SKYRIZI: An IL-23/p19 inhibitor2-7
HIGH LEVELS OF CLEARANCE in more patients compared to adalimumab
SUPERIOR AT WEEK 16: 72% OF SKYRIZI PATIENTS ACHIEVED PASI 90 VS 47% ADALIMUMAB (NRI)1,16*
| Co-primary endpoint: 84% of patients achieved sPGA 0/1 at Week 16 with SKYRIZI vs 60% adalimumab (P<0.0001).16 |
In patients with a response of PASI ≥50 to <90 after 16 weeks of adalimumab treatment (Part B)
3X MORE PATIENTS ACHIEVED PASI 90 AT WEEK 44 AFTER SWITCHING TO SKYRIZI THAN THOSE WHO STAYED ON ADALIMUMAB1,16*
RERANDOMIZATION: Adalimumab patients achieving PASI ≥50 to <90
| * | P<0.0001 vs adalimumab. |
| † | SKYRIZI doses denoted in blue: Patients were stratified by weight (≤100 kg vs >100 kg) and prior TNF inhibitor exposure (no vs yes) and randomized 1:1 to receive 150 mg SKYRIZI (Weeks 0, 4, and 16) or adalimumab (80 mg at Week 0, 40 mg every other week [EOW]) from Week 1. |
| ‡ | P=0.0012 vs adalimumab; §P=0.0142 vs adalimumab; llP=0.0001 vs adalimumab. |
| Adalimumab-treated patients achieving PASI 50 to <90 at Week 16 were stratified by weight and prior TNF inhibitor exposure and rerandomized 1:1 to either continue adalimumab EOW until Week 41 or switch to SKYRIZI (Weeks 16, 20, and 32). | |
| Inadequate or partial response in the IMMvent study was defined as PASI ≥50 to <90 at Week 16 in patients receiving adalimumab. |
|
100% IMPROVED OR OR MAINTAINED PASI RESPONSE AT WEEK 44 AFTER SWITCHING FROM ADALIMUMAB TO SKYRIZI (LOCF)25*
| * | Improved or maintained response (n=35/35) was defined as a patient who was PASI ≥75 to <90 upon entry of IMMvent Part B (Week 16) and either improved to a PASI 90 or PASI 100 response or maintained by remaining categorized as PASI ≥75 to <90 at Week 44. |
Subgroup analysis25
| The subgroup included in this analysis was composed of patients who had a PASI score ≥75 to <90 at Week 16 in Part A of the IMMvent randomized controlled trial while taking adalimumab, and who then either remained on adalimumab or were switched to SKYRIZI for Part B of the trial (n=35/109). |
| Limitations: This analysis is post hoc, does not assess a prespecified endpoint, was not adjusted for multiplicity, comprises a small sample size, and the assessed outcomes are dichotomous (yes/no for PASI response cut-offs). Therefore, treatment differences cannot beregarded as statistically significant. |
Study design16
IMMvent was a Phase 3, randomized, double-blind, double-dummy, active-comparator-controlled study to evaluate the efficacy and safety of SKYRIZI (150 mg) compared to adalimumab in adult patients with moderate to severe plaque psoriasis over 44 weeks. In Part A, patients were randomized 1:1 to either SKYRIZI (150 mg) at Weeks 0 and 4, and every 12 weeks thereafter, or adalimumab 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 adalimumab with a PASI score of ≥50 but <90 were rerandomized 1:1 to either receive SKYRIZI (150 mg) Weeks 16, 20, and 32, or continue adalimumab. Patients who continued SKYRIZI in Part B remained on every-12-week dosing.
IMMvent Phase 3 study design16
A 44-week, randomized comparative study vs adalimumab in patients with moderate to severe chronic plaque psoriasis (N=605)
COMPLETE CLEARANCE in more patients compared to adalimumab
SUPERIOR AT WEEK 16: 40% OF SKYRIZI PATIENTS ACHIEVED PASI 100 VS 23% ADALIMUMAB (NRI)1,16*
In patients with a response of PASI ≥50 to <90 after 16 weeks of adalimumab treatment
SUPERIOR AT WEEK 44: 40% MORE PATIENTS ACHIEVED PASI 100 AFTER SWITCHING TO SKYRIZI THAN THOSE WHO STAYED ON ADALIMUMAB (NRI)1,16*
| * | P<0.0001 vs adalimumab. |
| † | SKYRIZI doses denoted in blue: Patients were stratified by weight (≤100 kg vs >100 kg) and prior TNF inhibitor exposure (no vs yes) and randomized 1:1 to receive 150 mg SKYRIZI (Weeks 0, 4, and 16) or adalimumab (80 mg at Week 0, 40 mg every other week [EOW]) from Week 1. |
| ‡ | P=0.0171 vs adalimumab; §P=0.0220 vs adalimumab; llP=0.0022 vs adalimumab; ¶P=0.0073 vs adalimumab; #P=0.0002 vs adalimumab |
| Adalimumab-treated patients achieving PASI 50 to <90 at Week 16 were stratified by weight and prior TNF inhibitor exposure and rerandomized 1:1 to either continue adalimumab EOW until Week 41 or switch to SKYRIZI (Weeks 16, 20, and 32). | |
| Inadequate or partial response in the IMMvent study was defined as PASI ≥50 to <90 at Week 16 in patients receiving adalimumab. |
|
100% IMPROVED OR OR MAINTAINED PASI RESPONSE AT WEEK 44 AFTER SWITCHING FROM ADALIMUMAB TO SKYRIZI (LOCF)10*
| * | Improved or maintained response (n=35/35) was defined as a patient who was PASI ≥75 to <90 upon entry of IMMvent Part B (Week 16) and either improved to a PASI 90 or PASI 100 response or maintained by remaining categorized as PASI ≥75 to <90 at Week 44. |
Subgroup analysis10
| The subgroup included in this analysis was composed of patients who had a PASI score ≥75 to <90 at Week 16 in Part A of the IMMvent randomized controlled trial while taking adalimumab, and who then either remained on adalimumab or were switched to SKYRIZI for Part B of the trial (n=35/109). |
| Limitations: This analysis is post hoc, does not assess a prespecified endpoint, was not adjusted for multiplicity, comprises a small sample size, and the assessed outcomes are dichotomous (yes/no for PASI response cut-offs). Therefore, treatment differences cannot beregarded as statistically significant. |
Study design8
IMMvent was a Phase 3, randomized, double-blind, double-dummy, active-comparator-controlled study to evaluate the efficacy and safety of SKYRIZI (150 mg) compared to adalimumab in adult patients with moderate to severe plaque psoriasis over 44 weeks. In Part A, patients were randomized 1:1 to either SKYRIZI (150 mg) at Weeks 0 and 4, and every 12 weeks thereafter, or adalimumab 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 adalimumab with a PASI score of ≥50 but <90 were rerandomized 1:1 to either receive SKYRIZI (150 mg) Weeks 16, 20, and 32, or continue adalimumab. Patients who continued SKYRIZI in Part B remained on every-12-week dosing.
IMMvent Phase 3 study design16
A 44-week, randomized comparative study vs adalimumab in patients with moderate to severe chronic plaque psoriasis (N=605)
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