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VIDEO: Biosimilars show promise and progress
LAS VEGAS – There is reason to be optimistic about biosimilars for treating psoriasis, Bruce E. Strober, MD, PhD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
To date, the Food and Drug Administration has approved three biosimilar versions of agents used to treat psoriasis: adalimumab, infliximab, and etanercept.
“The biosimilar development and approval pathway is quite rigorous,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut, Farmington, in a video interview. Although none are yet available, “I can say with high confidence that biosimilar molecules are very comparable,” to the reference molecules, he said.
The impact of biosimilars on the market in the United States in terms of cost and access remains to be seen, Dr, Strober added.
However, “I do believe the science and the clinical trials process and the regulatory process are good,” and that, if clinicians had to use biosimilars for their patients, the patient experience would be safe and effective, he noted.
Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – There is reason to be optimistic about biosimilars for treating psoriasis, Bruce E. Strober, MD, PhD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
To date, the Food and Drug Administration has approved three biosimilar versions of agents used to treat psoriasis: adalimumab, infliximab, and etanercept.
“The biosimilar development and approval pathway is quite rigorous,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut, Farmington, in a video interview. Although none are yet available, “I can say with high confidence that biosimilar molecules are very comparable,” to the reference molecules, he said.
The impact of biosimilars on the market in the United States in terms of cost and access remains to be seen, Dr, Strober added.
However, “I do believe the science and the clinical trials process and the regulatory process are good,” and that, if clinicians had to use biosimilars for their patients, the patient experience would be safe and effective, he noted.
Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – There is reason to be optimistic about biosimilars for treating psoriasis, Bruce E. Strober, MD, PhD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
To date, the Food and Drug Administration has approved three biosimilar versions of agents used to treat psoriasis: adalimumab, infliximab, and etanercept.
“The biosimilar development and approval pathway is quite rigorous,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut, Farmington, in a video interview. Although none are yet available, “I can say with high confidence that biosimilar molecules are very comparable,” to the reference molecules, he said.
The impact of biosimilars on the market in the United States in terms of cost and access remains to be seen, Dr, Strober added.
However, “I do believe the science and the clinical trials process and the regulatory process are good,” and that, if clinicians had to use biosimilars for their patients, the patient experience would be safe and effective, he noted.
Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Optimize anti–TNF-alpha therapy for psoriasis
While anti–tumor necrosis factor (TNF)-alpha medications have shown effectiveness for psoriasis, ongoing issues include optimizing therapy, managing treatment in special populations, and comparing the drugs with newer therapies, according to Dr. Francisco A. Kerdel.
Among the concerns regarding optimizing anti–TNF-alpha therapy are loss of response, continuous versus intermittent dosing, combination therapy, and long-term safety and efficacy, Dr. Kerdel, professor and vice-chair of the department of dermatology, Florida International University, Miami, said in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
However, “no evidence-based guidelines are available for screening and monitoring patients receiving biologic therapy for psoriasis,” Dr. Kerdel noted.
Patient factors that impact the choice and potential response of anti–TNF-alpha therapy include not only physical issues such as weight, disease activity, and comorbidities, but also patient preferences for simpler dosing regimens or a desire to avoid injections, he said.
Despite these issues, there is currently no consensus on and no guidelines for switching treatments after failure with an anti–TNF-alpha agent, he noted.
Other questions associated with anti–TNF-alpha agents in psoriasis include whether the loading dose recommended by most drug labels is necessary, according to Dr. Kerdel. “In practice, many clinicians omit the loading dosage and initiate therapy with maintenance doses,” he said. In addition, “physicians should use clinical judgment when screening and monitoring patients taking biologic agents.”
From a dermatologist perspective, the top unmet therapeutic needs in the treatment of psoriasis were improved efficacy, improved tolerability, improved long-term safety, another oral treatment option, and a new mechanism of action, based on a survey that included 391 dermatologists (J Eur Acad Dermatol Venereol. 2015 Oct;29[10]:2002-10).
As psoriasis treatments evolve, other issues include compiling real-world, postmarketing data on biosimilars; monitoring patients for the emergence of significant adverse events; and searching for biomarkers to help target biologics to specific patients and psoriasis subtypes, Dr. Kerdel added.
SDEF and this news organization are owned by the same parent company.
Dr. Kerdel disclosed being a speaker for AbbVie, Amgen, Celgene, Galderma, and Janssen; conducting research for those 5 companies and for Novartis, Pfizer, and Valeant; he is also on the board of Celgene.
While anti–tumor necrosis factor (TNF)-alpha medications have shown effectiveness for psoriasis, ongoing issues include optimizing therapy, managing treatment in special populations, and comparing the drugs with newer therapies, according to Dr. Francisco A. Kerdel.
Among the concerns regarding optimizing anti–TNF-alpha therapy are loss of response, continuous versus intermittent dosing, combination therapy, and long-term safety and efficacy, Dr. Kerdel, professor and vice-chair of the department of dermatology, Florida International University, Miami, said in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
However, “no evidence-based guidelines are available for screening and monitoring patients receiving biologic therapy for psoriasis,” Dr. Kerdel noted.
Patient factors that impact the choice and potential response of anti–TNF-alpha therapy include not only physical issues such as weight, disease activity, and comorbidities, but also patient preferences for simpler dosing regimens or a desire to avoid injections, he said.
Despite these issues, there is currently no consensus on and no guidelines for switching treatments after failure with an anti–TNF-alpha agent, he noted.
Other questions associated with anti–TNF-alpha agents in psoriasis include whether the loading dose recommended by most drug labels is necessary, according to Dr. Kerdel. “In practice, many clinicians omit the loading dosage and initiate therapy with maintenance doses,” he said. In addition, “physicians should use clinical judgment when screening and monitoring patients taking biologic agents.”
From a dermatologist perspective, the top unmet therapeutic needs in the treatment of psoriasis were improved efficacy, improved tolerability, improved long-term safety, another oral treatment option, and a new mechanism of action, based on a survey that included 391 dermatologists (J Eur Acad Dermatol Venereol. 2015 Oct;29[10]:2002-10).
As psoriasis treatments evolve, other issues include compiling real-world, postmarketing data on biosimilars; monitoring patients for the emergence of significant adverse events; and searching for biomarkers to help target biologics to specific patients and psoriasis subtypes, Dr. Kerdel added.
SDEF and this news organization are owned by the same parent company.
Dr. Kerdel disclosed being a speaker for AbbVie, Amgen, Celgene, Galderma, and Janssen; conducting research for those 5 companies and for Novartis, Pfizer, and Valeant; he is also on the board of Celgene.
While anti–tumor necrosis factor (TNF)-alpha medications have shown effectiveness for psoriasis, ongoing issues include optimizing therapy, managing treatment in special populations, and comparing the drugs with newer therapies, according to Dr. Francisco A. Kerdel.
Among the concerns regarding optimizing anti–TNF-alpha therapy are loss of response, continuous versus intermittent dosing, combination therapy, and long-term safety and efficacy, Dr. Kerdel, professor and vice-chair of the department of dermatology, Florida International University, Miami, said in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
However, “no evidence-based guidelines are available for screening and monitoring patients receiving biologic therapy for psoriasis,” Dr. Kerdel noted.
Patient factors that impact the choice and potential response of anti–TNF-alpha therapy include not only physical issues such as weight, disease activity, and comorbidities, but also patient preferences for simpler dosing regimens or a desire to avoid injections, he said.
Despite these issues, there is currently no consensus on and no guidelines for switching treatments after failure with an anti–TNF-alpha agent, he noted.
Other questions associated with anti–TNF-alpha agents in psoriasis include whether the loading dose recommended by most drug labels is necessary, according to Dr. Kerdel. “In practice, many clinicians omit the loading dosage and initiate therapy with maintenance doses,” he said. In addition, “physicians should use clinical judgment when screening and monitoring patients taking biologic agents.”
From a dermatologist perspective, the top unmet therapeutic needs in the treatment of psoriasis were improved efficacy, improved tolerability, improved long-term safety, another oral treatment option, and a new mechanism of action, based on a survey that included 391 dermatologists (J Eur Acad Dermatol Venereol. 2015 Oct;29[10]:2002-10).
As psoriasis treatments evolve, other issues include compiling real-world, postmarketing data on biosimilars; monitoring patients for the emergence of significant adverse events; and searching for biomarkers to help target biologics to specific patients and psoriasis subtypes, Dr. Kerdel added.
SDEF and this news organization are owned by the same parent company.
Dr. Kerdel disclosed being a speaker for AbbVie, Amgen, Celgene, Galderma, and Janssen; conducting research for those 5 companies and for Novartis, Pfizer, and Valeant; he is also on the board of Celgene.
EXPERT ANALYSIS FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR
VIDEO: IL-23 inhibitors on the upswing
LAS VEGAS – Interleukin-23 (IL-23) inhibitors, currently in the pipeline for treating psoriasis, are showing great promise for the treatment of the disease, Bruce E. Strober, MD, PhD, said in a video interview at the Skin Disease Education Foundation’s Las Vegas Dermatology Seminar.
“There likely will be at least three, if not four, IL-23 inhibitors, all biologics, approved within the next 5 years,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut Health Center, Farmington. “The IL-23 inhibitors are specific, and they seem to be delivering as good or better efficacy than ustekinumab,” with the potential for longer dosing intervals, depending on the patient, he noted.
Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – Interleukin-23 (IL-23) inhibitors, currently in the pipeline for treating psoriasis, are showing great promise for the treatment of the disease, Bruce E. Strober, MD, PhD, said in a video interview at the Skin Disease Education Foundation’s Las Vegas Dermatology Seminar.
“There likely will be at least three, if not four, IL-23 inhibitors, all biologics, approved within the next 5 years,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut Health Center, Farmington. “The IL-23 inhibitors are specific, and they seem to be delivering as good or better efficacy than ustekinumab,” with the potential for longer dosing intervals, depending on the patient, he noted.
Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – Interleukin-23 (IL-23) inhibitors, currently in the pipeline for treating psoriasis, are showing great promise for the treatment of the disease, Bruce E. Strober, MD, PhD, said in a video interview at the Skin Disease Education Foundation’s Las Vegas Dermatology Seminar.
“There likely will be at least three, if not four, IL-23 inhibitors, all biologics, approved within the next 5 years,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut Health Center, Farmington. “The IL-23 inhibitors are specific, and they seem to be delivering as good or better efficacy than ustekinumab,” with the potential for longer dosing intervals, depending on the patient, he noted.
Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
EXPERT ANALYSIS FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR
Include quality of life measures in evaluating treatment success of psoriasis
No matter what the disease, physician judgment of disease severity correlates poorly with the patient’s quality of life, Dr. Joel Gelfand said during a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Patients with similar objective findings have varying health-related quality of life,” said Dr. Gelfand, professor of dermatology at the University of Pennsylvania, Philadelphia.
Dermatologists have several tools to measure quality of life and treatment, with varying levels of validation. For example, the Psoriasis Symptom Inventory measures symptoms including redness, itching, scaling, burning, stinging, cracking, flaking, and pain (J Dermatolog Treat. 2013 Oct;24[5]:356-60).
The Dermatology Life Quality Index (DLQI) is commonly used in clinical trials of psoriasis therapeutics and is frequently used in clinical practice in Europe, Dr. Gelfand said. The DLQI asks about symptoms, feelings, daily activities, leisure time, work/school functioning, and relationships, as well as the treatment itself.
He and his associates used this tool in a study of psoriasis patients seen in routine clinical follow-up in dermatology practices across the United States. The study found that approximately 19% of those who were almost clear (compared with 2% of those who were clear) met DLQI criteria for a treatment change (J Am Acad Dermatol. 2014 Oct;71[4]:633-41). European guidelines, he added, suggest that patients achieving a Psoriasis Area and Severity Index (PASI) score between 50 and 75 and a DLQI greater than 5 should modify their treatment regimens (Arch Dermatol Res. 2011 Jan; 303[1]: 1-10).
Dr. Gelfand described his clinical approach to psoriasis and evaluating quality of life in patients, which involves a global assessment (conducted by a medical assistant) with both a physical and emotional component.
First, patients are asked to think about how severe their physical symptoms of psoriasis have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. Next, patients are asked to think about how severe their psoriasis-related emotional symptoms (such as embarrassment, frustration, depression) have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. The patient’s responses help direct treatment plans.
Another reason to attend to quality of life in psoriasis patients: suicide risk. Suicide risk in psoriasis patients has not been well studied, said Dr. Gelfand, whose PubMed search of “psoriasis and suicide” in September yielded only 48 hits. However, one study of 217 patients who completed the Carroll Rating Scale for Depression showed that almost 10% reported a wish to be dead, and almost 6% reported active thoughts of suicide (Int J Dermatol. 1993 Mar;32[3]:188-90).
Another large study that used data from the National Health Service in England included 119,304 patients with psoriasis and found a high risk for suicide attempts and/or suicide in these patients (J R Soc Med. 2014 Feb 13;107[5]:194-204). High risk also was noted for patients with eczema, diabetes, epilepsy, asthma, and inflammatory joint disease, he said. In addition, the Centers for Disease Control and Prevention’s research on suicide risk factors includes medical conditions such as psoriasis, as well as demographic factors with rates being higher in middle-aged white males.
Dr. Gelfand disclosed serving as an investigator and/or consultant for multiple companies including AbbVie, AstraZeneca, Celgene, Coherus, Eli Lilly, Janssen, Merck, Pfizer, Regeneron, Sanofi, and Valeant.
SDEF and this news organization are owned by the same parent company.
No matter what the disease, physician judgment of disease severity correlates poorly with the patient’s quality of life, Dr. Joel Gelfand said during a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Patients with similar objective findings have varying health-related quality of life,” said Dr. Gelfand, professor of dermatology at the University of Pennsylvania, Philadelphia.
Dermatologists have several tools to measure quality of life and treatment, with varying levels of validation. For example, the Psoriasis Symptom Inventory measures symptoms including redness, itching, scaling, burning, stinging, cracking, flaking, and pain (J Dermatolog Treat. 2013 Oct;24[5]:356-60).
The Dermatology Life Quality Index (DLQI) is commonly used in clinical trials of psoriasis therapeutics and is frequently used in clinical practice in Europe, Dr. Gelfand said. The DLQI asks about symptoms, feelings, daily activities, leisure time, work/school functioning, and relationships, as well as the treatment itself.
He and his associates used this tool in a study of psoriasis patients seen in routine clinical follow-up in dermatology practices across the United States. The study found that approximately 19% of those who were almost clear (compared with 2% of those who were clear) met DLQI criteria for a treatment change (J Am Acad Dermatol. 2014 Oct;71[4]:633-41). European guidelines, he added, suggest that patients achieving a Psoriasis Area and Severity Index (PASI) score between 50 and 75 and a DLQI greater than 5 should modify their treatment regimens (Arch Dermatol Res. 2011 Jan; 303[1]: 1-10).
Dr. Gelfand described his clinical approach to psoriasis and evaluating quality of life in patients, which involves a global assessment (conducted by a medical assistant) with both a physical and emotional component.
