Brodalumab Versus Guselkumab in Patients with Moderate-to-Severe Psoriasis with an Inadequate Response to Ustekinumab : A Randomized, Multicenter, Double-Blind Phase 4 Trial (COBRA)
Reich, Kristian (University Medical Center Hamburg-Eppendorf, Hamburg, Germany)
Bianchi, Luca (U.O.S.D. di Dermatologia Fondazione PTV Policlinico Tor Vergata, Rome, Italy)
Khemis, Abdallah (Polyclinique Saint George, Groupe KANTYS, Nice, France)
Maul, Julia-Tatjana (University of Zürich)
Tsianakas, Athanasios (Fachklinik Bad Bentheim, Bad Bentheim, Germany)
Schempp, Christoph M. (University of Freiburg, Germany)
Petersen, Kim (LEO Pharma A/S, Ballerup, Denmark)
Noergaard, Mia M. (LEO Pharma A/S, Ballerup, Denmark)
Puig Sanz, Lluís (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Universitat Autònoma de Barcelona. Departament de Medicina

Fecha:	2024
Resumen:	Despite improved treatment options for plaque psoriasis within the last decades, some patients still have an inadequate response to treatment. Direct clinical evaluation between therapies used after biologic failure could facilitate physicians' choice of treatment. COBRA (NCT04533737) was a randomized (1:1), blinded (patient and assessor), 28-week, active-comparator trial conducted in Europe from December 2020 to December 2022. The objective was to compare the efficacy and safety of brodalumab versus guselkumab in adults with moderate-to-severe plaque psoriasis and inadequate response to ustekinumab. Patients received either brodalumab 210 mg or guselkumab 100 mg. The primary [having Psoriasis Area and Severity Index (PASI)-100 response at week 16] and key secondary (time to PASI-100 response) endpoints were tested in a fixed sequence. Due to delays and enrollment challenges, recruitment was terminated with 113 patients enrolled of 240 planned. The proportion of patients having PASI-100 at week 16 for brodalumab was 53. 4% compared with 35. 9% for guselkumab [odds ratio (OR) 2. 05; 95% confidence interval (CI) 0. 95, 4. 44; p = 0. 069]. As this was not statistically significant, the hierarchical testing procedure was stopped. All other secondary PASI endpoints had nominal p -values below 0. 05 in favor of brodalumab. In the time to PASI response analyses, brodalumab separated from guselkumab in estimated cumulative incidence of patients achieving a response from week 2 onward, suggesting fast onset of action with brodalumab. Quality of life measures improved in both treatment groups. The safety findings were consistent with the known safety profiles. Brodalumab showed a tendency toward better and earlier effect than guselkumab in patients who had failed ustekinumab. Thus, this trial provides important information in assisting physicians in their choice of therapy for patients who have failed their prior anti-interleukin (IL)-12/23 treatment.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Brodalumab ; Guselkumab ; Plaque psoriasis ; PASI
Publicado en:	Dermatology and Therapy, Vol. 14 (february 2024) , p. 453-468, ISSN 2190-9172

DOI: 10.1007/s13555-023-01092-x
PMID: 38300408

16 p, 1.2 MB

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