SAT0370 TUMOUR NECROSIS FACTOR INHIBITOR THERAPY DOES NOT REDUCE THE INCIDENCE OF COMORBIDITIES AND EXTRA-ARTICULAR MANIFESTATIONS IN ANKYLOSING SPONDYLITIS: AN ANALYSIS OF THREE US CLAIMS DATABASES
Authors: A. Deodhar, K. Winthrop, R. Bohn, B. Chan, R. Suruki, J. Stark, H. Yun, S. Siegel, L. Chen, J. Curtis
Journal: Annals of the Rheumatic Diseases (2020)

Background: Comorbidities and extra-articular manifestations (EAMs) substantially increase disease burden and mortality risk in patients (pts) with ankylosing spondylitis (AS). 1,2 Tumour necrosis factor inhibitors (TNFi) are highly efficacious and effective in AS treatment (tx), and are used after inadequate response to non-steroidal anti-inflammatory drugs. 3,4 However, the impact of TNFi on the incidence of comorbidities and EAMs in pts with AS is unknown. 5 Objectives: To determine the incidence of comorbidities and EAMs in TNFi vs non-TNFi treated pts with AS in the US. Methods: This was a retrospective, observational cohort study using data from 3 healthcare insurance claims databases: Multi-Payer Claims Database (MPCD Optum Insight; 2007–2010), Truven MarketScan ® (2010–2014) and US Medicare Fee-for-Service Claims database (2006–2014). Eligible pts: ≥20 years (yrs) for MarketScan/MPCD or ≥65 yrs for Medicare, had an AS diagnosis (≥2 International Classification of Disease, 9 th version [ICD-9] diagnosis codes of 720.0 from a rheumatologist) and ≥12 months’ continuous medical and pharmacy enrolment prior to AS diagnosis (AS index date). Pts with AS not receiving tx were excluded. Tx exposure was reported from the first date of a new prescription/administration of an AS tx (no prior exposure) after the AS index date. Crude incidence rates (IR; shown as cases/100 pt-yrs) were calculated for EAMs (uveitis, psoriasis [PSO], psoriatic arthritis [PsA], inflammatory bowel disease [IBD]), with follow-up until the earliest of: death, lost medical/pharmacy coverage, study period end, first outcome occurrence, tx switch/discontinuation. Hazard ratios (HRs) of comorbidities (hospitalised infection, solid cancers) and EAMs for propensity score (PS)-matched pt groups were calculated using Cox proportional hazard regression models. Pts with the specific comorbidity/EAM of interest prior to AS index date were excluded. PS analyses assessed probability of TNFi initiation vs non-TNFi tx and adjusted for factors including comorbidities and demographics. HRs with confidence intervals crossing 1 are not reported. Results: 20,460 pts with AS were eligible (MPCD: 2,384; MarketScan: 9,032; Medicare: 9,044). In all databases, crude IR of EAMs were higher for TNFi vs non-TNFi treated pts ( Figure 1 ). In the PS-matched cohort, incidences of hospitalised infections were lower in TNFi vs non-TNFi treated pts from the MarketScan and Medicare databases ( Figure 2 ). Higher incidences of solid cancers and EAMs were observed in TNFi vs non-TNFi treated pts; Medicare data ( Figure 2 ). A higher risk of PsA and PSO was seen in TNFi vs non-TNFi treated pts; MarketScan data ( Figure 2 ). PS-matched cohort data from the MPCD database were non-significant. Conclusion: Despite strong efficacy in treating AS-related signs and symptoms, similar incidence of comorbidities and increased incidence of some EAMs (IBD, PSO/PsA, uveitis) was seen in TNFi vs non-TNFi treated pts in the PS-matched analyses. This may be due to channelling of pts with more severe AS to receive TNFi, despite the PS-matched analysis aiming to overcome this. Moreover, prior medical history of Medicare pts may not be captured in the database, as pts are typically older with longer disease durations. While these results confirm previous findings, 6 a prospective observational study is required to generalise to pts outside the US. References: [1]Stolwijk C. Ann Rheum Dis 2015;74:1373–8; [2]Bremander A. Arthritis Care Res 2011;63:550–6; [3]Braun J. Scand J Rheumatol 2005;34:178–90; [4]Ji X. Front Pharmacol 2019;10:1476; [5]Maxwell LJ. Cochrane Database Syst Rev 2015:CD005468; [6]Walsh J. J Pharm Health Serv Res 2018;9:115–21. Acknowledgments: This study was funded by UCB Pharma. Editorial services were provided by Costello Medical. Disclosure of Interests: Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Kevin Winthrop Grant/research support from: Bristol-Myers Squibb, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, GSK, Pfizer Inc, Roche, UCB, Rhonda Bohn Consultant of: UCB Pharma, Benjamin Chan: None declared, Robert Suruki Employee of: UCB Pharma, Jeffrey Stark Employee of: UCB Pharma, Huifeng Yun Grant/research support from: Bristol-Myers Squibb and Pfizer, Sarah Siegel: None declared, Lang Chen: None declared, Jeffrey Curtis Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corona, Crescendo, Genentech, Janssen, Pfizer, Roche and UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corona, Crescendo, Genentech, Janssen, Pfizer, Roche and UCB Pharma