In the Journals

Brodalumab yields long-term skin clearance results in psoriasis

Most patients with moderate to severe plaque psoriasis who received treatment with brodalumab experienced long-term rates of skin clearance at 120 weeks, according to extension results of AMAGINE-2.

“The increased likelihood of achieving complete skin clearance associated with brodalumab may allow improvement of patient quality of life relative to other biologics associated with a lesser rate of achieving complete skin clearance,” Luis Puig, MD, director of the dermatology department at Hospital de la Santa Creu I Sant Pau in Barcelona, Spain, and colleagues wrote.

In the open-label extension study, patients received 140 mg or 210 mg brodalumab (Kyntheum, LEO Pharma) every 2 weeks, ustekinumab (Stelara, Janssen) or placebo during the 12-week induction phase, followed by a maintenance phase through week 52.

In the maintenance phase, patients receiving brodalumab were re-randomly assigned to brodalumab 140 mg every 2, 4 or 8 weeks, or 210 mg every 2 weeks. Those receiving ustekinumab continued with the treatment and those receiving placebo were switched to brodalumab 210 mg every 2 weeks.

Patients who experienced an inadequate response between weeks 16 and 52 were switched to brodalumab 210 mg every 2 weeks, defined as the rescue phase.

At week 52, patients on brodalumab continued with the treatment at their maintenance or rescue dosage and those originally randomly assigned to ustekinumab were switched to brodalumab 210 mg every 2 weeks.

Data included 1,790 patients who received any dose or interval of brodalumab, 274 patients who received ustekinumab in the maintenance phase and 168 patients who received continuous brodalumab 210 mg, every 2 weeks, in all extension phases.

In those who received continuous brodalumab at 210 mg, skin clearance was maintained from week 52 through week 120.

Those who switched to brodalumab from ustekinumab experienced an increased static physician’s global assessment (sPGA) score of 0 or 1, PASI 90 and PASI 100 response rates, which remained consistent through week 120.

In patients who switched from ustekinumab to brodalumab, PASI 100 response rates were 43.4% at week 52, 60.7% by week 56 and maintained through week 120, according to the study.

In the continuous brodalumab group, a PASI 100 response rate of 64.8% at week 52 was maintained through week 120.

Patients who received any dose of brodalumab experienced consistent skin clearance efficacy from week 52 through 120, with a small numerical decrease in efficacy from weeks 96 to 120, according to researchers.

Using observed data, PASI 75 was achieved in 84.4% of patients in the continuous brodalumab group at week 120. PASI 100 was achieved in 61.1% of these patients.

Moreover, a mean decrease in baseline PASI score of 57.1% was evident as early as week 2 in those treated with continuous brodalumab, compared with a mean decrease of 29.4% and 41.1% in those who received ustekinumab or any dose of brodalumab in the maintenance phase, respectively, the researchers wrote.

The researchers found similar rates of serious adverse events and those leading to treatment discontinuation across all treatment groups.

“The observed numerically greater efficacy rates with brodalumab than rates with other biologics may be due to the inhibition of [interleukin]-17 receptor instead of upstream components of the [interleukin]-17 pathway,” the researchers wrote. – by Abigail Sutton

 

 

Disclosures: The AMAGINE-2 study was supported by Amgen. Puig reports he has received consultant fees, speaking fees and/or honoraria from AbbVie, Almirall, Amgen, Baxalta, Biogen, Boehringer Ingelheim, Celgene, Gebro, Janssen, LEO Pharma, Eli Lilly and Co., Merck-Serono, MSD, Novartis, Pfizer, Regeneron, Roche and Sandoz, and has received institutional research funding related to the treatment of psoriasis from AbbVie, Amgen, Janssen, Eli Lilly and Co., Novartis and Pfizer. Please see the study for all other authors’ relevant financial disclosures.

Most patients with moderate to severe plaque psoriasis who received treatment with brodalumab experienced long-term rates of skin clearance at 120 weeks, according to extension results of AMAGINE-2.

“The increased likelihood of achieving complete skin clearance associated with brodalumab may allow improvement of patient quality of life relative to other biologics associated with a lesser rate of achieving complete skin clearance,” Luis Puig, MD, director of the dermatology department at Hospital de la Santa Creu I Sant Pau in Barcelona, Spain, and colleagues wrote.

In the open-label extension study, patients received 140 mg or 210 mg brodalumab (Kyntheum, LEO Pharma) every 2 weeks, ustekinumab (Stelara, Janssen) or placebo during the 12-week induction phase, followed by a maintenance phase through week 52.

In the maintenance phase, patients receiving brodalumab were re-randomly assigned to brodalumab 140 mg every 2, 4 or 8 weeks, or 210 mg every 2 weeks. Those receiving ustekinumab continued with the treatment and those receiving placebo were switched to brodalumab 210 mg every 2 weeks.

Patients who experienced an inadequate response between weeks 16 and 52 were switched to brodalumab 210 mg every 2 weeks, defined as the rescue phase.

At week 52, patients on brodalumab continued with the treatment at their maintenance or rescue dosage and those originally randomly assigned to ustekinumab were switched to brodalumab 210 mg every 2 weeks.

Data included 1,790 patients who received any dose or interval of brodalumab, 274 patients who received ustekinumab in the maintenance phase and 168 patients who received continuous brodalumab 210 mg, every 2 weeks, in all extension phases.

In those who received continuous brodalumab at 210 mg, skin clearance was maintained from week 52 through week 120.

Those who switched to brodalumab from ustekinumab experienced an increased static physician’s global assessment (sPGA) score of 0 or 1, PASI 90 and PASI 100 response rates, which remained consistent through week 120.

In patients who switched from ustekinumab to brodalumab, PASI 100 response rates were 43.4% at week 52, 60.7% by week 56 and maintained through week 120, according to the study.

In the continuous brodalumab group, a PASI 100 response rate of 64.8% at week 52 was maintained through week 120.

Patients who received any dose of brodalumab experienced consistent skin clearance efficacy from week 52 through 120, with a small numerical decrease in efficacy from weeks 96 to 120, according to researchers.

Using observed data, PASI 75 was achieved in 84.4% of patients in the continuous brodalumab group at week 120. PASI 100 was achieved in 61.1% of these patients.

Moreover, a mean decrease in baseline PASI score of 57.1% was evident as early as week 2 in those treated with continuous brodalumab, compared with a mean decrease of 29.4% and 41.1% in those who received ustekinumab or any dose of brodalumab in the maintenance phase, respectively, the researchers wrote.

The researchers found similar rates of serious adverse events and those leading to treatment discontinuation across all treatment groups.

“The observed numerically greater efficacy rates with brodalumab than rates with other biologics may be due to the inhibition of [interleukin]-17 receptor instead of upstream components of the [interleukin]-17 pathway,” the researchers wrote. – by Abigail Sutton

 

 

Disclosures: The AMAGINE-2 study was supported by Amgen. Puig reports he has received consultant fees, speaking fees and/or honoraria from AbbVie, Almirall, Amgen, Baxalta, Biogen, Boehringer Ingelheim, Celgene, Gebro, Janssen, LEO Pharma, Eli Lilly and Co., Merck-Serono, MSD, Novartis, Pfizer, Regeneron, Roche and Sandoz, and has received institutional research funding related to the treatment of psoriasis from AbbVie, Amgen, Janssen, Eli Lilly and Co., Novartis and Pfizer. Please see the study for all other authors’ relevant financial disclosures.