US-MULT-230356
The IL-23 inhibitor from AbbVie indicated for the treatment of moderately to severely active Crohn's disease (CD) in adults.1
*Clinical remission was defined as a CDAI <150 points.
†Endoscopic Response was defined as a 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, based on central reading. The sections evaluated on endoscopy are the: rectum, sigmoid and left colon, transverse colon, right colon and ileum (per SES-CD assessment).
Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR‑100)‡ to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.
ENDOSCOPIC OUTCOMES
40% of total patients demonstrated endoscopic response with SKYRIZI at Week 12, regardless of biologic experience1,3
Co-Primary Endpoints for ADVANCE:
Endoscopic Response AT WEEK 12:
40% SKYRIZI vs 12% placebo, p<0.001
Clinical Remission AT WEEK 12:
45% SKYRIZI vs 25% placebo, p<0.001
48% OF TOTAL PATIENTS DEMONSTRATED ENDOSCOPIC RESPONSE WITH SKYRIZI AT WEEK 52, REGARDLESS OF BIOLOGIC EXPERIENCE1,3
Co-Primary Endpoints for FORTIFY:
Endoscopic Response AT WEEK 52:
50% SKYRIZI 180 mg SC vs 22% placebo (induction responders), p<0.05
48% SKYRIZI 360 mg SC vs 22% placebo (induction responders), p<0.05
Clinical Remission AT WEEK 52:
61% SKYRIZI 180 mg SC vs 46% placebo (induction responders), p<0.05
57% SKYRIZI 360 mg SC vs 46% placebo (induction responders), p<0.05
Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100)† to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.
ENDOSCOPIC OUTCOMES IN CD
Dr. Casey Chapman, Dr. Bincy Abraham, and Dr. Anita Afzali describe SKYRIZI's Phase 3 clinical trial results. SKYRIZI is the first approved product in Crohn's disease with co-primary endpoints aligned to STRIDE-II guidelines.
CLINICAL OUTCOMES IN CD
Dr. Casey Chapman, Dr. Asher Kornbluth, and Dr. Jennifer Seminerio present SKYRIZI induction trial results at Weeks 4 and 12, and maintenance trial results at Week 52.
ENDOSCOPIC REMISSION DATA
Endoscopic Remission: SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer.
24% of total patients demonstrated endoscopic remission with SKYRIZI at Week 121
Ranked Secondary Endpoint for ADVANCE:
Endoscopic Remission AT WEEK 12
(Total Population):
24% SKYRIZI vs 9% placebo, p<0.001
Endoscopic Remission: SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer.
Data Limitations: Endoscopic remission sub-group data at Week 52 was not tested for multiplicity control, and cannot demonstrate a statistically significant difference in treatment effect for SKYRIZI vs placebo (induction responders). No statistical or clinical conclusions can be made.
Endoscopic Remission: SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer.
Endoscopic remission was observed at Week 52 in 41% (48/117) of subjects treated with the SKYRIZI 360 mg maintenance regimen and 13% (17/130) of subjects treated with placebo. This endpoint was not statistically significant under the pre-specified multiple testing procedure.
Endoscopic remission was observed at Week 52
Secondary Endpoints for FORTIFY:
Endoscopic Remission AT WEEK 52:
(Total Population):
33% SKYRIZI 180 mg SC vs
13% placebo (induction responders)
41% SKYRIZI 360 mg SC vs
13% placebo (induction responders)
This endpoint was not statistically significant under the prespecified multiple testing procedure.
Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100)† to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study
Data Limitations: Endoscopic remission and sub-group data at Week 52 was not tested for multiplicity control, and cannot demonstrate a statistically significant difference in treatment effect for SKYRIZI vs placebo (induction responders). No statistical or clinical conclusions can be made.
Endoscopic Remission: SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer.
CLINICAL REMISSION
Co-Primary Endpoints for FORTIFY:
Endoscopic Response AT WEEK 52:
50% SKYRIZI 180 mg SC vs 22% placebo (induction responders), p<0.05
48% SKYRIZI 360 mg SC vs 22% placebo (induction responders), p<0.05
Clinical Remission AT WEEK 52:
61% SKYRIZI 180 mg SC vs 46% placebo (induction responders), p<0.05
57% SKYRIZI 360 mg SC vs 46% placebo (induction responders), p<0.05
Did you know?
The induction-only group consisted of subjects who achieved clinical response (CR-100) to SKYRIZI induction therapy and were randomized to receive placebo in FORTIFY. The mean half-life of SKYRIZI is approximately 21 days for patients with CD which may have contributed to these rates.
Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100)† to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.
Co-Primary Endpoints for ADVANCE:
Endoscopic Response AT WEEK 12:
40% SKYRIZI vs 12% placebo, p<0.001
Clinical Remission AT WEEK 12:
45% SKYRIZI vs 25% placebo, p<0.001
EARLY CLINICAL RESPONSE (AT 4 WEEKS)
Data Limitations: Data not labeled as a ranked secondary endpoint were prespecified nonranked endpoints not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.
Clinical Response: Reduction of CDAI score ≥100 points from baseline.
60% OF SKYRIZI PATIENTS RESPONDED AT WEEK 12 AFTER INDUCTION
Data Limitations: Data not labeled as a ranked secondary endpoint were prespecified nonranked endpoints not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.
Clinical Response: Reduction of CDAI score ≥100 points from baseline.
PATIENT CASES
Improved Endoscopic Outcomes in a Bio-Naïve Clinical Trial Patient
Patient received SKYRIZI 600 mg IV (Induction) and 180 mg SC (Maintenance)
THIS IMAGE REPRESENTS AN INDIVIDUAL PATIENT WHO WAS TREATED WITH SKYRIZI WHO HAD ENDOSCOPIC REMISSION AT WEEK 52. IN THE FORTIFY MAINTENANCE CLINICAL TRIAL, ENDOSCOPIC REMISSION DATA AT WEEK 52 WAS NOT STATISTICALLY SIGNIFICANT UNDER THE
PRE-SPECIFIED MULTIPLE TESTING PROCEDURE.
IMAGES ARE FROM A CLINICAL TRIAL PATIENT TREATED WITH SKYRIZI. INDIVIDUAL RESULTS MAY VARY.
Improved Endoscopic Outcomes in a Biologic Failure Clinical Trial Patient
Patient received SKYRIZI 600 mg IV (Induction) and 360 mg SC (Maintenance)
THIS IMAGE REPRESENTS AN INDIVIDUAL PATIENT WHO WAS TREATED WITH SKYRIZI WHO HAD ENDOSCOPIC REMISSION AT WEEK 52. IN THE FORTIFY MAINTENANCE CLINICAL TRIAL, ENDOSCOPIC REMISSION DATA AT WEEK 52 WAS NOT STATISTICALLY SIGNIFICANT UNDER THE
PRE-SPECIFIED MULTIPLE TESTING PROCEDURE.
IMAGES ARE FROM A CLINICAL TRIAL PATIENT TREATED WITH SKYRIZI. INDIVIDUAL RESULTS MAY VARY.
HAVE YOU SEEN SKYRIZI'S
DOSING SCHEDULE?
DO YOU KNOW ABOUT SKYRIZI'S
WELL-STUDIED SAFETY PROFILE?
Images You Can See
Check out the SKYRIZI CD patient case studies with endoscopy images.
Patient Case Photo GalleryIndications
Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.
Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.
Important Safety Information
Hypersensitivity Reactions
SKYRIZI® (risankizumab-rzaa) is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately.
Infection
SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves.
Tuberculosis (TB)
Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB.
Hepatotoxicity in Treatment of Crohn’s Disease
Drug-induced liver injury was reported in a patient with Crohn’s disease who was hospitalized for a rash during induction dosing of SKYRIZI. For the treatment of Crohn’s disease, evaluate liver enzymes and bilirubin at baseline and during induction (12 weeks); monitor thereafter according to routine patient management. Consider an alternate treatment for patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct your patient to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.
Administration of Vaccines
Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines.
Adverse Reactions
Most common (≥1%) adverse reactions associated with SKYRIZI in plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo.
Most common (>3%) adverse reactions associated with SKYRIZI in Crohn’s disease are upper respiratory infections, headache, and arthralgia in induction and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection in maintenance.
Lipid Elevations: Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12 in patients treated with SKYRIZI in Crohn’s disease.
Dosage Forms and Strengths: SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, and a 600 mg/10 mL single-dose vial for intravenous infusion.
INDICATIONS
Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.
Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.
Please see Full Prescribing Information.
US-SKZG-220547
REFERENCES
Data Limitations: Post hoc analyses of SF and APS at Weeks 1-3 were not powered or tested to demonstrate a statistical significant difference in treatment effect for SKYRIZI vs. placebo. Assessment used non-responder imputation for missing data due to COVID-19 (NRI-NC); analysis used the Cochran-Mantel-Haenszel test.
SF/APS Measures: ≥60% decrease in average daily SF and/or ≥35% decrease in average daily APS score and both not worse than baseline, and/or a SF of 2.8 or less and APS of 1 or less.
APS=abdominal pain score; IV=intravenous; NRI-NC=non-responder imputation-no special handling for COVID-19; SF=stool frequency
References
Data Limitations: Post hoc analyses of SF and APS at Weeks 1-3 were not powered or tested to demonstrate a statistical significant difference in treatment effect for SKYRIZI vs. placebo. Assessment used non-responder imputation for missing data due to COVID-19 (NRI-NC); analysis used the Cochran-Mantel-Haenszel test.
SF/APS Measures: ≥60% decrease in average daily SF and/or ≥35% decrease in average daily APS score and both not worse than baseline, and/or a SF of 2.8 or less and APS of 1 or less.
APS=abdominal pain score; IV=intravenous; NRI-NC=non-responder imputation-no special handling for COVID-19; SF=stool frequency
References
The population of 450 included in this post hoc analysis represents those who received SKYRIZI 600 mg IV and/or 360 mg SC. All patients with insufficient data were counted as non-responders for CR-100 delayed response at Week 24.
*Data Limitations: Post hoc analysis of pooled data of clinical response (CR-100) from induction trials. Analysis is not multiplicity or placebo controlled, subjects were not restratified at Week 12 for Week 24 assessment and are not counted in the efficacy or safety analysis at Week 52. No clinical or statistical inferences can be made due to the exploratory nature of the assessment and should be interpreted with caution.
Induction period for SKYRIZI is 12 weeks.
Clinical Response: Reduction of CDAI score ≥100 points from baseline.
CDAI=Crohn's disease activity index; IV=intravenous; SC=subcutaneous
REFERENCES
*The four endoscopic variables are scored from 0 to 3 in each bowel segment (rectum, sigmoid and left colon, transverse colon, right colon and ileum).
†In diameter.
CD=Crohn's disease; SES-CD=simple endoscopic score for Crohn’s disease
References
Data Limitations: The post hoc analysis of patients who met the criteria for endoscopic response and endoscopic remission at Week 52 was not included in the pre-specified analysis for SKYRIZI and thus was not multiplicity controlled. No statistical or clinical conclusions can be drawn from this presentation and the results should be interpreted with caution.
Data Limitations: The post hoc analysis of patients who met the criteria for endoscopic response and endoscopic remission at Week 52 was not included in the pre-specified analysis for SKYRIZI and thus was not multiplicity controlled. No statistical or clinical conclusions can be drawn from this presentation and the results should be interpreted with caution.
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, based on central reading. The sections evaluated on endoscopy are the: rectum, sigmoid and left colon, transverse colon, right colon and ileum (per SES-CD assessment).
Endoscopic Remission: SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer.
Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100)* to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.
*Clinical response was defined as a reduction of CDAI score ≥100 points from baseline.
CDAI=Crohn's disease activity index; SES-CD=simple endoscopic score for Crohn's disease
REFERENCES
*As of January 2023.
†The total population in the ADVANCE and MOTIVATE studies includes patients dosed with risankizumab-rzaa 1200 mg IV, which did not demonstrate additional treatment benefit over the 600 mg dose and is not a recommended regimen.
aThe bio-naïve subpopulation includes patients who were bio‑exposed but did not have an inadequate response, loss of response, or intolerance to biologics (13%).
bPrior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics.
cThe bio-naïve subpopulation includes patients who were bio-exposed but did not have an inadequate response, loss of response, or intolerance to biologics (8%).
dClinical response was defined as a reduction of CDAI score ≥100 points from baseline.
