User login
Fixed combination topical shows promise for psoriasis
MIAMI – In an ongoing drive to identify an alternative to the mainstay treatment of psoriasis with topical corticosteroids, researchers evaluated a fixed-dose combination of halobetasol propionate 0.01% and tazarotene 0.045% lotion compared to its monads and vehicle in 212 people with moderate to severe psoriasis.
After 8 weeks of once-daily applications, combination therapy yielded significantly greater reductions in erythema, plaque elevation, and scaling at the target lesion, compared with the other groups in the phase II trial. The investigators also reported at safety profile consistent with halobetasol propionate or tazarotene monotherapy, meaning no new safety concerns emerged with the combination.
Participants were randomized to the combination, halobetasol propionate alone, tazarotene monotherapy, or vehicle in the multicenter, double blind study.
Efficacy evaluation
At 8 weeks, 53% of the combination group achieved treatment success, defined as at least a 2-point gain in Investigator’s Global Assessment of Disease Severity and a score of “clear” or “almost clear.” In contrast, 33% of the halobetasol propionate group, 19% in the tazarotene, and 10% of the vehicle only group achieved those endpoints in the intent-to-treat-analysis. The difference in efficacy between the combination group and vehicle was statistically significant (P less than .001).
On individual clinical efficacy measures, more than half of the patients in the combination treatment group achieved at least a 2-point improvement from baseline: 54% for erythema, 68% for plaque elevation, 65% for scaling. Each of these outcomes was significantly superior compared to the tazarotene or vehicle group (P less than or equal to .001).
“I was not surprised by the findings as the drugs work by complimentary mechanisms of action – so combination therapy should be effective,” Dr. Stein Gold said.
At baseline, IGA severity score of 3 was most common in each group and for each psoriasis sign at the target lesions. In each group, the mean age of participants ranged from 48 to 56 years; the proportion of men ranged from 59% to 68%; and 87% to 95% were white. The median target lesion sizes ranged from 25 to 32 cm2.
Safety outcomes
One patient in the vehicle-only group died. Three other participants experienced serious adverse events – one in each of the noncombination groups. None of these events were related to the study medications, the investigators noted. Application site reactions were the most common treatment-associated adverse events. Some skin atrophy was reported.
“These results show that the fixed combination of halobetasol propionate and tazarotene was effective and well tolerated,” said Dr. Stein Gold, who serves as division head of dermatology at Henry Ford Health System, West Bloomfield, Mich. “This would be a nice addition to our treatment armamentarium for patients with plaque psoriasis.”
Dr. Stein Gold is a speaker, consultant, and study investigator for Valeant Pharmaceuticals, which supported the study.
MIAMI – In an ongoing drive to identify an alternative to the mainstay treatment of psoriasis with topical corticosteroids, researchers evaluated a fixed-dose combination of halobetasol propionate 0.01% and tazarotene 0.045% lotion compared to its monads and vehicle in 212 people with moderate to severe psoriasis.
After 8 weeks of once-daily applications, combination therapy yielded significantly greater reductions in erythema, plaque elevation, and scaling at the target lesion, compared with the other groups in the phase II trial. The investigators also reported at safety profile consistent with halobetasol propionate or tazarotene monotherapy, meaning no new safety concerns emerged with the combination.
Participants were randomized to the combination, halobetasol propionate alone, tazarotene monotherapy, or vehicle in the multicenter, double blind study.
Efficacy evaluation
At 8 weeks, 53% of the combination group achieved treatment success, defined as at least a 2-point gain in Investigator’s Global Assessment of Disease Severity and a score of “clear” or “almost clear.” In contrast, 33% of the halobetasol propionate group, 19% in the tazarotene, and 10% of the vehicle only group achieved those endpoints in the intent-to-treat-analysis. The difference in efficacy between the combination group and vehicle was statistically significant (P less than .001).
On individual clinical efficacy measures, more than half of the patients in the combination treatment group achieved at least a 2-point improvement from baseline: 54% for erythema, 68% for plaque elevation, 65% for scaling. Each of these outcomes was significantly superior compared to the tazarotene or vehicle group (P less than or equal to .001).
“I was not surprised by the findings as the drugs work by complimentary mechanisms of action – so combination therapy should be effective,” Dr. Stein Gold said.
At baseline, IGA severity score of 3 was most common in each group and for each psoriasis sign at the target lesions. In each group, the mean age of participants ranged from 48 to 56 years; the proportion of men ranged from 59% to 68%; and 87% to 95% were white. The median target lesion sizes ranged from 25 to 32 cm2.
Safety outcomes
One patient in the vehicle-only group died. Three other participants experienced serious adverse events – one in each of the noncombination groups. None of these events were related to the study medications, the investigators noted. Application site reactions were the most common treatment-associated adverse events. Some skin atrophy was reported.
“These results show that the fixed combination of halobetasol propionate and tazarotene was effective and well tolerated,” said Dr. Stein Gold, who serves as division head of dermatology at Henry Ford Health System, West Bloomfield, Mich. “This would be a nice addition to our treatment armamentarium for patients with plaque psoriasis.”
Dr. Stein Gold is a speaker, consultant, and study investigator for Valeant Pharmaceuticals, which supported the study.
MIAMI – In an ongoing drive to identify an alternative to the mainstay treatment of psoriasis with topical corticosteroids, researchers evaluated a fixed-dose combination of halobetasol propionate 0.01% and tazarotene 0.045% lotion compared to its monads and vehicle in 212 people with moderate to severe psoriasis.
After 8 weeks of once-daily applications, combination therapy yielded significantly greater reductions in erythema, plaque elevation, and scaling at the target lesion, compared with the other groups in the phase II trial. The investigators also reported at safety profile consistent with halobetasol propionate or tazarotene monotherapy, meaning no new safety concerns emerged with the combination.
Participants were randomized to the combination, halobetasol propionate alone, tazarotene monotherapy, or vehicle in the multicenter, double blind study.
Efficacy evaluation
At 8 weeks, 53% of the combination group achieved treatment success, defined as at least a 2-point gain in Investigator’s Global Assessment of Disease Severity and a score of “clear” or “almost clear.” In contrast, 33% of the halobetasol propionate group, 19% in the tazarotene, and 10% of the vehicle only group achieved those endpoints in the intent-to-treat-analysis. The difference in efficacy between the combination group and vehicle was statistically significant (P less than .001).
On individual clinical efficacy measures, more than half of the patients in the combination treatment group achieved at least a 2-point improvement from baseline: 54% for erythema, 68% for plaque elevation, 65% for scaling. Each of these outcomes was significantly superior compared to the tazarotene or vehicle group (P less than or equal to .001).
“I was not surprised by the findings as the drugs work by complimentary mechanisms of action – so combination therapy should be effective,” Dr. Stein Gold said.
At baseline, IGA severity score of 3 was most common in each group and for each psoriasis sign at the target lesions. In each group, the mean age of participants ranged from 48 to 56 years; the proportion of men ranged from 59% to 68%; and 87% to 95% were white. The median target lesion sizes ranged from 25 to 32 cm2.
Safety outcomes
One patient in the vehicle-only group died. Three other participants experienced serious adverse events – one in each of the noncombination groups. None of these events were related to the study medications, the investigators noted. Application site reactions were the most common treatment-associated adverse events. Some skin atrophy was reported.
“These results show that the fixed combination of halobetasol propionate and tazarotene was effective and well tolerated,” said Dr. Stein Gold, who serves as division head of dermatology at Henry Ford Health System, West Bloomfield, Mich. “This would be a nice addition to our treatment armamentarium for patients with plaque psoriasis.”
Dr. Stein Gold is a speaker, consultant, and study investigator for Valeant Pharmaceuticals, which supported the study.
AT ODAC 2017
Key clinical point: A fixed dose combination of topical halobetasol propionate 0.01% and tazarotene 0.045% proved superior to either monotherapy or vehicle.
Major finding: Treatment success was achieved by 53% of a combination group compared with 33% of a halobetasol propionate group, 19% of a tazarotene group, and 10% of the vehicle-only group in an intent-to-treat-analysis.
Data source: A multicenter, randomized, double blind phase II study of 212 people with moderate to severe psoriasis.
Disclosures: Dr. Stein Gold is a speaker, consultant, and study investigator for Valeant Pharmaceuticals, which supported the study.
