Galapagos to showcase commitment to rheumatoid arthritis care at
the upcoming European League Against Rheumatism congress
Celebrating
EULAR’s 75th
anniversary with
focus on a new era of rheumatoid arthritis
care
Mechelen, Belgium; 25
May 2022,
22.01
CET; Galapagos NV (Euronext & Nasdaq:
GLPG) will present 11 abstracts at the European League Against
Rheumatism (EULAR) congress 2022, 01-04 June, taking place in
Copenhagen, Denmark. The broad range of abstracts include
trial data analyses supporting the efficacy and safety
profile of filgotinib and
real-world clinical data
around alignment of prescribing between physicians and rheumatoid
arthritis (RA) patients.
Galapagos is also hosting a hybrid symposium:
“Evolving patient care in RA: Can JAK
inhibitors meet patient and physician expectations for RA
treatment?”, which will include a discussion focused on
aligning physician and patient treatment goals, looking at what is
meant by ‘comprehensive care’ and how to ensure that people living
with RA are part of treatment and care goal setting. A
meet-the-expert session, “Patient-centred care in RA:
cutting through the jargon” will feature insights and
answers to audience questions on putting patients at the heart of
their RA care. Topics will be based on the new era in RA care, with
the availability of JAK inhibitors along with a growing body of
evidence providing a better understanding of the impact of pain and
fatigue, as well as physical symptoms.
A number of abstracts will present trial data
analyses on filgotinib, a once-daily oral preferential JAK-1
inhibitor, for the treatment of moderate to severe active RA. These
include long-term efficacy and safety data, new analyses on the
safety and efficacy of filgotinib in RA patients over the age of
75, and the effect of filgotinib on BMI and body weight.
Additionally, Galapagos will present preclinical data on selective
SIK3 (salt-inducible kinase) inhibition as a novel mode of action
for the treatment of RA.
“The presentations capture our broad range of
research and commitment to the RA community, demonstrating the
importance of patient and clinical insights and highlighting our
position as a science-driven company focusing on patient unmet
needs,” said Walid Abi-Saab, MD, Chief Medical Officer at
Galapagos. “We know that people living with RA continue to face
daily challenges and we learn from their real experiences to inform
our medicine development.”
Title |
Authors |
Time and Date |
Safety of filgotinib in patients with rheumatoid arthritis:
Analysis of lymphocytes in the long-term extension FINCH 4
study |
Jacques Eric Gottenberg, Gerd Burmester, Katrien Van Beneden, Chris
Watson, Ineke Seghers, Vijay Rajendran, Lorenzo Dagna, Maya H
Buch |
On-site & virtual displayPoster Number:
POS0513Date: Wednesday, 1 June 08:00 CEST – Sunday 31 July 2022
23:59 CEST (virtual display; onsite display timings TBC)
|
Effect of filgotinib (FIL) on body weight (BW) and body mass index
(BMI) and effect of baseline BMI on the efficacy and safety of FIL
in rheumatoid arthritis (RA) |
Alejandro Balsa, Siegfried Wassenberg, Anne Tournadre, Hans-Dieter
Orzechowski, Katrien Van Beneden, Vijay Rajendran, Udo Lendl,
Pieter-Jan Stiers, Chris Watson, Roberto Caporali, Patrick
Verschueren |
On-site & virtual displayPoster Number:
POS0518Date: Wednesday, 1 June 08:00 CEST – Sunday 31 July 2022
23:59 CEST (virtual display; onsite display timings TBC) |
Efficacy and safety of filgotinib in patients aged ≥75 years:
a post hoc subgroup analysis of the FINCH 4 long-term extension
(LTE) study |
Daniel Aletaha, René Westhovens, Bernard G Combe, Jacques-Eric
Gottenberg, Maya H Buch, Roberto Caporali, Jose A Gómez-Puerta,
Paul van Hoek, Vijay Rajendran, Pieter-Jan Stiers, Thijs Hendrikx,
Gerd R Burmester, Yoshiya Tanaka |
On-site & virtual displayPoster Number:
POS0676Date: Wednesday, 1 June 08:00 CEST – Sunday 31 July 2022
23:59 CEST (virtual display; onsite display timings TBC) |
The use of exposure-adjusted event rates versus exposure-adjusted
incidence rates in adverse event reporting: insights from
filgotinib integrated safety data in rheumatoid arthritis |
Patrick Durez, Eugen Feist, Ricardo Blanco, Vijay Rajendran, Nadia
Verbruggen, Katrien Van Beneden, James Galloway |
On-site & virtual displayPoster Number:
POS0663Date: Wednesday, 1 June 08:00 CEST – Sunday 31 July 2022
23:59 CEST (virtual display; onsite display timings TBC) |
Physicians’ reasons for prescribing Janus kinase inhibitors (JAKi)
in patients with rheumatoid arthritis (RA), and associated
alignment between physicians and patients in a real-world clinical
setting |
Peter C Taylor, Bruno Fautrel, Yves Piette, Susana Romero Yuste,
Jasper Broen, Martin Welcker, Elizabeth Holdsworth, Monia Zignani,
Katrien Van Beneden, Roberto Caporali, Rieke Alten |
On-site & virtual displayPoster Number:
POS0680Date: Wednesday, 1 June 08:00 CEST – Sunday 31 July 2022
23:59 CEST (virtual display; onsite display timings TBC)
|
Clinical outcomes up to Week 48 of ongoing filgotinib (FIL)
rheumatoid arthritis (RA) long-term extension (LTE) trial of
biologic disease-modifying antirheumatic drug (bDMARD) inadequate
responders (IR) initially on FIL or placebo in a Phase 3 parent
study (PS) |
Maya H. Buch, Tsutomu Takeuchi, Vijay Rajendran, JE Gottenberg,
Alena Pechonkina, YingMeei Tan, Qi Gong, Katrien Van Beneden,
Roberto Caporali |
Abstract publicationAbstract number: AB0394
|
Integrated safety analysis update for filgotinib (FIL) in patients
(pts) with moderately to severely active rheumatoid arthritis (RA)
receiving treatment over a median of 2.2 years (y) |
Kevin Winthrop, Yoshiya Tanaka, Tsutomu Takeuchi, Alan J Kivitz,
Mark C Genovese, Alena Pechonkina, Franziska Matzkies, Beatrix
Bartok, Kun Chen, Deyuan Jiang, Iyabode Tiamiyu, Robin Besuyen,
Sander Strengholt, Gerd R Burmester, Jacques-Eric
Gottenberg |
Poster tour presentation, on-site & virtual
displayPoster Number: POS0235Date: 3 June 2022,
12:10:00-12:18:00 CEST (poster tour)Session: “Rheumatoid
arthritis: JAKi and beyond” |
Clinical outcomes of methotrexate (MTX)-naïve rheumatoid arthritis
(RA) patients (pts) on filgotinib (FIL) long-term extension (LTE)
trial initially on FIL or MTX during the Phase 3 parent study
(PS) |
Daniel Aletaha, Rene Westhovens, Tatsuya Atsumi, YingMeei Tan,
Alena Pechonkina, Qi Gong, Vijay Rajendran, Sander Strengholt, Gerd
Rudiger Burmester |
On-site & virtual displayPoster Number:
POS0678Date: Wednesday, 1 June 08:00 CEST – Sunday 31 July 2022
23:59 CEST (virtual display; onsite display timings TBC) |
Clinical outcomes up to Week (W) 48 in the ongoing filgotinib (FIL)
long-term extension (LTE) trial of rheumatoid arthritis (RA)
patients (pts) with inadequate response (IR) to methotrexate (MTX)
initially treated with FIL or adalimumab (ADA) during the Phase 3
parent study (PS) |
Bernard Combe, Yoshiya Tanaka, Paul Emery, Alena Pechonkina, Albert
Kuo, Qi Gong, Katrien Van Beneden, Vijay Rajendran, Hendrik
Schulze-Koops |
On-site & virtual displayPoster Number:
POS0679Date: Wednesday, 1 June 08:00 CEST – Sunday 31 July 2022
23:59 CEST (virtual display; onsite display timings TBC)
|
Suboptimal management of rheumatoid arthritis in France: a
real-world study based on data from the French National Health Data
System |
Cécile Gaujoux-Viala, Jean-François Bergmann, Mélanie Goguillot,
Asma Melaine, Marie Guerin, Alban E |
On-site & virtual displayPoster Number:
POS0627Date: Wednesday, 1 June 08:00 CEST – Sunday 31 July 2022
23:59 CEST (virtual display; onsite display timings TBC) |
GLPG4399: selective SIK3 inhibition as a novel mode of action for
the treatment of inflammatory arthritic diseases (preclinical) |
GLPG4399: selective SIK3 inhibition as a novel mode of action for
the treatment of inflammatory arthritic diseases (preclinical) |
On-site & virtual displayPoster Number:
POS0442Date: Wednesday, 1 June 08:00 CEST – Sunday 31 July 2022
23:59 CEST (virtual display; onsite display timings TBC) |
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is an autoimmune
inflammatory disease that primarily causes pain, stiffness and
swelling in the joints. RA often follows a painful, progressively
debilitating course, depriving patients of the ability to continue
their daily lives and leading to physical disability. Despite
current treatments, RA continues to pose a substantial burden to
people living with the disease, comprised of the daily health
issues directly related to their RA, such as pain, and the
complications of managing comorbid conditions.1,2,3
About the FINCH 4 LTE
studyFINCH 4 is an ongoing phase 3 open-label LTE study of
filgotinib 200mg and filgotinib 100mg for rheumatoid arthritis (RA)
to evaluate the long-term safety and tolerability of filgotinib in
participants who have completed one of the parent studies of
filgotinib in RA. Eligible patients completed a prior phase 3
randomised double-blind study of filgotinib lasting 52 weeks (FINCH
1 or 3) or 24 weeks (FINCH 2).
