- 9 poster presentations and 3 abstracts publications
reinforce Galapagos' commitment to immunology and the rheumatoid
arthritis (RA) patient and healthcare
professional community
- New analyses will be presented from long-term extension
studies providing insights into
filgotinib's effectiveness and
safety
- Interim baseline characteristics, effectiveness and
safety outcomes will be published online from the real-world
FILOSOPHY study in RA patients
Mechelen, Belgium; 22 May 2023, 22:01
CET; Galapagos NV (Euronext & NASDAQ: GLPG) will present a
broad range of abstracts, including analysis from randomized
controlled trials (RCTs) and real-world evidence (RWE) studies at
the European League Against Rheumatism (EULAR) annual congress
taking place from 31 May to 3 June 2023 in Milan.
“We are focused on advancing treatment options for chronic,
debilitating immune-mediated diseases such as RA and are excited to
present further analyses on filgotinib’s efficacy and safety
profile at this year’s EULAR congress,” said Daniele D’Ambrosio,
MD, PhD, Therapeutic Area Head, Immunology, at Galapagos. “Our
presence at EULAR underscores our firm commitment to develop
transformational therapies to improve the lives of patients around
the world.”
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. Key presentations
include long-term efficacy and integrated safety data, post hoc
analysis identifying distinct trajectories of treatment responses
in patients with RA receiving filgotinib, the long-term clinical
profile of filgotinib in patients with RA by cardiovascular (CV)
risk factors, and the added value of filgotinib on pain relief in
patients with RA achieving remission in the Phase 3 FINCH 1, 2 and
3 studies (NCT02889796, NCT02873936 and NCT02886728). Additionally,
interim results from 500 patients on baseline characteristics as
well as effectiveness and safety outcomes from the FILOSOPHY
real-world evidence study (NCT04871919), which has now enrolled
over 1000 patients in RA, will be published online.
Furthermore, Galapagos is hosting a symposium: “JAK to
reality: seeking clarity in RA”, which will focus on key
considerations when selecting treatments for RA patients, efficacy
and safety of JAK inhibitors, and the practical use of JAK
inhibitors in the treatment of RA patients. An interactive
meet-the-expert session: “Burning questions: the practical
use of JAK inhibitors in RA”, will feature an expert
faculty sharing insights and answers to audience questions on
recent developments in the RA treatment landscape and the potential
implications for clinical practice. In addition to exhibiting an
interactive booth that attendees can explore at the congress,
Galapagos is also hosting a media roundtable discussion featuring
experts, including a patient representative, discussing the
real-life impact of RA and exploring solutions to overcome and
manage the burden of the disease.
Scientific abstracts include:
Abstract Title |
Authors |
Presentation details |
Integrated safety analysis of filgotinib in patients with moderate
to severe active rheumatoid arthritis with a maximum exposure of
8.3 years |
Kevin Winthrop, Daniel Aletaha, Roberto Caporali, Yoshiya Tanaka,
Tsutomu Takeuchi, Paul Van Hoek, Pieter-Jan Stiers, Vijay
Rajendran, Katrien Van Beneden, Jacques-Eric Gottenberg, Gerd R.
Burmester |
Poster Number: POS0844Date: 01 June 2023, 14:45–15:45 CET
|
Distinct treatment responses in patients with rheumatoid arthritis
receiving filgotinib 200 mg over 12 months: A post hoc analysis of
FINCH 1 |
Peter C. Taylor, Yoshiya Tanaka, Emily Aiello, Thomas Debray, Chris
Watson, Kristina Harris, Gerd Rüdiger Burmester |
Poster Number: POS0843Date: 01 June 2023, 14:45–15:45 CET
|
What trade-offs are acceptable to rheumatoid arthritis patients
during treatment selection? |
Rieke Alten, Juan Carlos Nieto Gonzalez, Peggy Jacques,
Carlomaurizio Montecucco, Robert Moots, Helga Radner, Sebastian
Heidenreich, Chiara Whichello, Nicolas Krucien, Monia Zignani,
Harald Vonkeman, Katrien Van Beneden |
Poster Number: POS0600-HPRDate: 31 May 2023, 15:30–16:30 CET
|
Safety and efficacy of filgotinib: an update from the DARWIN 3
Phase 2 long-term extension with a maximum of 8.2 years of
exposure |
Rene Westhovens, Rieke Alten, Lorenzo Dagna, Arthur Kavanaugh,
Kevin L. Winthrop, Jane Barry, Robin Besuyen, Claudio Corallo, Dick