Childhood psoriasis negatively impacts parental QOL
Parents of children with psoriasis experience significant negative quality-of-life issues, according to Dr. Megha Tollefson and her associates.
In interviews with 31 parents of children with psoriasis, four themes impacting quality of life emerged. Parental health and self-care were negatively affected, with 52% reporting affected sleep patterns and 35% reporting difficulty in maintaining self-care. Mental health issues were common as well, with 65% of parents reporting concern over their child’s condition and nearly half of parents reporting excess stress and sadness, anxiety, or depression.
Family and social functions were adversely affected as well, with parents commonly citing financial difficulty, tension with their spouse or significant other, difficulty in other relationships, a lack of awareness regarding psoriasis, and the burden of care. The final theme highlighted was the sacrifice of personal well-being and life pursuits, with 29% of parents reporting career impacts, 65% reporting a need for special accommodation for their child, and 48% reporting a feeling of having no time.
“The results of this study are a testament to the pervasiveness of childhood psoriasis in a parent’s life. Development of support strategies is recommended for children with psoriasis and their families,” Dr. Tollefson and her coauthors at the Mayo Clinic in Rochester, Minn., concluded.
Find the full study in the Journal of the American Academy of Dermatology (doi:10.1016/j.jaad.2016.09.014).
Parents of children with psoriasis experience significant negative quality-of-life issues, according to Dr. Megha Tollefson and her associates.
In interviews with 31 parents of children with psoriasis, four themes impacting quality of life emerged. Parental health and self-care were negatively affected, with 52% reporting affected sleep patterns and 35% reporting difficulty in maintaining self-care. Mental health issues were common as well, with 65% of parents reporting concern over their child’s condition and nearly half of parents reporting excess stress and sadness, anxiety, or depression.
Family and social functions were adversely affected as well, with parents commonly citing financial difficulty, tension with their spouse or significant other, difficulty in other relationships, a lack of awareness regarding psoriasis, and the burden of care. The final theme highlighted was the sacrifice of personal well-being and life pursuits, with 29% of parents reporting career impacts, 65% reporting a need for special accommodation for their child, and 48% reporting a feeling of having no time.
“The results of this study are a testament to the pervasiveness of childhood psoriasis in a parent’s life. Development of support strategies is recommended for children with psoriasis and their families,” Dr. Tollefson and her coauthors at the Mayo Clinic in Rochester, Minn., concluded.
Find the full study in the Journal of the American Academy of Dermatology (doi:10.1016/j.jaad.2016.09.014).
Parents of children with psoriasis experience significant negative quality-of-life issues, according to Dr. Megha Tollefson and her associates.
In interviews with 31 parents of children with psoriasis, four themes impacting quality of life emerged. Parental health and self-care were negatively affected, with 52% reporting affected sleep patterns and 35% reporting difficulty in maintaining self-care. Mental health issues were common as well, with 65% of parents reporting concern over their child’s condition and nearly half of parents reporting excess stress and sadness, anxiety, or depression.
Family and social functions were adversely affected as well, with parents commonly citing financial difficulty, tension with their spouse or significant other, difficulty in other relationships, a lack of awareness regarding psoriasis, and the burden of care. The final theme highlighted was the sacrifice of personal well-being and life pursuits, with 29% of parents reporting career impacts, 65% reporting a need for special accommodation for their child, and 48% reporting a feeling of having no time.
“The results of this study are a testament to the pervasiveness of childhood psoriasis in a parent’s life. Development of support strategies is recommended for children with psoriasis and their families,” Dr. Tollefson and her coauthors at the Mayo Clinic in Rochester, Minn., concluded.
Find the full study in the Journal of the American Academy of Dermatology (doi:10.1016/j.jaad.2016.09.014).
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Debunking Psoriasis Myths: Do Systemic Steroids Used in Psoriasis Patients Cause Pustular Psoriasis?
Myth: Systemic steroids cause pustular psoriasis
The advent of biologic therapy for psoriasis has changed the landscape of treatments offered to patients. Nevertheless, systemic therapies still play an important role, according to the American Academy of Dermatology psoriasis treatment guidelines, due to their oral route of administration and low cost compared to biologics. They are options for patients with moderate to severe psoriasis that is unresponsive to topical therapies or phototherapy. However, many dermatologists feel that it is inappropriate to prescribe oral steroids to psoriasis patients due to the risk for steroid-induced conversion to pustular psoriasis, the long-term side effects of steroids, and deterioration of psoriasis after withdrawal of steroids.
Pustular psoriasis appears clinically as white pustules (blisters of noninfectious pus) surrounded by red skin. The pus consists of white blood cells. There are a number of triggers in addition to systemic steroids, such as internal medications, irritating topical agents, overexposure to UV light, and pregnancy. Stopping an oral steroid abruptly can cause serious disease flares, fatigue, and joint pain.
Westphal et al described the case of a 70-year-old woman with palmoplantar psoriasis who was diagnosed with acute generalized exanthematous pustulosis that was treated with corticotherapy by injection and then oral prednisone. She experienced improvement, but her symptoms worsened when she was in the process of reducing the prednisone dose. The dose was increased again, and the same worsening of symptoms was experienced when the dose was reduced. After completely abandoning oral steroid therapy, she developed a severe case of generalized pustular psoriasis that was treated with acitretin. This case illustrates the dangerous consequences of abruptly discontinuing oral steroids.
However, dermatologists may be using oral steroids for psoriasis more often than treatment guidelines suggest. In 2014, Al-Dabagh et al evaluated how frequently systemic corticosteroids are prescribed for psoriasis in the United States. The researchers reported, "Despite the absence or discouragement of systemic corticosteroids in psoriasis management guidelines, systemic corticosteroids are among the most common systemic treatments used for psoriasis." They found that systemic corticosteroids were prescribed at 650,000 of 21,020,000 psoriasis visits, of which 93% were visits to dermatologists. Prednisone was the most commonly prescribed systemic corticosteroid, followed by methylprednisolone and dexamethasone. To prevent rebound flares, systemic corticosteroids were prescribed with a topical corticosteroid in 45% of the visits in patients with psoriasis as the sole diagnosis. They concluded, "The striking contrast between the guidelines for psoriasis management and actual practice suggests that there is an acute need to better understand the use of systemic corticosteroids for psoriasis."
The benefits of systemic corticosteroids versus the frequency of adverse reactions should be weighed by dermatologists and patients to make evidence-based decisions about treatment. Patients should take oral steroids exactly as prescribed by physicians.
References
Al-Dabagh A, Al-Dabagh R, Davis SA, et al. Systemic corticosteroids are frequently prescribed for psoriasis. J Cutan Med Surg. 2014;18:195-199.
Delzell E. What you need to know about steroids. National Psoriasis Foundation website. https://www.psoriasis.org/advance/what-you-need-to-know-about-steroids. Published September 2, 2015. Accessed January 13, 2017.
Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 2009;61:451-485.
Pustular psoriasis. National Psoriasis Foundation website. https://www.psoriasis.org/about-psoriasis/types/pustular. Accessed January 13, 2017.
Westphal DC, Schettini APM, de Souza PP, et al. Generalized pustular psoriasis induced by systemic steroid dose reduction. An Bras Dermatol. 2016;91:664-666.
Expert Commentaries on next page
Expert Commentaries
When I was a resident, I was trained not to use systemic steroids in psoriasis patients for the reasons noted above, and I have faithfully followed these instructions 9 years into practice. However, I see many patients with severe psoriasis who are given systemic steroids by other physicians (ie, rheumatologists for psoriatic arthritis, pulmonologists for asthma). I often tell patients afterwards of the dangers of systemic steroids and to have them tell their other doctors to be cautious when giving another course of systemic steroids. However, I have yet to see a generalized pustular psoriasis outbreak or flare in psoriasis vulgaris after a course of systemic steroids. While I do not recommend systemic steroids for psoriasis patients since we have so many other systemic agents, I wonder if the risks that we were all trained about are really that high.
—Jashin J. Wu, MD (Los Angeles, California)
How bad is it to give patients with psoriasis systemic steroids? Are psoriasis patients treated with systemic steroids likely to get a pustular flare? Are patients with psoriasis who suddenly stop their corticosteroids more likely to get a pustular flare than psoriasis patients who suddenly stop other systemic psoriasis treatments? I don't have the answers to these questions. My sense is that we have a lot of dogma and strong opinions but very little hard evidence to answer these questions.
