JYSELECA demonstrated rapid symptomatic improvement, clinical response and sustained clinical remission1,2
†p<0.05; ††p<0.01; †††p<0.001 JYSELECA vs. placebo (nominal p values, post hoc analysis).
In Biologic-Naïve patients, a stool frequency subscore of ≤1 was achieved as early as Day 3 and a rectal bleeding subscore of 0 was observed as early as Day 6 with JYSELECA 200 mg (nominal p<0.05 vs. placebo, post hoc analysis)2
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384. 2. Danese S, Ferrante M, Feagan BG, et al. Am J Gastroenterol 2022;118:138–147.
*p<0.05 JYSELECA vs. placebo.
††p<0.01; †††p<0.001 JYSELECA vs. placebo (nominal p values, not controlled for multiplicity).
In Biologic-Naïve patients, JYSELECA 200 mg demonstrated significantly higher rates of clinical response (nominal p<0.001), endoscopic response (nominal p<0.01) and clinical remission (p<0.05) vs. placebo at Week 101
Clinical response was defined as a Mayo Clinic Score reduction of ≥3 AND ≥30% from baseline, with a decrease in rectal bleeding subscore ≥1 OR absolute rectal bleeding subscore of 0 or 1.1 Clinical response was an exploratory endpoint.
Endoscopic response (improvement) was defined as an endoscopic subscore ≤1.1 Endoscopic response was an exploratory endpoint.
Clinical Remission was defined as an endoscopic subscore ≤1 (centrally read), a rectal bleeding subscore of 0, and a ≥1-point decrease in stool frequency subscore from baseline to achieve a subscore of 0 or 1.1
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384. 2. Danese S, Ferrante M, Feagan BG, et al. Am J Gastroenterol 2022;118:138–147.
**p<0.01; ****p<0.0001 JYSELECA vs. placebo.
Clinical Remission was defined as an endoscopic subscore ≤1 (centrally read), a rectal bleeding subscore of 0, and a ≥1-point decrease in stool frequency subscore from baseline to achieve a subscore of 0 or 1.1
6-month corticosteroid-free clinical remission was defined as a clinical remission with no corticosteroid use for ≥6 months prior to Week 58 among patients who were on corticosteroids at the beginning of the maintenance study.1
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384. 2. Danese S, Ferrante M, Feagan BG, et al. Am J Gastroenterol 2022;118:138–147. 3. Loftus EV Jr, Vermeire S, Feagan BG, et al. J Crohn's Colitis 2023;17:211–220.
Learn more about endoscopic and histologic findings in Biologic-Naïve patients at Week 58:
Learn more about sustained clinical remission in Biologic-Naive patients at Week 58:
†p<0.05; ††p<0.01 JYSELECA vs. placebo (nominal p values, post hoc analysis).
In Biologic-Experienced patients, a stool frequency subscore of ≤1 was achieved as early as Day 8 and a rectal bleeding subscore of 0 was observed as early as Day 5 with JYSELECA 200mg (nominal p<0.05 vs. placebo, post hoc analysis)2
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384. 2. Danese S, Ferrante M, Feagan BG, et al. Am J Gastroenterol 2022;118:138–147.
*p<0.05 JYSELECA vs. placebo.
††p<0.01; ††††p<0.0001 JYSELECA vs. placebo (nominal p values, not controlled for multiplicity).
In Biologic-Experienced patients, JYSELECA 200 mg demonstrated significantly higher rates of clinical response (nominal p<0.0001), endoscopic response (nominal p<0.01) and clinical remission (p<0.05) vs. placebo at Week 101
Clinical response was defined as a Mayo Clinic Score reduction of ≥3 AND ≥30% from baseline, with a decrease in rectal bleeding subscore ≥1 OR absolute rectal bleeding subscore of 0 or 1.1 Clinical response was an exploratory endpoint.
Endoscopic response (improvement) was defined as an endoscopic subscore ≤1.1 Endoscopic response was an exploratory endpoint.
Clinical Remission was defined as an endoscopic subscore ≤1 (centrally read), a rectal bleeding subscore of 0, and a ≥1-point decrease in stool frequency subscore from baseline to achieve a subscore of 0 or 1.1
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384. 2. Danese S, Ferrante M, Feagan BG, et al. Am J Gastroenterol 2022;118:138–147.
**p<0.01; ****p<0.0001 JYSELECA vs. placebo.
Clinical Remission was defined as an endoscopic subscore ≤1 (centrally read), a rectal bleeding subscore of 0, and a ≥1-point decrease in stool frequency subscore from baseline to achieve a subscore of 0 or 1.1
6-month corticosteroid-free clinical remission was defined as a clinical remission with no corticosteroid use for ≥6 months prior to Week 58 among patients who were on corticosteroids at the beginning of the maintenance study.1
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384. 2. Danese S, Ferrante M, Feagan BG, et al. Am J Gastroenterol 2022;118:138–147. 3. Loftus EV Jr, Vermeire S, Feagan BG, et al. J Crohn's Colitis 2023;17:211–220.
Learn more about endoscopic and histologic findings in Biologic-Experienced patients at Week 58:
Learn more about sustained clinical remission in Biologic-Experienced patients at Week 58:
JYSELECA was evaluated in the SELECTION
Phase IIb/III study1
Biologic-Naïve (n = 659)
Disease activity score
Severe endoscopic disease (endoscopic subscore = 3, spontaneous bleeding and ulcerations)
Biologic-Experienced (n = 689): Difficult to Treat
Disease activity score
Severe endoscopic disease (endoscopic subscore = 3, spontaneous bleeding and ulcerations)
Biologic-Experienced patients (n = 297/689) had experienced failure of both anti-integrin and TNF antagonists
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372-2384.
