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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05344482
• Other study ID #: CAIN457ATR02
• Status: Completed
• Start date: July 9, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: June 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Other:
• Secukinumab
Included all the patients treated with secukinumab

Locations

Country	Name	City	State
United States	Novartis Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients having absolute Psoriasis Area and Severity Index PASI=3 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.	at week 52
Secondary	Percentage of patients experiencing a 75% reduction in PASI (PASI75) from baseline	Speed of response to secukinumab according to previous biologic use was demonstrated.	at week 4
Secondary	Percentage of patients experiencing a 75% reduction in PASI (PASI90) from baseline	Speed of response to secukinumab according to previous biologic use was demonstrated.	at week 16
Secondary	Percentage of PASI 90 responders at week 52 out of PASI 90 responders at week 16	Sustainability rate between week 16 and week 52 which is defined as PASI 90 scores at both milestones was assessed.	at week 16 and week 52
Secondary	Percentage of patients experiencing a 100% reduction in PASI (PASI100) from baseline	PASI 100 responders rate at week 52 was assessed.	at week 52
Secondary	Percentage of PASI 90 responders among biologic naive patients vs. biologic experienced patients	Responders rates for biologic naive vs. non-naive patients in terms of PASI 90 at week 52 was evaluated.	at week 52
Secondary	Percentage of PASI 90 responder rates at week 52 among smokers vs. non-smokers	Effect of secukinumab treatment response for psoriasis patients (between smokers vs. non-smokers) at week 52 was assessed	at week 52
Secondary	Percentage of PASI 75 responder rates among very severe (PASI>20) patients prior the treatment	Effectiveness of secukinumab treatment for very severe ( PASI>20 ) psoriatic patients at week 52 was demonstrated.	at week 52
Secondary	Nail psoriasis: percentage of patients experiencing nail psoriasis, number of finger nails involved	Effectiveness of secukinumab in psoriatic manifestations was demonstrated.	at week 52
Secondary	Palmoplantar psoriasis: percentage of patients experiencing palmoplantar psoriasis	Effectiveness of secukinumab in psoriatic manifestations was demonstrated.	at week 52
Secondary	Scalp psoriasis: percentage of patients experiencing scalp psoriasis	Effectiveness of secukinumab in psoriatic manifestations was demonstrated.	at week 52
Secondary	Psoriatic arthritis: percentage of patients experiencing psoriatic arthritis	Effectiveness of secukinumab in psoriatic manifestations was demonstrated.	at week 52
Secondary	Percentage of patients who discontinued secukinumab at 52 weeks period	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.	at week 52
Secondary	Time to discontinuation	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.	at week 52

External Links

•   Results for CAIN457ATR02 from the Novartis Clinical Trials Website