From Clinical Trial Efficacy to Real-World Effectiveness First AJOVY® ▼ (fremanezumab) Data from European Real World Evidence Program
08 November 2021 - 8:25PM
Business Wire
FINESSE Study Interim Results presented at
German Society of Neurology (DGN) Congress 2021
- FINESSE is a prospective observational study for fremanezumab
to evaluate effectiveness in chronic and episodic migraine patients
in routine clinical practice
- First interim analysis of the non-interventional study FINESSE1
including 574 pre-treated patients with both chronic (41.6%) and
episodic (58.4%) migraine indicate effectiveness of fremanezumab
(AJOVY®) in German and Austrian real life clinical settings with
response rates in line with the results of
Phase-III-studies2,3,4
- Focusing on the 6-month period after the first dose of
fremanezumab, results indicate a reduction in migraine days,
reduction in migraine and headache-related disability as assessed
by MIDAS and HIT-6 scales respectively, as well as reduced use of
acute migraine medication.
8 November 2021, Teva Germany (GmbH) presented at the DGN
Congress 2021 the first interim analysis results of the FINESSE
study aiming to provide real-world evidence of fremanezumab
treatment outcomes by evaluating effectiveness in routine clinical
practice. 97.6% of patients included in the study had already
received preventive migraine therapies in the 10 years prior to
study entry, including antidepressants, anticonvulsants,
beta-blockers, ca-antagonists, onabotulinumtoxinA as well as other
anti-CGRP mAbs.1
The interim analysis results were shared in a poster
presentation at the congress by Prof. Andreas Straube, from
Ludwig-Maximilians University Munich, Germany, who is the principal
investigator of the study.
The presented FINESSE interim data1 indicate that real-world
response rates are consistent with Phase-III-study results of
fremanezumab.2,3,4 “The results indicate that anti-CGRP mAbs such
as fremanezumab also work outside of randomized clinical trials in
a migraine patient population who has previously experienced
inadequate response to multiple preventive therapies. Real-world
evidence can provide vital insight into treatment effects in more
naturalistic clinical settings, where many patients have multiple
co-morbidities”, said Professor Straube.
The primary endpoint measure was the proportion of patients
reaching ≥ 50% reduction in the monthly average number of
migraine days evaluated during the 6-month period after the
first dose of fremanezumab.
- 48.7% of the patients with 6-month data achieved the primary
endpoint, with a higher percentage in EM (53.2%) than CM patients
(43.0%). Real-world response rates are thus in line with
Phase-III-study results of fremanezumab.
- The mean number of migraine days per month (d/m) decreased from
12.7 (baseline) to 6.2 (month 6).
- From baseline to month 6, the mean MIDAS Score decreased from
74.8 at baseline to 32.8 and the mean HIT-6 Score from 65.9 at
baseline to 56.6
- Acute migraine medication use decreased from 9.6 days/month at
baseline to 4.4 d/m at month 6.
Danilo Lembo, Vice President Teva Medical Affairs EU
commented:
To provide further support in understanding migraine prevention
in clinical practice, we have initiated a comprehensive European
Real World Evidence program with FINESSE and PEARL studies which
are being carried out throughout Europe.
“Today we are excited to see these first interim results from
the FINESSE study which are a strong validation of the data
previously seen with Teva’s migraine preventive treatment.
“Real-world evidence (RWE) studies provide information that is
relevant to patient care and can help clinicians, researchers,
regulators and payers to better understand the drugs and their
impact on patients outcomes.
“Also real-world evidence is complementary to randomized
clinical trial and in recent years it has become increasingly
important to improve clinical practice, amend treatment guidelines
and support access decisions.”
About the Study
- FINESSE is a 49-month (25-month recruitment and 24-month
follow-up) multicenter, two-country (Germany/Austria), prospective
observational study.
- Eligible patients are adults (≥ 18 years) diagnosed with EM or
CM who have been prescribed fremanezumab according to the Summary
of Product Characteristics (SmPC).
- The primary endpoint is the proportion of patients reaching ≥
50% reduction in the monthly average number of migraine days
evaluated during the 6-month period after the first dose of
fremanezumab.
- Relevant secondary effectiveness endpoints include changes from
baseline in: (1) Monthly average number of migraine days; (2)
Disability scores; (3) Days of acute migraine medication use per
month.
- Effectiveness data is evaluated using data from patient diaries
and patient-reported outcome measures (disability scores).
- Recruitment of the FINESSE study is still ongoing.
About AJOVY® (fremanezumab-vfrm) injection
AJOVY is indicated for prophylaxis of migraine in adults who
have at least 4 migraine days per month. AJOVY is available as a
225 mg/1.5 mL single dose injection in a pre-filled syringe or a
pre-filled pen. Two dosing options are available: 225 mg once
monthly administered as one subcutaneous injection (monthly
dosing), or 675 mg every three months (quarterly dosing), which is
administered as three subcutaneous injections.
AJOVY can be administered either by a healthcare professional or
at home by a patient or caregiver. No starting dose is required to
begin treatment.
Information for Europe about AJOVY® can be found
here.
▼ This medicinal product is subject to additional
monitoring. This will allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse events.
Adverse events should be reported. Reporting forms and
information can be found at https://www.hpra.ie.
About Teva
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.
References:
- Straube A et al. Effectiveness of Fremanezumab for Preventive
Treatment in Migraine: The Non-Interventional FINESSE Study. Poster
presented at DGN Congress 2021, November 3-6, 2021
- Dodick DW et al. Effect of Fremanezumab Compared With Placebo
for Prevention of Episodic Migraine. A Randomized Clinical Trial.
JAMA. 2018;319(19):1999–2008. doi:10.1001/jama.2018.4853
- Silberstein SD, et al. Fremanezumab for the preventive
treatment of chronic migraine. N Engl J Med 2017;377:2113–22.
doi:10.1056/NEJMoa1709038
- Ferrari MD et al. Fremanezumab versus placebo for migraine
prevention in patients with documented failure to up to four
migraine preventive medication classes (FOCUS): a randomised,
double-blind, placebo-controlled, phase 3b trial. Lancet.
2019:394(10203):1030–1040. doi:10.1016/S0140-6736(19)31946-4
Safe Harbour Statement:
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,”
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assume no obligation to update or revise any forward-looking
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result of new information, future events or otherwise. You are
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Fiona Cohen, Teva Corporate Communications Europe : +31 6 2008
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