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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?
Arthritis Care and Research , 06/03/09

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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