User login
Psoriatic arthritis associated with heavy drinking
Heavy alcohol consumption was associated with incident psoriatic arthritis in women, Shaowei Wu, Ph.D., and his associates reported in a study of 116,430 female registered nurses in the Nurses’ Health Study II.
The investigators found 141 incident cases of psoriatic arthritis (PsA) during 1,137,763 years of follow-up in 1991-2005. The risk for PsA was not signficantly different between drinkers and nondrinkers for women who consumed 0.1-14.9 g/day (hazard ratio, 0.7) or 15-29.9 g/day (HR, 1.43), but women who consumed more than 30 g/day had a signficantly elevated risk (HR, 4.45). The results remained consistent when updated alcohol intake and 1991 baseline consumption was used, and when the analysis was restricted to those who developed psoriasis during follow-up.
“These findings are also in line with the biological evidence that high levels of alcohol intake contribute to systemic inflammation and may trigger psoriatic eruption, and thus may have important implications for the prevention of PsA,” the investigators concluded.
Find the full study in the Journal of Rheumatology (doi:10.3899/jrheum.140808).
Heavy alcohol consumption was associated with incident psoriatic arthritis in women, Shaowei Wu, Ph.D., and his associates reported in a study of 116,430 female registered nurses in the Nurses’ Health Study II.
The investigators found 141 incident cases of psoriatic arthritis (PsA) during 1,137,763 years of follow-up in 1991-2005. The risk for PsA was not signficantly different between drinkers and nondrinkers for women who consumed 0.1-14.9 g/day (hazard ratio, 0.7) or 15-29.9 g/day (HR, 1.43), but women who consumed more than 30 g/day had a signficantly elevated risk (HR, 4.45). The results remained consistent when updated alcohol intake and 1991 baseline consumption was used, and when the analysis was restricted to those who developed psoriasis during follow-up.
“These findings are also in line with the biological evidence that high levels of alcohol intake contribute to systemic inflammation and may trigger psoriatic eruption, and thus may have important implications for the prevention of PsA,” the investigators concluded.
Find the full study in the Journal of Rheumatology (doi:10.3899/jrheum.140808).
Heavy alcohol consumption was associated with incident psoriatic arthritis in women, Shaowei Wu, Ph.D., and his associates reported in a study of 116,430 female registered nurses in the Nurses’ Health Study II.
The investigators found 141 incident cases of psoriatic arthritis (PsA) during 1,137,763 years of follow-up in 1991-2005. The risk for PsA was not signficantly different between drinkers and nondrinkers for women who consumed 0.1-14.9 g/day (hazard ratio, 0.7) or 15-29.9 g/day (HR, 1.43), but women who consumed more than 30 g/day had a signficantly elevated risk (HR, 4.45). The results remained consistent when updated alcohol intake and 1991 baseline consumption was used, and when the analysis was restricted to those who developed psoriasis during follow-up.
“These findings are also in line with the biological evidence that high levels of alcohol intake contribute to systemic inflammation and may trigger psoriatic eruption, and thus may have important implications for the prevention of PsA,” the investigators concluded.
Find the full study in the Journal of Rheumatology (doi:10.3899/jrheum.140808).
Impact of Diet and Obesity on Psoriasis Severity
There is a higher prevalence of obesity in patients with psoriasis. Studies have shown that psoriasis patients may gain weight after the onset of psoriasis. Dr. Jeffrey Weinberg discusses the mechanisms of psoriasis that can lead to obesity. He also provides tips on how to evaluate the patient for comorbidities associated with obesity. Although there is no evidence that certain foods make psoriasis worse or better, recommending a healthy diet is important. Dr. Weinberg also discusses the impact of obesity on the efficacy of psoriasis treatments, such as the biologics.
The psoriasis audiocast series is created in collaboration with Cutis® and the National Psoriasis Foundation®.
Suggested Reading
Bremmer S, Van Voorhees AS, Hsu S, et al; for the National Psoriasis Foundation. Obesity and psoriasis: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2010;63:1058-1069.
There is a higher prevalence of obesity in patients with psoriasis. Studies have shown that psoriasis patients may gain weight after the onset of psoriasis. Dr. Jeffrey Weinberg discusses the mechanisms of psoriasis that can lead to obesity. He also provides tips on how to evaluate the patient for comorbidities associated with obesity. Although there is no evidence that certain foods make psoriasis worse or better, recommending a healthy diet is important. Dr. Weinberg also discusses the impact of obesity on the efficacy of psoriasis treatments, such as the biologics.
The psoriasis audiocast series is created in collaboration with Cutis® and the National Psoriasis Foundation®.
There is a higher prevalence of obesity in patients with psoriasis. Studies have shown that psoriasis patients may gain weight after the onset of psoriasis. Dr. Jeffrey Weinberg discusses the mechanisms of psoriasis that can lead to obesity. He also provides tips on how to evaluate the patient for comorbidities associated with obesity. Although there is no evidence that certain foods make psoriasis worse or better, recommending a healthy diet is important. Dr. Weinberg also discusses the impact of obesity on the efficacy of psoriasis treatments, such as the biologics.
The psoriasis audiocast series is created in collaboration with Cutis® and the National Psoriasis Foundation®.
Suggested Reading
Bremmer S, Van Voorhees AS, Hsu S, et al; for the National Psoriasis Foundation. Obesity and psoriasis: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2010;63:1058-1069.
Suggested Reading
Bremmer S, Van Voorhees AS, Hsu S, et al; for the National Psoriasis Foundation. Obesity and psoriasis: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2010;63:1058-1069.
Yoga for Dermatologic Conditions
Regardless of its spiritual origins, yoga has become a popular way of reaching mind and body well-being with nearly 30 million people practicing regularly worldwide.1 Yoga, which is the combination of physical postures, controlled breathing, and meditation or mindfulness, has long been used in complementary and alternative medicine around the world and recently has gained popularity as a therapeutic practice, with nearly 14 million Americans reporting that yoga was recommended to them by a physician or therapist.2,3 Studies suggest that people who participate in even brief yoga programs may see improvements in anxiety, somatic stress and discomfort, health-related quality of life, and self-rated sleep quality, all benefits that can help medical conditions, especially those that are dermatologic in nature.4,5
Stress and Dermatologic Conditions
The interaction between the mind, skin, and body is well known. Research in psychoneuroimmunology, the interaction between psychological processes and the nervous and immune systems, has examined the role of neuropeptides, hormones, and neurotransmitters in psychodermatological disorders. The correlation between neuroimmunological pathways and skin inflammation is now well recognized, specifically the interactions between the brain and skin underlying many dermatological diseases (eg, acne, alopecia areata, various types of eczema and dermatitis, oral and genital herpes, hyperhidrosis, pruritus, psoriasis, rosacea, urticaria, warts, breaking or ridging of the nails).6-9
Two biological systems are known to be affected by the systemic stress response: (1) the hypothalamic-pituitary-adrenal axis, which regulates the release of adrenocorticotropin, ß-endorphin, and cortisol, and (2) the sympathoadrenal medullary system, which regulates the release of catecholamines (eg, epinephrine, norepinephrine).7 Cortisol and catecholamines have been shown to have potent effects on the immune system as well as the inflammatory response.9 Additionally, it has been shown that cutaneous sensory nerve terminals release neuropeptides, including calcitonin gene-related peptide and substance P, both of which have different effects on the local inflammatory response.10,11
Psychological stress is well known to trigger many dermatologic conditions, but it also may lead to abnormal skin barrier function.12 The mechanism in which skin barrier function is affected appears to involve a stress-induced increase of endogenous glucocorticoids, which may consequently disrupt skin barrier function and recovery rates, stratum corneum cohesion, and epidermal antimicrobial function.13,14
Atopic dermatitis, for example, is classified as a psychophysiological disorder. Although it is not caused by stress, atopic dermatitis has been described to be precipitated or exacerbated by stress in patients.15 In fact, it was found that stressful life events preceded the onset of itching in more than 70% of patients with atopic dermatitis,16 which is especially relevant, as there is no cure and patients often experience a lifelong struggle with the condition. Additionally, stress mediates the degranulation of mast cells via corticotropin-releasing hormone and neuropeptides, and the upregulation of mast cell corticotropin-releasing hormone receptors supporting its putative role in the pathogenesis of urticaria.9,17 Furthermore, the increase in cortisol also has been described in the exacerbation of acne during times of stress.18
Psychological factors affect the management of skin conditions in more than one-third of reported dermatology patients; therefore, it is important to consider these factors in the treatment of chronic dermatological conditions, especially when they are inquired by the patient.19,20
Yoga Benefits in the Literature
The therapeutic potential of yoga has been explored in a growing number of randomized controlled trials to date.21 A recently published bibliometric analysis provided a comprehensive review of the characteristics of the randomized yoga trials available in the literature.22 The review included 366 full-text articles, with the 2 earliest studies published in 1975 and nearly 90% published within the last decade. In addition to healthy patients, it was found these randomized controlled yoga trials most commonly enrolled patients with breast cancer, depression, asthma, and type 2 diabetes mellitus.22 Another study examined psychological (eg, self-rated stress and stress behavior, anger, exhaustion, quality of life) and physiological (eg, blood pressure, heart rate, urinary catecholamines, salivary cortisol) measurements obtained before and after a 10-session yoga program that participants completed over a 4-month period, with results showing significant improvements (P<.05) on almost all stress-related subjective and physiological variables. Results were comparable with cognitive behavioral therapy.23
Not only has it been shown that yoga helps patients on a psychological level, but a recent study reported that 90-minute sessions of mindfulness meditation and gentle Hatha yoga over an 8-week period led to observable benefits on a cellular level, as telomere length was maintained in distressed breast cancer survivors compared to decreases in telomere length in the control group with patients who solely participated in a stress management seminar.24 To date, there are no known studies examining the effects of yoga on patients with skin cancer. However, a few studies have specifically examined the effect of yoga in managing non–cancer-related dermatologic issues. Specifically, one small study of psoriasis patients found that those who listened to mindfulness meditation tapes while undergoing standard phototherapy (psoralen plus UVA) healed faster than those who underwent phototherapy treatment alone.25
Because some dermatologic problems have comorbidities and increased risk factors of other medical problems, such as psoriasis with psoriatic arthritis and metabolic diseases (eg, abdominal obesity, diabetes, nonalcoholic fatty liver disease, dyslipidemia, metabolic syndrome, chronic kidney disease), it is even more pertinent to recommend approaches for healthy mind and body well-being as a supplement to medical care.26
Final Thoughts
With accurate diagnosis by a dermatologist, appropriate conventional treatments can improve dermatologic problems. These treatments alone can reduce patients’ stress and improve skin, hair, and nail conditions; however, if it is clear that stress is interfering with a patient’s overall well-being and ability to cope with his/her dermatologic condition, concurrent stress management interventions may be warranted. In some instances, recommending yoga sessions, mindful meditation, or breathing exercises may help, while in others referral to a mental health professional may be necessary.