First, patients are asked to think about how severe their physical symptoms of psoriasis have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. Next, patients are asked to think about how severe their psoriasis-related emotional symptoms (such as embarrassment, frustration, depression) have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. The patient’s responses help direct treatment plans.
Another reason to attend to quality of life in psoriasis patients: suicide risk. Suicide risk in psoriasis patients has not been well studied, said Dr. Gelfand, whose PubMed search of “psoriasis and suicide” in September yielded only 48 hits. However, one study of 217 patients who completed the Carroll Rating Scale for Depression showed that almost 10% reported a wish to be dead, and almost 6% reported active thoughts of suicide (Int J Dermatol. 1993 Mar;32[3]:188-90).
Another large study that used data from the National Health Service in England included 119,304 patients with psoriasis and found a high risk for suicide attempts and/or suicide in these patients (J R Soc Med. 2014 Feb 13;107[5]:194-204). High risk also was noted for patients with eczema, diabetes, epilepsy, asthma, and inflammatory joint disease, he said. In addition, the Centers for Disease Control and Prevention’s research on suicide risk factors includes medical conditions such as psoriasis, as well as demographic factors with rates being higher in middle-aged white males.
Dr. Gelfand disclosed serving as an investigator and/or consultant for multiple companies including AbbVie, AstraZeneca, Celgene, Coherus, Eli Lilly, Janssen, Merck, Pfizer, Regeneron, Sanofi, and Valeant.
SDEF and this news organization are owned by the same parent company.
No matter what the disease, physician judgment of disease severity correlates poorly with the patient’s quality of life, Dr. Joel Gelfand said during a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Patients with similar objective findings have varying health-related quality of life,” said Dr. Gelfand, professor of dermatology at the University of Pennsylvania, Philadelphia.
Dermatologists have several tools to measure quality of life and treatment, with varying levels of validation. For example, the Psoriasis Symptom Inventory measures symptoms including redness, itching, scaling, burning, stinging, cracking, flaking, and pain (J Dermatolog Treat. 2013 Oct;24[5]:356-60).
The Dermatology Life Quality Index (DLQI) is commonly used in clinical trials of psoriasis therapeutics and is frequently used in clinical practice in Europe, Dr. Gelfand said. The DLQI asks about symptoms, feelings, daily activities, leisure time, work/school functioning, and relationships, as well as the treatment itself.
He and his associates used this tool in a study of psoriasis patients seen in routine clinical follow-up in dermatology practices across the United States. The study found that approximately 19% of those who were almost clear (compared with 2% of those who were clear) met DLQI criteria for a treatment change (J Am Acad Dermatol. 2014 Oct;71[4]:633-41). European guidelines, he added, suggest that patients achieving a Psoriasis Area and Severity Index (PASI) score between 50 and 75 and a DLQI greater than 5 should modify their treatment regimens (Arch Dermatol Res. 2011 Jan; 303[1]: 1-10).
Dr. Gelfand described his clinical approach to psoriasis and evaluating quality of life in patients, which involves a global assessment (conducted by a medical assistant) with both a physical and emotional component.
First, patients are asked to think about how severe their physical symptoms of psoriasis have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. Next, patients are asked to think about how severe their psoriasis-related emotional symptoms (such as embarrassment, frustration, depression) have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. The patient’s responses help direct treatment plans.
Another reason to attend to quality of life in psoriasis patients: suicide risk. Suicide risk in psoriasis patients has not been well studied, said Dr. Gelfand, whose PubMed search of “psoriasis and suicide” in September yielded only 48 hits. However, one study of 217 patients who completed the Carroll Rating Scale for Depression showed that almost 10% reported a wish to be dead, and almost 6% reported active thoughts of suicide (Int J Dermatol. 1993 Mar;32[3]:188-90).
Another large study that used data from the National Health Service in England included 119,304 patients with psoriasis and found a high risk for suicide attempts and/or suicide in these patients (J R Soc Med. 2014 Feb 13;107[5]:194-204). High risk also was noted for patients with eczema, diabetes, epilepsy, asthma, and inflammatory joint disease, he said. In addition, the Centers for Disease Control and Prevention’s research on suicide risk factors includes medical conditions such as psoriasis, as well as demographic factors with rates being higher in middle-aged white males.
Dr. Gelfand disclosed serving as an investigator and/or consultant for multiple companies including AbbVie, AstraZeneca, Celgene, Coherus, Eli Lilly, Janssen, Merck, Pfizer, Regeneron, Sanofi, and Valeant.
SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR
Biologic-naive psoriasis patients get biggest boost with treatment
LAS VEGAS – Biologic-naive psoriasis patients had stronger responses to treatment than those who were previously treated and switched from one biologic to another, according to a systematic review of 15 studies in adults with psoriasis.
In a real-world setting, patients who fail treatment with a tumor necrosis factor–alfa (TNF-alfa) inhibitor or ustekinumab may be switched from one treatment to another, Steven R. Feldman, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., said in a poster presented at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “However, there is conflicting evidence of reduced effectiveness in later lines of treatment,” he added.
In four of the studies, biologic-naive patients showed significantly better responses when given anti-TNF agents than patients who had been treated with a biologic. Another study showed that the reduced effectiveness of adalimumab treatment was associated with the number of previous treatments with anti-TNFs (hazard ratio, 1.63). Another study found an association between previous treatment with etanercept and loss of response and serious adverse effects (HR, 4.32).
The other nine studies suggested some evidence of effectiveness for treatment with anti-TNFs or ustekinumab as later lines of treatment for psoriasis patients, but most of the studies (six of nine) did not include information on whether the results were statistically significant.
“More real-world evidence and future research in studies with large sample sizes are needed to further understand the role of anti-TNF and ustekinumab as later-line treatment in psoriasis management,” Dr. Feldman said.
He disclosed relationships with multiple companies, including study sponsor Novartis; one of the study coauthors is affiliated with Novartis. SDEF and this organization are owned by the same parent company.
LAS VEGAS – Biologic-naive psoriasis patients had stronger responses to treatment than those who were previously treated and switched from one biologic to another, according to a systematic review of 15 studies in adults with psoriasis.
In a real-world setting, patients who fail treatment with a tumor necrosis factor–alfa (TNF-alfa) inhibitor or ustekinumab may be switched from one treatment to another, Steven R. Feldman, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., said in a poster presented at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “However, there is conflicting evidence of reduced effectiveness in later lines of treatment,” he added.
In four of the studies, biologic-naive patients showed significantly better responses when given anti-TNF agents than patients who had been treated with a biologic. Another study showed that the reduced effectiveness of adalimumab treatment was associated with the number of previous treatments with anti-TNFs (hazard ratio, 1.63). Another study found an association between previous treatment with etanercept and loss of response and serious adverse effects (HR, 4.32).
The other nine studies suggested some evidence of effectiveness for treatment with anti-TNFs or ustekinumab as later lines of treatment for psoriasis patients, but most of the studies (six of nine) did not include information on whether the results were statistically significant.
“More real-world evidence and future research in studies with large sample sizes are needed to further understand the role of anti-TNF and ustekinumab as later-line treatment in psoriasis management,” Dr. Feldman said.
He disclosed relationships with multiple companies, including study sponsor Novartis; one of the study coauthors is affiliated with Novartis. SDEF and this organization are owned by the same parent company.
LAS VEGAS – Biologic-naive psoriasis patients had stronger responses to treatment than those who were previously treated and switched from one biologic to another, according to a systematic review of 15 studies in adults with psoriasis.
In a real-world setting, patients who fail treatment with a tumor necrosis factor–alfa (TNF-alfa) inhibitor or ustekinumab may be switched from one treatment to another, Steven R. Feldman, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., said in a poster presented at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “However, there is conflicting evidence of reduced effectiveness in later lines of treatment,” he added.
In four of the studies, biologic-naive patients showed significantly better responses when given anti-TNF agents than patients who had been treated with a biologic. Another study showed that the reduced effectiveness of adalimumab treatment was associated with the number of previous treatments with anti-TNFs (hazard ratio, 1.63). Another study found an association between previous treatment with etanercept and loss of response and serious adverse effects (HR, 4.32).
The other nine studies suggested some evidence of effectiveness for treatment with anti-TNFs or ustekinumab as later lines of treatment for psoriasis patients, but most of the studies (six of nine) did not include information on whether the results were statistically significant.
“More real-world evidence and future research in studies with large sample sizes are needed to further understand the role of anti-TNF and ustekinumab as later-line treatment in psoriasis management,” Dr. Feldman said.
He disclosed relationships with multiple companies, including study sponsor Novartis; one of the study coauthors is affiliated with Novartis. SDEF and this organization are owned by the same parent company.
AT SDEF LAS VEGAS DERMATOLOGY SEMINAR
Key clinical point:
Major finding: Biologic-naive psoriasis patients had stronger responses to treatment than those who were previously treated and switched from one biologic to another.
Data source: A systematic review of 15 observational studies of adults with psoriasis evaluating anti-TNF agents or ustekinumab as second-line or later-line treatments.
Disclosures: Dr. Feldman disclosed relationships with multiple companies, including study sponsor Novartis; one of the study coauthors is affiliated with Novartis.
Study offers reassuring data on certolizumab use in pregnancy
VIENNA – Data from a large prospective registry of pregnancy outcomes in women on certolizumab are reassuring to date, Alexa B. Kimball, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
“This unique dataset of pregnancies exposed to a single agent suggests that exposure is really not a problem, although we’ll continue to collect prospective data and anticipate doing so in women with psoriasis going forward,” said Dr. Kimball, professor of dermatology at Harvard Medical School, Boston.
Certolizumab is a tumor necrosis factor–alpha inhibitor currently approved in the United States for the treatment of Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. It is now in clinical trials for psoriasis, and Dr. Kimball said she expects that it will eventually receive an indication for that disease as well. In the interim, she switches her psoriasis patients who are pregnant or plan to become so to either off-label certolizumab or etanercept (Enbrel). She does the same for her psoriatic arthritis patients, although in that situation certolizumab is on-label therapy.
The reason she turns to etanercept or certolizumab in pregnancy or anticipated pregnancy is that these two biologics, unlike others, don’t cross the placenta in the third trimester.
“I’m concerned about the selective uptake of other monoclonal antibodies in the third trimester. We do see in babies born to moms exposed to these other drugs – like ustekinumab, infliximab, and adalimumab – that the baby’s drug blood levels at birth are higher than the mom’s, so you have potentially put them at some risk for infections unnecessarily and maybe have affected how their immune system develops. So if a woman comes to me who is pregnant and on a biologic agent I would either stop treatment in the second trimester or switch to etanercept or certolizumab,” the dermatologist said.
Of the 256 pregnancies prospectively followed in the UCB certolizumab registry, 80.9% resulted in live births, and 10.2% ended in spontaneous abortion or miscarriage. In addition, the induced abortion rate was 8.6%, and there was a single stillbirth.
Of note, the mean age at pregnancy was 31 years, and 29% of the women became pregnant at age 35 or older. In contrast, the mean age at first pregnancy in the general population is 26, and only about 10% are 35 or older. These data are consistent with Dr. Kimball’s own clinical experience, which is that women with moderate to severe psoriasis or psoriatic arthritis often have trouble conceiving, and if they eventually succeed it’s often at a more advanced age.
The rate of maternal complications in this series was unremarkable: preeclampsia in 3.5%, infection in 3.9%, disease flare in 5.1%, and gestational diabetes in 3.1%. The median gestational age at birth was 39 weeks. The rate of early preterm birth before 32 weeks was 3.5%, with 12.6% of babies arriving at 32-36 weeks. Considering these are older moms being treated for serious underlying systemic inflammatory diseases, these numbers look good, according to Dr. Kimball.
Most women were exposed to certolizumab during the first trimester at least, and many were on the drug throughout pregnancy.
She said about one-third of psoriasis patients experience improvement in their skin diseases during pregnancy.
“If they’re doing really well, I see no reason to keep them on systemic therapy during pregnancy. But I will say that I see a lot of very bad postpartum flares, and I’m quite cautious about that. For the women with psoriatic arthritis there may not be a choice; you may need to continue to treat them all the way through their pregnancy to keep from getting permanent joint destruction,” the dermatologist said.
Dr. Kimball reported receiving research grants from and serving as a consultant to UCB and numerous other pharmaceutical companies.
VIENNA – Data from a large prospective registry of pregnancy outcomes in women on certolizumab are reassuring to date, Alexa B. Kimball, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
“This unique dataset of pregnancies exposed to a single agent suggests that exposure is really not a problem, although we’ll continue to collect prospective data and anticipate doing so in women with psoriasis going forward,” said Dr. Kimball, professor of dermatology at Harvard Medical School, Boston.
Certolizumab is a tumor necrosis factor–alpha inhibitor currently approved in the United States for the treatment of Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. It is now in clinical trials for psoriasis, and Dr. Kimball said she expects that it will eventually receive an indication for that disease as well. In the interim, she switches her psoriasis patients who are pregnant or plan to become so to either off-label certolizumab or etanercept (Enbrel). She does the same for her psoriatic arthritis patients, although in that situation certolizumab is on-label therapy.
The reason she turns to etanercept or certolizumab in pregnancy or anticipated pregnancy is that these two biologics, unlike others, don’t cross the placenta in the third trimester.
“I’m concerned about the selective uptake of other monoclonal antibodies in the third trimester. We do see in babies born to moms exposed to these other drugs – like ustekinumab, infliximab, and adalimumab – that the baby’s drug blood levels at birth are higher than the mom’s, so you have potentially put them at some risk for infections unnecessarily and maybe have affected how their immune system develops. So if a woman comes to me who is pregnant and on a biologic agent I would either stop treatment in the second trimester or switch to etanercept or certolizumab,” the dermatologist said.
Of the 256 pregnancies prospectively followed in the UCB certolizumab registry, 80.9% resulted in live births, and 10.2% ended in spontaneous abortion or miscarriage. In addition, the induced abortion rate was 8.6%, and there was a single stillbirth.
Of note, the mean age at pregnancy was 31 years, and 29% of the women became pregnant at age 35 or older. In contrast, the mean age at first pregnancy in the general population is 26, and only about 10% are 35 or older. These data are consistent with Dr. Kimball’s own clinical experience, which is that women with moderate to severe psoriasis or psoriatic arthritis often have trouble conceiving, and if they eventually succeed it’s often at a more advanced age.
The rate of maternal complications in this series was unremarkable: preeclampsia in 3.5%, infection in 3.9%, disease flare in 5.1%, and gestational diabetes in 3.1%. The median gestational age at birth was 39 weeks. The rate of early preterm birth before 32 weeks was 3.5%, with 12.6% of babies arriving at 32-36 weeks. Considering these are older moms being treated for serious underlying systemic inflammatory diseases, these numbers look good, according to Dr. Kimball.
Most women were exposed to certolizumab during the first trimester at least, and many were on the drug throughout pregnancy.
She said about one-third of psoriasis patients experience improvement in their skin diseases during pregnancy.
“If they’re doing really well, I see no reason to keep them on systemic therapy during pregnancy. But I will say that I see a lot of very bad postpartum flares, and I’m quite cautious about that. For the women with psoriatic arthritis there may not be a choice; you may need to continue to treat them all the way through their pregnancy to keep from getting permanent joint destruction,” the dermatologist said.
Dr. Kimball reported receiving research grants from and serving as a consultant to UCB and numerous other pharmaceutical companies.
VIENNA – Data from a large prospective registry of pregnancy outcomes in women on certolizumab are reassuring to date, Alexa B. Kimball, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
“This unique dataset of pregnancies exposed to a single agent suggests that exposure is really not a problem, although we’ll continue to collect prospective data and anticipate doing so in women with psoriasis going forward,” said Dr. Kimball, professor of dermatology at Harvard Medical School, Boston.
Certolizumab is a tumor necrosis factor–alpha inhibitor currently approved in the United States for the treatment of Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. It is now in clinical trials for psoriasis, and Dr. Kimball said she expects that it will eventually receive an indication for that disease as well. In the interim, she switches her psoriasis patients who are pregnant or plan to become so to either off-label certolizumab or etanercept (Enbrel). She does the same for her psoriatic arthritis patients, although in that situation certolizumab is on-label therapy.
The reason she turns to etanercept or certolizumab in pregnancy or anticipated pregnancy is that these two biologics, unlike others, don’t cross the placenta in the third trimester.
“I’m concerned about the selective uptake of other monoclonal antibodies in the third trimester. We do see in babies born to moms exposed to these other drugs – like ustekinumab, infliximab, and adalimumab – that the baby’s drug blood levels at birth are higher than the mom’s, so you have potentially put them at some risk for infections unnecessarily and maybe have affected how their immune system develops. So if a woman comes to me who is pregnant and on a biologic agent I would either stop treatment in the second trimester or switch to etanercept or certolizumab,” the dermatologist said.
Of the 256 pregnancies prospectively followed in the UCB certolizumab registry, 80.9% resulted in live births, and 10.2% ended in spontaneous abortion or miscarriage. In addition, the induced abortion rate was 8.6%, and there was a single stillbirth.
Of note, the mean age at pregnancy was 31 years, and 29% of the women became pregnant at age 35 or older. In contrast, the mean age at first pregnancy in the general population is 26, and only about 10% are 35 or older. These data are consistent with Dr. Kimball’s own clinical experience, which is that women with moderate to severe psoriasis or psoriatic arthritis often have trouble conceiving, and if they eventually succeed it’s often at a more advanced age.
The rate of maternal complications in this series was unremarkable: preeclampsia in 3.5%, infection in 3.9%, disease flare in 5.1%, and gestational diabetes in 3.1%. The median gestational age at birth was 39 weeks. The rate of early preterm birth before 32 weeks was 3.5%, with 12.6% of babies arriving at 32-36 weeks. Considering these are older moms being treated for serious underlying systemic inflammatory diseases, these numbers look good, according to Dr. Kimball.
Most women were exposed to certolizumab during the first trimester at least, and many were on the drug throughout pregnancy.
She said about one-third of psoriasis patients experience improvement in their skin diseases during pregnancy.
“If they’re doing really well, I see no reason to keep them on systemic therapy during pregnancy. But I will say that I see a lot of very bad postpartum flares, and I’m quite cautious about that. For the women with psoriatic arthritis there may not be a choice; you may need to continue to treat them all the way through their pregnancy to keep from getting permanent joint destruction,” the dermatologist said.
Dr. Kimball reported receiving research grants from and serving as a consultant to UCB and numerous other pharmaceutical companies.
AT THE EADV CONGRESS
Key clinical point:
Major finding: The rate of major congenital malformations in a large prospective series of pregnancies in women on certolizumab was reassuringly low at 4.2%, with no pattern of malformations being seen.
Data source: This was a report on maternal and fetal outcomes of 256 prospectively followed pregnancies in women on certolizumab.
Disclosures: The presenter reported receiving research funds from and serving as a consultant to UCB, which markets certolizumab and maintains the pregnancy registry.
What good are biosimilars if patients won’t use them?
BOSTON – Biosimilar versions of disease-modifying antirheumatic drugs have arrived in the United States, but even the best, most efficacious drugs are worthless if patients don’t want to take them.
“The science is important, the medicine is important, but at the end of the day, acceptance and use is what’s going to measure success,” said Seth D. Ginsberg, at a biosimilars symposium sponsored by Corrona, a business that provides registry data and consulting services to biopharmaceutical companies.
He illustrated the value of biologic agents with this anecdote: “When we got started long, long ago, we used to hold patient events,” he said “and we usually set up for 100. The instructions to meeting planners were right before the event that it was protocol to pull the front 25, the front-right quarter of chairs. Why? To make room for those who can’t walk, to make room for the wheelchairs,” he said.
“Today, if we have one wheelchair at an event, it’s an outlier, and I can’t think of a better way to summarize the impact that biologics have had on our lives,” he said.
Biosimilar confidence
His group has launched “Operation: Biosimilar Confidence” which is designed to educate patients and physicians about the clinical value and scientific underpinnings of biosimilars, as well as the thorough development, review, and regulatory processes involved.
The goal of the project is to instill confidence in patients by helping them to understand the manufacturer’s safety track record, reliability of the biosimilar supply chain, and the availability to them of support services, if they make the switch to a biosimilar.
“Generics don’t have equivalent patient-support programs, and the projection is theoretically that [biosimilar] manufacturers won’t either. We will not accept that. We are going to do everything we can for those patients, to advocate for the continuation of the support programs that we rely on as patients,” he said.
Patient concerns
Surveys of patient concerns about biosimilars have highlighted four key areas:
- What is the manufacturer’s overall safety record in both biologic agents and small-molecule therapies?
- Supply-chain logistic – Will the manufacturer commit to consistent production and supply?
- Will biosimilar manufacturers provide patient support at levels equal to those offered by innovator biologic makers, and what kind of support will be available – phone, websites, social media, copays, etc.?
- Payer ethics – Will payers offer lower copays, deductibles, or premiums, and are payers as concerned as patients about product safety, supply chain, and support?
The implementation strategy for the campaign will focus on speaking directly to patients through CreakyJoints.org, partner Global Healthy Living Foundation, patient and physician organizations, social and conventional media, advertising, and one-on-one encounters.
“We have to talk directly and indirectly to employers and employee-advocacy groups. We have to let these big self-insured employers understand what the perspective of the patient is and what life is like thanks to these medicine, and why biosimilars are a critical component to the success of living with these conditions,” he said.
Advocates also have to work with the media to create “a surround-sound message that reaches all audiences with additional frequency.”
“We cannot allow Wall Street Journal business analysts to dictate the conversations about biosimilars. Why? They’re looking at one thing, and only one thing, and they’re ignoring the patient perspective,” Ginsberg said.
Lastly, patient groups need to work closely with payers, physician groups, and manufacturers to ensure that biosimilars can be smoothly integrated into the healthcare system, he emphasized.
“I want to be crystal clear here: We can’t wait for biosimilars. Bring it on! We want them,” he said.
BOSTON – Biosimilar versions of disease-modifying antirheumatic drugs have arrived in the United States, but even the best, most efficacious drugs are worthless if patients don’t want to take them.
“The science is important, the medicine is important, but at the end of the day, acceptance and use is what’s going to measure success,” said Seth D. Ginsberg, at a biosimilars symposium sponsored by Corrona, a business that provides registry data and consulting services to biopharmaceutical companies.
