Effects of Different Secukinumab Maintenance Regimens on Long-Term Outcomes in Patients With Psoriasis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Adult patients with moderate-to-severe plaque psoriasis

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Standard Maintenance

    Drug

    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

    Drug

    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).

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: standard maintenance cohort1 intervention
Group B: non-standard maintenance cohort1 intervention

Trial outcomes

Primary outcomes

1

Time to onset of secondary failure

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

Time frame
36 months

Secondary outcomes

1

Failure-free survival rate

Failure-free survival rate is defined as the proportion of patients who have not yet experienced a "failure" event at a specific time point.

Time frame
12, 24, and 36 months
2

Proportion of patients receiving different dose escalation strategies

Dose escalation strategies included re-initiation of intensive dosing or shortening of the fixed injection interval (from Q4W to Q2W).

Time frame
12, 24, 36 months
3

Median time to regain treatment response

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.

Time frame
12, 24, 36 months

Other outcomes

Sponsors and contacts

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