Plaque psoriasis: SKYRIZI (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.1
Psoriatic arthritis: SKYRIZI alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs.1
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KEEPsAKE 1: Trial of SKYRIZI in psoriatic arthritis:
csDMARD-IR population2
Study findings at-a-glance
Study Design Overview
KEEPsAKE 2: Trial of SKYRIZI in psoriatic arthritis:
csDMARD-IR and/or bio-IR population2,4
Study findings at-a-glance
Study Design Overview
Primary Endpoint ACR20 Response
*P<0.0012-4
Adapted from Kristensen et al. 2021
aBased on full analysis set, NRI-C was used for missing data.
bBased on full analysis set, NRI (as observed with imputation) was used for missing data.
Two randomized, double-blind, placebo-controlled studies assessing the safety and efficacy of 1,407 patients (964 in KEEPsAKE-1 and 443 in KEEPsAKE-2) ≥18 years old with active PsA.
DB, double-blind; NRI, nonresponder imputation; NRI-C, nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; PBO, placebo.
ACR50 Response Over Time
*P<0.0012-4
Adapted from Kristensen et al. 2021
aBased on full analysis set, NRI-C was used for missing data.
bBased on full analysis set, NRI (as observed with imputation) was used for missing data.
Two randomized, double-blind, placebo-controlled studies assessing the safety and efficacy of 1,407 patients (964 in KEEPsAKE-1 and 443 in KEEPsAKE-2) ≥18 years old with active PsA.
DB, double-blind; NRI, nonresponder imputation; NRI-C, nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; PBO, placebo.
ACR70 Response Over Time
*P<0.0012-4
Adapted from Kristensen et al. 2021
aBased on full analysis set, NRI-C was used for missing data.
bBased on full analysis set, NRI (as observed with imputation) was used for missing data.
Two randomized, double-blind, placebo-controlled studies assessing the safety and efficacy of 1,407 patients (964 in KEEPsAKE-1 and 443 in KEEPsAKE-2) ≥18 years old with active PsA.
DB, double-blind; NRI, nonresponder imputation; NRI-C, nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; PBO, placebo.
Resolution of Enthesitis with SKYRIZI at Week 522-4
cPooled from KEEPsAKE 1 and KEEPsAKE 2.
dAmong patients with LEI >0
eAmong patients with LDI >0
Resolution of Dactylitis with SKYRIZI at Week 522-4
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References
- SKYRIZI Summary of Product Characteristics.
- Kristensen LE, et al. Presentation at European Academy of Dermatology and Venereology Congress, 29 September–2 October 2021, virtual: D1T01.4A.
- Kristensen LE, et al. Presentation at European Academy of Dermatology and Venereology Congress, 29 September–2 October 2021, virtual: abstract AB0559.
- Östör A, et al. Presentation at European Academy of Dermatology and Venereology Congress, 29 September–2 October 2021, virtual: abstract OP0228.
UK-RISN-220209. Date of preparation: September 2022.
SKYRIZI® (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.1
SKYRIZI® (risankizumab) alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs.1
The recommended dose of SKYRIZI is 150mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
SKYRIZI is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Some patients may not be suitable for SKYRIZI. You are advised to read the Prescribing Information (which can be found on tab above). Please also refer to the SKYRIZI Summary of Product Characteristics for important information including special warnings/precautions for use and summary of adverse reactions.
Study design information can be found on the Study Design page.
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.
Adverse events should also be reported to AbbVie on [email protected]
