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Unmet Needs in Psoriasis
The concept of unmet needs in psoriasis is not new. We are aware that both patients and physicians feel there are gaps in the management and treatment of the condition. Lebwohl et al (J Am Acad Dermatol. 2014;70:871-881) performed an extensive survey to further the understanding of the unmet needs of psoriasis and psoriatic arthritis (PsA) patients. The survey was a large, multinational, population-based analysis of psoriasis and/or PsA patients in North America and Europe. In terms of methodology, surveyed individuals were selected by list-assisted random digit dialing and did not have to currently be under the care of a health care provider, a patient organization member, or receiving treatment. Overall, the survey screened 139,948 households, and 3426 patients completed the survey.
The population prevalence of psoriasis and/or PsA ranged from 1.4% in Spain to 3.3% in Canada, with an overall prevalence of 1.9%. Seventy-nine percent of patients had psoriasis alone, while 21% experienced PsA with or without psoriasis.
When rating disease severity at its worst, 27% of those with psoriasis and 53% with psoriasis and/or PsA rated it as severe. Itching (43%), scales (23%), and flaking (20%) were considered the most bothersome signs or symptoms by psoriasis patients, and 45% of them had not seen a physician in 1 year. More than 80% of psoriasis patients with at least 4 palms body surface area and 59% of the PsA cohort were receiving no treatment or only topical treatment. Of patients who had received oral or biologic therapy, 57% and 45%, respectively, discontinued therapy, most often for safety or tolerability reasons and a lack or loss of efficacy.
The authors concluded that the following identified unmet needs warrant additional attention and action: improved severity assessment, PsA screening, patient awareness, and treatment options. They noted that their findings suggest there is a high rate of undertreatment of both psoriasis and PsA and a mismatch between patient and physician assessment of severity.
What’s the issue?
Again we are faced with data suggesting that our patients perceive deficiencies in their psoriasis care. Therefore, it is important that we continue to educate our patients and ourselves so that we can narrow these gaps. How will you react to these findings in your management of psoriasis?
The concept of unmet needs in psoriasis is not new. We are aware that both patients and physicians feel there are gaps in the management and treatment of the condition. Lebwohl et al (J Am Acad Dermatol. 2014;70:871-881) performed an extensive survey to further the understanding of the unmet needs of psoriasis and psoriatic arthritis (PsA) patients. The survey was a large, multinational, population-based analysis of psoriasis and/or PsA patients in North America and Europe. In terms of methodology, surveyed individuals were selected by list-assisted random digit dialing and did not have to currently be under the care of a health care provider, a patient organization member, or receiving treatment. Overall, the survey screened 139,948 households, and 3426 patients completed the survey.
The population prevalence of psoriasis and/or PsA ranged from 1.4% in Spain to 3.3% in Canada, with an overall prevalence of 1.9%. Seventy-nine percent of patients had psoriasis alone, while 21% experienced PsA with or without psoriasis.
When rating disease severity at its worst, 27% of those with psoriasis and 53% with psoriasis and/or PsA rated it as severe. Itching (43%), scales (23%), and flaking (20%) were considered the most bothersome signs or symptoms by psoriasis patients, and 45% of them had not seen a physician in 1 year. More than 80% of psoriasis patients with at least 4 palms body surface area and 59% of the PsA cohort were receiving no treatment or only topical treatment. Of patients who had received oral or biologic therapy, 57% and 45%, respectively, discontinued therapy, most often for safety or tolerability reasons and a lack or loss of efficacy.
The authors concluded that the following identified unmet needs warrant additional attention and action: improved severity assessment, PsA screening, patient awareness, and treatment options. They noted that their findings suggest there is a high rate of undertreatment of both psoriasis and PsA and a mismatch between patient and physician assessment of severity.
What’s the issue?
Again we are faced with data suggesting that our patients perceive deficiencies in their psoriasis care. Therefore, it is important that we continue to educate our patients and ourselves so that we can narrow these gaps. How will you react to these findings in your management of psoriasis?
The concept of unmet needs in psoriasis is not new. We are aware that both patients and physicians feel there are gaps in the management and treatment of the condition. Lebwohl et al (J Am Acad Dermatol. 2014;70:871-881) performed an extensive survey to further the understanding of the unmet needs of psoriasis and psoriatic arthritis (PsA) patients. The survey was a large, multinational, population-based analysis of psoriasis and/or PsA patients in North America and Europe. In terms of methodology, surveyed individuals were selected by list-assisted random digit dialing and did not have to currently be under the care of a health care provider, a patient organization member, or receiving treatment. Overall, the survey screened 139,948 households, and 3426 patients completed the survey.
The population prevalence of psoriasis and/or PsA ranged from 1.4% in Spain to 3.3% in Canada, with an overall prevalence of 1.9%. Seventy-nine percent of patients had psoriasis alone, while 21% experienced PsA with or without psoriasis.
When rating disease severity at its worst, 27% of those with psoriasis and 53% with psoriasis and/or PsA rated it as severe. Itching (43%), scales (23%), and flaking (20%) were considered the most bothersome signs or symptoms by psoriasis patients, and 45% of them had not seen a physician in 1 year. More than 80% of psoriasis patients with at least 4 palms body surface area and 59% of the PsA cohort were receiving no treatment or only topical treatment. Of patients who had received oral or biologic therapy, 57% and 45%, respectively, discontinued therapy, most often for safety or tolerability reasons and a lack or loss of efficacy.
The authors concluded that the following identified unmet needs warrant additional attention and action: improved severity assessment, PsA screening, patient awareness, and treatment options. They noted that their findings suggest there is a high rate of undertreatment of both psoriasis and PsA and a mismatch between patient and physician assessment of severity.
What’s the issue?
Again we are faced with data suggesting that our patients perceive deficiencies in their psoriasis care. Therefore, it is important that we continue to educate our patients and ourselves so that we can narrow these gaps. How will you react to these findings in your management of psoriasis?
The Impact of Diet and Exercise in Psoriasis
It is well established that increased body mass index and weight gain are risk factors for psoriasis, and the prevalence of obesity in patients with psoriasis is higher than in the general population. However, there are limited data concerning the role of diet and exercise in psoriasis.
Naldi et al (Br J Dermatol. 2014;170:634-642) assessed the impact of dietary intervention in combination with physical exercise for weight loss on improving psoriasis in overweight or obese individuals. The investigators evaluated 303 overweight or obese patients with moderate to severe chronic plaque psoriasis who did not achieve clearance after 4 weeks of continuous systemic treatment. Patients were randomized to 2 regimens: a 20-week quantitative and qualitative dietary plan associated with physical exercise for weight loss, or simple informative counseling at baseline about the utility of weight loss for clinical control of psoriatic disease. The main outcome was any reduction of the psoriasis area and severity index (PASI) from baseline to week 20.
Analysis of the intention-to-treat population showed a median reduction in the PASI score of 48% (95% confidence interval, 33.3%-58.3%) in the diet arm and 25.5% (95% confidence interval, 18.2%-33.3%) in the counseling arm (P=.02). The weight-loss target (a ≥5% reduction from baseline) was reached by 29.8% of patients in the diet arm compared to 14.5% in the counseling arm (P=.001).
The authors concluded that a 20-week dietetic intervention associated with increased physical exercise reduced psoriasis severity in systemically treated overweight or obese patients with active psoriasis.
What’s the issue?
As we would expect, a direct dietary intervention had a great impact on the study population. Will you try to adopt a structured dietary intervention in your patient population?
It is well established that increased body mass index and weight gain are risk factors for psoriasis, and the prevalence of obesity in patients with psoriasis is higher than in the general population. However, there are limited data concerning the role of diet and exercise in psoriasis.
Naldi et al (Br J Dermatol. 2014;170:634-642) assessed the impact of dietary intervention in combination with physical exercise for weight loss on improving psoriasis in overweight or obese individuals. The investigators evaluated 303 overweight or obese patients with moderate to severe chronic plaque psoriasis who did not achieve clearance after 4 weeks of continuous systemic treatment. Patients were randomized to 2 regimens: a 20-week quantitative and qualitative dietary plan associated with physical exercise for weight loss, or simple informative counseling at baseline about the utility of weight loss for clinical control of psoriatic disease. The main outcome was any reduction of the psoriasis area and severity index (PASI) from baseline to week 20.
Analysis of the intention-to-treat population showed a median reduction in the PASI score of 48% (95% confidence interval, 33.3%-58.3%) in the diet arm and 25.5% (95% confidence interval, 18.2%-33.3%) in the counseling arm (P=.02). The weight-loss target (a ≥5% reduction from baseline) was reached by 29.8% of patients in the diet arm compared to 14.5% in the counseling arm (P=.001).
The authors concluded that a 20-week dietetic intervention associated with increased physical exercise reduced psoriasis severity in systemically treated overweight or obese patients with active psoriasis.
What’s the issue?
As we would expect, a direct dietary intervention had a great impact on the study population. Will you try to adopt a structured dietary intervention in your patient population?
It is well established that increased body mass index and weight gain are risk factors for psoriasis, and the prevalence of obesity in patients with psoriasis is higher than in the general population. However, there are limited data concerning the role of diet and exercise in psoriasis.
Naldi et al (Br J Dermatol. 2014;170:634-642) assessed the impact of dietary intervention in combination with physical exercise for weight loss on improving psoriasis in overweight or obese individuals. The investigators evaluated 303 overweight or obese patients with moderate to severe chronic plaque psoriasis who did not achieve clearance after 4 weeks of continuous systemic treatment. Patients were randomized to 2 regimens: a 20-week quantitative and qualitative dietary plan associated with physical exercise for weight loss, or simple informative counseling at baseline about the utility of weight loss for clinical control of psoriatic disease. The main outcome was any reduction of the psoriasis area and severity index (PASI) from baseline to week 20.
Analysis of the intention-to-treat population showed a median reduction in the PASI score of 48% (95% confidence interval, 33.3%-58.3%) in the diet arm and 25.5% (95% confidence interval, 18.2%-33.3%) in the counseling arm (P=.02). The weight-loss target (a ≥5% reduction from baseline) was reached by 29.8% of patients in the diet arm compared to 14.5% in the counseling arm (P=.001).
The authors concluded that a 20-week dietetic intervention associated with increased physical exercise reduced psoriasis severity in systemically treated overweight or obese patients with active psoriasis.
What’s the issue?
As we would expect, a direct dietary intervention had a great impact on the study population. Will you try to adopt a structured dietary intervention in your patient population?
Comorbidities: The List Grows
There is a growing amount of literature demonstrating that psoriasis is a chronic and debilitating inflammatory disease associated with serious comorbidities. Emerging comorbidities of psoriasis include cardiovascular disease and metabolic syndrome. Psoriasis patients have an increased prevalence of the core components of metabolic syndrome, including obesity, dyslipidemia, and insulin resistance.
According to van der Voort et al (J Am Acad Dermatol. 2014;70:517-524), prior case-controlled studies observed an increased prevalence of nonalcoholic fatty liver disease (NAFLD) in patients with psoriasis, which they noted as a relevant factor in selecting optimal psoriasis treatment. Their study sought to compare the prevalence of NAFLD in participants with psoriasis and those without psoriasis. They conducted a large prospective population-based cohort study that enrolled elderly participants (>55 years). Nonalcoholic fatty liver disease was diagnosed as fatty liver on ultrasonography in the absence of other liver diseases. A multivariable logistic regression model was used to assess if psoriasis was associated with NAFLD after adjusting for demographic and lifestyle characteristics as well as laboratory findings.
In total, 2292 participants were included in the study; 118 (5.1%) participants had psoriasis. The prevalence of NAFLD was 46.2% in participants with psoriasis compared to 33.3% in those without psoriasis (P=.005); psoriasis was significantly associated with NAFLD. After the authors adjusted for alcohol consumption, pack-years and smoking status, presence of metabolic syndrome, and alanine aminotransferase levels, psoriasis remained a significant predictor of NAFLD (adjusted odds ratio, 1.7; 95% confidence interval, 1.1-2.6). The authors concluded that elderly participants with psoriasis were 70% more likely to have NAFLD than those without psoriasis independent of common NAFLD risk factors.
What’s the issue?
This study gives us a new comorbidity to be aware of and monitor. In considering therapy in this population, it also is important to consider the risk for NAFLD when selecting treatments that may have hepatic toxicity or are metabolized by the liver. How will this study change your approach to patients with psoriasis?
There is a growing amount of literature demonstrating that psoriasis is a chronic and debilitating inflammatory disease associated with serious comorbidities. Emerging comorbidities of psoriasis include cardiovascular disease and metabolic syndrome. Psoriasis patients have an increased prevalence of the core components of metabolic syndrome, including obesity, dyslipidemia, and insulin resistance.
According to van der Voort et al (J Am Acad Dermatol. 2014;70:517-524), prior case-controlled studies observed an increased prevalence of nonalcoholic fatty liver disease (NAFLD) in patients with psoriasis, which they noted as a relevant factor in selecting optimal psoriasis treatment. Their study sought to compare the prevalence of NAFLD in participants with psoriasis and those without psoriasis. They conducted a large prospective population-based cohort study that enrolled elderly participants (>55 years). Nonalcoholic fatty liver disease was diagnosed as fatty liver on ultrasonography in the absence of other liver diseases. A multivariable logistic regression model was used to assess if psoriasis was associated with NAFLD after adjusting for demographic and lifestyle characteristics as well as laboratory findings.
