Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials

Lebwohl, Mark; Soliman, Ahmed M.; Yang, Hongbo; Wang, Jessie; Hagan, Kaitlin; Padilla, Byron; Pinter, Andreas

doi:10.1007/s13555-021-00660-3

Cited by 6 publications

(10 citation statements)

References 20 publications

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“…It has been approved by European Medicines Agency in April 2019 for the management of moderate‐to‐severe psoriasis and in 2021 for the treatment of psoriatic arthritis. Its efficacy and safety were showed by several clinical trials 16,17 . Particularly, risankizumab has been showed to be more effective than adalimumab, secukinumab and ustekinumab 18–20 .…”

Section: Introductionmentioning

confidence: 99%

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Risankizumab treatment in psoriasis patients who failed anti‐IL17: A 52‐week real‐life study

Megna

Potestio

Ruggiero

et al. 2022

Dermatologic Therapy

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Recent knowledge on the key role of interleukin (IL) 23/17 axis in psoriasis pathogenesis, led to development of new biologic drugs. Risankizumab is a humanized immunoglobulin G1 monoclonal antibody specifically targeting IL23. Its efficacy and safety were showed by both clinical trials and real‐life experiences. However, real‐life data on effectiveness and safety of risankizumab in patients who previously failed anti‐IL17 are scant. To assess the efficacy and safety of risankizumab in patients who previously failed anti‐IL17. A 52‐week real‐life retrospective study was performed to assess the long‐term efficacy and safety of risankizumab in patients who previously failed anti‐IL17. A total of 39 patients (26 male, 66.7%; mean age 50.5 ± 13.7 years) were enrolled. A statistically significant reduction of psoriasis area severity index (PASI) and body surface area (BSA) was assessed at each follow‐up (PASI at baseline vs. week 52: 13.7 ± 5.8 vs. 0.9 ± 0.8, p < 0.0001; BSA 21.9 ± 14.6 vs. 1.9 ± 1.7, p < 0.0001). Nail psoriasis severity index improved as well, being statistically significative only at week 16 and thereafter [9.3 ± 4.7 at baseline, 4.1 ± 2.4 (p < 0.01) at week 16, 1.4 ± 0.8 (p < 0.0001) at week 52]. Treatment was discontinued for primary and secondary inefficacy in 1(2.6%) and 3(7.7%) patients, respectively. No cases of serious adverse events were assessed. Our real‐life study confirmed the efficacy and safety of risankizumab, suggesting it as a valuable therapeutic weapon among the armamentarium of biologics, also in psoriasis patients who previously failed anti‐IL17 treatments.

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Section: Introductionmentioning

confidence: 99%

“…Its efficacy and safety were showed by several clinical trials. 16,17 Particularly, risankizumab has been showed to be more effective than adalimumab, secukinumab and ustekinumab. [18][19][20] Promising results have been showed in real-life settings as well.…”

Section: Introductionmentioning

confidence: 99%

Risankizumab treatment in psoriasis patients who failed anti‐IL17: A 52‐week real‐life study

Megna

Potestio

Ruggiero

et al. 2022

Dermatologic Therapy

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“…Given the small number of clinical trials and systematic reviews, case series have been included, despite the fact that the evaluation of efficacy and effectiveness in them is very limited. 19–30 The studies that have been evaluated are: 8 clinical trials with high evidence, 19 , 20 , 23–26 , 28 , 29 3 case series, one prospective, 21 and 2 retrospective, 22 , 27 of which the evidence is of low quality, and a cohort study of medium evidence quality. 30 …”

Section: Resultsmentioning

confidence: 99%

“… Low Lebwohl. et al 23 Design: Clinical Trial Aim : This study aimed to estimate the duration of PASI 90 and DLQI 0/1 among patients with moderate to severe psoriasis receiving RZB and other treatments. Endpoints : PASI 90, DLQI 0/1 Pivotal trial patients : *UltIMMa-1, UltIMMa-2, IMMvent, and IMMhance Overall population: =2101 RZB only=895 RZB and RZB/PBO=406 ADA and ADA/RZB=303 PBO/RZB=300 UltIMMa-1, UltIMMa-2, IMMvent, and IMMhance Patients treated with only RZB throughout the study period experienced the longest DLQI 0/1 duration from baseline to week 52 [213.7 days (59% over 1 year)], followed by patients who received ADA and ADA/RZB [159.1 days (44% over 1 year)], and only UST [144.3 days (40% over 1 year)].…”

Section: Resultsmentioning

confidence: 99%

Risankizumab for the Treatment of Moderate to Severe Psoriasis: Impact on Health-Related Quality of Life and Psychological Wellbeing

Gracia‐Cazaña¹,

Bernal-Masferrer²,

Morales-Callaghan³

et al. 2023

CCID

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Biologic treatments are increasingly being used in the management of moderate to severe plaque psoriasis (PSO). Risankizumab (RZB) is a humanized monoclonal antibody that specifically blocks the p19 subunit of interleukin 23, which in turn regulates the activation, differentiation, and survival of Th17. RZB has proved their efficacy and their safety compared to anti-TNF. However, studies that assess and compare the improvement in other secondary PROs such as the patient’s quality of life are still scarce. Health-related quality of life (HRQoL) is the sum of physical health, well-being, and participation; it defines the functional effect of a disease or its treatment and how it is perceived by the patient. The objective of this paper is to analyze the literature on the impact of treatment with RZB on the quality of life of patients with PSO and their psychological well-being. A bibliographic search was carried out to identify all the papers published from July 2015 to June 1, 2022, on RZB treatment in psoriasis and its impact on health-related quality of life and psychological well-being, finally twenty articles have been evaluated in full text, of which 8 were excluded because they did not meet the inclusion criteria. Risankizumab has shown not only to have very relevant data on effectiveness and safety, but all of this is associated with an improvement in quality of life related to health and psychological well-being measured on generic and specific quality of life scales, both in pivotal trials, ad hoc analysis, and data in real clinical practice.

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“…Its safety and efficacy profiles have been evaluated by several trials and real world evidence studies, which confirmed risankizumab promising results in the management of moderate to severe psoriasis. [106][107][108][109][110] Tildrakizumab represents the latest IL-23 inhibitor available in clinical practice in Italy. It is a fully humanized IgG1/k antibody selectively binding to the p19 subunit of the IL-23.…”

Section: Anti-il23mentioning

confidence: 99%

Towards Personalized Medicine in Psoriasis: Current Progress

Camela¹,

Potestio²,

Ruggiero³

et al. 2022

PTT

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Although innovative targeted therapies have positively revolutionized psoriasis treatment shifting treatment goals to complete or almost complete skin clearance, primary or secondary lack of efficacy is still possible. Hence, identifying robust biomarkers that reflect the various clinical psoriasis phenotypes would allow stratify patients in subgroups or endotypes, and tailor treatments according to the characteristics of each individual (precision medicine). To sum up the current progress in personalized medicine for psoriasis, we performed a review on the available evidence on biomarkers predictive of response to psoriasis treatments, with focus on phototherapy and systemic agents. Relevant literature published in English was searched for using the following databases from the last five years up to March 20, 2022: PubMed, Embase, Google Scholar, EBSCO, MEDLINE, and the Cochrane library. Currently, more evidence exists towards biologicals, as justified by the huge health care costs as compared to phototherapy or conventional systemic drugs. Among them, most of the studies focused on anti-TNF and IL12/23, with still few on IL17 (mainly secukinumab). The most discussed biomarker gene is the HLA-C*02:06 status that has been shown to be associated with psoriasis, and also differential response to biologicals. Although its positivity is associated with great response to MTX, debatable results were retrieved concerning both anti-TNF and IL12/23 while it seems not to affect secukinumab response. Personalized treatment in psoriasis would provide excellent outcome minimizing the risk of side effects. To date, although several candidates were proposed and assessed, the scarcity and heterogeneity of the results do not allow the identification of the gold-standard biomarker per each treatment. Anyway, the creation of a more comprehensive panel would be more reliable for the treatment decision process.

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Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials

Cited by 6 publications

References 20 publications

Risankizumab treatment in psoriasis patients who failed anti‐IL17: A 52‐week real‐life study

Risankizumab treatment in psoriasis patients who failed anti‐IL17: A 52‐week real‐life study

Risankizumab for the Treatment of Moderate to Severe Psoriasis: Impact on Health-Related Quality of Life and Psychological Wellbeing

Towards Personalized Medicine in Psoriasis: Current Progress

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