Clinical trial NCT05787236: A Study of Moderate-to-severe Plaque Psoriasis Patients Response to Secukinumab Treatment in Real-world Setting
Official title: Moderate-to-severe Plaque Psoriasis Patients Response to Secukinumab Treatment in Real-world Setting: a Monocentric, Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate-to-severe Plaque Psoriasis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-03-28
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of patients achieving PASI 75 or higher response at Week 8
timeFrame: Week 8
measure: Percentage of patients achieving PASI 90 or higher response at Week 16
timeFrame: Week 16
measure: Percentage of patients achieving PASI 90 or higher response at Week 52
timeFrame: Week 52
measure: Number of injections needed to achieve at least PASI 90
timeFrame: Weeks 16 and 52
measure: Percentage of patients with psoriatic arthritis (PsA) who achieved at least PASI 90 at Week 16 with secukinumab
timeFrame: Week 16
measure: Percentage of patients with relapse event after treatment discontinuation
timeFrame: Up to 52 weeks
measure: Length of remission period for patients with relapse, calculated from the last treatment date until relapse or starting recurrent symptom(s) or sign(s)
timeFrame: Up to 52 weeks
measure: Percentage of patients achieving Dermatology Life Quality Index (DLQI) 0/1 at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Mangga Besar Clinic
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: