Investigation of plaque psoriasis relapse after secukinumab withdrawal in patients from two Phase 3 studies
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Investigation of plaque psoriasis relapse after secukinumab withdrawal in patients from two Phase 3 studies. / Lebwohl, Mark; Iversen, Lars; Eidsmo, Liv; Krueger, James G; Suárez-Fariñas, Mayte; Tomalin, Lewis; Kolbinger, Frank; You, Ruquan; Milutinovic, Marina.
I: Clinical and Experimental Dermatology, 2024.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Investigation of plaque psoriasis relapse after secukinumab withdrawal in patients from two Phase 3 studies
AU - Lebwohl, Mark
AU - Iversen, Lars
AU - Eidsmo, Liv
AU - Krueger, James G
AU - Suárez-Fariñas, Mayte
AU - Tomalin, Lewis
AU - Kolbinger, Frank
AU - You, Ruquan
AU - Milutinovic, Marina
N1 - © The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists.
PY - 2024
Y1 - 2024
N2 - BACKGROUND: Secukinumab is effective against a range of psoriatic manifestations. Investigating psoriasis (PsO) relapse following secukinumab discontinuation could provide insights into long-term PsO remission.OBJECTIVE: To examine PsO relapse rates upon treatment discontinuation following one year of secukinumab treatment.METHODS: This study (NCT01544595) is an extension of the Phase 3 ERASURE/FIXTURE studies in patients with moderate-to-severe plaque PsO. After one year of secukinumab 300 mg or 150 mg treatment, Week 52 PASI75 responders were randomly assigned to receive placebo. Upon relapse, patients receiving placebo were switched to their previous secukinumab dose. The study primary outcome was non-relapse rate after secukinumab withdrawal.RESULTS: Following the last dose of secukinumab 300 mg, 21% and 10% of patients who switched to placebo did not relapse at one and two years after discontinuation, respectively. Patients who received secukinumab 150 mg for one year showed a lower proportion of non-relapse following treatment discontinuation (14% and 6%) at one and two years, respectively). Non-relapsing patients maintained low mean PASI (2.8) at one year drug-free versus baseline (20.9); 1.7 at two years drug-free versus baseline (19.2). Disease duration (P=0.017) and severity (P=0.022) were significantly associated with time-to-relapse in patients initially treated with secukinumab 300 mg; patients with shorter disease duration and lower baseline PASI remained relapse-free for longer.CONCLUSIONS: Following discontinuation of secukinumab, a proportion of patients stayed relapse-free. Further, patients with shorter disease duration remained relapse-free for longer, suggesting that earlier treatment with secukinumab may result in long-term clinical control of moderate-to-severe PsO.
AB - BACKGROUND: Secukinumab is effective against a range of psoriatic manifestations. Investigating psoriasis (PsO) relapse following secukinumab discontinuation could provide insights into long-term PsO remission.OBJECTIVE: To examine PsO relapse rates upon treatment discontinuation following one year of secukinumab treatment.METHODS: This study (NCT01544595) is an extension of the Phase 3 ERASURE/FIXTURE studies in patients with moderate-to-severe plaque PsO. After one year of secukinumab 300 mg or 150 mg treatment, Week 52 PASI75 responders were randomly assigned to receive placebo. Upon relapse, patients receiving placebo were switched to their previous secukinumab dose. The study primary outcome was non-relapse rate after secukinumab withdrawal.RESULTS: Following the last dose of secukinumab 300 mg, 21% and 10% of patients who switched to placebo did not relapse at one and two years after discontinuation, respectively. Patients who received secukinumab 150 mg for one year showed a lower proportion of non-relapse following treatment discontinuation (14% and 6%) at one and two years, respectively). Non-relapsing patients maintained low mean PASI (2.8) at one year drug-free versus baseline (20.9); 1.7 at two years drug-free versus baseline (19.2). Disease duration (P=0.017) and severity (P=0.022) were significantly associated with time-to-relapse in patients initially treated with secukinumab 300 mg; patients with shorter disease duration and lower baseline PASI remained relapse-free for longer.CONCLUSIONS: Following discontinuation of secukinumab, a proportion of patients stayed relapse-free. Further, patients with shorter disease duration remained relapse-free for longer, suggesting that earlier treatment with secukinumab may result in long-term clinical control of moderate-to-severe PsO.
U2 - 10.1093/ced/llad329
DO - 10.1093/ced/llad329
M3 - Journal article
C2 - 37820029
JO - Transactions of the St. John's Hospital Dermatological Society
JF - Transactions of the St. John's Hospital Dermatological Society
SN - 0307-6938
ER -
ID: 389904038