Efficacy and Safety Analysis of Combination Therapy Consisting of Intravenous Immunoglobulin and Corticosteroids versus Respective Monotherapies in the Treatment of Relapsed ITP in Adults

Abstract

Objective In this study, we aimed to evaluate the efficacy and safety of combination therapy, consisting of intravenous immunoglobulin (IVIg) and corticosteroids, in comparison to respective monotherapies in the treatment of relapsed immune thrombocytopenia (ITP) in adults. Methods A retrospective analysis of clinical data was conducted on 205 adult patients with relapsed ITP who received first-line combination therapy or monotherapy in multiple centers across China from January 2010 to December 2022. The study evaluated the patients' clinical characteristics, efficacy, and safety. Results We found that the proportion of patients with platelet counts in complete response was significantly higher in the combination group (71.83%) compared with the IVIg group (43.48%) and the corticosteroids group (23.08%). The mean PLT _max in the combination group (178 × 10 ⁹ /L) was significantly higher than that in the IVIg group (109 × 10 ⁹ /L) and the corticosteroids group (76 × 10 ⁹ /L). Additionally, the average time for platelet counts to reach 30 × 10 ⁹ /L, 50 × 10 ⁹ /L, and 100 × 10 ⁹ /L in the combination group was significantly shorter than in the monotherapy groups. The proportion curves for reaching these platelet counts during treatment were also significantly different from those in the monotherapy groups. However, there were no significant differences in the effective rate, clinical characteristics, and adverse events among the three groups. Conclusion We concluded that combining IVIg and corticosteroids was a more effective and faster treatment for relapsed ITP in adults than using either therapy alone. The findings of this study provided clinical evidence and reference for the use of first-line combination therapy in the treatment of relapsed ITP in adults.

Keywords: adult relapse; combination therapy; first-line drugs; primary immune thrombocytopenia.

Fig. 1

Curves of platelet counts in each group during the course of treatment. The platelet count of the combination group was significantly higher than that of the corticosteroids group from day 1 to day 7, and platelet counts were consistently significantly higher in the intravenous immunoglobulin (IVIg) group from day 3 to day 7. Compared with the corticosteroids group, the platelet count of the IVIg group showed a statistically significant difference from day 1 to day 6, and the difference disappeared with the increase of platelet count in the corticosteroids group on day 7 ( p  = 0.08) ( t -test, * p  < 0.05, ** p  < 0.01, *** p  < 0.001).

Fig. 2

The PLT _max of each group during the course of treatment. Mean with 95% confidence intervals of PLT _max of patients in each group during the course of treatment ( t -test, * p  < 0.05, ** p  < 0.01, *** p  < 0.001).

Fig. 3

The treatment days corresponding to the platelet count reaching 30 × 10 ⁹ /L, 50 × 10 ⁹ /L, and 100 × 10 ⁹ /L for the first time. We calculated the mean with 95% confidence intervals for the number of days in which patients achieved platelet counts of 30 × 10 ⁹ /L, 50 × 10 ⁹ /L, and 100 × 10 ⁹ /L for the first time in each group. Patients who did not reach it were not included in the statistics ( t -test, * p  < 0.05, ** p  < 0.01, *** p  < 0.001).

Fig. 4

The percentage of patients in each group whose platelet count did not reach 30 × 10 ⁹ /L ( A ), 50 × 10 ⁹ /L ( B ), and 100 × 10 ⁹ /L ( C ) per day. The Kaplan–Meier method was used to calculate the number of patients with platelet counts reaching 30 × 10 ⁹ /L, 50 × 10 ⁹ /L, and 100 × 10 ⁹ /L every day, and the percentage curve of each group was drawn. The differences between groups were compared using the log-rank test (* p  < 0.05, ** p  < 0.01, *** p  < 0.001, **** p  < 0.0001).