A report on the adverse events of special interest from the Romanian Registry of Rheumatic Diseases in patients treated with biologic and targeted synthetic disease-modifying anti-rheumatic drugs during 2022

Abstract

Background. The evolution of the therapeutic arsenal in inflammatory rheumatic diseases has dramatically improved their evolution and prognosis. On the other hand, the information of the safety data, especially for conditions that may appear in a longer time of exposure, are not reflected by clinical trials, due to their limited time design. Patient registries are a valuable source of safety data applicable to real-world (unselected) patients. The evaluation of these data completes the evidence from the various development programs, with the aim of more concrete knowledge of each therapeutic class (therapeutic agent). Aim. The present report descriptively presents the adverse events (AE) of special interest, recorded by the Romanian Registry of Rheumatic Diseases (RRBR), during 2022, in relation to the dynamics of the recent years. Methods. The observational study included all AEs reported in the RRBR in 2022, their severity class, the relationship with exposure to the therapeutic agent. Results. For a cohort of 10676 patients who were exposed to at least one course of treatment, with data in the RRBR during 2022, there were 669 AEs reported: 432 reports for patients with rheumatoid arthritis (RA), 195 records for patients with ankylosing spondylitis (AS) and 42 reports for patients with psoriatic arthritis (PsA). The most common AEs were infections, especially in RA patients. Of all AEs, 94 (14%) were serious AEs, the majority reported in the RA group (16%). A number of 15 MACE, 13 solid malignancy and 19 deaths were reported in the last year. Conclusion. The distribution of EA by disease, the dominance in RA, as well as the distribution by therapeutic groups is in accordance with scientific data, with the exception of breast cancer, which is more frequently reported in RRBR. EA are underreported in the destinated section in the RRBR, an aspect that gives a limit of this report. This represents an unmet need in terms of safety data reporting, that calls for increased knowledge of EA reporting requirements.

Keywords

• biologics
• romanian registry of rheumatic diseases
• adverse events