In total, 2292 participants were included in the study; 118 (5.1%) participants had psoriasis. The prevalence of NAFLD was 46.2% in participants with psoriasis compared to 33.3% in those without psoriasis (P=.005); psoriasis was significantly associated with NAFLD. After the authors adjusted for alcohol consumption, pack-years and smoking status, presence of metabolic syndrome, and alanine aminotransferase levels, psoriasis remained a significant predictor of NAFLD (adjusted odds ratio, 1.7; 95% confidence interval, 1.1-2.6). The authors concluded that elderly participants with psoriasis were 70% more likely to have NAFLD than those without psoriasis independent of common NAFLD risk factors.
What’s the issue?
This study gives us a new comorbidity to be aware of and monitor. In considering therapy in this population, it also is important to consider the risk for NAFLD when selecting treatments that may have hepatic toxicity or are metabolized by the liver. How will this study change your approach to patients with psoriasis?
There is a growing amount of literature demonstrating that psoriasis is a chronic and debilitating inflammatory disease associated with serious comorbidities. Emerging comorbidities of psoriasis include cardiovascular disease and metabolic syndrome. Psoriasis patients have an increased prevalence of the core components of metabolic syndrome, including obesity, dyslipidemia, and insulin resistance.
According to van der Voort et al (J Am Acad Dermatol. 2014;70:517-524), prior case-controlled studies observed an increased prevalence of nonalcoholic fatty liver disease (NAFLD) in patients with psoriasis, which they noted as a relevant factor in selecting optimal psoriasis treatment. Their study sought to compare the prevalence of NAFLD in participants with psoriasis and those without psoriasis. They conducted a large prospective population-based cohort study that enrolled elderly participants (>55 years). Nonalcoholic fatty liver disease was diagnosed as fatty liver on ultrasonography in the absence of other liver diseases. A multivariable logistic regression model was used to assess if psoriasis was associated with NAFLD after adjusting for demographic and lifestyle characteristics as well as laboratory findings.
In total, 2292 participants were included in the study; 118 (5.1%) participants had psoriasis. The prevalence of NAFLD was 46.2% in participants with psoriasis compared to 33.3% in those without psoriasis (P=.005); psoriasis was significantly associated with NAFLD. After the authors adjusted for alcohol consumption, pack-years and smoking status, presence of metabolic syndrome, and alanine aminotransferase levels, psoriasis remained a significant predictor of NAFLD (adjusted odds ratio, 1.7; 95% confidence interval, 1.1-2.6). The authors concluded that elderly participants with psoriasis were 70% more likely to have NAFLD than those without psoriasis independent of common NAFLD risk factors.
What’s the issue?
This study gives us a new comorbidity to be aware of and monitor. In considering therapy in this population, it also is important to consider the risk for NAFLD when selecting treatments that may have hepatic toxicity or are metabolized by the liver. How will this study change your approach to patients with psoriasis?
Biosimilar Dilemma
The passage of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) allowed for the creation of a regulatory pathway for new, safe, and effective biosimilar agents. Although the medical community always needs new and affordable treatments, patients and physicians are aware of and concerned about the risks associated with biologics and the lack of long-term safety data for new treatments.
In contrast to generic drugs, which are chemically identical to their branded counterparts, biosimilar agents are not chemically identical to their branded biologic counterparts because as large complex molecules derived from living cells using recombinant DNA technology, biologics can never be exactly replicated due to their inherent variability.
Because of these substantial differences, the National Psoriasis Foundation released a policy in July 2013 to ensure patient safety.
The National Psoriasis Foundation recommends that the patient-provider relationship remain at the center of all treatment planning and supports a prohibition on biosimilar substitution unless all of the following minimal thresholds are met:
- the biosimilar has been designated by the Food and Drug Administration as interchangeable with the prescribed biologic for the specified indicated use;
- the biosimilar has a unique nonproprietary name to eliminate confusion, to allow providers to accurately track the therapeutic agent in a patient's permanent record, and to allow for the collection of adverse event information;
- the biosimilar product follows the same route of administration and dosage form as the reference product;
- the pharmacist notifies the prescriber in writing or electronic communication of the intention to substitute at least 24 hours prior to the substitution;
- if explicit permission from prescribing physician and patient is not obtained within 24 hours, then the original prescription must be filled;
- the patient (or patient's authorized representative) must be informed and educated about a biosimilar substitution at the point of sale; and
- upon notification of a substitution, the pharmacy and the prescribing physician are to retain a permanent record in the patient's medical record of the biosimilar substitution.