He illustrated the value of biologic agents with this anecdote: “When we got started long, long ago, we used to hold patient events,” he said “and we usually set up for 100. The instructions to meeting planners were right before the event that it was protocol to pull the front 25, the front-right quarter of chairs. Why? To make room for those who can’t walk, to make room for the wheelchairs,” he said.
“Today, if we have one wheelchair at an event, it’s an outlier, and I can’t think of a better way to summarize the impact that biologics have had on our lives,” he said.
Biosimilar confidence
His group has launched “Operation: Biosimilar Confidence” which is designed to educate patients and physicians about the clinical value and scientific underpinnings of biosimilars, as well as the thorough development, review, and regulatory processes involved.
The goal of the project is to instill confidence in patients by helping them to understand the manufacturer’s safety track record, reliability of the biosimilar supply chain, and the availability to them of support services, if they make the switch to a biosimilar.
“Generics don’t have equivalent patient-support programs, and the projection is theoretically that [biosimilar] manufacturers won’t either. We will not accept that. We are going to do everything we can for those patients, to advocate for the continuation of the support programs that we rely on as patients,” he said.
Patient concerns
Surveys of patient concerns about biosimilars have highlighted four key areas:
- What is the manufacturer’s overall safety record in both biologic agents and small-molecule therapies?
- Supply-chain logistic – Will the manufacturer commit to consistent production and supply?
- Will biosimilar manufacturers provide patient support at levels equal to those offered by innovator biologic makers, and what kind of support will be available – phone, websites, social media, copays, etc.?
- Payer ethics – Will payers offer lower copays, deductibles, or premiums, and are payers as concerned as patients about product safety, supply chain, and support?
The implementation strategy for the campaign will focus on speaking directly to patients through CreakyJoints.org, partner Global Healthy Living Foundation, patient and physician organizations, social and conventional media, advertising, and one-on-one encounters.
“We have to talk directly and indirectly to employers and employee-advocacy groups. We have to let these big self-insured employers understand what the perspective of the patient is and what life is like thanks to these medicine, and why biosimilars are a critical component to the success of living with these conditions,” he said.
Advocates also have to work with the media to create “a surround-sound message that reaches all audiences with additional frequency.”
“We cannot allow Wall Street Journal business analysts to dictate the conversations about biosimilars. Why? They’re looking at one thing, and only one thing, and they’re ignoring the patient perspective,” Ginsberg said.
Lastly, patient groups need to work closely with payers, physician groups, and manufacturers to ensure that biosimilars can be smoothly integrated into the healthcare system, he emphasized.
“I want to be crystal clear here: We can’t wait for biosimilars. Bring it on! We want them,” he said.
BOSTON – Biosimilar versions of disease-modifying antirheumatic drugs have arrived in the United States, but even the best, most efficacious drugs are worthless if patients don’t want to take them.
“The science is important, the medicine is important, but at the end of the day, acceptance and use is what’s going to measure success,” said Seth D. Ginsberg, at a biosimilars symposium sponsored by Corrona, a business that provides registry data and consulting services to biopharmaceutical companies.
He illustrated the value of biologic agents with this anecdote: “When we got started long, long ago, we used to hold patient events,” he said “and we usually set up for 100. The instructions to meeting planners were right before the event that it was protocol to pull the front 25, the front-right quarter of chairs. Why? To make room for those who can’t walk, to make room for the wheelchairs,” he said.
“Today, if we have one wheelchair at an event, it’s an outlier, and I can’t think of a better way to summarize the impact that biologics have had on our lives,” he said.
Biosimilar confidence
His group has launched “Operation: Biosimilar Confidence” which is designed to educate patients and physicians about the clinical value and scientific underpinnings of biosimilars, as well as the thorough development, review, and regulatory processes involved.
The goal of the project is to instill confidence in patients by helping them to understand the manufacturer’s safety track record, reliability of the biosimilar supply chain, and the availability to them of support services, if they make the switch to a biosimilar.
“Generics don’t have equivalent patient-support programs, and the projection is theoretically that [biosimilar] manufacturers won’t either. We will not accept that. We are going to do everything we can for those patients, to advocate for the continuation of the support programs that we rely on as patients,” he said.
Patient concerns
Surveys of patient concerns about biosimilars have highlighted four key areas:
- What is the manufacturer’s overall safety record in both biologic agents and small-molecule therapies?
- Supply-chain logistic – Will the manufacturer commit to consistent production and supply?
- Will biosimilar manufacturers provide patient support at levels equal to those offered by innovator biologic makers, and what kind of support will be available – phone, websites, social media, copays, etc.?
- Payer ethics – Will payers offer lower copays, deductibles, or premiums, and are payers as concerned as patients about product safety, supply chain, and support?
The implementation strategy for the campaign will focus on speaking directly to patients through CreakyJoints.org, partner Global Healthy Living Foundation, patient and physician organizations, social and conventional media, advertising, and one-on-one encounters.
“We have to talk directly and indirectly to employers and employee-advocacy groups. We have to let these big self-insured employers understand what the perspective of the patient is and what life is like thanks to these medicine, and why biosimilars are a critical component to the success of living with these conditions,” he said.
Advocates also have to work with the media to create “a surround-sound message that reaches all audiences with additional frequency.”
“We cannot allow Wall Street Journal business analysts to dictate the conversations about biosimilars. Why? They’re looking at one thing, and only one thing, and they’re ignoring the patient perspective,” Ginsberg said.
Lastly, patient groups need to work closely with payers, physician groups, and manufacturers to ensure that biosimilars can be smoothly integrated into the healthcare system, he emphasized.
“I want to be crystal clear here: We can’t wait for biosimilars. Bring it on! We want them,” he said.
EXPERT ANALYSIS FROM A BIOSIMILARS IN RHEUMATOLOGY SYMPOSIUM
FDA: Etanercept first biologic approved for pediatric psoriasis
Etanercept has been received Food and Drug Administration approval for treating chronic moderate to severe plaque psoriasis in children and adolescents, aged 4-17 years, making this the first biologic and first systemic treatment approved in the United States for pediatric psoriasis.
Etanercept, a tumor necrosis factor blocker marketed as Enbrel, was approved in 1998 for treating moderately to severely active rheumatoid arthritis and has been approved for several other indications since then, including psoriatic arthritis and moderate to severe psoriasis in adults, and polyarticular juvenile idiopathic arthritis in patients aged 2 years and older.
Etanercept has been received Food and Drug Administration approval for treating chronic moderate to severe plaque psoriasis in children and adolescents, aged 4-17 years, making this the first biologic and first systemic treatment approved in the United States for pediatric psoriasis.
Etanercept, a tumor necrosis factor blocker marketed as Enbrel, was approved in 1998 for treating moderately to severely active rheumatoid arthritis and has been approved for several other indications since then, including psoriatic arthritis and moderate to severe psoriasis in adults, and polyarticular juvenile idiopathic arthritis in patients aged 2 years and older.
Etanercept has been received Food and Drug Administration approval for treating chronic moderate to severe plaque psoriasis in children and adolescents, aged 4-17 years, making this the first biologic and first systemic treatment approved in the United States for pediatric psoriasis.
Etanercept, a tumor necrosis factor blocker marketed as Enbrel, was approved in 1998 for treating moderately to severely active rheumatoid arthritis and has been approved for several other indications since then, including psoriatic arthritis and moderate to severe psoriasis in adults, and polyarticular juvenile idiopathic arthritis in patients aged 2 years and older.
Close monitoring of psoriasis patients can delay PsA onset
NEWPORT BEACH, CALIF. – A patient with psoriasis can develop crippling psoriatic arthritis (PsA) within 5 to 10 years of diagnosis, but monitoring patients for signs of trouble can help prevent the onset of PsA, according to Alan Menter, MD.