de Vries, Nicolas Martin, Chris Watson, Mark C. Genovese, Alberto
Spindler, Mykola Stanislavchuk, Maria Greenwald, Paul Emery |
Poster Number: POS0829Date: 01 June 2023, 14:45–15:45 CET
|
Long-term clinical profile of filgotinib (FIL) in patients (pts)
with rheumatoid arthritis (RA) by cardiovascular (CV) risk factors:
a post hoc subgroup analysis |
Maya H Buch, Jose A Gómez-Puerta, Gerd Rüdiger Burmester, Bernard G
Combe, Vijay Rajendran, Pieter-Jan Stiers, Paul Van Hoek, Katrien
Van Beneden, Jacques-Eric Gottenberg, Yoshiya Tanaka, Daniel
Aletaha, René Westhovens, Roberto Caporali |
Poster Number: POS0308Date: 03 June 2023, 10:00–11:30 CET
Poster tour - discussion session: 10:05–10:10 CET |
Real-world experience with filgotinib (FIL) for rheumatoid
arthritis (RA) in Germany: A retrospective chart review |
Olaf Schultz, Christoph Fiehn, Christian Kneitz, Nils Picker,
Daniel Kromer, Monia Zignani, Francesco De Leonardis, Hans-Dieter
Orzechowski, Margot Gurrath, Klaus Krüger |
Poster Number: POS0851Date: 01 June 2023, 14:45–15:45 CET
|
Efficacy of filgotinib (FIL) in patients (pts) with rheumatoid
arthritis (RA): Week (W) 156 results from a long-term extension
(LTE) study |
Maya H Buch, Daniel Aletaha, Roberto Caporali, Bernard G Combe,
Hendrik Schulze-Koops, Jacques-Eric Gottenberg, Yoshiya Tanaka,
Ricardo Blanco, Tsutomu Takeuchi, Edmund V Ekoka Omoruyi,
Katrien Van Beneden, Vijay Rajendran, Chris Watson, Francesco De
Leonardis, Paul Emery |
Poster Number: POS0853Date: 01 June 2023,
14:45–15:45 CET |
Cardiovascular (CV) and malignancy events in the filgotinib (FIL)
rheumatoid arthritis (RA) clinical development program up to 8.3
years |
Xavier Mariette, Sven Borchmann, Sandrine Aspeslagh, Jaime
Calvo-Alén, Richard Moriggl, Zoltan Szekanecz, Francesco De
Leonardis, Nadia Verbruggen, Paul Van Hoek, Marc Schmalzing,
Andreas Stallmach, Christina Charles-Schoeman, Vijay Rajendran,
Christine Rudolph, Chris Watson, Yoshiya Tanaka, Ernest Choy |
Poster Number: POS0824Date: 01 June 2023, 14:45–15:45 CET
|
Interim update on baseline characteristics and effectiveness from a
prospective observational study of patients with rheumatoid
arthritis (RA) treated with filgotinib (FILOSOPHY) |
Roberto Caporali, Jérôme Avouac, Karen Bevers, Gerd Burmester,
Thomas P.A. Debray, Francesco De Leonardis, Kristina Harris, Neil
Betteridge, Susana Romero Yuste, Patrick Verschueren, Monia
Zignani, James Galloway |
Poster Number: POS0466Date: 31 May 2023, 15:30–16:30 CETSession:
Poster viewPoster discussion session: NA |
Safety outcomes in patients (pts) with rheumatoid arthritis (RA)
treated with filgotinib (FIL) in FILOSOPHY: interim results from a
prospective observational study |
Patrick Verschueren, Jérôme Avouac, Karen Bevers, Susana Romero
Yuste, Roberto Caporali, Thomas P.A. Debray, Francesco De
Leonardis, James Galloway, Monia Zignani, Gerd Burmester |
Abstract publication Abstract number:
AB0191 |
Effect of filgotinib on pain in patients with rheumatoid arthritis
in the Phase 3 FINCH 1, 2 and 3 studies |
Peter C. Taylor, Arthur Kavanaugh, Peter Nash, Janet Pope, Georg
Pongratz, Bruno Fautrel, Rieke Alten, Ken Hasegawa, Shangbang Rao,
Dick de Vries, Pieter-Jan Stiers, Chris Watson, Rene
Westhovens |
Abstract publication Abstract number:
AB0290 |
Safety of filgotinib in patients with RA: Laboratory analysis
results from a long-term extension study (encore from ACR
2022) |
Ennio Giulio Favalli, Maya H Buch, James Galloway, Arnaud
Constantin, Patrick Durez, Paul Van Hoek, Christopher Watson,
Pieter-Jan Stiers, Vijay Rajendran, Katrien Van Beneden, Tsutomu
Takeuchi, Bernard Combe |
Abstract publication Abstract number:
AB0454 |
About rheumatoid
arthritis (RA)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 filgotinibFilgotinib is
marketed as Jyseleca® in Europe and Japan for the treatment of
adults with moderate to severe active RA who have responded
inadequately or are intolerant to one or more disease modifying
anti-rheumatic drugs. Filgotinib is also marketed as Jyseleca® in
Europe and Japan for the treatment of adult patients with moderate
to severe active ulcerative colitis (UC) who have had an inadequate
response with, lost response to, or were intolerant to either
conventional therapy or a biologic agent. Jyseleca® 100mg and
200mg are registered in the above-mentioned territories. 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.
