An IL-23/p19 inhibitor from AbbVie, SKYRIZI 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 (DMARDs).1
In KEEPsAKE-1: SKYRIZI vs placebo in bio-naïve patients with active PsA
SKYRIZI MET THE PRIMARY ENDPOINT OF ACR20 AT WEEK 24 (NRI) WITH 57% OF SKYRIZI PATIENTS ACHIEVING ACR20 VS 34% PLACEBO (P≤0.001)1,2
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| SKYRIZI dosing: Participants received 150 mg (two 75-mg subcutaneous injections) at Week 0, 4, and every 12 weeks thereafter. | |
| * | P<0.001 vs placebo. |
| Primary Week 24 analysis used NRI incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) and a mixed-effect model for repeated measures considering intercurrent events. Week 52 and Week 100 were not multiplicity controlled. Week 52 and Week 100 analyses used NRI-MI (as observed with missing data).2,4 | |
MDA is achieved when meeting 5 of 7 criteria listed below:5
| * | KEEPsAKE-1: Except for pneumonia, which was reported for 2 patients (0.4%) in the placebo group, no serious AE or severe TEAE was reported for >1 patient in either group. |
| † | One death (urosepsis) in an 81-year-old male patient. |
| ‡ | KEEPsAKE-1 SKYRIZI: urosepsis (1 patient, resulting in death), cellulitis (1 patient), gastroenteritis (1 patient), COVID-19 pneumonia (1 patient), and viral upper respiratory tract infection leading to pneumonia (1 patient); placebo: pneumonia (2 patients), oral bacterial infection (one patient), dysentery (1 patient), appendicitis (1 patient), and cellulitis (1 patient). KEEPsAKE-2 SKYRIZI: abscess and cellulitis (1 patient) and gastroenteritis (1 patient); placebo: erysipelas, gastroenteritis, postoperative abscess, upper respiratory tract infection, and urinary tract infection (each reported for 1 patient). |
| § | KEEPsAKE-1: All nonserious, resolved with oral antiviral agents and did not result in discontinuation of the study drug. |
| || | KEEPsAKE-2: Both were nonmelanoma skin cancer. |
| ¶ | All nonserious and did not result in discontinuation of the study drug. |
| * | Long-term safety was evaluated using integrated all-risankizumab safety data sets (data cutoff March 25, 2023) from 20 Phase 1–4 clinical trials in PsO and 4 Phase 2 and 3 trials in PsA. Median (range) of treatment duration for PsO was 4.1 years (81 days to 8.8 years) and for PsA was 2.8 years (84 days to 4.0 years). For all patients who received ≥1 dose of risankizumab (all administered doses, 18 mg to 180 mg), AEs and AEs of special interest were assessed and recorded through the end of exposure (last dose to first dose + 5 geometric-mean half-lives [20 weeks]). |
| † | Excluding COVID-related infections. |
| ‡ | Excluding tuberculosis and herpes zoster. |
| § | One case of active tuberculosis was reported from Taiwan. The patient in a long-term open-label psoriasis study had latent tuberculosis diagnosed at screening of the feeder study and received isoniazid prophylaxis. He presented with a cough for 4 years after study initiation and was diagnosed based on positive sputum and chest x-ray (diagnostic results such as PCR/culture were not provided). |
| || | By system organ class. |
| ¶ | Reported events: eczema (2), Stevens-Johnson syndrome (2), urticaria (2), angioedema (1), drug hypersensitivity (1), erythema multiforme (1), and hypersensitivity (1). |
Study design
KEEPsAKE-1 AND KEEPsAKE-2 STUDY DESIGN1,2,6
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.
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 randomized 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.
Dosing: SKYRIZI was dosed 150 mg (two 75-mg subcutaneous injections) at Week 0, Week 4, and every 12 weeks thereafter.
EU INDICATIONS AND IMPORTANT SAFETY INFORMATION ABOUT SKYRIZI (risankizumab)
Indications1
Skyrizi (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Skyrizi, alone or in combination with methotrexate (MTX), 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 (DMARDs).
Skyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.
Important Safety Information1
Risankizumab is contraindicated in patients hypersensitive to the active substance or to any of the excipients, and in patients with clinically important active infections (e.g. active tuberculosis). Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Patients treated with risankizumab should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and risankizumab should not be administered until the infection resolves.
Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.
If a serious hypersensitivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated.
The most frequently reported adverse reactions were upper respiratory infections (from 13% in psoriasis to 15.6% in Crohn’s disease). Commonly (≥ 1/100 to < 1/10) reported adverse reactions included tinea infections, headache, pruritus, rash, fatigue, and injection site reactions.
This is not a complete summary of all safety information.
Please see the SmPC for complete prescribing information.
| References: 1. SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd; January 2024. 2. Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2022;81(2):225-231. doi:10.1136/annrheumdis-2021-221019 3. Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study. Rheumatology (Oxford). 2023;62(6):2113-2121. doi:10.1093/rheumatology/keac607 4. Kristensen L, Papp K, White D, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 100-week results from the KEEPsAKE 1 and KEEPsAKE 2 trials. Poster presented at: 2022 European Academy of Dermatology and Venereology Virtual Congress; September 7-10, 2022. 5. Coates LC, Fransen J, Helliwell PS. Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment. Ann Rheum Dis. 2010;69(1):48-53. doi:10.1136/ard.2008.102053 6. Östör A, Van den Bosch F, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2022;81(3):351-358. doi:10.1136/annrheumdis-2021-221048 7. Gordon KB, Blauvelt A, Bachelez H, et al. Long-term safety of risankizumab in patients with psoriatic disease: integrated analysis of psoriasis and psoriatic arthritis clinical trial data. Poster presented at: 2023 European Academy of Dermatology and Venereology Congress; October 11-14, 2023; Berlin, Germany. 8. Gordon KB, Blauvelt A, Coates LC, et al. Risankizumab long-term safety in patients with psoriatic disease: integrated analyses of data from psoriasis and psoriatic arthritis clinical trials. Poster presented at: 2022 European Academy of Dermatology and Venereology Virtual Congress; September 7-10, 2022. Poster 1607. |
| ACR: American College of Rheumatology; AE: adverse events; BSA: body surface area; DMARD: disease-modifying antirheumatic drug; E: event; HAQ-DI: Health Assessment Questionnaire-Disability Index; IL: interleukin; LEI: Leeds enthesitis index; MACE: major adverse cardiovascular event; MDA: minimal disease activity; mNAPSI: modified Nail Psoriasis Severity Index; mTSS: moadified total Sharp score; MTX: methotrexate; NMSC: nonmelanoma skin cancer; NRI: nonresponder imputation; NRI-C: nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; NRI-MI: nonresponder imputation–multiple imputation; OLE: open-label extension; PASI: Psoriasis Area and Severity Index; PBO: placebo; PCR: polymerase chain reaction; PsA: psoriatic arthritis; PsO: psoriasis; PY: patient-year; RCT: randomzied control trial; SD: standard deviation; TB: tuberculosis; TEAE: treatment-emergent adverse events; VAS: visual analogue scale. |
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| ALL-SKZD-240005 February 2024 |