JYSELECA demonstrated rapid symptomatic improvement, clinical response and sustained clinical remission1–3
In Biologic-Naïve patients, reduction in stool frequency was observed as early as Day 6, and improvement in rectal bleeding was observed as early as Day 42
*p<0.05; **p<0.01; ***p<0.001; ****p< 0.0001 JYSELECA vs. placebo (post-hoc analysis).
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384. 2. Danese S, Hibi T, Ritter TE, et al. ECCO 2021. OP37. 3. Vermeire S, Oortwijn A, Feagan BG, et al. DDW 2021. FR537.
Bio-Naïve
†p<0.05; ††p< 0.01; †††p< 0.001; ††††p<0.0001 JYSELECA vs. placebo (nominal p values, post-hoc analysis).
Reference: 1. Vermeire S, Oortwijn A, Feagan BG, et al. DDW 2021. FR537.
In Biologic-Naïve patients, JYSELECA demonstrated partial Mayo Clinic Score remission as early as Week 21
Bio-Naïve
In Biologic-Naïve patients, JYSELECA demonstrated significantly higher rates of clinical response, endoscopic response, and clinical remission vs. placebo at Week 101
* P < 0.05 JYSELECA vs placebo.
†† P < 0.01; ††† P < 0.001 JYSELECA vs placebo (nominal P values, not controlled for multiplicity).
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
Reference: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384.
Learn more about histologic remission at Week 10 in Biologic-Naïve patients:
Bio-Naïve
Significantly more patients on JYSELECA achieved clinical remission and histologic remission vs. placebo at week 581
Among patients in remission at Week 58, 93% were continuously without corticosteroid use for at least the 6 previous months (post-hoc analysis)2
**p<0.01; ****p<0.0001 JYSELECA vs. placebo.
Clinical remission was defined by an endoscopic subscore ≤1 (centrally read), a rectal bleeding subscore of 0, a ≥1-point decrease in stool frequency subscore from baseline to achieve subscore of 0 or 1.1
Histologic remission was defined as no or 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
6-month corticosteroid-free clinical remission was defined as 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. Loftus EV Jr, Vermeire S, Feagan B, et al. ECCO 2021. DOP82.
Learn about endoscopic findings in Biologic-Naïve patients at Week 58:
In Biologic-Experienced patients, reduction in stool frequency was observed as early as Day 2, and improvement in rectal bleeding was observed as early as Day 32
*p<0.05; **p<0.01; ***p<0.001; ****p<0.0001 JYSELECA vs. placebo (post-hoc analysis).
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384. 2. Danese S, Hibi T, Ritter TE, et al. ECCO 2021. OP37. 3. Vermeire S, Oortwijn A, Feagan BG, et al. DDW 2021. FR537.
Bio-Experienced
In Biologic-Experienced patients, JYSELECA demonstrated symptomatic remission as early as Week 21
† P < 0.05; ††† P < 0.001; †††† P < 0.0001 JYSELECA vs placebo (nominal P value, post-hoc analysis).
Reference: 1. Vermeire S, Oortwijn A, Feagan BG, et al. DDW 2021. FR537.
Bio-Experienced
In Biologic-Experienced patients, JYSELECA demonstrated significantly higher rates of clinical response, endoscopic response and clinical remission vs. placebo at Week 101
*p<0.05 JYSELECA vs. placebo.
††p<0.01; ††††p<0.0001 JYSELECA vs. placebo (nominal p values, not controlled for multiplicity).
Clinical response was defined as an Mayo Clinic Score reduction of ≥3 AND ≥30% from baseline, with 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 by an endoscopic subscore ≤1 (centrally read), rectal bleeding subscore = 0, stool frequency subscore ≥1-point decrease from baseline to achieve subscore of 0 or 1.1
Reference: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384
Learn more about histologic remission at Week 10 in Biologic-Experienced patients:
Bio-Experienced
In the total population, significantly more patients on JYSELECA achieved clinical remission and histologic remission vs. placebo at Week 581
Among patients in remission at Week 58, 93% were continuously without corticosteroid use for at least the 6 previous months (post-hoc analysis)2
**p<0.01; ****p<0.0001 JYSELECA vs. placebo
Clinical remission was defined by an endoscopic subscore ≤1 (centrally read), a rectal bleeding subscore of 0, a ≥1-point decrease in stool frequency subscore from baseline to achieve subscore of 0 or 1.1
Histologic remission was defined as no or 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
6-month corticosteroid-free clinical remission was defined as clinical remission with no corticosteroid use for ≥6 months prior to Week 58 among patients who were on corticosteroids at the beginning of maintenance study.1
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384. 2. Loftus EV Jr, Vermeire S, Feagan B, et al. ECCO 2021. DOP82.
Learn about endoscopic findings in Biologic-Experienced patients at Week 58:
JYSELECA can help improve the quality of life for your patients with UC1,2
JYSELECA was associated with higher rates of clinically meaningful improvements in quality of life vs. placebo at both Week 10 and Week 582
****p<0.0001 JYSELECA vs. placebo (nominal p values, not controlled for multiplicity).
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384. 2. Sandborn WJ, Peyrin-Biroulet L, Danese S. et al. UEGW 2021. P0457.
†††p<0.001; ††††p<0.0001 JYSELECA vs. placebo (nominal p values, not controlled for multiplicity). Values have been rounded to the nearest whole number; exact values for the Week 58 total population are as follows: placebo 32.6%, JYSELECA 68.3% (difference 35.6%)
IBDQ, Inflammatory Bowel Disease Questionnaire, comprises 32 questions divided into four health subscales: bowel symptoms (10 questions); systemic symptoms, including sleep disorders and fatigue (5 questions); emotional function, such as depression, aggression, and irritation (12 questions); and social function, meaning the ability to participate in social activities and to work (5 questions).1
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384. 2. Sandborn WJ, Peyrin-Biroulet L, Danese S. et al. UEGW 2021. P0457.
†††† P < 0.0001 JYSELECA vs placebo (nominal P value, not controlled for multiplicity). Values have been rounded to the nearest whole number; exact values for Week 10 Biologic-Experienced patients are as follows: placebo 35.2%, JYSELECA 55.3% (difference 20.5%)
EQ-5D VAS, EuroQOL (5 Dimensions) visual analogue scale, is a standardised instrument developed by the EuroQOL Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of two components: a descriptive system of the subject’s health and a rating of current health state using a 0 to 100 visual analogue scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.1
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384. 2. Sandborn WJ, Peyrin-Biroulet L, Danese S. et al. UEGW 2021. P0457.
††p<0.01; †††p<0.001; ††††p<0.0001 JYSELECA vs. placebo (nominal p values, not controlled for multiplicity). Values have been rounded to the nearest whole number; exact values for Week 10 Biologic-Experienced patients are as follows: placebo 45.1%, JYSELECA 63.4% (difference 18.7%).
WPAI-UC, Work Productivity and Activity Impairment questionnaire for patients with UC, consists of six questions designed to measure the effects of general health and symptom severity on work productivity and regular activities during the past 7 days.1
References: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384. 2. Sandborn WJ, Peyrin-Biroulet L, Danese S. et al. UEGW 2021. P0457.
JYSELECA was evaluated in the SELECTION
Phase IIb/III study1
Disease activity score
Severe endoscopic disease (endoscopic subscore = 3, spontaneous bleeding and ulcerations)
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 tumour necrosis factor antagonists
Learn more about the SELECTION study:
JYSELECA (200 mg once daily) met its primary endpoint of clinical
remission in both induction and maintenance studies1
Induction studies: at Week 10, 26% of Biologic-Naïve patients and 12% of Biologic-Experienced patients on JYSELECA achieved clinical remission vs. 15% and 4% on placebo, respectively (p<0.05, for both studies)
Maintenance study: at Week 58, 37% of the total patient population on JYSELECA achieved clinical remission vs. 11%
on placebo (p<0.0001)
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:
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’s 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 upon 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 on concomitant corticosteroids were required to begin tapering corticosteroid therapy, starting at Week 14 of the study.
Reference: 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.2
Reference: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384.
Twice as many Biologic-Naïve patients on JYSELECA achieved histologic remission vs. placebo at Week 101
Mucosal healing was achieved by 23% of Biologic-Naïve patients on JYSELECA vs. 11% of patients on placebo at Week 10 (post-hoc analysis)1
**** P < 0.0001 JYSELECA vs placebo.
Histologic remission was defined as no or 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
Reference: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384
Endoscopic response (endoscopic subscore ≤1) and remission (endoscopic subscore of 0) at Week 581
Mucosal healing was achieved by 33% of patients on JYSELECA vs. 10% of patients on placebo at Week 58 (post-hoc analysis)1
One-in-four Biologic-Naïve patients achieved endoscopic remission at Week 581
* P < 0.05 JYSELECA vs placebo.
†††† P < 0.0001 JYSELECA vs placebo (nominal P value, not controlled for multiplicity).
Endoscopic response (improvement) was defined as an endoscopic subscore ≤1.1 Endoscopic response was an exploratory endpoint. Endoscopic remission was defined as an endoscopic subscore of 0.1
Endoscopic response was defined as an endoscopic subscore of 0.1
Reference: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384
One-fifth of Biologic-Experienced patients on JYSELECA achieved histologic remission at Week 101,2
Mucosal healing was achieved by 10% of Biologic-Experienced patients on JYSELECA vs. 4% of patients on placebo at Week 10 (post-hoc analysis)1
†† P < 0.01 JYSELECA vs placebo (nominal P value, not controlled for multiplicity).
Reference: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384
Mucosal healing, was achieved by 33% of patients on JYSELECA vs. 10% of patients on placebo at Week 58 (post-hoc analysis)1
In the total population, 16% of patients receiving JYSELECA achieved endoscopic remission vs. 6% of those receiving placebo at Week 58 (p = 0.02)1
* P < 0.05 JYSELECA vs placebo.
†††† Endoscopic response (improvement) was defined as an endoscopic subscore ≤1.1 Endoscopic response was an exploratory endpoint..
Endoscopic response (improvement) was defined as an endoscopic subscore ≤1.1 Endoscopic response was an exploratory endpoint.
Endoscopic response was defined by an endoscopic subscore of 0.1
Reference: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384
New and updated treatment targets (STRIDE-II):
• Time to expected response, remission, and endoscopic healing
• Clinical response and remission and normalisation of C-reactive protein are immediate short-term targets
• Symptomatic relief is an immediate goal that is highly rated by patients
• Reduction of faecal calprotectin to an acceptable range is now a formal intermediate treatment target
• Absence of disability, restoration of QOL are the new long-term targets
• Histologic healing is now 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.
Jyseleca, Galapagos and the Galapagos logo are registered trademarks of Galapagos NV.
UK-IBD-FIL-202203-00033
Date of preparation March 2022
Jyseleca, Galapagos and the Galapagos logo are registered trademarks of Galapagos NV.
UK-IBD-FIL-202203-00033
Date of preparation March 2022
© 2022 Galapagos NV. All rights reserved.
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