UK-RISN-230338. Date of preparation January 2024.
Find out more about the efficacy of SKYRIZI
Explore the durability of response with SKYRIZI through clinical trials and long-term data in psoriasis and psoriatic arthritis. Start by selecting a study from the menu below.
LONG-TERM DATA
HEAD-TO-HEAD TRIALS
SKYRIZI IN PsA
SKYRIZI LONG-TERM DATA: LIMMitless
Durable efficacy in psoriasis achieved by SKYRIZI patients through to 5.8 years*5
>85% of SKYRIZI patients achieved PASI 90 at 304 weeks*5
Adapted from Papp K, et al. 2023.
aBecause of differences in base study lengths, some patients enrolled in the LIMMitless study earlier than 52 weeks.
*Results from 304 week interim analysis including integrated data from five Phase II/III studies (UltIMMA-1, UltIMMa-2, SustaIMM, IMMvent, and NCT03255382) and the LIMMitless study.
Efficacy and safety assessments were performed every 12 weeks until week 156 and every 24 weeks thereafter. Efficacy was assessed by PASI 90, PASI 100, sPGA 0/1, mean PASI percent improvement. Quality of life was assessed by DLQI 0/1. LOCF (last observation carried forward): used completed evaluation from the most recent visit to impute missing data at later visits. PASI 90 = 90% improvement in Psoriasis Area and Severity Index.
DLQI, Dermatology Life Quality Index; LOCF, last observation carried forward; PASI, Psoriasis Area Severity Index; sPGA, static Physicians Global Assessment.
>60% of SKYRIZI patients achieved PASI 100 at 304 weeks*5
Adapted from Papp K, et al. 2023.
aBecause of differences in base study lengths, some patients enrolled in the LIMMitless study earlier than 52 weeks.
*Results from 304 week interim analysis including integrated data from five Phase II/III studies (UltIMMA-1, UltIMMa-2, SustaIMM, IMMvent, and NCT03255382) and the LIMMitless study.
Efficacy and safety assessments were performed every 12 weeks until week 156 and every 24 weeks thereafter. Efficacy was assessed by PASI 90, PASI 100, sPGA 0/1, mean PASI percent improvement. Quality of life was assessed by DLQI 0/1. LOCF (last observation carried forward): used completed evaluation from the most recent visit to impute missing data at later visits. PASI 100 = 100% improvement in Psoriasis Area and Severity Index.
DLQI, Dermatology Life Quality Index; LOCF, last observation carried forward; PASI, Psoriasis Area Severity Index; sPGA, static Physicians Global Assessment.
LIMMitless OLE Study Design5
LIMMitless is an ongoing Phase III, single-arm, multicentre, international, open-label extension in which all patients received SKYRIZI (150 mg) every 12 weeks. The 304 week analysis included patients who were initially randomised to receive SKYRIZI (150 mg) in 1 of 5 base Phase II/III studies. Results from 304 week interim analysis included integrated data from five Phase II/III studies (UltIMMa-1, UltIMMa-2, SustaIMM, IMMvent, and NCT03255382) and the LIMMitless study. Efficacy and safety assessments were performed every 12 weeks until week 156 and every 24 weeks thereafter. Efficacy was assessed by PASI 90, PASI 100, sPGA 0/1, mean PASI percent improvement. Quality of life was assessed by DLQI 0/1.
Adapted from Papp K, et al. 2023.
DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area Severity Index; RZB, risankizumab; sPGA, static Physicians Global Assessment.
Efficacy and safety assessments were performed every 12 weeks until week 156 and every 24 weeks thereafter:
− PASI 90
− PASI 100
− sPGA 0/1
− Mean PASI percent improvement
− DLQI 0/1
Safety was assessed via adverse event monitoring through the cutoff date for this analysis (May 22, 2023)
LIMMitless OLE baseline demographicsa5
Adapted from Papp K, et al. 2023.
BSA, body surface area; DLQI, Dermatology Life Quality Index; OLE, open-label extension; PASI, Psoriasis Area and Severity Index; Q1/Q3, quartile 1/3; RZB, risankizumab; SD, standard deviation; sPGA, static Physician’s Global Assessment; TNF, tumour necrosis factor.
aBaseline at the start of base study.
bDiagnosed or suspected.
cBased on n=838; data not collected in NCT03255382.
Consistent safety profile through 324 weeks5
Adapted from Papp K, et al. 2023.
