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Editorial
. 2012 Mar 23;14(2):113.
doi: 10.1186/ar3751.

Meryl Streep and the problems of clinical trials

Editorial

Meryl Streep and the problems of clinical trials

David A Isenberg. Arthritis Res Ther. .

Abstract

A clinical trial of lupus patients with nephritis was established to determine any possible role for Atacicept, a biologic drug that blocks two B-cell-activating factors (BLyS and APRIL). The trial was stopped after just six patients had been enrolled because three patients developed serious infections. Initial concerns that the biologic was the main cause of the increased susceptibility to these infections have had to be revised on close inspection of the data. The evidence clearly points to a previously unrecognised capacity for mycophenolate to cause notable drops in immunoglobulin levels as the prime suspect.

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References

    1. Ginzler EM, Wax S, Rajeswaran A, Copt S, Hilson J, Romos E, Singer NG. Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated study. Arthritis Res Ther. 2012;14:R33. doi: 10.1186/ar3738. - DOI - PMC - PubMed
    1. McMillan R, Longmire R, Yelenosky R. The effect of corticosteroids on human IgG synthesis. J Immunol. 1976;116:1592–1595. - PubMed
    1. Broeders EN, Wissing KM, Hazzan M, Ghisdal L, Hoang AD, Noel C, Mascart F, Abramowicz D. Evolution of immunoglobulin and mannose binding protein levels after renal transplantation: association with infectious complications. Transpl Int. 2008;21:57–64. - PubMed
    1. Appel GB, Contreras G, Dooley MA, Ginzler EM, Isenberg D, Jayne D, Li L-S, M Eduardo, Sánhez-Guerrero J, Solomons N, Wofsy D. Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis. J Am Soc Nephrol. 2009;20:1103–1112. doi: 10.1681/ASN.2008101028. - DOI - PMC - PubMed
    1. Dooley MA, Jayne D, Ginzler EM, Isenberg DA, Olsen NJ, Wofsy D, Eitna F, Appel G, Contreras G, Lisk L, Solomon N. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med. 2011;365:1886–1895. doi: 10.1056/NEJMoa1014460. - DOI - PubMed

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