FRI0118 INFECTION OUTCOMES IN PATIENTS WITH RA TREATED WITH ABATACEPT AND OTHER DMARDS: RESULTS FROM A 10-YEAR INTERNATIONAL POST-APPROVAL STUDY
Authors: Teresa Simon, Samy Suissa, Mary Lou Skovron, Thomas Frisell, Johan Askling, Kaleb Michaud, Sofia Pedro, Anja Strangfeld, Maarten Boers, Diane Lacaille, Marc Hochberg, Veena Hoffman, Andres Gomez
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> The abatacept global post-marketing epidemiology programme consists of observational studies based on biologic disease registries and healthcare claims databases to assess infection and malignancy risks associated with abatacept treatment, as used in routine clinical practice. <h3>Objectives</h3> To evaluate the risk of infection in patients with RA treated with abatacept versus conventional synthetic (cs)DMARDs and other biologic (b) or targeted synthetic (ts)DMARDs. <h3>Methods</h3> Data were analysed from five cohorts: two biologic registries (the Anti-Rheumatic Therapy in Sweden register and the Rheumatoid Arthritis Observation of Biologic Therapy German registry), a disease registry (FORWARD, The National Databank for Rheumatic Diseases in the USA) and two healthcare claims databases (the population-based British Columbia Canadian RA Cohort and the US Optum Research Database). Crude incidence rates (per 1000 patient-years of exposure) with 95% CIs were calculated for hospitalised infections and opportunistic infections. Adjusted risk ratios (RRs) with 95% CIs were estimated using multivariate models adjusting for demographics, co-morbidities and other potential cofounders within each database and were subsequently pooled using a random effects model for meta-analyses.<sup>1</sup> <h3>Results</h3> From all cohorts, patients treated with abatacept (∼6400), csDMARDs (∼137K) and other b/tsDMARDs (∼54K) were followed up for a mean of 2.3–3.7, 2.2–6.2 and 2.3–4.7 years, respectively. Patients were mainly female (71–86%), with a mean age ranging from 49–63 years, and 3–18% had a history of prior severe infections across treatment groups/cohorts. A greater number of abatacept-treated patients had a history of ≥2 prior biologics (44–85% vs csDMARDs, 11% [FORWARD] and other b/tsDMARDs, 0–19%). In abatacept-treated patients, incidence rates for hospitalised infections ranged from 16–56 and opportunistic infections from 0.4–7.8 (Table). Adjusted RRs (95% CIs) for abatacept vs csDMARDs (range: 0.3 [0.2, 0.7] to 2.2 [1.3, 3.7]; pooled estimate: 1.2 [0.6, 2.2]) and abatacept vs other b/tsDMARDs (range: 0.5 [0.3, 0.8] to 1.3 [0.8, 2.1]; pooled estimate: 0.9 [0.6, 1.3]) showed no increased risk in hospitalised infections. <h3>Conclusion</h3> In this large, international post-marketing epidemiology programme, pre-specified infection risks were more frequent with abatacept than csDMARDs and b/tsDMARDs in some, but not all, cohorts. Increased risks for individual outcomes/cohorts may be attributed to prior biologic exposure, study design and practice pattern differences. These data are consistent with the current safety profile of abatacept. <h3>References</h3> [1] DerSimonian R, Laird N. Control Clin Trials 1986;7:177–188. <h3>Acknowledgement</h3> Professional Medical writing: Rachel Rankin, PhD, Caudex; funding: Bristol-Myers Squibb <h3>Disclosure of Interests</h3> Teresa Simon Employee of: Bristol-Myers Squibb, Samy Suissa Grant/research support from: Advisory board meetings, or as speaker, or received research grants from AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Novartis, Speakers bureau: Advisory board meetings, or as speaker, or received research grants from AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Novartis, Mary Lou Skovron Shareholder of: Bristol-Myers Squibb, Consultant for: Bristol-Myers Squibb, Thomas Frisell: None declared, Johan Askling Grant/research support from: Karolinska Institutet (JA) has or has had research agreements with the following pharmaceutical companies, mainly in the context of the ATRIS national safety monitoring programme for rheumatology biologicals: Abbvie, BMS, MSD, Eli Lilly, Pfizer, Roche, Samsung Bioepis, and UCB., Consultant for: Karolinska Institutet has received remuneration for JA participating in ad boards arranged by Lilly, Novartis, and Pfizer., Kaleb Michaud Grant/research support from: Research grant funding in the last 2 years from Rheumatology Research Foundation and Pfizer, Sofia Pedro Employee of: FORWARD, The National Data Bank of Rheumatic Diseases, Anja Strangfeld Speakers bureau: Speakers fees from Bristol-Myers Squibb, MSD, Pfizer, Roche, Maarten Boers Consultant for: Bristol-Myers Squibb, Teva, Novartis, Pfizer, GlaxoSmithKline, Diane Lacaille Grant/research support from: Bristol-Myers Squibb and Eli Lilly Canada, Marc Hochberg Shareholder of: BriOri Biotech, Theralogix LLC., Consultant for: Bristol Myers Squibb, Eli Lilly, EMD Serono, Novartis Pharma AG, Pfizer Inc., Samumed LLC, Symic Bio Inc., Theralogix LLC, TissueGene Inc., TLC Biopharmaceuticals, Inc., Zynerba, Galapagos, IQVIA, Hoffman LaRoche., Veena Hoffman Shareholder of: UnitedHealth Group, Inc (parent company of Optum), Employee of: Optum, Andres Gomez Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb