Initial management of immune thrombocytopenic purpura in adults: a randomized controlled trial comparing intermittent anti-D with routine care.

Abstract

We conducted a randomized clinical trial in adults with a new diagnosis of ITP and a platelet count <30000/muL to test the hypothesis that initial intermittent treatment with anti-D may avoid or defer the need for splenectomy when compared to current routine care (glucocorticoid treatment, followed by splenectomy). Splenectomy was to be performed in the anti-D group if patients failed to respond to three consecutive anti-D treatments given within 10 days. The incidences of splenectomy were 14 of 37 (38%) in the routine care group and 14 of 33 (42%) in the anti-D group (absolute risk reduction = 4.6% in favor of the routine care group, 95% CI, -18.4 to 27.6%). However, splenectomy was performed prematurely, not according to the protocol, in 11 of 14 patients in the anti-D group. The median time to splenectomy was 36 days (range, 9-78) in the routine care group and 112 days (range, 19-558) in the anti-D group (P = 0.045 at 100 days after randomization, P = 0.840 at 1 year after randomization, using log-rank analysis). Patients in the anti-D group were treated with prednisone for fewer days (70 days) compared to the routine care group (112 days, P = 0.01). No major bleeding events occurred. In this study, initial treatment of patients with intermittent anti-D initially deferred splenectomy. Whether our aggressive regimen of anti-D could have prevented splenectomy if it had been adhered to in all patients remains uncertain. However, compliance with this anti-D regimen was not feasible for many patients and/or their physicians.

• Authors: James N George, Gary E Raskob, Sara K Vesely, Dennis Moore Jr, Roger M Lyons, Everardo Cobos, Brenda L Towell, Panpit Klug, Troy H Guthrie
• Journal: American journal of hematology (Am J Hematol) Vol. 74 Issue 3 Pg. 161-9 (Nov 2003) ISSN: 0361-8609 [Print] United States
• PMID: 14587042 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2003 Wiley-Liss, Inc.

Chemical References

• Glucocorticoids
• Isoantibodies
• RHO(D) antibody
• Rho(D) Immune Globulin
• Prednisone

Topics

• Adult
• Aged
• Disease Management
• Female
• Glucocorticoids (administration & dosage, therapeutic use)
• Hemorrhage (chemically induced)
• Humans
• Isoantibodies (administration & dosage, therapeutic use, toxicity)
• Male
• Middle Aged
• Prednisone (administration & dosage, therapeutic use)
• Purpura, Thrombocytopenic, Idiopathic (complications, drug therapy, surgery)
• Remission Induction
• Rho(D) Immune Globulin
• Splenectomy (statistics & numerical data)
• Treatment Outcome