COBRA study subgroups results presented at
the 37th Congress of the European Committee for Treatment
and Research in Multiple Sclerosis (ECTRIMS)
- Non-interventional study analysis found no evidence of
safety concerns with infants of mothers with multiple sclerosis
(MS) who were exposed to glatiramer acetate (GA) treatment during
pregnancy and breastfeeding
- Maternal pregnancy and breastfeeding exposure to GA in this
study did not adversely affect offspring with regard to
hospitalisations and antibiotic treatments, developmental delay, or
growth in the first 18 months of life
Teva Pharmaceuticals Europe BV, a European
affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE:
TEVA) and St. Josef Hospital – Katholisches Klinikum Bochum
(Bochum, Germany), presented today at ECTRIMS congress new analyses
of the COBRA study, a real-world evidence study on the safety of
COPAXONE® (glatiramer acetate or GA) used by mothers with multiple
sclerosis (MS) during pregnancy and breastfeeding.
The new analysis of COBRA study, which currently represents the
largest dataset of child outcomes breastfed by mothers treated with
GA, assessed 99 mothers with MS and their infants. It concluded
that no evidence was found to suggest that infants were adversely
affected by maternal exposure to GA during pregnancy and
breastfeeding with regard to hospitalisations and antibiotic
treatments, developmental delay, or growth in the first 18 months
of life1.
Professor Kerstin Hellwig, Principal Study Investigator,
Department of Neurology, St. Josef Hospital, Ruhr University
Bochum, Germany noted:
“Our new analysis, which included 50 offspring in the GA group
and 50 in a control group (offspring of mothers with MS not treated
with any disease-modifying treatment during pregnancy and
breastfeeding), is an important contribution to the significant
unmet medical need. There is historically limited clinical safety
data for infants who are breastfed by mothers undergoing treatment
for MS including during the pregnancy period. We found no evidence
that GA exposure was associated with developmental delay, body
growth issues or increased hospitalisation and antibiotic use in
group of infants from the GA cohort in comparison with
controls.
“Half of all MS pregnancies are unplanned, so a woman is on
average exposed to disease modifying therapies (DMTs) in the first
30 days of her child’s development until she discovers her
pregnancy and the treatment can be discontinued. While re-staring
DMT during breastfeeding, a mother has concerns whether her
exposure to DMT during pregnancy and breastfeeding may harm her
child. Our new analyses of the COBRA study provide data that
cumulative maternal exposure to GA during pregnancy and
breastfeeding did not adversely affect the babies regarding the
parameters studied within the first 18 months after birth”
The COBRA study used data from the German Multiple Sclerosis and
Pregnancy Registry (DMSKW) from 2011 to 2020. Patients were
eligible for the study if they were diagnosed with relapsing MS
(RMS), gave a live birth, were breastfeeding under GA treatment
(COPAXONE® 20 or 40 mg/mL) or breastfeeding under no DMT
treatment.
Danilo Lembo M.D. VP Medical Europe, Teva Pharmaceuticals
comments: “The onset of multiple sclerosis (MS) occurs in women
between the ages of 20 and 40 years old; therefore, MS affects
women during a key moment in their lives when they’re thinking of
having children. This is one of the reasons why family planning, is
such an important aspect of MS care in women. Our mission at Teva
is to improve the lives of patients, supporting them with important
medicines throughout life’s stages, and during family planning in
particular.”
The data presentation follows extensive ongoing study of
COPAXONE® in a variety of real-world settings that seek to improve
treatment decision making. Modern approaches in the care of women
with MS after child birth nowadays include that physicians inform
them about the benefits of breastfeeding for both the mother with
MS and her offspring; encourage the mother to breastfeed if
possible; and finally support the patient and her decision. ”
References
- A. Ciplea et. Al, Safety analysis of offspring breastfed by
mothers on glatiramer acetate therapy for relapsing multiple
sclerosis; presented at EAN 2021.
- Saneea Almas, Jesse Vance, Teresa Baker, and Thomas Hale,
Management of Multiple Sclerosis in the Breastfeeding Mother,
Multiple Sclerosis International Volume 2016, Article ID 6527458,
http://dx.doi.org/10.1155/2016/6527458
- Pakpoor J, Disanto G, Lacey MV, Hellwig K, Giovannoni G,
Ramagopalan, Breastfeeding and multiple sclerosis relapses: a
meta-analysis. SVJ Neurol. 2012 Oct; 259(10):2246-8.
About the Study
“Real-world safety of Copaxone in Offspring of Breastfeeding and
Treated Relapsing Multiple Sclerosis (RMS) pAtients” (COBRA study)
is a retrospective data analysis using data of the German Multiple
Sclerosis and Pregnancy Registry. In new subgroup analyses, 50
offspring from the glatiramer acetate (GA) cohort (49 pregnancies;
49 women) and 50 from the control (50 pregnancies; 50 women) were
included. Maternal demographics and RMS prognostic factors were
descriptively comparable between cohorts. “Cumulative” maternal
GA-exposure was higher in the GA cohort vs control, because 100% of
offspring’s mothers received GA also at some point during pregnancy
(vs 26%).
Safety outcomes in ≤18 months of postpartum follow up showed
similar results between cohorts, offspring frequency and incidence
of hospitalisations. Annualized number of hospitalisations was 0.22
[95% confidence interval {CI}=0.09–0.35] in the GA cohort vs the
control (0.26 [95% CI=0.12–0.40]). Frequency and incidence of
antibiotic use were similar between cohorts. Growth parameters
(body weight, body length and head circumference) were also
comparable between cohorts at birth as well as at each of the other
five time points studied. Paediatrician check-ups until 12 months
identified 2 offspring with developmental delays; all in the
control cohort (4%, n=50; [95% CI=0.49–13.71]).
About COPAXONE®
COPAXONE® (glatiramer acetate injection) is indicated for the
treatment of patients with relapsing forms of multiple sclerosis.
The most common side effects of COPAXONE® are redness, pain,
swelling, itching, or a lump at the site of injection, flushing,
rash, shortness of breath, and chest pain. A decision must be made
whether to discontinue breast-feeding or to discontinue/abstain
from Copaxone therapy taking into account the benefit of breast
feeding for the child and the benefit of therapy for the woman.
www.CopaxonePrescribingInformation.com. For hardcopy releases,
please see enclosed full prescribing information. The COPAXONE®
brand is approved in more than 50 countries worldwide, including
the United States, Russia, Canada, Mexico, Australia, Israel, and
all European countries.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, which are based on management’s current beliefs and
expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements. You
can identify these forward-looking statements by the use of words
such as “should,” “expect,” “anticipate,” “estimate,” “target,”
“may,” “project,” “guidance,” “intend,” “plan,” “believe” and other
words and terms of similar meaning and expression in connection
with any discussion of future operating or financial
performance.
Important factors that could cause or contribute to such
differences include risks relating to the commercial success of
COPAXONE®; our ability to successfully compete in the marketplace,
including our ability to develop and commercialize
biopharmaceutical products, competition for our specialty products,
including AUSTEDO®, AJOVY® and COPAXONE®; our ability to achieve
expected results from investments in our product pipeline, our
ability to develop and commercialize additional pharmaceutical
products, and the effectiveness of our patents and other measures
to protect our intellectual property rights; our substantial
indebtedness; our business and operations in general, including
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version on businesswire.com: https://www.businesswire.com/news/home/20211012006208/en/
Media Enquiries Fiona Cohen, Teva Europe + 31 6 2008 2545
Fiona.cohen@tevaeu.com
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