Use of Steroids in Subjects with ITP in Spain: Duration and Toxicity

Introduction

Steroids are the first-line treatment for individuals suffering from immune thrombocytopenia (ITP). A short usage is recommended, with no more than 8 weeks of prednisone or 3 cycles of dexamethasone. Prophylaxis against infections and osteopenia could be suggested in case of longer use. The objective of this project is to determine the duration of steroid treatment, efficacy, toxicity, and the indication and duration of prophylaxis in real national clinical practice.

Methods

This is a national, retrospective, multicenter observational study conducted by the Spanish ITP Group (GEPTI). It includes patients over 18 years of age diagnosed with ITP who received steroid treatment between January 2021 and December 2022 in our setting. Definitions of ITP type and response criteria follow the International Working Group standards. The prophylaxis against infections and osteopenia evaluated follows Spanish group of ITP (GEPTI) recommendations. Toxicity was defined as the incidence of infections requiring hospitalization or emergency assistants, bone fractures, vascular events, and the development or worsening of diabetes (DM), dyslipidemia (DLP), or hypertension (HTN).

Results

A total of 217 patients were evaluated, 22 (10%) received 2 or more steroid courses of treatment during the evaluated period. The total number of treatments evaluated was 276. The median age of the patients was 56 years (IQR: 34.3-71.8), with 60.5% being women. In 64.3% of cases, ITP was newly diagnosed, and in 26.1%, they were chronic at the beginning of steroid treatment. In this serie, 39% of patients had two or more vascular risk factors, the most frequent ones were dyslipidemia (27.9%), overweight/obesity (27.8%), smoking (27.2%), and high blood pressure (24.6%) and 2.5% of patients were positive for hepatitis B surface antigen (HBsAg).

Prednisone was the most used steroid (52.5%), at a dose of 1 mg/kg/day in the majority of treatments (42.8%) with a median treatment duration of 9 weeks (IQR: 6-15). Dexamethasone was used in 39.1% of subjects, with 84.6% of patients receiving a maximum of 2 cycles. The overall response rate was 77.2% (complete response 50%, response 27.2%). Other immunosuppressant drugs were used in 9.2% of cases. With a median follow-up of 29 months (IQR: 22-37) from the start of treatment, relapse rate was 44.6%.

Prophylaxis for Pneumocystis was performed in 9.4% of the series, herpes viruses and fungi prophylaxis were indicated in 0.4% of cases and 83% of HBsAg-positive patients received antiviral prophylaxis. 22.2% of patients received osteopenia prophylaxis with vitamin D and/or calcium supplements. Densitometry evaluation was requested in only 1.8% of patients with indication. During follow-up, 7.6% of patients had a severe infection, with respiratory tract being the most common (13/19 infections). Bacterial infection were stablished in 5/19 cases and SARS-CoV-2 in 7/19 cases. Six bone fractures were reported, two of them spontaneous. The mortality rate was 5.1%.

Conclusions

The duration of steroid treatment adheres to recommendations, especially in patients treated with dexamethasone. The indication for prophylaxis needs significant improvement, especially in case of osteopenia/osteoporosis, with a higher than expected incidence of fractures compared to recently described data of 1.2/1000 subjects.