PRESCRIBING INFORMATION

RESOURCES AND EVENTS

SmPC 180mg

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SmPC 600mg

Skyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.¹

_{All superscript letters can be found by clicking the "Definitions" button.}

PRIMARY ENDPOINTS

References:

1. SKYRIZI^® Summary of Product Characteristics. Available at www.medicines.ie.

2. Louis E, et al. Risankizumab for Ulcerative Colitis: Two Randomized Clinical Trials. JAMA. 2024;332(11):881–897.

_{All superscript letters can be found by clicking the "Definitions" button.}

**MUCOSAL HEALING^* AT WEEK 12**^1,2

Endoscopic Improvement (endoscopic subscore of 1 or less without friability) at week 12

MUCOSAL HEALING^* AT WEEK 52^1,2

Endoscopic Improvement (endoscopic subscore of 1 or less without friability) at week 52

HISTOLOGIC ENDOSCOPIC MUCOSAL HEALING AT WEEK 12^1,2

Defined as an endoscopic subscore ≤1 without the evidence of friability and Geboes score ≤3.1.

References:

1. SKYRIZI^® Summary of Product Characteristics. Available at www.medicines.ie.

2. Louis E, et al. Risankizumab for Ulcerative Colitis: Two Randomized Clinical Trials. JAMA. 2024;332(11):881–897.

_{All superscript letters can be found by clicking the "Definitions" button.}

EARLY CLINICAL RESPONSE AT WEEK 4 OF INDUCTION^1,2

Clinical Response per partial adapted Mayo score: defined as decrease of ≥1 point and ≥30% from baseline and a decrease in RBS ≥1 or an absolute RBS ≤1

SYMPTOM CONTROL AND PATIENT OUTCOMES

AT WEEK 12^1,2*

References:

1. SKYRIZI^® Summary of Product Characteristics. Available at www.medicines.ie.

2. Louis E, et al. Risankizumab for Ulcerative Colitis: Two Randomized Clinical Trials. JAMA. 2024;332(11):881–897.

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SKYRIZI PRESCRIBING INFORMATION

IE-SKZG-250047 | Date of preparation: January 2026

Definitions:

AbbVie defines control as endoscopic response and clinical remission.

Endoscopic response: greater than 50% decrease in SES-CD from baseline, or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease.¹

Clinical remission (SF/APS): average daily SF ≤2.8 and not worse than baseline and average daily APS ≤1 and not worse than baseline.¹

Please refer to the Summary of Product Characteristics for complete prescribing information, available at www.medicines.ie.

Abbreviations:

APS: Abdominal pain score; AT: Advanced therapy; CI: Confi dence interval;

ES: Endoscopic subscore; OR: Odds ratio;

RBS: Rectal bleeding subscore;

SES-CD: Simple Endoscopic Score - Crohn’s Disease; SFS: Stool frequency subscore;

UC: Ulcerative Colitis.

References:

1. SKYRIZI^® Summary of Product Characteristics. Available at www.medicines.ie.

2. Louis E, et al. Risankizumab for Ulcerative Colitis: Two Randomized Clinical Trials. JAMA. 2024;332(11):881–897.

Skyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.¹

PRIMARY ENDPOINTS

**MUCOSAL HEALING^* AT WEEK 12**^1,2

Endoscopic Improvement (endoscopic subscore of 1 or less without friability) at week 12

MUCOSAL HEALING^* AT WEEK 52^1,2

Endoscopic Improvement (endoscopic subscore of 1 or less without friability) at week 52

HISTOLOGIC ENDOSCOPIC MUCOSAL HEALING AT WEEK 12^1,2

Defined as an endoscopic subscore ≤1 without the evidence of friability and Geboes score ≤3.1.

EARLY CLINICAL RESPONSE AT WEEK 4 OF INDUCTION^1,2

Clinical Response per partial adapted Mayo score: defined as decrease of ≥1 point and ≥30% from baseline and a decrease in RBS ≥1 or an absolute RBS ≤1

SYMPTOM CONTROL AND PATIENT OUTCOMES

AT WEEK 12^1,2*