ACR50 Response Over Time

^*P<0.001^5-7
Adapted from Kristensen LE, 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.
ACR, American College of Rheumatology scale; CI, confidence interval; NRI, nonresponder imputation; NRI-C, nonresponder imputation incorporating multiple imputation to handle missingdata due to COVID-19; PBO, placebo; PsA, psoriatic arthritis.

ACR70 Response Over Time

^*P<0.001^5-7
Adapted from Kristensen LE, 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.
ACR, American College of Rheumatology scale; CI, confidence interval; NRI, nonresponder imputation; NRI-C, nonresponder imputation incorporating multiple imputation to handle missingdata due to COVID-19; PBO, placebo; PsA, psoriatic arthritis.

^cPooled from KEEPsAKE 1 and KEEPsAKE 2.
^dAmong patients with LEI >0.
^eAmong patients with LDI >0.
LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index.

KEEPsAKE 1: Trial of SKYRIZI in psoriatic arthritis: csDMARD-IR population^5,7

Conclusion

Two randomised, 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

SKYRIZI is dosed 150 mg at Week 0, Week 4, and every 12 weeks thereafter. At week 24 when the placebo cohort were switched over to SKYRIZI, loading doses were not administered and patients were immediately switched to 12 weekly dosing.

Study design⁵

In the two randomised, double-blind, placebo-controlled KEEPsAKE-1 and KEEPsAKE-2 studies, patients had a diagnosis of PsA ≥6 months based on Classification Criteria for Psoriatic Arthritis (CASPAR), a median duration of PsA of 4.9 years at baseline, ≥5 tender joints and ≥5 swollen joints, and active plaque psoriasis or nail psoriasis at baseline. 55.9% of subjects had ≥3% body surface area with active plaque psoriasis. 63.4% and 27.9% of subjects had enthesitis and dactylitis, respectively.

In KEEPsAKE-1, all subjects had a previous inadequate response or intolerance to nonbiologic DMARD therapy and were biologic naïve.
In KEEPsAKE-2, 53.5% of subjects had a previous inadequate response or intolerance to nonbiologic DMARD therapy and 46.5% of subjects had a previous inadequate response or intolerance to biologic therapy.

In both studies, subjects were randomised to receive SKYRIZI 150 mg or placebo at Weeks 0, 4, and 16. Starting from Week 28, all subjects received SKYRIZI every 12 weeks. Both studies include a long-term extension for up to an additional 204 weeks. 59.6% of subjects from both studies were receiving concomitant MTX, 11.6% were receiving concomitant nonbiologic DMARDs other than MTX, and 28.9% were receiving SKYRIZI monotherapy. SKYRIZI was dosed 150 mg at Week 0, Week 4, and every 12 weeks thereafter.
Dosing of ustekinumab was 90mg for patients weighing over 100kg.

ACR20, ≥20% improvement in American College of Rheumatology score; CASPAR, Classification Criteria for Psoriatic Arthritis; csDMARD, conventional synthetic disease-modifying antirheumatic drug; MTX, methotrexate; PsA, psoriatic arthritis; q12w, every 12 weeks; SC, subcutaneous.

Safety Profile in Psoriatic Arthritis

Safety events from KEEPsAKE 1 and KEEPsAKE 2 through to week 52⁷

Adapted from Kristensen LE, et al. 2021.

^aSafety reported through data cutoff date (19 April 2021), which includes data through week 52. Data are from any RZB 150-mg group that includes all patients who received RZB 150 mg, including those who started on RZB 150 mg at randomisation and who switched from placebo to RZB 150 mg after week 24.
^b10 of the 27 events were cases of COVID-19.
^cAn 81-year-old male patient randomised to RZB died of urosepsis on day 96, and a 41-year-old male patient randomised to RZB experienced sudden death on day 502.
E, events; MACE, major adverse cardiovascular events; NMSC, non-melanoma skin cancer; PY, patient-years; RZB, risankizumab; TB, tuberculosis; TEAE, treatment-emergent adverse events.