Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis: A phase 2 study

Neurology

Volumn 82, Issue 7, 2014, Pages 573-581

  Sorensen, Per S ^a   Lisby, Steen ^b   Grove, Richard ^c   Derosier, Frederick ^d   Shackelford, Steve ^d   Havrdova, Eva ^e   Drulovic, Jelena ^f   Filippi, Massimo ^g  

^a International Center for Research and Research Training in Endocrine Disruption of Male Reproduction and Child Health   (Denmark)

^b Genmab   (Denmark)

^c GLAXOSMITHKLINE   (Canada)

^d GLAXOSMITHKLINE   (United States)

^e CHARLES UNIVERSITY   (Czech Republic)

^f UNIVERSITY OF BELGRADE   (Serbia)

^g VITA SALUTE SAN RAFFAELE UNIVERSITY   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

CD19 ANTIBODY; CORTICOSTEROID; GADOLINIUM; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; OFATUMUMAB; PLACEBO;

ADULT; ANTIGEN EXPRESSION; ARTICLE; B LYMPHOCYTE; BACKACHE; BRONCHOSPASM; CELL COUNT; CLINICAL ARTICLE; CONTROLLED STUDY; COUGHING; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTROENCEPHALOGRAM; ERYTHEMA; FATIGUE; FEMALE; HEADACHE; HOT FLUSH; HUMAN; INFLUENZA; INFUSION RELATED REACTION; MALE; MENSTRUATION DISORDER; MIDDLE AGED; MULTIPLE SCLEROSIS; NOSE OBSTRUCTION; NUCLEAR MAGNETIC RESONANCE IMAGING; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RADIOLOGICAL PARAMETERS; RANDOMIZED CONTROLLED TRIAL; SKIN PRURITUS; THROAT IRRITATION; UPPER RESPIRATORY TRACT INFECTION; VIRUS INFECTION;

ADULT; ANTIBODIES, MONOCLONAL; ANTIGENS, CD19; ANTIGENS, CD20; DOUBLE-BLIND METHOD; EVIDENCE-BASED MEDICINE; FEMALE; HUMANS; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84895734917     PISSN: 00283878     EISSN: 1526632X     Source Type: Journal    
DOI: 10.1212/WNL.0000000000000125     Document Type: Article

References (30)

1. Meier UC, Giovannoni G, Tzartos JS, Khan G. Translational mini-review series on B cell subsets in disease: B cells in multiple sclerosis: drivers of disease pathogenesis and Trojan horse for Epstein-Barr virus entry to the central nervous system? Clin Exp Immunol 2012;167:1-6.
2. Ontaneda D, Hyland M, Cohen JA. Multiple sclerosis: new insights in pathogenesis and novel therapeutics. Annu Rev Med 2012;63:389-404.
3. Rizvi SA, Agius MA. Current approved options for treating patients with multiple sclerosis. Neurology 2004;63:S8-S14.
4. Owens GP, Bennett JL, Gilden DH, Burgoon MP. The B cell response in multiple sclerosis. Neurol Res 2006;28: 236-244.
5. von Budingen HC, Bar-Or A, Zamvil SS. B cells in multiple sclerosis: connecting the dots. Curr Opin Immunol 2011;23:713-720.
6. Hauser SL, Waubant E, Arnold DL, et al. B-cell depletion with rituximab in relapsing-remitting multiple sclerosis. N Engl J Med 2008;358:676-688.
7. He D, Zhou H, Han W, Zhang S. Rituximab for relapsing-remitting multiple sclerosis. Cochrane Database Syst Rev 2011;(12):CD009130.
8. Gensicke H, Leppert D, Yaldizli O, et al. Monoclonal antibodies and recombinant immunoglobulins for the treatment of multiple sclerosis. CNS Drugs 2012;26:11-37.
9. Kappos L, Bates D, Edan G, et al. Natalizumab treatment for multiple sclerosis: updated recommendations for patient selection and monitoring. Lancet Neurol 2011;10: 745-758.
10. Kappos L, Li D, Calabresi PA, et al. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet 2011;378: 1779-1787.
11. O'Connor P,Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med 2011;365:1293-1303.
12. Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012;367:1087-1097.
13. Bleeker WK, Munk ME, Mackus WJ, et al. Estimation of dose requirements for sustained in vivo activity of a therapeutic human anti-CD20 antibody. Br J Haematol 2008; 140:303-312.
14. Reagan JL, Castillo JJ. Ofatumumab for newly diagnosed and relapsed/refractory chronic lymphocytic leukemia. Expert Rev Anticancer Ther 2011;11:151-160.
15. Bello C, Veliz M, Pinilla-Ibarz J. Ofatumumab in the treatment of low-grade non-Hodgkin's lymphomas and chronic lymphocytic leukemia. Expert Rev Clin Immunol 2011;7:295-300.
16. Czuczman MS, Fayad L, Delwail V, et al. Ofatumumab monotherapy in rituximab-refractory follicular lymphoma: results from a multicenter study. Blood 2012;119:3698-3704.
17. Czuczman MS, Hess G, Gadeberg OV, et al. Chemoimmunotherapy with ofatumumab in combination with CHOP in previously untreated follicular lymphoma. Br J Haematol 2012;157:438-445.
18. GlaxoSmithKline. Arzerra (ofatumumab) prescribing information [online]. Available at: www.gsksource.com/gskprm/ htdocs/documents/ARZERRA.PDF. Accessed April 24, 2013.
19. Hagenbeek A, Gadeberg O, Johnson P, et al. First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial. Blood 2008;111:5486-5495.
20. Matasar MJ, Czuczman MS, Rodriguez MA, et al. Ofatumumab in combination with ICE or DHAP chemotherapy in relapsed or refractory intermediate grade B-cell lymphoma. Blood 2013;122:499-506.
21. Wierda WG, Kipps TJ, Mayer J, et al. Ofatumumab as single-agent CD20 immunotherapy in fludarabinerefractory chronic lymphocytic leukemia. J Clin Oncol 2010;28:1749-1755.
22. Wierda WG, Padmanabhan S, Chan GW, Gupta IV, Lisby S, Osterborg A. Ofatumumab is active in patients with fludarabine-refractory CLL irrespective of prior rituximab: results from the phase 2 international study. Blood 2011;118:5126-5129.
23. Ostergaard M, Baslund B, Rigby W, et al. Ofatumumab, a human anti-CD20 monoclonal antibody, for treatment of rheumatoid arthritis with an inadequate response to one or more disease-modifying antirheumatic drugs: results of a randomized, double-blind, placebo-controlled, phase I/II study. Arthritis Rheum 2010;62:2227-2238.
24. Polman CH, Reingold SC, Edan G, et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria." Ann Neurol 2005;58:840-846.
25. Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an Expanded Disability Status Scale (EDSS). Neurology 1983;33:1444-1452.
26. National Cancer Institute common terminology criteria for adverse events v3.0 [online]. 2006. Available at: http://ctep.cancer.gov/protocolDevelopment/ electronic-applications/docs/ctcaev3.pdf. Accessed August 15, 2013.
27. Winkler U, Jensen M, Manzke O, Schulz H, Diehl V, Engert A. Cytokine-release syndrome in patients with B-cell chronic lymphocytic leukemia and high lymphocyte counts after treatment with an anti-CD20 monoclonal antibody (rituximab, IDEC-C2B8). Blood 1999;94: 2217-2224.
28. Sorensen PS, Lycke J, Eralinna JP, et al. Simvastatin as add-on therapy to interferon beta-1a for relapsing-remitting multiple sclerosis (SIMCOMBIN study): a placebocontrolled randomised phase 4 trial. Lancet Neurol 2011; 10:691-701.
29. Sorensen PS, Mellgren SI, Svenningsson A, et al. NORdic trial of oral Methylprednisolone as add-on therapy to Interferon beta-1a for treatment of relapsing-remitting Multiple Sclerosis (NORMIMS study): a randomised, placebo-controlled trial. Lancet Neurol 2009;8:519-529.
30. Sell S, Max EE. Immunology, Immunopathology, and Immunity, 6th ed. Washington, DC: ASM Press; 2001.