Efficacy and safety of biologic agents in rheumatic diseases

To evaluate the reasons for and the frequency of biologic agents switch and safety of biologic treatment in patients with different rheumatic diseases in a retrospective open label cohort study.

Material and methods

We recrutied consecutive patients who were treated with any biologic agent and were followed for at least 6 months, regardless of the diagnosis or treatment.

Results

One hundred fifty nine patients (89 female and 70 male; median age 46 years; median duration of the disease 12 years) with ankylosing spondylitis (n=83), rheumatoid arthritis (n=58), psoriatic arthritis (n=15), systemic lupus erythematosus (n=2), Takayasu’s arteritis (n=1) were included. They were treated with infliximab (INF) (n=63), adalimumab (ADA) (n=42), etanercept (ETC) (n=18), rituximab (RTM) (n=16), abatacept (n=7), golimumab (n=6), tocilizumab (n=3), belimumab (n=2), and certolizumab pegol (n=2). Forty four patients (27.7%) required switch of biologic agent as a result of loss of response (n=22), adverse events or infusion reactions (n=8) or for other reasons. The frequency of switch was higher in patients who were treated with ETC (14.8%) and INF (14.0%). In total, the incidence of adverse events was 8.59 per 100 patient years. Treatment with INF and RTM was associated with a higher incidence of adverse events compared with ADA and ETC. However, the difference did not reach statistical significance. Ten patients developed tuberculosis during the treatment with INF. Infusion reactions were most common during treatment with RTM (43.8%; P<0.01).

Conclusion

Approximately one third of patients with rheumatic diseases required a biologic switch due to a loss of response, adverse events or for other reasons.

Key words

Biologic agents, rheumatic diseases, infliximab, adalimumab, etanercept, rituximab, ankylosing spondylitis.