Psoriasis Collection

COPENHAGEN – The increased risk of MI and stroke in patients who develop psoriasis as young adults is essentially confined to those having a positive family history of cardiovascular disease, according to a Danish national study presented at the annual congress of the European Academy of Dermatology and Venereology.

“We found a significantly increased risk of MACE [major adverse cardiovascular events] in patients with psoriasis only when a family history of cardiovascular disease was present. This just highlights why it’s important that future studies of cardiovascular risk in psoriasis should include family history. Also, an increased focus on cardiovascular disease in relatives may be appropriate in the cardiovascular risk assessment of patients with psoriasis,” said Dr. Alexander Egeberg of the University of Copenhagen.

He presented a population-based study involving 15 years of follow-up of 30,278 Danes diagnosed with psoriasis in their 20s and a control group consisting of nearly 2.7 million of their Danish contemporaries who were not. None had personal history of acute MI or stroke at baseline. Family medical history, including whether cardiovascular disease occurred in first-degree relatives, was available for all subjects.

Dr. Egeberg and coinvestigators mapped the incidence of acute MI, ischemic stroke, or cardiovascular death in psoriasis patients and the general population controls during follow-up.

“When you look at the patients who developed psoriasis and didn’t have a positive family history of cardiovascular disease, there are almost no cardiovascular events for the entire country,” Dr. Egeberg observed.

In contrast, in a multivariate analysis adjusted for age, gender, socioeconomic status, comorbid cardiovascular disease, smoking, and the use of cardiovascular medications, patients with mild psoriasis and a positive family history for cardiovascular disease had a 28% greater risk of a premature cardiovascular event than the general population during follow-up out to roughly age 40. Those with a positive family history and severe psoriasis as defined by the use of systemic therapies had a 62% increase in risk. Both of these elevated risks were statistically significant.

Among young adult Danes with a positive family history for cardiovascular disease, there were 222 MACE events during 62,225 person-years of follow-up in the mild psoriasis group and 31 events during 6,848 person-years in the 4,504 subjects with severe psoriasis. The resultant incidence rates in both groups were significantly higher than in the control group, who experienced 28,846 MACE events during 16.1 million person-years of follow-up.

In contrast, fewer than 10 MACE events occurred in Danish psoriasis patients without a family history of cardiovascular disease.

A positive family history was also associated with increased MACE in the nonpsoriatic general population, although it didn’t confer as great a risk as in the Danes with psoriasis.

A point worthy of consideration, Dr. Egeberg noted, is that the epidemiology of psoriasis in Denmark apparently differs in several important ways from psoriasis in the United States and some other countries. For one, the prevalence is higher in Scandinavian countries – 7.1% in a Danish national cross-sectional study (Int J Dermatol. 2013 Jun;52[6]:681-3) and 8% in neighboring Norway – as compared with 2%-3% in much of the rest of the world.

Moreover, according to the same cross-sectional study, the prevalence of traditional cardiovascular risk factors, such as smoking and the components of the metabolic syndrome, isn’t higher in Danish psoriasis patients than in the country’s general population. That’s in contrast to the situation in the United Kingdom, where Dr. Joel M. Gelfand of the University of Pennsylvania and associates reported a decade ago in a landmark study that the prevalence of hypertension, obesity, hyperlipidemia, diabetes, and smoking were all higher in persons with psoriasis than in the general population (J Am Acad Dermatol. 2006 Nov;55[5]:829-35). Similar findings were subsequently reported in U.S. psoriasis patients.

Despite their absence of elevated levels of the standard cardiovascular risk factors, Danish psoriasis patients as a group do face a clinically significant increase in cardiovascular risk, compared with the general population, as shown in yet another Danish national cohort study in which the rate ratios for cardiovascular death for mild and severe psoriasis were 1.14 and 1.57, respectively, compared with controls (J Intern Med. 2011 Aug;270[2]:147-57).

In an even more recent Danish nationwide study, the overall death rate was found to be 25.4 per 1,000 person-years in patients with severe psoriasis, 17.0 in those with mild psoriasis, and 13.8 per 1,000 person-years in the general population (J Eur Acad Dermatol Venereol. 2015 May;29[5]:1002-5).

Dr. Egeberg said his new Danish findings suggest that even in psoriasis patients with a greater burden of systemic inflammation as expressed in severe disease, that burden alone doesn’t translate into increased cardiovascular risk. Rather, elevated cardiovascular risk appears to be a consequence of heritable factors, Dr. Egeberg said.

An important caveat regarding this study, he continued, is that the mean age at which participants were diagnosed with psoriasis was 26.6 years. It’s unclear whether the study findings extend to individuals who develop the dermatologic disease later in life.

Dr. Egeberg reported having no financial conflicts regarding this study, supported by Danish national research funding.

[email protected]

COPENHAGEN – The increased risk of MI and stroke in patients who develop psoriasis as young adults is essentially confined to those having a positive family history of cardiovascular disease, according to a Danish national study presented at the annual congress of the European Academy of Dermatology and Venereology.

“We found a significantly increased risk of MACE [major adverse cardiovascular events] in patients with psoriasis only when a family history of cardiovascular disease was present. This just highlights why it’s important that future studies of cardiovascular risk in psoriasis should include family history. Also, an increased focus on cardiovascular disease in relatives may be appropriate in the cardiovascular risk assessment of patients with psoriasis,” said Dr. Alexander Egeberg of the University of Copenhagen.

