SKYRIZI is indicated for the treatment of adult patients with moderately to severely active Crohnʼs disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.1
Endoscopic and symptom control is defined as endoscopic response (40% ADVANCE, 29% MOTIVATE) and clinical remission (43% ADVANCE, 35% MOTIVATE) at Week 12.1
SKYRIZI in Crohn’s disease is approved for use with an On-Body Injector (OBI).
SKYRIZI INCLUDED COPRIMARY ENDPOINTS OF BOTH CLINICAL REMISSION AND ENDOSCOPIC RESPONSE AT WEEK 121
The First Pivotal Studies in Crohn’s Disease to Include Endoscopic Response as a Coprimary Endpoint1
Mucosal Healing at Weeks 12* and 521†
Clinical Remission at Weeks 12 and 521‡
Maintenance of Clinical Remission at Week 521§
Established in 9 Phase 3 Clinical Trials Across 3 Approved Indications of Crohn’s Disease, Plaque Psoriasis, and Psoriatic Arthritis1
SKYRIZI met primaryII endpoint (clinical remission at Week 24 non-inferiority and endoscopic remission at Week 48, superiority) and secondary endpoints compared with ustekinumab2, including superiority in clinical¶ and endoscopic remission** at Week 48.
Note to Affiliate: please evaluate superiority data pillar against local regulations to ensure prominence of non-inferiority endpoint is sufficient
*Mucosal healing at Week 12: Statistically significant under multiplicity control for risankizumab vs placebo comparison (MOTIVATE P≤0.01) (ADVANCE P<0.001).1
†Mucosal healing at Week 52: Nominal P<0.001 for risankizumab vs placebo comparison without overall type I error control (FORTIFY).1
‡Clinical remission at Week 12 and 52: Statistically significant under multiplicity control for risankizumab vs placebo comparison (MOTIVATE P≤0.01) (ADVANCE P<0.001) (FORTIFY P≤0.01).1
§Maintenance of clinical remission at Week 52: Nominal P≤0.01 for risankizumab vs placebo comparison without overall type I error control (FORTIFY).1
IIClinical remission at Week 24 tested for non-inferiority in 50% of subjects, therefore no superiority claim can be made (SEQUENCE).2
¶CDAI clinical remission: CDAI <150 (SEQUENCE).2
**Endoscopic remission: SES-CD ≤4 and at least a 2-point reduction vs baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer (SEQUENCE).2
Mucosal Healing1*
Week 12 Induction Studies†
- MOTIVATE: Placebo (n=186): 4% of patients; SKYRIZI 600 mg IV (n=190): 14% of patients. Statistically significant under multiplicity control for SKYRIZI vs placebo comparison (P≤0.01).
- ADVANCE: Placebo (n=173): 8% of patients; SKYRIZI 600 mg IV (n=336): 21% of patients. Statistically significant under multiplicity control for SKYRIZI vs placebo comparison (P<0.001).
Week 52 Maintenance Study‡
- FORTIFY: Placebo/SKYRIZI induction responders (n=162): 10% of patients; SKYRIZI 360 mg SubQ (n=141): 31% of patients. Nominal P<0.001 SKYRIZI vs placebo comparison.
Clinical Remission (SF/APS)1*
Week 12 Induction Studies†
- MOTIVATE: Placebo (n=187): 19% of patients; SKYRIZI 600 mg IV (n=191): 35% of patients. Statistically significant under multiplicity control for SKYRIZI vs placebo comparison (P≤0.01).
- ADVANCE: Placebo (n=175): 22% of patients; SKYRIZI 600 mg IV (n=336): 43% of patients. Statistically significant under multiplicity control for SKYRIZI vs placebo comparison (P<0.001).
Week 52 Maintenance Study‡
- FORTIFY: Placebo/SKYRIZI induction responders (n=164): 40% of patients; SKYRIZI 360 mg SubQ (n=141): 52% of patients. Statistically significant under multiplicity control for SKYRIZI vs placebo comparison (P≤0.01).
Maintenance of Clinical Remission (SF/APS)1
Week 52 Maintenance Study‡
- FORTIFY: Placebo/SKYRIZI induction responders (n=91): 51% of patients; SKYRIZI 360 mg SubQ (n=72): 69% of patients. Nominal P≤0.01 SKYRIZI vs placebo comparison.
Nominal P values denote data not controlled for multiplicity. No clinical inferences can be drawn.
*NRI-C: Nonresponder imputation COVID-19, incorporating multiple imputation for missing data due to COVID-19 infection or logistical restrictions used for categorical endpoints; patients with missing data for all other reasons were counted as nonresponders.3,4
†The total population in the MOTIVATE and ADVANCE studies includes patients dosed with risankizumab 1200 mg IV, which is not an approved dose for CD.1
‡The total population in the FORTIFY study includes patients dosed with risankizumab 1200 mg IV induction and risankizumab 180 mg SubQ maintenance, which are not approved doses for Crohnʼs disease.1
Mucosal healing (ulcer-free endoscopy): SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥1 at baseline, as scored by a central reviewer.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
Maintenance of clinical remission (SF/APS): Clinical remission at Week 52 in subjects with SF/APS clinical remission at Week 0.1
Coprimary Endpoints of the SKYRIZI Phase 3 Clinical Trials1*
IMPORTANT CONTEXT ABOUT PLACEBO (SKYRIZI induction responders): The placebo group in the maintenance study FORTIFY consisted of subjects who achieved clinical response to risankizumab induction therapy and were randomized to receive placebo in the maintenance study (FORTIFY). Therefore, the placebo arm is referred to as “Placebo (SKYRIZI Induction Responders)” in the maintenance study sections on this site and referred to as “rizankizumab IV/placebo SC” in the SmPC.1
All P values shown are statistically significant under multiplicity control for SKYRIZI vs placebo comparison.1
*NRI-C: Nonresponder imputation COVID-19, incorporating multiple imputation for missing data due to COVID-19 infection or logistical restrictions used for categorical endpoints; patients with missing data for all other reasons were counted as nonresponders.3,4
†The total population in the MOTIVATE and ADVANCE studies includes patients dosed with risankizumab 1200 mg IV, which is not an approved dose for CD.1
‡The total population in the FORTIFY study includes patients dosed with risankizumab 1200 mg IV induction and risankizumab 180 mg SubQ maintenance, which are not approved doses for Crohnʼs disease.1
¶Clinical response: ≥30% decrease in SF and/or ≥30% decrease in APS and both not worse than baseline.1
Coprimary Endpoint Definitions
§Endoscopic response: Decrease in SES-CD >50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease), as scored by a central reviewer.1
ǁClinical remission (SF/APS): Average daily SF ≤2.8 and not worse than baseline and average daily APS ≤1 and not worse than baseline.1
APS=abdominal pain score; IV=intravenous; SES-CD=Simple Endoscopic Score for Crohn’s Disease; SF=stool frequency; SubQ=subcutaneous.
SKYRIZI Introduction Card
Download this summary of SKYRIZIʼs key clinical and safety data for easy reference in the future.
SKYRIZI Introduction Video
Listen to a quick introduction of SKYRIZIʼs pivotal trials, which included endoscopic response and clinical remission as coprimary endpoints—a first for any CD treatment.1
SKYRIZI Key Messages Video
Listen to more details about SKYRIZIʼs key clinical and safety data, as well as its dosing regimen.
Indication1
SKYRIZI is indicated for the treatment of adult patients with moderately to severely active Crohnʼs disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.
Important Safety Information1
Affiliate to insert local ISI.
References: 1. SKYRIZI [Summary of Product Characteristics]. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co; January 2024. 2. Peyrin-Biroulet L, Chapman JC, Colombel JF, et al. Risankizumab versus ustekinumab for patients with moderate to severe Crohn’s disease: results from the phase 3b SEQUENCE study. Abstract presented at: United European Gastroenterology Week (UEGW); October 14-17, 2023; Copenhagen, Denmark. 3. D’Haens G, Panaccione R, Baert F, et al. Risankizumab as induction therapy for Crohn’s disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399(10340):2015-2030. doi:10.1016/S0140-6736(22)00467-6 4. Ferrante M, Panaccione R, Baert F, et al. Risankizumab as maintenance therapy for moderately to severely active Crohn’s disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046. doi:10.1016/S0140-6736(22)00466-4