The Incidence of Serious Infections is not Increased in Patients with
Rheumatoid Arthritis Treated with Anti-TNF Drugs Compared to Those
Treated with Traditional DMARDs: Results from a National Prospective
Study
Category: 18. RA treatment — biologics and gene therapy
Author(s): William Dixon, Kath Watson, Kimme Hyrich, Mark Lunt, Alan
Silman, Deborah Symmons, BSR Biologics Register, BSRBR Control Centre
Consortium. University of Manchester, Manchester, United Kingdom  
Presentation Number: 1990
Purpose: There are consistent reports of serious infections following
the use of anti-TNF agents in patients with RA. However, patients with
RA are at increased risk of infections in the absence of biologic
therapy due both to disease and immunosuppressive treatment. We have
examined whether there is an excess risk of infection following
anti-TNF therapy and if there are differences in those treated with
the monoclonal antibodies: infliximab (INF) and adalimumab (ADA),
compared to the soluble TNF receptor antagonist etanercept (ETA).
Methods: Using the UK nationwide register we prospectively followed
5304 previously anti-TNF naïve patients: 2247 ETA, 2398 INF and 659
ADA. They were compared with a similarly recruited cohort of 648
subjects with active disease requiring DMARD therapy. 20 of the DMARD
group switched to anti-TNF therapy and contributed follow-up time to
both groups. All were followed 6 monthly to April 2005 to ascertain
any serious infection, defined as those requiring hospitalization,
intravenous antibiotics or resulting in death. Infection rates were
calculated per 1000 patient years (pyr) from registration but, for
this analysis, follow up was censored if the patient switched or
started (DMARD group) anti-TNF therapy. Infections occurring after
discontinuation of an anti-TNF drug were therefore excluded. Incidence
rate ratios were calculated after adjustment for age, gender, disease
duration, disease severity, baseline steroid use, co-morbidities and
smoking.
Results: The infection incidence/1000 pyr in each of the groups was as
follows: all anti-TNF 63.9, ETA 63.9, INF 61.4, ADA 77.7 and DMARD
66.4. The baseline characteristics of the 3 anti-TNF groups were very
similar. The DMARD group were older but had less severe disease of
shorter duration. After adjustment the incidence rate ratios compared
to the DMARD cohort (95% confidence intervals) were: all anti-TNF 1.00
(0.55, 1.83), ETA 0.97 (0.52, 1.83), INF 0.98 (0.53, 1.80) and ADA
1.27 (0.65, 2.46).
Conclusion: The serious infection incidence is broadly in line with
published reports from long term surveillance studies but does not
appear to be increased in real world use after adjustment for baseline
risk

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