I don't typically prescribe systemic steroids to psoriasis patients, but systemic steroids are widely used. Sometimes there are problems. I have seen patients who received systemic steroids for psoriasis and who went on to have a pustular flare, but it's possible the systemic steroid was given because those patients were headed toward the pustular flare already.
I once had a psoriasis patient who came to see me with a suddenly inflamed tender joint. Not knowing what to do, I called a rheumatologist to see the patient. The rheumatologist, too busy to work the patient in, told me to give the patient a 2-week prednisone taper. I did, and nothing untoward happened with the psoriasis. This one anecdote doesn't give me much confidence that systemic steroids are safe for psoriasis patients.
Clearly, long-term steroids cause a host of problems (eg, osteoporosis, diabetes). But I'm not sure that the dogma that systemic steroids should be avoided in patients with psoriasis is well supported. Systemic steroids are being widely used, and I don't see an epidemic of pustular flares.
Is it a mistake to give systemic steroids to psoriasis patients? I just don't know.
—Steven R. Feldman, MD, PhD (Winston-Salem, North Carolina)
Myth: Systemic steroids cause pustular psoriasis
The advent of biologic therapy for psoriasis has changed the landscape of treatments offered to patients. Nevertheless, systemic therapies still play an important role, according to the American Academy of Dermatology psoriasis treatment guidelines, due to their oral route of administration and low cost compared to biologics. They are options for patients with moderate to severe psoriasis that is unresponsive to topical therapies or phototherapy. However, many dermatologists feel that it is inappropriate to prescribe oral steroids to psoriasis patients due to the risk for steroid-induced conversion to pustular psoriasis, the long-term side effects of steroids, and deterioration of psoriasis after withdrawal of steroids.
Pustular psoriasis appears clinically as white pustules (blisters of noninfectious pus) surrounded by red skin. The pus consists of white blood cells. There are a number of triggers in addition to systemic steroids, such as internal medications, irritating topical agents, overexposure to UV light, and pregnancy. Stopping an oral steroid abruptly can cause serious disease flares, fatigue, and joint pain.
Westphal et al described the case of a 70-year-old woman with palmoplantar psoriasis who was diagnosed with acute generalized exanthematous pustulosis that was treated with corticotherapy by injection and then oral prednisone. She experienced improvement, but her symptoms worsened when she was in the process of reducing the prednisone dose. The dose was increased again, and the same worsening of symptoms was experienced when the dose was reduced. After completely abandoning oral steroid therapy, she developed a severe case of generalized pustular psoriasis that was treated with acitretin. This case illustrates the dangerous consequences of abruptly discontinuing oral steroids.
However, dermatologists may be using oral steroids for psoriasis more often than treatment guidelines suggest. In 2014, Al-Dabagh et al evaluated how frequently systemic corticosteroids are prescribed for psoriasis in the United States. The researchers reported, "Despite the absence or discouragement of systemic corticosteroids in psoriasis management guidelines, systemic corticosteroids are among the most common systemic treatments used for psoriasis." They found that systemic corticosteroids were prescribed at 650,000 of 21,020,000 psoriasis visits, of which 93% were visits to dermatologists. Prednisone was the most commonly prescribed systemic corticosteroid, followed by methylprednisolone and dexamethasone. To prevent rebound flares, systemic corticosteroids were prescribed with a topical corticosteroid in 45% of the visits in patients with psoriasis as the sole diagnosis. They concluded, "The striking contrast between the guidelines for psoriasis management and actual practice suggests that there is an acute need to better understand the use of systemic corticosteroids for psoriasis."
The benefits of systemic corticosteroids versus the frequency of adverse reactions should be weighed by dermatologists and patients to make evidence-based decisions about treatment. Patients should take oral steroids exactly as prescribed by physicians.
References
Al-Dabagh A, Al-Dabagh R, Davis SA, et al. Systemic corticosteroids are frequently prescribed for psoriasis. J Cutan Med Surg. 2014;18:195-199.
Delzell E. What you need to know about steroids. National Psoriasis Foundation website. https://www.psoriasis.org/advance/what-you-need-to-know-about-steroids. Published September 2, 2015. Accessed January 13, 2017.
Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 2009;61:451-485.
Pustular psoriasis. National Psoriasis Foundation website. https://www.psoriasis.org/about-psoriasis/types/pustular. Accessed January 13, 2017.
Westphal DC, Schettini APM, de Souza PP, et al. Generalized pustular psoriasis induced by systemic steroid dose reduction. An Bras Dermatol. 2016;91:664-666.
Expert Commentaries on next page
Expert Commentaries
When I was a resident, I was trained not to use systemic steroids in psoriasis patients for the reasons noted above, and I have faithfully followed these instructions 9 years into practice. However, I see many patients with severe psoriasis who are given systemic steroids by other physicians (ie, rheumatologists for psoriatic arthritis, pulmonologists for asthma). I often tell patients afterwards of the dangers of systemic steroids and to have them tell their other doctors to be cautious when giving another course of systemic steroids. However, I have yet to see a generalized pustular psoriasis outbreak or flare in psoriasis vulgaris after a course of systemic steroids. While I do not recommend systemic steroids for psoriasis patients since we have so many other systemic agents, I wonder if the risks that we were all trained about are really that high.
—Jashin J. Wu, MD (Los Angeles, California)
How bad is it to give patients with psoriasis systemic steroids? Are psoriasis patients treated with systemic steroids likely to get a pustular flare? Are patients with psoriasis who suddenly stop their corticosteroids more likely to get a pustular flare than psoriasis patients who suddenly stop other systemic psoriasis treatments? I don't have the answers to these questions. My sense is that we have a lot of dogma and strong opinions but very little hard evidence to answer these questions.
I don't typically prescribe systemic steroids to psoriasis patients, but systemic steroids are widely used. Sometimes there are problems. I have seen patients who received systemic steroids for psoriasis and who went on to have a pustular flare, but it's possible the systemic steroid was given because those patients were headed toward the pustular flare already.
I once had a psoriasis patient who came to see me with a suddenly inflamed tender joint. Not knowing what to do, I called a rheumatologist to see the patient. The rheumatologist, too busy to work the patient in, told me to give the patient a 2-week prednisone taper. I did, and nothing untoward happened with the psoriasis. This one anecdote doesn't give me much confidence that systemic steroids are safe for psoriasis patients.
Clearly, long-term steroids cause a host of problems (eg, osteoporosis, diabetes). But I'm not sure that the dogma that systemic steroids should be avoided in patients with psoriasis is well supported. Systemic steroids are being widely used, and I don't see an epidemic of pustular flares.
Is it a mistake to give systemic steroids to psoriasis patients? I just don't know.
—Steven R. Feldman, MD, PhD (Winston-Salem, North Carolina)
Myth: Systemic steroids cause pustular psoriasis
The advent of biologic therapy for psoriasis has changed the landscape of treatments offered to patients. Nevertheless, systemic therapies still play an important role, according to the American Academy of Dermatology psoriasis treatment guidelines, due to their oral route of administration and low cost compared to biologics. They are options for patients with moderate to severe psoriasis that is unresponsive to topical therapies or phototherapy. However, many dermatologists feel that it is inappropriate to prescribe oral steroids to psoriasis patients due to the risk for steroid-induced conversion to pustular psoriasis, the long-term side effects of steroids, and deterioration of psoriasis after withdrawal of steroids.
Pustular psoriasis appears clinically as white pustules (blisters of noninfectious pus) surrounded by red skin. The pus consists of white blood cells. There are a number of triggers in addition to systemic steroids, such as internal medications, irritating topical agents, overexposure to UV light, and pregnancy. Stopping an oral steroid abruptly can cause serious disease flares, fatigue, and joint pain.
Westphal et al described the case of a 70-year-old woman with palmoplantar psoriasis who was diagnosed with acute generalized exanthematous pustulosis that was treated with corticotherapy by injection and then oral prednisone. She experienced improvement, but her symptoms worsened when she was in the process of reducing the prednisone dose. The dose was increased again, and the same worsening of symptoms was experienced when the dose was reduced. After completely abandoning oral steroid therapy, she developed a severe case of generalized pustular psoriasis that was treated with acitretin. This case illustrates the dangerous consequences of abruptly discontinuing oral steroids.
However, dermatologists may be using oral steroids for psoriasis more often than treatment guidelines suggest. In 2014, Al-Dabagh et al evaluated how frequently systemic corticosteroids are prescribed for psoriasis in the United States. The researchers reported, "Despite the absence or discouragement of systemic corticosteroids in psoriasis management guidelines, systemic corticosteroids are among the most common systemic treatments used for psoriasis." They found that systemic corticosteroids were prescribed at 650,000 of 21,020,000 psoriasis visits, of which 93% were visits to dermatologists. Prednisone was the most commonly prescribed systemic corticosteroid, followed by methylprednisolone and dexamethasone. To prevent rebound flares, systemic corticosteroids were prescribed with a topical corticosteroid in 45% of the visits in patients with psoriasis as the sole diagnosis. They concluded, "The striking contrast between the guidelines for psoriasis management and actual practice suggests that there is an acute need to better understand the use of systemic corticosteroids for psoriasis."
The benefits of systemic corticosteroids versus the frequency of adverse reactions should be weighed by dermatologists and patients to make evidence-based decisions about treatment. Patients should take oral steroids exactly as prescribed by physicians.
References
Al-Dabagh A, Al-Dabagh R, Davis SA, et al. Systemic corticosteroids are frequently prescribed for psoriasis. J Cutan Med Surg. 2014;18:195-199.
Delzell E. What you need to know about steroids. National Psoriasis Foundation website. https://www.psoriasis.org/advance/what-you-need-to-know-about-steroids. Published September 2, 2015. Accessed January 13, 2017.
Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 2009;61:451-485.
Pustular psoriasis. National Psoriasis Foundation website. https://www.psoriasis.org/about-psoriasis/types/pustular. Accessed January 13, 2017.
Westphal DC, Schettini APM, de Souza PP, et al. Generalized pustular psoriasis induced by systemic steroid dose reduction. An Bras Dermatol. 2016;91:664-666.
Expert Commentaries on next page
Expert Commentaries
When I was a resident, I was trained not to use systemic steroids in psoriasis patients for the reasons noted above, and I have faithfully followed these instructions 9 years into practice. However, I see many patients with severe psoriasis who are given systemic steroids by other physicians (ie, rheumatologists for psoriatic arthritis, pulmonologists for asthma). I often tell patients afterwards of the dangers of systemic steroids and to have them tell their other doctors to be cautious when giving another course of systemic steroids. However, I have yet to see a generalized pustular psoriasis outbreak or flare in psoriasis vulgaris after a course of systemic steroids. While I do not recommend systemic steroids for psoriasis patients since we have so many other systemic agents, I wonder if the risks that we were all trained about are really that high.
—Jashin J. Wu, MD (Los Angeles, California)
How bad is it to give patients with psoriasis systemic steroids? Are psoriasis patients treated with systemic steroids likely to get a pustular flare? Are patients with psoriasis who suddenly stop their corticosteroids more likely to get a pustular flare than psoriasis patients who suddenly stop other systemic psoriasis treatments? I don't have the answers to these questions. My sense is that we have a lot of dogma and strong opinions but very little hard evidence to answer these questions.
I don't typically prescribe systemic steroids to psoriasis patients, but systemic steroids are widely used. Sometimes there are problems. I have seen patients who received systemic steroids for psoriasis and who went on to have a pustular flare, but it's possible the systemic steroid was given because those patients were headed toward the pustular flare already.
I once had a psoriasis patient who came to see me with a suddenly inflamed tender joint. Not knowing what to do, I called a rheumatologist to see the patient. The rheumatologist, too busy to work the patient in, told me to give the patient a 2-week prednisone taper. I did, and nothing untoward happened with the psoriasis. This one anecdote doesn't give me much confidence that systemic steroids are safe for psoriasis patients.
Clearly, long-term steroids cause a host of problems (eg, osteoporosis, diabetes). But I'm not sure that the dogma that systemic steroids should be avoided in patients with psoriasis is well supported. Systemic steroids are being widely used, and I don't see an epidemic of pustular flares.
Is it a mistake to give systemic steroids to psoriasis patients? I just don't know.
—Steven R. Feldman, MD, PhD (Winston-Salem, North Carolina)
Medicare payments set for infliximab biosimilar Inflectra
Payment for the infliximab biosimilar drug Inflectra will now be covered by Medicare, the drug’s manufacturer, Pfizer, said in an announcement.
The Centers for Medicare & Medicaid Services (CMS) included Inflectra (infliximab-dyyb) in its January 2017 Average Sales Price pricing file, which went into effect Jan. 1, 2017. Pfizer said that Inflectra is priced at a 15% discount to the current wholesale acquisition cost for the infliximab originator Remicade, but this price does not include discounts to payers, providers, distributors, and other purchasing organizations.
For the first quarter of 2017, the payment limit set by the CMS for Inflectra is $100.306 per 10-mg unit and $82.218 for Remicade.
Various national and regional wholesalers across the country began receiving shipments of Inflectra in November 2016, according to Pfizer.
In conjunction with the availability of Inflectra, Pfizer announced its enCompass program, “a comprehensive reimbursement service and patient support program offering coding and reimbursement support for providers, copay assistance to eligible patients who have commercial insurance that covers Inflectra, and financial assistance for eligible uninsured and underinsured patients.”
The FDA approved Inflectra in April 2016 for all of the same indications as Remicade: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis, and ulcerative colitis.
Payment for the infliximab biosimilar drug Inflectra will now be covered by Medicare, the drug’s manufacturer, Pfizer, said in an announcement.
The Centers for Medicare & Medicaid Services (CMS) included Inflectra (infliximab-dyyb) in its January 2017 Average Sales Price pricing file, which went into effect Jan. 1, 2017. Pfizer said that Inflectra is priced at a 15% discount to the current wholesale acquisition cost for the infliximab originator Remicade, but this price does not include discounts to payers, providers, distributors, and other purchasing organizations.
For the first quarter of 2017, the payment limit set by the CMS for Inflectra is $100.306 per 10-mg unit and $82.218 for Remicade.
Various national and regional wholesalers across the country began receiving shipments of Inflectra in November 2016, according to Pfizer.
In conjunction with the availability of Inflectra, Pfizer announced its enCompass program, “a comprehensive reimbursement service and patient support program offering coding and reimbursement support for providers, copay assistance to eligible patients who have commercial insurance that covers Inflectra, and financial assistance for eligible uninsured and underinsured patients.”
The FDA approved Inflectra in April 2016 for all of the same indications as Remicade: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis, and ulcerative colitis.
Payment for the infliximab biosimilar drug Inflectra will now be covered by Medicare, the drug’s manufacturer, Pfizer, said in an announcement.
The Centers for Medicare & Medicaid Services (CMS) included Inflectra (infliximab-dyyb) in its January 2017 Average Sales Price pricing file, which went into effect Jan. 1, 2017. Pfizer said that Inflectra is priced at a 15% discount to the current wholesale acquisition cost for the infliximab originator Remicade, but this price does not include discounts to payers, providers, distributors, and other purchasing organizations.
For the first quarter of 2017, the payment limit set by the CMS for Inflectra is $100.306 per 10-mg unit and $82.218 for Remicade.
Various national and regional wholesalers across the country began receiving shipments of Inflectra in November 2016, according to Pfizer.
In conjunction with the availability of Inflectra, Pfizer announced its enCompass program, “a comprehensive reimbursement service and patient support program offering coding and reimbursement support for providers, copay assistance to eligible patients who have commercial insurance that covers Inflectra, and financial assistance for eligible uninsured and underinsured patients.”
The FDA approved Inflectra in April 2016 for all of the same indications as Remicade: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis, and ulcerative colitis.
Initial suboptimal responders to secukinumab usually bloom later
VIENNA – When the occasional patient on secukinumab for moderate to severe psoriasis fails to achieve a PASI 75 response initially, don’t despair: Continuing treatment with the biologic usually gets them over that bar, Christopher E. Griffiths, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
A new secondary pooled analysis of four phase III, 52-week, pivotal clinical trials of secukinumab (Cosentyx) indicates that more than three-quarters of initial suboptimal responders will go on to achieve a PASI 75 response. Moreover, more than one-third will have a PASI 90 response by week 16, which is sustained through week 52. And almost one in five slow responders will have a PASI 100 response – clear skin – at week 52, according to Dr. Griffiths, professor of dermatology at the University of Manchester, England.
