- Nine presentations demonstrate Galapagos’ commitment to inflammation and the ulcerative colitis (UC) community
- Four new analyses from Phase 3 SELECTION and SELECTION long term extension studies of Jyseleca® (filgotinib) provide additional insights into the management of ulcerative colitis (UC)
- Initial results from European real-world survey investigating the disease burden, including residual disease symptoms and quality of life
“At Galapagos, we believe taking a holistic approach to the management of ulcerative colitis is incredibly important and can make a real difference for people living with this disease,” said Dr.
The new analyses provide further evidence of the efficacy and safety profile of filgotinib 200mg, when used in appropriate patients for the treatment of UC:
- Holistic assessment of disease and reporting of subjective measures alongside objective measures can be equally important in setting treatment goals to improve outcomes in UC. In this novel post-hoc analysis of the SELECTION program a combined composite endpoint, including clinical, biological, health related quality of life (HRQoL) remission and endoscopic improvements was assessed for patients treated with filgotinib (100mg and 200mg) versus placebo.
- In the SELECTION study, filgotinib 200mg was well tolerated and efficacious at inducing and maintaining clinical remission versus placebo in patients with ulcerative colitis1. This interim analysis of SELECTION LTE assesses the efficacy and safety outcomes of long-term treatment with filgotinib 200mg, up to 96 weeks.
- Long-term treatment regimens in UC can present challenges for patients who may need to interrupt therapy for various reasons2. A post-hoc analysis of the SELECTION and SELECTION LTE studies was undertaken to evaluate the efficacy and safety of re-treatment with filgotinib, following treatment interruption.
- There is a clinical need to understand the impact of treatment in elderly patients, where there is a growing prevalence of inflammatory bowel disease (IBD)3. This post-hoc analysis of data from the SELECTION program evaluates the efficacy and safety of filgotinib, stratified by age.
In addition to the clinical data, Galapagos will present initial results from a European real-world survey investigating the disease burden, including residual disease symptoms and quality of life impairment in moderate to severe UC patients in remission and not in remission.
Oral and poster presentations
Abstract Title | Authors | Presentation Date/Time |
Exploring disease control by combining clinical, biological, and health-related quality of life remission with endoscopic improvements among Ulcerative Colitis patients treated with filgotinib: A post-hoc analysis from the SELECTION trial | Oral presentation: OP07 Date: Session: Navigating the Oceans of IBD - Scientific Session 3: Aiming high with treatment goals in IBD: The modern Icarus? Session time: 16:00 – Presentation time: 16:40 – | |
Efficacy and safety of filgotinib in patients with Ulcerative Colitis stratified by age: Post hoc analysis of the phase 2b/3 SELECTION and SELECTION LTE studies | Digital Oral presentation: DOP37 Date: Session: DOP Session 5: The Southern: Small molecules in IBD Session time: 17:30 – Presentation time: 17:30 – | |
Re-treatment with filgotinib in patients with Ulcerative Colitis following treatment interruption: Analysis of the SELECTION and SELECTION LTE studies | Poster: P517 Date: Session: Guided poster session Poster discussion session: 12:30 – | |
Efficacy and safety outcomes of long-term treatment with filgotinib 200 mg among patients with Ulcerative Colitis: An interim analysis of SELECTIONLTE | Poster: P491 Date: Session: Guided poster session Poster discussion session: 12:30 – | |
Rates of clinical remission among patients with Ulcerative Colitis from real-world clinical practice settings from | Poster: P506 Date: Session: Guided poster session Poster discussion session: 12:30 – | |
Indicators for inadequate response among patients with Ulcerative Colitis treated with advanced therapies in German clinical practice | Poster: P598 Date: Session: Guided poster session Poster discussion session: 12:30 – | |
Indicators for inadequate response to advanced therapy in patients with Ulcerative Colitis: results from a medical chart review in the | Poster: P389 Date: Session: Guided poster session Poster discussion session: 12:30 – | |
Insights from patients with Ulcerative Colitis on disease burden: Findings from a real-world survey in | Poster: P293 Date: Session: Guided poster session Poster discussion session: 12:30 – |
About Ulcerative Colitis
Ulcerative colitis (UC) is a debilitating inflammatory bowel disease (IBD) that occurs as a result of an abnormal immune system response. Across
About the SELECTION Phase 3 Trial
The SELECTION Phase 3 trial is a multi-center, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of the preferential JAK1 inhibitor filgotinib in adult patients with moderately to severely active UC1. The SELECTION trial comprises two induction trials and a maintenance trial. The Induction Study A enrolled biologic-naïve patients, and the Induction Study B enrolled biologic-experienced patients.
The primary objectives of SELECTION were to evaluate the efficacy of filgotinib compared with placebo in establishing clinical remission as determined by the Mayo endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and ≥ 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 at Week 10 in the induction studies and Week 58 in the maintenance study. Eligible patients who were enrolled in the SELECTION trial were enrolled in the ongoing SELECTION long-term extension trial to evaluate the long-term safety of filgotinib in patients with UC. A majority of patients included in the SELECTION trial (n=1348) had a Mayo Clinic Score (MCS) score of 9 or higher at baseline, and 43% of biologic experienced patients (n=297/689) had insufficient response to a TNF antagonist and vedoluzimab as well.
About filgotinib
Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the
Jyseleca® is a trademark of
About the filgotinib collaboration
About Galapagos
1. Feagan BF et al.
2. Rubin DT. Gastroenterol Hepatol (2019); 15 :612-5
3. Zammarchi et al. BMG Gastroneterol (2020); 20 :147
4. Burisch J. et al. Journal of Crohn’s and Colitis (2013); 7:322-337
Contact
Investors:
Senior Director Investor Relations
+1 781 296 1143
Director Investor Relations
+32 495 58 46 63
ir@glpg.com
Media:
Senior Director Therapeutic Areas Communications
+44 7717 801900
Head of Corporate Communication
+32 479 490 603
communications@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 inherent risks associated with clinical trial and product development activities, including the filgotinib clinical program and the SELECTION Phase 3 trial, 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 or efficacy concerns or other reasons), the timing or likelihood of regulatory authorities approval of marketing authorization for filgotinib for other indications, such regulatory authorities requiring additional studies, 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, Galapagos' reliance on collaborations with third parties (including our collaboration partner for filgotinib, Gilead) and that Galapagos’ estimations regarding its filgotinib development program, regarding the commercial potential of filgotinib and regarding the out roll in Europe may be incorrect and, the uncertainties relating to the impact of the COVID-19 pandemic on our strategy, business plans and focus, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended
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