Novartis drug Revolade® shows long-term disease control for chronic/persistent immune thrombocytopenia (ITP)
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Novartis International AG /
Novartis drug Revolade® shows long-term disease control for chronic/persistent
immune thrombocytopenia (ITP)
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* Nearly 70% of patients maintained platelet counts of >=30×10(9)/L without
rescue therapy for prolonged periods, reducing the overall risk of bleeding
* More than one-third of patients permanently stopped one or more concomitant
ITP medications (including corticosteroids, danazol, azathioprine)
* Study establishes long-term safety profile for and demonstrates treatment
benefit with Revolade
Basel, October 18, 2017 - Novartis today announced long-term study results
supporting the positive safety and efficacy of Revolade (eltrombopag) in adults
with chronic/persistent (enrolling patients that were 6 or more months from
diagnosis) immune (idiopathic) thrombocytopenia (ITP) were published online in
Blood. The EXTEND study found that a majority of patients maintained a
substantial clinical response and many no longer needed concomitant ITP
medications. The research evaluated patients for up to 8 years of continuous
treatment (median exposure of 2.4 years)[1],[2].
ITP is a rare and potentially serious blood disorder where the blood doesn't
clot as it should due to a low number of platelets. As a result, patients with
ITP experience bruising, bleeding and, in rare cases, serious hemorrhaging that
can be fatal[3]. The goal of treatment in chronic/persistent ITP is to maintain
a safe platelet count that reduces the risk of bleeding[1],[3].
"The EXTEND data published in Blood validate Revolade as an important oral
treatment option that, by often increasing platelet counts, significantly
decreased bleeding rates and reduced the need for concurrent therapies in
certain patients with chronic/persistent immune thrombocytopenia," said lead
author James Bussel, M.D., professor emeritus of pediatrics at Weill Cornell
Medicine. "With this information, physicians can better optimize long-term
disease management for appropriate patients living with this chronic disease."
The efficacy results of EXTEND demonstrated that median platelet counts were
elevated to >=50×10(9)/L within two weeks of Revolade treatment, with median
platelet counts >50×10(9)/L maintained for more than four years. Post-baseline,
overall bleeding rates declined and the majority of bleeding that occurred
during the study was Grade 1 or 2 according to the World Health Organization
bleeding scale. Some patients (39%) were capable of reducing or permanently
stopping one or more concomitant ITP medications without the need for rescue
therapy, many of which sustained reduction for at least 24 weeks[1],[2],[4].
"We conducted this trial, the largest of its kind in adult patients, to ensure
that clinicians have comprehensive data on hand as they work with their ITP
patients to make treatment decisions," said Vas Narasimhan, M.D., Global Head
Drug Development and Chief Medical Officer, Novartis. "The EXTEND results
reinforce Revolade as a trusted treatment option that can be used over the long-
term for those living with this chronic and rare disease."
Overall, the safety profile of Revolade was consistent with previous studies.
The most common adverse events were headache (28%), nasopharyngitis (25%) and
upper respiratory tract infection (23%). During treatment on EXTEND, 6% of
patients experienced thromboembolic events[1],[2],[4].
About the EXTEND Clinical Trial
EXTEND, an open-label extension study of four trials (TRA100773A, TRA100773B,
TRA102537/RAISE and TRA108057/REPEAT) of Revolade, enrolled 302 adults with
chronic/persistent ITP (6 or more months from diagnosis) who had received prior
therapy for their ITP, and is the largest study of its kind. To qualify for the
prior trials, patients must have had thrombocytopenia for at least 6 months
(chronic ITP was previously defined as thrombocytopenia for 6 or more
months).The objectives were to assess the safety and efficacy of long-term
treatment with Revolade, including the proportion of patients achieving stable
platelet counts during treatment with Revolade; maximum duration of platelet
count elevation >=50×10(9)/L or >=30×10(9)/L during treatment with Revolade, and
the effect of Revolade on reducing and/or sparing concomitant ITP therapies,
while maintaining a platelet count >=50×10(9)/L[1],[2].
The study allowed each patient to achieve an individualized dose and schedule of
eltrombopag based upon their platelet counts in the desired range between 50 to
200 Gi/L. Therefore, patients who were enrolled in EXTEND must have completed
the treatment and follow-up periods as defined in previous protocol and must
have not experienced eltrombopag-related toxicity or other drug intolerance on
prior eltrombopag study even if resolved. In addition, patients who discontinued
from a previous study due to toxicity were not eligible unless they received
placebo[1],[2].
