A Study of Moderate-to-severe Plaque Psoriasis Patients Response to Secukinumab Treatment in Real-world Setting

Moderate-to-severe Plaque Psoriasis Patients Response to Secukinumab Treatment in Real-world Setting: a Monocentric, Retrospective Study

This study was a one-arm, retrospective cohort study that observed clinical psoriasis patients who received secukinumab treatment in Indonesia from the 01 August 2017 until the 31 October 2020. Patients' data were obtained from the medical records of a dermatology clinic in Jakarta, Indonesia. The primary endpoints were set at Week 16, and secondary endpoints at Weeks 16 and 52. At each endpoint, the study assessed effectiveness by measuring the proportion of psoriasis patients receiving secukinumab who achieved Psoriasis Area and Severity Index (PASI) 75 (at Week 8) and PASI 90 (at Weeks 16 and 52).

Study Overview

• Status: Completed
• Conditions: Moderate-to-severe Plaque Psoriasis

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • Mangga Besar Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

Inclusion Criteria

• Male or female, aged at least 18 years old.
• Diagnosed as moderate-to-severe plaque type psoriasis with PASI score ≥ 5 prior to initiating secukinumab treatment.
• Treated with secukinumab for a minimum of 8 weeks after the initial secukinumab treatment without any interruption.
• Patients included in this study received the initial secukinumab treatment within the period of 1 August 2017 to 31 October 2019. With the secondary endpoint of 52 weeks, the latest recorded data included in the analysis was recorded on 31 October 2020.

Exclusion Criteria

• Patients with other types of psoriasis.
• Patients with incomplete information on PASI score at Weeks 0, 8, and 16 in their medical records.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Secukinumab; Clinical psoriasis patients who received secukinumab treatment in Indonesia from 1 August 2017 to 31 October 2020.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients achieving Psoriasis Area and Severity Index (PASI) score <1, PASI score < 2, PASI score < 3, and PASI score < 5 at Week 16	The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients achieving PASI 75 or higher response at Week 8	PASI 75 response was defined as ≥ 75% improvement (reduction) in PASI score compared to baseline.	Week 8
Percentage of patients achieving PASI 90 or higher response at Week 16	PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.	Week 16
Percentage of patients achieving PASI 90 or higher response at Week 52	PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.	Week 52
Number of injections needed to achieve at least PASI 90	PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.	Weeks 16 and 52
Percentage of patients with psoriatic arthritis (PsA) who achieved at least PASI 90 at Week 16 with secukinumab	PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.	Week 16
Percentage of patients with relapse event after treatment discontinuation		Up to 52 weeks
Length of remission period for patients with relapse, calculated from the last treatment date until relapse or starting recurrent symptom(s) or sign(s)		Up to 52 weeks
Percentage of patients achieving Dermatology Life Quality Index (DLQI) 0/1 at Week 52	DLQI is a ten-item general dermatology disability index designed to assess healthrelated quality of life in adult participants with skin diseases such psoriasis. It is a selfadministered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) 1 ( a little) to 3 (very much). "Not relevant" is a valid score also and is scored as 0.	Week 52

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): March 15, 2022

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CAIN457AID01