He presented a population-based study involving 15 years of follow-up of 30,278 Danes diagnosed with psoriasis in their 20s and a control group consisting of nearly 2.7 million of their Danish contemporaries who were not. None had personal history of acute MI or stroke at baseline. Family medical history, including whether cardiovascular disease occurred in first-degree relatives, was available for all subjects.

Dr. Egeberg and coinvestigators mapped the incidence of acute MI, ischemic stroke, or cardiovascular death in psoriasis patients and the general population controls during follow-up.

“When you look at the patients who developed psoriasis and didn’t have a positive family history of cardiovascular disease, there are almost no cardiovascular events for the entire country,” Dr. Egeberg observed.

In contrast, in a multivariate analysis adjusted for age, gender, socioeconomic status, comorbid cardiovascular disease, smoking, and the use of cardiovascular medications, patients with mild psoriasis and a positive family history for cardiovascular disease had a 28% greater risk of a premature cardiovascular event than the general population during follow-up out to roughly age 40. Those with a positive family history and severe psoriasis as defined by the use of systemic therapies had a 62% increase in risk. Both of these elevated risks were statistically significant.

Among young adult Danes with a positive family history for cardiovascular disease, there were 222 MACE events during 62,225 person-years of follow-up in the mild psoriasis group and 31 events during 6,848 person-years in the 4,504 subjects with severe psoriasis. The resultant incidence rates in both groups were significantly higher than in the control group, who experienced 28,846 MACE events during 16.1 million person-years of follow-up.

In contrast, fewer than 10 MACE events occurred in Danish psoriasis patients without a family history of cardiovascular disease.

A positive family history was also associated with increased MACE in the nonpsoriatic general population, although it didn’t confer as great a risk as in the Danes with psoriasis.

A point worthy of consideration, Dr. Egeberg noted, is that the epidemiology of psoriasis in Denmark apparently differs in several important ways from psoriasis in the United States and some other countries. For one, the prevalence is higher in Scandinavian countries – 7.1% in a Danish national cross-sectional study (Int J Dermatol. 2013 Jun;52[6]:681-3) and 8% in neighboring Norway – as compared with 2%-3% in much of the rest of the world.

Moreover, according to the same cross-sectional study, the prevalence of traditional cardiovascular risk factors, such as smoking and the components of the metabolic syndrome, isn’t higher in Danish psoriasis patients than in the country’s general population. That’s in contrast to the situation in the United Kingdom, where Dr. Joel M. Gelfand of the University of Pennsylvania and associates reported a decade ago in a landmark study that the prevalence of hypertension, obesity, hyperlipidemia, diabetes, and smoking were all higher in persons with psoriasis than in the general population (J Am Acad Dermatol. 2006 Nov;55[5]:829-35). Similar findings were subsequently reported in U.S. psoriasis patients.

Despite their absence of elevated levels of the standard cardiovascular risk factors, Danish psoriasis patients as a group do face a clinically significant increase in cardiovascular risk, compared with the general population, as shown in yet another Danish national cohort study in which the rate ratios for cardiovascular death for mild and severe psoriasis were 1.14 and 1.57, respectively, compared with controls (J Intern Med. 2011 Aug;270[2]:147-57).

In an even more recent Danish nationwide study, the overall death rate was found to be 25.4 per 1,000 person-years in patients with severe psoriasis, 17.0 in those with mild psoriasis, and 13.8 per 1,000 person-years in the general population (J Eur Acad Dermatol Venereol. 2015 May;29[5]:1002-5).

Dr. Egeberg said his new Danish findings suggest that even in psoriasis patients with a greater burden of systemic inflammation as expressed in severe disease, that burden alone doesn’t translate into increased cardiovascular risk. Rather, elevated cardiovascular risk appears to be a consequence of heritable factors, Dr. Egeberg said.

An important caveat regarding this study, he continued, is that the mean age at which participants were diagnosed with psoriasis was 26.6 years. It’s unclear whether the study findings extend to individuals who develop the dermatologic disease later in life.

Dr. Egeberg reported having no financial conflicts regarding this study, supported by Danish national research funding.

[email protected]

COPENHAGEN – The increased risk of MI and stroke in patients who develop psoriasis as young adults is essentially confined to those having a positive family history of cardiovascular disease, according to a Danish national study presented at the annual congress of the European Academy of Dermatology and Venereology.

“We found a significantly increased risk of MACE [major adverse cardiovascular events] in patients with psoriasis only when a family history of cardiovascular disease was present. This just highlights why it’s important that future studies of cardiovascular risk in psoriasis should include family history. Also, an increased focus on cardiovascular disease in relatives may be appropriate in the cardiovascular risk assessment of patients with psoriasis,” said Dr. Alexander Egeberg of the University of Copenhagen.

He presented a population-based study involving 15 years of follow-up of 30,278 Danes diagnosed with psoriasis in their 20s and a control group consisting of nearly 2.7 million of their Danish contemporaries who were not. None had personal history of acute MI or stroke at baseline. Family medical history, including whether cardiovascular disease occurred in first-degree relatives, was available for all subjects.

