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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12, 24, and 36 months |
| Proportion of patients receiving different dose escalation strategies |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with moderate-to-severe plaque psoriasis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue TAO, MD | Contact | +86 13851998148 | taoyue18@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medicine School | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34081304 | Background | 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. | |
| 27027388 | Background | 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. |
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| 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). |
|
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 | 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 |
| 34139083 | Background | 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. |
| 27663079 | Background | 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. |
| 25007392 | Background | 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. |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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