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MIAMI – Skin clearance rates among people with moderate to severe plaque psoriasis treated with brodalumab were superior to clearance rates among those treated with ustekinumab in a study that also provided comparisons between white and nonwhite patients.
In the study, presented in a poster at the 2018 Orlando Dermatology Aesthetic and Clinical Conference, there were no significant difference in overall efficacy, safety, or health-related quality of life outcomes between white and nonwhite patients treated with either biologic.
Additional analyses specific to patients with skin of color can be beneficial, Amy McMichael, MD, one of the investigators, said in an interview. “Patients with skin of color experience differences in psoriasis-related symptoms,” noted Dr. McMichael, chair of dermatology at Wake Forest Baptist Medical Center in Winston-Salem, N.C. “Greater degrees of skin involvement have been shown in African-American patients, as have differences in erythema, scaling, dyspigmentation, and plaque thickness.”
She and her colleagues evaluated 1,849 participants in phase 3 brodalumab clinical trials, which included ustekinumab-treated patients as a comparison group. Approximately 10% of the AMAGINE-2 and AMAGINE-3 study populations were skin of color participants. The results reported at the meeting were from their ad hoc study of 12-week induction findings from the 52-week clinical trials.
At week 12, 70% of white and 63% of nonwhite participants treated with ustekinumab achieved a Psoriasis Area and Severity Index (PASI) 75. At the same time, 86% of white and 88% of nonwhite patients treated with brodalumab achieved the same outcome. Similarly, PASI 90 and PASI 100 scores did not differ significantly between the 1,667 white and 182 skin of color participants.
The two biologics act on different aspects of the molecular pathway involved in psoriasis. Brodalumab (Siliq) specifically blocks the interleukin-17 receptor, whereas other biologics used to treat psoriasis, including ustekinumab (Stelara), an IL-12 and -23 antagonist, target upstream molecules in the inflammatory pathway. Dr. McMichael said, “The superior skin clearance rates seen in patients treated with brodalumab may be due to its target being a receptor as opposed to a ligand.”
Treatment-emergent adverse event rates were similar between the white and nonwhite patients. Treatment-emergent adverse events were reported in 58% and 57% of the white brodalumab and ustekinumab groups, respectively, and in 53% and 47% of the nonwhite brodalumab and ustekinumab groups, respectively. Serious adverse events occurred in 1.2% and 1.1% of the white brodalumab and ustekinumab cohorts, respectively, and in 1.7% and 0% of the nonwhite participants, respectively.
The investigators also assessed health-related quality of life and again found outcomes were similar between white and nonwhite participants. For example, among those treated with brodalumab, 80% of white and 78% of nonwhite patients achieved a score improvement of 5 or greater on the Dermatology Life Quality Index. Of those randomized to ustekinumab, 76% of white patients and 73% of nonwhite patients achieved the same outcome.
“We plan to perform a further analysis evaluating the Dr. McMichael said. Additionally, a population-based study to investigate treatment patterns in patients with psoriasis across racial and socioeconomic groups could also shed light on how patients with skin of color manage their psoriasis, she added.
Dr. McMichael’s disclosures include having been an investigator for Allergan, Incyte, and Samumed and a consultant to Aclaris, Galderma, IntraDerm, Johnson & Johnson, Merz, Pfizer, and Procter & Gamble.
SOURCE: McMichael A et al. ODAC 2018.
MIAMI – Skin clearance rates among people with moderate to severe plaque psoriasis treated with brodalumab were superior to clearance rates among those treated with ustekinumab in a study that also provided comparisons between white and nonwhite patients.
In the study, presented in a poster at the 2018 Orlando Dermatology Aesthetic and Clinical Conference, there were no significant difference in overall efficacy, safety, or health-related quality of life outcomes between white and nonwhite patients treated with either biologic.
Additional analyses specific to patients with skin of color can be beneficial, Amy McMichael, MD, one of the investigators, said in an interview. “Patients with skin of color experience differences in psoriasis-related symptoms,” noted Dr. McMichael, chair of dermatology at Wake Forest Baptist Medical Center in Winston-Salem, N.C. “Greater degrees of skin involvement have been shown in African-American patients, as have differences in erythema, scaling, dyspigmentation, and plaque thickness.”
She and her colleagues evaluated 1,849 participants in phase 3 brodalumab clinical trials, which included ustekinumab-treated patients as a comparison group. Approximately 10% of the AMAGINE-2 and AMAGINE-3 study populations were skin of color participants. The results reported at the meeting were from their ad hoc study of 12-week induction findings from the 52-week clinical trials.
At week 12, 70% of white and 63% of nonwhite participants treated with ustekinumab achieved a Psoriasis Area and Severity Index (PASI) 75. At the same time, 86% of white and 88% of nonwhite patients treated with brodalumab achieved the same outcome. Similarly, PASI 90 and PASI 100 scores did not differ significantly between the 1,667 white and 182 skin of color participants.
The two biologics act on different aspects of the molecular pathway involved in psoriasis. Brodalumab (Siliq) specifically blocks the interleukin-17 receptor, whereas other biologics used to treat psoriasis, including ustekinumab (Stelara), an IL-12 and -23 antagonist, target upstream molecules in the inflammatory pathway. Dr. McMichael said, “The superior skin clearance rates seen in patients treated with brodalumab may be due to its target being a receptor as opposed to a ligand.”