Beyond the direct physiological effects of stress, it also is worth mentioning that patients who deal with stress also tend to scratch, pick, or irritate their skin more and often lack the motivation to adhere to skin care regimens or treatments, again supporting the idea that our approach in managing these patients must be multifaceted. As dermatologists in training, residents should be cognizant of the potential psychological sequelae of some dermatologic problems and be aware of the possible use of supplemental interventions by our patients.
1. Dangerfield A. Yoga wars. BBC News. http://news.bbc.co.uk/1/hi/7844691.stm. Published January 23, 2009. Accessed March 25, 2015.
2. Yoga Journal releases 2012 yoga in America market study [press release]. San Francisco, CA: Yoga Journal; December 6, 2012.
3. De Michaelis E. A History of Modern Yoga: Patanjali and Western Esotericism. London, United Kingdom: A&C Black; 2005.
4. Telles S, Singh N, Yadav A, et al. Effect of yoga on different aspects of mental health. Indian J Physiol Pharmacol. 2012;56:245-254.
5. Rodriguez-Vallecillo E, Woodbury-Fariña MA. Dermatological manifestations of stress in normal and psychiatric populations. Psychiatr Clin North Am. 2014;37:625-651.
6. Stander S, Raap U, Weisshaar E, et al. Pathogenesis of pruritus. J Dtsch Dermatol Ges. 2011;9:456-463.
7. Arck PC, Slominski A, Theoharides TC, et al. Neuroimmunology of stress: skin takes center stage. J Invest Dermatol. 2006;126:1697-1704.
8. Recognizing the mind-skin connection. Harvard Health Publications Web site. http://www.health.harvard.edu/newsletter_article/Recognizing_the_mind-skin_connection. Published November 1, 2006. Accessed March 31, 2015.
9. Tausk F, Elenkov I, Moynihan J. Psychoneuroimmunology. Dermatol Ther. 2008;21:22-31.
10. Pavlovic S, Liezmann C, Blois SM, et al. Substance P is a key mediator of stress-induced protection from allergic sensitization via modified antigen presentation. J Immunol. 2011;186:848-855.
11. Toyoda M, Nakamura M, Makino T, et al. Nerve growth factor and substance P are useful plasma markers of disease activity in atopic dermatitis. Br J Dermatol. 2002;147:71-79.
12. Koo JYM, Lee CS. General approach to evaluating psychodermatological disorders. In: Koo JYM, Lee CS, eds. Psychocutaneous Medicine. New York, NY: Marcel Dekker; 2003:1-29.
13. Garg A, Chren MM, Sands LP, et al. Psychological stress perturbs epidermal permeability barrier homeostasis: implications for the pathogenesis of stress-associated skin disorders. Arch Dermatol. 2001;137:53-59.
14. Elias PM, Sun R, Eder AR, et al. Treating atopic dermatitis at the source: corrective barrier repair therapy based upon new pathogenic insights. Expert Rev Dermatol. 2013;8:27-36.
15. Morren MA, Przybilla B, Bamelis M, et al. Atopic dermatitis: triggering factors. J Am Acad Dermatol. 1994;31:467-473.
16. Faulstich ME, Williamson DA. An overview of atopic dermatitis: toward a bio-behavioural integration. J Psychosom Res. 1985;29:647-654.
17. Theoharides TC, Donelan JM, Papadopoulou N, et al. Mast cells as targets of corticotropin-releasing factor and related peptides. Trends Pharmacol Sci. 2004;25:563-568.
18. Suh DH, Kwon HH. What’s new in the physiopathology of acne [published online ahead of print Jan 24, 2015]? Br J Dermatol. doi:10.1111/bjd.13634.
19. Picardi A, Mazzotti E, Pasquini P. Prevalence and correlates of suicidal ideation among patients with skin disease. J Am Acad Dermatol. 2006;54:420-426.
20. Ponarovsky B, Amital D, Lazarov A, et al. Anxiety and depression in patients with allergic and non-allergic cutaneous disorders. Int J Dermatol. 2011;50:1217-1222.
21. Khalsa SB. Yoga as a therapeutic intervention: a bibliometric analysis of published research studies. Indian J Physiol Pharmacol. 2004;48:269-285.
22. Cramer H, Lauche R, Dobos G. Characteristics of randomized controlled trials of yoga: a bibliometric analysis. BMC Complement Altern Med. 2014;14:328.
23. Granath J, Ingvarsson S, von Thiele U, et al. Stress management: a randomized study of cognitive behavioural therapy and yoga. Cogn Behav Ther. 2006;35:3-10.
24. Carlson LE, Beattie TL, Giese-Davis J, et al. Mindfulness-based cancer recovery and supportive-expressive therapy maintain telomere length relative to controls in distressed breast cancer survivors. Cancer. 2015;121:476-484.
25. Kabat-Zinn J, Wheeler E, Light T, et al. Influence of a mindfulness meditation-based stress reduction intervention on rates of skin clearing in patients with moderate to severe psoriasis undergoing phototherapy (UVB) and photochemotherapy (PUVA). Psychosom Med. 1998;60:625-632.
26. Gisondi P, Galvan A, Idolazzi L, et al. Management of moderate to severe psoriasis in patients with metabolic comorbidities. Front Med (Lausanne). 2015;2:1.
Regardless of its spiritual origins, yoga has become a popular way of reaching mind and body well-being with nearly 30 million people practicing regularly worldwide.1 Yoga, which is the combination of physical postures, controlled breathing, and meditation or mindfulness, has long been used in complementary and alternative medicine around the world and recently has gained popularity as a therapeutic practice, with nearly 14 million Americans reporting that yoga was recommended to them by a physician or therapist.2,3 Studies suggest that people who participate in even brief yoga programs may see improvements in anxiety, somatic stress and discomfort, health-related quality of life, and self-rated sleep quality, all benefits that can help medical conditions, especially those that are dermatologic in nature.4,5
Stress and Dermatologic Conditions
The interaction between the mind, skin, and body is well known. Research in psychoneuroimmunology, the interaction between psychological processes and the nervous and immune systems, has examined the role of neuropeptides, hormones, and neurotransmitters in psychodermatological disorders. The correlation between neuroimmunological pathways and skin inflammation is now well recognized, specifically the interactions between the brain and skin underlying many dermatological diseases (eg, acne, alopecia areata, various types of eczema and dermatitis, oral and genital herpes, hyperhidrosis, pruritus, psoriasis, rosacea, urticaria, warts, breaking or ridging of the nails).6-9
Two biological systems are known to be affected by the systemic stress response: (1) the hypothalamic-pituitary-adrenal axis, which regulates the release of adrenocorticotropin, ß-endorphin, and cortisol, and (2) the sympathoadrenal medullary system, which regulates the release of catecholamines (eg, epinephrine, norepinephrine).7 Cortisol and catecholamines have been shown to have potent effects on the immune system as well as the inflammatory response.9 Additionally, it has been shown that cutaneous sensory nerve terminals release neuropeptides, including calcitonin gene-related peptide and substance P, both of which have different effects on the local inflammatory response.10,11
Psychological stress is well known to trigger many dermatologic conditions, but it also may lead to abnormal skin barrier function.12 The mechanism in which skin barrier function is affected appears to involve a stress-induced increase of endogenous glucocorticoids, which may consequently disrupt skin barrier function and recovery rates, stratum corneum cohesion, and epidermal antimicrobial function.13,14
Atopic dermatitis, for example, is classified as a psychophysiological disorder. Although it is not caused by stress, atopic dermatitis has been described to be precipitated or exacerbated by stress in patients.15 In fact, it was found that stressful life events preceded the onset of itching in more than 70% of patients with atopic dermatitis,16 which is especially relevant, as there is no cure and patients often experience a lifelong struggle with the condition. Additionally, stress mediates the degranulation of mast cells via corticotropin-releasing hormone and neuropeptides, and the upregulation of mast cell corticotropin-releasing hormone receptors supporting its putative role in the pathogenesis of urticaria.9,17 Furthermore, the increase in cortisol also has been described in the exacerbation of acne during times of stress.18
Psychological factors affect the management of skin conditions in more than one-third of reported dermatology patients; therefore, it is important to consider these factors in the treatment of chronic dermatological conditions, especially when they are inquired by the patient.19,20
Yoga Benefits in the Literature
The therapeutic potential of yoga has been explored in a growing number of randomized controlled trials to date.21 A recently published bibliometric analysis provided a comprehensive review of the characteristics of the randomized yoga trials available in the literature.22 The review included 366 full-text articles, with the 2 earliest studies published in 1975 and nearly 90% published within the last decade. In addition to healthy patients, it was found these randomized controlled yoga trials most commonly enrolled patients with breast cancer, depression, asthma, and type 2 diabetes mellitus.22 Another study examined psychological (eg, self-rated stress and stress behavior, anger, exhaustion, quality of life) and physiological (eg, blood pressure, heart rate, urinary catecholamines, salivary cortisol) measurements obtained before and after a 10-session yoga program that participants completed over a 4-month period, with results showing significant improvements (P<.05) on almost all stress-related subjective and physiological variables. Results were comparable with cognitive behavioral therapy.23
Not only has it been shown that yoga helps patients on a psychological level, but a recent study reported that 90-minute sessions of mindfulness meditation and gentle Hatha yoga over an 8-week period led to observable benefits on a cellular level, as telomere length was maintained in distressed breast cancer survivors compared to decreases in telomere length in the control group with patients who solely participated in a stress management seminar.24 To date, there are no known studies examining the effects of yoga on patients with skin cancer. However, a few studies have specifically examined the effect of yoga in managing non–cancer-related dermatologic issues. Specifically, one small study of psoriasis patients found that those who listened to mindfulness meditation tapes while undergoing standard phototherapy (psoralen plus UVA) healed faster than those who underwent phototherapy treatment alone.25
Because some dermatologic problems have comorbidities and increased risk factors of other medical problems, such as psoriasis with psoriatic arthritis and metabolic diseases (eg, abdominal obesity, diabetes, nonalcoholic fatty liver disease, dyslipidemia, metabolic syndrome, chronic kidney disease), it is even more pertinent to recommend approaches for healthy mind and body well-being as a supplement to medical care.26
Final Thoughts
With accurate diagnosis by a dermatologist, appropriate conventional treatments can improve dermatologic problems. These treatments alone can reduce patients’ stress and improve skin, hair, and nail conditions; however, if it is clear that stress is interfering with a patient’s overall well-being and ability to cope with his/her dermatologic condition, concurrent stress management interventions may be warranted. In some instances, recommending yoga sessions, mindful meditation, or breathing exercises may help, while in others referral to a mental health professional may be necessary.
