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Low-dose anti-CD20 veltuzumab given intravenously or subcutaneously is active in relapsed immune thrombocytopenia: a phase I study.

Abstract
Low doses of the humanized anti-CD20 monoclonal antibody, veltuzumab, were evaluated in 41 patients with immune thrombocytopenia (ITP), including 9 with ITP ≤1 year duration previously treated with steroids and/or immunoglobulins, and 32 with ITP >1 year and additional prior therapies. They received two doses of 80-320 mg veltuzumab 2 weeks apart, initially by intravenous (IV) infusion (N = 7), or later by subcutaneous (SC) injections (N = 34), with only one Grade 3 infusion reaction and no other safety issues. Thirty-eight response-assessable patients had 21 (55%) objective responses (platelet count ≥30 × 10(9) /l and ≥2 × baseline), including 11 (29%) complete responses (CRs) (platelet count ≥100 × 10(9) /l). Responses (including CRs) occurred with both IV and SC administration, at all veltuzumab dose levels, and regardless of ITP duration. Responders with ITP ≤1 year had a longer median time to relapse (14·4 months) than those with ITP >1 year (5·8 months). Three patients have maintained a response for up to 4·3 years. SC injections resulted in delayed and lower peak serum levels of veltuzumab, but B-cell depletion occurred after first administration even at the lowest doses. Eight patients, including 6 responders, developed anti-veltuzumab antibodies following treatment (human anti-veltuzumab antibody, 19·5%). Low-dose SC veltuzumab appears convenient, well-tolerated, and with promising clinical activity in relapsed ITP.(Clinicaltrials.gov identifier: NCT00547066.).
AuthorsHoward A Liebman, Mansoor N Saleh, James B Bussel, Ovidiu George Negrea, Heather Horne, William A Wegener, David M Goldenberg
JournalBritish journal of haematology (Br J Haematol) Vol. 162 Issue 5 Pg. 693-701 (Sep 2013) ISSN: 1365-2141 [Electronic] England
PMID23829485 (Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Copyright© 2013 John Wiley & Sons Ltd.
Chemical References
  • Antibodies, Monoclonal, Humanized
  • Antigens, CD20
  • veltuzumab
Topics
  • Antibodies, Monoclonal, Humanized (administration & dosage, adverse effects, blood, therapeutic use)
  • Antigens, CD20 (immunology)
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Humans
  • Infusions, Intravenous
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Purpura, Thrombocytopenic, Idiopathic (blood, drug therapy)
  • Recurrence
  • Treatment Outcome

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