The CABLIVI group (72)† reached platelet count normalization* significantly faster than the PEX and immunosuppressive therapy group (73).
time to platelet normalization* with CABLIVI
Compared with PEX and immunosuppressive therapy alone (73), the CABLIVI group (72) demonstrated a significant reduction in a composite endpoint of aTTP-related events (36 [49.3%] vs 9 [12.7%], respectively):
|CABLIVI + PEX + Immunosuppressive Therapy N=72, n (%)†||PEX +
Immunosuppressive Therapy N=73, n (%)
|aTTP-related death||0||3 (4.1%)|
|Recurrence during treatment‡||3 (4.2%)||28 (38.4%)|
|≥1 major thromboembolic event||6 (8.5%)||6 (8.2%)|
|Total||9 (12.7%)||36 (49.3%)|
Four aTTP-related deaths occurred during the trial, including 1 non–treatment-related death in the CABLIVI group during the treatment-free follow-up period and 3 deaths in the placebo group during the treatment period.2
during treatment and through 28 days post-treatment vs PEX and immunosuppressive therapy alone
9 (13%) vs 28 (38%); P<0.001
aTTP=acquired thrombotic thrombocytopenic purpura; HR=hazard ratio; PEX=plasma exchange.
*Platelet count normalization was defined as platelet count ≥150,000/µL with discontinuation of daily PEX 5 days thereafter.2
†71 patients received at least 1 dose of study drug.
‡Thrombocytopenia after initial recovery of platelet count (platelet count ≥150,000/µL) that required reinitiation of daily PEX was considered a recurrence. Recurrences were termed exacerbations if they occurred within 30 days of the last PEX and relapses if they occurred more than 30 days after the last PEX.2
CABLIVI is contraindicated in patients with a previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of its excipients. Hypersensitivity reactions have included urticaria.
The most common adverse reactions (>15% of patients) were epistaxis (29%), headache (21%) and gingival bleeding (16%).
Concomitant use of CABLIVI with any anticoagulant may increase the risk of bleeding. Assess and monitor closely for bleeding with concomitant use.
There are no available data on CABLIVI use in pregnant women to inform a drug associated risk of major birth defects and miscarriage.
CABLIVI (caplacizumab-yhdp) is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.