Jyseleca® is a trademark of Galapagos NV and Gilead Sciences,
Inc. or its related companies. Except for filgotinib’s approval as
Jyseleca® for the treatment of moderate to severe active RA and UC
by the relevant regulatory authorities in the European Union, Great
Britain, and Japan, our drug candidates are investigational; their
efficacy and safety have not been fully evaluated by any regulatory
authority.
About GalapagosGalapagos is a fully integrated
biotechnology company united around a single purpose: to transform
patient outcomes through life-changing science
and innovation for more years of life and quality of
life. We focus on the key therapeutic areas of immunology and
oncology, where we have developed a deep scientific expertise in
multiple drug modalities, including small molecules and cell
therapies. Our portfolio comprises discovery through to
commercialized programs and our first medicine for rheumatoid
arthritis and ulcerative colitis is available in Europe and Japan.
For additional information, please visit www.glpg.com or
follow us on LinkedIn or Twitter.
Contacts
Media
relations contactMarieke
Vermeersch +32 479 490
603 media@glpg.com |
Investor
relations contact Sofie Van Gijsel +1 781 296
1143Sandra Cauwenberghs +32 495 58 46 63 ir@glpg.com |
Forward-looking statementsThis press release
includes forward-looking statements, all of which involve certain
risks and uncertainties. These statements are often, but not
always, made through the use of words or phrases such as “will,”
“commit,” “potential,” “continue,” “develop,” and “advance,” as
well as any similar expressions. Forward-looking statements
contained in this release include, but are not limited to,
statement regarding preliminary, interim and topline data from our
studies, including, but not limited to, the FILOSOPHY and Phase 3
FINCH 1, 2 and 3 studies, and any other analyses related to our
portfolio, and statements regarding the expected timing, design and
readouts of our ongoing studies and trials, and our plans and
strategy with respect to filgotinib and such studies and trials.
Any forward-looking statements in this release are based on our
management’s current expectations and beliefs, and are not
guarantees of future performance. Forward-looking statements
involve known and unknown risks, uncertainties and other factors
which might cause our actual results, performance or achievements
to be materially different from any historic or future results,
performance or achievements expressed or implied by such
statements. These risks, uncertainties and other factors include,
without limitation, the risk that ongoing and future clinical
studies with filgotinib (including the FILOSOPHY study) may not be
completed in the currently envisaged timelines or at all, the
inherent risks and uncertainties associated with competitive
developments, clinical trials, recruitment of patients, product
development activities and regulatory approval requirements
(including that data from ongoing and planned clinical research
programs, including, without limitation, the data from the ongoing
FILOSOPHY study, may not support the further development of
filgotinib due to safety, efficacy or other reasons and that data
readouts in the future may not reflect interim data results), and
the risk that we will not be able to continue to execute on our
currently contemplated business plan and/or will need to revise our
business plan. A further list of these risks, uncertainties and
other risks can be found in our filings and report with the
Securities and Exchange Commission (SEC), including in our most
recent Annual Report on Form 20-F filed with the SEC, as
supplemented and/or modified by any other filings and reports that
we have made or will make with the SEC in the future. Given these
risks and uncertainties, the reader is advised not to place any
undue reliance on such forward-looking statements. In addition,
even if our results, performance or achievements are consistent
with such forward-looking statements, they may not be predictive of
results, performance or achievements in future periods. These
forward-looking statements speak only as of the date hereof. We
expressly disclaim any obligation to update any such statements in
this release, unless 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 demonstrates commitment to immunology with new data
in rheumatoid arthritis at EULAR 2023
Galapagos (EU:GLPG)
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