Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 May 1;158(5):533-541.
doi: 10.1001/jamadermatol.2022.0655.

Long-term Efficacy and Safety of Up to 108 Weeks of Ixekizumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis: The IXORA-PEDS Randomized Clinical Trial

Amy S Paller  1   2 , Marieke M B Seyger  3 , Gabriel A Magariños  4 , Andreas Pinter  5 , Jennifer C Cather  6 , Claudia Rodriguez-Capriles  7 , Danting Zhu  7 , Najwa Somani  7 , Alyssa Garrelts  7 , Kim A Papp  8 ; IXORA-PEDS Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Long-term Efficacy and Safety of Up to 108 Weeks of Ixekizumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis: The IXORA-PEDS Randomized Clinical Trial

Amy S Paller et al. JAMA Dermatol. .

Erratum in

  • Errors in Figure 2 and Table 3.
    [No authors listed] [No authors listed] JAMA Dermatol. 2022 Oct 1;158(10):1221. doi: 10.1001/jamadermatol.2022.3698. JAMA Dermatol. 2022. PMID: 35976631 Free PMC article. No abstract available.

Abstract

Importance: About 1% of children and adolescents worldwide are affected by plaque psoriasis.

Objective: To evaluate the long-term efficacy and safety of ixekizumab for pediatric patients with moderate to severe psoriasis.

Design, setting, and participants: This multicenter randomized clinical trial (IXORA-PEDS) evaluated pediatric patients with plaque psoriasis. Participants were aged 6 years to younger than 18 years; had moderate to severe psoriasis, which was defined as Psoriasis Area and Severity Index (PASI) of 12 or higher, static Physician's Global Assessment (sPGA) score of 3 or higher, and psoriasis-affected body surface area of 10% or greater at screening and baseline; were candidates for phototherapy or systemic therapy; or had psoriasis that was not adequately controlled by topical therapies. Data analysis, which followed the intention-to-treat principle, was conducted from May to October 2021.

Interventions: Pediatric patients were randomized 2:1 to receive either a weight-based dose of ixekizumab every 4 weeks or placebo. After a 12-week placebo-controlled period, patients entered a 48-week, open-label ixekizumab maintenance period (weeks 12-60), followed by an extension period that lasted through 108 weeks. A substudy evaluated the randomized withdrawal of ixekizumab after week 60.

Main outcomes and measures: Efficacy outcomes at week 108 included the percentage of patients achieving 75% (PASI 75), 90% (PASI 90), or 100% (PASI 100) improvement from baseline; an sPGA score of 0 or 1 or score of 0; and improvement of 4 points or higher from baseline in the Itch Numeric Rating Scale. Safety outcomes included assessments of adverse events (AEs), including treatment-emergent AEs, serious AEs, and AEs of special interest, as well as improvement from baseline in a range of challenging body areas. Missing data for categorical outcomes were imputed using modified nonresponder imputation.

Results: A total of 171 patients (mean [SD] age, 13.5 [3.04] years; 99 female children [57.9%]) were randomized to either ixekizumab (n = 115) or placebo (n = 56). Of 166 patients who entered the maintenance period, 139 (83.7%) completed week 108 of the trial. Primary and gated secondary end points were sustained through week 108, with patients achieving PASI 75 (91.7% [n = 86]), PASI 90 (79.0% [n = 74]), PASI 100 (55.1% [n = 52]), sPGA 0 or 1 (78.3% [n = 74]), and sPGA 0 (52.4% [n = 49]). Fifty-five patients (78.5%) reported an Itch Numeric Rating Scale improvement of 4 points or higher. In patients who received ixekizumab, at week 108, clearance of nail psoriasis was reported in 68.1% (n = 28), clearance of palmoplantar psoriasis was reported in 90.0% (n = 10), clearance of scalp psoriasis was reported in 76.2% (n = 83), and clearance of genital psoriasis was reported in 87.5% (n = 24). There were no new safety findings during weeks 48 to 108 of the trial, including no new cases of inflammatory bowel disease or candida infection.

