OP0226 SOLID TUMOUR OUTCOMES IN PATIENTS WITH RA TREATED WITH ABATACEPT AND OTHER DMARDS: RESULTS FROM A 10-YEAR INTERNATIONAL POST-APPROVAL STUDY

Background The abatacept global post-marketing epidemiology programme includes observational studies based on biologic disease registries and healthcare claims database studies to evaluate infection and malignancy risks associated with abatacept treatment, as used in routine clinical practice. Objectives To assess the risk of solid tumour malignancies in patients with RA treated with abatacept vs conventional synthetic (cs)DMARDs and other biologic (b) or targeted synthetic (ts)DMARDs. Methods Data were analysed from four cohorts: two biologic registries (the Anti-Rheumatic Therapy in Sweden [ARTIS] register and the Rheumatoid Arthritis Observation of Biologic Therapy [RABBIT] German registry), a disease registry (FORWARD, The National Databank for Rheumatic Diseases in the USA) and a healthcare claims database (the population-based British Columbia Canadian RA Cohort [BC]). Exposure defined as “ever exposed” unless specified. Crude incidence rates (per 1000 patient-years of exposure) with 95% CIs were calculated for overall malignancy, breast cancer, lung cancer and lymphoma. Adjusted risk ratios (RRs) with 95% CIs were estimated using multivariate models adjusting for demographics, comorbidities and other potential cofounders within each database and were subsequently pooled using a random-effects model for meta-analyses.1 Results Patients treated with abatacept (∼5100), csDMARDs (∼74K) and other b/tsDMARDs (∼37K) were followed up for a mean of 3.0–3.7, 3.0–6.2 and 3.0–4.7 years, respectively. Patients were mainly female (71–86%), with a mean age ranging from 55–63 years, and 4–34% had a history of malignancy. A greater number of abatacept-treated patients had been treated with ≥2 prior biologics (abatacept, 44–85%; csDMARDs, 11% [FORWARD] and other b/tsDMARDs, 0–19%). The incidence rate of overall malignancy in abatacept-treated patients was low (Table). Adjusted RRs (95% CIs) for abatacept vs csDMARDs (range: 0.8 [0.2, 3.4] to 1.3 [0.5, 3.3]; pooled estimate: 1.1 [0.8, 1.5]) and abatacept vs other b/tsDMARDs (range: 1.0 [0.4, 2.6] to 1.2 [0.6, 2.3]; pooled estimate: 1.0 [0.8, 1.3]) showed no increased risk in overall malignancy. Although individual registries showed a slight increase in breast (BC), lung (RABBIT) and lymphoma (ARTIS) cancers in patients treated with abatacept, numbers were too low to make an accurate comparative risk assessment. Conclusion While the development of malignancy is a potential risk associated with the use of immunomodulators, data from this large, international, post-marketing epidemiology programme suggest that the risks of overall malignancy and breast, lung or lymphoma cancers were not significantly increased in patients treated with abatacept. These data are consistent with the established safety profile of abatacept. Reference [1] DerSimonian R, Laird N. Control Clin Trials 1986;7:177–88. Acknowledgement Professional Medical writing: Claire Line, PhD, Caudex; funding: Bristol-Myers Squibb Disclosure of Interests 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., Andres Gomez Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb