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      Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis

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          Abstract

          Background:

          Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, we assessed the efficacy and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis.

          Methods:

          This study was a 52-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial. A sub-population of study participants (≥18 years) of Chinese ethnicity were randomized to receive subcutaneous injections of 300 or 150 mg secukinumab, or placebo. The co-primary endpoints were psoriasis area severity index (PASI) 75 and Investigator's Global Assessment (IGA) 0/1 at Week 12.

          Results:

          A total of 441 Chinese patients were enrolled in this study. Co-primary outcomes were achieved; 300 and 150 mg secukinumab were superior to placebo as shown in the proportion of patients that achieved PASI 75 (97.7% and 87.2% vs. 3.7%, respectively; P < 0.001), and IGA 0/1 (82.3% and 69.7% vs. 2.7%; P < 0.001) at Week 12. Treatment efficacy was maintained until Week 52. There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.

          Conclusion:

          Secukinumab is highly effective and well tolerated in Chinese patients with moderate to severe plaque psoriasis.

          Trial Registration:

          ClinicalTrials.gov, NCT03066609; https://clinicaltrials.gov/ct2/show/record/NCT03066609.

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          Secukinumab in plaque psoriasis--results of two phase 3 trials.

          Richard Langley, Boni Elewski, Mark Lebwohl … (2014)
          Interleukin-17A is considered to be central to the pathogenesis of psoriasis. We evaluated secukinumab, a fully human anti-interleukin-17A monoclonal antibody, in patients with moderate-to-severe plaque psoriasis. In two phase 3, double-blind, 52-week trials, ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis) and FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis), we randomly assigned 738 patients (in the ERASURE study) and 1306 patients (in the FIXTURE study) to subcutaneous secukinumab at a dose of 300 mg or 150 mg (administered once weekly for 5 weeks, then every 4 weeks), placebo, or (in the FIXTURE study only) etanercept at a dose of 50 mg (administered twice weekly for 12 weeks, then once weekly). The objective of each study was to show the superiority of secukinumab over placebo at week 12 with respect to the proportion of patients who had a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) and a score of 0 (clear) or 1 (almost clear) on a 5-point modified investigator's global assessment (coprimary end points). The proportion of patients who met the criterion for PASI 75 at week 12 was higher with each secukinumab dose than with placebo or etanercept: in the ERASURE study, the rates were 81.6% with 300 mg of secukinumab, 71.6% with 150 mg of secukinumab, and 4.5% with placebo; in the FIXTURE study, the rates were 77.1% with 300 mg of secukinumab, 67.0% with 150 mg of secukinumab, 44.0% with etanercept, and 4.9% with placebo (P<0.001 for each secukinumab dose vs. comparators). The proportion of patients with a response of 0 or 1 on the modified investigator's global assessment at week 12 was higher with each secukinumab dose than with placebo or etanercept: in the ERASURE study, the rates were 65.3% with 300 mg of secukinumab, 51.2% with 150 mg of secukinumab, and 2.4% with placebo; in the FIXTURE study, the rates were 62.5% with 300 mg of secukinumab, 51.1% with 150 mg of secukinumab, 27.2% with etanercept, and 2.8% with placebo (P<0.001 for each secukinumab dose vs. comparators). The rates of infection were higher with secukinumab than with placebo in both studies and were similar to those with etanercept. Secukinumab was effective for psoriasis in two randomized trials, validating interleukin-17A as a therapeutic target. (Funded by Novartis Pharmaceuticals; ERASURE and FIXTURE ClinicalTrials.gov numbers, NCT01365455 and NCT01358578, respectively.).
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            Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2).

            Kim Papp, Richard Langley, Mark G. Lebwohl … (2008)
            Ustekinumab, a human monoclonal antibody against interleukins 12 and 23, has shown therapeutic potential for psoriasis. This study assessed the efficacy and safety of ustekinumab in psoriasis patients and assessed dosing intensification in partial responders. In this multicentre, phase III, double-blind, placebo-controlled study, 1230 patients with moderate-to-severe psoriasis (defined by a psoriasis area and severity index [PASI] score > or =12, and at least 10% total body surface area involvement) were randomly assigned to receive ustekinumab 45 mg (n=409) or 90 mg (n=411) at weeks 0 and 4, then every 12 weeks, or placebo (n=410). Partial responders (ie, patients achieving > or =50% but <75% improvement from baseline in PASI) were re-randomised at week 28 to continue dosing every 12 weeks or escalate to dosing every 8 weeks. Both randomisations were done with a minimisation method via a centralised interactive voice response. The primary endpoint was the proportion of patients achieving at least 75% improvement in PASI (PASI 75) at week 12. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00307437. All randomised patients were included in the efficacy analysis. 273 (66.7%) patients receiving ustekinumab 45 mg, 311 (75.7%) receiving ustekinumab 90 mg, and 15 (3.7%) receiving placebo achieved the primary endpoint (difference in response rate 63.1%, 95% CI 58.2-68.0, p<0.0001 for the 45 mg group vs placebo and 72.0%, 67.5-76.5, p<0.0001 for the 90 mg group vs placebo). More partial responders at week 28 who received ustekinumab 90 mg every 8 weeks achieved PASI 75 at week 52 than did those who continued to receive the same dose every 12 weeks (22 [68.8%] vs 11 [33.3%]; difference in response rate 35.4%, 95% CI 12.7-58.1, p=0.004). There was no such response to changes in dosing intensity in partial responders treated with ustekinumab 45 mg. During the placebo-controlled phase, 217 (53.1%) patients in the 45 mg group, 197 (47.9%) in the 90 mg group, and 204 (49.8%) in the placebo group experienced adverse events; serious adverse events were seen in eight (2.0%) patients in the 45 mg group, five (1.2%) in the 90 mg group, and eight (2.0%) in the placebo group. Although treatment with ustekinumab every 12 weeks is effective for most patients with moderate-to-severe psoriasis, intensification of dosing to once every 8 weeks with ustekinumab 90 mg might be necessary to elicit a full response in patients who only partially respond to the initial regimen.
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              The Immunologic Role of IL-17 in Psoriasis and Psoriatic Arthritis Pathogenesis

              Andrew Blauvelt, Andrea Chiricozzi (2018)
              Psoriasis is a chronic, immune-mediated, inflammatory disease that is pathogenically driven by proinflammatory cytokines. This article reviews the immunologic role of interleukin (IL)-17, the major effector cytokine in the pathogenesis of psoriatic disease, along with the rationale for targeting the IL-17 cytokine family (IL-17A, IL-17F, and IL-17 receptor A) in the treatment of psoriasis and psoriatic arthritis. Emerging evidence indicates that major sources of IL-17A in patients with psoriatic disease are mast cells, γδ T cells, αβ T cells, and innate lymphoid cells in lesional skin and synovial fluid. Within the skin and joints, IL-17A acts on cellular targets, including keratinocytes, neutrophils, endothelial cells, fibroblasts, osteoclasts, chondrocytes, and osteoblasts, to stimulate production of various antimicrobial peptides, chemokines, and proinflammatory and proliferative cytokines, which, in turn, promote tissue inflammation and bone remodeling. The critical importance of the IL-23/IL-17A axis to the pathogenesis of psoriatic disease has resulted in many new biologic treatments targeting these cytokines. These biologics dramatically improve skin and joint symptoms in patients with moderate-to-severe psoriasis and psoriatic arthritis.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Chin Med J (Engl)
                Journal ID (iso-abbrev): Chin Med J (Engl)
                Journal ID (publisher-id): CM9
                Title: Chinese Medical Journal
                Publisher: Lippincott Williams & Wilkins (Hagerstown, MD )
                ISSN (Print): 0366-6999
                ISSN (Electronic): 2542-5641
                Publication date (Print): 20 November 2020
                Publication date (Electronic): 14 October 2020
                Volume: 133
                Issue: 22
                Pages: 2665-2673
                Affiliations
                [1 ]Department of Dermatology, Peking University People's Hospital, Beijing 100044, China
                [2 ]Institute of Dermatology, Chinese Academy of Medical Science & Peking Union Medical College, Beijing 100730, China
                [3 ]Department of Dermatology, Changhai Hospital, Shanghai 200433, China
                [4 ]Department of Dermatology, Tianjin Medical University General Hospital, Tianjin 300052, China
                [5 ]Department of Dermatology, Second Affiliated Hospital School of Medicine, Zhejiang University, Hangzhou, Zhejiang 311215, China
                [6 ]Department of Dermatology, General Hospital of Northern Theater Command, Shenyang, Liaoning 110016, China
                [7 ]Department of Dermatology, Huashan Hospital, Fudan University, Shanghai 200040, China
                [8 ]Department of Dermatology and Venereology, Chinese People's Liberation Army General Hospital, Beijing 100853, China
                [9 ]Department of Dermatology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310016, China
                [10 ]Department of Dermatology, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong 510120, China
                [11 ]Department of Dermatology, Zhejiang Provincial People's Hospital, Zhejiang, Hangzhou, Zhejiang 310014, China
                [12 ]Department of Dermatology, Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei 430030, China
                [13 ]Department of Dermatology, Peking University First Hospital, Beijing 100034, China
                [14 ]Department of Dermatology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China
                [15 ]Department of Dermatology, First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China
                [16 ]Department of Dermatology, The First Hospital of Jilin University, Changchun, Jilin 130021, China
                [17 ]Department of Dermatology, Guangdong General Hospital, Guangzhou, Guangdong 510080, China
                [18 ]Beijing Novartis Pharma Co. Ltd., Shanghai 201203, China
                [19 ]Novartis Pharma AG, Basel 6463, Switzerland.
                Author notes
                Correspondence to: Prof. Jian-Zhong Zhang, Department of Dermatology, Peking University People's Hospital, Beijing 100044, ChinaE-Mail: rmzjz@ 123456126.com
                Article
                Publisher ID: CMJ-2020-2243 Accession ID: 00005
                DOI: 10.1097/CM9.0000000000001163
                PMC ID: 7647502
                PubMed ID: 33060370
                SO-VID: ea3516cc-e626-4174-a06e-5de1c9c6e5fe
                Copyright © Copyright © 2020 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license.
                License:

                This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0

                History
                Date received : 29 June 2020
                Categories
                Subject: Original Articles
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                Keywords: chinese,psoriasis,il-17,dermatology,clinical trial,pasi
                Data availability:
                Keywords: chinese, psoriasis, il-17, dermatology, clinical trial, pasi

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