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DURABLE REMISSION

Clinical Remission
Maintenance of Clinical Remission

RINVOQ ACHIEVED SIGNIFICANTLY HIGHER RATES OF
CLINICAL REMISSION VS PLACEBO AT WEEK 52^1,2

RINVOQ achieved the primary endpoint of clinical remission per adapted Mayo score (aMs) ≤2 in both Induction and Maintenance studies, which was
Stool frequency subscore (SFS) ≤1 and not greater than baseline, rectal bleeding subscore (RBS) = 0, endoscopic subscore 0 or 1 without friability.^1,2

RINVOQ PATIENTS ACHIEVED DURABLE
CLINICAL REMISSION VS PLACEBO AT WEEK 52^1,2

At Week 8 Induction, 26% of patients in U-ACHIEVE, and 34% of patients in U-ACCOMPLISH treated with RINVOQ 45 mg OD achieved clinical remission per adapted Mayo score.^1,2 These patients were eligible to be assessed for maintenance of remission at Week 52 of U-ACHIEVE maintenance.

Clinical remission per partial Mayo score up to Week 52
Stool frequency + rectal bleeding + Physician’s Global Assessment

^*Clinical remission per partial Mayo score, defined by partial Mayo score ≤2 with no subscore >1.
Error bars show 95% CI.

Adapted from Danese S. et al, 2022.

CORTICOSTEROID-FREE REMISSION

Patients who were in clinical remission per adapted Mayo score at the end of 8-week RINVOQ 45 mg induction treatment (n=159) and at Week 52 of maintenance treatment & corticosteroid-free ≥90 DAYS immediately preceding Week 52

Corticosteroid-free clinical remission per adapted Mayo score at Week 52 vs placebo
Stool frequency subscore + rectal bleeding subscore + endoscopic subscore
Secondary endpoint

Adapted from Danese S. et al, 2022.

DEFINING CLINICAL REMISSION PER ADAPTED MAYO SCORE:^1,2

ADAPTED MAYO
SCORE

STOOL FREQUENCY

Subscore

& not greater than baseline

RECTAL BLEEDING

Subscore

ENDOSCOPIC

Subscore

without friability

ADAPTED MAYO
SCORE

STOOL FREQUENCY

Subscore

& not greater than baseline

RECTAL BLEEDING

Subscore

ENDOSCOPIC

Subscore

without friability

RINVOQ UC: PHASE 3

STUDY DESIGN^1,2

U-ACHIEVE Induction (N=473) and U-ACCOMPLISH (N=515) were replicate, multicentre, double-blind, placebo-controlled clinical studies.

U-ACHIEVE Maintenance was a multicentre, double-blind, placebo-controlled clinical study (N=451) in patients who achieved clinical response per aMs (decrease ≥2 points and ≥30% from baseline and a decrease in RBS ≥1 from baseline or an absolute RBS ≤1) with 8-week RINVOQ 45 mg OD induction treatment.

PATIENTS WITH MODERATELY TO SEVERLY ACTIVE UC WITH INADEQUATE RESPONSE, LOSS OF RESPONSE, OR INTOLERANCE TO:
ORAL AMINOSALICYLATES, IMMUNOSUPPRESSANTS, CORTICOSTEROIDS AND/OR BIOLOGICS

Adapted from Danese S. et al, 2022.

^*Placebo responders to 8-week placebo continued to receive placebo in the U-ACHIEVE maintenance study and were not part of the primary efficacy analysis.
^†Primary efficacy analysis = first 451 clinical responders to 8-week RINVOQ 45 mg induction.
^‡Patients who did not achieve clinical response at Week 8 continued into an additional 8-week open-label extension period with RINVOQ 45 mg OD.
Responders to RINVOQ 45 mg OD at Week 16 were then eligible for enrolment into U-ACHIEVE Maintenance (these patients were not included in the primary efficacy analysis).

PRIMARY ENDPOINT ASSESSED AT WEEK 52^1,2

Clinical remission per adapted Mayo score (≤2, with SFS ≤1 and not greater than baseline, RBS=0, and ESS ≤1 without friability)

MAINTENANCE RANKED SECONDARY ENDPOINTS ASSESSED AT WEEK 52^1,2

1. Mucosal healing^* (ESS 0 or 1)

2. Maintenance of clinical remission per adapted Mayo score^†‡

3. Steroid-free remission^† (Clinical remission per adapted Mayo score at Week 8 induction, Week 52 Maintenance + corticosteroid-free ≥ 90 days immediately preceding Week 52)

4. Maintenance of mucosal healing

5. Endoscopic remission (ESS 0)

6. Maintenance of clinical response per adapted Mayo score (decrease ≥2 points and ≥30% from baseline + decrease RBS ≥1 from baseline or an absolute RBS ≤1)

7. Histologic-endoscopic mucosal healing (ESS 0 or 1 + Geboes ≤3.1)

8. Change from baseline in IBDQ score

9. Deep mucosal healing^* (ESS 0 + Geboes <2)

10. No bowel urgency

11. No abdominal pain

12. Change from baseline in FACIT-F score

^*In the clinical studies, 'mucosal healing' (ESS ≤1) was termed 'endoscopic improvement' and 'deep mucosal healing' (ESS 0 + Geboes <2) was termed 'mucosal healing'.^†Assessed in patients who achieved clinical remission per adapted Mayo score with 8-week RINVOQ 45 mg OD induction treatment (n=159).^‡Patients who achieved clinical response per adapted Mayo score with RINVOQ 45 mg OD were eligible to enter the 52-week maintenance study.

BASELINE CHARACTERISTICS²
AT WEEK 52

VARIABLE	MAINTENANCE (U-ACHIEVE WEEK 52)^*
VARIABLE	PLACEBO N=149	PLACEBO 15 mg N=148	RINVOQ 30 mg N=154
Female, % (n)	43.0 (64)	35.8 (53)	44.2 (68)
Race, white, % (n)	62.4 (93)	65.5 (97)	65.6 (101)
Age, median (IQR), y	40.0 (21.0)	40.0 (22.0)	41.0 (7.0)
Disease duration, median (IQR), y	6.2 (8.6)	6.4 (10.6)	6.0 (9.7)
Weight, median (IQR), kg	70.0 (21.2)	71.5 (25.6)	68.8 (29.0)
Faecal calprotectin, median (IQR), mg/kg	1991 (3193)	1718 (2502)	1465 (1750)
hs-CRP, median (IQR), mg/L	4.3 (8.0)	3.8 (10.0)	4.1 (7.1)
Baseline aminosalicylates use, % (n)	66.4 (99)	66.9 (99)	68.8 (106)
Baseline corticosteroid use,^† % (n)	40.3 (60)	37.2 (55)	37.0 (57)
Baseline immunosuppressant (methotrexate) use, % (n)	0	0.7 (1)	0.6 (1)
Biologic-IR, % (n)	54.4 (81)	48.0 (71)	47.4 (73)
Number of prior biologics, 1	20.1 (30)	20.3 (30)	22.1 (34)
Number of prior biologics, 2	22.8 (34)	21.6 (32)	15.6 (24)
Number of prior biologics, 3	10.7 (16)	6.8 (10)	10.4 (16)
Number of prior biologics, ≥4	2.7 (4)	0.7 (1)	1.9 (3)
Baseline adapted Mayo score,^† % (n)
≤7	58.4 (87)	60.1 (89)	57.9 (88)
>7	41.6 (62)	39.9 (59)	42.1 (64)
Baseline endoscopic subscore = 3, % (n)	65.8 (98)	65.6 (100)	70.1 (108)