CO-PRIMARY
ENDPOINTS
Endoscopic Responsea (>50% decrease in SES-CD) and Clinical Remissionb (CDAI <150) at Week 12
Endoscopic Responsea (>50% decrease in SES-CD) and Clinical Remissionb (CDAI <150) at Week 12
Endoscopic Responsea (>50% decrease in SES-CD) and Clinical Remissionb (CDAI <150) at Week 52
DURATION
12-week, randomized, double-blind, placebo-controlled, multi-center study
12-week, randomized, double-blind, placebo-controlled, multi-center study
52-week, randomized, double-blind, placebo-controlled, multi-center study
CONCOMITANT
THERAPIES
All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, corticosteroids, and Crohn's-related antibiotics
All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, corticosteroids, and Crohn's-related antibiotics
All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, and Crohn's-related antibiotics
Patients taking corticosteroids at the start of FORTIFY had their therapy tapered
DOSING
IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mgc or placebo at Weeks 0, 4, and 8
IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mgc or placebo at Weeks 0, 4, and 8
Subcutaneous injection of SKYRIZI 180 mg, SKYRIZI 360 mg or placebo starting at Week 12 and every 8 weeks after
INCLUSION
CRITERIA
Moderately to severely active CD:
Moderately to severely active CD:
Moderately to severely active CD:
| ADVANCE N=850 |
|
|---|---|
| CO-PRIMARY ENDPOINTS |
Endoscopic Responsea (>50% decrease in SES-CD) and Clinical Remissionb (CDAI <150) at Week 12 |
| DURATION | 12-week, randomized, double-blind, placebo-controlled, multi-center study |
| CONCOMITANT THERAPIES |
All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, corticosteroids, and Crohn's-related antibiotics |
| DOSING | IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mgc or placebo, at Weeks 0, 4, and 8 |
| INCLUSION CRITERIA |
Moderately to severely active CD:
|
| MOTIVATE N=569 |
|
|---|---|
| CO-PRIMARY ENDPOINTS |
Endoscopic Responsea (>50% decrease in SES-CD) and Clinical Remissionb (CDAI <150) at Week 12 |
| DURATION | 12-week, randomized, double-blind, placebo-controlled, multi-center study |
| CONCOMITANT THERAPIES |
All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, corticosteroids, and Crohn's-related antibiotics |
| DOSING | IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mgc or placebo, at Weeks 0, 4, and 8 |
| INCLUSION CRITERIA |
Moderately to severely active CD:
|
| FORTIFY N=382 |
|
|---|---|
| CO-PRIMARY ENDPOINTS |
Endoscopic Responsea (>50% decrease in SES-CD) and Clinical Remissionb (CDAI <150) at Week 52 |
| DURATION | 52-week, randomized, double-blind, placebo-controlled, multi-center study |
| CONCOMITANT THERAPIES |
All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, and Crohn's-related antibiotics Patients taking corticosteroids at the start of FORTIFY had their therapy tapered |
| DOSING | Subcutaneous injection of SKYRIZI 180 mg, SKYRIZI 360 mg or placebo starting at Week 12 and every 8 weeks after |
| INCLUSION CRITERIA |
Moderately to severely active CD:
|
aEndoscopic response was defined as a 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, based on central reading. The sections evaluated on endoscopy are the: rectum, sigmoid and left colon, transverse colon, right colon and ileum (per SES-CD assessment).
bClinical remission was defined as a CDAI score <150 points.
cThe 1200 mg IV induction dose did not demonstrate additional treatment benefit over the 600 mg IV dose and is not a recommended regimen.
dThe bio-naïve subpopulation includes patients who were bio‑exposed but did not have an inadequate response, loss of response, or intolerance to biologics (13%).
ePrior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics.
fClinical response was defined as a reduction of CDAI score ≥100 points from baseline.
