JYSELECA demonstrated rapid symptomatic improvement, clinical response and sustained clinical remission1–3


Bio-Naïve

Reduction in the frequency of bloody diarrhoea as early as Day 6 (post hoc analysis)2

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

Partial Mayo Clinic Score remission (≤2 and no individual subscore >1) in Biologic-Naïve patients in post-hoc analysis1

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

Clinical response, endoscopic response and clinical remission at Week 101

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

Remission at Week 581

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:






Bio-Experienced

Reduction in the frequency of bloody diarrhoea as early as Day 3 (post-hoc analysis)2

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

Partial Mayo Clinic Score remission (≤2 and no individual subscore >1) in Biologic-Experienced patients in post-hoc analysis1

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

Clinical response, endoscopic response and clinical remission at Week 101

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

Remission at Week 581

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

Proportion of patients achieving minimum clinically important difference in quality of life measures at Week 582

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.  


Patients achieving minimal clinically important difference (defined as an increase from induction baseline 
of ≥16) in IBDQ total score at Weeks 10 and 582

†††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.


Patients achieving a minimal clinically important difference (defined as an increase from induction baseline of ≥10) in EQ-5D VAS at Weeks 10 and 582

†††† 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. 



Proportion of patients achieving minimal clinically important difference (defined as a decrease from induction baseline of ≥7%) in WPAI-UC (Activity Impairment) at Weeks 10 and 582

††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

1348

patients with moderately to severely active UC (defined by Mayo Clinic Score 6–12; endoscopic subscore ≥2; rectal bleeding subscore ≥1; stool frequency subscore ≥1; and Physician’s Global Assessment subscore ≥2)


Baseline disease characteristics1

Biologic-Naïve (n = 659)




Disease activity score



Mean Mayo Clinic score = 8.6
0 12

Severe endoscopic disease (endoscopic subscore = 3, spontaneous bleeding and ulcerations)



~56%
0 100
Biologic-Experienced (n = 689): Difficult to Treat




Disease activity score



Mean Mayo Clinic score = 9.3
0 12

Severe endoscopic disease (endoscopic subscore = 3, spontaneous bleeding and ulcerations)



~78%
0 100

~43%
Refractory patient population

Biologic-Experienced patients (n=297/689) had experienced failure of both anti-integrin and tumour necrosis factor antagonists 




Learn more about the SELECTION study:

Key endpoints of the SELECTION study1

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: