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

Moderate-to-severe Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05787236
• Other study ID #: CAIN457AID01
• Status: Completed
• Start date: November 5, 2020
• Est. completion date: March 15, 2022

Study information

• Verified date: March 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Moderate-to-severe Plaque Psoriasis
• Psoriasis

Locations

Country	Name	City	State
Indonesia	Mangga Besar Clinic	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of patients with relapse event after treatment discontinuation		Up to 52 weeks
Secondary	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
Secondary	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