About filgotinibFilgotinib is
approved and marketed as Jyseleca (200mg and 100mg tablets) in the
European Union, Great Britain, and Japan for the treatment of
adults with moderate to severe active rheumatoid arthritis (RA) who
have responded inadequately or are intolerant to one or more
disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be
used as monotherapy or in combination with methotrexate (MTX).
Filgotinib is also approved and marketed as Jyseleca (200mg
tablets) in the European Union, Great Britain and Japan for the
treatment of adult patients with moderately to severely active UC
who have had an inadequate response with, lost response to, or were
intolerant to either conventional therapy or a biologic agent.
The European Summary of Product Characteristics
for filgotinib, which includes contraindications and special
warnings and precautions, is available at www.ema.europa.eu. The
Great Britain Summary of Product Characteristics for filgotinib can
be found at www.medicines.org.uk/emc and the Northern Ireland
Summary of Product Characteristics for filgotinib can be found at
www.emcmedicines.com/en-GB/northernireland, respectively. The
interview form from the Japanese Ministry of Health, Labour and
Welfare is available at www.info.pmda.go.jp. A global Phase 3
program with filgotinib is ongoing in Crohn’s Disease. More
information about clinical trials can be accessed at
https://www.clinicaltrials.gov.
Jyseleca® is a trademark of Galapagos NV and
Gilead Sciences, Inc. or its related companies.
About the filgotinib
collaborationGilead and Galapagos NV are collaborative
partners in the global development and commercialization of
filgotinib. Galapagos is responsible for the commercialization of
filgotinib in Europe, while Gilead remains responsible for
filgotinib outside of Europe, including in Japan, where filgotinib
is co-marketed with Eisai.
About
GalapagosGalapagos NV discovers, develops, and
commercializes small molecule medicines with novel modes of action.
Our pipeline comprises discovery through Phase 3 programs in
inflammation, fibrosis, and other indications. Our ambition is to
become a leading global biopharmaceutical company focused on the
discovery, development, and commercialization of innovative
medicines. More information at www.glpg.com.
ContactInvestors:Sofie
Van GijselHead of Investor Relations+1 781 296 1143
Sandra CauwenberghsDirector Investor Relations+32 495 58 46
63ir@glpg.com
Media:Marieke VermeerschHead of Corporate
Communication+32 479 490 603
media@glpg.com
Forward-looking statements
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, that are subject to risks,
uncertainties and other factors that could cause actual results to
differ materially from those referred to in the forward-looking
statements and, therefore, the reader should not place undue
reliance on them. These risks, uncertainties and other factors
include, without limitation, the risk that ongoing and future
clinical studies with filgotinib may not be completed in the
currently envisaged timelines or at all, the inherent risks
associated with clinical trial and product development activities,
including the filgotinib clinical program and the FINCH 4 LTE
study, the inherent uncertainties associated with competitive
developments, clinical trial and product development activities and
regulatory approval requirements (including that data from the
ongoing and planned clinical research programs may not support
registration or further development of filgotinib due to safety,
efficacy or other reasons), the risks that regulatory authorities
will require additional studies, Galapagos' reliance on
collaborations with third parties (including our collaboration
partner for filgotinib, Gilead) and that Galapagos’ estimations
regarding its filgotinib development program and regarding the
commercial potential of filgotinib, may be incorrect, the risk that
Galapagos will not be able to continue to execute on its currently
contemplated business plan and/or will need to revise its business
plan, as well as those risks and uncertainties identified in our
Annual Report on Form 20-F for the year ended 31 December 2021 and
our subsequent filings with the U.S. Securities and Exchange
Commission (SEC). All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. The forward-looking statements contained herein are
based on management’s current expectations and beliefs and speak
only as of the date hereof, and Galapagos makes no commitment to
update any forward-looking statements in this document, unless
specifically required by law or regulation.
1 Taylor PC, Moore A, Vasilescu R, Alvir J,
Tarallo M. A structured literature review of the burden of illness
and unmet needs in patients with rheumatoid arthritis: a current
perspective. Rheumatology International. 2016;36(5):685-95.2 Radner
H, et al. Comorbidity affects all domains of physical function and
quality of life in patients with rheumatoid arthritis Rheumatology
2011 Feb;50(2):381-8. 3 An J, et al. Prevalence of comorbidities
and their associations with health-related quality of life and
healthcare expenditures in patients with rheumatoid arthritis Clin
Rheumatol. 2019; 38(10):2717-2726.
- Galapagos to showcase commitment to rheumatoid arthritis care
at the upcoming European League Against Rheumatism congress
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