Background Rheumatoid arthritis (RA) is a systemic disease of small and large joints with many extra-articular manifestations. Biologic agents (BAs) offer a better outcome when disease is not adequately controlled by DMARDs. Nevertheless, many doubts still exist about the safety of BAs compared to classical treatment.
Objectives To estimate the safety of BAs compared to DMARDs in this real world study at a single rheumatologic center.
Methods This is a retrospective study of 1.494 patients' files (1.173 women and 321 men, mean age at disease initiation 48.9 years). Demographic and clinical data were recorded during every patient's visit. Adverse reactions (ARs) were classified according to the international CTCAE (Common Terminology Criteria for Adverse Events) system: scale 1 to 5 with parallel increase of severity (1=mild AR without any intervention, 2=medial severity with non-invasive treatment, 3=serious AR but not life-threatening, 4=serious, life-threatening AR and 5=death).
Results There were 1471 patients with DMARDs administration during their follow-up (65.5 months/patient, 8037 patient-years) and 471 patients with BAs (43.5 months/patient, 1711 patient-years). During DMARDs administration there were totally recorded 908 ARs, 81 infections, 45 admissions (18 due to infections) and 58 serious ARs (CTCAE=3-5). In patients with BAs, there were totally recorded 579 ARs, 195 infections, 84 admissions (40 due to infections) and 89 serious ARs. Of patients with DMARDs, 34.9% had at least one AR (95% CI 0.323-0.376, std error 0.135) compared to 54.7% of patients with BAs (95% CI 0.503-0.592, std error 0.229). Statistical analysis showed that BAs had significantly much more ARs compared to DMARDs (p<0.0001). Direct comparison between DMARDs and BAs (per 100 patient-years) showed 11.3 vs. 33.8 total ARs, 1.0 vs. 11.4 infections, 0.72 vs. 5.2 serious ARs, 0.56 vs. 4.9 admissions and 0.23 vs. 2.34 admissions due to infections, respectively.
Conclusions Biologic treatment appears to have more frequent and devastating ARs compared to DMARDs in this real world study of our clinic. Further studies are needed to confirm these results, where co-morbidities and other predictive factors must be taken into account.
Disclosure of Interest None declared
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