Single-center series and systematic review of randomized controlled trials of malignancies in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis receiving anti-tumor necrosis factor-alpha; therapy: Is there a need for more comprehensive screening procedures?
Nannini C et al. – The results of randomized controlled trials (RCTs) show that 26% of malignancies occur within 12 weeks from enrollment in patients receiving anti-TNF therapies suggesting the need for a revision of current cancer screening procedures in RCTs and in clinical practice. Methods- A systematic review to monitor the occurrence of malignancies among pts with RA, psoriatic arthritis (PsA), and ankylosing spondylitis (AS) treated with anti-TNF therapy
- Primary outcome: report of frequency of malignancies in RCTs and the latency between the therapy introduction and the occurrence of the neoplasm
- 363 consecutive RA, PsA, and AS pts requiring anti-TNF therapy from 2002 to 2006, underwent extensive cancer screening procedures
- An historical controlled group of 73 pts treated between Jan 1999 and Dec 2001 underwent the screening procedures accepted for the RCT procedures
Results- 36 RCTs; malignancies occurred in 60/8,015 (0.75%) pts randomized to the active treatment arm and in 21/3,991 (0.52%) pts in the placebo arms
- In the personal retrospective case series, 0.27% pts and 4.1% controls developed cancer over the f/u period
- Mean ± SD f/u duration was 40.9 ± 16.7 mo in study pts and 50.6 ± 18.1 mo in controls
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