Adverse Drug Reaction

Study data from University of Toronto update knowledge of adverse drug reactions

Adverse Drug Reaction Library Library Home This article was published in Pain & Central Nervous System Week, which you can subscribe to online.

"Safety data were abstracted and risk estimates were calculated using three approaches, meta-analysis with and without adjustment for exposure and simple exposure-adjusted pooling. Eighteen randomised trials involving 8808 RA subjects were included. Treatment with recommended doses of anti-TNF found no increase in the odds of death (odds ratio (OR) 1.39; 95% CI 0.74 to 2.62), serious adverse events (OR 1.11; 95% CI 0.94 to 1.32), serious infection (OR 1.21; 95% CI 0.89 to 1.63), lymphoma (OR 1.26; 95% CI 0.52 to 3.06), non-melanoma skin cancers (OR 1.27; 95% CI 0.67 to 2.42) or the composite endpoint of non-cutaneous cancers plus melanomas (OR 1.31; 95% CI 0.69 to 2.48) when evaluated using the unadjusted meta-analytic method. Risk estimates were similar with the other methods. For subjects who received two to three times the recommended doses of anti-TNF the risk of serious infection was increased with the unadjusted meta-analytic and pooled analysis, (OR 2.07; 95% CI 1.31 to 3.26) and (risk ratio (RR) 1.83; 95% CI 1.18 to 2.85), respectively, but not increased in the exposure-adjusted meta-analysis (RR 1.99; 95% CI 0.90 to 4.37). Meta-regression identified that the risk of serious infection with anti-TNF therapy decreases with increasing trial duration (p = 0.035). Meta-analytic and exposure-adjusted pooled analyses on over 8800 RA subjects in RCT treated over an average of 0.8 years did not identify an increased risk of serious adverse events with recommended doses," wrote J.P. Leombruno and colleagues, University of Toronto.

The researchers concluded: "High-dose anti-TNF therapy was associated with a twofold increase in the risk of serious infections."

Leombruno and colleagues published their study in Annals of the Rheumatic Diseases (The safety of anti-tumour necrosis factor treatments in rheumatoid arthritis: meta and exposure-adjusted pooled analyses of serious adverse events. Annals of the Rheumatic Diseases, 2009;68(7):1136-1145).

For additional information, contact J.P. Leombruno, University of Toronto, Leslie Dan Faculty Pharmacy, Dept. of Pharmaceutical Science, 144 College St., Suite 604, Toronto, ON M5S 3M2, Canada.

Publisher contact information for the journal Annals of the Rheumatic Diseases is: B M J Publishing Group, British Med Association House, Tavistock Square, London WC1H 9JR, England.

Keywords: Canada, Toronto, Adverse Drug Reactions, Adverse Drug Effect, Adverse Drug Event, Adverse Drug Reaction, Anticancer Therapy, Arthritis, Clinical Trial Research, Hematology, Lymphoma, Necrosis, Non-Melanoma Skin Cancer, Non-Melanoma Skin Carcinoma, Oncology, Rheumatic Disease, Rheumatoid Arthritis, Therapy, Treatment, University of Toronto.

This article was prepared by Pain & Central Nervous System Week editors from staff and other reports. Copyright 2009, Pain & Central Nervous System Week via NewsRx.com.