Dr. Egeberg and coinvestigators mapped the incidence of acute MI, ischemic stroke, or cardiovascular death in psoriasis patients and the general population controls during follow-up.

“When you look at the patients who developed psoriasis and didn’t have a positive family history of cardiovascular disease, there are almost no cardiovascular events for the entire country,” Dr. Egeberg observed.

In contrast, in a multivariate analysis adjusted for age, gender, socioeconomic status, comorbid cardiovascular disease, smoking, and the use of cardiovascular medications, patients with mild psoriasis and a positive family history for cardiovascular disease had a 28% greater risk of a premature cardiovascular event than the general population during follow-up out to roughly age 40. Those with a positive family history and severe psoriasis as defined by the use of systemic therapies had a 62% increase in risk. Both of these elevated risks were statistically significant.

Among young adult Danes with a positive family history for cardiovascular disease, there were 222 MACE events during 62,225 person-years of follow-up in the mild psoriasis group and 31 events during 6,848 person-years in the 4,504 subjects with severe psoriasis. The resultant incidence rates in both groups were significantly higher than in the control group, who experienced 28,846 MACE events during 16.1 million person-years of follow-up.

In contrast, fewer than 10 MACE events occurred in Danish psoriasis patients without a family history of cardiovascular disease.

A positive family history was also associated with increased MACE in the nonpsoriatic general population, although it didn’t confer as great a risk as in the Danes with psoriasis.

A point worthy of consideration, Dr. Egeberg noted, is that the epidemiology of psoriasis in Denmark apparently differs in several important ways from psoriasis in the United States and some other countries. For one, the prevalence is higher in Scandinavian countries – 7.1% in a Danish national cross-sectional study (Int J Dermatol. 2013 Jun;52[6]:681-3) and 8% in neighboring Norway – as compared with 2%-3% in much of the rest of the world.

Moreover, according to the same cross-sectional study, the prevalence of traditional cardiovascular risk factors, such as smoking and the components of the metabolic syndrome, isn’t higher in Danish psoriasis patients than in the country’s general population. That’s in contrast to the situation in the United Kingdom, where Dr. Joel M. Gelfand of the University of Pennsylvania and associates reported a decade ago in a landmark study that the prevalence of hypertension, obesity, hyperlipidemia, diabetes, and smoking were all higher in persons with psoriasis than in the general population (J Am Acad Dermatol. 2006 Nov;55[5]:829-35). Similar findings were subsequently reported in U.S. psoriasis patients.

Despite their absence of elevated levels of the standard cardiovascular risk factors, Danish psoriasis patients as a group do face a clinically significant increase in cardiovascular risk, compared with the general population, as shown in yet another Danish national cohort study in which the rate ratios for cardiovascular death for mild and severe psoriasis were 1.14 and 1.57, respectively, compared with controls (J Intern Med. 2011 Aug;270[2]:147-57).

In an even more recent Danish nationwide study, the overall death rate was found to be 25.4 per 1,000 person-years in patients with severe psoriasis, 17.0 in those with mild psoriasis, and 13.8 per 1,000 person-years in the general population (J Eur Acad Dermatol Venereol. 2015 May;29[5]:1002-5).

Dr. Egeberg said his new Danish findings suggest that even in psoriasis patients with a greater burden of systemic inflammation as expressed in severe disease, that burden alone doesn’t translate into increased cardiovascular risk. Rather, elevated cardiovascular risk appears to be a consequence of heritable factors, Dr. Egeberg said.

An important caveat regarding this study, he continued, is that the mean age at which participants were diagnosed with psoriasis was 26.6 years. It’s unclear whether the study findings extend to individuals who develop the dermatologic disease later in life.

Dr. Egeberg reported having no financial conflicts regarding this study, supported by Danish national research funding.

[email protected]

COPENHAGEN – An oral small molecule with a novel mechanism of action for treatment of moderate to severe plaque psoriasis is being developed as a potential first-line systemic treatment in view of its highly favorable safety profile.

The investigational drug, known for now as CF101, is a first-in-class agonist of the A3 adenosine receptor. This cell surface receptor is upregulated in the pathologic cells of certain inflammatory diseases, but has little or no expression in normal cells. This high degree of specificity accounts for its safety, which in a recent phase II/III trial was essentially indistinguishable from placebo, making it an attractive potential alternative to methotrexate or biologics as a starting point in systemic therapy, Pnina Fishman, Ph.D., said at the annual congress of the European Academy of Dermatology and Venereology.

Planning is underway for a pivotal phase III trial of CF101 in psoriasis, which is also being organized for CF101 in rheumatoid arthritis on the strength of favorable phase II findings, according to Dr. Fishman, CEO of Can-Fite BioPharma, an Israeli biotech company that is developing the drug.

The phase II/III psoriasis trial was a 326-patient, double-blind, placebo-controlled study. It showed efficacy comparable to and in some respects better than that reported in the phase III ESTEEM-1 study of the oral phosphodiesterase 4 inhibitor apremilast (J Am Acad Dermatol. 2015 Jul;73:37-49).

Moreover, it appears that the twice-daily 2-mg dosing of CF101 studied in the phase II/III trial was suboptimal in light of the observed linear increase in Psoriasis Area and Severity Index (PASI)-75, -90, and -100 response rates over time. Those response rates rose steadily until the study’s end at week 32 with no evidence of a plateau. In contrast, in ESTEEM-1, the improvement with apremilast (Otezla) leveled off starting at about week 20, she observed.