Even a simple foot examination can make a huge difference, noted Dr. Menter, chief of the division of dermatology and director of the Psoriasis Research Institute at Baylor University Medical Center, Dallas. “At every visit, you and I should be looking for early signs of joint disease,” he said at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar. “We should not let these patients develop any joint disease because we have drugs that can prevent joint destruction.”
Dr. Menter pointed out that PsA is a disease that is distinct from psoriasis. “It’s linked to psoriasis, but genetically, there are differences,” he said, “and immunologically, what goes on in skin is not identical.”
He provided the following pearls regarding diagnosing PsA:
• Be on the lookout for “sausage fingers” and “sausage toes,” both signs of PsA. “You and I are very visual people, and we can see a swollen toe or finger very easily,” Dr. Menter said. “I take the shoes off every psoriasis patient at every visit and run my thumb and index finger down the Achilles. I look for a swollen Achilles – classic enthesitis.” In some cases, swollen big toes in psoriasis patients may be misdiagnosed as gout instead of PsA, he noted.
• Ask patients about how their joints feel when they wake up in the morning: Do they have swelling and tenderness? “That’s an early marker of psoriatic arthritis disease,” Dr. Menter said. In contrast, in a patient with osteoarthritis, “the more they use their joints, the worse it gets.”
• The severity of psoriasis has nothing to do with the severity of PsA. “You can have 50% of the body covered with psoriasis but no arthritis,” he said. “Or you can have someone with one patch of psoriasis on the scalp with devastating joint disease.”
• Be aware that there are five PsA subtypes that can occur in combination with each other:
1. Dactylitis. This is the form that causes the “sausage digit.”
2. Asymmetric oligoarthritis. This is the type most commonly seen on presentation, when there are few joints affected.
3. Symmetric arthritis. This form is more common in females and difficult to differentiate from rheumatoid arthritis.
4. Distal interphalangeal joint arthritis. This type is often linked to dactylitis and nail dystrophy.
5. Arthritis mutilans. This is more common in females, linked to long disease duration, and present in an estimated 5% of cases.
Dr. Menter suggested that dermatologists refer suspected cases of PsA to a rheumatologist. Since patients may have to wait 6-10 weeks for an appointment, he recommended that dermatologists consider NSAIDs, such as the over-the-counter naproxen and prescription meloxicam and celecoxib in the meantime. Dermatologists may also consider bringing up the use of methotrexate and biologics, he said.
Dr. Menter disclosed relationships with multiple pharmaceutical companies, including AbbVie, Allergan, Amgen, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by Frontline Medical Communications.
NEWPORT BEACH, CALIF. – A patient with psoriasis can develop crippling psoriatic arthritis (PsA) within 5 to 10 years of diagnosis, but monitoring patients for signs of trouble can help prevent the onset of PsA, according to Alan Menter, MD.
Even a simple foot examination can make a huge difference, noted Dr. Menter, chief of the division of dermatology and director of the Psoriasis Research Institute at Baylor University Medical Center, Dallas. “At every visit, you and I should be looking for early signs of joint disease,” he said at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar. “We should not let these patients develop any joint disease because we have drugs that can prevent joint destruction.”
Dr. Menter pointed out that PsA is a disease that is distinct from psoriasis. “It’s linked to psoriasis, but genetically, there are differences,” he said, “and immunologically, what goes on in skin is not identical.”
He provided the following pearls regarding diagnosing PsA:
• Be on the lookout for “sausage fingers” and “sausage toes,” both signs of PsA. “You and I are very visual people, and we can see a swollen toe or finger very easily,” Dr. Menter said. “I take the shoes off every psoriasis patient at every visit and run my thumb and index finger down the Achilles. I look for a swollen Achilles – classic enthesitis.” In some cases, swollen big toes in psoriasis patients may be misdiagnosed as gout instead of PsA, he noted.
• Ask patients about how their joints feel when they wake up in the morning: Do they have swelling and tenderness? “That’s an early marker of psoriatic arthritis disease,” Dr. Menter said. In contrast, in a patient with osteoarthritis, “the more they use their joints, the worse it gets.”
• The severity of psoriasis has nothing to do with the severity of PsA. “You can have 50% of the body covered with psoriasis but no arthritis,” he said. “Or you can have someone with one patch of psoriasis on the scalp with devastating joint disease.”
• Be aware that there are five PsA subtypes that can occur in combination with each other:
1. Dactylitis. This is the form that causes the “sausage digit.”
2. Asymmetric oligoarthritis. This is the type most commonly seen on presentation, when there are few joints affected.
3. Symmetric arthritis. This form is more common in females and difficult to differentiate from rheumatoid arthritis.
4. Distal interphalangeal joint arthritis. This type is often linked to dactylitis and nail dystrophy.
5. Arthritis mutilans. This is more common in females, linked to long disease duration, and present in an estimated 5% of cases.
Dr. Menter suggested that dermatologists refer suspected cases of PsA to a rheumatologist. Since patients may have to wait 6-10 weeks for an appointment, he recommended that dermatologists consider NSAIDs, such as the over-the-counter naproxen and prescription meloxicam and celecoxib in the meantime. Dermatologists may also consider bringing up the use of methotrexate and biologics, he said.
Dr. Menter disclosed relationships with multiple pharmaceutical companies, including AbbVie, Allergan, Amgen, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by Frontline Medical Communications.
NEWPORT BEACH, CALIF. – A patient with psoriasis can develop crippling psoriatic arthritis (PsA) within 5 to 10 years of diagnosis, but monitoring patients for signs of trouble can help prevent the onset of PsA, according to Alan Menter, MD.
Even a simple foot examination can make a huge difference, noted Dr. Menter, chief of the division of dermatology and director of the Psoriasis Research Institute at Baylor University Medical Center, Dallas. “At every visit, you and I should be looking for early signs of joint disease,” he said at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar. “We should not let these patients develop any joint disease because we have drugs that can prevent joint destruction.”
Dr. Menter pointed out that PsA is a disease that is distinct from psoriasis. “It’s linked to psoriasis, but genetically, there are differences,” he said, “and immunologically, what goes on in skin is not identical.”
He provided the following pearls regarding diagnosing PsA:
• Be on the lookout for “sausage fingers” and “sausage toes,” both signs of PsA. “You and I are very visual people, and we can see a swollen toe or finger very easily,” Dr. Menter said. “I take the shoes off every psoriasis patient at every visit and run my thumb and index finger down the Achilles. I look for a swollen Achilles – classic enthesitis.” In some cases, swollen big toes in psoriasis patients may be misdiagnosed as gout instead of PsA, he noted.
• Ask patients about how their joints feel when they wake up in the morning: Do they have swelling and tenderness? “That’s an early marker of psoriatic arthritis disease,” Dr. Menter said. In contrast, in a patient with osteoarthritis, “the more they use their joints, the worse it gets.”
• The severity of psoriasis has nothing to do with the severity of PsA. “You can have 50% of the body covered with psoriasis but no arthritis,” he said. “Or you can have someone with one patch of psoriasis on the scalp with devastating joint disease.”
• Be aware that there are five PsA subtypes that can occur in combination with each other:
1. Dactylitis. This is the form that causes the “sausage digit.”
2. Asymmetric oligoarthritis. This is the type most commonly seen on presentation, when there are few joints affected.
3. Symmetric arthritis. This form is more common in females and difficult to differentiate from rheumatoid arthritis.
4. Distal interphalangeal joint arthritis. This type is often linked to dactylitis and nail dystrophy.
5. Arthritis mutilans. This is more common in females, linked to long disease duration, and present in an estimated 5% of cases.
