Psoriasis, Psoriasis (PsO)
Conditions
Keywords
psoriasis, secukinumab
Brief summary
To evaluate the long-term efficacy of two maintenance treatment patterns of secukinumab-the standard maintenance group and the non-standard maintenance group-by assessing the median time to onset and incidence of secondary failure, as well as the time to regain response after dose escalation of secukinumab (including re-initiation of intensive dosing or shortening of the injection interval) in patients who experienced secondary failure.
Interventions
5-week standard induction period (Weeks 0, 1, 2, 3, 4) followed by 300 mg maintenance treatment with ≥90% of recorded injection intervals falling within every 4 weeks ± 7 days (21-35 days).
DRUGNon-standard Maintenance
5-week standard induction period (Weeks 0, 1, 2, 3, 4) followed by at least 3 consecutive documented 300 mg maintenance injections with intervals all longer than 5 weeks (\>35 days); or followed by at least 3 consecutive documented 150 mg maintenance injections with intervals falling within every 4 weeks ± 7 days (21-35 days).
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years, with a clinical diagnosis of moderate-to-severe plaque psoriasis. * Initiated secukinumab treatment at our center between January 2020 and December 2025, and completed the standard 5-week induction period. * Achieved PASI 75 response at the end of the induction period. * Had a clearly defined maintenance treatment pattern (standard or non-standard), with complete treatment records and regular efficacy assessments. * Complete electronic medical record data available for extraction.
Exclusion criteria
* Failure to complete the induction period, or failure to achieve PASI 75 response by the end of the induction period. * Irregular maintenance treatment pattern, or substantial missing data. * Use of other targeted biologic agents or small molecule drugs during the maintenance period. * Permanent discontinuation of treatment for non-efficacy reasons, such as pregnancy, severe infection, or malignancy. * Participation in other interventional clinical trials that may confound efficacy assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to onset of secondary failure | 36 months | Secondary failure was defined as a sustained increase in disease activity during maintenance treatment, leading to loss of PASI 50 response.Time to failure was defined as the time from the start of the maintenance period (after Week 5) to the first occurrence meeting the above criteria for secondary failure.PASI 50 is defined as achieving at least a 50% reduction (improvement) from baseline in the Psoriasis Area and Severity Index (PASI) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Failure-free survival rate | 12, 24, and 36 months | Failure-free survival rate is defined as the proportion of patients who have not yet experienced a "failure" event at a specific time point. |
| Proportion of patients receiving different dose escalation strategies | 12, 24, 36 months | Dose escalation strategies included re-initiation of intensive dosing or shortening of the fixed injection interval (from Q4W to Q2W). |
| Median time to regain treatment response | 12, 24, 36 months | To evaluate the median time to regain treatment response (PASI 75) after different dose escalation strategies.PASI 75 is defined as achieving at least a 75% reduction (improvement) from baseline in the Psoriasis Area and Severity Index (PASI) score. |
Countries
China
Contacts
CONTACTYue TAO, MD
Outcome results
None listed