He presented a secondary analysis of four phase III studies: ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis), FEATURE (First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks), FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis), and JUNCTURE (Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results). The analysis was conducted to provide additional perspective on the product labeling statement that treatment discontinuation should be considered in patients who haven’t responded to secukinumab by week 16.
The four studies featured a total of 2,405 patients with moderate to severe psoriasis on secukinumab at the approved dosing schedule.
The key findings: At week 12 – the primary endpoint in the four trials – only 5.2% of patients on secukinumab had not achieved a PASI 75 response. Yet just 4 weeks later, at week 16, 56% of this group had managed to get there. Seventy-seven percent of early non- or partial responders achieved a PASI 75 response at some point during weeks 13-52, and 55% had a PASI 75 response at 52 weeks.
Thirty-five percent of early poor responders achieved PASI 90 at 16 weeks and 37% at 52 weeks. Twelve percent of patients who didn’t get to PASI 75 at 12 weeks had a PASI 100 response by 16 weeks, and nearly 18% did by week 52.
This analysis was supported by secukinumab manufacturer Novartis. Dr. Griffiths reported receiving research funds from and serving as a consultant to Novartis and numerous other pharmaceutical companies.
VIENNA – When the occasional patient on secukinumab for moderate to severe psoriasis fails to achieve a PASI 75 response initially, don’t despair: Continuing treatment with the biologic usually gets them over that bar, Christopher E. Griffiths, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
A new secondary pooled analysis of four phase III, 52-week, pivotal clinical trials of secukinumab (Cosentyx) indicates that more than three-quarters of initial suboptimal responders will go on to achieve a PASI 75 response. Moreover, more than one-third will have a PASI 90 response by week 16, which is sustained through week 52. And almost one in five slow responders will have a PASI 100 response – clear skin – at week 52, according to Dr. Griffiths, professor of dermatology at the University of Manchester, England.
He presented a secondary analysis of four phase III studies: ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis), FEATURE (First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks), FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis), and JUNCTURE (Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results). The analysis was conducted to provide additional perspective on the product labeling statement that treatment discontinuation should be considered in patients who haven’t responded to secukinumab by week 16.
The four studies featured a total of 2,405 patients with moderate to severe psoriasis on secukinumab at the approved dosing schedule.
The key findings: At week 12 – the primary endpoint in the four trials – only 5.2% of patients on secukinumab had not achieved a PASI 75 response. Yet just 4 weeks later, at week 16, 56% of this group had managed to get there. Seventy-seven percent of early non- or partial responders achieved a PASI 75 response at some point during weeks 13-52, and 55% had a PASI 75 response at 52 weeks.
Thirty-five percent of early poor responders achieved PASI 90 at 16 weeks and 37% at 52 weeks. Twelve percent of patients who didn’t get to PASI 75 at 12 weeks had a PASI 100 response by 16 weeks, and nearly 18% did by week 52.
This analysis was supported by secukinumab manufacturer Novartis. Dr. Griffiths reported receiving research funds from and serving as a consultant to Novartis and numerous other pharmaceutical companies.
VIENNA – When the occasional patient on secukinumab for moderate to severe psoriasis fails to achieve a PASI 75 response initially, don’t despair: Continuing treatment with the biologic usually gets them over that bar, Christopher E. Griffiths, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
A new secondary pooled analysis of four phase III, 52-week, pivotal clinical trials of secukinumab (Cosentyx) indicates that more than three-quarters of initial suboptimal responders will go on to achieve a PASI 75 response. Moreover, more than one-third will have a PASI 90 response by week 16, which is sustained through week 52. And almost one in five slow responders will have a PASI 100 response – clear skin – at week 52, according to Dr. Griffiths, professor of dermatology at the University of Manchester, England.
He presented a secondary analysis of four phase III studies: ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis), FEATURE (First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks), FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis), and JUNCTURE (Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results). The analysis was conducted to provide additional perspective on the product labeling statement that treatment discontinuation should be considered in patients who haven’t responded to secukinumab by week 16.
The four studies featured a total of 2,405 patients with moderate to severe psoriasis on secukinumab at the approved dosing schedule.
The key findings: At week 12 – the primary endpoint in the four trials – only 5.2% of patients on secukinumab had not achieved a PASI 75 response. Yet just 4 weeks later, at week 16, 56% of this group had managed to get there. Seventy-seven percent of early non- or partial responders achieved a PASI 75 response at some point during weeks 13-52, and 55% had a PASI 75 response at 52 weeks.
Thirty-five percent of early poor responders achieved PASI 90 at 16 weeks and 37% at 52 weeks. Twelve percent of patients who didn’t get to PASI 75 at 12 weeks had a PASI 100 response by 16 weeks, and nearly 18% did by week 52.
This analysis was supported by secukinumab manufacturer Novartis. Dr. Griffiths reported receiving research funds from and serving as a consultant to Novartis and numerous other pharmaceutical companies.
AT THE EADV CONGRESS
Key clinical point:
Major finding: Most psoriasis patients who don’t achieve a PASI 75 response by week 12 on secukinumab will do so by week 16 and will maintain that response through week 52.
Data source: A pooled secondary analysis of PASI response rates in four phase III randomized clinical trials of secukinumab featuring 2,405 patients with moderate to severe psoriasis who were on the biologic for 52 weeks, including the 119 who did not achieve a PASI 75 response by week 12.
Disclosures: This analysis of four phase III clinical trials was sponsored by Novartis, as were the trials. The presenter reported receiving research funding from and serving as a consultant to Novartis and other pharmaceutical companies.
Secukinumab tames severe scalp psoriasis
VIENNA – Secukinumab proved highly effective specifically for the treatment of moderate to severe scalp psoriasis in a phase IIIb clinical trial, Mark G. Lebwohl, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The scalp is one of the areas most commonly affected by psoriasis, yet few treatment trials have focused on patients with primarily moderate to severe scalp psoriasis. This phase IIIb study was designed to do just that. The 102 participants had psoriasis over a mean of 60% of their scalp for at least 6 months at baseline despite various forms of therapy; 40% had 70% or greater scalp involvement. The study population’s mean baseline Psoriasis Scalp Severity Index score was 34 out of a possible 72, noted Dr. Lebwohl, professor and chairman of the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York.
“The mean involved body surface area was only 11.2%, and the PASI was 8.4. That is below the entry score required for most biologic studies, yet scalp involvement was substantial,” he observed.
Participants in the double-blind trial were randomized to either subcutaneous secukinumab (Cosentyx) at 300 mg on the approved treatment schedule for psoriasis or to placebo, with the primary endpoint being at least a 90% improvement in Psoriasis Area and Severity Index scores (PASI 90 response) at 12 weeks.
“The results were striking. Quite stunning,” Dr. Lebwohl said.
A PASI 90 response was achieved in 53% of secukinumab-treated patients, compared with 2% of controls. Already by week 3 a significant difference was apparent between the two study arms: At that early point, 12% of the secukinumab group, but none of the controls, had a PASI 90 response.
The secondary endpoint was change in the Investigator’s Global Assessment of scalp disease. At baseline, roughly 80% of patients had an IGA of 3 out of a possible 4 and the rest were at 4. At 3 weeks, 26% of the secukinumab group had a score of 0 or 1, signifying a clear or almost clear scalp, compared with 6% of controls. At 12 weeks, 57% of patients on secukinumab had an IGA of 0 or 1, as did 6% of those on placebo.
Side effects of secukinumab in the 12-week study were minimal. There were no serious adverse events. One case of candidiasis occurred in each study arm. Both responded readily to standard therapy.
Secukinumab is a fully human monoclonal antibody that inhibits interleukin-17A. It’s approved for treatment of moderate-to-severe psoriasis, psoriatic arthritis, and ankylosing spondylitis.
This phase IIIb clinical trial was sponsored by Novartis. Dr. Lebwohl reported that his department receives research funding from Novartis and roughly a dozen other pharmaceutical companies.
VIENNA – Secukinumab proved highly effective specifically for the treatment of moderate to severe scalp psoriasis in a phase IIIb clinical trial, Mark G. Lebwohl, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The scalp is one of the areas most commonly affected by psoriasis, yet few treatment trials have focused on patients with primarily moderate to severe scalp psoriasis. This phase IIIb study was designed to do just that. The 102 participants had psoriasis over a mean of 60% of their scalp for at least 6 months at baseline despite various forms of therapy; 40% had 70% or greater scalp involvement. The study population’s mean baseline Psoriasis Scalp Severity Index score was 34 out of a possible 72, noted Dr. Lebwohl, professor and chairman of the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York.