Dr. Menter suggested that dermatologists refer suspected cases of PsA to a rheumatologist. Since patients may have to wait 6-10 weeks for an appointment, he recommended that dermatologists consider NSAIDs, such as the over-the-counter naproxen and prescription meloxicam and celecoxib in the meantime. Dermatologists may also consider bringing up the use of methotrexate and biologics, he said.
Dr. Menter disclosed relationships with multiple pharmaceutical companies, including AbbVie, Allergan, Amgen, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by Frontline Medical Communications.
EXPERT ANALYSIS FROM SDEF WOMEN'S & PEDIATRIC DERMATOLOGY SEMINAR
PsA bone loss measurement: A surrogate for radiographic progression?
An advanced computer assisted digital x-ray radiogrammetry technique that measures bone thickness has the potential to be a surrogate marker of radiographic progression in psoriatic arthritis, according to a report in Arthritis Research & Therapy.
The method uses software called BoneXpert to sensitively differentiate between the different stages of disease manifestation affecting bone integrity. Digital x-ray radiogrammetry (DXR) with BoneXpert has a clinical advantage over standard techniques such as radiographs through its ability to be integrated into a picture archiving and communication system that allows direct image analysis and quantification of bone loss, according to the study authors, led by Alexander Pfeil, MD, of Jena (Germany) University Hospital – Friedrich Schiller University.
The researchers used the computer-assisted diagnosis software to measure the metacarpal index (MCI) and its cortical thickness score (MCI T-score) in the metacarpal bones of 104 psoriatic arthritis (PsA) patients who fulfilled the CASPAR criteria. All patients were treated either with nonsteroidal anti-inflammatory drugs or disease-modifying antirheumatic drugs (Arthritis Res Ther. 2016;18:248. doi: 10.1186/s13075-016-1145-4).
In the total PsA cohort, the MCI T-score showed a significantly reduced negative value of –1.289. “The reduced MCI T-score was clearly associated with a reduced bone mineral density of the metacarpal bones in PsA,” the investigators wrote.
For all scores, the researchers found a severity-dependent reduction for the BoneXpert parameters of MCI, MCI T-score, T, and Bone Health Index.
The strongest reductions were seen for MCI and T using the Proliferation Score (MCI: –28.3%; T: –31.9%) and the Destruction Score (MCI: –30.8%; T: –30.9%) of the Psoriatic Arthritis Ratingen Score.
A reduced MCI and T-score was directly associated with cortical thinning and the periarticular demineralization of the metacarpal bones, and highlighted a direct association with bone destruction and bone proliferation in PsA, the investigators said.
“The measurement of periarticular bone loss can be considered a complementary approach to verify PsA-related bony changes and a surrogate marker for PsA progression,” the researchers suggested.
The technique’s high reproducibility can also be used to optimize an appropriate individual therapeutic strategy, they added.
The study had no specific funding source, and the authors declared no conflicts of interest.
An advanced computer assisted digital x-ray radiogrammetry technique that measures bone thickness has the potential to be a surrogate marker of radiographic progression in psoriatic arthritis, according to a report in Arthritis Research & Therapy.
The method uses software called BoneXpert to sensitively differentiate between the different stages of disease manifestation affecting bone integrity. Digital x-ray radiogrammetry (DXR) with BoneXpert has a clinical advantage over standard techniques such as radiographs through its ability to be integrated into a picture archiving and communication system that allows direct image analysis and quantification of bone loss, according to the study authors, led by Alexander Pfeil, MD, of Jena (Germany) University Hospital – Friedrich Schiller University.
The researchers used the computer-assisted diagnosis software to measure the metacarpal index (MCI) and its cortical thickness score (MCI T-score) in the metacarpal bones of 104 psoriatic arthritis (PsA) patients who fulfilled the CASPAR criteria. All patients were treated either with nonsteroidal anti-inflammatory drugs or disease-modifying antirheumatic drugs (Arthritis Res Ther. 2016;18:248. doi: 10.1186/s13075-016-1145-4).
In the total PsA cohort, the MCI T-score showed a significantly reduced negative value of –1.289. “The reduced MCI T-score was clearly associated with a reduced bone mineral density of the metacarpal bones in PsA,” the investigators wrote.
For all scores, the researchers found a severity-dependent reduction for the BoneXpert parameters of MCI, MCI T-score, T, and Bone Health Index.
The strongest reductions were seen for MCI and T using the Proliferation Score (MCI: –28.3%; T: –31.9%) and the Destruction Score (MCI: –30.8%; T: –30.9%) of the Psoriatic Arthritis Ratingen Score.
A reduced MCI and T-score was directly associated with cortical thinning and the periarticular demineralization of the metacarpal bones, and highlighted a direct association with bone destruction and bone proliferation in PsA, the investigators said.
“The measurement of periarticular bone loss can be considered a complementary approach to verify PsA-related bony changes and a surrogate marker for PsA progression,” the researchers suggested.
The technique’s high reproducibility can also be used to optimize an appropriate individual therapeutic strategy, they added.
The study had no specific funding source, and the authors declared no conflicts of interest.
An advanced computer assisted digital x-ray radiogrammetry technique that measures bone thickness has the potential to be a surrogate marker of radiographic progression in psoriatic arthritis, according to a report in Arthritis Research & Therapy.
The method uses software called BoneXpert to sensitively differentiate between the different stages of disease manifestation affecting bone integrity. Digital x-ray radiogrammetry (DXR) with BoneXpert has a clinical advantage over standard techniques such as radiographs through its ability to be integrated into a picture archiving and communication system that allows direct image analysis and quantification of bone loss, according to the study authors, led by Alexander Pfeil, MD, of Jena (Germany) University Hospital – Friedrich Schiller University.
The researchers used the computer-assisted diagnosis software to measure the metacarpal index (MCI) and its cortical thickness score (MCI T-score) in the metacarpal bones of 104 psoriatic arthritis (PsA) patients who fulfilled the CASPAR criteria. All patients were treated either with nonsteroidal anti-inflammatory drugs or disease-modifying antirheumatic drugs (Arthritis Res Ther. 2016;18:248. doi: 10.1186/s13075-016-1145-4).
In the total PsA cohort, the MCI T-score showed a significantly reduced negative value of –1.289. “The reduced MCI T-score was clearly associated with a reduced bone mineral density of the metacarpal bones in PsA,” the investigators wrote.
For all scores, the researchers found a severity-dependent reduction for the BoneXpert parameters of MCI, MCI T-score, T, and Bone Health Index.
The strongest reductions were seen for MCI and T using the Proliferation Score (MCI: –28.3%; T: –31.9%) and the Destruction Score (MCI: –30.8%; T: –30.9%) of the Psoriatic Arthritis Ratingen Score.
A reduced MCI and T-score was directly associated with cortical thinning and the periarticular demineralization of the metacarpal bones, and highlighted a direct association with bone destruction and bone proliferation in PsA, the investigators said.
“The measurement of periarticular bone loss can be considered a complementary approach to verify PsA-related bony changes and a surrogate marker for PsA progression,” the researchers suggested.
The technique’s high reproducibility can also be used to optimize an appropriate individual therapeutic strategy, they added.
The study had no specific funding source, and the authors declared no conflicts of interest.
FROM ARTHRITIS RESEARCH & THERAPY
Key clinical point:
Main finding: In the total PsA cohort, the MCI T-score showed a significantly reduced negative value of –1.289.
Data source: A cohort of 104 PsA patients fulfilling the CASPAR criteria who were taking nonsteroidal inflammatory drugs or disease-modifying antirheumatic drugs.
Disclosures: The study had no specific funding source, and the authors declared no conflicts of interest.