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|Positive Trial Results with Filgotinib in Psoriatic Arthritis and Ankylosing Spondylitis Both Published in The Lancet|
-- Phase 2 EQUATOR Data Demonstrating Efficacy in Psoriatic Arthritis Also Presented in a Plenary Session at 2018 ACR/ARHP Annual Meeting --
“The results of the EQUATOR and TORTUGA studies demonstrate that
filgotinib improved the signs and symptoms of patients with psoriatic
arthritis whose disease had not responded to prior therapies and
independently, for those with ankylosing spondylitis,” said
“We are pleased that filgotinib demonstrates a consistent safety and
efficacy profile across multiple inflammatory conditions, including
psoriatic arthritis and ankylosing spondylitis,” said Dr.
Phase 2 EQUATOR Study in Psoriatic Arthritis [ACR/ARHP Abstract #1821]
Data from EQUATOR, a placebo-controlled trial of 131 adults with
moderately to severely active psoriatic arthritis who had an inadequate
response or were intolerant to at least one conventional
disease-modifying anti-rheumatic drug (cDMARD), demonstrated the
efficacy of filgotinib in this patient population. The study achieved
its primary endpoint at Week 16, with 80 percent of patients on
filgotinib 200mg once-daily achieving ACR20, compared with 33 percent on
placebo (p<0.001). ACR50 and ACR70 responses at Week 16 were also
significantly higher for filgotinib compared with placebo (ACR50: 48
percent for filgotinib vs 15 percent for placebo, p<0.001; ACR70: 23
percent vs 6 percent, p<0.01). These data were previously announced in
The study also found greater improvement in disease signs and symptoms for patients receiving filgotinib 200mg once-daily compared with placebo at Week 16, as measured by Minimal Disease Activity (MDA) (23 percent vs 9 percent, p<0.05) and the Psoriasis Area and Severity Index 75 percent improvement from baseline (PASI75) (45 percent vs 15 percent, p<0.01). The data showed greater improvement from baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) for those receiving filgotinib compared with placebo (-0.57 vs -0.28, p<0.001).
Safety-related outcomes were similar between the filgotinib and placebo arms of the study, including rates of treatment-emergent adverse events (57 percent and 59 percent, respectively) and infections and infestations (22 percent and 21 percent). Two serious treatment-emergent adverse events were reported: one hip fracture in the placebo group and one case of fatal pneumonia in the filgotinib treatment group, which was the only serious infection and the only death in the study. No deep venous thrombosis, pulmonary embolism, malignancies, gastrointestinal perforations, opportunistic infections/active tuberculosis or cases of Herpes zoster were reported.
“Effective treatment for psoriatic arthritis is critical for relieving
pain and inflammation and helping to prevent joint damage.
Unfortunately, not all patients respond to currently available
Phase 2 TORTUGA Study in Ankylosing Spondylitis
In the Phase 2 TORTUGA study, adults with moderately to severely active ankylosing spondylitis who were treated with filgotinib 200mg once-daily achieved significantly greater improvements in AS Disease Activity Score (ASDAS), the primary endpoint, at Week 12. The mean change from baseline in ASDAS was -1.5 for patients treated with filgotinib versus -0.6 for those treated with placebo (p<0.0001). ASAS20 and ASAS40 responses at Week 12 were also significantly higher for filgotinib compared with placebo (ASAS20: 76 percent for filgotinib vs 40 percent for placebo, p<0.0001; ASAS40: 38 percent vs 19 percent, p<0.05).
Adverse events were generally mild or moderate in severity and were reported in an equal proportion of patients in the filgotinib and placebo groups (31 percent). Laboratory changes were consistent with those previously reported for filgotinib, and no new safety signals were observed in the study. There was one treatment-emergent serious adverse event of pneumonia reported for a patient receiving filgotinib who recovered after hospital-based antibiotic treatment. One patient with an inherited risk for thrombosis who was randomized to filgotinib experienced a non-serious deep venous thrombosis after completing the course of study drug. No deaths, malignancies, hepatic events, gastrointestinal perforations, opportunistic infections/active tuberculosis, or cases of Herpes zoster were reported.
Full results of both studies are now available in The Lancet:
Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active psoriatic arthritis (EQUATOR): results from a randomised, placebo-controlled, phase 2 trial: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32483-8/fulltext
Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active ankylosing spondylitis (TORTUGA): results from a randomised, placebo-controlled, phase 2 trial: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32463-2/fulltext
Filgotinib is investigational and not approved anywhere globally. Its efficacy and safety have not been established. For information about the clinical trials with filgotinib: www.clinicaltrials.gov.
About the EQUATOR Trial
Initiated by Galapagos in
The primary objective of EQUATOR was to evaluate the effect of filgotinib compared to placebo on the signs and symptoms of psoriatic arthritis, as assessed by the proportion of patients achieving ACR20 at Week 16. Secondary objectives included the proportion of patients achieving ACR50/70 and MDA as well as the effects of filgotinib on psoriasis, dactylitis (whole finger inflammation) and enthesitis (inflammation of the tendons).
About the TORTUGA Study
TORTUGA was a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study to assess the safety and efficacy of filgotinib in adult patients with moderately to severely active AS. The trial was conducted in Belgium, Bulgaria, Czech Republic, Estonia, Poland, Spain and Ukraine. In total, 116 patients were randomized in a 1:1 ratio to receive filgotinib 200 mg or placebo once daily for 12 weeks.
The primary objective of TORTUGA was to evaluate the effect of filgotinib compared to placebo on the signs and symptoms of AS, as assessed at Week 12 by ASDAS (a standard composite index for assessing the disease, which incorporates five disease activity variables).
About the Galapagos – Gilead Collaboration
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. Filgotinib is being investigated in several clinical trials in inflammatory diseases, including the Phase 3 trials in rheumatoid arthritis FINCH 1, 2 and 3, the EQUATOR Phase 2 program in psoriatic arthritis, the TORTUGA study in ankylosing spondylitis, the DIVERSITY Phase 3 trial in Crohn’s disease (also small bowel and fistulizing Crohn’s disease Phase 2 studies) and the Phase 3 SELECTION trial in ulcerative colitis.
Galapagos Forward-Looking Statement
This release may contain forward-looking statements with respect to
Galapagos, including statements regarding Galapagos' strategic
ambitions, the mechanism of action and potential safety and efficacy of
filgotinib, the anticipated timing of clinical studies with filgotinib
and the progression and results of such studies. Galapagos cautions the
reader that forward-looking statements are not guarantees of future
performance. Forward-looking statements involve known and unknown risks,
uncertainties and other factors which might cause the actual results,
financial condition and liquidity, performance or achievements of
Galapagos, or industry results, to be materially different from any
historic or future results, financial conditions and liquidity,
performance or achievements expressed or implied by such forward-looking
statements. In addition, even if Galapagos' results, performance,
financial condition and liquidity, and the development of the industry
in which it operates are consistent with such forward-looking
statements, they may not be predictive of results or developments in
future periods. Among the factors that may result in differences are 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),
Galapagos' reliance on collaborations with third parties (including its
collaboration partner for filgotinib, Gilead), and estimating the
commercial potential of Galapagos' product candidates. A further list
and description of these risks, uncertainties and other risks can be
found in Galapagos'
Gilead Forward-Looking Statement
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the
possibility of unfavorable results from ongoing and additional clinical
trials involving filgotinib and the possibility that we are unable to
complete one or more of such trials on the currently anticipated
timelines. Further, it is possible that the parties may make a strategic
decision to discontinue development of filgotinib, and as a result,
filgotinib may never be successfully commercialized. All statements
other than statements of historical fact are statements that could be
deemed forward-looking statements. These risks, uncertainties and other
factors could cause actual results to differ materially from those
referred to in the forward-looking statements. The reader is cautioned
not to rely on these forward-looking statements. These and other risks
are described in detail in Gilead’s Quarterly Report on Form 10-Q for
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