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Efficacy and safety of ustekinumab in psoriasis: Our experience
P8121
P8263
Effect of ixekizumab treatment on scalp psoriasis: Results from a phase 2 study in patients with moderate to severe psoriasis Richard Langley, MD, Dalhouise University, Halifax, Nova Scotia, Canada; Baojin Zhu, PhD, Eli Lilly and Company, Indianapolis, IN, United States; Craig Leonardi, MD, St. Louis University School of Medicine, St. Louis, MO, United States; Emily Edson-Heredia, MPH, Eli Lilly and Company, Indianapolis, IN, United States; Gregory Cameron, PhD, Eli Lilly and Company, Indianapolis, IN, United States; Janelle Erickson, PhD, Eli Lilly and Company, Indianapolis, IN, United States; Michael Heffernan, MD, Eli Lilly and Company, Indianapolis, IN, United States; Tomoko Maeda-Chubachi, MD, PhD, Eli Lilly and Company, Indianapolis, IN, United States
Efficacy and drug survival rates for adalimumab in patients with psoriasis vulgaris Jorge Alonso Suarez Perez, MD, Virgen de la Victoria University Hospital, Malaga, Spain; Enrique Herrera, PhD, Virgen de la Victoria University Hospital, Malaga, Spain; Enrique Herrera Acosta, MD, Virgen de la Victoria University Hospital, Malaga, Spain; Maria Victoria Mendiola Fernandez, MD, Virgen de la Victoria University Hospital, Malaga, Spain; Paula Martın Cuervas, MD, Virgen de la Victoria University Hospital, Malaga, Spain Introduction: Introduction of the biologic agents in dermatology challenged the established principles of psoriasis management. In contrast to the traditional systemic agents, such as cyclosporine or methotrexate, in which the rotational treatment principle has been used because of the risk of the cumulative end-organ toxicity, biologic agents are used for long-term treatment. Adherence to treatment is an overall marker of treatment success, because it depends on drug efficacy, side effects, and patients’ satisfaction with the treatment. Long-term data of adherence to biologic treatment in psoriasis are lacking. Methods: This study is based on data from University Hospital of Malaga. Baseline data, sex, age, psoriatic arthritis, PASI, body mass index, time on treatment, and reason for stopping treatment were recorded. Hazard ratios for factors determining drug survival were calculated by logistic regression (P \ .05 was considered significant). Data were analyzed using SPSS 20.0 statistical package.
Background: Ixekizumab, an anti-IL-17 monoclonal antibody, has been shown to be effective in treating psoriasis over 12 weeks of treatment in a phase 2 study. In this analysis, the effects of ixekizumab treatment on scalp psoriasis were evaluated in a subset of patients with moderate to severe psoriasis. Methods: Data for this post hoc analysis were from a randomized, double-blind, placebo-controlled phase 2 clinical trial in patients (N ¼ 142) treated with subcutaneous placebo or ixekizumab (10, 25, 75, 150 mg dose groups). Improvements in scalp psoriasis from baseline were analyzed in combined low dose (10 mg and 25 mg, N ¼ 58) and high dose (75 mg and 150 mg, N ¼ 57) groups. Changes in the Psoriasis Scalp Severity Index (PSSI) were compared between placebo (N ¼ 27) and the low and high dose groups at Weeks 1 and 12 using ANCOVA after adjustment for baseline values. The proportions of patients achieving scalp psoriasis clearance (PSSI ¼ 0) between groups was compared using the Fisher exact test. Results: A total of 106 of 142 patients (75%) had scalp psoriasis at baseline. Significant differences in PSSI were observed as early as week 1 in the high dose group compared to placebo (-6.3 vs. -2.4; P ¼ .011) while the low dose group showed no significant differences compared to placebo (-3.9 vs. -2.4; P ¼ .403) at week 1. At week 12, significant differences in PSSI for both low dose (-13.9; P ¼.025) and high dose groups (-15.7; P \.0001) were observed compared to placebo (-7.1). The majority of patients with scalp psoriasis at baseline reached scalp psoriasis clearance (PSSI ¼ 0) at week 12 for the high dose group (78%; P \.0001), while 49% patients had scalp psoriasis clearance in the low dose group compared to 15% (P ¼ .013) of patients in the placebo group.