“The mean involved body surface area was only 11.2%, and the PASI was 8.4. That is below the entry score required for most biologic studies, yet scalp involvement was substantial,” he observed.
Participants in the double-blind trial were randomized to either subcutaneous secukinumab (Cosentyx) at 300 mg on the approved treatment schedule for psoriasis or to placebo, with the primary endpoint being at least a 90% improvement in Psoriasis Area and Severity Index scores (PASI 90 response) at 12 weeks.
“The results were striking. Quite stunning,” Dr. Lebwohl said.
A PASI 90 response was achieved in 53% of secukinumab-treated patients, compared with 2% of controls. Already by week 3 a significant difference was apparent between the two study arms: At that early point, 12% of the secukinumab group, but none of the controls, had a PASI 90 response.
The secondary endpoint was change in the Investigator’s Global Assessment of scalp disease. At baseline, roughly 80% of patients had an IGA of 3 out of a possible 4 and the rest were at 4. At 3 weeks, 26% of the secukinumab group had a score of 0 or 1, signifying a clear or almost clear scalp, compared with 6% of controls. At 12 weeks, 57% of patients on secukinumab had an IGA of 0 or 1, as did 6% of those on placebo.
Side effects of secukinumab in the 12-week study were minimal. There were no serious adverse events. One case of candidiasis occurred in each study arm. Both responded readily to standard therapy.
Secukinumab is a fully human monoclonal antibody that inhibits interleukin-17A. It’s approved for treatment of moderate-to-severe psoriasis, psoriatic arthritis, and ankylosing spondylitis.
This phase IIIb clinical trial was sponsored by Novartis. Dr. Lebwohl reported that his department receives research funding from Novartis and roughly a dozen other pharmaceutical companies.
VIENNA – Secukinumab proved highly effective specifically for the treatment of moderate to severe scalp psoriasis in a phase IIIb clinical trial, Mark G. Lebwohl, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The scalp is one of the areas most commonly affected by psoriasis, yet few treatment trials have focused on patients with primarily moderate to severe scalp psoriasis. This phase IIIb study was designed to do just that. The 102 participants had psoriasis over a mean of 60% of their scalp for at least 6 months at baseline despite various forms of therapy; 40% had 70% or greater scalp involvement. The study population’s mean baseline Psoriasis Scalp Severity Index score was 34 out of a possible 72, noted Dr. Lebwohl, professor and chairman of the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York.
“The mean involved body surface area was only 11.2%, and the PASI was 8.4. That is below the entry score required for most biologic studies, yet scalp involvement was substantial,” he observed.
Participants in the double-blind trial were randomized to either subcutaneous secukinumab (Cosentyx) at 300 mg on the approved treatment schedule for psoriasis or to placebo, with the primary endpoint being at least a 90% improvement in Psoriasis Area and Severity Index scores (PASI 90 response) at 12 weeks.
“The results were striking. Quite stunning,” Dr. Lebwohl said.
A PASI 90 response was achieved in 53% of secukinumab-treated patients, compared with 2% of controls. Already by week 3 a significant difference was apparent between the two study arms: At that early point, 12% of the secukinumab group, but none of the controls, had a PASI 90 response.
The secondary endpoint was change in the Investigator’s Global Assessment of scalp disease. At baseline, roughly 80% of patients had an IGA of 3 out of a possible 4 and the rest were at 4. At 3 weeks, 26% of the secukinumab group had a score of 0 or 1, signifying a clear or almost clear scalp, compared with 6% of controls. At 12 weeks, 57% of patients on secukinumab had an IGA of 0 or 1, as did 6% of those on placebo.
Side effects of secukinumab in the 12-week study were minimal. There were no serious adverse events. One case of candidiasis occurred in each study arm. Both responded readily to standard therapy.
Secukinumab is a fully human monoclonal antibody that inhibits interleukin-17A. It’s approved for treatment of moderate-to-severe psoriasis, psoriatic arthritis, and ankylosing spondylitis.
This phase IIIb clinical trial was sponsored by Novartis. Dr. Lebwohl reported that his department receives research funding from Novartis and roughly a dozen other pharmaceutical companies.
AT THE EADV CONGRESS
Key clinical point:
Major finding: 53% of patients with chronic moderate to severe scalp psoriasis experienced at least a 90% improvement after 12 weeks on secukinumab, compared with 2% of controls.
Data source: This prospective, double-blind, phase IIIb clinical trial randomized 102 patients with moderate to severe scalp psoriasis to secukinumab or placebo.
Disclosures: The study was sponsored by Novartis. The presenter reported that his academic department receives research funding from Novartis and roughly a dozen other pharmaceutical companies.
Ixekizumab proves highly effective for palmoplantar, scalp psoriasis
VIENNA – Ixekizumab proved markedly more effective than etanercept for treatment of palmoplantar psoriasis in a head-to-head contest in the landmark phase III UNCOVER-3 trial, Alan Menter, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
Significant improvement in palmoplantar disease was seen as early as week 2 in patients randomized to ixekizumab (Taltz), a humanized monoclonal antibody directed against interleukin-17A. Moreover, the early improvement was maintained out to week 60 with administration of 80 mg of ixekizumab by subcutaneous injection every 4 weeks in the open-label extension phase of UNCOVER-3. This pivotal trial, including 1,346 patients with moderate to severe psoriasis, helped win regulatory approval for ixekizumab for treatment of chronic plaque psoriasis.
The primary results of UNCOVER-3 have been published. At week 60, at least 80% of patients on maintenance therapy with ixekizumab had a PASI 75 response and at least 73% were rated clear or almost clear (N Engl J Med. 2016 Jul 28;375[4]:345-56).
Dr. Menter and Dr. Reich presented new subgroup analyses focused specifically on palmoplantar and scalp psoriasis because these two expressions of the disease are very important in clinical practice, albeit for different reasons.
Scalp psoriasis is extremely common in patients with plaque psoriasis. In fact, nearly 91% of subjects in UNCOVER-3 had scalp involvement.
“That’s a higher percentage than we’re accustomed to seeing in daily practice. It suggests scalp psoriasis may be more common than previously thought in patients with moderate or severe psoriasis,” said Dr. Reich, professor of dermatology at Georg-August-University in Gottingen, Germany, and a partner at the Dermatologikum Hamburg.
At week 60, more than 77% of patients on ixekizumab achieved a Psoriasis Scalp Severity Index 100 response (PSSI 100), meaning they had complete resolution of their scalp psoriasis. More than 80% achieved a PSSI 90 response indicative of complete or near complete resolution of their scalp involvement, the dermatologist reported.
“I often tell my patients that it’s because of palmoplantar psoriasis that I have so many white hairs. It’s certainly a disease that none of us cope with well topically, phototherapy-wise, PUVA-wise, or with systemic therapy. All of the studies done to date with our systemic therapies show significantly lower effect on palmoplantar psoriasis than for psoriasis at other sites. When I did the REVEAL study for Humira [adalimumab], we published a week 16 PASI 75 rate of 71%. When we did the palmoplantar psoriasis cohort, it was less than 40%,” recalled Dr. Menter, who is chair of dermatology at Baylor University Medical Center, Dallas.
“Even though palmoplantar disease affects less than 5% of the body surface area, the quality of life impact for patients with significant palmoplantar pustular or plaque psoriasis is very significant,” Dr. Menter continued. “We’ve worked with our hand surgeons and our foot surgeons to show that the impairment equals that seen in patients with severe rheumatoid arthritis or osteoarthritis of the hands and feet. So it is a huge issue.”
He reported on the 115 UNCOVER-3 participants with palmoplantar involvement. Within 2 weeks after the first 80-mg dose of ixekizumab, recipients had a 60% improvement in their Palmoplantar Psoriasis Area and Severity Index (PPSI) scores.
“It was very dramatic. These are figures that we haven’t seen with methotrexate, with retinoids, or with TNF-alpha blockers,” according to Dr. Menter.
At week 12 in UNCOVER-3, patients randomized to ixekizumab at 80 mg every 2 weeks showed an 85% improvement from baseline in PPSI scores. Those on ixekizumab at 80 mg every 4 weeks had a 78% improvement from baseline, while patients on etanercept at 50 mg twice weekly showed a 52% improvement.
