Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP

A Special Drug Use-results Survey to Evaluate the Safety and Efficacy of Subcutaneous Administration of Cosentyx in Pediatric Patients With Psoriasis Vulgaris, Psoriatic Arthritis, or Pustular Psoriasis

This was a multicenter, centrally registered observational study without a control group. This observational study was a specified drug use-results survey conducted under GPSP to collect information on safety and efficacy during the observation period (52 weeks after the start of treatment with this drug) in pediatric patients with psoriasis vulgaris, psoriatic arthritis, or pustular psoriasis who received this drug.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris; Pustular Psoriasis; Psoriatic Arthritis
• Intervention / Treatment: Other: Cosentyx

Detailed Description

For patients who discontinued or completed this drug before the end of the observation period, the investigator recorded adverse events that occurred within 30 days after the day following the last administration of this drug, or the day of discontinuation of the survey (the day when discontinuation of the survey was judged), whichever is later, in the CRF.

If a patient withdraw consent, information was collected during the observation period up to the date of consent withdrawal.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Japan
  • Akita, Japan, 010-8543
    • Novartis Investigative Site
  • Kyoto, Japan, 616-8313
    • Novartis Investigative Site
  • Wakayama, Japan, 641-0051
    • Novartis Investigative Site
  • Aichi
    • Nagoya-city, Aichi, Japan, 467-8602
      • Novartis Investigative Site
  • Fukuoka
    • Fukuoka city, Fukuoka, Japan, 814 0180
      • Novartis Investigative Site
    • Kitakyushu, Fukuoka, Japan, 807-8556
      • Novartis Investigative Site
  • Hokkaido
    • Obihiro, Hokkaido, Japan, 080 0013
      • Novartis Investigative Site
    • Sapporo, Hokkaido, Japan, 064-0807
      • Novartis Investigative Site
  • Ibaraki
    • Mito, Ibaraki, Japan, 310-0015
      • Novartis Investigative Site
  • Ishikawa
    • Kahoku-gun, Ishikawa, Japan, 920-0293
      • Novartis Investigative Site
  • Kyoto
    • Kamigyo-ku, Kyoto, Japan, 602-8026
      • Novartis Investigative Site
    • Kyoto-city, Kyoto, Japan, 602-8566
      • Novartis Investigative Site
  • Miyagi
    • Sendai city, Miyagi, Japan, 983 8512
      • Novartis Investigative Site
  • Nara
    • Ikoma, Nara, Japan, 630-0293
      • Novartis Investigative Site
  • Osaka
    • Moriguchi, Osaka, Japan, 570-8507
      • Novartis Investigative Site
    • Osaka Sayama, Osaka, Japan, 589 8511
      • Novartis Investigative Site
    • Sakai-city, Osaka, Japan, 591 8025
      • Novartis Investigative Site
    • Takatsuki, Osaka, Japan, 569-8686
      • Novartis Investigative Site
  • Tokyo
    • Chuo ku, Tokyo, Japan, 104 8560
      • Novartis Investigative Site
    • Shinjuku Ku, Tokyo, Japan, 160-0023
      • Novartis Investigative Site
    • Sumida-Ku, Tokyo, Japan, 130-8587
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

pediatric patients who received Cosentyx

Description

Inclusion Criteria:

• Patients who have obtained written consent from their legally acceptable representative to cooperate in this survey before the start of treatment with this drug
• Patients aged less than 18 years at the start of treatment with this drug
• Patients newly treated with this drug for any of the following diseases: Psoriasis vulgaris, psoriatic arthritis, pustular psoriasis

Exclusion Criteria:

• Prior treatment with this drug
• Participation in an interventional study (e.g., a clinical trial) at the time of starting this drug.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cosentyx; Cosentyx for Subcutaneous Injection	Other: Cosentyx; There was no treatment allocation. Patients administered Cosentyx by prescription that had started before inclusion of the patient into the study were enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of serious adverse events	Incidence of SAEs was collected	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects with psoriasis vulgaris and psoriatic arthritis: IGA mod 2011 with 0 or 1 response	Investigator's Global Assessment (IGA) rating scale is: 0 - no signs of psoriasis. Postinflammatory hyperpigmentation may be present.; - Normal to pink lesions, no thickening, focal scaling absent or minimal; - Pink to pale red lesions, minimal to mild thickening, and mainly fine scaling.; - Clearly distinguishable erythema of dull red to bright red, clearly distinguishable to moderate thickening, moderate scaling.; - Light red to dark red lesions, high thickness with hard margins, high/rough scaling covering almost all or all lesions.	Baseline, week 4, week 12, week 24 and week 52
Subjects with psoriasis vulgaris and psoriatic arthritis: PASI 75/90/100 response	Psoriasis Area and Severity Index (PASI) 75/90 response is defined as ≥ 75%, ≥ 90% improvement (reduction) in PASI score compared to Baseline. PASI 100 response means no sign of body psoriasis.	Baseline, week 4, week 12, week 24 and week 52
All patients: Change from baseline in CDLQI	Children's Dermatology Life Quality Index (CDLQI) is a global dermatology disability index designed to assess health-related quality of life in pediatric patients and consists of 10 questions about symptoms and feelings, leisure, school and holidays, personal relationships, sleep, and treatment. The total CDLQI score is the sum of 10 questions and ranges from 0 ~ 30. Higher scores indicate more impairment of health-related quality of life.	Baseline, week 4, week 12, week 24 and week 52
Subjects with psoriatic arthritis: Change from baseline in C-HAQ	Childhood Health Assessment Questionnaire (C-HAQ) is used to assess the QOL of patients with psoriatic arthritis. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other "activities". Higher scores mean worse quality of life.	Baseline, week 4, week 12, week 24 and week 52
Incidence of adverse events and adverse reactions included in the safety specifications	Important identified risks or important potential risks specified in the Risk Management Plan at the time of planning the surveillance were determined to be identified in the surveillance. The following items were set as the safety specifications for the surveillance: Serious infections; Neutrophil count decreased; Hypersensitivity Reactions; inflammatory bowel disease; Erythroderma (exfoliative dermatitis); Malignancies; Cardiovascular/cerebrovascular events; Tuberculosis; Events related to suicide/self-injury	52 weeks
Subjects with psoriatic arthritis: Change from baseline in JADAS -27	Juvenile Arthritis Disease Activity Score (JADAS) score was used to assess disease activity in patients with juvenile idiopathic arthritis including psoriatic arthritis. The investigator assessed each of the 4 components of the JADAS for patients with psoriatic arthritis (Rater's Global Assessment, Patient's or guardian's global assessment, Number of active arthritis and CRP) and record the results in the CRF. JADAS-27 is the sum of the 4 scores (0 ~ 57).	Baseline, week 4, week 12, week 24 and week 52
Subjects with pustular psoriasis: Change from Baseline in the Japanese Dermatological Association (JDA) Severity Index	The investigator determined the severity based on the areas of erythema with pustules, areas of erythema (total), areas of edema, fever, WBC count, CRP, and serum albumin. The total score in the severity index is divided into 0 ~ 17 points (1 ~ 6 = mild, 7 ~ 10 = moderate, 11 ~ 17 = severe).	Baseline, week 4, week 12, week 24 and week 52
Subjects with pustular psoriasis: General improvement in GPP	GPP: Generalized Pustular Psoriasis The investigator assessed the General improvement rating (Responder, partial-responder, non-responder, aggravated, indeterminate) of pustular psoriasis symptoms at each observation time point compared to the start of treatment with this drug.	Baseline, week 4, week 12, week 24 and week 52
Incidence of adverse events and adverse drug reactions	Incidence of AEs and ADRs was collected	52 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): September 28, 2024
• Study Completion (Actual): September 28, 2024

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: pediatric; NIS; psoriatic arthritis; Japan; psoriasis vulgaris; Cosentyx; pustular psoriasis
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Arthritis; Psoriasis; Arthritis, Psoriatic
• Other Study ID Numbers: CAIN457L1401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO