- Preliminary results from real-world
FILOSOPHY, FILgotinib Observational Study Of Patient Health-related
outcomes, in the first 200 patients with moderately to severely
active rheumatoid arthritis (RA)
- Data showed that filgotinib induced
rapid relief in pain and fatigue as early as Week 1 as well as
improvements in disease activity1 at Month 1
- 7 additional presentations
encompassing key analyses of filgotinib, including long term,
integrated safety data and safety data in specific subpopulations,
demonstrating Galapagos’ commitment to the RA patient and HCP
community
Mechelen, Belgium; 8
November 2022, 22.01 CET, Galapagos NV
(Euronext & NASDAQ: GLPG) will
present new data
on filgotinib at
the American College of Rheumatology
(ACR)
Convergence 2022
meeting taking place in
Philadelphia, Pennsylvania from
10-14 November
2022.
Dr. Walid Abi-Saab, Chief Medical officer, at
Galapagos said, “We are excited to present data at ACR which
highlights our continued commitment to patients and the healthcare
provider community, in particular initial data from our first
international, real-world arthritis study. We believe that it’s not
only important to control disease activity to prevent long term
irreparable disability, but also to take a comprehensive approach
to the disease by aiming at improving quality of life of patients
and their families. These initial results are encouraging, and we
look forward to seeing further results as the study continues.”
Over the last two decades, disease activity in
rheumatoid arthritis (RA) has improved, yet fatigue and pain
continue to hinder patients’ quality of life (QOL), and ability to
function.2,3 Less than 30% of patients are satisfied with their
pain levels and 40-80% of RA patients are affected by fatigue.4,5
Pain and fatigue have negative impacts on mental and physical QOL,
including social functioning.6
Interim data from the FILOSOPHY study of
patients aged ≥18 years with moderately to severely active RA, who
are prescribed filgotinib for the first time, showed rapid
improvements in pain (VAS scale) and fatigue as early as week 1,
with mean changes from baseline in VAS pain score of -11.9 and
-22.2 at Week 1 and Month 1, respectively, and from baseline in
FACIT-F7 score of 3.7 and 6.8 at Week 1 and Month 1, respectively.1
The FILOSOPHY study also showed improvements in disease activity,
with a mean change from baseline in Clinical Disease Activity Index
(CDAI) score of -13.7 at Month 1.1 The interim results are based on
data from 200 patients enrolled in Germany, the United Kingdom, the
Netherlands, Belgium, and Italy, representing real-world patients
with moderately to severely active RA.1
Other abstracts being presented at ACR
Convergence 2022 include analyses of filgotinib safety, and
clinical outcomes, in adult patients with RA with up to 8.2 years
of exposure to filgotinib, including the most recent integrated
safety data from 7 clinical trials (pooled phase 2 and 3 clinical
data) that looked at the overall RA population as well as at
subgroups of patients with risk factors for cardiovascular events,
and another abstract describing laboratory results from a long-term
Phase 3 extension study. Two encore abstracts will be presented on
the effect of filgotinib on body weight and BMI, and insights from
a post-hoc analysis of filgotinib integrated safety data.
Scientific Abstracts:
Abstract Title |
Authors |
Presentation date/time |
Galapagos-driven original abstracts |
Baseline characteristics of and early outcomes in the first 200
patients with RA treated with filgotinib in a prospective
observational study |
James Galloway, Karen Bevers, Patrick Verschueren, Roberto F.
