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Completed

NCT Number: NCT05344482

Evaluation of the Effectiveness of Secukinumab in Patients With Moderate to Severe Plaque Psoriasis

This study was a real-life study which was based on secondary data collection from the electronic or paper medical records from the Dermatology Clinics of the 14 University, Training & Research Hospitals in Turkey. Data were extracted between 02 September 2020 and 29 April 2021.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

About this study

The study was a retrospective, multicenter, cohort study which was based on data collection at week 4,16 and 52 of secukinumab treatment of moderate to severe plaque psoriasis.

The observational design of the study allowed data collection about secukinumab treatment patterns and clinical and demographic characteristics of plaque psoriasis patients treated with secukinumab for 52 weeks in Turkey. The adults included in the study were treated with secukinumab for 52 weeks. The adults with no available data of PASI scores at specific time points (4, 16 and 52 weeks) and no definite description of treatment cessation were excluded. The study population consisted of adults treated with secukinumab for 52 weeks and adults dropped out before 52 weeks with available data of PASI scores at 4, 16 and 52 weeks and definite description of treatment cessation.

Retrospective data collection from secondary sources (hospital medical records) allowed time and cost saving since description of patients' characteristics, analyses of outcomes of interest and their determinants could be made in a short period of time.

The study consisted of the following periods:

  • The index date was the date of initiation of secukinumab
  • The study (index) period was between 18 May 2018 to 31 May 2020
  • The follow-up (post-index) period was 4,16 and 52 weeks post-index

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A diagnosis of psoriasis
  • Age ≥ 18 years at registry baseline.
  • Patients with a firm diagnosis of chronic plaque psoriasis for at least 6 months before enrollment
  • Secukinumab treatment should be initiated 52 weeks before data collection date
  • Moderate to severe plaque psoriasis with PASI score of ≥10 before initiating secukinumab.

Exclusion criteria

  • Patients diagnosed with others types of psoriasis (pustular psoriasis, erythrodermic psoriasis etc) are excluded.
  • Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA

Treatment and study plan

secukinumab

Other

Included all the patients treated with secukinumab

Primary outcomes

  1. Percentage of patients having absolute Psoriasis Area and Severity Index PASI≤3 at week 52

    Time frame: at week 52

    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). Assessment of the effectiveness of secukinumab in subjects with moderate to severe plaque psoriasis was performed based on the percentage of patients who had absolute PASI ≤3 at week 52 in Turkey.

Secondary outcomes

  1. Percentage of patients experiencing a 75% reduction in PASI (PASI75) from baseline

    Time frame: at week 4

    Speed of response to secukinumab according to previous biologic use was demonstrated.

  2. Percentage of patients experiencing a 75% reduction in PASI (PASI90) from baseline

    Time frame: at week 16

    Speed of response to secukinumab according to previous biologic use was demonstrated.

  3. Percentage of PASI 90 responders at week 52 out of PASI 90 responders at week 16

    Time frame: at week 16 and week 52

    Sustainability rate between week 16 and week 52 which is defined as PASI 90 scores at both milestones was assessed.

  4. Percentage of patients experiencing a 100% reduction in PASI (PASI100) from baseline

    Time frame: at week 52

    PASI 100 responders rate at week 52 was assessed.

  5. Percentage of PASI 90 responders among biologic naive patients vs. biologic experienced patients

    Time frame: at week 52

    Responders rates for biologic naive vs. non-naive patients in terms of PASI 90 at week 52 was evaluated.

  6. Percentage of PASI 90 responder rates at week 52 among smokers vs. non-smokers

    Time frame: at week 52

    Effect of secukinumab treatment response for psoriasis patients (between smokers vs. non-smokers) at week 52 was assessed

  7. Percentage of PASI 75 responder rates among very severe (PASI>20) patients prior the treatment

    Time frame: at week 52

    Effectiveness of secukinumab treatment for very severe ( PASI>20 ) psoriatic patients at week 52 was demonstrated.

  8. Nail psoriasis: percentage of patients experiencing nail psoriasis, number of finger nails involved

    Time frame: at week 52

    Effectiveness of secukinumab in psoriatic manifestations was demonstrated.

  9. Palmoplantar psoriasis: percentage of patients experiencing palmoplantar psoriasis

    Time frame: at week 52

    Effectiveness of secukinumab in psoriatic manifestations was demonstrated.

  10. Scalp psoriasis: percentage of patients experiencing scalp psoriasis

    Time frame: at week 52

    Effectiveness of secukinumab in psoriatic manifestations was demonstrated.

  11. Psoriatic arthritis: percentage of patients experiencing psoriatic arthritis

    Time frame: at week 52

    Effectiveness of secukinumab in psoriatic manifestations was demonstrated.

  12. Percentage of patients who discontinued secukinumab at 52 weeks period

    Time frame: at week 52

    Drug survival as measured by percentage of patients who were persistent secukinumab users, or percentage of patients who discontinued secukinumab at 52 weeks period was reported to describe secukinumab treatment utilization patterns.

  13. Time to discontinuation

    Time frame: at week 52

    Time to discontinuation defined as time from treatment initiation to treatment stop. For patients who stopped secukinumab but re initiated treatment within 90 days after stop date without any other systemic treatment in between will be considered as continued/persistent users.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Retrospective Multicenter Study for the Assessment of Effectiveness of Secukinumab as Assessed by Psoriasis Area and Severity Index With Subcutaneous Administration in Adult Patients With Moderate to Severe Plaque Psoriasis in Turkish Population

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 25, 2022
Registry last updated
Jul 1, 2022

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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