RhIG for the treatment of immune thrombocytopenia: consensus and controversy (CME)

Abstract

Anti-D immune globulin (RhIG) is a front-line option in North America for the treatment of immune thrombocytopenia (ITP) in children and adults. Recently, addition of a Food and Drug Administration-mandated black box warning highlighted the risks of intravascular hemolysis, renal failure, and disseminated intravascular coagulation after anti-D infusion, prompting concern within the medical community regarding its use. A working group convened in response to this warning to prepare a consensus document regarding the safety of RhIG because there has been no increased incidence of adverse events since the initial discovery of these reactions many years ago. The efficacy of anti-D is well documented and only briefly reviewed. The estimated incidence and proposed mechanisms for the rare, major treatment-related complications are discussed, and signal detection data associated with heightened risk of acute hemolytic reactions are presented. The importance of considering host factors, given the rarity of severe reactions, is emphasized. Safety profiles of parallel treatment options are reviewed. The working group consensus is that RhIG has comparable safety and efficacy to other front-line agents for the treatment of children and adults with ITP. Safety may be further improved by careful patient selection.

2011 yılında çocukluk çağı immün trombositopenik purpura hastalığı izlem ve tedavisinde değişiklikler

“…Generally, a reduciton of 0.5-1 g/dl is observed in hemoglobin. However, high success rates in acute ITP have been reported with a dose of 75 ug/kg (48).…”

Is anti-D immunoglobulin still a frontline treatment option for immune thrombocytopenia?

“…5 The adverse events reported to the FDA and to Cangene BioPharma, the maker of WinRho SDF, the most widely used anti-D preparation, have been comprehensively reviewed in a recent publication and the data are summarized in Table 2. 3 The incidence of the severe hemolytic reactions is estimated at 1 in 1115 patients and has not significantly changed since licensure (Table 2). 3 Severe hemolytic reactions occurred within 4 hours in 94% of cases.…”

“…3 The incidence of the severe hemolytic reactions is estimated at 1 in 1115 patients and has not significantly changed since licensure (Table 2). 3 Severe hemolytic reactions occurred within 4 hours in 94% of cases. The risk of development of acute hemolytic reactions appears to be highest in adults Ͼ 65 years of age, patients with baseline hemolysis or renal function abnormalities, and those with current or recent significant infection, especially EBV.…”

“…Anti-D has been shown to have comparable efficacy rates to IVIG (ϳ 70%) 1,2 and an overall favorable side effect profile. 3,4 In 2010, a specific warning was issued by the Food and Drug Administration (FDA) highlighting the risk of intravascular hemolysis, acute renal failure, and disseminated intravascular coagulation (DIC) after administration of anti-D to patients with ITP. 5 In the years that have followed, anecdotal evidence suggests that providers are less comfortable with using anti-D and the data support that the use of the agent for frontline therapy has significantly decreased in the postwarning period, although the decline may have begun before the warning.…”

“…During the postinfusion period, clinicians should monitor for any evidence of severe hemolysis by obtaining a complete blood count and urinalysis and should perform further testing as necessary. 3 After discharge, patients and families should be educated about signs and symptoms that warrant evaluation. Future studies should address possible alternative administration strategies (including subcutaneous administration), the application of monitoring recommendations in routine clinical practice, the effect that the recommended monitoring has had on reducing the number of serious hemolytic reactions, and the role of routine premedication strategies (eg, corticosteroids, diphenhydramine, acetaminophen) to decrease infusion reactions.…”