Clinical research studyLong-term TNF-α Blockade in Patients with Amyloid A Amyloidosis Complicating Rheumatic Diseases
Section snippets
Patients
The patients included in this study were all patients with amyloid A amyloidosis secondary to an immune-mediated inflammatory disease who were treated and followed up prospectively in 4 Spanish hospitals from January 2001 to October 2006. This study represents an extension of a previous study.4 Amyloid A amyloidosis was confirmed histologically by Congo-red staining and immunohistochemistry. Informed consent was obtained from all patients, and the treatment was approved by the local health
Results
From January 1, 2001, to October 31, 2006, a cohort of 36 patients with amyloid A amyloidosis was generated. The patients were treated with anti-tumor necrosis factor drugs for a total of 102.97 patient-years (median follow-up 34.6 months). Thirty-five propensity score-matched control subjects were chosen from the BIOBADASER registry. All patients had highly active immune-mediated inflammatory diseases refractory to other treatments.
Discussion
The present study showed the sustained efficacy of tumor necrosis factor-α antagonists in treating amyloid A amyloidosis secondary to rheumatic diseases. A continuous reduction in proteinuria with this therapy was associated with the stabilization of kidney function and a marked reduction of acute phase reactants. However, both infections and deaths were common.
Having found that tumor necrosis factor-α antagonists might be useful to treat amyloid A amyloidosis in studies with a short follow-up,4
Conclusions
We have shown that anti-tumor necrosis factor drugs may be useful to treat kidney amyloidosis but could increase the risk and severity of infections. The long-term follow-up of these patients is essential to define the true effect of these drugs on patient survival. In view of the difficulties in recruiting patients to such trials, multicenter studies would be advisable.
Acknowledgment
The authors thank the rheumatologists who contribute to the BIOBADASER registry.
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Funding: None. The drugs administered to our patients were supplied by the sanitary service as part of the medical care that they normally received.
Conflict of Interest: None of the authors have any conflicts of interest associated with the work presented in this manuscript; however, Antonio Fernández-Nebro has earned $1500 or more per year as speaker or consultant (included all companies) for Abbott, Roche, Schering-Plough, and Bristol-Meyer-Squibb companies during the past 3 years, and Rosario García-Vicuña has earned $1500 or more per year as speaker or consultant (included all companies) for Abbott, Roche, Schering-Plough, and Wyeth companies during the past 3 years.
Authorship: All authors had access to the data and played a role in writing this manuscript. Dr Fernández-Nebro had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study conception and design: Fernández-Nebro, García-Vicuña, Olivé. Acquisition of data: Fernández-Nebro, Herranz, Riera, Castro. Analysis and interpretation of data: Fernández-Nebro, García de Yébenes, García-Vicuña, Olivé.