Revolade was started at a dose of 50 mg/day and titrated to 25-75 mg/day or less
often based on platelet counts. Maintenance dosing continued after minimization
of concomitant ITP medication and optimization of Revolade dosing. The overall
median duration of exposure was 2.37 years (range, 2 days to 8.76 years) and
mean average daily dose was 50.2 (range, 1-75) mg/day[1],[2]. One hundred thirty
five adult patients (45%) completed the study and 75 adult patients (25%) were
treated for four or more years. Most patients were aged <65 years, female, and
had platelet counts <30×10(9)/L at baseline. About one-third were using
concomitant medications at baseline, and 53% had received three or more prior
ITP therapies[1],[2]. In addition, 91% (276/302) of patients achieved platelet
counts >=30×10(9)/L without rescue treatment, and 86% (259/302) achieved
platelet counts >=50×10(9)/L without rescue treatment[1],[2],[4].
Grade 3 and 4 adverse events (AEs) occurred in 26% and 6% of patients,
respectively. Grade 3 cataracts occurred in four (1%) patients and Grade 3 pain
in extremity in six (2%) patients. Grade 3 AEs occurring in three (<1%) patients
each included diarrhea, headache, migraine, dyspnea, decreased platelet count,
and menorrhagia; those occurring in five (2%) patients each included pneumonia,
fatigue, back pain, increased alanine aminotransferase, increased aspartate
aminotransferase, anemia, and hypertension. Grade 4 anemia and thrombocytopenia
occurred in three (<1%) and four (1%) patients, respectively. All other Grade 4
events occurred in one patient each[1],[2].
About Chronic/Persistent ITP
Chronic/persistent ITP is a rare and potentially serious blood disorder that is
characterized by the improper functioning or destruction of platelets, which are
blood cells that allow the blood to clot properly[3]. People who have ITP often
have purple bruises or tiny red or purple dots on the skin[3]. They also display
symptoms such as nosebleeds, bleeding from the gums during dental work, or other
bleeding that is hard to stop[3]. The potential for drops in platelet counts may
also cause emotional distress and may result in a hindered ability to do work or
embarrassment due to visible symptoms[5].
ITP is classified by duration from diagnosis into: acute (0-3 months),
persistent (3-12 months duration) and chronic (>12 months duration).
Chronic/persistent ITP is more likely to occur in adults, and women are affected
two to three times more often than men[3].
The goal of treatment in chronic/persistent ITP is to maintain a safe platelet
count that reduces the risk of bleeding. Treatment is determined by the severity
of the symptoms. In most cases, drugs that alter the immune system's attack on
the platelets are prescribed to help manage bleeding and bruising in adults.
About Eltrombopag
Eltrombopag, marketed as Promacta(®) in the United States and Revolade(®) in
countries outside the US, is approved in more than 100 countries worldwide for
the treatment of thrombocytopenia in adult patients with chronic immune
(idiopathic) thrombocytopenic purpura (ITP) who have had an inadequate response
or are intolerant to other treatments, approved in over 45 countries worldwide
for the treatment of patients with severe aplastic anemia (SAA) who are
refractory to other treatments, and also approved in more than 50 countries for
the treatment of thrombocytopenia in patients with chronic hepatitis C to allow
them to initiate and maintain interferon-based therapy. Eltrombopag is approved
in the US and in the European Union for the treatment of thrombocytopenia in
pediatric patients 1 year and older with chronic immune (idiopathic)
thrombocytopenia (ITP) who have had an insufficient response to corticosteroids
and immunoglobulins.
Important Safety Information for Revolade(®) (eltrombopag)
Revolade may cause serious side effects, such as liver problems, high platelet
counts and a higher chance for blood clots, bleeding after stopping treatment,
and bone marrow problems.
Revolade may damage the liver and cause serious, even life threatening, illness.
Blood tests to check the liver are needed before taking Revolade and during
treatment. When certain antiviral treatments are given together with Revolade
for the treatment of thrombocytopenia due to hepatitis C virus (HCV) infections,
some liver problems can get worse.