At 60 weeks, PPSI 100 response rates – that is, clear palms and soles – were 60%-70% in the various ixekizumab-treated groups.
“To me, the big issue now is what about palmoplantar pustulosis, a totally different disease, and a disease with equally serious issues for our patients. I’m looking forward to studies in that population. I sincerely hope these new agents such as ixekizumab will have a significant role to play,” he said.
Dr. Menter and Dr. Reich reported receiving research support from and serving as consultants to Eli Lilly, which sponsored the UNCOVER-3 trial and markets ixekizumab, as well as numerous other pharmaceutical companies.
VIENNA – Ixekizumab proved markedly more effective than etanercept for treatment of palmoplantar psoriasis in a head-to-head contest in the landmark phase III UNCOVER-3 trial, Alan Menter, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
Significant improvement in palmoplantar disease was seen as early as week 2 in patients randomized to ixekizumab (Taltz), a humanized monoclonal antibody directed against interleukin-17A. Moreover, the early improvement was maintained out to week 60 with administration of 80 mg of ixekizumab by subcutaneous injection every 4 weeks in the open-label extension phase of UNCOVER-3. This pivotal trial, including 1,346 patients with moderate to severe psoriasis, helped win regulatory approval for ixekizumab for treatment of chronic plaque psoriasis.
The primary results of UNCOVER-3 have been published. At week 60, at least 80% of patients on maintenance therapy with ixekizumab had a PASI 75 response and at least 73% were rated clear or almost clear (N Engl J Med. 2016 Jul 28;375[4]:345-56).
Dr. Menter and Dr. Reich presented new subgroup analyses focused specifically on palmoplantar and scalp psoriasis because these two expressions of the disease are very important in clinical practice, albeit for different reasons.
Scalp psoriasis is extremely common in patients with plaque psoriasis. In fact, nearly 91% of subjects in UNCOVER-3 had scalp involvement.
“That’s a higher percentage than we’re accustomed to seeing in daily practice. It suggests scalp psoriasis may be more common than previously thought in patients with moderate or severe psoriasis,” said Dr. Reich, professor of dermatology at Georg-August-University in Gottingen, Germany, and a partner at the Dermatologikum Hamburg.
At week 60, more than 77% of patients on ixekizumab achieved a Psoriasis Scalp Severity Index 100 response (PSSI 100), meaning they had complete resolution of their scalp psoriasis. More than 80% achieved a PSSI 90 response indicative of complete or near complete resolution of their scalp involvement, the dermatologist reported.
“I often tell my patients that it’s because of palmoplantar psoriasis that I have so many white hairs. It’s certainly a disease that none of us cope with well topically, phototherapy-wise, PUVA-wise, or with systemic therapy. All of the studies done to date with our systemic therapies show significantly lower effect on palmoplantar psoriasis than for psoriasis at other sites. When I did the REVEAL study for Humira [adalimumab], we published a week 16 PASI 75 rate of 71%. When we did the palmoplantar psoriasis cohort, it was less than 40%,” recalled Dr. Menter, who is chair of dermatology at Baylor University Medical Center, Dallas.
“Even though palmoplantar disease affects less than 5% of the body surface area, the quality of life impact for patients with significant palmoplantar pustular or plaque psoriasis is very significant,” Dr. Menter continued. “We’ve worked with our hand surgeons and our foot surgeons to show that the impairment equals that seen in patients with severe rheumatoid arthritis or osteoarthritis of the hands and feet. So it is a huge issue.”
He reported on the 115 UNCOVER-3 participants with palmoplantar involvement. Within 2 weeks after the first 80-mg dose of ixekizumab, recipients had a 60% improvement in their Palmoplantar Psoriasis Area and Severity Index (PPSI) scores.
“It was very dramatic. These are figures that we haven’t seen with methotrexate, with retinoids, or with TNF-alpha blockers,” according to Dr. Menter.
At week 12 in UNCOVER-3, patients randomized to ixekizumab at 80 mg every 2 weeks showed an 85% improvement from baseline in PPSI scores. Those on ixekizumab at 80 mg every 4 weeks had a 78% improvement from baseline, while patients on etanercept at 50 mg twice weekly showed a 52% improvement.
At 60 weeks, PPSI 100 response rates – that is, clear palms and soles – were 60%-70% in the various ixekizumab-treated groups.
“To me, the big issue now is what about palmoplantar pustulosis, a totally different disease, and a disease with equally serious issues for our patients. I’m looking forward to studies in that population. I sincerely hope these new agents such as ixekizumab will have a significant role to play,” he said.
Dr. Menter and Dr. Reich reported receiving research support from and serving as consultants to Eli Lilly, which sponsored the UNCOVER-3 trial and markets ixekizumab, as well as numerous other pharmaceutical companies.
VIENNA – Ixekizumab proved markedly more effective than etanercept for treatment of palmoplantar psoriasis in a head-to-head contest in the landmark phase III UNCOVER-3 trial, Alan Menter, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
Significant improvement in palmoplantar disease was seen as early as week 2 in patients randomized to ixekizumab (Taltz), a humanized monoclonal antibody directed against interleukin-17A. Moreover, the early improvement was maintained out to week 60 with administration of 80 mg of ixekizumab by subcutaneous injection every 4 weeks in the open-label extension phase of UNCOVER-3. This pivotal trial, including 1,346 patients with moderate to severe psoriasis, helped win regulatory approval for ixekizumab for treatment of chronic plaque psoriasis.
The primary results of UNCOVER-3 have been published. At week 60, at least 80% of patients on maintenance therapy with ixekizumab had a PASI 75 response and at least 73% were rated clear or almost clear (N Engl J Med. 2016 Jul 28;375[4]:345-56).
Dr. Menter and Dr. Reich presented new subgroup analyses focused specifically on palmoplantar and scalp psoriasis because these two expressions of the disease are very important in clinical practice, albeit for different reasons.
Scalp psoriasis is extremely common in patients with plaque psoriasis. In fact, nearly 91% of subjects in UNCOVER-3 had scalp involvement.
“That’s a higher percentage than we’re accustomed to seeing in daily practice. It suggests scalp psoriasis may be more common than previously thought in patients with moderate or severe psoriasis,” said Dr. Reich, professor of dermatology at Georg-August-University in Gottingen, Germany, and a partner at the Dermatologikum Hamburg.
At week 60, more than 77% of patients on ixekizumab achieved a Psoriasis Scalp Severity Index 100 response (PSSI 100), meaning they had complete resolution of their scalp psoriasis. More than 80% achieved a PSSI 90 response indicative of complete or near complete resolution of their scalp involvement, the dermatologist reported.
“I often tell my patients that it’s because of palmoplantar psoriasis that I have so many white hairs. It’s certainly a disease that none of us cope with well topically, phototherapy-wise, PUVA-wise, or with systemic therapy. All of the studies done to date with our systemic therapies show significantly lower effect on palmoplantar psoriasis than for psoriasis at other sites. When I did the REVEAL study for Humira [adalimumab], we published a week 16 PASI 75 rate of 71%. When we did the palmoplantar psoriasis cohort, it was less than 40%,” recalled Dr. Menter, who is chair of dermatology at Baylor University Medical Center, Dallas.
“Even though palmoplantar disease affects less than 5% of the body surface area, the quality of life impact for patients with significant palmoplantar pustular or plaque psoriasis is very significant,” Dr. Menter continued. “We’ve worked with our hand surgeons and our foot surgeons to show that the impairment equals that seen in patients with severe rheumatoid arthritis or osteoarthritis of the hands and feet. So it is a huge issue.”
He reported on the 115 UNCOVER-3 participants with palmoplantar involvement. Within 2 weeks after the first 80-mg dose of ixekizumab, recipients had a 60% improvement in their Palmoplantar Psoriasis Area and Severity Index (PPSI) scores.
“It was very dramatic. These are figures that we haven’t seen with methotrexate, with retinoids, or with TNF-alpha blockers,” according to Dr. Menter.
At week 12 in UNCOVER-3, patients randomized to ixekizumab at 80 mg every 2 weeks showed an 85% improvement from baseline in PPSI scores. Those on ixekizumab at 80 mg every 4 weeks had a 78% improvement from baseline, while patients on etanercept at 50 mg twice weekly showed a 52% improvement.
