Anti–TNF-alpha Plus Corticosteroids Linked to Infections

VBCR - April 2014, Volume 3, No 2 - Psoriatic Arthritis
Frederique Evans, MBS

Infections may be associated with comorbidity and mortality in patients with psoriatic arthritis (PA) and ankylosing spondylitis (AS; spondyloarthropathy [SpA]), and rheumatoid arthritis (RA). Results from a retrospective observational study suggest that anti–tumor necrosis factor; (TNF)-alpha and corticosteroids (CS) combination promote infection; disease-modifying antirheumatic drugs (DMARDs) were found to be relatively safe (Germano V, et al. J Transl Med. 2014;12:77).

“Physicians, therefore, should be aware that there may be an increased risk of infection when using anti–TNF-alpha and CS therapy together,” Valentina Germano, Department of Clinical and Molecular Medicine, Sapienza University of Rome, Italy, and colleagues stated. Although CSs may delay radiographic joint damage, the authors added, they should be carefully used with biologics.

The impact of DMARDs, CSs, and 3 TNF-alpha antagonists licensed in Italy was evaluated, in monotherapy and combination therapy, among patients with RA and SpA. In particular, they looked at incidence rates per 100 patient-years and stratified the patients according to therapy. All RA and SpA outpatients who visited the Immuno-rheumatology Division of the S. Andrea University in Rome between November 2003 and December 2009 were included. The 1987 American College of Rheumatology guidelines were used to diagnose patients with RA; Moll and Wright criteria were used for patients with PA; and the modified New York criteria were used for AS. Patients were followed in 3 month intervals, and stratified based on therapy: DMARDs alone, DMARDs plus CS, anti-TNF-alpha alone, anti–TNF-alpha plus CS, anti–TNF-alpha plus DMARDs, and anti–TNF-alpha plus DMARDs and CSs.

Overall, 341 patients with a total of 911.8 patient-years of follow-up, and a median of 26.04 months of follow-up were included in the analysis. Fifty-two percent (n = 176) of the patients had at least 1 infection. Infection rates were 3.8 per 100 patient-months in the first 6 months of treatment. In particular, the investigators found that women had a statistically significant increased risk of infection compared with men. In addition, they found that the rate of infection tended to decrease with increased age-groups; the association was not statistically significant, they noted.

Infection rates between RA and SpA were similar. Disease activity was also associated with infection rates, with moderate and severe disease activity linked to increased rate of infection. In addition, the investigators observed that vaccination against influenza and the absence of comorbidities tended to reduce infection rates; this association was not statistically significant.

The respiratory tract was the most frequent site of infection, and bacteria was associated with three-quarters of all infections. In addition, multivariate analysis demonstrated that adding anti-TNF-alpha to DMARDs doubled the infection incidence rate ratios compared with DMARDs alone, anti–TNF-alpha plus CSs tripled it, and anti–TNF-alpha plus CSs plus DMARDs increased the risk 2.5 times.

“The search for personalized treatment options should be driven by these considerations, trying to maintain with DMARDs the remission phases induced by biologics, as indicated by EULAR [European League Against Rheumatism],” the investigators concluded.

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