Effects of Different Secukinumab Maintenance Regimens on Long-Term Outcomes in Patients With Psoriasis
9. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
120
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yue TAO, MD
- Telefonnummer: +86 13851998148
- E-mail: taoyue18@126.com
Studiesteder
-
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Jiangsu
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Nanjing, Jiangsu, Kina, 210008
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medicine School
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Kontakt:
- Yue TAO, MD
- Telefonnummer: +86 13851998148
- E-mail: taoyue@126.com
-
Ledende efterforsker:
- Yue TAO, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Adult patients with moderate-to-severe plaque psoriasis
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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).
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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).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Time to onset of secondary failure
Tidsramme: 36 months
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Failure-free survival rate
Tidsramme: 12, 24, and 36 months
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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
Tidsramme: 12, 24, 36 months
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Dose escalation strategies included re-initiation of intensive dosing or shortening of the fixed injection interval (from Q4W to Q2W).
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12, 24, 36 months
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Median time to regain treatment response
Tidsramme: 12, 24, 36 months
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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.
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12, 24, 36 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
1. marts 2027
Datoer for studieregistrering
Først indsendt
22. maj 2026
Først indsendt, der opfyldte QC-kriterier
9. juni 2026
Først opslået (Faktiske)
11. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juni 2026
Sidst verificeret
1. maj 2026
Mere information
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