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J Clin Virol. 2013 Jun;57(2):115-9. doi: 10.1016/j.jcv.2013.01.016. Epub 2013 Feb 17.

Reactivation of latent viruses in individuals receiving rituximab for new onset type 1 diabetes.

Collaborators (144)

Skyler JS, Greenbaum CJ, Kenyon NS, Rafkin-Mervis L, Sosenko JM, Lachin JM, Krause-Steinrauf H, McGee PF, Hess K, Raiden E, Fradkin J, Leschek E, Savage P, Spain L, Blumberg E, Braun J, Laffel L, Naji A, Nerup J, Orchard T, Tsiatis A, Veatch R, Wallace D, Lernmark A, Lo B, Mitchell H, Steffes M, Zinman B, Loechelt B, Baden L, Green M, Weinberg A, Eisenbarth GS, Davis B, Marcovina S, Palmer JP, Weinberg A, Winter W, Yu L, Davis B, Babu S, Davis B, Ochs HD, Torgerson TR, Ocheltree E, Berger J, Koralnik I, Tyler K, Leschek RT, Pescovitz MD, Buckingham B, Fathman C, Gitelman S, Herold K, Kenyon N, Krause-Steinrauf H, Looney J, Lunney J, Ng D, Rodriguez H, Spain L, Greenbaum C, Lachin JM, Leschek E, Skyler JS, Owens K, Greenbaum C, Bollyky J, Sanda S, McCulloch-Olson M, Hefty D, Webber C, Kuhns K, Murphy C, Goland R, Greenberg E, Gallagher MP, Trast J, Chan M, Rodriguez H, Pescovitz M, Christner L, Nicholson M, Mendez M, Wilson DM, A B, Aye T, Esrey T, Soto A, Perry J, Baker B, Rigby A, Riley K, Chatav M, Berry B, Gitelman SE, Rosenthal SM, Anderson M, Adi S, Breen K, Hamilton C, Gottlieb P, Chase H, Rawley-Payne M, George S, Weiner L, Schatz D, Haller M, Clare-Salzler M, Cook R, Mancini D, Abraham A, Hicks E, Cole G, Marks JB, Pugliese A, Matheson D, Blaschke C, Arazo L, Cisneros M, Moran A, Wagner J, Nathan B, Boes MA, Becker D, Toledo F, Riley K, Delallo K, Smith K, Raskin P, White P, Dickson B, Adhikari S, Siegelman M, Alford M, Torres N, Harden T, Pruneda L, Cordova E, Wherrett D, Eisel LA, Ahenkorah B, Razack N, Sriskandarajah M.

Author information

Divison of Adult Infectious Diseases, University of Colorado School of Medicine, Aurora, USA.



Rituximab has been successfully used as an experimental therapy in different autoimmune diseases. Recently, a double-blind placebo-controlled phase-2 study in early onset type 1 diabetes showed that rituximab delayed progression of the disease. However, like with any immunosuppressive therapy, there is a concern of opportunistic viral reactivations with the use of rituximab, including herpes and polyomaviruses.


To study the incidence of new infections and reactivations with BK, JC, Epstein-Barr and cytomegalovirus (BKV, JCV, EBV and CMV) in T1D participants in the phase-2 rituximab study.


Subjects received 4 weekly doses of rituximab (N = 57) or placebo (N = 30) during the first month of study. Blood samples obtained at weeks 0, 12, 26, 56 and 78 were assayed for CMV, EBV, BKV and JCV by real-time DNA PCR and serology.


EBV reactivations were diagnosed by PCR in 25% of placebo, but none of rituximab recipients (p < 0.01). There were no episodes of CMV viremia in either treatment group. BKV viremias were significantly more common in the rituximab recipients (9%) compared with placebo controls (0, p < 0.01). No JCV reactivations were detected in this study, but among 6 rituximab and 2 placebo recipients who seroconverted for JCV during the study, only one rituximab recipient had detectable viremia. All infections were asymptomatic.


Four doses of rituximab administered to individuals with early onset T1D decreased the incidence of asymptomatic EBV reactivations, as predicted by the rituximab-mediated elimination of memory B-cells, but increased the frequency of asymptomatic viremias caused by polyomaviruses.

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