Amgen, AstraZeneca: Brodalumab effectively treated psoriasis patients

Brodalumab treatment in patients with moderate-to-severe plaque psoriasis met primary and secondary endpoints for disease improvement when compared with placebo, according to phase 3 study results from Amgen and AstraZeneca.

“Data from the AMAGINE-1 study suggest that brodalumab may offer a new level of efficacy for patients with moderate-to-severe plaque psoriasis,” Sean E. Harper, MD, vice president of research and development at Amgen, said in a news release. “This is the first read-out from our phase 3 psoriasis clinical program, and we look forward to obtaining additional phase 3 data from our two head-to-head studies vs. ustekinumab later this year.”

Brodalumab, “a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor,” is an investigational treatment for psoriasis and asthma (phase 2), according to the release.

Six hundred sixty-one patients with moderate-to-severe plaque psoriasis were randomly assigned 210 mg brodalumab, 140 mg brodalumab or placebo every two weeks for 12 weeks via subcutaneous injection. Forty-six percent of patients reported previous use of biologics.

Patients who were assigned brodalumab and achieved clear or almost clear skin at week 12, according to static Physician Global Assessment (sPGA), were randomly reassigned placebo or continued current dose of brodalumab. Patients originally receiving placebo or not qualifying for re-randomization received 210 mg brodalumab semimonthly.

Patients who achieved at least a 75% improvement from baseline in disease severity at week 12, according to the Psoriasis Severity Index (PASI 75) and patients achieving clear or almost clear skin according sPGA were primary endpoints.

“A significantly higher proportion of patients treated with brodalumab achieved a PASI 75 response, as well as PASI 90 and PASI 100 responses at week 12 [secondary endpoints] compared with placebo,” the release stated.

PASI 75 response was achieved by 83.3% of patients receiving 210 mg brodalumab, 60.3% of patients receiving 140 mg brodalumab and 2.7% of placebo-treated patients. PASI 90 and PASI 100 responses were achieved by 70.3% and 41.9% of patients in the 210-mg group, 42.5% and 23.3% in the 140-mg group, and 0.9% and 0.5% in the placebo cohort, respectively.

Common adverse events associated with brodalumab were nasopharyngitis, upper respiratory tract infection and headache. Serious adverse events occurred in 1.8% of the 210-mg group, 2.7% in the 140-mg arm and 1.4% of placebo-treated patients, the release stated.

“We are encouraged by brodalumab’s emerging profile and look forward to presenting the full data in the appropriate scientific forum,” Briggs W. Morrison, MD, executive vice president of global medicines development at AstraZeneca, said in the release.