AE, adverse event; E, events; MACE, major adverse cardiovascular event; NMSC, nonmelanoma skin cancer; PYs, patient-years; RZB, risankizumab; TEAE, treatment-emergent AE.
aPrimary psoriasis safety pool includes UltIMMa-1, UltMMa-2, IMMhance, IMMvent and NCT0205448110 studies.
b16-week safety data for patients who received RZB 150 mg UltIMMa-1, UltMMa-2, and IMMvent (primary psoriasis safety pool) are included in the 324-week LIMMitless results.
cDue to natural causes (n=1), accident (n=1), cardiovascular event (n=1), cardiac arrest (n=1), sudden cardiac death (n=1), cause unknown (n=2), and COVID-19 infection (n=1); none related to RZB.
dMACE rate in the LIMMitless study is consistent with the incidence rate of MACE in the Psoriasis Longitudinal Assessment and Registry (PSOLAR; 0.57 E/100PY; 95% CI, 0.50–0.65).
eMalignancy types excluding NMSC were colorectal (n=7), skin (n=5), breast (n=4), prostate (n=3), urothelial (n=3), uterine (n=2), brain (n=1), gastric (n=1), and head and neck (n=1).
fSerious hypersensitivity reactions (all of which were considered unrelated to study drug) were paraphenylenediamine allergy (n=1; mild, attributed to hair dye application), generalized microbial eczema (n=1; moderate, attributed to prolonged duration of generalized eczema and lack of response to treatment with hydrocortisone), and Stevens-Johnson syndrome (n=2; severe, attributed to addition of chlorpromazine [n=1] and attributed to addition of Bactrim [n=1]).
gOne nonserious event of ulcerative colitis, considered unrelated to RZB.
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More expert perspectives
View expert perspectives on SKYRIZI’s efficacy data, dosing regimen and safety profile.
UK-RISN-230309. Date of preparation February 2024.
References
- Reich K, et al. Lancet 2019; 394: 576-586.
- Gordon KB, et al. Lancet 2018; 392: 650-661.
- Warren RB, et al. Risankizumab vs Secukinumab in Patients with Moderate-to-Severe Plaque Psoriasis: A Phase 3 Trial, Presented at AAD 2020.
- SKYRIZI: Summary of Product Characteristics.
- Papp KA, et al. Long-Term Safety and Efficacy of Risankizumab for the Treatment of Moderate-to-Severe Plaque Psoriasis: Interim Analysis of the LIMMitless Open-label Extension Trial for up to 6 Years of Follow-up. Presented at EADV, 11–14 October 2023, Berlin, Germany; P2428.
UK-RISN-230308. Date of preparation: February 2024.
Important safety information for SKYRIZI®▼(risankizumab) in Psoriasis and Psoriatic Arthritis¹
SKYRIZI should be initiated and supervised by healthcare professionals experienced in the diagnosis and treatment of Psoriasis and Psoriatic arthritis.
Some patients may not be suitable for SKYRIZI (risankizumab). You are strongly advised to read the prescribing information, which can be found at the top of this webpage and below, and the Summary of Product Characteristics (SmPC) which are available online in the Electronic Medicines Compendium (EMC) from the links below.
SKYRIZI 150 mg solution for injection in pre-filled pen CLICK HERE.
SKYRIZI 150 mg solution for injection in pre-filled syringe CLICK HERE.
SKYRIZI PRESCRIBING INFORMATION CLICK HERE.
SKYRIZI is contraindicated in patients;
- with hypersensitivity to the active substance or to any of the excipients,
- with clinically important active infections (e.g. active tuberculosis).
Cautions (See Prescribing Information and SmPC for full details including screening and monitoring requirements):
It is preferable to avoid the use of SKYRIZI during pregnancy. Women of childbearing potential should use an effective method of contraception during treatment and for at least 21 weeks after treatment. It is unknown whether risankizumab is excreted in human milk. A decision should be made whether to discontinue/abstain from risankizumab therapy, taking into account the benefit of breast-feeding to the child and the benefit of risankizumab therapy to the woman.
Dosing in Psoriasis and Psoriatic Arthritis
The recommended dose of SKYRIZI is 150mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
Adverse reactions
For adverse reactions, please refer to the prescribing information and the SKYRIZI summary of product characteristics available online in the Electronic Medicines Compendium via the links above.
Important safety information for HUMIRA® (adalimumab) in Psoriasis and Psoriatic Arthritis²
HUMIRA is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which HUMIRA is indicated.
Psoriatic arthritis: HUMIRA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. HUMIRA has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.
Psoriasis: HUMIRA is indicated for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who are candidates for systematic therapy
Paediatric plaque psoriasis: HUMIRA is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Some patients may not be suitable for HUMIRA. You are strongly advised to read the prescribing information, which can be found at the top of this webpage and below, and the Summary of Product Characteristics (SmPC) which are available online in the Electronic Medicines Compendium (EMC).
HUMIRA 40 mg solution for injection in pre-filled pen CLICK HERE.
ADALIMUMAB PRESCRIBING INFORMATION CLICK HERE.
References
1. SKYRIZI Summary of Product Characteristics
2. HUMIRA Summary of Product Characteristics