A doctor will order the blood tests and any other tests required. In some cases,
Revolade treatment may need to be stopped. Patients should tell a doctor right
away if they have any of these signs and symptoms of liver problems: yellowing
of the skin or the whites of the eyes (jaundice), unusual darkening of the
urine, unusual tiredness, or right upper stomach area pain.
Patients have a higher chance of getting a blood clot if their platelet count is
too high during treatment with Revolade, but blood clots can occur with normal
or even low platelet counts. Patients who have cirrhosis of the liver are at
risk of a blood clot in a blood vessel that feeds the liver. Patients may have
severe complications from some forms of blood clots, such as clots that travel
to the lungs or that cause heart attacks or strokes. A doctor will check the
patient's blood platelet counts, and change the dose or stop Revolade if
platelet counts get too high. Patients should tell their doctor right away if
they have signs and symptoms of a blood clot in the leg, such as swelling or
pain/tenderness of one leg.
When patients with chronic ITP stop taking Revolade, their blood platelet count
will drop back down to what it was before they started taking Revolade. These
effects are most likely to happen within 4 weeks after patients stop taking
Revolade. The lower platelet counts may increase risk of bleeding. A doctor will
check platelet counts for at least 4 weeks after patients stop taking Revolade.
Patients should tell their doctor or pharmacist if they have any bruising or
bleeding after they stop taking Revolade.
Patients being treated for the disease may have problems with their bone marrow.
Medicines like Revolade could make this problem worse. Signs of bone marrow
changes may show up as abnormal results in blood tests. A doctor may also carry
out tests to directly check the bone marrow during treatment with Revolade.
The most common side effects of Revolade when used to treat adult patients with
chronic ITP include headache, anemia, decreased appetite, insomnia, cough,
nausea, diarrhea, alopecia, pruritus, myalgia, pyrexia, fatigue, influenza-like
illness, asthenia, chills and peripheral edema.
The most common side effects of Revolade when used to treat pediatric patients
with chronic ITP include upper respiratory tract infection, nasopharyngitis,
cough, diarrhea, pyrexia, rhinitis, abdominal pain, oropharyngeal pain,
toothache, rash, increased AST and rhinorrhea.
The most common side effects of Revolade when used to treat patients with
chronic HCV and antiviral agents include headache, anemia, decreased appetite,
insomnia, cough, nausea, diarrhea, alopecia, pruritus, myalgia, pyrexia,
fatigue, influenza-like illness, asthenia, chills and peripheral edema.
The most common side effects of Revolade when used to treat patients with severe
aplastic anemia (SAA) include headache, dizziness, insomnia, cough, dyspnea,
oropharyngeal pain, rhinorrhea, nausea, diarrhea, abdominal pain, transaminases
increased, ecchymosis, arthralgia, muscle spasms, pain in extremities, fatigue,
febrile neutropenia, and pyrexia. Common side effects that may show up in blood
tests include increase in some liver enzymes and laboratory tests that may show
abnormal changes to the cells in the bone marrow.
Please see full EU Summary of Product Characteristics for Revolade
(eltrombopag).
Disclaimer
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About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has
leading positions globally in each of these areas. In 2016, the Group achieved
net sales of USD 48.5 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
119,000 full-time-equivalent associates. Novartis products are sold in
approximately 155 countries around the world. For more information, please visit
http://www.novartis.com.
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James Bussel, M.D. has received research support payments for his service on an
advisory board as well as participated in speakers' bureaus sponsored by
Novartis Pharmaceuticals.
References
[1] Wong R, et al. Safety and efficacy of long-term treatment of
chronic/persistent ITP with eltrombopag: final results of the EXTEND study.
Blood. October 2017; Online First Edition
[2] Bussel J, et al. Final Safety and Efficacy Results from the EXTEND Study:
Treatment with Eltrombopag (EPAG) in Adults with Chronic Immune Thrombocytopenia
(cITP). 2016 Congress of the European Hematology Association (EHA). Copenhagen,
Denmark.
[3] Immune Thrombocytopenia. US National Institutes of Health website
http://www.nhlbi.nih.gov/book/export/html/4917. Accessed October 16, 2017.
[4] Novartis Data on File.
[5] Mathias S, et al. "Impact of Chronic Immune Thrombocytopenic Purpura (ITP)
on health-related quality of life: a conceptual model starting with the patient
perspective." Health and quality of life outcomes 6.1(2008):1.
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Datum: 18.10.2017 - 07:15 Uhr
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