The DOI matches its Crossref record; 11 of the 11 references it cites were found in a registry or an index.
Caplacizumab for Acquired Thrombotic Thrombocytopenic Purpura
Open accessAbstract
BACKGROUND: Acquired thrombotic thrombocytopenic purpura (TTP) is caused by aggregation of platelets on ultralarge von Willebrand factor multimers. This microvascular thrombosis causes multiorgan ischemia with potentially life-threatening complications. Daily plasma exchange and immunosuppressive therapies induce remission, but mortality and morbidity due to microthrombosis remain high. METHODS: Caplacizumab, an anti-von Willebrand factor humanized single-variable-domain immunoglobulin (Nanobody), inhibits the interaction between ultralarge von Willebrand factor multimers and platelets. In this phase 2, controlled study, we randomly assigned patients with acquired TTP to subcutaneous caplacizumab (10 mg daily) or placebo during plasma exchange and for 30 days afterward. The primary end point was the time to a response, defined as confirmed normalization of the platelet count. Major secondary end points included exacerbations and relapses. RESULTS: Seventy-five patients underwent randomization (36 were assigned to receive caplacizumab, and 39 to receive placebo). The time to a response was significantly reduced with caplacizumab as compared with placebo (39% reduction in median time, P=0.005). Three patients in the caplacizumab group had an exacerbation, as compared with 11 patients in the placebo group. Eight patients in the caplacizumab group had a relapse in the first month after stopping the study drug, of whom 7 had ADAMTS13 activity that remained below 10%, suggesting unresolved autoimmune activity. Bleeding-related adverse events, most of which were mild to moderate in severity, were more common with caplacizumab than with placebo (54% of patients vs. 38%). The frequencies of other adverse events were similar in the two groups. Two patients in the placebo group died, as compared with none in the caplacizumab group. CONCLUSIONS: Caplacizumab induced a faster resolution of the acute TTP episode than did placebo. The platelet-protective effect of caplacizumab was maintained during the treatment period. Caplacizumab was associated with an increased tendency toward bleeding, as compared with placebo. (Funded by Ablynx; ClinicalTrials.gov number, NCT01151423.).
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Scully, M., Hunt, B. J., Benjamin, S., Liesner, R., Rose, P., Peyvandi, F., Cheung, B., Machin, S. J., & on behalf of British Committee for Standards in Haematology (2012) · British Journal of Haematology · doi:10.1111/j.1365-2141.2012.09167.x · Cited by 863
Self-citationVon Willebrand factor, ADAMTS13, and thrombotic thrombocytopenic purpura
Sadler, J. E. (2008) · Blood · doi:10.1182/blood-2008-02-078170 · Cited by 574
Deford, C. C., Reese, J. A., Schwartz, L. H., Perdue, J. J., Kremer Hovinga, J. A., Lämmle, B., Terrell, D. R., Vesely, S. K., & George, J. N. (2013) · Blood · doi:10.1182/blood-2013-04-496752 · Cited by 220
Self-citationHosler, G. A., Cusumano, A. M., & Hutchins, G. M. (2003) · Archives of Pathology & Laboratory Medicine · doi:10.5858/2003-127-834-ttpahu · Cited by 220
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Self-citationManagement of thrombotic thrombocytopenic purpura: current perspectives
Scully, M., & Blombery, P. A. (2014) · Journal of Blood Medicine · doi:10.2147/jbm.s46458 · Cited by 148
Self-citationCallewaert, F., Roodt, J. P., Ulrichts, H., Stöhr, T., van Rensburg, W. J. J., Lamprecht, S., Rossenu, S., Priem, S., Willems, W. F., & Holz, J.-B. (2012) · Blood · doi:10.1182/blood-2012-04-420943 · Cited by 142
Self-citationRelationship between ADAMTS13 activity in clinical remission and the risk of TTP relapse
Jin, M., Casper, T. C., Cataland, S. R., Kennedy, M. S., Lin, S., Li, Y. J., & Wu, H. M. (2008) · British Journal of Haematology · doi:10.1111/j.1365-2141.2008.07107.x · Cited by 140
Self-citationDepression and cognitive impairment following recovery from thrombotic thrombocytopenic purpura
Han, B., Page, E. E., Stewart, L. M., Deford, C. C., Scott, J. G., Schwartz, L. H., Perdue, J. J., Terrell, D. R., Vesely, S. K., & George, J. N. (2015) · American Journal of Hematology · doi:10.1002/ajh.24060 · Cited by 88
Management and outcomes for patients with TTP: analysis of 100 cases at a single institution
Chaturvedi, S., Carcioppolo, D., Zhang, L., & McCrae, K. R. (2013) · American Journal of Hematology · doi:10.1002/ajh.23455 · Cited by 37
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Bannas, P., Hambach, J., & Koch-Nolte, F. (2017) · Frontiers in Immunology · doi:10.3389/fimmu.2017.01603 · Cited by 572
“Caplacizumab, the first nanobody expected to be licensed for clinical use in 2018, consists of a dimeric nanobody (directed against von Willebrand factor) (71).”
BackgroundMechanisms of Autoantibody-Induced Pathology
Ludwig, R. J., Vanhoorelbeke, K., Leypoldt, F., Kaya, Z., Bieber, K., McLachlan, S. M., Komorowski, L., Luo, J., Cabral-Marques, O., Hammers, C. M., et al. (2017) · Frontiers in Immunology · doi:10.3389/fimmu.2017.00603 · Cited by 469
Durable antitumor responses to CD47 blockade require adaptive immune stimulation
Sockolosky, J. T., Dougan, M., Ingram, J. R., Ho, C. C. M., Kauke, M. J., Almo, S. C., Ploegh, H. L., & Garcia, K. C. (2016) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.1604268113 · Cited by 366
Camelid and shark single domain antibodies: Structural features and therapeutic potential
Könning, D., Zielonka, S., Grzeschik, J., Empting, M., Valldorf, B., Krah, S., Schröter, C., Sellmann, C., Hock, B., & Kolmar, H. (2017) · Current Opinion in Structural Biology · doi:10.1016/j.sbi.2016.10.019 · Cited by 214
Metadata
- Authors
- Peyvandi, F., Scully, M., Kremer Hovinga, J. A., Cataland, S., Knöbl, P., Wu, H., Artoni, A., Westwood, J.-P., Mansouri Taleghani, M., Jilma, B., Callewaert, F., Ulrichts, H., Duby, C., & Tersago, D.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-02-11
- Volume
- 374
- Issue
- 6
- Pages
- 511-522
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2317056394
- Cited by
- 666
- References
- 11
- FWCI
- 35.33
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Peyvandi, F., Scully, M., Kremer Hovinga, J. A., Cataland, S., Knöbl, P., Wu, H., Artoni, A., Westwood, J.-P., Mansouri Taleghani, M., Jilma, B., Callewaert, F., Ulrichts, H., Duby, C., & Tersago, D. (2016). Caplacizumab for Acquired Thrombotic Thrombocytopenic Purpura. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1505533
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