Adverse Events and Infections in Patients with Rheumatoid Arthritis Treated with Conventional Drugs or Biologic Agents: A Real World Study

Christos E. Lampropoulos¹, Philippos Orfanos², Vasiliki-Kalliopi Bournia³, Theofilos P. Karatsourakis⁴, Clio P. Mavragani⁵, Dimitrios Pikazis⁴, Menelaos N. Manoussakis⁶, Athanasios G. Tzioufas⁴, Haralampos M. Moutsopoulos⁷ and Panayiotis G. Vlachoyiannopoulos³, ¹Department of Pathophysiology, School of Medicine, National University of Athens, Athens, Greece, ²Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National University of Athens, Athens, Greece, ³First Department of Propedeutic Internal Medicine, Laikon Hospital, Athens University Medical School, Athens, Greece, ⁴Pathophysiology, School of Medicine, National University of Athens, Athens, Greece, ⁵Department of Experimental Physiology, School of Medicine, University of Athens, Athens, Greece, Athens, Greece, ⁶Pathophysiology, School of Medicine, National University of Athens, Greece, Athens, Greece, ⁷Department of Pathophysiology, School of Medicine, University of Athens, Athens, Greece

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Adverse events, Biologic agents, DMARDs, infection and rheumatoid arthritis (RA)

Session Information

Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy: Safety of Biologics and Small Molecules in Rheumatoid Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose: Rheumatoid arthritis (RA) is a chronic, inflammatory disease with joint destruction and permanent disability. 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. Purpose of the study was to test the hypothesis that adverse events (AEs), including infections, are rather common in patients receiving BAs than in those with DMARDs.

Methods: Analysis of the medical records of patients with RA followed in a single outpatient clinic was performed. In total, 1403 adults (295 men, 1108 women) were included in the analysis (969 treated with DMARDs only, 434 with biologics). All AEs and infections were recorded and their severity was graded according to international criteria. Cox proportional-hazards models were performed to examine the association of treatment groups and other confounding factors with the risk of first AE or infection. Incident rates were calculated as number of events/100 person-years.

Results: The risk of first AE or infection, mild or serious, was significantly increased in patients with biologics (Figure 1, p<0.001). Hazard ratios ranged from 1.93 (95% CI: 1.59 to 2.34) for any AE to 5.92 (95% CI: 2.55 to 13.75) for serious infection (Table 1). Age, ESR>40mm/h and total steroid dose >500mg were significant detrimental risk factors. The risk for infection was equal across biologic agents, but infliximab and adalimumab were marginally significantly associated with AEs in general (Figure 2, p<0.05).

There were 519 AEs in the biologic group with an IR of 35.5 events/100 PY (IRR=2.24 95% CI: 1.96 to 2.55), as compared with 407 and 15.9 events/100 PY with DMARDs only. When only the follow-up time up until the first AE or infection in both treatment groups was counted in, the IRR for the biologic group was 2.14 for any first AE (95% CI: 1.78 to 2.58), 4.43 for first serious AE (95% CI: 2.83 to 7.09), 5.27 for any first infection (95% CI: 3.62 to 7.8) and 7.93 for first serious infection (95% CI: 3.60 to 19.83).

Conclusion: Biologic agents are associated with a higher frequency and severity of AEs and infections compared to conventional DMARDs.

Disclosure:

C. E. Lampropoulos,
None;

P. Orfanos,
None;

V. K. Bournia,
None;

T. P. Karatsourakis,
None;

C. P. Mavragani,
None;

D. Pikazis,
None;

M. N. Manoussakis,
None;

A. G. Tzioufas,
None;

H. M. Moutsopoulos,
None;

P. G. Vlachoyiannopoulos,
None.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/adverse-events-and-infections-in-patients-with-rheumatoid-arthritis-treated-with-conventional-drugs-or-biologic-agents-a-real-world-study/