May 13, 2019
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Brodalumab viable option for psoriasis across racial, ethnic subgroups

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Brodalumab was associated with skin clearance in the treatment of moderate to severe plaque psoriasis across various subgroups defined by race or ethnicity, according to a study.

In two phase 2, multicenter, randomized, double-blind, placebo- and active comparator-controlled studies — AMAGINE-2/-3 — patients were self-categorized into racial subgroups of black Asian or white, or the nonmutually exclusive ethnic subgroup Hispanic/Latino.

Patients received brodalumab 210 mg (Siliq, Valeant Pharmaceuticals) every 2 weeks or ustekinumab 45 mg (Stelara, Janssen; 90 mg in patients weighing > 100 kg) for 52 weeks.

Patients were randomly assigned to brodalumab or ustekinumab with the first dose followed by a second dose 4 weeks later and then doses every 12 weeks, or a placebo was giving during the 12-week induction phase, according to researchers.

This was followed by a maintenance phase through week 52. During the maintenance phase, patients receiving brodalumab were re-randomly assigned to a different dose and interval of brodalumab. Patients receiving ustekinumab continued taking it, and patients receiving placebo were switched to brodalumab 210 mg twice weekly.

There were 56 self-reported black patients, 63 Asian patients, 1,667 white patients and 200 patients of the nonmutually exclusive ethnic subgroup Hispanic/Latino.

There were 1,221 male patients with a mean age of 45 years.

A total of 613 patients received ustekinumab and 1,236 received brodalumab twice weekly. At baseline, patients had similar disease characteristics, duration of disease and Psoriasis Area and Severity Index (PASI) score.

A total of 339 patients were re-randomly assigned to continue brodalumab twice weekly.

Skin clearance response rates were similar across racial and ethnic subgroups at weeks 12 and 52 in those who received brodalumab 210 mg twice weekly.

At week 52, those in the black subgroup assigned ustekinumab had a lower rate of skin clearance efficacy that the other racial and ethnic subgroups assigned ustekinumab.

Patients achieved higher rates of PASI 75, PASI 90 and PASI 100 than those who received ustekinumab across all subgroups at week 12 and 52.

Among those assigned brodalumab, 66.7% of black patients achieved a Psoriasis Symptom Inventory (PSI) response at week 12, as well as 79.5% in Asian patients and 64.2% in white patients.

Furthermore, 55.3% of patients in the Hispanic/Latino ethnic subgroup achieved a PSI response.

For those assigned ustekinumab, 60% of black patients achieved a PSI response, as well as 50% of Asian patients, 53.7% of white patients and 47.1% of Hispanics, researchers reported.

“Because of the unique manifestations of psoriasis symptoms in patients with skin of color, specific analyses evaluating the efficacy, safety and health outcomes of therapies for psoriasis in patients with skin of color are needed,” the researchers wrote. – by Abigail Sutton

 

Disclosures: McMichael reports being an investigator for Allergan, Casseopea, Concert, Incyte and Samumed and a consultant for Aclaris, Galderma, IntraDerm, Johnson & Johnson, Merz, Pfizer, PharmaDerm, Procter & Gamble and Samumed. Please see the study for all other authors’ relevant financial disclosures.