POS0825 CANCER RISK IN PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH JANUS KINASE INHIBITORS: A NATIONWIDE DANISH REGISTER-BASED COHORT STUDY

Background Concerns regarding the risk of cancer with janus kinase inhibitor (JAKi) use in patients rheumatoid arthritis (RA) escalated after release results from Pfizer’s clinical trial, ORAL Surveillance . [1] The trial showed increased risks major adverse cardiovascular events and tofacitinib compared tumour necrosis factor recipients. Precautionary considerations on JAKi high-risk subsets RA have since been issued by European Medicines Agency. Objectives We aimed to investigate first primary treated (tofacitinib baricitinib) those who received biologic disease-modifying anti-rheumatic drugs (bDMARDs) a real-world setting. Methods performed an observational cohort study using nationwide registers Denmark. Patients aged 18+ years, without previous diagnosis, initiated treatment or bDMARDs 1 January 2017 31 December 2020 were identified Danish Rheumatology Quality Register (DANBIO) followed for any (except non-melanoma skin cancer). applied inverse probability weighting (IPTW) account covariate differences between groups. IPTW-generated weights used cause-specific Cox (CSC) models calculate hazard ratios (HRs) incidence JAKi-treated bDMARD-treated RA. Multiple subgroup sensitivity analyses performed. Results 875 4247 bDMARDs, respectively. group contributed 1315 person years (PYRS) 19 cancers, while bDMARD 8597 PYRS 111 cancers. corresponding crude rates per 1000 14.4 12.9 (bDMARD). Comparing two groups weighted CSC models, HR 1.41 (95%CI 0.76 2.37, 95% confidence intervals) was seen JAKi- versus Conclusion not associated statistically significant bDMARDs. However, estimates elevated many analyses, excess cannot be ruled out. More studies investigating are highly warranted. Reference [1]Ytterberg SR, Bhatt DL, Mikuls TR, et al. Cardiovascular Cancer Risk Tofacitinib Rheumatoid Arthritis. N Engl J Med 2022; 386: 316-326. 2022/01/27. DOI: 10.1056/NEJMoa2109927. Table 1. Number patients, (PYRS), (IR), type analysis, choice statistical model, Cancers NMSC) Crude IR (per years) (95%CI) vs (all patients) IPTW + (0.76 2.37) model b 1.17 (0.72 1.91) 2 c 1.37 (0.81 2.32) Age 50+ d 653 - ≥15 18.3 3099 6274 103 16.4 (0.75 2.30) 1.19 1.97) 1.40 2.42) 65+ 268 401 11 27.4 1364 2711 65 24.0 1.34 (0.55 2.81) 1.20 (0.62 2.29) 1.25 (0.61 2.56) Notes JAKi: inhibitors, bDMARDs: biological drugs, N: number of, 95%CI: intervals, NMSC: cancer, IPTW: treatment, CSC: proportional regression death as competing risk. a: combined CSC. b: unweighted age underlying timescale adjustment sex. c: but all covariates (not shown this abstract) no missing information. d: cancers according data legislation indirect anonymisation. Acknowledgements authors wish extend our thanks departments rheumatology reporting contributing DANBIO register. financially supported Rheumatism Association Society. funders involved neither planning, performance, nor submission abstract. Disclosure Interests Rasmus Westermann: None declared, René Lindholm Cordtz: Kirsten Duch: Lene Mellemkjær Shareholder of: Have immediate family member owns stocks Novo Nordisk., Employee is employed at Merete Lund Hetland Speakers bureau: Pfizer, Medac, Sandoz. No personal income. Paid my institution., Grant/research support from: AbbVie, Biogen, BMS, Celtrion, Eli Lilly Denmark A/S, Janssen Biologics B.V, Lundbeck Fonden, MSD, Novartis, Roche, Samsung Biopis, Sandoz: institution. MLH has chaired steering committee Registry (DANBIO, DRQ), which receives public funding hospital owners pharmaceutical companies. co-chairs EuroSpA, generates evidence psoriatic axial spondylorthritis based secondary partly funded Novartis., Andrea Michelle Burden: Ole Hejlesen: Martin Bøgsted: Dreyer BMS: Reports safety. Grant Member Steering comity national database 6