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

Completed

• Conditions: Moderate-to-severe Plaque Psoriasis

• Registration Number: NCT05787236
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-05
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15
• Status Verified: 2023-03
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Last Update Submitted: 2023-03-15
• Study First Posted: 2023-03-28
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with relapse event after treatment discontinuation	Up to 52 weeks
Percentage of patients with psoriatic arthritis (PsA) who achieved at least PASI 90 at Week 16 with secukinumab	Week 16	PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.
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 PASI 75 or higher response at Week 8	Week 8	PASI 75 response was defined as ≥ 75% improvement (reduction) in PASI score compared to baseline.
Number of injections needed to achieve at least PASI 90	Weeks 16 and 52	PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.
Percentage of patients achieving PASI 90 or higher response at Week 52	Week 52	PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.
Percentage of patients achieving PASI 90 or higher response at Week 16	Week 16	PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.
Percentage of patients achieving Dermatology Life Quality Index (DLQI) 0/1 at Week 52	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.

Trial Locations

Locations (1)

Mangga Besar Clinic; 🇮🇩 Jakarta, Indonesia