At 60 weeks, PPSI 100 response rates – that is, clear palms and soles – were 60%-70% in the various ixekizumab-treated groups.
“To me, the big issue now is what about palmoplantar pustulosis, a totally different disease, and a disease with equally serious issues for our patients. I’m looking forward to studies in that population. I sincerely hope these new agents such as ixekizumab will have a significant role to play,” he said.
Dr. Menter and Dr. Reich reported receiving research support from and serving as consultants to Eli Lilly, which sponsored the UNCOVER-3 trial and markets ixekizumab, as well as numerous other pharmaceutical companies.
EXPERT ANALYSIS FROM THE EADV CONGRESS
Addressing Patient Concerns About Treatment Safety Data
Latest ixekizumab safety data called ‘very reassuring’
VIENNA – Updated longer-term safety data for ixekizumab in patients with moderate to severe plaque psoriasis continue to show no new safety signals, Alexa B. Kimball, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The safety database now includes 4,213 psoriasis patients on ixekizumab (Taltz) for a total of 7,843 patient-years of regular ongoing follow-up in seven different phase I-III clinical trials. And with a large group of patients now having been on the novel humanized monoclonal antibody targeting interleukin-17A for 2 years and smaller numbers out to 5 years, there have been no surprises, according to Dr. Kimball, professor of dermatology at Harvard Medical School, Boston.
The key trends in the safety analysis are that the number of patients with an adverse event resulting in ixekizumab discontinuation is very low, yet adverse event rates are declining over time.
“This is pretty common in clinical trials,” according to the dermatologist. “In those first 12 weeks of a study you are seeing the patients very frequently, asking them very detailed questions, and we often pick up adverse events more frequently as a result. Upper respiratory infections are a good example: In the first month a patient will remember what happened last week. But if you haven’t seen a patient in 3 months they might not remember that 10 weeks ago they had a little cold. That’s why we tend to see URI rates go down over time. Now, if you see adverse events go up over time – especially for things like malignancy – then there is certainly cause for concern that there’s a cumulative problem with toxicity. That is clearly not a problem with this drug.”
Turning to selected adverse events of interest, Dr. Kimball noted that 2.1% of patients have experienced oral candidiasis while on ixekizumab.
“Oral Candida infection is one of the known side effects with this drug. It doesn’t happen very frequently, and to date, the infections have been very manageable, but it is something you want to have in your mind because it does happen,” she noted.
Serious infections have occurred in 105 patients, 2.5% of those on ixekizumab. Major adverse cardiovascular events have occurred in 1.0%, nonmelanoma skin cancers in 0.7%, and other cancers in 1.1%. Of note, only 5 patients (0.1%) have developed Crohn’s disease, 10 have been diagnosed with ulcerative colitis, and there have been no completed suicides.
The safety follow-up is ongoing.
The safety registry is supported by Eli Lilly, which markets ixekizumab. Dr. Kimball reported receiving research funding from and serving as a consultant to Eli Lilly and numerous other pharmaceutical companies.
VIENNA – Updated longer-term safety data for ixekizumab in patients with moderate to severe plaque psoriasis continue to show no new safety signals, Alexa B. Kimball, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The safety database now includes 4,213 psoriasis patients on ixekizumab (Taltz) for a total of 7,843 patient-years of regular ongoing follow-up in seven different phase I-III clinical trials. And with a large group of patients now having been on the novel humanized monoclonal antibody targeting interleukin-17A for 2 years and smaller numbers out to 5 years, there have been no surprises, according to Dr. Kimball, professor of dermatology at Harvard Medical School, Boston.
The key trends in the safety analysis are that the number of patients with an adverse event resulting in ixekizumab discontinuation is very low, yet adverse event rates are declining over time.
“This is pretty common in clinical trials,” according to the dermatologist. “In those first 12 weeks of a study you are seeing the patients very frequently, asking them very detailed questions, and we often pick up adverse events more frequently as a result. Upper respiratory infections are a good example: In the first month a patient will remember what happened last week. But if you haven’t seen a patient in 3 months they might not remember that 10 weeks ago they had a little cold. That’s why we tend to see URI rates go down over time. Now, if you see adverse events go up over time – especially for things like malignancy – then there is certainly cause for concern that there’s a cumulative problem with toxicity. That is clearly not a problem with this drug.”
Turning to selected adverse events of interest, Dr. Kimball noted that 2.1% of patients have experienced oral candidiasis while on ixekizumab.
“Oral Candida infection is one of the known side effects with this drug. It doesn’t happen very frequently, and to date, the infections have been very manageable, but it is something you want to have in your mind because it does happen,” she noted.
Serious infections have occurred in 105 patients, 2.5% of those on ixekizumab. Major adverse cardiovascular events have occurred in 1.0%, nonmelanoma skin cancers in 0.7%, and other cancers in 1.1%. Of note, only 5 patients (0.1%) have developed Crohn’s disease, 10 have been diagnosed with ulcerative colitis, and there have been no completed suicides.
The safety follow-up is ongoing.
The safety registry is supported by Eli Lilly, which markets ixekizumab. Dr. Kimball reported receiving research funding from and serving as a consultant to Eli Lilly and numerous other pharmaceutical companies.
VIENNA – Updated longer-term safety data for ixekizumab in patients with moderate to severe plaque psoriasis continue to show no new safety signals, Alexa B. Kimball, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The safety database now includes 4,213 psoriasis patients on ixekizumab (Taltz) for a total of 7,843 patient-years of regular ongoing follow-up in seven different phase I-III clinical trials. And with a large group of patients now having been on the novel humanized monoclonal antibody targeting interleukin-17A for 2 years and smaller numbers out to 5 years, there have been no surprises, according to Dr. Kimball, professor of dermatology at Harvard Medical School, Boston.
The key trends in the safety analysis are that the number of patients with an adverse event resulting in ixekizumab discontinuation is very low, yet adverse event rates are declining over time.
“This is pretty common in clinical trials,” according to the dermatologist. “In those first 12 weeks of a study you are seeing the patients very frequently, asking them very detailed questions, and we often pick up adverse events more frequently as a result. Upper respiratory infections are a good example: In the first month a patient will remember what happened last week. But if you haven’t seen a patient in 3 months they might not remember that 10 weeks ago they had a little cold. That’s why we tend to see URI rates go down over time. Now, if you see adverse events go up over time – especially for things like malignancy – then there is certainly cause for concern that there’s a cumulative problem with toxicity. That is clearly not a problem with this drug.”
Turning to selected adverse events of interest, Dr. Kimball noted that 2.1% of patients have experienced oral candidiasis while on ixekizumab.
“Oral Candida infection is one of the known side effects with this drug. It doesn’t happen very frequently, and to date, the infections have been very manageable, but it is something you want to have in your mind because it does happen,” she noted.
Serious infections have occurred in 105 patients, 2.5% of those on ixekizumab. Major adverse cardiovascular events have occurred in 1.0%, nonmelanoma skin cancers in 0.7%, and other cancers in 1.1%. Of note, only 5 patients (0.1%) have developed Crohn’s disease, 10 have been diagnosed with ulcerative colitis, and there have been no completed suicides.
The safety follow-up is ongoing.
The safety registry is supported by Eli Lilly, which markets ixekizumab. Dr. Kimball reported receiving research funding from and serving as a consultant to Eli Lilly and numerous other pharmaceutical companies.
THE EADV CONGRESS
Psoriasis and Internal Disease: Report From the Mount Sinai Winter Symposium
At the 19th Annual Mount Sinai Winter Symposium, Dr. Jashin J. Wu spoke about psoriasis and internal disease. He discussed psoriasis and noncardiovascular comorbidities as well as cardiovascular comorbidities. Dr. Wu also addressed if treating psoriasis can improve cardiovascular disease.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
At the 19th Annual Mount Sinai Winter Symposium, Dr. Jashin J. Wu spoke about psoriasis and internal disease. He discussed psoriasis and noncardiovascular comorbidities as well as cardiovascular comorbidities. Dr. Wu also addressed if treating psoriasis can improve cardiovascular disease.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
At the 19th Annual Mount Sinai Winter Symposium, Dr. Jashin J. Wu spoke about psoriasis and internal disease. He discussed psoriasis and noncardiovascular comorbidities as well as cardiovascular comorbidities. Dr. Wu also addressed if treating psoriasis can improve cardiovascular disease.
