Clinical potential of brodalumab in the management of psoriasis: the evidence to date Laura F Sandoval,1 Brooke Williams,1 Steven R Feldman1 3 1Department of Dermatology, Center for Dermatology Research, Wake Forest School of Medicine, Winston-Salem, NC, USA; 2Department of Pathology, Wake Forest School of Medicine, Winston-Salem, NC, USA; 3Department of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA Abstract: Brodalumab is an anti-IL-17 receptor monoclonal antibody currently in development for the treatment of moderate-to-severe plaque psoriasis. Two of the four subjects who received brodalumab 140 mg SC achieved a PASI score of 50. PK was reported in the Phase I trial of brodalumab (AMG 827). Medical and scientific articles about Psoriasis, written by P Klekotka. 2, Clinical Trial, Efficacy and safety of brodalumab in subpopulations of patients with difficult-to-treat moderate-to-severe plaque psoriasis. 2 clinical studies in healthy adults and subjects with psoriasis were used to construct a population PK model. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis.
For patients with co-existent moderate to severe plaque Pso weighing more than 220 lbs (100 kg) the recommended dose is 90 mg subcutaneous injection at weeks 0 and 4, and then every 12 weeks 66. AMAGINE-2 and -3 are two Phase III studies to evaluate the efficacy and safety of induction and maintenance regimens of brodalumab compared with placebo and ustekinumab in subjects with moderate-to-severe plaque Pso 78, 79. Gregersen PK, Amos CI, Lee AT, Lu Y, Remmers EF, Kastner DL, et al. The midazolam PK profile will be assessed over the 12 hour postdose period. Subjects with a diagnosis of moderate to severe chronic plaque psoriasis. Treatment preferences for moderate to severe psoriasis in childhood are unknown. Brodalumab, a human anti-interleukin-17-receptor antibody in the treatment of Japanese patients with moderate-to-severe plaque psoriasis: Efficacy and safety results from a phase II randomized controlled study. On 9 May 2014, AstraZeneca and Amgen announced that the Phase III AMAGINE-1 study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis met all primary and secondary endpoints for both evaluated doses. In a Phase IIb study, subjects with uncontrolled severe asthma and elevated baseline blood eosinophil levels taking benralizumab (anti-IL-5R mAb) had a statistically significant reduction in their asthma exacerbation rate (AER), as well as improvements in lung function (FEV1) and asthma control versus subjects taking placebo over a period of one year.
The primary efficacy endpoint was the proportion of subjects achieving ACR20 (20 improvement according to the American College of Rheumatology criteria) at Week 24. Phase 3 study in patients with moderate-to-severe chronic plaque psoriasis. With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-1). The PK properties of 1 were superior to those of maraviroc in preclinical species, including rat, dog, and monkey.