Durability
» Sustained PASI response in PsO patients.1,2
IMPROVEMENTS IN PASI 90 AND PASI 100 MAINTAINED FOR ~5 YEARS:1,2
LIMMitless is an ongoing, Phase 3, single-arm, multicentre, international, open-label extension (OLE) study evaluating the effi cacy and safety of SKYRIZI (150 mg). All patients in LIMMitless received SKYRIZI 150 mg for the duration of their participation in the study. Patients were initially randomised to receive SKYRIZI 150 mg in 1 of 5 base Phase 2/3 studies as listed in the fi gure below. 897 of 955 patients who completed one of the 5 base studies entered the LIMMitless OLE study and continued to receive SKYRIZI 150 mg every 12 weeks.
OLE limitations: In an open-label extension, there is a potential for enrichment of the long-term data in the remaining populations. Patients who are unable to tolerate or do not respond to the drug often drop out.
Observed cases (OC): No imputation of missing data; patients missing data at a visit were excluded from the observed analysis for that visit.
Dosing: SKYRIZI 150 mg (two 75 mg subcutaneous injections) at Week 0, Week 4, and every 12 weeks thereafter.
Assessments: Efficacy was assessed every 12 weeks by PASI 90, PASI 100, sPGA 0/1, and mean PASI percent improvement. Quality of life was assessed every 24 weeks by DLQI 0/1.
» Improved PsA signs and symptoms up to 1 year.3-6*
*As measured by ACR20.
IMPROVEMENTS IN ACR20, ACR50 AND ACR70 MAINTAINED AT 52 WEEKS:1-3
PBS Information
SKYRIZI: Authority required for the treatment of adults with severe plaque psoriasis. SKYRIZI is not listed on the PBS for the treatment of psoriatic arthritis. Refer to PBS Schedule for full authority information.
Please review the full Product Information (PI) before prescribing, available below.
Abbreviations: ACR, American College of Rheumatology; AE, adverse event; bDMARD, biologic disease modifying anti-rheumatic drug; csDMARD, conventional synthetic disease modifying antirheumatic drug; DLQI, Dermatology Life Quality Index; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; IR, inadequate response; mNAPSI, modified Nail Psoriasis Severity Index; mTSS, modified total Sharp score; NRI, non-responder imputation; OC, observed cases; OLE, open-label extension; PASI, Psoriasis Area Severity Index; PCS, physical component summary; PsA, psoriatic arthritis; PsO, psoriasis; RCT, randomised controlled trial; sPGA, static Physician's Global Assessment.
References: 1. Papp KA et al. Br J Dermatol 2021;185(6):1135–1145. 2. Papp KA et al. Poster presented at: the 31st Congress of the European Academy of Dermatology and Venerology, 7–10 September 2022. P1603. 3. Kristensen LE et al. Ann Rheum Dis 2022;81(2):225–31. 4. Kristensen LE et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 52-Week Results From KEEPsAKE 1. Poster presented at the Fall Clinical Dermatology Conference (FC21), October 21–24, 2021, Las Vegas, Nevada, Hybrid Meeting. 5. Östör A et al. Ann Rheum Dis 2022;81(3):351–8. 6. Östör A et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 52- Week Results From KEEPsAKE 2. Poster presented at the Fall Clinical Dermatology Conference (FC21), October 21–24, 2021, Las Vegas, Nevada, Hybrid Meeting.
AU-SKZD-210069. April 2024