS, TJC, SJC, PtGA, Pain, CRP, ESR) were higher than in the IFX cohort from 2010-2012 when GLM was first introduced while the mean MDGA remained the same between the two groups. Treatment with IFX, GLM and GLM-IV significantly improved all disease parameters over time (P&lt;0.001) from baseline to 6 months and up to 120, 78 and 42 months, respectively. The proportion of patients in SDAI remission at 12, 24 and 36 months reached 16.2%, 20.8% and 22.8% in IFX-patients; 34.7%, 47.5% and 52.7% in GLM-patients and 33.8%, 47.5% and 61.9% in GLM-IV-patients (p=0.1978 and p=0.0081 vs IFX). AEs were reported for 61.5%, 67.4% and 59.2% (105, 113 and 82.6 events/100 PYs) and SAEs for 21.2%, 15.5% and 3.8% (11.7, 34.4 and 9.0 events/100 PYs) covering 2714, 1077 and 257 years of exposure for IFX, GLM and GLM-IV-treated patients, respectively. The most frequently occurring AEs were arthralgia and upper respiratory tract infection (&gt;5%). Eighteen, 7 and 1 deaths occurred among IFX-, GLM- and GLM-IV-treated patients, respectively. The proportion of patients who discontinued treatment were 74.0% over a mean 3.0 years of exposure to IFX-, 52.8% over 2.0 years of exposure to GLM and 45.2% over 1.6 year of exposure to GLM-IV. <h3>Conclusion</h3> In this real-world study of Canadian patients with RA, differences in baseline characteristics between patients treated with an anti-TNF over time and between agents shows potential selection biases when selecting a given therapy and may impact the proportion of patients achieving a target-specific outcome. Treatment significantly reduced disease activity and improved functionality in a similar fashion and were also safe and well tolerated. <h3> Disclosure of Interests: </h3> Proton Rahman: None declared, Philip Baer Grant/research support from: Janssen sponsored study, Consultant for: Eli Lilly, Pfizer, Abbvie, Amgen, Merck, Novartis, Sanofi Genzyme, Paladin, Janssen, Johnson &amp; Johnson, Speakers bureau: Eli Lilly, Pfizer, Abbvie, Amgen, Janssen, Denis Choquette Grant/research support from: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Consultant for: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Speakers bureau: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Rafat Faraawi: None declared, Louis Bessette Grant/research support from: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Consultant for: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Celgene, Lilly, Novartis, Speakers bureau: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, Milton Baker Grant/research support from: Janssen Sponsored Study, Raman Rai Consultant for: Janssen, Amgen, BMS, Roche, Abbvie, Pfizer, Merck, Novartis, Speakers bureau: Janssen, Amgen, Roche, BMS, Abbvie, John Kelsall Grant/research support from: Janssen Sponsored Study, Larissa Lisnevskaia Grant/research support from: Janssen Sponsored Study, Jodie Reis Grant/research support from: Janssen Sponsored Study, Keltie Anderson Grant/research support from: Janssen Sponsored Study, Wojciech Olszynski Grant/research support from: Janssen sponsored study, Emmanouil Rampakakis : None declared, Odalis Asin MIilan Employee of: Employee of Janssen, Allen Lehman Employee of: Employee of Janssen, Meagan Rachich Shareholder of: Janssen, Employee of: Employee of Janssen, Francois Nantel Shareholder of: Janssen, Employee of: Employee of Janssen