Beyond the direct physiological effects of stress, it also is worth mentioning that patients who deal with stress also tend to scratch, pick, or irritate their skin more and often lack the motivation to adhere to skin care regimens or treatments, again supporting the idea that our approach in managing these patients must be multifaceted. As dermatologists in training, residents should be cognizant of the potential psychological sequelae of some dermatologic problems and be aware of the possible use of supplemental interventions by our patients.
Regardless of its spiritual origins, yoga has become a popular way of reaching mind and body well-being with nearly 30 million people practicing regularly worldwide.1 Yoga, which is the combination of physical postures, controlled breathing, and meditation or mindfulness, has long been used in complementary and alternative medicine around the world and recently has gained popularity as a therapeutic practice, with nearly 14 million Americans reporting that yoga was recommended to them by a physician or therapist.2,3 Studies suggest that people who participate in even brief yoga programs may see improvements in anxiety, somatic stress and discomfort, health-related quality of life, and self-rated sleep quality, all benefits that can help medical conditions, especially those that are dermatologic in nature.4,5
Stress and Dermatologic Conditions
The interaction between the mind, skin, and body is well known. Research in psychoneuroimmunology, the interaction between psychological processes and the nervous and immune systems, has examined the role of neuropeptides, hormones, and neurotransmitters in psychodermatological disorders. The correlation between neuroimmunological pathways and skin inflammation is now well recognized, specifically the interactions between the brain and skin underlying many dermatological diseases (eg, acne, alopecia areata, various types of eczema and dermatitis, oral and genital herpes, hyperhidrosis, pruritus, psoriasis, rosacea, urticaria, warts, breaking or ridging of the nails).6-9
Two biological systems are known to be affected by the systemic stress response: (1) the hypothalamic-pituitary-adrenal axis, which regulates the release of adrenocorticotropin, ß-endorphin, and cortisol, and (2) the sympathoadrenal medullary system, which regulates the release of catecholamines (eg, epinephrine, norepinephrine).7 Cortisol and catecholamines have been shown to have potent effects on the immune system as well as the inflammatory response.9 Additionally, it has been shown that cutaneous sensory nerve terminals release neuropeptides, including calcitonin gene-related peptide and substance P, both of which have different effects on the local inflammatory response.10,11
Psychological stress is well known to trigger many dermatologic conditions, but it also may lead to abnormal skin barrier function.12 The mechanism in which skin barrier function is affected appears to involve a stress-induced increase of endogenous glucocorticoids, which may consequently disrupt skin barrier function and recovery rates, stratum corneum cohesion, and epidermal antimicrobial function.13,14
Atopic dermatitis, for example, is classified as a psychophysiological disorder. Although it is not caused by stress, atopic dermatitis has been described to be precipitated or exacerbated by stress in patients.15 In fact, it was found that stressful life events preceded the onset of itching in more than 70% of patients with atopic dermatitis,16 which is especially relevant, as there is no cure and patients often experience a lifelong struggle with the condition. Additionally, stress mediates the degranulation of mast cells via corticotropin-releasing hormone and neuropeptides, and the upregulation of mast cell corticotropin-releasing hormone receptors supporting its putative role in the pathogenesis of urticaria.9,17 Furthermore, the increase in cortisol also has been described in the exacerbation of acne during times of stress.18
Psychological factors affect the management of skin conditions in more than one-third of reported dermatology patients; therefore, it is important to consider these factors in the treatment of chronic dermatological conditions, especially when they are inquired by the patient.19,20
Yoga Benefits in the Literature
The therapeutic potential of yoga has been explored in a growing number of randomized controlled trials to date.21 A recently published bibliometric analysis provided a comprehensive review of the characteristics of the randomized yoga trials available in the literature.22 The review included 366 full-text articles, with the 2 earliest studies published in 1975 and nearly 90% published within the last decade. In addition to healthy patients, it was found these randomized controlled yoga trials most commonly enrolled patients with breast cancer, depression, asthma, and type 2 diabetes mellitus.22 Another study examined psychological (eg, self-rated stress and stress behavior, anger, exhaustion, quality of life) and physiological (eg, blood pressure, heart rate, urinary catecholamines, salivary cortisol) measurements obtained before and after a 10-session yoga program that participants completed over a 4-month period, with results showing significant improvements (P<.05) on almost all stress-related subjective and physiological variables. Results were comparable with cognitive behavioral therapy.23
Not only has it been shown that yoga helps patients on a psychological level, but a recent study reported that 90-minute sessions of mindfulness meditation and gentle Hatha yoga over an 8-week period led to observable benefits on a cellular level, as telomere length was maintained in distressed breast cancer survivors compared to decreases in telomere length in the control group with patients who solely participated in a stress management seminar.24 To date, there are no known studies examining the effects of yoga on patients with skin cancer. However, a few studies have specifically examined the effect of yoga in managing non–cancer-related dermatologic issues. Specifically, one small study of psoriasis patients found that those who listened to mindfulness meditation tapes while undergoing standard phototherapy (psoralen plus UVA) healed faster than those who underwent phototherapy treatment alone.25
Because some dermatologic problems have comorbidities and increased risk factors of other medical problems, such as psoriasis with psoriatic arthritis and metabolic diseases (eg, abdominal obesity, diabetes, nonalcoholic fatty liver disease, dyslipidemia, metabolic syndrome, chronic kidney disease), it is even more pertinent to recommend approaches for healthy mind and body well-being as a supplement to medical care.26
Final Thoughts
With accurate diagnosis by a dermatologist, appropriate conventional treatments can improve dermatologic problems. These treatments alone can reduce patients’ stress and improve skin, hair, and nail conditions; however, if it is clear that stress is interfering with a patient’s overall well-being and ability to cope with his/her dermatologic condition, concurrent stress management interventions may be warranted. In some instances, recommending yoga sessions, mindful meditation, or breathing exercises may help, while in others referral to a mental health professional may be necessary.
Beyond the direct physiological effects of stress, it also is worth mentioning that patients who deal with stress also tend to scratch, pick, or irritate their skin more and often lack the motivation to adhere to skin care regimens or treatments, again supporting the idea that our approach in managing these patients must be multifaceted. As dermatologists in training, residents should be cognizant of the potential psychological sequelae of some dermatologic problems and be aware of the possible use of supplemental interventions by our patients.
1. Dangerfield A. Yoga wars. BBC News. http://news.bbc.co.uk/1/hi/7844691.stm. Published January 23, 2009. Accessed March 25, 2015.
2. Yoga Journal releases 2012 yoga in America market study [press release]. San Francisco, CA: Yoga Journal; December 6, 2012.
3. De Michaelis E. A History of Modern Yoga: Patanjali and Western Esotericism. London, United Kingdom: A&C Black; 2005.
4. Telles S, Singh N, Yadav A, et al. Effect of yoga on different aspects of mental health. Indian J Physiol Pharmacol. 2012;56:245-254.
5. Rodriguez-Vallecillo E, Woodbury-Fariña MA. Dermatological manifestations of stress in normal and psychiatric populations. Psychiatr Clin North Am. 2014;37:625-651.
6. Stander S, Raap U, Weisshaar E, et al. Pathogenesis of pruritus. J Dtsch Dermatol Ges. 2011;9:456-463.
7. Arck PC, Slominski A, Theoharides TC, et al. Neuroimmunology of stress: skin takes center stage. J Invest Dermatol. 2006;126:1697-1704.
8. Recognizing the mind-skin connection. Harvard Health Publications Web site. http://www.health.harvard.edu/newsletter_article/Recognizing_the_mind-skin_connection. Published November 1, 2006. Accessed March 31, 2015.
9. Tausk F, Elenkov I, Moynihan J. Psychoneuroimmunology. Dermatol Ther. 2008;21:22-31.
10. Pavlovic S, Liezmann C, Blois SM, et al. Substance P is a key mediator of stress-induced protection from allergic sensitization via modified antigen presentation. J Immunol. 2011;186:848-855.
11. Toyoda M, Nakamura M, Makino T, et al. Nerve growth factor and substance P are useful plasma markers of disease activity in atopic dermatitis. Br J Dermatol. 2002;147:71-79.
12. Koo JYM, Lee CS. General approach to evaluating psychodermatological disorders. In: Koo JYM, Lee CS, eds. Psychocutaneous Medicine. New York, NY: Marcel Dekker; 2003:1-29.
13. Garg A, Chren MM, Sands LP, et al. Psychological stress perturbs epidermal permeability barrier homeostasis: implications for the pathogenesis of stress-associated skin disorders. Arch Dermatol. 2001;137:53-59.
14. Elias PM, Sun R, Eder AR, et al. Treating atopic dermatitis at the source: corrective barrier repair therapy based upon new pathogenic insights. Expert Rev Dermatol. 2013;8:27-36.
15. Morren MA, Przybilla B, Bamelis M, et al. Atopic dermatitis: triggering factors. J Am Acad Dermatol. 1994;31:467-473.
16. Faulstich ME, Williamson DA. An overview of atopic dermatitis: toward a bio-behavioural integration. J Psychosom Res. 1985;29:647-654.
17. Theoharides TC, Donelan JM, Papadopoulou N, et al. Mast cells as targets of corticotropin-releasing factor and related peptides. Trends Pharmacol Sci. 2004;25:563-568.
18. Suh DH, Kwon HH. What’s new in the physiopathology of acne [published online ahead of print Jan 24, 2015]? Br J Dermatol. doi:10.1111/bjd.13634.
19. Picardi A, Mazzotti E, Pasquini P. Prevalence and correlates of suicidal ideation among patients with skin disease. J Am Acad Dermatol. 2006;54:420-426.
20. Ponarovsky B, Amital D, Lazarov A, et al. Anxiety and depression in patients with allergic and non-allergic cutaneous disorders. Int J Dermatol. 2011;50:1217-1222.
21. Khalsa SB. Yoga as a therapeutic intervention: a bibliometric analysis of published research studies. Indian J Physiol Pharmacol. 2004;48:269-285.
22. Cramer H, Lauche R, Dobos G. Characteristics of randomized controlled trials of yoga: a bibliometric analysis. BMC Complement Altern Med. 2014;14:328.
23. Granath J, Ingvarsson S, von Thiele U, et al. Stress management: a randomized study of cognitive behavioural therapy and yoga. Cogn Behav Ther. 2006;35:3-10.
24. Carlson LE, Beattie TL, Giese-Davis J, et al. Mindfulness-based cancer recovery and supportive-expressive therapy maintain telomere length relative to controls in distressed breast cancer survivors. Cancer. 2015;121:476-484.
25. Kabat-Zinn J, Wheeler E, Light T, et al. Influence of a mindfulness meditation-based stress reduction intervention on rates of skin clearing in patients with moderate to severe psoriasis undergoing phototherapy (UVB) and photochemotherapy (PUVA). Psychosom Med. 1998;60:625-632.
26. Gisondi P, Galvan A, Idolazzi L, et al. Management of moderate to severe psoriasis in patients with metabolic comorbidities. Front Med (Lausanne). 2015;2:1.
1. Dangerfield A. Yoga wars. BBC News. http://news.bbc.co.uk/1/hi/7844691.stm. Published January 23, 2009. Accessed March 25, 2015.
2. Yoga Journal releases 2012 yoga in America market study [press release]. San Francisco, CA: Yoga Journal; December 6, 2012.
3. De Michaelis E. A History of Modern Yoga: Patanjali and Western Esotericism. London, United Kingdom: A&C Black; 2005.
4. Telles S, Singh N, Yadav A, et al. Effect of yoga on different aspects of mental health. Indian J Physiol Pharmacol. 2012;56:245-254.
5. Rodriguez-Vallecillo E, Woodbury-Fariña MA. Dermatological manifestations of stress in normal and psychiatric populations. Psychiatr Clin North Am. 2014;37:625-651.
6. Stander S, Raap U, Weisshaar E, et al. Pathogenesis of pruritus. J Dtsch Dermatol Ges. 2011;9:456-463.
7. Arck PC, Slominski A, Theoharides TC, et al. Neuroimmunology of stress: skin takes center stage. J Invest Dermatol. 2006;126:1697-1704.
8. Recognizing the mind-skin connection. Harvard Health Publications Web site. http://www.health.harvard.edu/newsletter_article/Recognizing_the_mind-skin_connection. Published November 1, 2006. Accessed March 31, 2015.
9. Tausk F, Elenkov I, Moynihan J. Psychoneuroimmunology. Dermatol Ther. 2008;21:22-31.
10. Pavlovic S, Liezmann C, Blois SM, et al. Substance P is a key mediator of stress-induced protection from allergic sensitization via modified antigen presentation. J Immunol. 2011;186:848-855.
11. Toyoda M, Nakamura M, Makino T, et al. Nerve growth factor and substance P are useful plasma markers of disease activity in atopic dermatitis. Br J Dermatol. 2002;147:71-79.
12. Koo JYM, Lee CS. General approach to evaluating psychodermatological disorders. In: Koo JYM, Lee CS, eds. Psychocutaneous Medicine. New York, NY: Marcel Dekker; 2003:1-29.
13. Garg A, Chren MM, Sands LP, et al. Psychological stress perturbs epidermal permeability barrier homeostasis: implications for the pathogenesis of stress-associated skin disorders. Arch Dermatol. 2001;137:53-59.
14. Elias PM, Sun R, Eder AR, et al. Treating atopic dermatitis at the source: corrective barrier repair therapy based upon new pathogenic insights. Expert Rev Dermatol. 2013;8:27-36.
15. Morren MA, Przybilla B, Bamelis M, et al. Atopic dermatitis: triggering factors. J Am Acad Dermatol. 1994;31:467-473.
16. Faulstich ME, Williamson DA. An overview of atopic dermatitis: toward a bio-behavioural integration. J Psychosom Res. 1985;29:647-654.
17. Theoharides TC, Donelan JM, Papadopoulou N, et al. Mast cells as targets of corticotropin-releasing factor and related peptides. Trends Pharmacol Sci. 2004;25:563-568.
18. Suh DH, Kwon HH. What’s new in the physiopathology of acne [published online ahead of print Jan 24, 2015]? Br J Dermatol. doi:10.1111/bjd.13634.
19. Picardi A, Mazzotti E, Pasquini P. Prevalence and correlates of suicidal ideation among patients with skin disease. J Am Acad Dermatol. 2006;54:420-426.
20. Ponarovsky B, Amital D, Lazarov A, et al. Anxiety and depression in patients with allergic and non-allergic cutaneous disorders. Int J Dermatol. 2011;50:1217-1222.
21. Khalsa SB. Yoga as a therapeutic intervention: a bibliometric analysis of published research studies. Indian J Physiol Pharmacol. 2004;48:269-285.
22. Cramer H, Lauche R, Dobos G. Characteristics of randomized controlled trials of yoga: a bibliometric analysis. BMC Complement Altern Med. 2014;14:328.
23. Granath J, Ingvarsson S, von Thiele U, et al. Stress management: a randomized study of cognitive behavioural therapy and yoga. Cogn Behav Ther. 2006;35:3-10.
24. Carlson LE, Beattie TL, Giese-Davis J, et al. Mindfulness-based cancer recovery and supportive-expressive therapy maintain telomere length relative to controls in distressed breast cancer survivors. Cancer. 2015;121:476-484.
25. Kabat-Zinn J, Wheeler E, Light T, et al. Influence of a mindfulness meditation-based stress reduction intervention on rates of skin clearing in patients with moderate to severe psoriasis undergoing phototherapy (UVB) and photochemotherapy (PUVA). Psychosom Med. 1998;60:625-632.
26. Gisondi P, Galvan A, Idolazzi L, et al. Management of moderate to severe psoriasis in patients with metabolic comorbidities. Front Med (Lausanne). 2015;2:1.
To Stop or Not to Stop
With the advent of biologic therapies, there has been debate about the necessity to stop these therapies prior to elective surgery. The concern has been that there might be an increased risk for perioperative infections in the presence of these agents. Several current guidelines of care recommend a planned break from biologic therapy in patients undergoing major surgical procedures; for example, the British Association of Dermatologists and the British Society for Rheumatology recommend stopping biologics for at least 4 half-lives before surgery.
Bakkour et al published a study online on March 2 in the Journal of the European Academy of Dermatology and Venereology that audited the management of biologic therapy perioperatively in a tertiary referral psoriasis clinic against guidelines of care. In addition, they investigated the effects of continuing and stopping biologic therapy in psoriasis and psoriatic arthritis patients. Information was collected on the biologics used, whether they were held perioperatively, and whether patients developed postoperative complications and/or disease flare.
The authors identified 42 patients who had a total of 77 procedures performed. Procedures included cutaneous surgery, orthopedic procedures, and cardiothoracic surgery. Biologic therapy was continued in 76% of procedures. Comparing those who continued with those who stopped biologic therapy, there was no significant difference in postoperative risk for infection and delayed wound healing. This finding included patients who underwent major surgery. Interestingly, the interruption of biologic therapy perioperatively was associated with a significant (P=.003) risk for flare of psoriasis or psoriatic arthritis.
What’s the issue?
The authors concluded that continuing biologic therapy did not increase the risk for postoperative complications. However, stopping biologic therapy perioperatively significantly increased the risk for disease flare.
Although this study was small, it shed light on an issue of great interest in the use of biologic therapy. It showed that there is a potential downside to stopping these agents before surgery. Further data are needed to fully elucidate the proper management in these cases.
With the advent of biologic therapies, there has been debate about the necessity to stop these therapies prior to elective surgery. The concern has been that there might be an increased risk for perioperative infections in the presence of these agents. Several current guidelines of care recommend a planned break from biologic therapy in patients undergoing major surgical procedures; for example, the British Association of Dermatologists and the British Society for Rheumatology recommend stopping biologics for at least 4 half-lives before surgery.
Bakkour et al published a study online on March 2 in the Journal of the European Academy of Dermatology and Venereology that audited the management of biologic therapy perioperatively in a tertiary referral psoriasis clinic against guidelines of care. In addition, they investigated the effects of continuing and stopping biologic therapy in psoriasis and psoriatic arthritis patients. Information was collected on the biologics used, whether they were held perioperatively, and whether patients developed postoperative complications and/or disease flare.
The authors identified 42 patients who had a total of 77 procedures performed. Procedures included cutaneous surgery, orthopedic procedures, and cardiothoracic surgery. Biologic therapy was continued in 76% of procedures. Comparing those who continued with those who stopped biologic therapy, there was no significant difference in postoperative risk for infection and delayed wound healing. This finding included patients who underwent major surgery. Interestingly, the interruption of biologic therapy perioperatively was associated with a significant (P=.003) risk for flare of psoriasis or psoriatic arthritis.
What’s the issue?
The authors concluded that continuing biologic therapy did not increase the risk for postoperative complications. However, stopping biologic therapy perioperatively significantly increased the risk for disease flare.
Although this study was small, it shed light on an issue of great interest in the use of biologic therapy. It showed that there is a potential downside to stopping these agents before surgery. Further data are needed to fully elucidate the proper management in these cases.
With the advent of biologic therapies, there has been debate about the necessity to stop these therapies prior to elective surgery. The concern has been that there might be an increased risk for perioperative infections in the presence of these agents. Several current guidelines of care recommend a planned break from biologic therapy in patients undergoing major surgical procedures; for example, the British Association of Dermatologists and the British Society for Rheumatology recommend stopping biologics for at least 4 half-lives before surgery.
Bakkour et al published a study online on March 2 in the Journal of the European Academy of Dermatology and Venereology that audited the management of biologic therapy perioperatively in a tertiary referral psoriasis clinic against guidelines of care. In addition, they investigated the effects of continuing and stopping biologic therapy in psoriasis and psoriatic arthritis patients. Information was collected on the biologics used, whether they were held perioperatively, and whether patients developed postoperative complications and/or disease flare.
The authors identified 42 patients who had a total of 77 procedures performed. Procedures included cutaneous surgery, orthopedic procedures, and cardiothoracic surgery. Biologic therapy was continued in 76% of procedures. Comparing those who continued with those who stopped biologic therapy, there was no significant difference in postoperative risk for infection and delayed wound healing. This finding included patients who underwent major surgery. Interestingly, the interruption of biologic therapy perioperatively was associated with a significant (P=.003) risk for flare of psoriasis or psoriatic arthritis.
What’s the issue?
The authors concluded that continuing biologic therapy did not increase the risk for postoperative complications. However, stopping biologic therapy perioperatively significantly increased the risk for disease flare.
Although this study was small, it shed light on an issue of great interest in the use of biologic therapy. It showed that there is a potential downside to stopping these agents before surgery. Further data are needed to fully elucidate the proper management in these cases.
Apremilast meets psoriasis endpoints at week 32
SAN FRANCISCO – Apremilast met its primary endpoint at week 32 with no new or serious safety signals among patients with moderate to severe plaque psoriasis, according to phase III data from the ongoing LIBERATE study.
At week 16, 40% of patients who received oral apremilast achieved PASI-75, compared with 12% of the placebo group, Dr. Kristian Reich reported at the annual meeting of the American Academy of Dermatology.
By week 32, PASI-75 response for apremilast had further risen to 53%, he added. “This drug may not be a quick fix, but the longer you give it, the higher the response,” said Dr. Reich of SCIderm Research Institute and Dermatologikum Hamburg in Germany.
The randomized, double-blind LIBERATE study compared the safety and efficacy of apremilast (30 mg twice daily) and injectable etanercept (50 mg weekly) with placebo among 250 patients with plaque psoriasis who had not previously received biologic therapy. Patients received one of the three treatments through week 16, and then all were switched to or continued apremilast.
At week 16, PASI-75 response rates were 40% for apremilast, 48% for etanercept, and 12% for placebo (P < .0001 for apremilast versus placebo), reported Dr. Reich. The high rate of response to placebo might have occurred because patients in the study were treatment naive, he said. At week 32, PASI-75 response rates were 53% for patients who received apremilast from baseline, and 61% for patients who switched from etanercept to apremilast at week 16.
Based on the results, “I would probably use apremilast more in the moderate [psoriasis] space than in the severe space, but its efficacy does not correlate with baseline disease severity, as far as I know,” said Dr. Reich. Apremilast also beat placebo in analyses of secondary endpoints, including static physician global assessment of clear or almost clear and the Dermatology Quality of Life Index, he added.
Safety analyses showed that the drug was generally well tolerated. Fewer than 4% of patients discontinued treatment because of adverse events, the most common of which were diarrhea, nausea, vomiting, and headache (including tension headache). No new side effects emerged after patients switched from etanercept to apremilast at week 16, he said.
A post hoc analysis found that apremilast was noninferior to etanercept (P > .05) in terms of PASI-75, although the study was not powered to directly compare the two biologics, Dr. Reich noted.
Celgene Corporation makes apremilast and sponsored the study. Dr. Reich reported serving as a speaker for and receiving honoraria from Celgene.
SAN FRANCISCO – Apremilast met its primary endpoint at week 32 with no new or serious safety signals among patients with moderate to severe plaque psoriasis, according to phase III data from the ongoing LIBERATE study.
At week 16, 40% of patients who received oral apremilast achieved PASI-75, compared with 12% of the placebo group, Dr. Kristian Reich reported at the annual meeting of the American Academy of Dermatology.
By week 32, PASI-75 response for apremilast had further risen to 53%, he added. “This drug may not be a quick fix, but the longer you give it, the higher the response,” said Dr. Reich of SCIderm Research Institute and Dermatologikum Hamburg in Germany.
The randomized, double-blind LIBERATE study compared the safety and efficacy of apremilast (30 mg twice daily) and injectable etanercept (50 mg weekly) with placebo among 250 patients with plaque psoriasis who had not previously received biologic therapy. Patients received one of the three treatments through week 16, and then all were switched to or continued apremilast.
At week 16, PASI-75 response rates were 40% for apremilast, 48% for etanercept, and 12% for placebo (P < .0001 for apremilast versus placebo), reported Dr. Reich. The high rate of response to placebo might have occurred because patients in the study were treatment naive, he said. At week 32, PASI-75 response rates were 53% for patients who received apremilast from baseline, and 61% for patients who switched from etanercept to apremilast at week 16.
Based on the results, “I would probably use apremilast more in the moderate [psoriasis] space than in the severe space, but its efficacy does not correlate with baseline disease severity, as far as I know,” said Dr. Reich. Apremilast also beat placebo in analyses of secondary endpoints, including static physician global assessment of clear or almost clear and the Dermatology Quality of Life Index, he added.
Safety analyses showed that the drug was generally well tolerated. Fewer than 4% of patients discontinued treatment because of adverse events, the most common of which were diarrhea, nausea, vomiting, and headache (including tension headache). No new side effects emerged after patients switched from etanercept to apremilast at week 16, he said.
A post hoc analysis found that apremilast was noninferior to etanercept (P > .05) in terms of PASI-75, although the study was not powered to directly compare the two biologics, Dr. Reich noted.
Celgene Corporation makes apremilast and sponsored the study. Dr. Reich reported serving as a speaker for and receiving honoraria from Celgene.
SAN FRANCISCO – Apremilast met its primary endpoint at week 32 with no new or serious safety signals among patients with moderate to severe plaque psoriasis, according to phase III data from the ongoing LIBERATE study.
At week 16, 40% of patients who received oral apremilast achieved PASI-75, compared with 12% of the placebo group, Dr. Kristian Reich reported at the annual meeting of the American Academy of Dermatology.
By week 32, PASI-75 response for apremilast had further risen to 53%, he added. “This drug may not be a quick fix, but the longer you give it, the higher the response,” said Dr. Reich of SCIderm Research Institute and Dermatologikum Hamburg in Germany.
The randomized, double-blind LIBERATE study compared the safety and efficacy of apremilast (30 mg twice daily) and injectable etanercept (50 mg weekly) with placebo among 250 patients with plaque psoriasis who had not previously received biologic therapy. Patients received one of the three treatments through week 16, and then all were switched to or continued apremilast.
At week 16, PASI-75 response rates were 40% for apremilast, 48% for etanercept, and 12% for placebo (P < .0001 for apremilast versus placebo), reported Dr. Reich. The high rate of response to placebo might have occurred because patients in the study were treatment naive, he said. At week 32, PASI-75 response rates were 53% for patients who received apremilast from baseline, and 61% for patients who switched from etanercept to apremilast at week 16.
Based on the results, “I would probably use apremilast more in the moderate [psoriasis] space than in the severe space, but its efficacy does not correlate with baseline disease severity, as far as I know,” said Dr. Reich. Apremilast also beat placebo in analyses of secondary endpoints, including static physician global assessment of clear or almost clear and the Dermatology Quality of Life Index, he added.
Safety analyses showed that the drug was generally well tolerated. Fewer than 4% of patients discontinued treatment because of adverse events, the most common of which were diarrhea, nausea, vomiting, and headache (including tension headache). No new side effects emerged after patients switched from etanercept to apremilast at week 16, he said.
A post hoc analysis found that apremilast was noninferior to etanercept (P > .05) in terms of PASI-75, although the study was not powered to directly compare the two biologics, Dr. Reich noted.
Celgene Corporation makes apremilast and sponsored the study. Dr. Reich reported serving as a speaker for and receiving honoraria from Celgene.
AT THE AAD ANNUAL MEETING
Key clinical point: Oral apremilast beat placebo and showed durable efficacy in patients with moderate to severe plaque psoriasis.
Major finding: PASI-75 response rates were 40% at week 16 (compared with 12% for placebo) and 53% at week 32.
Data source: Ongoing phase IIIb study of apremilast, etanercept, and placebo among 250 patients with moderate to severe plaque psoriasis.
Disclosures: Celgene Corporation makes apremilast and sponsored the study. Dr. Reich reported serving as a speaker for and receiving honoraria from Celgene.
Ixekizumab met psoriasis endpoints by week 12, with durable response at 60 weeks
SAN FRANCISCO – More than 80% of psoriasis patients who received ixekizumab achieved a 75% reduction in the Psoriasis Area and Severity Index score and static Physician Global Assessment scores of clear or almost clear skin at 12 weeks, based on the results of a phase III trial.
In addition, 35% of patients who received 80 mg ixekizumab twice monthly for 12 weeks achieved complete resolution of their psoriasis plaques (PASI 100), reported Dr. Kenneth Gordon of Northwestern University in Chicago. “The overall safety profile for ixekizumab was acceptable during both the induction and maintenance phases,” Dr. Gordon said at the annual meeting of the American Academy of Dermatology.
Ixekizumab is a monoclonal antibody that targets interleukin (IL)-17A, a major cytokine in the pathogenesis of psoriasis. Dr. Gordon and his associates conducted a randomized induction and withdrawal trial that compared twice-monthly or monthly treatment of the biologic with placebo among 1,296 patients. During the 12-week induction phase, 431 patients received placebo, 433 received 80 mg ixekizumab every 2 weeks, and 432 received 80 mg ixekizumab every 4 weeks, said Dr. Gordon. He and his associates then rerandomized the responders (based on PASI 75 and static Patient Global Assessment [sPGA] scores) to one of the three protocols, and followed these patients until week 60.
About 80% of patients who received ixekizumab every 2 or 4 weeks achieved sPGA scores of 0 or 1 (clear or almost clear) at 12 weeks, compared with 3% of the placebo group, said Dr. Gordon. Rates of PASI 75 response at 12 weeks were 89% for patients treated twice monthly, 83% for patients treated monthly, and 4% for the placebo group. Rates of PASI 100 were 35%, 33%, and 0%, respectively.
Among initial responders who were rerandomized to monthly ixekizumab, 73% maintained sPGA scores of clear or almost clear at week 60, while 78% maintained or achieved PASI 75, and 52% maintained or achieved PASI 100, said Dr. Gordon. The investigators also found a significant positive linear correlation between PASI response and scores on the Dermatology Quality of Life Index (DLQI), with P values ranging from less than .001 to less than .002, Dr. Gordon reported. “We are seeing that clearance is very important in quality of life,” he added. “More patients reported no itching or other negative impact on quality of life with higher levels of response.”
Serious adverse events at week 12 affected 1.4% of the twice-monthly ixekizumab group, 2.8% of the monthly ixekizumab group, and 1.2% of the placebo group, Dr. Gordon reported. Rates of candidiasis were similar among all three arms. Between weeks 12 and 60, the monthly treatment group had three major adverse cardiac events, but exposure-adjusted rates of adverse events for this group were similar to those during the induction period, he added.
Eli Lilly sponsored the trial. Dr. Gordon reported receiving research funding from Eli Lilly and several other pharmaceutical companies.
SAN FRANCISCO – More than 80% of psoriasis patients who received ixekizumab achieved a 75% reduction in the Psoriasis Area and Severity Index score and static Physician Global Assessment scores of clear or almost clear skin at 12 weeks, based on the results of a phase III trial.
In addition, 35% of patients who received 80 mg ixekizumab twice monthly for 12 weeks achieved complete resolution of their psoriasis plaques (PASI 100), reported Dr. Kenneth Gordon of Northwestern University in Chicago. “The overall safety profile for ixekizumab was acceptable during both the induction and maintenance phases,” Dr. Gordon said at the annual meeting of the American Academy of Dermatology.
Ixekizumab is a monoclonal antibody that targets interleukin (IL)-17A, a major cytokine in the pathogenesis of psoriasis. Dr. Gordon and his associates conducted a randomized induction and withdrawal trial that compared twice-monthly or monthly treatment of the biologic with placebo among 1,296 patients. During the 12-week induction phase, 431 patients received placebo, 433 received 80 mg ixekizumab every 2 weeks, and 432 received 80 mg ixekizumab every 4 weeks, said Dr. Gordon. He and his associates then rerandomized the responders (based on PASI 75 and static Patient Global Assessment [sPGA] scores) to one of the three protocols, and followed these patients until week 60.
About 80% of patients who received ixekizumab every 2 or 4 weeks achieved sPGA scores of 0 or 1 (clear or almost clear) at 12 weeks, compared with 3% of the placebo group, said Dr. Gordon. Rates of PASI 75 response at 12 weeks were 89% for patients treated twice monthly, 83% for patients treated monthly, and 4% for the placebo group. Rates of PASI 100 were 35%, 33%, and 0%, respectively.
Among initial responders who were rerandomized to monthly ixekizumab, 73% maintained sPGA scores of clear or almost clear at week 60, while 78% maintained or achieved PASI 75, and 52% maintained or achieved PASI 100, said Dr. Gordon. The investigators also found a significant positive linear correlation between PASI response and scores on the Dermatology Quality of Life Index (DLQI), with P values ranging from less than .001 to less than .002, Dr. Gordon reported. “We are seeing that clearance is very important in quality of life,” he added. “More patients reported no itching or other negative impact on quality of life with higher levels of response.”
Serious adverse events at week 12 affected 1.4% of the twice-monthly ixekizumab group, 2.8% of the monthly ixekizumab group, and 1.2% of the placebo group, Dr. Gordon reported. Rates of candidiasis were similar among all three arms. Between weeks 12 and 60, the monthly treatment group had three major adverse cardiac events, but exposure-adjusted rates of adverse events for this group were similar to those during the induction period, he added.
Eli Lilly sponsored the trial. Dr. Gordon reported receiving research funding from Eli Lilly and several other pharmaceutical companies.
SAN FRANCISCO – More than 80% of psoriasis patients who received ixekizumab achieved a 75% reduction in the Psoriasis Area and Severity Index score and static Physician Global Assessment scores of clear or almost clear skin at 12 weeks, based on the results of a phase III trial.
In addition, 35% of patients who received 80 mg ixekizumab twice monthly for 12 weeks achieved complete resolution of their psoriasis plaques (PASI 100), reported Dr. Kenneth Gordon of Northwestern University in Chicago. “The overall safety profile for ixekizumab was acceptable during both the induction and maintenance phases,” Dr. Gordon said at the annual meeting of the American Academy of Dermatology.
Ixekizumab is a monoclonal antibody that targets interleukin (IL)-17A, a major cytokine in the pathogenesis of psoriasis. Dr. Gordon and his associates conducted a randomized induction and withdrawal trial that compared twice-monthly or monthly treatment of the biologic with placebo among 1,296 patients. During the 12-week induction phase, 431 patients received placebo, 433 received 80 mg ixekizumab every 2 weeks, and 432 received 80 mg ixekizumab every 4 weeks, said Dr. Gordon. He and his associates then rerandomized the responders (based on PASI 75 and static Patient Global Assessment [sPGA] scores) to one of the three protocols, and followed these patients until week 60.
About 80% of patients who received ixekizumab every 2 or 4 weeks achieved sPGA scores of 0 or 1 (clear or almost clear) at 12 weeks, compared with 3% of the placebo group, said Dr. Gordon. Rates of PASI 75 response at 12 weeks were 89% for patients treated twice monthly, 83% for patients treated monthly, and 4% for the placebo group. Rates of PASI 100 were 35%, 33%, and 0%, respectively.
Among initial responders who were rerandomized to monthly ixekizumab, 73% maintained sPGA scores of clear or almost clear at week 60, while 78% maintained or achieved PASI 75, and 52% maintained or achieved PASI 100, said Dr. Gordon. The investigators also found a significant positive linear correlation between PASI response and scores on the Dermatology Quality of Life Index (DLQI), with P values ranging from less than .001 to less than .002, Dr. Gordon reported. “We are seeing that clearance is very important in quality of life,” he added. “More patients reported no itching or other negative impact on quality of life with higher levels of response.”
Serious adverse events at week 12 affected 1.4% of the twice-monthly ixekizumab group, 2.8% of the monthly ixekizumab group, and 1.2% of the placebo group, Dr. Gordon reported. Rates of candidiasis were similar among all three arms. Between weeks 12 and 60, the monthly treatment group had three major adverse cardiac events, but exposure-adjusted rates of adverse events for this group were similar to those during the induction period, he added.
Eli Lilly sponsored the trial. Dr. Gordon reported receiving research funding from Eli Lilly and several other pharmaceutical companies.
AT THE AAD ANNUAL MEETING
Key clinical point: The investigational anti-IL-17A antibody ixekizumab met its endpoints at week 12 in patients with plaque psoriasis, and showed durability of response at 60 weeks.
Major finding: More than 80% of treated patients achieved PASI 75 and static Physician Global Assessment scores of clear or almost clear skin at 12 weeks.
Data source: A phase III trial of 1,296 patients with plaque psoriasis.
Disclosures: Eli Lilly sponsored the trial. Dr. Gordon reported receiving research funding from Eli Lilly and several other pharmaceutical companies.
Traditional risk factors raise cardiovascular risk in PsA
Psoriatic arthritis is associated with higher rates of self-reported angina pectoris, percutaneous coronary intervention, hypertension, obesity, and smoking than are observed in the general population, a large population-based cohort study found.
However, the overall rate of cardiovascular (CV) disease (defined as one or more of angina pectoris, myocardial infarction, cerebrovascular stroke, coronary artery bypass graft, or percutaneous coronary intervention) was 8% in both the 338 patients with psoriatic arthritis (PsA) and the 50,468 controls in the Nord-Trøndelag Health Study. A similar percentage of patients with PsA (13.4%) and controls (11.3%) were deemed to be at very high 10-year risk for a fatal cardiovascular event based on the Systematic Coronary Risk Evaluation (SCORE) algorithm, and the median risk calculated by the algorithm was similar for both groups, Dr. Agnete Malm Gulati of St. Olavs Hospital, Trondheim, Norway, and her coauthors reported. But patients with PsA had significantly higher C-reactive protein levels, body mass index, and diastolic blood pressure, which are not included in the SCORE algorithm.
Patients with PsA had lived with the disease for a mean of 9.3 years, and both patients and controls had a mean age of about 54 years.
The study’s authors said their findings supported previous suggestions that the increased risk of CV disease in psoriatic arthritis was largely a reflection of an increased prevalence of conventional risk factors such as obesity, smoking, and hypertension (Ann. Rheum. Dis. 2015 March 26 [doi:10.1136/annrheumdis-2014-206824]).
“In RA [rheumatoid arthritis], it is shown that atherosclerosis cannot solely be explained by the presence of traditional CV risk factors, and chronic inflammation has also been proposed as being responsible for the enhanced development of atherosclerosis in these patients, [and] this may also be the case for patients with PsA,” the investigators wrote.
The study was supported by Revmafondet i Trondheim, and one author reported financial support from Pfizer. There were no other conflicts of interest declared.
Psoriatic arthritis is associated with higher rates of self-reported angina pectoris, percutaneous coronary intervention, hypertension, obesity, and smoking than are observed in the general population, a large population-based cohort study found.
However, the overall rate of cardiovascular (CV) disease (defined as one or more of angina pectoris, myocardial infarction, cerebrovascular stroke, coronary artery bypass graft, or percutaneous coronary intervention) was 8% in both the 338 patients with psoriatic arthritis (PsA) and the 50,468 controls in the Nord-Trøndelag Health Study. A similar percentage of patients with PsA (13.4%) and controls (11.3%) were deemed to be at very high 10-year risk for a fatal cardiovascular event based on the Systematic Coronary Risk Evaluation (SCORE) algorithm, and the median risk calculated by the algorithm was similar for both groups, Dr. Agnete Malm Gulati of St. Olavs Hospital, Trondheim, Norway, and her coauthors reported. But patients with PsA had significantly higher C-reactive protein levels, body mass index, and diastolic blood pressure, which are not included in the SCORE algorithm.
Patients with PsA had lived with the disease for a mean of 9.3 years, and both patients and controls had a mean age of about 54 years.
