Clinical trial NCT05344482: Evaluation of the Effectiveness of Secukinumab in Patients With Moderate to Severe Plaque Psoriasis
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Keywords: Secukinumab,
real life,
PASI,
effectiveness,
anti-IL17
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-04-25
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of adults diagnosed as chronic plaque psoriasis with no previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, whose PASI score was ≥10 before initiation of secukinumab in whom secukinumab had been initiated for at least 52 weeks before data collection date.

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients having absolute Psoriasis Area and Severity Index PASI≤3 at week 52
timeFrame: at week 52
Secondary outcomes:
measure: Percentage of patients experiencing a 75% reduction in PASI (PASI75) from baseline
timeFrame: at week 4
measure: Percentage of patients experiencing a 75% reduction in PASI (PASI90) from baseline
timeFrame: at week 16
measure: Percentage of PASI 90 responders at week 52 out of PASI 90 responders at week 16
timeFrame: at week 16 and week 52
measure: Percentage of patients experiencing a 100% reduction in PASI (PASI100) from baseline
timeFrame: at week 52
measure: Percentage of PASI 90 responders among biologic naive patients vs. biologic experienced patients
timeFrame: at week 52
measure: Percentage of PASI 90 responder rates at week 52 among smokers vs. non-smokers
timeFrame: at week 52
measure: Percentage of PASI 75 responder rates among very severe (PASI>20) patients prior the treatment
timeFrame: at week 52
measure: Nail psoriasis: percentage of patients experiencing nail psoriasis, number of finger nails involved
timeFrame: at week 52
measure: Palmoplantar psoriasis: percentage of patients experiencing palmoplantar psoriasis
timeFrame: at week 52
measure: Scalp psoriasis: percentage of patients experiencing scalp psoriasis
timeFrame: at week 52
measure: Psoriatic arthritis: percentage of patients experiencing psoriatic arthritis
timeFrame: at week 52
measure: Percentage of patients who discontinued secukinumab at 52 weeks period
timeFrame: at week 52
measure: Time to discontinuation
timeFrame: at week 52
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: