Adverse events from the Romanian Registry of Rheumatic Diseases in patients treated with biologic and targeted synthetic disease-modifying anti-rheumatic drugs during 2019

• Main Authors: Corina Mogosan, Claudiu C. Popescu, Catalin Codreanu
• Format: Article
• Language: English
• Published: Amaltea Medical Publishing House 2020-03-01
• Series: Romanian Journal of Rheumatology
• Subjects: biologics; romanian registry of rheumatic diseases; adverse events
• Online Access: https://rjr.com.ro/articles/2020.1/RJR_2020_1_Art-03.pdf

Background. The novel therapies in inflammatory rheumatic diseases have changed dramatically the evolution of these conditions, improving patient outcomes, as well as the quality of life. Nevertheless, the efficacy data continuously needs safety reports, on short and long term. Aim. The present study reports adverse events (AEs) captured by the Romanian Registry of Rheumatic Diseases (RRBR, in Romanian), during 2019. Methods. This observational study included all AEs reported in RRBR in 2019, the severity class, outcome and previous exposure to the therapeutic agent. Results. For the active cohort of 9,255 patients that had at least one visit during 2019, there have been 934 reported AEs: 568 cases for rheumatoid arthritis (RA) patients, 291 cases for ankylosing spondylitis (AS) patients and 75 cases for psoriatic arthritis (PsA) patients. The most prevalent AEs were infections, especially in RA patients. Of all AEs, 102 (11%) were serious AEs, with an equal impact of 11% in RA and AS groups. A number of 25 deaths were reported during the last year. Conclusion. AEs seem to be under-reported in the RRBR database, is accordance with literature data for registries which not do have a standardized method for AE reporting. This is an unmet need for safety data that also requires improving the knowledge about AE reporting requirements.