In the recent phase II/III trial, the PASI-75 rate for CF101 at week 12 – the prespecified primary endpoint – was not significantly better than placebo was. However, the PASI-75 response rate continued to climb such that by week 32, it was 35.3%, similar to the 33.1% PASI-75 response seen at 16 weeks in ESTEEM-1. PASI improved by an average of 57% from baseline to week 32 with CF101 with no plateau in sight, and by 55% with apremilast at week 16, with a leveling off at week 20. This is why the upcoming phase III trial will employ a higher dose of CF101 than twice-daily 2-mg dose used in the phase II/III study and will run longer. The goal is to achieve higher PASI response rates faster than obtainable with 2 mg BID, Dr. Fishman explained.

She added that the PASI-90 response data in the phase II/III trial bode particularly well for the future of CF101 as a first-line systemic agent. At week 32, this stringent outcome measure was achieved by 26.9% of participants who hadn’t previously been on methotrexate or a biologic and by 13.7% of those who had. And as was the case for the PASI-75 results, the PASI-90 response increased in linear fashion out to 32 weeks with no plateau. In ESTEEM-1, the PASI-90 rate was 9.8% at week 16.

No treatment-related adverse events were seen in the phase II/III CF101 study, Dr. Fishman reported.

The study was sponsored by Can-Fite BioPharma and presented by Dr. Fishman, who is the company’s CEO.

[email protected]

COPENHAGEN – An oral small molecule with a novel mechanism of action for treatment of moderate to severe plaque psoriasis is being developed as a potential first-line systemic treatment in view of its highly favorable safety profile.

The investigational drug, known for now as CF101, is a first-in-class agonist of the A3 adenosine receptor. This cell surface receptor is upregulated in the pathologic cells of certain inflammatory diseases, but has little or no expression in normal cells. This high degree of specificity accounts for its safety, which in a recent phase II/III trial was essentially indistinguishable from placebo, making it an attractive potential alternative to methotrexate or biologics as a starting point in systemic therapy, Pnina Fishman, Ph.D., said at the annual congress of the European Academy of Dermatology and Venereology.

Planning is underway for a pivotal phase III trial of CF101 in psoriasis, which is also being organized for CF101 in rheumatoid arthritis on the strength of favorable phase II findings, according to Dr. Fishman, CEO of Can-Fite BioPharma, an Israeli biotech company that is developing the drug.

The phase II/III psoriasis trial was a 326-patient, double-blind, placebo-controlled study. It showed efficacy comparable to and in some respects better than that reported in the phase III ESTEEM-1 study of the oral phosphodiesterase 4 inhibitor apremilast (J Am Acad Dermatol. 2015 Jul;73:37-49).

Moreover, it appears that the twice-daily 2-mg dosing of CF101 studied in the phase II/III trial was suboptimal in light of the observed linear increase in Psoriasis Area and Severity Index (PASI)-75, -90, and -100 response rates over time. Those response rates rose steadily until the study’s end at week 32 with no evidence of a plateau. In contrast, in ESTEEM-1, the improvement with apremilast (Otezla) leveled off starting at about week 20, she observed.

In the recent phase II/III trial, the PASI-75 rate for CF101 at week 12 – the prespecified primary endpoint – was not significantly better than placebo was. However, the PASI-75 response rate continued to climb such that by week 32, it was 35.3%, similar to the 33.1% PASI-75 response seen at 16 weeks in ESTEEM-1. PASI improved by an average of 57% from baseline to week 32 with CF101 with no plateau in sight, and by 55% with apremilast at week 16, with a leveling off at week 20. This is why the upcoming phase III trial will employ a higher dose of CF101 than twice-daily 2-mg dose used in the phase II/III study and will run longer. The goal is to achieve higher PASI response rates faster than obtainable with 2 mg BID, Dr. Fishman explained.

She added that the PASI-90 response data in the phase II/III trial bode particularly well for the future of CF101 as a first-line systemic agent. At week 32, this stringent outcome measure was achieved by 26.9% of participants who hadn’t previously been on methotrexate or a biologic and by 13.7% of those who had. And as was the case for the PASI-75 results, the PASI-90 response increased in linear fashion out to 32 weeks with no plateau. In ESTEEM-1, the PASI-90 rate was 9.8% at week 16.

No treatment-related adverse events were seen in the phase II/III CF101 study, Dr. Fishman reported.

The study was sponsored by Can-Fite BioPharma and presented by Dr. Fishman, who is the company’s CEO.

[email protected]

COPENHAGEN – An oral small molecule with a novel mechanism of action for treatment of moderate to severe plaque psoriasis is being developed as a potential first-line systemic treatment in view of its highly favorable safety profile.

The investigational drug, known for now as CF101, is a first-in-class agonist of the A3 adenosine receptor. This cell surface receptor is upregulated in the pathologic cells of certain inflammatory diseases, but has little or no expression in normal cells. This high degree of specificity accounts for its safety, which in a recent phase II/III trial was essentially indistinguishable from placebo, making it an attractive potential alternative to methotrexate or biologics as a starting point in systemic therapy, Pnina Fishman, Ph.D., said at the annual congress of the European Academy of Dermatology and Venereology.

Planning is underway for a pivotal phase III trial of CF101 in psoriasis, which is also being organized for CF101 in rheumatoid arthritis on the strength of favorable phase II findings, according to Dr. Fishman, CEO of Can-Fite BioPharma, an Israeli biotech company that is developing the drug.

The phase II/III psoriasis trial was a 326-patient, double-blind, placebo-controlled study. It showed efficacy comparable to and in some respects better than that reported in the phase III ESTEEM-1 study of the oral phosphodiesterase 4 inhibitor apremilast (J Am Acad Dermatol. 2015 Jul;73:37-49).

Moreover, it appears that the twice-daily 2-mg dosing of CF101 studied in the phase II/III trial was suboptimal in light of the observed linear increase in Psoriasis Area and Severity Index (PASI)-75, -90, and -100 response rates over time. Those response rates rose steadily until the study’s end at week 32 with no evidence of a plateau. In contrast, in ESTEEM-1, the improvement with apremilast (Otezla) leveled off starting at about week 20, she observed.

In the recent phase II/III trial, the PASI-75 rate for CF101 at week 12 – the prespecified primary endpoint – was not significantly better than placebo was. However, the PASI-75 response rate continued to climb such that by week 32, it was 35.3%, similar to the 33.1% PASI-75 response seen at 16 weeks in ESTEEM-1. PASI improved by an average of 57% from baseline to week 32 with CF101 with no plateau in sight, and by 55% with apremilast at week 16, with a leveling off at week 20. This is why the upcoming phase III trial will employ a higher dose of CF101 than twice-daily 2-mg dose used in the phase II/III study and will run longer. The goal is to achieve higher PASI response rates faster than obtainable with 2 mg BID, Dr. Fishman explained.

She added that the PASI-90 response data in the phase II/III trial bode particularly well for the future of CF101 as a first-line systemic agent. At week 32, this stringent outcome measure was achieved by 26.9% of participants who hadn’t previously been on methotrexate or a biologic and by 13.7% of those who had. And as was the case for the PASI-75 results, the PASI-90 response increased in linear fashion out to 32 weeks with no plateau. In ESTEEM-1, the PASI-90 rate was 9.8% at week 16.

No treatment-related adverse events were seen in the phase II/III CF101 study, Dr. Fishman reported.

The study was sponsored by Can-Fite BioPharma and presented by Dr. Fishman, who is the company’s CEO.

[email protected]

Although a wide variety of treatment modalities exist for the management of psoriasis, nontreatment, undertreatment, and treatment dissatisfaction represent key clinical challenges. Careful tailoring of therapeutic regimens to meet individual patient needs and priorities may therefore be critical to improving treatment adherence and clinical outcomes. Importantly, systemic therapies such as methotrexate (MTX) may be particularly useful for individualizing patient treatment regimens and appear to be underutilized components of treatment optimization.

A majority of psoriasis patients have mild to moderate disease and many are treated primarily with topical medications. Although these treatments generally are safe and effective, practical limitations (eg, formulation, ease of application) may affect patients’ treatment adherence and satisfaction even in the context of high efficacy. Systemic therapies, although associated with a distinct set of risks and treatment challenges, may enable patients to overcome many of these limitations, particularly in patients with moderate to severe disease or impaired quality of life as well as those with an inadequate response to or dissatisfaction with topical treatments.

Systemic Treatment Options

Among the systemic treatment options for psoriasis, biologic therapies often are most highly regarded due to their strong efficacy, although traditional systemic therapies such as MTX, cyclosporine, and acitretin remain important treatment options and have an extensive history in the treatment of psoriasis. In addition to typically being required by insurance companies prior to the initiation of biologic therapies, traditional systemic therapies also may be preferred by patients because of the options for oral and subcutaneous administration and their relatively low costs. Furthermore, systemic therapies may be critical in patients for whom biologic therapies are relatively contraindicated, such as those with an increased risk of infection, history of malignancy, or hypersensitivity to any of the product’s ingredients.

Among traditional systemic therapies, MTX is one of the most frequently used psoriasis treatment worldwide and can be highly effective for even severe cases. Importantly, MTX is a valuable component of combination treatments for psoriasis and is frequently coadministered with topical and biologic agents and phototherapy, suggesting that MTX may be a particularly useful option to consider when adjusting a patient’s treatment regimen.

Benefits of Subcutaneous Methotrexate Administration

Methotrexate can be delivered either orally or parenterally, contributing to its compatibility with a wide variety of psoriasis treatment regimens and patient preferences. Administration is predominantly oral in the United States, but parenteral MTX (most commonly delivered subcutaneously) can confer important benefits and is used regularly in countries outside of the United States.

An important advantage of subcutaneous versus oral MTX is greater bioavailability, particularly at higher doses. In studies of healthy volunteers or patients with rheumatoid arthritis, the bioavailability of MTX following oral administration appears to plateau at doses of 15 mg or higher,¹ whereas that of subcutaneous MTX appears to increase linearly at a wide range of doses and exceeds that of oral MTX at each dose examined.^1,2 A switch from oral to subcutaneous MTX may therefore benefit patients experiencing suboptimal disease control.

Another important benefit of subcutanoues versus oral MTX is the potential for reduced intensity of gastrointestinal adverse events.^2,3 In a study of patients with rheumatoid arthritis, those who received subcutaneous MTX reported less severe nausea, vomiting, abdominal pain, and diarrhea than those who received oral MTX,³ which may improve treatment adherence and potentially enable patients to tolerate higher doses. Because gastrointestinal adverse events are a common cause of MTX treatment discontinuation, a switch from oral to subcutaneous MTX may be an important strategy to enable more patients to benefit from this treatment option.

Subcutaneous MTX presents some potential challenges, including patients’ fear of needles and difficulties with drawing and administering an accurate drug dose using a vial, needle, and syringe. However, recent developments in autoinjector technology have produced MTX injection devices that largely mitigate many of these challenges. Methotrexate autoinjectors allow for the accurate administration of prespecified doses, and patients generally find them easy to use.⁴ Furthermore, MTX autoinjectors have been associated with low levels of adminsitration-site pain (median pain score on a visual analog scale, 1.0/100 mm in one study⁴), and the concealment of a needle from view may potentially lessen needle phobia.

Role of Subcutaneous Methotrexate in Patient Care

The types of patients expected to benefit most from subcutaneous MTX include those with moderate to severe psoriasis and those who have experienced dissatisfaction with topical medications or phototherapy. The increased bioavailability of subcutaneous MTX as well as the reduced intensity of gastrointestinal adverse events compared with oral MTX may enable patients to achieve a greater clinical response, and the systemic route of administration may improve treatment adherence and patient satisfaction among those who are dissatisfied with topical treatment regimens. Notably, an additional benefit of optimizing MTX treatment may be the potential to prevent or delay progression to biologic therapies, which may be an important goal of both patients and physicians to prevent higher health care costs.

Another principal role of subcutaneous MTX is as a component of combination therapy with topicals or other systemic therapies for either long-term care or periodic treatment of disease flares. Methotrexate is a frequent component of combination therapies, and subcutaneous administration may be preferable for many patients, particularly those who are already accustomed to injectable therapies (eg, biologic agents) and those who regularly visit a physician who can perform the injections (eg, for regular phototherapy treatments). Interestingly, the coadministration of MTX may be especially valuable in the context of biologic therapies, as concomitant MTX is associated with a reduced incidence of antidrug antibodies and may therefore enhance or prolong responses to biologic agents.

Final Thoughts

Because subcutaneous MTX is infrequently used for the treatment of psoriasis in the United States, increased awareness of its unique advantages may provide new opportunities for patients to tailor treatment regimens to meet individual needs and preferences. Treatment optimization across a broad range of patient characteristics may be critical to improving adherence and satisfaction in psoriasis patients and may be considered a major therapeutic goal.

Acknowledgment

Medical writing assistance was provided by Anna Abt, PhD, of ETHOS Health Communications in Newtown, Pennsylvania, with financial support from LEO Pharma.

Although a wide variety of treatment modalities exist for the management of psoriasis, nontreatment, undertreatment, and treatment dissatisfaction represent key clinical challenges. Careful tailoring of therapeutic regimens to meet individual patient needs and priorities may therefore be critical to improving treatment adherence and clinical outcomes. Importantly, systemic therapies such as methotrexate (MTX) may be particularly useful for individualizing patient treatment regimens and appear to be underutilized components of treatment optimization.

A majority of psoriasis patients have mild to moderate disease and many are treated primarily with topical medications. Although these treatments generally are safe and effective, practical limitations (eg, formulation, ease of application) may affect patients’ treatment adherence and satisfaction even in the context of high efficacy. Systemic therapies, although associated with a distinct set of risks and treatment challenges, may enable patients to overcome many of these limitations, particularly in patients with moderate to severe disease or impaired quality of life as well as those with an inadequate response to or dissatisfaction with topical treatments.

Systemic Treatment Options

Among the systemic treatment options for psoriasis, biologic therapies often are most highly regarded due to their strong efficacy, although traditional systemic therapies such as MTX, cyclosporine, and acitretin remain important treatment options and have an extensive history in the treatment of psoriasis. In addition to typically being required by insurance companies prior to the initiation of biologic therapies, traditional systemic therapies also may be preferred by patients because of the options for oral and subcutaneous administration and their relatively low costs. Furthermore, systemic therapies may be critical in patients for whom biologic therapies are relatively contraindicated, such as those with an increased risk of infection, history of malignancy, or hypersensitivity to any of the product’s ingredients.

Among traditional systemic therapies, MTX is one of the most frequently used psoriasis treatment worldwide and can be highly effective for even severe cases. Importantly, MTX is a valuable component of combination treatments for psoriasis and is frequently coadministered with topical and biologic agents and phototherapy, suggesting that MTX may be a particularly useful option to consider when adjusting a patient’s treatment regimen.

Benefits of Subcutaneous Methotrexate Administration

Methotrexate can be delivered either orally or parenterally, contributing to its compatibility with a wide variety of psoriasis treatment regimens and patient preferences. Administration is predominantly oral in the United States, but parenteral MTX (most commonly delivered subcutaneously) can confer important benefits and is used regularly in countries outside of the United States.

