RESEARCH - The safety of Remicade combined with background treatments in RA

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Arthritis Rheum. 2006 Mar 29;54(4):1075-1086 [Epub ahead of print]

The safety of infliximab, combined with background treatments, among

patients with rheumatoid arthritis and various comorbidities: A large,

randomized, placebo-controlled trial.

Westhovens R, Yocum D, Han J, Berman A, Strusberg I, Geusens P, Rahman MU.

UZ Gasthuisberg, Leuven, Belgium.

OBJECTIVE: To assess the risk of serious infections following 22 weeks of

infliximab therapy, and to further characterize the safety profile of

infliximab in combination with background treatments during 1 year in

patients with rheumatoid arthritis (RA) with various comorbidities. METHODS:

Patients with active RA despite receiving methotrexate (MTX) were randomly

assigned to receive infusions of placebo (group 1, n = 363), 3 mg/kg

infliximab (group 2, n = 360), or 10 mg/kg infliximab (group 3, n = 361) at

weeks 0, 2, 6, and 14. At week 22, patients in placebo group 1 began

receiving 3 mg/kg infliximab, and patients in group 3 continued to receive

an infliximab dose of 10 mg/kg. Patients in group 2 who failed to meet

predefined response criteria received increasing doses of infliximab in

increments of 1.5 mg/kg. RESULTS: At week 22, the relative risk of

developing serious infections in groups 2 and 3, compared with group 1, was

1.0 (95% confidence interval [95% CI] 0.3-3.1, P = 0.995) and 3.1 (95% CI

1.2-7.9, P = 0.013), respectively. The incidence of serious adverse events

was 7.8% in groups 2 and 3 compared with 7.5% in group 1. From week 22 to

week 54, 11.8%, 9.9%, and 10.3% of patients in groups 1, 2, and 3,

respectively, reported occurrences of serious adverse events. Through week

54, 1 patient in group 1, 2 patients in group 2, and 4 patients in group 3

developed active tuberculosis.

CONCLUSION: The risk of serious infections in patients receiving the

approved infliximab dose of 3 mg/kg plus MTX was similar to that in patients

receiving MTX alone. Patients receiving the unapproved induction regimen of

10 mg/kg infliximab plus MTX followed by a 10 mg/kg maintenance regimen had

an increased risk of serious infections through week 22.

PMID: 16572442

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

6572442

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