Caporali, Susana Romero Yuste, Jérôme Avouac, Emilia Gvozdenovic,
Kristina Harris, Monia Zignani, Gerd Burmester |
Poster Number: 0276Date: 12 November 2022, 1:00–3:00 PMSession: RA
– Treatment poster I |
Malignancy events in the filgotinib rheumatoid arthritis and
ulcerative colitis clinical development programs |
Xavier Mariette, Sandrine Aspeslagh, Richard Moriggl, Vijay
Rajendran, Christine Rudolph, Paul Van Hoek, Nadia Verbruggen,
Chris Watson, Sven Borchmann, Andreas Stallmach |
Poster Number: 0277Date: 12 November 2022, 1:00–3:00 PMSession: RA
– Treatment poster I |
Exploratory analysis of filgotinib safety data in patients with
moderately to severely active RA and an increased risk of
cardiovascular events: data from phase 2 and 3 clinical trials |
Maya H. Buch, Gerd R. Burmester, Xavier Mariette, Christina
Charles-Schoeman, Vijay Rajendran, Pieter-Jan Stiers, Agustin
Cerani, Paul Van Hoek, Katrien Van Beneden, Yoshiya Tanaka, Hendrik
Schulze-Koops, René Westhovens, Ennio Giulio Favalli |
Poster Number: 0275Date: 12 November 2022, 1:00–3:00 PMSession: RA
– Treatment poster I |
Safety of filgotinib in patients with RA: Laboratory analysis
results from a long-term extension study |
Maya Buch, James Galloway, Ennio Giulio Favalli, Arnaud Constantin,
Patrick Durez, Paul Van Hoek, Christopher Watson, Pieter-Jan
Stiers, Vijay Rajendran, Katrien Van Beneden, Tsutomu Takeuchi,
Bernard Combe |
Poster Number: 0280Date: 12 November 2022, 1:00–3:00 PMSession: RA
– Treatment poster I |
Clinical outcomes of filgotinib in patients with RA aged ≥65 years:
A post hoc subgroup analysis of phase 2 and 3 clinical trials and
ongoing long-term extensions |
Maya Buch, Bernard Combe, Jose A. Gómez-Puerta, Roberto Caporali,
Jacques-Eric Gottenberg, Paul Van Hoek, Vijay Rajendran, Pieter-Jan
Stiers, Katrien Van Beneden, Daniel Aletaha, Gerd Burmester, René
Westhovens, Yoshiya Tanaka |
Poster Number: 0281Date: 12 November 2022, 1:00–3:00 PMSession: RA
– Treatment poster I |
An update on the integrated safety analysis of filgotinib in
patients with moderately to severely active RA |
Kevin Winthrop, Daniel Aletaha, Roberto F. Caporali, Yoshiya
Tanaka, Tsutomu Takeuchi, Paul Van Hoek, Chris Watson, Pieter-Jan
Stiers, Vijay Rajendran, Katrien Van Beneden, Jacques-Eric
Gottenberg, Gerd R. Burmester |
Poster Number: 0273Date: 12 November 2022, 1:00–3:00 PMSession: RA
– Treatment poster I |
Galapagos-driven encore abstracts |
|
The use of exposure-adjusted event rates versus exposure-adjusted
incidence rates in adverse event reporting: Insights from
filgotinib integrated safety data in RA (EULAR 2022
encore) |
Patrick Durez, Eugen Feist, Ricardo Blanco, Vijay Rajendran, Nadia
Verbruggen, Katrien Van Beneden, James Galloway |
Poster Number: 0278Date: 12 November 2022, 1:00–3:00 PMSession: RA
– Treatment poster I |
Effect of filgotinib on body weight and BMI and effect of baseline
BMI on the efficacy and safety of filgotinib in RA (EULAR 2022
encore) |
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 |
Poster Number: 0279Date: 12 November 2022, 1:00–3:00 PMSession: RA
– Treatment poster I |
About
filgotinibFilgotinib is marketed as Jyseleca in
the European Union (incl. Norway), Great Britain, and Japan for the
treatment of adults with moderately to severely active rheumatoid
arthritis (RA) who have responded inadequately or are intolerant to
one or more disease modifying anti-rheumatic drugs (DMARDs).
Filgotinib is also marketed as Jyseleca in the European Union
(incl. Norway), Great Britain, and Japan for the treatment of adult
patients with moderately to severely 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 (filgotinib) 100mg and 200mg are registered in the
above-mentioned territories. 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.
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 moderately
to severely 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
FILOSOPHYFILOSOPHY (FILgotinib Observational Study
Of Patient Health-related outcomes), is a prospective,
observational, non-interventional cohort Phase 4 study enrolling
approximately 1500 patients aged ≥ 18 years with moderately to
severely active RA across Europe. Data will be collected by the
clinical sites and patients using an electronic case report form
(eCRF) and electronic patient reported outcomes (ePRO) via mobile
devices. Each enrolled patient will be followed for 24 months or
until discontinuation of the study, whichever occurs first.
The primary objective of the study is to
evaluate the treatment persistence rate at 24 months, defined as
the rate of patients continuing to receive filgotinib 24 months
from treatment initiation. Secondary objectives include
effectiveness, evaluation of the effect of filgotinib on patient
reported outcomes (PROs) including on pain, fatigue and work
productivity, and rate of adverse events (AEs) and serious adverse
events (SAEs) as well as adverse events of interest. More
information is available on clinicaltrials.gov, identifier
NCT04871919.
About GalapagosGalapagos is a
fully integrated biotechnology company focused on discovering,
developing, and commercializing innovative medicines. We are
committed to improving patients’ lives worldwide by targeting
diseases with high unmet needs. Our R&D capabilities cover
multiple drug modalities, including small molecules and cell
therapies. Our portfolio comprises discovery through to Phase 4
programs in immunology, oncology and other indications. Our first
medicine for rheumatoid arthritis and ulcerative colitis is
available in the European Union, Norway, Great Britain, and Japan.
For additional information, please visit www.glpg.com or
follow us on LinkedIn or Twitter.
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 603media@glpg.com
Forward Looking Statements
This press release includes forward-looking
statements, all of which involve certain risks and uncertainties.
These statements are often, but are not always, made through the
use of words or phrases such as “may,” “upcoming,” “future,”
“potential,” “will,” and “plan,” as well as similar expressions.
Forward-looking statements contained in this release include, but
are not limited to, statements regarding interim data from the
FILOSOPHY study and other analyses of filgotinib and Galapagos’
plans and strategy with respect to Jyseleca and the FILOSOPHY
study. Of note, the FILOSOPHY study is ongoing and these interim
results may not continue or be confirmed upon completion of the
study. Any forward-looking statements in this release are based on
Galapagos 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 Galapagos’ actual results, performance or
achievements to be materially different from any historic or future
results, performance or achievements expressed or implied by such
forward-looking statements. 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 FILOSOPHY study, the inherent risks and 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, including but not limited to the data from the ongoing
FILOSOPHY study, may not support registration or further
development of filgotinib due to safety, efficacy or
other reasons), the risks related to continued regulatory
review of filgotinib following approval by relevant regulatory
authorities, including EMA’s safety review of JAK inhibitors used
to treat certain inflammatory disorders, the risks
that regulatory authorities may require additional
post-approval trials of filgotinib or any other product candidates
that are approved in the future, 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, and risks related to
the ongoing COVID-19 pandemic, as well as those risks and
uncertainties identified in our most recent Annual Report on Form
20-F filed with the U.S. Securities and Exchange Commission
(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 Galapagos’ 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
of publication of this release. Galapagos expressly disclaims any
obligation to update any such forward-looking statements in this
release unless required by law or regulation.
1 Galloway J, Bevers K, Vershueren P, et al.
Presented at: ACR Convergence 2022; November 10-14, 2022;
Philadelphia, Pennsylvania.2 Nieuwenhuis WP, de Wit MP, Boonen A,
et al. Changes in the clinical presentation of patients with
rheumatoid arthritis from the early 1990s to the years 2010:
earlier identification but more severe patient reported outcomes.
Annals of the Rheumatic Diseases.
2016;75:2054-2056.3 Gossec L, Steinberg G, Rouanet
S, Combe B. Fatigue in rheumatoid arthritis: quantitative findings
on the efficacy of tocilizumab and on factors associated with
fatigue. The French multicentre prospective PEPS Study. Clin Exp
Rheumatol. 2015;33(5):664-70.4 Santos EJF, Duarte
C, da Silva JAP, Ferreira RJO. The impact of fatigue in rheumatoid
arthritis and the challenges of its assessment. Rheumatology
(Oxford). 2019;58(Suppl
5):v3-v9.5 Taylor P, Manger B, Alvaro-Gracia J, et
al. Patient perceptions concerning pain management in the treatment
of rheumatoid arthritis. J Int Med Res.
2010;38(4):1213-24.6 Wysocka-Skurska I,
Sierakowska M, Kułak W. Evaluation of quality of life in chronic,
progressing rheumatic diseases based on the example of
osteoarthritis and rheumatoid arthritis. Clin Interv Aging.
2016;11:1741-1750.
7 The FACIT Fatigue Scale is a short, 13-item
tool that measures an individual’s level of fatigue during their
usual daily activities over the past week.
- Galapagos to present encouraging initial data from FILOSOPHY
real-world arthritis study at ACR Convergence 2022
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