Effects of Different Secukinumab Maintenance Regimens on Long-Term Outcomes in Patients With Psoriasis
June 9, 2026 updated by: taoyue, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Effects of Different Secukinumab Maintenance Regimens on Long-Term Outcomes in Patients With Psoriasis: A Single-Center Real-World Cross-Sectional Retrospective Study
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yue TAO, MD
- Phone Number: +86 13851998148
- Email: taoyue18@126.com
Study Locations
-
-
Jiangsu
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Nanjing, Jiangsu, China, 210008
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medicine School
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Contact:
- Yue TAO, MD
- Phone Number: +86 13851998148
- Email: taoyue@126.com
-
Principal Investigator:
- Yue TAO, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Adult patients with moderate-to-severe plaque psoriasis
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
standard maintenance cohort
Patients who, after completing the 5-week standard induction period (Weeks 0, 1, 2, 3, 4), received 300 mg maintenance treatment with ≥90% of recorded injection intervals falling within every 4 weeks ± 7 days (21-35 days).
|
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).
|
|
non-standard maintenance cohort
Patients who, after completing the standard induction period, during the maintenance treatment phase, had either: at least 3 consecutive documented 300 mg maintenance injections with intervals all longer than 5 weeks (>35 days); or at least 3 consecutive documented 150 mg maintenance injections with intervals falling within every 4 weeks ± 7 days (21-35 days). |
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to onset of secondary failure
Time Frame: 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
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36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Failure-free survival rate
Time Frame: 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.
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12, 24, and 36 months
|
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Proportion of patients receiving different dose escalation strategies
Time Frame: 12, 24, 36 months
|
Dose escalation strategies included re-initiation of intensive dosing or shortening of the fixed injection interval (from Q4W to Q2W).
|
12, 24, 36 months
|
|
Median time to regain treatment response
Time Frame: 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.
|
12, 24, 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K, Puig L, Nakagawa H, Spelman L, Sigurgeirsson B, Rivas E, Tsai TF, Wasel N, Tyring S, Salko T, Hampele I, Notter M, Karpov A, Helou S, Papavassilis C; ERASURE Study Group; FIXTURE Study Group. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014 Jul 24;371(4):326-38. doi: 10.1056/NEJMoa1314258. Epub 2014 Jul 9.
- Gambardella A, Licata G, Sohrt A. Dose Adjustment of Biologic Treatments for Moderate-to-Severe Plaque Psoriasis in the Real World: A Systematic Review. Dermatol Ther (Heidelb). 2021 Aug;11(4):1141-1156. doi: 10.1007/s13555-021-00559-z. Epub 2021 Jun 3.
- Menter A, Papp KA, Gooderham M, Pariser DM, Augustin M, Kerdel FA, Fakharzadeh S, Goyal K, Calabro S, Langholff W, Chavers S, Naessens D, Sermon J, Krueger GG. Drug survival of biologic therapy in a large, disease-based registry of patients with psoriasis: results from the Psoriasis Longitudinal Assessment and Registry (PSOLAR). J Eur Acad Dermatol Venereol. 2016 Jul;30(7):1148-58. doi: 10.1111/jdv.13611. Epub 2016 Mar 30.
- Nast A, Altenburg A, Augustin M, Boehncke WH, Harle P, Klaus J, Koza J, Mrowietz U, Ockenfels HM, Philipp S, Reich K, Rosenbach T, Schlaeger M, Schmid-Ott G, Sebastian M, von Kiedrowski R, Weberschock T, Dressler C. German S3-Guideline on the treatment of Psoriasis vulgaris, adapted from EuroGuiDerm - Part 1: Treatment goals and treatment recommendations. J Dtsch Dermatol Ges. 2021 Jun;19(6):934-150. doi: 10.1111/ddg.14508. No abstract available.
- Blauvelt A, Reich K, Tsai TF, Tyring S, Vanaclocha F, Kingo K, Ziv M, Pinter A, Vender R, Hugot S, You R, Milutinovic M, Thaci D. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. J Am Acad Dermatol. 2017 Jan;76(1):60-69.e9. doi: 10.1016/j.jaad.2016.08.008. Epub 2016 Sep 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
May 22, 2026
First Submitted That Met QC Criteria
June 9, 2026
First Posted (Actual)
June 11, 2026
Study Record Updates
Last Update Posted (Actual)
June 11, 2026
Last Update Submitted That Met QC Criteria
June 9, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SEMLOP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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