Abstract
Both intravenous methylprednisolone (methyl-Pd) and intravenous immunoglobulin (IVIg) have been used as standard initial therapies in adult patients with immune thrombocytopenia (ITP). Nonetheless, few studies have addressed whether there are differences in clinical efficacy between these two treatments. In this study, we compared platelet responses, toxicities, and bleeding-related mortality associated with these two treatments in adult ITP.
Adult patients newly diagnosed with ITP, with platelet counts of less than 20,000/mL, were prospectively enrolled. Patients with comorbidities such as diabetes and uncontrolled cardiovascular disorders and who were pregnant were excluded. Patients who entered the study between 1993 and 2002 received intravenous methyl-Pd therapy (10 mg/kg/day for 3 days) followed by oral Pd (1 mg/kg/day). Patients who entered the study between 2003 and 2008 received IVIg (400 mg/kg/day for 5 days) together with oral Pd (1 mg/kg/day). After 6 weeks, the prednisolone began to be tapered in both arms. Early response and maintenance of response were assessed at 7 days and 6 months after treatment, respectively, based on the outcome criteria proposed by an international working group (Blood 2009).
Of 87 patients enrolled, 77 (88.5%) were eligible for analysis. Initial platelet counts did not differ between the two groups. Early responses occurred in 30 of 39 patients (76.9%) receiving methyl-Pd versus 33 of 38 patients (86.6%) receiving IVIg (p = 0.187). Maintenance of response was observed in 28 patients (71.8%) in the methyl-Pd arm and 23 patients (60.5%) in the IVIg arm (p = 0.187). The time to a complete response in the IVIg arm (6 days; range, 1–35 days) was shorter than that in the methyl-Pd arm (13.5 days; range, 2–29 days) (p = 0.002). Side effects were mild and tolerable in both arms. Five years after treatment initiation, 5 patients (12.8%) and 7 patients (18.4%) were still under salvage treatment in the methyl-Pd and IVIg arms, respectively. During a median follow-up of 98 months (range, 33-228 months) in the methyl-Pd arm and 71 months (range, 52-180 months) in the IVIg arm, 19 patients (48.7%) and 18 patients (47.4%) patients required one or more salvage treatments, respectively (p = 0.906). No bleeding-related death was observed in either group during the follow-up period.
These results indicate that neither the early response rate nor the long-term outcome differs between methyl-Pd and IVIg treatments. IVIg, however, more rapidly induces a complete response than methyl-Pd.
No relevant conflicts of interest to declare.
Author notes
Asterisk with author names denotes non-ASH members.
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