Moderate-to-severe Plaque Psoriasis Patients Response to Secukinumab Treatment in Real-world Setting: a Monocentric, Retrospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Time Frame: 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.
Secondary Outcomes
- Percentage of patients achieving PASI 75 or higher response at Week 8(Week 8)
- Percentage of patients with psoriatic arthritis (PsA) who achieved at least PASI 90 at Week 16 with secukinumab(Week 16)
- 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)
- Number of injections needed to achieve at least PASI 90(Weeks 16 and 52)
- Percentage of patients with relapse event after treatment discontinuation(Up to 52 weeks)
- Percentage of patients achieving PASI 90 or higher response at Week 52(Week 52)
- Percentage of patients achieving PASI 90 or higher response at Week 16(Week 16)
- Percentage of patients achieving Dermatology Life Quality Index (DLQI) 0/1 at Week 52(Week 52)