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

Study Overview
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Brief Summary
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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).

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

Conditions
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Moderate-to-severe Plaque Psoriasis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Secukinumab<br>Clinical psoriasis patients who received secukinumab treatment in Indonesia from 1 August 2017 to 31 October 2020. | |

What is the study measuring?
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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 |