VARIABLE	MAINTENANCE (U-ACHIEVE WEEK 52)^*
VARIABLE	PLACEBO N=149	PLACEBO 15 mg N=148
Female, % (n)	43.0 (64)	35.8 (53)
Race, white, % (n)	62.4 (93)	65.5 (97)
Age, median (IQR), y	40.0 (21.0)	40.0 (22.0)
Disease duration, median (IQR), y	6.2 (8.6)	6.4 (10.6)
Weight, median (IQR), kg	70.0 (21.2)	71.5 (25.6)
Faecal calprotectin, median (IQR), mg/kg	1991 (3193)	1718 (2502)
hs-CRP, median (IQR), mg/L	4.3 (8.0)	3.8 (10.0)
Baseline aminosalicylates use, % (n)	66.4 (99)	66.9 (99)
Baseline corticosteroid use,^† % (n)	40.3 (60)	37.2 (55)
Baseline immunosuppressant (methotrexate) use, % (n)	0	0.7 (1)
Biologic-IR, % (n)	54.4 (81)	48.0 (71)
Number of prior biologics, 1	20.1 (30)	20.3 (30)
Number of prior biologics, 2	22.8 (34)	21.6 (32)
Number of prior biologics, 3	10.7 (16)	6.8 (10)
Number of prior biologics, ≥4	2.7 (4)	0.7 (1)
Baseline adapted Mayo score,^† % (n)
≤7	58.4 (87)	60.1 (89)
>7	41.6 (62)	39.9 (59)
Baseline endoscopic subscore = 3, % (n)	65.8 (98)	65.6 (100)

VARIABLE	MAINTENANCE (U-ACHIEVE WEEK 52)^*
VARIABLE	RINVOQ 30 mg N=154
Female, % (n)	44.2 (68)
Race, white, % (n)	65.6 (101)
Age, median (IQR), y	41.0 (7.0)
Disease duration, median (IQR), y	6.0 (9.7)
Weight, median (IQR), kg	68.8 (29.0)
Faecal calprotectin, median (IQR), mg/kg	1465 (1750)
hs-CRP, median (IQR), mg/L	4.1 (7.1)
Baseline aminosalicylates use, % (n)	68.8 (106)
Baseline corticosteroid use,^† % (n)	37.0 (57)
Baseline immunosuppressant (methotrexate) use, % (n)	0.6 (1)
Biologic-IR, % (n)	47.4 (73)
Number of prior biologics, 1	22.1 (34)
Number of prior biologics, 2	15.6 (24)
Number of prior biologics, 3	10.4 (16)
Number of prior biologics, ≥4	1.9 (3)
Baseline adapted Mayo score,^† % (n)
≤7	57.9 (88)
>7	42.1 (64)
Baseline endoscopic subscore = 3, % (n)	70.1 (108)

Adapted from Danese S. et al, 2022.

^*Patients who achieved clinical response based on adapted Mayo score following 8-week treatment with upadacitinib 45 mg OD in U-ACHIEVE or U‑ACCOMPLISH induction studies.^†Corticosteroids dosages are converted to equivalent daily dosage of prednisone in mg. The maximum dose of prednisolone allowed as concomitant therapy was 30 mg, equivalent to prednisone.

ENDPOINT DEFINITIONS^1-4

ENDPOINT	DEFINITION	SFS, RBS AND ENDOSCOPIC SCORING
Clinical remission per adapted Mayo score at Induction Week 8 & Maintenance Week 52	• Adapted Mayo score ≤2 • SFS ≤1 and not greater than baseline • RBS = 0 • Endoscopic subscore ≤1 without friability	• SFS ≤1: Normal or 1-2 stools more than normal • RBS = 0: No visible blood • Endoscopic subscore ≤1: Inactive or mild disease • Endoscopic subscore =2: Moderate disease
Clinical response per adapted Mayo score at Induction Week 8 & Maintenance Week 52	• Decrease in adapted Mayo score ≥2 points and ≥30% from baseline • Decrease in RBS ≥1 from baseline or an absolute RBS ≤1	• RBS ≤1: No visible blood or streaks of blood with stool lessthan half the time
Clinical response per partial adapted Mayo score at Induction Week 2	• Decrease in partial adapted Mayo score ≥1 point and ≥30% from baseline • Decrease in RBS ≥1 or an absolute RBS ≤1

Components of the Mayo/partial Mayo/adapted Mayo score	Rectal Bleeding Subscore [RBS] (0-3)	Stool Frequency Subscore [SFS] (0-3)	Physician Global Assessment [PGA] (0-3)	Endoscopy (0-3)	Score Range
Mayo score	✓	✓	✓	✓	0-12
Partial Mayo score	✓	✓	✓		0-9
Adapted Mayo score	✓	✓		✓	0-9
Partial adapted Mayo score	✓	✓			0-6

Components of the Mayo/partial Mayo/adapted Mayo score	Rectal Bleeding Subscore [RBS] (0-3)	Stool Frequency Subscore [SFS] (0-3)	Physician Global Assessment [PGA] (0-3)
Mayo score	✓	✓	✓
Partial Mayo score	✓	✓	✓
Adapted Mayo score	✓	✓
Partial adapted Mayo score	✓	✓

Components of the Mayo/partial Mayo/adapted Mayo score	Endoscopy (0-3)	Score Range
Mayo score	✓	0-12
Partial Mayo score		0-9
Adapted Mayo score	✓	0-9
Partial adapted Mayo score		0-6

ENDPOINT	DEFINITION	ENDOSCOPIC SCORING
Mucosal healing at Induction Week 8 & Maintenance Week 52	Endoscopic subscore ≤1	Mayo endoscopic subscore ranges from 0 to 3: (0) Inactive disease and normal mucosa; (1) Mild disease (erythema and mild friability); (2) Moderate disease (marked erythema, absent vascular pattern, friability, erosions), (3) Severe disease (spontaneous bleeding and diffuse ulceration)
Endoscopic remission at Induction Week 8 & Maintenance Week 52	Endoscopic subscore = 0

ENDPOINT	DEFINITION	CLINICAL INTERPRETATION	ENDOSCOPIC AND GEBOES SCORING
Histologic-endoscopic mucosal healing	• Endoscopic subscore ≤1 without friability • Geboes score ≤3.1	• Inactive or mild endoscopic disease • Histologic improvement defined by: • Neutrophil infiltration in <5% of crypts • No crypt destruction • No erosions, ulcerations, or granulation tissue	Mayo endoscopic subscore (0 to 3): (0) Inactive disease and normal mucosa (1) Mild disease (erythema and mild friability) (2) Moderate disease (marked erythema, absent vascular pattern, friability, erosions) (3) Severe disease (spontaneous bleeding and diffuse ulceration)
Deep mucosal healing	• Endoscopic subscore = 0 • Geboes score <2	• Inactive endoscopic disease • Histologic remission defined by: • No neutrophils in the epithelial crypts or lamina propria • No increase in eosinophils • No crypt destruction • No erosions, ulcerations, or granulation tissue	Geboes Index (Grades 0-5): Grade 0: structural change only Grade 1: chronic inflammation Grade 2: lamina propria neutrophils Grade 3: neutrophils in epithelium Grade 4: crypt destruction Grade 5: erosions or ulcers

ENDPOINT	DEFINITION
Histologic-endoscopic mucosal healing	• Endoscopic subscore ≤1 without friability • Geboes score ≤3.1
Deep mucosal healing	• Endoscopic subscore = 0 • Geboes score <2

ENDPOINT	CLINICAL INTERPRETATION
Histologic-endoscopic mucosal healing	• Inactive or mild endoscopic disease • Histologic improvement defined by: • Neutrophil infiltration in <5% of crypts • No crypt destruction • No erosions, ulcerations, or granulation tissue
Deep mucosal healing	• Inactive endoscopic disease • Histologic remission defined by: • No neutrophils in the epithelial crypts or lamina propria • No increase in eosinophils • No crypt destruction • No erosions, ulcerations, or granulation tissue

ENDPOINT	ENDOSCOPIC AND GEBOES SCORING
Histologic-endoscopic mucosal healing	Mayo endoscopic subscore (0 to 3): (0) Inactive disease and normal mucosa (1) Mild disease (erythema and mild friability) (2) Moderate disease (marked erythema, absent vascular pattern, friability, erosions) (3) Severe disease (spontaneous bleeding and diffuse ulceration)
Deep mucosal healing	Geboes Index (Grades 0-5): Grade 0: structural change only Grade 1: chronic inflammation Grade 2: lamina propria neutrophils Grade 3: neutrophils in epithelium Grade 4: crypt destruction Grade 5: erosions or ulcers

THIS LIST IS NOT EXHAUSTIVE. PLEASE SEE STUDY APPENDIX FOR FULL INCLUSION AND EXCLUSION CRITERIA.

INCLUSION CRITERIA

• Age 16-75 years with a confirmed UC diagnosis for ≥90 days prior to baseline^*

• Active disease (Adapted Mayo score [Mayo score excluding Physician’s Global Assessment; PGA] of 5-9; centrally assessed Mayo endoscopic subscore of 2 or 3)

• Demonstrated prior inadequate response (IR), loss of response, or intolerance to ≥1 oral aminosalicylate, corticosteroid, immunosuppressant, and/or biologic therapy (infliximab, adalimumab, golimumab, vedolizumab, and/or ustekinumab).

• Enrolment of patients with ≥3 biologics failure was limited to <30% of the total population with prior biologic failure

• Patients with previous biologic exposure but not failure (provided their biologic exposure duration was <1 year) were limited to <20% of the total population without prior biologic failure

• Female patients of childbearing potential had to have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the baseline visit prior to treatment dosing

• Female patients must have met the contraception recommendations

EXCLUSION CRITERIA

• Diagnosis of Crohn's disease

• Diagnosis of indeterminate colitis

• Diagnosis of fulminant colitis

• Diagnosis of toxic megacolon

• Disease limited to the rectum

• Active infection

• Previous exposure to JAK inhibitors

INCLUSION CRITERIA

• Age 16-75 years with a confirmed UC diagnosis for ≥90 days prior to baseline^*

• Active disease (Adapted Mayo score [Mayo score excluding Physician’s Global Assessment; PGA] of 5-9; centrally assessed Mayo endoscopic subscore of 2 or 3)

• Demonstrated prior inadequate response (IR), loss of response, or intolerance to ≥1 oral aminosalicylate, corticosteroid, immunosuppressant, and/or biologic therapy (infliximab, adalimumab, golimumab, vedolizumab, and/or ustekinumab).

• Enrolment of patients with ≥3 biologics failure was limited to <30% of the total population with prior biologic failure

• Patients with previous biologic exposure but not failure (provided their biologic exposure duration was <1 year) were limited to <20% of the total population without prior biologic failure

• Female patients of childbearing potential had to have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the baseline visit prior to treatment dosing

• Female patients must have met the contraception recommendations

EXCLUSION CRITERIA

• Diagnosis of Crohn's disease

• Diagnosis of indeterminate colitis

• Diagnosis of fulminant colitis

• Diagnosis of toxic megacolon

• Disease limited to the rectum

• Active infection

• Previous exposure to JAK inhibitors

^*Adolescent patients aged 16 and 17 years old had to weigh ≥40 kg and to have met the definition of Tanner Stage 5 at the screening visit

aMs, adapted Mayo score; ESS, endoscopic subscore; FACIT-F, Functional Assessment of Chronic Illness Therapy - Fatigue; hs-CRP, high-sensitivity C-reactive protein; IBDQ, Inflammatory Bowel Disease Questionnaire; IQR, interquartile range; OD, once daily; PGA, Physician Global Assessment; RBS, Rectal Bleeding Subscore; RIN, RINVOQ; SFS, Stool Frequency Subscore; UC, ulcerative colitis.

RINVOQ Summary of Product Characteristics.
Danese S, Vermeire S, et al. Lancet. 2022. 399(10341):2113–2128. DOI: https://doi.org/10.1016/S0140-6736(22)00581-5.
Rutgeerts P, et al. NEJM. 2005. 353;2462–76.
Geboes K, et al. Gut. 2000;47:404–9.

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DURABLE REMISSION

RINVOQ ACHIEVED SIGNIFICANTLY HIGHER RATES OF
CLINICAL REMISSION VS PLACEBO AT WEEK 52^1,2

RINVOQ PATIENTS ACHIEVED DURABLE
CLINICAL REMISSION VS PLACEBO AT WEEK 52^1,2

CORTICOSTEROID-FREE REMISSION

DEFINING CLINICAL REMISSION PER ADAPTED MAYO SCORE:^1,2

ADAPTED MAYO
SCORE

STOOL FREQUENCY

RECTAL BLEEDING

ENDOSCOPIC

ADAPTED MAYO
SCORE

STOOL FREQUENCY

RECTAL BLEEDING

ENDOSCOPIC

RINVOQ UC: PHASE 3

STUDY DESIGN^1,2

PRIMARY ENDPOINT ASSESSED AT WEEK 52^1,2

MAINTENANCE RANKED SECONDARY ENDPOINTS ASSESSED AT WEEK 52^1,2

BASELINE CHARACTERISTICS²
AT WEEK 52

ENDPOINT DEFINITIONS^1-4

THIS LIST IS NOT EXHAUSTIVE. PLEASE SEE STUDY APPENDIX FOR FULL INCLUSION AND EXCLUSION CRITERIA.

Our therapy areas

Additional info

This website is for UK Healthcare Professionals only

Welcome

FIND OUT MORE ABOUT...

DURABLE REMISSION

RINVOQ ACHIEVED SIGNIFICANTLY HIGHER RATES OF CLINICAL REMISSION VS PLACEBO AT WEEK 521,2

RINVOQ PATIENTS ACHIEVED DURABLE CLINICAL REMISSION VS PLACEBO AT WEEK 521,2

CLINICAL REMISSION* RATES PER PARTIAL MAYO SCORE OVER 1 YEAR¹˒²

DURABLE CLINICAL REMISSION WITHOUT STEROIDS AT WEEK 52¹˒²

CORTICOSTEROID-FREE REMISSION

DEFINING CLINICAL REMISSION PER ADAPTED MAYO SCORE:1,2

ADAPTED MAYO SCORE

STOOL FREQUENCY

RECTAL BLEEDING

ENDOSCOPIC

ADAPTED MAYO SCORE

STOOL FREQUENCY

RECTAL BLEEDING

ENDOSCOPIC

RINVOQ UC: PHASE 3

STUDY DESIGN1,2

PRIMARY ENDPOINT ASSESSED AT WEEK 521,2

MAINTENANCE RANKED SECONDARY ENDPOINTS ASSESSED AT WEEK 521,2

BASELINE CHARACTERISTICS2 AT WEEK 52

ENDPOINT DEFINITIONS1-4

THIS LIST IS NOT EXHAUSTIVE. PLEASE SEE STUDY APPENDIX FOR FULL INCLUSION AND EXCLUSION CRITERIA.

Abbreviations

References

Our therapy areas

Additional info

This website is for UK Healthcare Professionals only

Welcome

RINVOQ ACHIEVED SIGNIFICANTLY HIGHER RATES OF
CLINICAL REMISSION VS PLACEBO AT WEEK 52^1,2

RINVOQ PATIENTS ACHIEVED DURABLE
CLINICAL REMISSION VS PLACEBO AT WEEK 52^1,2

DEFINING CLINICAL REMISSION PER ADAPTED MAYO SCORE:^1,2

ADAPTED MAYO
SCORE

ADAPTED MAYO
SCORE

STUDY DESIGN^1,2

PRIMARY ENDPOINT ASSESSED AT WEEK 52^1,2

MAINTENANCE RANKED SECONDARY ENDPOINTS ASSESSED AT WEEK 52^1,2

BASELINE CHARACTERISTICS²
AT WEEK 52

ENDPOINT DEFINITIONS^1-4