The study’s authors said their findings supported previous suggestions that the increased risk of CV disease in psoriatic arthritis was largely a reflection of an increased prevalence of conventional risk factors such as obesity, smoking, and hypertension (Ann. Rheum. Dis. 2015 March 26 [doi:10.1136/annrheumdis-2014-206824]).
“In RA [rheumatoid arthritis], it is shown that atherosclerosis cannot solely be explained by the presence of traditional CV risk factors, and chronic inflammation has also been proposed as being responsible for the enhanced development of atherosclerosis in these patients, [and] this may also be the case for patients with PsA,” the investigators wrote.
The study was supported by Revmafondet i Trondheim, and one author reported financial support from Pfizer. There were no other conflicts of interest declared.
Psoriatic arthritis is associated with higher rates of self-reported angina pectoris, percutaneous coronary intervention, hypertension, obesity, and smoking than are observed in the general population, a large population-based cohort study found.
However, the overall rate of cardiovascular (CV) disease (defined as one or more of angina pectoris, myocardial infarction, cerebrovascular stroke, coronary artery bypass graft, or percutaneous coronary intervention) was 8% in both the 338 patients with psoriatic arthritis (PsA) and the 50,468 controls in the Nord-Trøndelag Health Study. A similar percentage of patients with PsA (13.4%) and controls (11.3%) were deemed to be at very high 10-year risk for a fatal cardiovascular event based on the Systematic Coronary Risk Evaluation (SCORE) algorithm, and the median risk calculated by the algorithm was similar for both groups, Dr. Agnete Malm Gulati of St. Olavs Hospital, Trondheim, Norway, and her coauthors reported. But patients with PsA had significantly higher C-reactive protein levels, body mass index, and diastolic blood pressure, which are not included in the SCORE algorithm.
Patients with PsA had lived with the disease for a mean of 9.3 years, and both patients and controls had a mean age of about 54 years.
The study’s authors said their findings supported previous suggestions that the increased risk of CV disease in psoriatic arthritis was largely a reflection of an increased prevalence of conventional risk factors such as obesity, smoking, and hypertension (Ann. Rheum. Dis. 2015 March 26 [doi:10.1136/annrheumdis-2014-206824]).
“In RA [rheumatoid arthritis], it is shown that atherosclerosis cannot solely be explained by the presence of traditional CV risk factors, and chronic inflammation has also been proposed as being responsible for the enhanced development of atherosclerosis in these patients, [and] this may also be the case for patients with PsA,” the investigators wrote.
The study was supported by Revmafondet i Trondheim, and one author reported financial support from Pfizer. There were no other conflicts of interest declared.
FROM ANNALS OF THE RHEUMATIC DISEASES
Key clinical point: The increased risk of cardiovascular disease in psoriatic arthritis is largely because of an increased prevalence of conventional risk factors such as obesity, smoking, and hypertension.
Major finding: Psoriatic arthritis is associated with higher rates of self-reported angina pectoris, percutaneous coronary intervention, hypertension, obesity, and smoking.
Data source: A prospective, population-based cohort study of 338 patients with psoriatic arthritis and 50,468 controls.
Disclosures: The study was supported by Revmafondet i Trondheim, and one author reported financial support from Pfizer. There were no other conflicts of interest declared.
No increased risk of lung disease with methotrexate
Methotrexate is not associated with an increased risk of pulmonary disease in patients taking it for the treatment of psoriatic arthritis, psoriasis, or inflammatory bowel disease, a meta-analysis has found.
The analysis of results from seven double-blind, randomized, controlled studies, involving a total of 1,640 participants, showed no increased risk of total adverse respiratory events – infectious or noninfectious – or pulmonary deaths in patients taking methotrexate, compared with controls, according to Dr. Richard Conway of the department of rheumatology at Galway (Ireland) University Hospitals and his coauthors.
Methotrexate has previously been implicated as a cause of lung toxicity, and the prevalence of methotrexate-related interstitial lung disease has been reported as high as 11.6% in rheumatoid arthritis, but studies of methotrexate-induced lung disease are confounded by the higher risk of pulmonary infections among patients with rheumatoid arthritis, the authors said (BMJ 2015 [doi:10.1136/bmj.h1269]).
“These findings, coupled with those of a previous study in rheumatoid arthritis, suggest that methotrexate-related lung disease is rare, if it exists at all,” the investigators wrote.
The investigators had no specific source of funding for the study and had no conflicts of interest to declare.
Methotrexate is not associated with an increased risk of pulmonary disease in patients taking it for the treatment of psoriatic arthritis, psoriasis, or inflammatory bowel disease, a meta-analysis has found.
The analysis of results from seven double-blind, randomized, controlled studies, involving a total of 1,640 participants, showed no increased risk of total adverse respiratory events – infectious or noninfectious – or pulmonary deaths in patients taking methotrexate, compared with controls, according to Dr. Richard Conway of the department of rheumatology at Galway (Ireland) University Hospitals and his coauthors.
Methotrexate has previously been implicated as a cause of lung toxicity, and the prevalence of methotrexate-related interstitial lung disease has been reported as high as 11.6% in rheumatoid arthritis, but studies of methotrexate-induced lung disease are confounded by the higher risk of pulmonary infections among patients with rheumatoid arthritis, the authors said (BMJ 2015 [doi:10.1136/bmj.h1269]).
“These findings, coupled with those of a previous study in rheumatoid arthritis, suggest that methotrexate-related lung disease is rare, if it exists at all,” the investigators wrote.
The investigators had no specific source of funding for the study and had no conflicts of interest to declare.
Methotrexate is not associated with an increased risk of pulmonary disease in patients taking it for the treatment of psoriatic arthritis, psoriasis, or inflammatory bowel disease, a meta-analysis has found.
The analysis of results from seven double-blind, randomized, controlled studies, involving a total of 1,640 participants, showed no increased risk of total adverse respiratory events – infectious or noninfectious – or pulmonary deaths in patients taking methotrexate, compared with controls, according to Dr. Richard Conway of the department of rheumatology at Galway (Ireland) University Hospitals and his coauthors.
Methotrexate has previously been implicated as a cause of lung toxicity, and the prevalence of methotrexate-related interstitial lung disease has been reported as high as 11.6% in rheumatoid arthritis, but studies of methotrexate-induced lung disease are confounded by the higher risk of pulmonary infections among patients with rheumatoid arthritis, the authors said (BMJ 2015 [doi:10.1136/bmj.h1269]).
“These findings, coupled with those of a previous study in rheumatoid arthritis, suggest that methotrexate-related lung disease is rare, if it exists at all,” the investigators wrote.
The investigators had no specific source of funding for the study and had no conflicts of interest to declare.
FROM BMJ
Key clinical point: Methotrexate is not associated with an increased risk of pulmonary disease.
Major finding: There was no increased risk of total adverse respiratory events – infectious or noninfectious – or pulmonary deaths in patients taking methotrexate, compared with controls.
Data source: Meta-analysis of seven double-blind, randomized, controlled studies, involving a total of 1,640 participants.
Disclosures: The investigators had no specific source of funding for the study and had no conflicts of interest to declare.
Methotrexate and biologics linked to higher zoster risk in psoriasis
The combination of methotrexate and biologics for the treatment of psoriasis may increase the risk of herpes zoster infection, according to a large, database cohort study published in JAMA Dermatology.
Analysis of medical records for 95,941 patients with psoriasis showed treatment with both biologic medications and methotrexate was associated with a significant 66% increase in the incidence of herpes zoster, compared with a control group, during more than 11 years of follow-up. Episodes of herpes zoster (HZ) occurring in a patient following at least 6 consecutive treatment-free months or in a patient who did not receive any of the listed medications at any time during follow-up were counted as HZ episodes in the control group. The multivariate regression analysis was adjusted for age, sex, psoriasis severity, Charlson comorbidity index, steroid administration per year, and socioeconomic status.
The study found phototherapy, methotrexate alone, cyclosporine, or biologic medications as single agents did not significantly increase the risk, while acitretin therapy was associated with a significant 31% decrease in the incidence of herpes zoster (JAMA Dermatol. 2015 March 22 [doi:10.1001/jamadermatol.2014.4956]).
“Our study results might suggest the need for prophylactic vaccination against VZV [varicella zoster virus] in patients with psoriasis and multiple risk factors for HZ (eg, age, female sex) as part of the preparation for biologic medication treatments in the appropriate clinical setting,” wrote Dr. Guy Shalom of Soroka Medical Center, Beer-Sheva, Israel, and his coauthors.
One author reported consultancies and research grants from a range of pharmaceutical companies. There were no other disclosures.
The combination of methotrexate and biologics for the treatment of psoriasis may increase the risk of herpes zoster infection, according to a large, database cohort study published in JAMA Dermatology.
Analysis of medical records for 95,941 patients with psoriasis showed treatment with both biologic medications and methotrexate was associated with a significant 66% increase in the incidence of herpes zoster, compared with a control group, during more than 11 years of follow-up. Episodes of herpes zoster (HZ) occurring in a patient following at least 6 consecutive treatment-free months or in a patient who did not receive any of the listed medications at any time during follow-up were counted as HZ episodes in the control group. The multivariate regression analysis was adjusted for age, sex, psoriasis severity, Charlson comorbidity index, steroid administration per year, and socioeconomic status.
The study found phototherapy, methotrexate alone, cyclosporine, or biologic medications as single agents did not significantly increase the risk, while acitretin therapy was associated with a significant 31% decrease in the incidence of herpes zoster (JAMA Dermatol. 2015 March 22 [doi:10.1001/jamadermatol.2014.4956]).
“Our study results might suggest the need for prophylactic vaccination against VZV [varicella zoster virus] in patients with psoriasis and multiple risk factors for HZ (eg, age, female sex) as part of the preparation for biologic medication treatments in the appropriate clinical setting,” wrote Dr. Guy Shalom of Soroka Medical Center, Beer-Sheva, Israel, and his coauthors.
One author reported consultancies and research grants from a range of pharmaceutical companies. There were no other disclosures.
The combination of methotrexate and biologics for the treatment of psoriasis may increase the risk of herpes zoster infection, according to a large, database cohort study published in JAMA Dermatology.