Results: In total, 50 patients with psoriasis vulgaris treated with adalimumab. The 3year drug survival is 70%. Significant predictors of drug survival were body mass index. The major reasons for stopping treatment were loss of efficacy. Conclusions: In clinical practice, the efficacy and patient adherence to adalimumab are excellent and comparable to the data obtained in clinical trials. Adalimumab appears to be associated with the lowest rate of discontinuation. This may be because of greater superior effiacy and to a decreased likelihood of experiencing adverse events. Commercial support: None identified.
Conclusion: In this phase 2 study, improvements in scalp psoriasis were observed as early as week 1 and were maintained through 12 weeks of treatment with ixekizumab in the high dose group. Differences from placebo were also observed at 12 weeks in the low dose group. Further studies will more clearly define ixekizumab’s efficacy in treating scalp psoriasis. Sponsored 100% by Eli Lilly and Company.
P7638 Effect of once-daily calcipotriene plus betamethasone dipropionate topical suspension on the hypothalamo-pituitary-adrenal (HPA) axis and calcium metabolism in adolescents with extensive scalp psoriasis: An open, noncontrolled, 8-week trial Lawrence F. Eichenfield, MD, Rady Children’s Hospital, San Diego, CA, United States; Cecilia Ganslandt, MD, LEO Pharma A/S, Ballerup, Denmark; Joel Schlessinger, MD, Skin Specialists, PC, Omaha, NE, United States; Merle Kurvits, MS, LEO Pharma A/S, Ballerup, Denmark Background: Safety and efficacy of the fixed combination of calcipotriene plus betamethasone dipropionate in topical suspension (C/BD) has been investigated in adult patients with extensive psoriasis on body and scalp. However, no trials in adolescent patients have been conducted. Aims: To investigate the safety and efficacy of C/BD in adolescents with scalp psoriasis, as the first of 2 separate, parallel trials. Methods: This prospective, noncontrolled, multicenter trial enrolled subjects in the United States aged 12-17 years with moderate to severe scalp psoriasis affecting at least 20% of the scalp area. C/BD topical suspension was applied once daily for up to 8 weeks. Primary endpoints were adverse drug reactions, subjects with serum cortisol ¼ 18 mcg/dL at 30 minutes, and at both 30 and 60 minutes, after injection of synthetic adrenocorticotropic hormone (ACTH) at weeks 4 and 8, and changes from baseline in albumin-corrected serum calcium, 24-hour urinary calcium excretion and urine calcium:creatinine ratio. Other endpoints included subjects with clear or almost clear disease on the Investigator’s Global Assessment (IGA), subjects who rated their psoriasis as clear or very mild on the Patient’s Global Assessment (PaGA) scale, and Patient’s Assessment of Itching. Results: Thirty-one subjects (19 boys and 12 girls, median age 15 years) were assigned to treatment. Mean extent of scalp psoriasis was 60.4% and scalp psoriasis was graded as moderate in 67.7% of subjects at baseline. The mean weekly dose of topical suspension applied was 24.6 g/week. One patient was reported with HPA axis suppression at week 4 which was mild, transient, and without clinical manifestations. No subjects showed signs of suppression at week 8. There were no relevant changes in serum or urinary calcium. No other adverse drug reactions were reported. At the end of treatment, 54.8% of subjects were clear or almost clear according to the IGA and 58.1% of subjects rated their scalp psoriasis as clear or very mild on the PaGA scale. At week 8, 90.3% of subjects reported no or mild itching, compared to 64.5% at baseline.
P8710 Efficacy and safety of ustekinumab in psoriasis: Our experience Carmen Rodriguez-Cerdeira, PhD, MD, Chuvi, University of Vigo, Vigo, Spain
Conclusions: C/BD topical suspension was well tolerated and associated with a low incidence of HPA axis suppression which did not increase over time in this adolescent population with extensive scalp psoriasis. There was no impact on calcium metabolism. C/BD topical suspension showed clinically relevant improvements in IGA, PaGA, and itching.
This is an observational, longitudinal, retrospective study of a group of patients with moderate to severe plaque psoriasis who had been treated with ustekinumab (45 mg at weeks 0, 4, and every 12 weeks thereafter) for up to 2 years. The efficacy of the drug was evaluated by measuring the psoriasis area and severity index (PASI), the body surface area (BSA), and index of the quality of life (DLQI). A statically significant improvement was observed in the PASI, BSA, and DLQI after 4, 12, and 20 weeks of therapy. After 2 years of treatment, the PASI 75 and 90 values were 100% and 97%, respectively. When it comes to safety, ustekinumab was well tolerated and no remarkable side effects were recorded.
Sponsored 100% by LEO Pharma A/S.
Commercial support: None identified.
