Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab

Summary

The trial investigates the efficacy and safety of brodalumab against guselkumab in treatment for patients with moderate-to-severe plaque psoriasis who still have some remaining symptoms after ustekinumab treatment.

Timeline

Start

2020-12-17

Primary completion

2022-09-08

Completion

2022-12-07

Outcome

Missed primary endpoint

Stopped (Enrollment): “The recruitment was terminated early due to delays and slow recruitment that significantly jeopardized the trial timelines. There were no safety concerns related to the early termination of the trial.”

paper 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]. PMID 38300408 ↗

Publications

• Results Reich K, Bianchi L, Khemis A, Maul JT, Tsianakas A, Schempp CM, Petersen K, Noergaard MM, Puig L. 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). Dermatol Ther (Heidelb). 2024 Feb;14(2):453-468. doi: 10.1007/s13555-023-01092-x. Epub 2024 Feb 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brodalumab	Monoclonal antibody	210 mg	Subcutaneous
Comparator	Guselkumab	Monoclonal antibody	100 mg	Subcutaneous

Indications