Analysis of medical records for 95,941 patients with psoriasis showed treatment with both biologic medications and methotrexate was associated with a significant 66% increase in the incidence of herpes zoster, compared with a control group, during more than 11 years of follow-up. Episodes of herpes zoster (HZ) occurring in a patient following at least 6 consecutive treatment-free months or in a patient who did not receive any of the listed medications at any time during follow-up were counted as HZ episodes in the control group. The multivariate regression analysis was adjusted for age, sex, psoriasis severity, Charlson comorbidity index, steroid administration per year, and socioeconomic status.
The study found phototherapy, methotrexate alone, cyclosporine, or biologic medications as single agents did not significantly increase the risk, while acitretin therapy was associated with a significant 31% decrease in the incidence of herpes zoster (JAMA Dermatol. 2015 March 22 [doi:10.1001/jamadermatol.2014.4956]).
“Our study results might suggest the need for prophylactic vaccination against VZV [varicella zoster virus] in patients with psoriasis and multiple risk factors for HZ (eg, age, female sex) as part of the preparation for biologic medication treatments in the appropriate clinical setting,” wrote Dr. Guy Shalom of Soroka Medical Center, Beer-Sheva, Israel, and his coauthors.
One author reported consultancies and research grants from a range of pharmaceutical companies. There were no other disclosures.
FROM JAMA DERMATOLOGY
Key clinical point: The combination of methotrexate and biologics for the treatment of psoriasis may increase the risk of herpes zoster infection.
Major finding: Combination therapy with both biologic medications and methotrexate was associated with a significant 66% increase in the incidence of herpes zoster over more than 11 years of follow-up
Data source: Analysis of medical records for 95,941 patients with psoriasis.
Disclosures: One author reported consultancies and research grants from a range of pharmaceutical companies. There were no other disclosures.
Secukinumab beat ustekinumab for psoriasis, with difference by week four
SAN FRANCISCO– Secukinumab met its primary endpoint in a head-to-head trial, achieving 21% more PASI 90 responses than ustekinumab in patients with moderate to severe plaque psoriasis, according to interim, week 16 results from the phase IIIb CLEAR trial.
Patients’ responses to the two biologic agents had diverged by four weeks of treatment, when half the secukinumab group had achieved the secondary endpoint of PASI 75, compared with 20.6% of the ustekinumab group (P < .0001), Dr. Diamant Thaci said at the annual meeting of the American Academy of Dermatology.
“Secukinumab was superior to ustekinumab, even at early time points,” said Dr. Thaci of the Comprehensive Center for Inflammation Medicine at University Medical School Schleswig-Holstein, Lübeck, Germany. “This was very remarkable. Especially remarkable was the early difference for PASI 75.”
The biologic agents also showed similar safety profiles, and secukinumab yielded no new safety signals besides those observed in its pivotal phase III studies. “The most common adverse events were what we have seen in daily practice, including headache, nasopharyngitis, diarrhea, fatigue, and arthralgia,” Dr. Thaci said.
Secukinumab works by binding specifically to the interleukin-17A cytokine, thereby blocking its interaction with its receptor. The 52-week, phase IIIb CLEAR trial, which is underway at 134 sites in 24 countries, is comparing the safety and efficacy of secukinumab and ustekinumab in 679 patients with moderate to severe plaque psoriasis. Patients had baseline PASI scores of at least 12 and at least 10% body surface area involvement, no previous exposure to either biologic agent, and inadequate responses to topical treatments or phototherapy. Researchers randomized the patients to either 300 mg secukinumab given subcutaneously at baseline, at weeks one through four, and every four weeks thereafter, or to ustekinumab, dosed according to label.
The study cohorts resembled one another demographically at baseline. At week 16, 79% of patients given secukinumab had achieved a PASI 90 response, compared with 57.6% of the ustekinumab group (P < .0001). Furthermore, 44.3% of the secukinumab arm had achieved the secondary endpoint of completely clear skin (a PASI 100 response), compared with 28.4% of the ustekinumab group (P < .0001), Dr. Thaci reported.
After an average of 110 to 111 days of treatment, infections and infestations developed in 29.3% of the secukinumab group and 25.3% of ustekinumab group. Three percent of each group developed serious but non-fatal adverse events, with no deaths reported to date.
“Secukinumab treatment – even at early time points – has demonstrated superiority to ustekinumab in clearing the skin of subjects with moderate to severe psoriasis, with a comparable safety profile,” Dr. Thaci concluded. “It is very clear that we will be able to show and to observe that his agent is leading to improved quality of life.”
Dr. Thaci reported receiving research support from Dignity Sciences.
SAN FRANCISCO– Secukinumab met its primary endpoint in a head-to-head trial, achieving 21% more PASI 90 responses than ustekinumab in patients with moderate to severe plaque psoriasis, according to interim, week 16 results from the phase IIIb CLEAR trial.
Patients’ responses to the two biologic agents had diverged by four weeks of treatment, when half the secukinumab group had achieved the secondary endpoint of PASI 75, compared with 20.6% of the ustekinumab group (P < .0001), Dr. Diamant Thaci said at the annual meeting of the American Academy of Dermatology.
“Secukinumab was superior to ustekinumab, even at early time points,” said Dr. Thaci of the Comprehensive Center for Inflammation Medicine at University Medical School Schleswig-Holstein, Lübeck, Germany. “This was very remarkable. Especially remarkable was the early difference for PASI 75.”
The biologic agents also showed similar safety profiles, and secukinumab yielded no new safety signals besides those observed in its pivotal phase III studies. “The most common adverse events were what we have seen in daily practice, including headache, nasopharyngitis, diarrhea, fatigue, and arthralgia,” Dr. Thaci said.
Secukinumab works by binding specifically to the interleukin-17A cytokine, thereby blocking its interaction with its receptor. The 52-week, phase IIIb CLEAR trial, which is underway at 134 sites in 24 countries, is comparing the safety and efficacy of secukinumab and ustekinumab in 679 patients with moderate to severe plaque psoriasis. Patients had baseline PASI scores of at least 12 and at least 10% body surface area involvement, no previous exposure to either biologic agent, and inadequate responses to topical treatments or phototherapy. Researchers randomized the patients to either 300 mg secukinumab given subcutaneously at baseline, at weeks one through four, and every four weeks thereafter, or to ustekinumab, dosed according to label.
The study cohorts resembled one another demographically at baseline. At week 16, 79% of patients given secukinumab had achieved a PASI 90 response, compared with 57.6% of the ustekinumab group (P < .0001). Furthermore, 44.3% of the secukinumab arm had achieved the secondary endpoint of completely clear skin (a PASI 100 response), compared with 28.4% of the ustekinumab group (P < .0001), Dr. Thaci reported.
After an average of 110 to 111 days of treatment, infections and infestations developed in 29.3% of the secukinumab group and 25.3% of ustekinumab group. Three percent of each group developed serious but non-fatal adverse events, with no deaths reported to date.
“Secukinumab treatment – even at early time points – has demonstrated superiority to ustekinumab in clearing the skin of subjects with moderate to severe psoriasis, with a comparable safety profile,” Dr. Thaci concluded. “It is very clear that we will be able to show and to observe that his agent is leading to improved quality of life.”
Dr. Thaci reported receiving research support from Dignity Sciences.
SAN FRANCISCO– Secukinumab met its primary endpoint in a head-to-head trial, achieving 21% more PASI 90 responses than ustekinumab in patients with moderate to severe plaque psoriasis, according to interim, week 16 results from the phase IIIb CLEAR trial.
Patients’ responses to the two biologic agents had diverged by four weeks of treatment, when half the secukinumab group had achieved the secondary endpoint of PASI 75, compared with 20.6% of the ustekinumab group (P < .0001), Dr. Diamant Thaci said at the annual meeting of the American Academy of Dermatology.
“Secukinumab was superior to ustekinumab, even at early time points,” said Dr. Thaci of the Comprehensive Center for Inflammation Medicine at University Medical School Schleswig-Holstein, Lübeck, Germany. “This was very remarkable. Especially remarkable was the early difference for PASI 75.”
The biologic agents also showed similar safety profiles, and secukinumab yielded no new safety signals besides those observed in its pivotal phase III studies. “The most common adverse events were what we have seen in daily practice, including headache, nasopharyngitis, diarrhea, fatigue, and arthralgia,” Dr. Thaci said.
Secukinumab works by binding specifically to the interleukin-17A cytokine, thereby blocking its interaction with its receptor. The 52-week, phase IIIb CLEAR trial, which is underway at 134 sites in 24 countries, is comparing the safety and efficacy of secukinumab and ustekinumab in 679 patients with moderate to severe plaque psoriasis. Patients had baseline PASI scores of at least 12 and at least 10% body surface area involvement, no previous exposure to either biologic agent, and inadequate responses to topical treatments or phototherapy. Researchers randomized the patients to either 300 mg secukinumab given subcutaneously at baseline, at weeks one through four, and every four weeks thereafter, or to ustekinumab, dosed according to label.
The study cohorts resembled one another demographically at baseline. At week 16, 79% of patients given secukinumab had achieved a PASI 90 response, compared with 57.6% of the ustekinumab group (P < .0001). Furthermore, 44.3% of the secukinumab arm had achieved the secondary endpoint of completely clear skin (a PASI 100 response), compared with 28.4% of the ustekinumab group (P < .0001), Dr. Thaci reported.
After an average of 110 to 111 days of treatment, infections and infestations developed in 29.3% of the secukinumab group and 25.3% of ustekinumab group. Three percent of each group developed serious but non-fatal adverse events, with no deaths reported to date.
“Secukinumab treatment – even at early time points – has demonstrated superiority to ustekinumab in clearing the skin of subjects with moderate to severe psoriasis, with a comparable safety profile,” Dr. Thaci concluded. “It is very clear that we will be able to show and to observe that his agent is leading to improved quality of life.”
Dr. Thaci reported receiving research support from Dignity Sciences.
Key clinical point:Secukinumab achieved significantly better responses than ustekinumab in the treatment of moderate to severe psoriasis.
Major finding:At week 16, 79% of patients given secukinumab had achieved a PASI 90 response, compared with 57.6% of the ustekinumab group (P < .0001).
Data source: Interim results from a phase IIIb trial comparing secukinumab and ustekinumab in 679 patients with moderate to severe plaque psoriasis.
Disclosures: Dr. Thaci reported receiving research support from Dignity Sciences.