AB168
J AM ACAD DERMATOL
MAY 2014
P8263
Effect of ixekizumab treatment on scalp psoriasis: Results from a phase 2 study in patients with moderate to severe psoriasis Richard Langley, MD, Dalhouise University, Halifax, Nova Scotia, Canada; Baojin Zhu, PhD, Eli Lilly and Company, Indianapolis, IN, United States; Craig Leonardi, MD, St. Louis University School of Medicine, St. Louis, MO, United States; Emily Edson-Heredia, MPH, Eli Lilly and Company, Indianapolis, IN, United States; Gregory Cameron, PhD, Eli Lilly and Company, Indianapolis, IN, United States; Janelle Erickson, PhD, Eli Lilly and Company, Indianapolis, IN, United States; Michael Heffernan, MD, Eli Lilly and Company, Indianapolis, IN, United States; Tomoko Maeda-Chubachi, MD, PhD, Eli Lilly and Company, Indianapolis, IN, United States
Efficacy and drug survival rates for adalimumab in patients with psoriasis vulgaris Jorge Alonso Suarez Perez, MD, Virgen de la Victoria University Hospital, Malaga, Spain; Enrique Herrera, PhD, Virgen de la Victoria University Hospital, Malaga, Spain; Enrique Herrera Acosta, MD, Virgen de la Victoria University Hospital, Malaga, Spain; Maria Victoria Mendiola Fernandez, MD, Virgen de la Victoria University Hospital, Malaga, Spain; Paula Martın Cuervas, MD, Virgen de la Victoria University Hospital, Malaga, Spain Introduction: Introduction of the biologic agents in dermatology challenged the established principles of psoriasis management. In contrast to the traditional systemic agents, such as cyclosporine or methotrexate, in which the rotational treatment principle has been used because of the risk of the cumulative end-organ toxicity, biologic agents are used for long-term treatment. Adherence to treatment is an overall marker of treatment success, because it depends on drug efficacy, side effects, and patients’ satisfaction with the treatment. Long-term data of adherence to biologic treatment in psoriasis are lacking. Methods: This study is based on data from University Hospital of Malaga. Baseline data, sex, age, psoriatic arthritis, PASI, body mass index, time on treatment, and reason for stopping treatment were recorded. Hazard ratios for factors determining drug survival were calculated by logistic regression (P \ .05 was considered significant). Data were analyzed using SPSS 20.0 statistical package.
Background: Ixekizumab, an anti-IL-17 monoclonal antibody, has been shown to be effective in treating psoriasis over 12 weeks of treatment in a phase 2 study. In this analysis, the effects of ixekizumab treatment on scalp psoriasis were evaluated in a subset of patients with moderate to severe psoriasis. Methods: Data for this post hoc analysis were from a randomized, double-blind, placebo-controlled phase 2 clinical trial in patients (N ¼ 142) treated with subcutaneous placebo or ixekizumab (10, 25, 75, 150 mg dose groups). Improvements in scalp psoriasis from baseline were analyzed in combined low dose (10 mg and 25 mg, N ¼ 58) and high dose (75 mg and 150 mg, N ¼ 57) groups. Changes in the Psoriasis Scalp Severity Index (PSSI) were compared between placebo (N ¼ 27) and the low and high dose groups at Weeks 1 and 12 using ANCOVA after adjustment for baseline values. The proportions of patients achieving scalp psoriasis clearance (PSSI ¼ 0) between groups was compared using the Fisher exact test. Results: A total of 106 of 142 patients (75%) had scalp psoriasis at baseline. Significant differences in PSSI were observed as early as week 1 in the high dose group compared to placebo (-6.3 vs. -2.4; P ¼ .011) while the low dose group showed no significant differences compared to placebo (-3.9 vs. -2.4; P ¼ .403) at week 1. At week 12, significant differences in PSSI for both low dose (-13.9; P ¼.025) and high dose groups (-15.7; P \.0001) were observed compared to placebo (-7.1). The majority of patients with scalp psoriasis at baseline reached scalp psoriasis clearance (PSSI ¼ 0) at week 12 for the high dose group (78%; P \.0001), while 49% patients had scalp psoriasis clearance in the low dose group compared to 15% (P ¼ .013) of patients in the placebo group.
Results: In total, 50 patients with psoriasis vulgaris treated with adalimumab. The 3year drug survival is 70%. Significant predictors of drug survival were body mass index. The major reasons for stopping treatment were loss of efficacy. Conclusions: In clinical practice, the efficacy and patient adherence to adalimumab are excellent and comparable to the data obtained in clinical trials. Adalimumab appears to be associated with the lowest rate of discontinuation. This may be because of greater superior effiacy and to a decreased likelihood of experiencing adverse events. Commercial support: None identified.
Conclusion: In this phase 2 study, improvements in scalp psoriasis were observed as early as week 1 and were maintained through 12 weeks of treatment with ixekizumab in the high dose group. Differences from placebo were also observed at 12 weeks in the low dose group. Further studies will more clearly define ixekizumab’s efficacy in treating scalp psoriasis. Sponsored 100% by Eli Lilly and Company.
P7638 Effect of once-daily calcipotriene plus betamethasone dipropionate topical suspension on the hypothalamo-pituitary-adrenal (HPA) axis and calcium metabolism in adolescents with extensive scalp psoriasis: An open, noncontrolled, 8-week trial Lawrence F. Eichenfield, MD, Rady Children’s Hospital, San Diego, CA, United States; Cecilia Ganslandt, MD, LEO Pharma A/S, Ballerup, Denmark; Joel Schlessinger, MD, Skin Specialists, PC, Omaha, NE, United States; Merle Kurvits, MS, LEO Pharma A/S, Ballerup, Denmark Background: Safety and efficacy of the fixed combination of calcipotriene plus betamethasone dipropionate in topical suspension (C/BD) has been investigated in adult patients with extensive psoriasis on body and scalp. However, no trials in adolescent patients have been conducted. Aims: To investigate the safety and efficacy of C/BD in adolescents with scalp psoriasis, as the first of 2 separate, parallel trials. Methods: This prospective, noncontrolled, multicenter trial enrolled subjects in the United States aged 12-17 years with moderate to severe scalp psoriasis affecting at least 20% of the scalp area. C/BD topical suspension was applied once daily for up to 8 weeks. Primary endpoints were adverse drug reactions, subjects with serum cortisol ¼ 18 mcg/dL at 30 minutes, and at both 30 and 60 minutes, after injection of synthetic adrenocorticotropic hormone (ACTH) at weeks 4 and 8, and changes from baseline in albumin-corrected serum calcium, 24-hour urinary calcium excretion and urine calcium:creatinine ratio. Other endpoints included subjects with clear or almost clear disease on the Investigator’s Global Assessment (IGA), subjects who rated their psoriasis as clear or very mild on the Patient’s Global Assessment (PaGA) scale, and Patient’s Assessment of Itching. Results: Thirty-one subjects (19 boys and 12 girls, median age 15 years) were assigned to treatment. Mean extent of scalp psoriasis was 60.4% and scalp psoriasis was graded as moderate in 67.7% of subjects at baseline. The mean weekly dose of topical suspension applied was 24.6 g/week. One patient was reported with HPA axis suppression at week 4 which was mild, transient, and without clinical manifestations. No subjects showed signs of suppression at week 8. There were no relevant changes in serum or urinary calcium. No other adverse drug reactions were reported. At the end of treatment, 54.8% of subjects were clear or almost clear according to the IGA and 58.1% of subjects rated their scalp psoriasis as clear or very mild on the PaGA scale. At week 8, 90.3% of subjects reported no or mild itching, compared to 64.5% at baseline.
P8710 Efficacy and safety of ustekinumab in psoriasis: Our experience Carmen Rodriguez-Cerdeira, PhD, MD, Chuvi, University of Vigo, Vigo, Spain
Conclusions: C/BD topical suspension was well tolerated and associated with a low incidence of HPA axis suppression which did not increase over time in this adolescent population with extensive scalp psoriasis. There was no impact on calcium metabolism. C/BD topical suspension showed clinically relevant improvements in IGA, PaGA, and itching.
This is an observational, longitudinal, retrospective study of a group of patients with moderate to severe plaque psoriasis who had been treated with ustekinumab (45 mg at weeks 0, 4, and every 12 weeks thereafter) for up to 2 years. The efficacy of the drug was evaluated by measuring the psoriasis area and severity index (PASI), the body surface area (BSA), and index of the quality of life (DLQI). A statically significant improvement was observed in the PASI, BSA, and DLQI after 4, 12, and 20 weeks of therapy. After 2 years of treatment, the PASI 75 and 90 values were 100% and 97%, respectively. When it comes to safety, ustekinumab was well tolerated and no remarkable side effects were recorded.
Sponsored 100% by LEO Pharma A/S.
Commercial support: None identified.
AB168
J AM ACAD DERMATOL
MAY 2014