Treatment-emergent adverse event rates were similar between the white and nonwhite patients. Treatment-emergent adverse events were reported in 58% and 57% of the white brodalumab and ustekinumab groups, respectively, and in 53% and 47% of the nonwhite brodalumab and ustekinumab groups, respectively. Serious adverse events occurred in 1.2% and 1.1% of the white brodalumab and ustekinumab cohorts, respectively, and in 1.7% and 0% of the nonwhite participants, respectively.
The investigators also assessed health-related quality of life and again found outcomes were similar between white and nonwhite participants. For example, among those treated with brodalumab, 80% of white and 78% of nonwhite patients achieved a score improvement of 5 or greater on the Dermatology Life Quality Index. Of those randomized to ustekinumab, 76% of white patients and 73% of nonwhite patients achieved the same outcome.
“We plan to perform a further analysis evaluating the Dr. McMichael said. Additionally, a population-based study to investigate treatment patterns in patients with psoriasis across racial and socioeconomic groups could also shed light on how patients with skin of color manage their psoriasis, she added.
Dr. McMichael’s disclosures include having been an investigator for Allergan, Incyte, and Samumed and a consultant to Aclaris, Galderma, IntraDerm, Johnson & Johnson, Merz, Pfizer, and Procter & Gamble.
SOURCE: McMichael A et al. ODAC 2018.
MIAMI – Skin clearance rates among people with moderate to severe plaque psoriasis treated with brodalumab were superior to clearance rates among those treated with ustekinumab in a study that also provided comparisons between white and nonwhite patients.
In the study, presented in a poster at the 2018 Orlando Dermatology Aesthetic and Clinical Conference, there were no significant difference in overall efficacy, safety, or health-related quality of life outcomes between white and nonwhite patients treated with either biologic.
Additional analyses specific to patients with skin of color can be beneficial, Amy McMichael, MD, one of the investigators, said in an interview. “Patients with skin of color experience differences in psoriasis-related symptoms,” noted Dr. McMichael, chair of dermatology at Wake Forest Baptist Medical Center in Winston-Salem, N.C. “Greater degrees of skin involvement have been shown in African-American patients, as have differences in erythema, scaling, dyspigmentation, and plaque thickness.”
She and her colleagues evaluated 1,849 participants in phase 3 brodalumab clinical trials, which included ustekinumab-treated patients as a comparison group. Approximately 10% of the AMAGINE-2 and AMAGINE-3 study populations were skin of color participants. The results reported at the meeting were from their ad hoc study of 12-week induction findings from the 52-week clinical trials.
At week 12, 70% of white and 63% of nonwhite participants treated with ustekinumab achieved a Psoriasis Area and Severity Index (PASI) 75. At the same time, 86% of white and 88% of nonwhite patients treated with brodalumab achieved the same outcome. Similarly, PASI 90 and PASI 100 scores did not differ significantly between the 1,667 white and 182 skin of color participants.
The two biologics act on different aspects of the molecular pathway involved in psoriasis. Brodalumab (Siliq) specifically blocks the interleukin-17 receptor, whereas other biologics used to treat psoriasis, including ustekinumab (Stelara), an IL-12 and -23 antagonist, target upstream molecules in the inflammatory pathway. Dr. McMichael said, “The superior skin clearance rates seen in patients treated with brodalumab may be due to its target being a receptor as opposed to a ligand.”
Treatment-emergent adverse event rates were similar between the white and nonwhite patients. Treatment-emergent adverse events were reported in 58% and 57% of the white brodalumab and ustekinumab groups, respectively, and in 53% and 47% of the nonwhite brodalumab and ustekinumab groups, respectively. Serious adverse events occurred in 1.2% and 1.1% of the white brodalumab and ustekinumab cohorts, respectively, and in 1.7% and 0% of the nonwhite participants, respectively.
The investigators also assessed health-related quality of life and again found outcomes were similar between white and nonwhite participants. For example, among those treated with brodalumab, 80% of white and 78% of nonwhite patients achieved a score improvement of 5 or greater on the Dermatology Life Quality Index. Of those randomized to ustekinumab, 76% of white patients and 73% of nonwhite patients achieved the same outcome.
“We plan to perform a further analysis evaluating the Dr. McMichael said. Additionally, a population-based study to investigate treatment patterns in patients with psoriasis across racial and socioeconomic groups could also shed light on how patients with skin of color manage their psoriasis, she added.
Dr. McMichael’s disclosures include having been an investigator for Allergan, Incyte, and Samumed and a consultant to Aclaris, Galderma, IntraDerm, Johnson & Johnson, Merz, Pfizer, and Procter & Gamble.
SOURCE: McMichael A et al. ODAC 2018.
REPORTING FROM ODAC 2018
Key clinical point: Responses to brodalumab and ustekinumab were comparable in nonwhite and white patients with psoriasis.
Major finding: At week 12, 70% of white and 63% of nonwhite participants treated with ustekinumab achieved PASI 75, a nonsignificant difference.
Study details: An ad hoc comparison of week 12 phase 3 study data in 1,849 patients including 182 patients with skin of color.
Disclosures: Dr. McMichael’s disclosures include having been an investigator for Allergan, Incyte, and Samumed; and a consultant to Aclaris, Galderma, IntraDerm, Johnson & Johnson, Merz, Pfizer, and Procter & Gamble.
Source: McMichael A et al. ODAC 2018.