Rheumatoid arthritis

Biologic infection risk defined in Lancet meta-analysis

Tuesday, 12 May 2015


Evidence for the risk of serious infection with biologics has been conflicting but the Lancet has just published the most comprehensive meta-analysis of randomised trials to date.

The analysis of data from 42330 patients with rheumatoid arthritis from 106 randomised trials found that compared with traditional DMARDS standard-dose biological drugs (OR 1·31) and high-dose biological drugs (OR 1·90) were associated with an increased risk of serious infections, although low-dose biological drugs (OR 0·93) were not.

The absolute increase in the number of serious infections per 1000 patients treated each year ranged from six for standard-dose biological drugs to 55 for combination biological therapy, compared with traditional DMARDs, the researchers from the University of Alabama reported in the Lancet. 

The risk was lower in patients who were methotrexate naive compared with traditional DMARD-experienced or anti-tumour necrosis factor biological drug-experienced patients. 

“This new knowledge, when balanced against the clinically important benefits of biological drugs, will help patients and their physicians to make evidence-based decisions that align with their values, preferences, and tolerance of risks of harm and benefits,” the authors concluded.

In an accompanying editorial William Dixon from the Arthritis Research UK Centre for Epidemiology said that despite the meta-analysis many unanswered questions remain, the most important of which was the potential harm caused by different biological drugs.

He noted that such estimates were addressed in the meta-analysis but advised reading with caution because of differences such as those in the underlying populations, calendar years, and stages of disease.

“Practising clinicians do not really need to know whether biological drugs, as a group, increase infection. Instead, they need to know how infection rates differ by drug to allow them to select the best treatment for a given situation,” he said. 

The ultimate goal should be to provide personalised estimates of harm for each drug, alongside stratified measures of benefit, to allow doctors to choose the right treatment for the right patient, he concluded.

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