SKYRIZI VS HUMIRA® (adalimumab)2
SUPERIOR RATES OF PASI 90 AT WEEK 16
IN A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY
CO-PRIMARY ENDPOINTS IN ULTIMMA-1 AND ULTIMMA-2 (NRI)1,4
PASI 90 at Week 16
UltIMMa-1:
SKYRIZI 75% (229/304),
placebo 5% (5/102)
UltIMMa-2:
SKYRIZI 75% (220/294),
placebo 2% (2/98)
p<0.0001.
sPGA 0/1 at Week 16
UltIMMa-1:
SKYRIZI 88% (267/304), placebo 8% (8/102)
UltIMMa-2:
SKYRIZI 84% (246/294), placebo 5% (5/98)
NRI=Nonresponder imputation.
Study Design:
UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate Phase 3, randomized, double-blind, placebo- and active-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks and biologic active control (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe plaque psoriasis. Patients received SKYRIZI 150 mg at Week 0, Week 4, and every 12 weeks thereafter.1,4
In Part A of IMMvent,
a 2-part, Phase 3 study
SKYRIZI DEMONSTRATED SUPERIOR RATES OF PASI 90 VS HUMIRA® (adalimumab) AT WEEK 162
72% OF SKYRIZI PATIENTS ACHIEVED PASI 90 VS 47% OF HUMIRA PATIENTS (NRI)2
WEEK 16 RESULTS (PART A)
*p<0.0001
Part A Co-Primary Endpoints: PASI 90 and sPGA 0/1 at Week 16
STUDY DESIGN:
IMMvent was a Phase 3, randomized, double-blind, double-dummy, active-controlled study to evaluate the efficacy and safety of SKYRIZI (150 mg) compared to HUMIRA in adult patients with moderate to severe plaque psoriasis over 44 weeks.3
In Part A of the study, patients were randomized 1:1 to either SKYRIZI (150 mg) at Weeks 0 and 4, and every 12 weeks thereafter, or HUMIRA at an initial dose of 80 mg followed by 40 mg every other week starting 1 week after the initial dose. At Week 16, in Part B, patients taking HUMIRA with a PASI score of ≥50 but <90 were re-randomized 1:1 to either receive SKYRIZI (150 mg) at Weeks 16, 20, and 32, or continue HUMIRA. Patients who continued SKYRIZI in Part B remained on every-12-week dosing.3
NRI=Nonresponder imputation.
In Part B, HUMIRA patients who achieved PASI 50 to <90 were re-randomized 1:1
3x MORE PATIENTS ACHIEVED PASI 90 AFTER SWITCHING TO SKYRIZI THAN THOSE WHO REMAINED ON HUMIRA® (adalimumab)2
66% OF SKYRIZI PATIENTS ACHIEVED PASI 90 VS 21% OF HUMIRA PATIENTS (NRI)2
WEEK 44 RESULTS (PART B)
*p<0.0001
PART B Primary Endpoint: PASI 90 at Week 44
STUDY DESIGN:
IMMvent was a Phase 3, randomized, double-blind, double-dummy, active-controlled study to evaluate the efficacy and safety of SKYRIZI (150 mg) compared to HUMIRA in adult patients with moderate to severe plaque psoriasis over 44 weeks.3
In Part A of the study, patients were randomized 1:1 to either SKYRIZI (150 mg) at Weeks 0 and 4, and every 12 weeks thereafter, or HUMIRA at an initial dose of 80 mg followed by 40 mg every other week starting 1 week after the initial dose. At Week 16, in Part B, patients taking HUMIRA with a PASI score of ≥50 but <90 were re-randomized 1:1 to either receive SKYRIZI (150 mg) at Weeks 16, 20, and 32, or continue HUMIRA. Patients who continued SKYRIZI in Part B remained on every-12-week dosing.3
NRI=Nonresponder imputation.
Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy. See
In Part A of IMMvent,
a 2-part, Phase 3 study
SKYRIZI DEMONSTRATED SUPERIOR RATES OF PASI 100 VS HUMIRA® (adalimumab) AT WEEK 162
40% OF SKYRIZI PATIENTS ACHIEVED COMPLETE CLEARANCE (PASI 100) VS 23% OF HUMIRA PATIENTS (NRI)2
WEEK 16 RESULTS (PART A)
*p<0.0001
Part A Ranked Secondary Endpoints: PASI 75 and PASI 100 at Week 16
STUDY DESIGN:
IMMvent was a Phase 3, randomized, double-blind, double-dummy, active-controlled study to evaluate the efficacy and safety of SKYRIZI (150 mg) compared to HUMIRA in adult patients with moderate to severe plaque psoriasis over 44 weeks.3
In Part A of the study, patients were randomized 1:1 to either SKYRIZI (150 mg) at Weeks 0 and 4, and every 12 weeks thereafter, or HUMIRA at an initial dose of 80 mg followed by 40 mg every other week starting 1 week after the initial dose. At Week 16, in Part B, patients taking HUMIRA with a PASI score of ≥50 but <90 were re-randomized 1:1 to either receive SKYRIZI (150 mg) at Weeks 16, 20, and 32, or continue HUMIRA. Patients who continued SKYRIZI in Part B remained on every-12-week dosing.3
NRI=Nonresponder imputation.
In Part B, HUMIRA patients who achieved PASI 50 to <90 were re-randomized 1:1
MORE PATIENTS ACHIEVED PASI 100 AFTER SWITCHING TO SKYRIZI THAN THOSE WHO REMAINED ON HUMIRA® (adalimumab)2
40% OF SKYRIZI PATIENTS ACHIEVED Complete clearance (PASI 100) VS 7% OF HUMIRA PATIENTS (NRI)2
WEEK 44 RESULTS (PART B)
*p<0.0001
Part B Ranked Secondary Endpoint: PASI 100 at Week 44
STUDY DESIGN:
IMMvent was a Phase 3, randomized, double-blind, double-dummy, active-controlled study to evaluate the efficacy and safety of SKYRIZI (150 mg) compared to HUMIRA in adult patients with moderate to severe plaque psoriasis over 44 weeks.3
In Part A of the study, patients were randomized 1:1 to either SKYRIZI (150 mg) at Weeks 0 and 4, and every 12 weeks thereafter, or HUMIRA at an initial dose of 80 mg followed by 40 mg every other week starting 1 week after the initial dose. At Week 16, in Part B, patients taking HUMIRA with a PASI score of ≥50 but <90 were re-randomized 1:1 to either receive SKYRIZI (150 mg) at Weeks 16, 20, and 32, or continue HUMIRA. Patients who continued SKYRIZI in Part B remained on every-12-week dosing.3
NRI=Nonresponder imputation.
Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy. See
4 DOSES PER YEAR
4 doses per year after 2 initiation doses
at Weeks 0 and 4 (150 mg/dose)1