Learn more about the SELECTION study:
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372-2384
Learn more about the SELECTION study and updates to STRIDE recommendations:
GB-UC-JY-202303-00005 | Date of preparation: October 2023
The SELECTION study was a randomised, double-blind, placebo-controlled combined Phase IIb/III study. In the induction studies, patients with moderately to severely active UC, defined by a Mayo Clinic Score of 6–12, endoscopy subscore ≥2, rectal bleeding subscore ≥1, stool frequency subscore ≥1 and Physician Global Assessment subscore ≥2, were randomised (2:2:1) to receive either 200 mg or 100 mg of once-daily JYSELECA or placebo. Patients with UC who achieved clinical remission or response at Week 10 were re-randomised (2:1) at Week 11 to receive their induction dose of JYSELECA or placebo through Week 58 (maintenance study).
n represents the number of patients at the beginning of each study.
a Participants from both cohorts who achieved either clinical remission or clinical response at Week 10 on induction phase completion were re-randomised upon entering the maintenance study at Week 11.
b Non-responders were those who did not achieve clinical remission or clinical response at Week 10.
c Participants entering maintenance phase and receiving concomitant corticosteroids were required to begin tapering corticosteroid therapy, starting at Week 14 of the study.
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384.
The SELECTION study endpoints included requirement of an endoscopic subscore of 0, histologic remission and ≥6-month corticosteroid-free
clinical remission.
Reference: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384.
JYSELECA was tested in a comprehensive study programme involving Biologic-Naïve and Biologic-Experienced patients with high inflammatory burden
at baseline.
Reference: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384.
*p<0.05; ****p<0.0001 JYSELECA vs. placebo.
In the total population, mucosal healing was achieved by 33% of patients receiving JYSELECA 200 mg vs. 10% of patients receiving placebo at Week 58 (nominal p<0.0001, post hoc analysis)1,2
Endoscopic response was defined as an endoscopic subscore of 0.1
Histologic remission was defined as no or a mild increase in chronic inflammatory infiltrate in the lamina propria; no neutrophils in the lamina propria or epithelium; and no erosion, ulceration or granulation tissue using Geboes Index: Grade 0 of ≤0.3, Grade 1 of ≤1.1, Grade 2a of ≤2A.3, Grade 2b of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0 and Grade 5 of 5.0 (centrally read).1
Mucosal healing was defined as endoscopic response (improvement) and histologic remission in the same patient.1
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384. 2. Peyrin-Biroulet L, Loftus EV Jr, Hibi T, et al. ECCO 2021. P383.
*p<0.05; ****p<0.0001 JYSELECA vs. placebo.
In the total patient population, mucosal healing was achieved by 33% of patients receiving JYSELECA 200 mg vs. 10% of patients receiving placebo at Week 58 (nominal p<0.0001, post hoc analysis)1,2
Endoscopic response was defined by an endoscopic subscore of 0.1
Histologic remission was defined as no or a mild increase in chronic inflammatory infiltrate in the lamina propria; no neutrophils in the lamina propria or epithelium; and no erosion, ulceration or granulation tissue using Geboes Index: Grade 0 of ≤0.3, Grade 1 of ≤1.1, Grade 2a of ≤2A.3, Grade 2b of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0 and Grade 5 of 5.0 (centrally read).1
Mucosal healing was defined as endoscopic response (improvement) and histologic remission in the same patient.1
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384. 2. Peyrin-Biroulet L, Loftus EV Jr, Hibi T, et al. ECCO 2021. P383.
STRIDE-II treatment targets:
• Guidance is provided regarding time to expected response, remission, and endoscopic healing
• Clinical response and remission and normalisation of C-reactive protein are immediate short-term targets
• Symptomatic improvement is an immediate goal that is highly rated by patients
• Reduction of faecal calprotectin to an acceptable range is a formal intermediate treatment target
• Absence of disability and restoration of quality of life are long-term targets
• Histologic healing is a recognised important adjunctive measure
Many SELECTION trial endpoints are in line with the
STRIDE-II recommendations
Reference: 1 .Turner D, Ricciuto A, Lewis A, et al. Gastroenterology 2021;160:1570–1583.
**p<0.01 JYSELECA vs. placebo.
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384.
**p<0.01 JYSELECA vs. placebo.
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384.
Adverse events should be reported.
For Great Britain, reporting forms and information can be found at yellowcard.mhra.gov.uk or via the Yellow Card app (download from the Apple App Store or Google Play Store). Adverse events should also be reported to Galapagos via email to DrugSafety.UK.Ireland@glpg.com or 0800 072 7878.
Adverse events should be reported.
For Northern Ireland, reporting forms and information can be found at yellowcard.mhra.gov.uk or via the Yellow Card app (download from the Apple App Store or Google Play Store). Adverse events should also be reported to Galapagos via email to DrugSafety.UK.Ireland@glpg.com or 0800 072 7878.
Adverse events should be reported.
For the Republic of Ireland, reporting forms and information can be found at www.hpra.ie and can be reported to HPRA on +353 1 6764971.
Adverse events should also be reported to Galapagos via email to DrugSafety.UK.Ireland@glpg.com or 00800 7878 1345.
Jyseleca, Galapagos and the Galapagos logo are registered trademarks of Galapagos NV.
GB-IBD-FIL-202211-00008
Date of preparation: November 2023
Contact Us
Galapagos Biotech Ltd
148 Belmont Rd, Uxbridge UB8 1QS
medicalinfo@glpg.com
Jyseleca, Galapagos and the Galapagos logo are registered trademarks of Galapagos NV.
GB-IBD-FIL-202211-00008
Date of preparation: November 2023
Contact Us
Galapagos Biotech Ltd
148 Belmont Rd, Uxbridge UB8 1QS
medicalinfo@glpg.com
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