APS=abdominal pain score; CD=Crohn's disease; CDAI=Crohn’s disease activity index; IV=intravenous; SC=subcutaneous; SES-CD=simple endoscopic score for Crohn’s disease; SF=stool frequency
References
US-SKZG-230070
Male, n (%)
88
(50)
189
(56)
Age (years),
mean (SD)
37.1
(13.4)
38.3
(13.3)
Disease duration
(years), mean (SD)
8.2
(7.1)
9.0
(8.8)
hs-CRP (mg/L),
median (IQR)
8.4
(2.8-21.9)
7.3
(2.8-21.8)
CDAI, mean (SD)
319.2
(59.4)
311.2
(62.4)
SES-CD, mean (SD)
13.8
(6.8)
14.7
(7.7)
Corticosteroid
use, n (%)
50
(29)
102
(30)
Biologics failure
history
0, n (%)
78
(45)
141
(42)
1, n (%)
41
(23)
100
(30)
>1, n (%)
56
(32)
95
(28)
Male, n (%)
99
(53)
92
(48)
Age (years),
mean (SD)
39.3
(13.5)
40.2
(13.6)
Disease duration
(years), mean (SD)
12.5
(9.7)
10.9
(7.7)
hs-CRP (mg/L),
median (IQR)
9.4
(3.6-28.2)
9.3
(3.5-23.0)
CDAI, mean (SD)
319.6
(69.8)
310.7
(63.6)
SES-CD, mean (SD)
15.0
(8.1)
14.4
(7.6)
Corticosteroid
use, n (%)
68
(36)
65
(34)
Biologics failure
history
0, n (%)
0
0
1, n (%)
88
(47)
92
(48)
>1, n (%)
99
(53)
99
(52)
FORTIFY |
Placebo
|
SKYRIZI
|
SKYRIZI
|
|
|---|---|---|---|---|
| BASELINE OF INDUCTION (ADVANCE, MOTIVATE) | ||||
Male, |
72 |
62 |
67 |
|
Age (years), |
38.0 |
39.2 |
36.2 |
|
Disease |
9.6 |
10.6 |
8.6 |
|
Baseline |
33 |
37 |
34 |
|
Baseline |
40 |
47 |
36 |
|
Biologics |
||||
0, n (%) |
31 |
40 |
34 |
|
1, n (%) |
49 |
34 |
42 |
|
>1, n (%) |
50 |
61 |
41 |
|
Baseline |
314.2 |
327.6 |
316.2 |
|
Baseline |
14.1 |
14.9 |
14.3 |
|
Baseline |
5.8 |
6.2 |
5.9 |
|
Baseline |
1.9 |
2.0 |
1.9 |
|
Baseline FCP (mg/kg), |
904.0 |
1666.0 |
1622.0 |
|
Baseline |
7.9 |
8.7 |
10.6 |
|
| Week 0 of Maintenance | ||||
CDAI at |
111.6 |
117.6 |
125.4 |
|
SES-CD at |
7.9 |
7.8 |
8.3 |
|
SF at |
1.4 |
2.1 |
1.9 |
|
APS at |
0.6 |
0.6 |
0.6 |
|
FCP at Week 0 (mg/kg), |
300.0 |
361 |
485.5 |
|
hs-CRP at Week 0 (mg/L), |
3.6 |
3.7 |
4.0 |
|
Disease duration (years), mean (SD)
9.6 (8.8)
9.3 (8.1)
Baseline immunomodulator use, n (%)
40 (24.4)
40 (28.4)
Baseline steroid use, n (%)
51 (31.1)
42 (29.8)
Biologics failure history
0, n (%)
41 (25.0)
39 (27.7)
1, n (%)
60 (36.6)
51 (36.2)
>1, n (%)
63 (38.4)
51 (36.2)
Baseline CDAI, mean (SD)
307.4 (64.9)
308.9 (61.1)
Baseline SES-CD, mean (SD)
14.0 (7.1)
14.3 (7.4)
Baseline SF, mean (SD)
5.8 (2.7)
5.9 (2.6)
Baseline APS, mean (SD)
1.9 (0.5)
1.8 (0.5)
Baseline FCP, median (min,max)
794.5
(30, 11378)
1543.0
(30, 14649)
Baseline hs-CRP, median (min,max) (mg/L)
7.6
(0.3, 181)
10.1
(0.3, 129)
CDAI at Week 0, mean (SD)
133.6 (80.6)
137.2 (67.7)
SES-CD at Week 0, mean (SD)
7.6
(0.3, 181)
8.5 (7.3)
SF at Week 0, mean (SD)
1.8 (1.8)
2.1 (1.8)
APS at Week 0, mean (SD)
0.7 (0.6)
0.7 (0.6)
FCP at Week 0, median (min,max) (mg/kg)
307
(30, 28013)
424
(30, 14804)
hs-CRP at Week 0, median (min,max) (mg/L)
4.1
(0.2, 53.4)
3.9
(0.2, 258)
Includes randomized subjects who received at least one dose of study drug, who had baseline eligible SES-CD ≥6 (≥4 for isolated ileal disease), and who received 12-week SKYRIZI IV treatment.
APS=abdominal pain score; CDAI=Crohn’s disease activity index; FCP=fecal calprotectin; hs-CRP=high-sensitivity C-reactive protein; IQR=interquartile range; IV=intravenous; SC=subcutaneous; SD=standard deviation; SES-CD=simple endoscopic score for Crohn’s disease; SF=stool frequency
References
US-SKZG-230070
Intention-to-treat 1A population, Non-responder imputation - COVID-19
Data Limitations: Data was not multiplicity controlled, and not powered to demonstrate statistical difference in treatment effect for SKYRIZI vs placebo (induction responders). No statistical or clinical conclusions can be made.
Clinical Remission: Defined as a CDAI score <150 points.
Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100)* to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.
*Clinical response was defined as a reduction of CDAI score ≥100 points from baseline.
CDAI=Crohn's disease activity index
REFERENCE
US-SKZD-210908
