SKYRIZI VS OTEZLA® (apremilast)2
Superior rates of PASI 90 AT WEEK 16
in a 2-part,
open-label, assessor-blinded study
in Moderate Plaque Psoriasis Patients
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
IMMpulse: a Phase 4, 2-part, open-label, assessor-blinded study
SUPERIOR RATES OF PASI 90 WITH SKYRIZI VS OTEZLA AT WEEK 16 (PERIOD A)2
In appropriate patients with moderate plaque psoriasis ready for systemic therapy
OTEZLA is a registered trademark of Amgen Inc. See US Prescribing Information for further information.
STUDY DESIGN:
IMMpulse was a 52 week, Phase 4, multicenter, randomized, open-label, efficacy assessor-blinded study of SKYRIZI compared to OTEZLA for the treatment of adults with moderate plaque psoriasis who are candidates for systemic therapy. Patients were randomly assigned (1:2) to either SKYRIZI 150 mg as single subcutaneous injection at Weeks 0, 4, and every 12 weeks thereafter or OTEZLA 30 mg orally twice daily, post-titration per label. The co-primary endpoints of Period A were achievement of PASI 90 and sPGA 0/1 at Week 16. The primary endpoint of Period B was achievement of PASI 90 at Week 52 among patients who failed to achieve PASI 75 with OTEZLA at Week 16. Patients were eligible for inclusion in this study if they had baseline PASI ≥12, BSA 10%-15%, and sPGA=3.2
NRI-MI=Nonresponder Imputation incorporating multiple imputation for missing data due to COVID-19; PASI=Psoriasis Area and Severity Index; PASI 75=≥75% improvement in Psoriasis Area and Severity Index; PASI 90=≥90% improvement in Psoriasis Area and Severity Index; sPGA 0/1=static Physician’s Global Assessment rating of “clear or almost clear.”
IMMpulse: a Phase 4, 2-part, open-label, assessor-blinded study
MEAN PASI RATES WITH SKYRIZI VS OTEZLA AT WEEK 16 (PERIOD A)2,3
In appropriate patients with moderate plaque psoriasis ready for systemic therapy
OTEZLA is a registered trademark of Amgen Inc. See US Prescribing Information for further information.
§p<0.001.
DATA LIMITATIONS:
Mean change in PASI at Week 16 was a pre-specified, non-ranked endpoint and was not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
STUDY DESIGN:
IMMpulse was a 52 week, Phase 4, multicenter, randomized, open-label, efficacy assessor-blinded study of SKYRIZI compared to OTEZLA for the treatment of adults with moderate plaque psoriasis who are candidates for systemic therapy. Patients were randomly assigned (1:2) to either SKYRIZI 150 mg as single subcutaneous injection at Weeks 0, 4, and every 12 weeks thereafter or OTEZLA 30 mg orally twice daily, post-titration per label. The co-primary endpoints of Period A were achievement of PASI 90 and sPGA 0/1 at Week 16. The primary endpoint of Period B was achievement of PASI 90 at Week 52 among patients who failed to achieve PASI 75 with OTEZLA at Week 16. Patients were eligible for inclusion in this study if they had baseline PASI ≥12, BSA 10%-15%, and sPGA=3.2
MMRM=Mixed model for repeated measures.
IMMpulse: a Phase 4, 2-part, open-label, assessor-blinded study
OVERALL RATES OF AEs AND TEAEs WITH SKYRIZI AND OTEZLA AT WEEK 16 (PERIOD A)2
In appropriate patients with moderate plaque psoriasis ready for systemic therapy
OTEZLA is a registered trademark of Amgen Inc. See US Prescribing Information for further information.
For Period B:
Period B safety rates (E/100PYs) in the continuous SKYRIZI population (n=118) were consistent with safety rates from Period A, with the exception of: serious AEs (8.9), serious infections (0.8), injection site reactions (5.7), and hypersensitivity (4.1).3
SKYRIZI safety in Period A
No patients taking SKYRIZI experienced adjudicated MACE, any infection, serious infections, hepatic events, serious hypersensitivity, IBD, or malignancy.
There were no deaths or cases of tuberculosis reported in the study.
In the IMMpulse study, most frequent adverse events (≥5%) in risankizumab-treated patients were COVID-19 and nasopharyngitis and among apremilast-treated patients were diarrhea, nausea, and headache.
Most common adverse reactions (≥1%) associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
Adverse reaction rates observed in clinical trials may not predict rates observed in clinical practice.
STUDY DESIGN:
IMMpulse was a 52 week, Phase 4, multicenter, randomized, open-label, efficacy assessor-blinded study of SKYRIZI compared to OTEZLA for the treatment of adults with moderate plaque psoriasis who are candidates for systemic therapy. Patients were randomly assigned (1:2) to either SKYRIZI 150 mg as single subcutaneous injection at Weeks 0, 4, and every 12 weeks thereafter or OTEZLA 30 mg orally twice daily, post-titration per label. The co-primary endpoints of Period A were achievement of PASI 90 and sPGA 0/1 at Week 16. The primary endpoint of Period B was achievement of PASI 90 at Week 52 among patients who failed to achieve PASI 75 with OTEZLA at Week 16. Patients were eligible for inclusion in this study if they had baseline PASI ≥12, BSA 10%-15%, and sPGA=3.2
STUDY DESIGN:
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.
AE=Adverse event; IBD=Inflammatory bowel disease; MACE=Major adverse cardiovascular event;
TEAE=Treatment-emergent adverse event.
Safety Profile Established
in Ps and PsA1
4 DOSES PER YEAR
4 doses per year after 2 initiation doses
at Weeks 0 and 4 (150 mg/dose)1
