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Completed

NCT Number: NCT05787236

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

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).

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Key information

Conditions

Moderate-to-severe Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mangga Besar Clinic

Jakarta, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. Percentage of patients achieving PASI 75 or higher response at Week 8

    Time frame: Week 8

    PASI 75 response was defined as ≥ 75% improvement (reduction) in PASI score compared to baseline.

  2. Percentage of patients achieving PASI 90 or higher response at Week 16

    Time frame: Week 16

    PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.

  3. Percentage of patients achieving PASI 90 or higher response at Week 52

    Time frame: Week 52

    PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.

  4. Number of injections needed to achieve at least PASI 90

    Time frame: Weeks 16 and 52

    PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.

  5. Percentage of patients with psoriatic arthritis (PsA) who achieved at least PASI 90 at Week 16 with secukinumab

    Time frame: Week 16

    PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.

  6. Percentage of patients with relapse event after treatment discontinuation

    Time frame: Up to 52 weeks

  7. Length of remission period for patients with relapse, calculated from the last treatment date until relapse or starting recurrent symptom(s) or sign(s)

    Time frame: Up to 52 weeks

  8. Percentage of patients achieving Dermatology Life Quality Index (DLQI) 0/1 at Week 52

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2023
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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