An important advantage of subcutaneous versus oral MTX is greater bioavailability, particularly at higher doses. In studies of healthy volunteers or patients with rheumatoid arthritis, the bioavailability of MTX following oral administration appears to plateau at doses of 15 mg or higher,¹ whereas that of subcutaneous MTX appears to increase linearly at a wide range of doses and exceeds that of oral MTX at each dose examined.^1,2 A switch from oral to subcutaneous MTX may therefore benefit patients experiencing suboptimal disease control.

Another important benefit of subcutanoues versus oral MTX is the potential for reduced intensity of gastrointestinal adverse events.^2,3 In a study of patients with rheumatoid arthritis, those who received subcutaneous MTX reported less severe nausea, vomiting, abdominal pain, and diarrhea than those who received oral MTX,³ which may improve treatment adherence and potentially enable patients to tolerate higher doses. Because gastrointestinal adverse events are a common cause of MTX treatment discontinuation, a switch from oral to subcutaneous MTX may be an important strategy to enable more patients to benefit from this treatment option.

Subcutaneous MTX presents some potential challenges, including patients’ fear of needles and difficulties with drawing and administering an accurate drug dose using a vial, needle, and syringe. However, recent developments in autoinjector technology have produced MTX injection devices that largely mitigate many of these challenges. Methotrexate autoinjectors allow for the accurate administration of prespecified doses, and patients generally find them easy to use.⁴ Furthermore, MTX autoinjectors have been associated with low levels of adminsitration-site pain (median pain score on a visual analog scale, 1.0/100 mm in one study⁴), and the concealment of a needle from view may potentially lessen needle phobia.

Role of Subcutaneous Methotrexate in Patient Care

The types of patients expected to benefit most from subcutaneous MTX include those with moderate to severe psoriasis and those who have experienced dissatisfaction with topical medications or phototherapy. The increased bioavailability of subcutaneous MTX as well as the reduced intensity of gastrointestinal adverse events compared with oral MTX may enable patients to achieve a greater clinical response, and the systemic route of administration may improve treatment adherence and patient satisfaction among those who are dissatisfied with topical treatment regimens. Notably, an additional benefit of optimizing MTX treatment may be the potential to prevent or delay progression to biologic therapies, which may be an important goal of both patients and physicians to prevent higher health care costs.

Another principal role of subcutaneous MTX is as a component of combination therapy with topicals or other systemic therapies for either long-term care or periodic treatment of disease flares. Methotrexate is a frequent component of combination therapies, and subcutaneous administration may be preferable for many patients, particularly those who are already accustomed to injectable therapies (eg, biologic agents) and those who regularly visit a physician who can perform the injections (eg, for regular phototherapy treatments). Interestingly, the coadministration of MTX may be especially valuable in the context of biologic therapies, as concomitant MTX is associated with a reduced incidence of antidrug antibodies and may therefore enhance or prolong responses to biologic agents.

Final Thoughts

Because subcutaneous MTX is infrequently used for the treatment of psoriasis in the United States, increased awareness of its unique advantages may provide new opportunities for patients to tailor treatment regimens to meet individual needs and preferences. Treatment optimization across a broad range of patient characteristics may be critical to improving adherence and satisfaction in psoriasis patients and may be considered a major therapeutic goal.

Acknowledgment

Medical writing assistance was provided by Anna Abt, PhD, of ETHOS Health Communications in Newtown, Pennsylvania, with financial support from LEO Pharma.

Although a wide variety of treatment modalities exist for the management of psoriasis, nontreatment, undertreatment, and treatment dissatisfaction represent key clinical challenges. Careful tailoring of therapeutic regimens to meet individual patient needs and priorities may therefore be critical to improving treatment adherence and clinical outcomes. Importantly, systemic therapies such as methotrexate (MTX) may be particularly useful for individualizing patient treatment regimens and appear to be underutilized components of treatment optimization.

A majority of psoriasis patients have mild to moderate disease and many are treated primarily with topical medications. Although these treatments generally are safe and effective, practical limitations (eg, formulation, ease of application) may affect patients’ treatment adherence and satisfaction even in the context of high efficacy. Systemic therapies, although associated with a distinct set of risks and treatment challenges, may enable patients to overcome many of these limitations, particularly in patients with moderate to severe disease or impaired quality of life as well as those with an inadequate response to or dissatisfaction with topical treatments.

Systemic Treatment Options

Among the systemic treatment options for psoriasis, biologic therapies often are most highly regarded due to their strong efficacy, although traditional systemic therapies such as MTX, cyclosporine, and acitretin remain important treatment options and have an extensive history in the treatment of psoriasis. In addition to typically being required by insurance companies prior to the initiation of biologic therapies, traditional systemic therapies also may be preferred by patients because of the options for oral and subcutaneous administration and their relatively low costs. Furthermore, systemic therapies may be critical in patients for whom biologic therapies are relatively contraindicated, such as those with an increased risk of infection, history of malignancy, or hypersensitivity to any of the product’s ingredients.

Among traditional systemic therapies, MTX is one of the most frequently used psoriasis treatment worldwide and can be highly effective for even severe cases. Importantly, MTX is a valuable component of combination treatments for psoriasis and is frequently coadministered with topical and biologic agents and phototherapy, suggesting that MTX may be a particularly useful option to consider when adjusting a patient’s treatment regimen.

