Avatrombopag 20mg tablets

ABSTRACT Objective This systematic review and meta‐analysis aimed to evaluate the risk of thromboembolic events and assess the overall safety and effectiveness of avatrombopag in adult patients with immune thrombocytopenia using real‐world evidence. Methods A systematic search was conducted following the PRISMA 2020 guidelines. Observational studies (2020–2024) on adults with primary immune thrombocytopenia treated with avatrombopag were included. Primary outcomes were thromboembolic complications and treatment response; secondary outcomes included time to response, treatment discontinuation, and adverse events. Random‐effects meta‐analyses were performed to synthesise pooled proportions and rates. Risk of bias was assessed using the ROBINS‐Version 2 tool. Results Fifteen studies were included. The pooled proportion of patients with thromboembolic events was 2.82% (95% confidence interval: 1.61%–4.27%), with an incidence rate of 3.29 per 100 patient‐years (95% CI: 1.81–5.08). Response and complete response were achieved by 80.0% and 92.0% of patients, respectively. The median time to response was 11 days, and the discontinuation rate was 18.9%. Adverse events occurred in 4.1% of patients. Conclusion In real‐world practice, avatrombopag demonstrated high platelet response rates and a low pooled incidence of thrombotic events. These findings add real‐world evidence on avatrombopag outcomes in adult immune thrombocytopenia.

Abstract licence: CC BY-NC-ND 4.0

Non-peptidic thrombopoietin receptor agonists (TPO-RAs), including eltrombopag, avatrombopag and hetrombopag, are used as second-line therapies for immune thrombocytopenia (ITP). However, concerns regarding their hepatic safety persist. The present study conducted a meta-analysis by searching PubMed, Web of Science and the Chinese Medical Association Journal Database for randomized controlled trials evaluating non-peptidic TPO-RAs in ITP that reported hepatic enzyme outcomes, specifically alanine aminotransferase and/or aspartate aminotransferase. The present meta-analysis therefore assessed data from 13 randomized controlled trials involving 1,480 patients (1,034 in the intervention arm and 446 in the control arm) to evaluate the risk of hepatic enzyme abnormalities associated with these aforementioned agents. The results revealed that non-peptidic TPO-RAs did not significantly increase the incidence of hepatic enzyme elevation events in the intervention group compared with that in the control group [odds ratio (OR)=1.30; 95% CI, 0.82-2.07; P=0.27]. The risk of hepatic enzyme elevation events in patients receiving TPO-RAs remained non-significant when analyses were restricted to studies with a treatment duration of ≥6 weeks (OR=1.28; 95% CI: 0.78-2.08; P=0.33), to studies that exclusively enrolled adults (OR=1.24; 95% CI, 0.77-1.99; P=0.37, and to studies reporting severe transaminase elevations defined as ≥3 times the upper limit of that considered normal (OR=1.66; 95% CI, 0.59-4.65; P=0.34). Subgroup analyses also showed no significant increase in hepatic enzyme elevation events with eltrombopag (OR=1.68; 95% CI, 0.93-3.04; P=0.09), avatrombopag (OR=0.88; 95% CI, 0.09-8.46; P=0.91) or hetrombopag (OR=1.04; 95% CI, 0.30-3.65; P=0.95). These findings suggest that non-peptidic TPO-RAs did not significantly increase the incidence of hepatic enzyme elevation events in patients with ITP compared with that in controls and support their continued clinical use with appropriate liver function monitoring. The present meta-analysis was registered in the International Prospective Register of Systematic Reviews (registration no. CRD420251084782).

Abstract licence: CC BY-NC-ND