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risk (HR=0.85; 95% CI 0.03-0.68;
p=0.014), this effect diminished
over time. The risk for relapse
increased by 0.2 percent per day fol-
lowing administration, until about
2.6 years, when the risk of relapse
became equivalent to that in non–
rituximab-treated patients.
“One of the questions in our
field is whether timed retreatment
or maintenance with rituximab
(which is accepted practice in other
hematologic conditions) should be
considered for patients with TTP in
remission,” Dr. Sun noted. “[These
data] potentially provide support for
the idea of maintenance rituximab
dosing within a two- to three-year
timeframe.”
The study’s findings are limited
by its retrospective design, non-
standardized treatment approach,
and potential selection bias.
“Although our data did not directly
address whether patients at higher
risk for relapse derive more benefit
from rituximab, we see this work as
a starting point for risk-stratifying
patients with TTP for the use of
rituximab and other immunomod-
ulatory agents,” Dr. Sun concluded.
“However, before [the risk factors
identified in our study] are used
to guide any treatment decisions,
[they] will need to be evaluated
prospectively in future studies.”
The authors report no relevant
conflicts of interest.
REFERENCE
Sun L, Mack JP, Li A, et al. Predictors of relapse and efficacy
of rituximab in autoimmune thrombotic thrombocytopenic
purpura (TTP): a multi-institutional registry-based
analysis. Abstract #375. Presented at the 2018 ASH
Annual Meeting, December 2, 2018; San Diego, CA.
NOW APPROVED
Effi cacy in treatment-naïve patients (N=29) 1
72%
CR/CRc
rate*
90%
ORR
45%
bridged to stem cell
transplantation
* CRc = clinical complete response; defi ned as complete response with residual skin abnormality not indicative of active disease. 2
CR = complete response; ORR = overall response rate.
Median duration of CR/CRc has not yet been reached in treatment-naïve
patients (range, 1.3-32.2+ months). 1
Median overall survival has not yet been reached; median follow-up 23.0 months
(range, 0.2-41.0+ months). 1
In the pivotal cohort, treatment-naïve patients (N=13) achieved a 54% CR/CRc rate,
77% ORR, and 46% bridged to stem cell transplantation. 1,2
ELZONRIS TM (tagraxofusp-erzs) was evaluated in treatment-naïve and previously-treated patients with BPDCN in
an open-label, multicenter clinical study (N=44). The pivotal cohort consisted of 13 treatment-naïve patients. 1,2
VISIT ELZONRIS.COM/HCP FOR MORE INFORMATION.
Hypersensitivity Reactions ADVERSE REACTIONS:
• ELZONRIS can cause severe hypersensitivity reactions. Grade 3
or higher events were reported in 10% of patients in clinical
trials. Monitor patients for hypersensitivity reactions during
treatment with ELZONRIS. Interrupt ELZONRIS infusion and
provide supportive care as needed if a hypersensitivity
reaction should occur. If the reaction is severe, discontinue
ELZONRIS permanently
Hepatotoxicity
• Elevations in liver enzymes can occur with ELZONRIS.
Grade 3 or higher elevations in liver enzymes occurred
in approximately 40% of patients in clinical trials
• Monitor alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) prior to each infusion with ELZONRIS.
Temporarily withhold ELZONRIS if the transaminases rise to
greater than 5 times the upper limit of normal (ULN) and
resume treatment upon normalization or when resolved The most common adverse reactions in the clinical trials
(incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue,
peripheral edema, pyrexia, and weight increase. The most
common laboratory abnormalities (incidence ≥ 50%) are
decreases in albumin, platelets, hemoglobin, calcium,
sodium, and increases in glucose, ALT, and AST.
Please see Brief Summary of full Prescribing Information,
including Boxed WARNING, on the following pages.
To report SUSPECTED ADVERSE REACTIONS, contact Stemline
Therapeutics, Inc. at 1- 877-332-7961 or contact the FDA at
1- 800-FDA-1088 or www.fda.gov/medwatch.
References: 1. Data on fi le. Stemline Therapeutics, Inc. 2. ELZONRIS [prescribing
information]. New York, NY, US: Stemline Therapeutics, Inc.; December 2018.