On this episode, Pip and Rich VAY-HIT2, a trial recently published in the New England Journal of Medicine. This study randomised patients with relapsed/refractory ITP after first line corticosteroids to eltrombopag + ianalumab or placebo.
As the thrombopoietin receptor agonists such as eltrombopag are often given for extensive periods, there's a lot of interest in giving additional treatment that can result in a relatively short course of treatment. Ianalumab is an anti-B-Cell Activating Factor (BAFF) Receptor monoclonal antibody.
VAY-HIT2 was a phase 3, randomised, double-blind trial, assigning, in a 1:1:1 ratio, adults with primary ITP and an insufficient response or a relapse after first-line glucocorticoid therapy to receive eltrombopag + ianalumab at a dose of 9 mg or 3 mg per kilogram of body weight or placebo once monthly for 4 months.
The trial did meet its primary endpoint but there's a lot to discuss, most importantly the quality of life end points - and the interpretation is not straight forward!
Conflict of interest disclosure here: Pip has received travel expenses and payment for attending an advisory board for Novartis. Pip is also leading a Novartis-sponsored UK audit of the treatment of warm autoimmune haemolytic anaemia on behalf of HaemSTAR (www.haemstar.org/TRUTH).
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