Conclusions and relevance: Results of this study showed improvements across patient-reported outcomes and objective measures of complete skin clearance of psoriasis among pediatric patients who received ixekizumab, and these response rates were sustained through week 108 of the trial. Safety of ixekizumab was consistent with previously reported findings in this population and the known safety profile of this treatment.

Trial registration: ClinicalTrials.gov Identifier: NCT03073200.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Paller reported receiving personal fees for consulting from Eli Lilly, AbbVie, UCB, LEO Pharma, and Exicure outside the submitted work as well as receiving grants to institution as an investigator from Eli Lilly, AbbVie, Janssen, Novartis, and UCB outside the submitted work. Dr Seyger reported receiving grants from Eli Lilly and other funding from Amgen, Janssen, and Novartis outside the submitted work. Dr Magariños reported receiving personal fees from AbbVie, Biogen, Boehringer, Eli Lilly and Co, Janssen, Novartis, and Pfizer outside the submitted work. Dr Cather reported receiving personal fees for advisory board, speaking, and/or clinical trial from AbbVie, Amgen, Bristol Myers Squibb, Celgene, ChemoCentryx, Galderma, UCB, Janssen, Anaptys, and Eli Lilly outside the submitted work. Dr Somani reported receiving other as an employee and minor shareholder from Eli Lilly during the conduct of the study. Dr Garrelts reported receiving other as an employee and shareholder from Eli Lilly during the conduct of the study and outside the submitted work. Dr Papp reported receiving grants, personal fees, and other as a consultant from Eli Lilly during the conduct of the study as well as receiving grants and other as a consultant from AbbVie, UCB, and Novartis; other as a consultant from Sandoz; grants from Amgen, Arcutis, Avillion, Bausch Health, Dermavant, Incyte, LEO Pharma, Pfizer, and Sun Pharma; and personal fees from Bausch Health, Bristol Myers Squibb, Dermavant, and Novartis outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram Through Week 108 of the IXORA-PEDS Trial
Figure 2.
Figure 2.. Proportion of Patients Achieving End Points and Observed and Imputed Response Rates
The numbers of responders at milestone intervals were as follows: Psoriasis Area and Severity Index (PASI) 90: 71 at week 12, 79 at week 48, 76 at week 60, and 74 at week 108; PASI 100: 44 at week 12, 51 at week 48, 50 at week 60, and 52 at week 108. NRI indicates nonresponder imputation; sPGA, static Physician’s Global Assessment.
See this image and copyright information in PMC

References

    1. Paller AS, Seyger MMB, Alejandro Magariños G, et al. ; IXORA-PEDS study group . Efficacy and safety of ixekizumab in a phase III, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis (IXORA-PEDS). Br J Dermatol. 2020;183(2):231-241. doi:10.1111/bjd.19147 - DOI - PMC - PubMed
    1. Napolitano M, Megna M, Balato A, et al. . Systemic treatment of pediatric psoriasis: a review. Dermatol Ther (Heidelb). 2016;6(2):125-142. doi:10.1007/s13555-016-0117-6 - DOI - PMC - PubMed
    1. Augustin M, Glaeske G, Radtke MA, Christophers E, Reich K, Schäfer I. Epidemiology and comorbidity of psoriasis in children. Br J Dermatol. 2010;162(3):633-636. doi:10.1111/j.1365-2133.2009.09593.x - DOI - PubMed
    1. Libon F, Lebas E, De Schaetzen V, Sabatiello M, De Schepper S, Nikkels AF. Biologicals for moderate-to-severe plaque type psoriasis in pediatric patients. Expert Rev Clin Immunol. 2021;17(9):947-955. doi:10.1080/1744666X.2021.1958675 - DOI - PubMed
    1. Gånemo A, Wahlgren CF, Svensson Å. Quality of life and clinical features in Swedish children with psoriasis. Pediatr Dermatol. 2011;28(4):375-379. doi:10.1111/j.1525-1470.2010.01292.x - DOI - PubMed

Publication types

Substances

Associated data