What’s the issue?
The tension between lowering costs and using trusted therapeutic options will be at the center of the debate over biosimilar agents. The National Psoriasis Foundation policy protects physicians and patients and helps maintain their autonomy. As these drugs are developed and studied, we will have more information to inform our decisions. How will you and your patients respond to the availability of biosimilar agents?
The passage of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) allowed for the creation of a regulatory pathway for new, safe, and effective biosimilar agents. Although the medical community always needs new and affordable treatments, patients and physicians are aware of and concerned about the risks associated with biologics and the lack of long-term safety data for new treatments.
In contrast to generic drugs, which are chemically identical to their branded counterparts, biosimilar agents are not chemically identical to their branded biologic counterparts because as large complex molecules derived from living cells using recombinant DNA technology, biologics can never be exactly replicated due to their inherent variability.
Because of these substantial differences, the National Psoriasis Foundation released a policy in July 2013 to ensure patient safety.
The National Psoriasis Foundation recommends that the patient-provider relationship remain at the center of all treatment planning and supports a prohibition on biosimilar substitution unless all of the following minimal thresholds are met:
- the biosimilar has been designated by the Food and Drug Administration as interchangeable with the prescribed biologic for the specified indicated use;
- the biosimilar has a unique nonproprietary name to eliminate confusion, to allow providers to accurately track the therapeutic agent in a patient's permanent record, and to allow for the collection of adverse event information;
- the biosimilar product follows the same route of administration and dosage form as the reference product;
- the pharmacist notifies the prescriber in writing or electronic communication of the intention to substitute at least 24 hours prior to the substitution;
- if explicit permission from prescribing physician and patient is not obtained within 24 hours, then the original prescription must be filled;
- the patient (or patient's authorized representative) must be informed and educated about a biosimilar substitution at the point of sale; and
- upon notification of a substitution, the pharmacy and the prescribing physician are to retain a permanent record in the patient's medical record of the biosimilar substitution.
What’s the issue?
The tension between lowering costs and using trusted therapeutic options will be at the center of the debate over biosimilar agents. The National Psoriasis Foundation policy protects physicians and patients and helps maintain their autonomy. As these drugs are developed and studied, we will have more information to inform our decisions. How will you and your patients respond to the availability of biosimilar agents?
The passage of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) allowed for the creation of a regulatory pathway for new, safe, and effective biosimilar agents. Although the medical community always needs new and affordable treatments, patients and physicians are aware of and concerned about the risks associated with biologics and the lack of long-term safety data for new treatments.
In contrast to generic drugs, which are chemically identical to their branded counterparts, biosimilar agents are not chemically identical to their branded biologic counterparts because as large complex molecules derived from living cells using recombinant DNA technology, biologics can never be exactly replicated due to their inherent variability.
Because of these substantial differences, the National Psoriasis Foundation released a policy in July 2013 to ensure patient safety.
The National Psoriasis Foundation recommends that the patient-provider relationship remain at the center of all treatment planning and supports a prohibition on biosimilar substitution unless all of the following minimal thresholds are met:
- the biosimilar has been designated by the Food and Drug Administration as interchangeable with the prescribed biologic for the specified indicated use;
- the biosimilar has a unique nonproprietary name to eliminate confusion, to allow providers to accurately track the therapeutic agent in a patient's permanent record, and to allow for the collection of adverse event information;
- the biosimilar product follows the same route of administration and dosage form as the reference product;
- the pharmacist notifies the prescriber in writing or electronic communication of the intention to substitute at least 24 hours prior to the substitution;
- if explicit permission from prescribing physician and patient is not obtained within 24 hours, then the original prescription must be filled;
- the patient (or patient's authorized representative) must be informed and educated about a biosimilar substitution at the point of sale; and
- upon notification of a substitution, the pharmacy and the prescribing physician are to retain a permanent record in the patient's medical record of the biosimilar substitution.
What’s the issue?
The tension between lowering costs and using trusted therapeutic options will be at the center of the debate over biosimilar agents. The National Psoriasis Foundation policy protects physicians and patients and helps maintain their autonomy. As these drugs are developed and studied, we will have more information to inform our decisions. How will you and your patients respond to the availability of biosimilar agents?
