EAST HANOVER, N.J.,
Oct. 9, 2018 /PRNewswire/
-- Results from a post hoc analysis of the Phase II
SUSTAIN study of crizanlizumab, a humanized anti-P-selectin
monoclonal antibody being investigated for the treatment of sickle
cell disease (SCD), have been published in the American Journal
of Hematology. The analysis showed that more patients treated
with crizanlizumab did not experience a vaso-occlusive crisis (VOC)
vs those treated with placebo (35.8% vs 16.9%), specifically
patients with a history of 2-10 VOCs in the previous year.
VOCs are a painful complication of SCD and the main reason why
patients seek medical care in hospitals1,2. VOCs, which
are triggered by multi-cell adhesion, are associated with increased
morbidity and mortality, and can result in stroke, as well as organ
damage or failure3,4. Currently, treatment options for
VOCs are limited5.
"The unpredictable, intense painful crises that patients with
sickle cell disease experience are the hallmark of the disease and
the primary cause of hospitalizations in this patient population,"
said Abdullah Kutlar, MD, Director,
Sickle Cell Center at the Medical College of
Georgia, Augusta
University, Augusta, Georgia, and
primary author of the SUSTAIN analysis. "I am encouraged that
results from this post hoc analysis of SUSTAIN study data found
that crizanlizumab could substantially delay or prevent these
crises, which also may mean less organ damage in the long
run."
The post hoc analysis reviewed 52-week results from 132
patients, including 67 treated with crizanlizumab 5 mg/kg and 65
who received placebo. All evaluated patients had a history of at
least 2 VOCs in the year prior to the study, with 62.9% (n=83)
having experienced 2-4 events and 37.1% (n=49) with 5-10 events.
The most common genotype in SCD, homozygous hemoglobin S (HbSS),
was identified in most SUSTAIN patients (n=94; 71.2%), and patients
with this genotype were evenly distributed between study arms.
The analysis found that treatment with crizanlizumab may prevent
VOCs, both in patients who had 2-4 and 5-10 disease-related pain
events in the year prior to the study, as well as those with
HbSS.
Of the subgroups evaluated, a considerable number of patients
across multiple subgroups treated with crizanlizumab did not
experience a VOC compared with those treated with placebo,
including:
- Those with 2-4 events in the year prior to participating in the
study (17 out of 42 patients or 40.5% vs 10 out of 41 patients, or
24.4%)
- Those with 5-10 events in the year prior to participating in
the study (7 out of 25 patients or 28.0% vs 1 out of 24 patients,
or 4.2%)
- Those with the HbSS genotype (15 out of 47 patients or 31.9% vs
8 out of 47 patients, or 17.0%)
- Those also with concomitant use of hydroxyurea (14 out of 42
patients 33.3% vs 7 out of 40 patients, or 17.5%)
No new safety concerns emerged in the post hoc analysis as
adverse events attributed to treatment were similar between the
crizanlizumab and placebo arms across all subgroups.
"The insights gained from this analysis and others from the
SUSTAIN study, strengthen our belief that crizanlizumab may become
an important new therapeutic option for sickle cell patients who
continue to need step changes in medical innovation," said
Samit Hirawat, MD, Head, Novartis
Oncology Global Drug Development. "This is another example of what
we mean when we say we are reimagining medicine."
About the SUSTAIN trial
The Phase II SUSTAIN trial
was a multicenter, multinational, randomized, placebo-controlled,
double-blind,12-month study to assess safety and efficacy of the
anti-P-selectin antibody crizanlizumab with or without concomitant
use of hydroxyurea therapy in sickle cell disease patients with
sickle cell-related pain crises. Primary results were published in
The New England Journal of Medicine and showed that
crizanlizumab reduced the median annual rate of sickle cell pain
crises (SCPCs) by 45.3% compared to placebo (1.63 vs 2.98, p=0.010)
in patients with or without hydroxyurea therapy6.
Adverse events that occurred in 10% or more of the patients in
either active-treatment group (2.5 mg/kg; 5 mg/kg) and at a
frequency that was at least twice as high as that in the placebo
group were arthralgia, diarrhea, pruritus, vomiting, and chest
pain. There were no apparent increases in infections with
crizanlizumab treatment6.
About crizanlizumab (SEG101)
Crizanlizumab
(SEG101) is a humanized anti-P-selectin monoclonal
antibody being investigated for the prevention of
vaso-occlusive crises (VOCs) in patients with sickle cell
disease (SCD)6. Crizanlizumab binds a molecule called
P-selectin on the surface of endothelial cells and platelets in the
blood vessels, causing a blockade of P-selectin6.
P-selectin is one of the major drivers of the vaso-occlusive
process6. Results from the Phase II SUSTAIN study
demonstrated that crizanlizumab reduced the median annual rate
of VOCs that lead to a healthcare visit compared to placebo in
patients with SCD regardless of whether or not they were taking
hydroxyurea6.
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About Novartis
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References
- Puri L, Nottage KA, Hankins JS, et al. State of the art
management of acute vaso-occlusive pain in sickle cell disease.
Paediatr Drugs. 2018;(1)20:29-42.
- Gutsaeva D, Parkerson J, Yerigenahally S, et al. Inhibition of
cell adhesion by anti–P-selectin aptamer: a new potential
therapeutic agent for sickle cell disease. Blood.
2011;117(2):727-735.
- Ballas SK, Gupta K, Adams-Graves P. Sickle cell pain: a
critical reappraisal. Blood. 2012:120(18):3647-3656
- Piel F, Steinberg M, Rees D.
Sickle cell disease. N Engl J Med.
2017;376(16):1561-1573.
- Ballas SK, Lusardi M. Hospital readmission for acute adult
sickle cell painful episodes: frequency, etiology, and prognostic
significance. Am J Hematol. 2005;79(1):17-25.
- Ataga KI, Kutlar A, Kanter J et al. Crizanlizumab for the
Prevention of Pain Crises in Sickle Cell Disease. N Engl J
Med. 2017 Feb
2;376(5):429-439.
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