Background/Purpose: Our objectives were to estimate and compare the incidence rate of malignancies between biologic and csDMARD-treated RA patients.

Methods: We conducted an historical cohort study within our national claim database that prospectively records individual health resource use of 86% of the French population (65 million inhabitants). RA adult patients were identified based on ICD-10 code (M05 or M06) between 2007-2016. Patients with previouscancer history were excluded.

Treatment exposures were incident first use of any treatment: csDMARD (methotrexate, leflunomide, sulfasalazine, azathioprine, hydroxychloroquine) or biologics (anti-TNF, rituximab, abatacept, tocilizumab, ustekinumab, anakinra). To identify incident treatment periods, a one year period prior our period of analysis was analysed; only patients that did not receive any treatment during this period were included. .Exposure definition was considered with a 90-day latency after treatment initiation and a 180-day remanence period after drug discontinuation.

To compare the risk of malignancies between csDMARD and biologics treated patients, a dynamically propensity score (including age, sexe, year of first occurrence of RA code, date of treatment initiation, number of previous DMARDs, Charlson comorbidity index, diagnosis of tobacco and/or alcohol-associated disorders, number of hospitalisations for RA, cumulative corticosteroid dose ) was constructed using pooled logistic regression. Hazard Ratios (HRs) for risk of cancer were estimated using Cox proportional hazards model after dynamically propensity score matching. Exposure was considered as a time-dependent variable. Sensitivity analyses are ongoing to assess the robustness of our results.

Results: Between 2007 and 2016, 83 706 RA patients exposed to csDMARD (n=63837) and/or biologics (n=19869) were identified. After propensity score matching, analyses were conducted on 19687 patients in each group (mean age: 51 ±14 yrs; female: 74.6%). Malignancies occurred in 435 patients exposed to biologics and 357 patients exposed to csDMARD,

The HR for overall risk of malignancies, risk of solid cancer (excluding non-melanoma skin cancer), lymphoma, and other hematologic malignancies did not differ significantly between csDMARD and all biologics analysed together (table). Regarding organ specific cancer, no difference was observed, except for risk of prostate cancer in men that occurred significantly less frequently in biologic treated patients (HR: 0.47 [0.29;0.76], p=0.003).

Conclusion: Using a large nationwide healthcare database, representative of the French population, the overall risk of malignancies and the risk of organ-specific cancers and hematologic malignancies in biologic treated RA patients did not differ from that of patients treated with csDMARD. Except for prostate cancer in men, which occurred less  frequently in biologics treated patients. The reason of this difference remains unclear, but could be linked to a high frequency of screening before introducing biologic.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/risk-of-malignancies-associated-with-biologics-in-rheumatoid-arthritis-analysis-of-a-national-claim-database/