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my personal edition > arthritis other > news
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DGReview
Infliximab Safe For Patients With Spondyloarthropathy Despite Some Occurrence Of Infection
A DGReview of :"Systematic safety follow up in a cohort of 107 patients with spondyloarthropathy treated with infliximab: a new perspective on the role of host defence in the pathogenesis of the disease?"
Annals of the Rheumatic Diseases (ARD Online)
09/03/2003
By Deanna M Green, PhD
Infliximab has a positive safety profile in patients with spondyloarthropathy (SpA); however patients should be carefully monitored for potential infection, according to a recent Belgian study.
Anti-tumour necrosis factor agents, such as infliximab, are often used to treat rheumatoid arthritis and Crohn's disease. However, safety concerns have been raised since the drugs' inhibitory effects on the immune system could lead to severe infections, malignancies, and immune mediated diseases.
This is of particular concern in patients with SpA, since the pathogenesis of this disease has been linked to a defective host defence. However, recent studies have demonstrated effective results with infliximab treatment in SpA patients.
Dr. Dominique Baeten and colleagues at the Ghent University Hospital, Ghent, Belgium, evaluated the long term safety profile of infliximab in patients with SpA by conducting a systematic review of adverse events reported by these patients.
The cohort study included 107 patients (73 men and 34 women) between the ages of 26 and 73 with active SpA. Patients received intravenous infliximab (5 mg/kg) at start of study, week 2 and week 6. Serious and treatment-related adverse events were evaluated over a total of 191.5 patient years.
Overall, 20 serious or treatment-related adverse events were reported, including 14 infectious adverse events.
Of 10 serious events, 8 were severe infections, namely 2 disseminated tuberculosis and 3 retropharyngeal abscesses. Other serious non-infectious events included a spinocellular skin carcinoma and an infusion reaction.
Ten minor treatment related events occurred, including clear bacterial focus, skin eruptions, and a mild infusion reaction. None required hospital admission and all recovered with antibiotics.
Although no cases of demyelinating disease or lupus-like syndrome were reported, 3 patients with ankylosing spondylitis and no history of psoriasis developed palmoplantar pustulosis during treatment.
Overall, infliximab discontinuation was only necessary in 5 patients, all of whom experienced serious infections, and 92% of patients were continuing treatment at an average of 1.8 years.
Dr. Baeten concludes that "although the global safety of infliximab in SpA is good compared with previous reports in rheumatoid arthritis and Crohn's disease, the occurrence of infections such as tuberculosis and retropharyngeal abscesses highlights the importance of careful screening and follow up."
Ann Rheum Dis 2003 Sept;62:9:829-834.
"Systematic safety follow up in a cohort of 107 patients with spondyloarthropathy treated with infliximab: a new perspective on the role of host defence in the pathogenesis of the disease?"
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