Benefits of Subcutaneous Methotrexate Administration

Methotrexate can be delivered either orally or parenterally, contributing to its compatibility with a wide variety of psoriasis treatment regimens and patient preferences. Administration is predominantly oral in the United States, but parenteral MTX (most commonly delivered subcutaneously) can confer important benefits and is used regularly in countries outside of the United States.

An important advantage of subcutaneous versus oral MTX is greater bioavailability, particularly at higher doses. In studies of healthy volunteers or patients with rheumatoid arthritis, the bioavailability of MTX following oral administration appears to plateau at doses of 15 mg or higher,¹ whereas that of subcutaneous MTX appears to increase linearly at a wide range of doses and exceeds that of oral MTX at each dose examined.^1,2 A switch from oral to subcutaneous MTX may therefore benefit patients experiencing suboptimal disease control.

Another important benefit of subcutanoues versus oral MTX is the potential for reduced intensity of gastrointestinal adverse events.^2,3 In a study of patients with rheumatoid arthritis, those who received subcutaneous MTX reported less severe nausea, vomiting, abdominal pain, and diarrhea than those who received oral MTX,³ which may improve treatment adherence and potentially enable patients to tolerate higher doses. Because gastrointestinal adverse events are a common cause of MTX treatment discontinuation, a switch from oral to subcutaneous MTX may be an important strategy to enable more patients to benefit from this treatment option.

Subcutaneous MTX presents some potential challenges, including patients’ fear of needles and difficulties with drawing and administering an accurate drug dose using a vial, needle, and syringe. However, recent developments in autoinjector technology have produced MTX injection devices that largely mitigate many of these challenges. Methotrexate autoinjectors allow for the accurate administration of prespecified doses, and patients generally find them easy to use.⁴ Furthermore, MTX autoinjectors have been associated with low levels of adminsitration-site pain (median pain score on a visual analog scale, 1.0/100 mm in one study⁴), and the concealment of a needle from view may potentially lessen needle phobia.

Role of Subcutaneous Methotrexate in Patient Care

The types of patients expected to benefit most from subcutaneous MTX include those with moderate to severe psoriasis and those who have experienced dissatisfaction with topical medications or phototherapy. The increased bioavailability of subcutaneous MTX as well as the reduced intensity of gastrointestinal adverse events compared with oral MTX may enable patients to achieve a greater clinical response, and the systemic route of administration may improve treatment adherence and patient satisfaction among those who are dissatisfied with topical treatment regimens. Notably, an additional benefit of optimizing MTX treatment may be the potential to prevent or delay progression to biologic therapies, which may be an important goal of both patients and physicians to prevent higher health care costs.

Another principal role of subcutaneous MTX is as a component of combination therapy with topicals or other systemic therapies for either long-term care or periodic treatment of disease flares. Methotrexate is a frequent component of combination therapies, and subcutaneous administration may be preferable for many patients, particularly those who are already accustomed to injectable therapies (eg, biologic agents) and those who regularly visit a physician who can perform the injections (eg, for regular phototherapy treatments). Interestingly, the coadministration of MTX may be especially valuable in the context of biologic therapies, as concomitant MTX is associated with a reduced incidence of antidrug antibodies and may therefore enhance or prolong responses to biologic agents.

Final Thoughts

Because subcutaneous MTX is infrequently used for the treatment of psoriasis in the United States, increased awareness of its unique advantages may provide new opportunities for patients to tailor treatment regimens to meet individual needs and preferences. Treatment optimization across a broad range of patient characteristics may be critical to improving adherence and satisfaction in psoriasis patients and may be considered a major therapeutic goal.

Acknowledgment

Medical writing assistance was provided by Anna Abt, PhD, of ETHOS Health Communications in Newtown, Pennsylvania, with financial support from LEO Pharma.

Patients with psoriatic arthritis taking methotrexate demonstrated an improvement in peripheral joint disease, skin disease, enthesitis, dactylitis, and nail disease over 12 weeks in a subanalysis of methotrexate users in the TICOPA (Tight Control of Psoriatic Arthritis) study.

Out of the original 206 patients in the open-label, randomized, controlled TICOPA study, the subanalysis involved 188 who received methotrexate in its first 12 weeks. Substudy authors Dr. Laura C. Coates and Dr. Philip S. Helliwell of the Leeds Institute of Rheumatic and Musculoskeletal Medicine at the University of Leeds (England) verified a maximum dose at 12 weeks of at least 15 mg/week in 175, 20 mg/week in 122, and 25 mg/week in 86 (J Rheumatol. Dec 15. doi: 10.3899/jrheum.150614).

©Thinkstock.com

The proportions of patients achieving American College of Rheumatology (ACR) outcomes at 12 weeks were 40.8% for ACR20, 18.8% for ACR50, and 8.6% for ACR70. A total of 22.4% achieved minimal disease activity, defined as meeting five of these seven criteria: 0-1 tender joints, 0-1 swollen joints, Psoriasis Area and Severity Index (PASI) of 1 or less or body surface area involvement of 3 or less, patient pain visual analog score (VAS) of 15 or less, patient global disease activity VAS of 20 or less, health assessment questionnaire of 0.5 or less, and 0-1 tender entheseal points.

Other improvements that occurred at 12 weeks included 27.2% reaching a PASI75, a 62.7% drop in dactylitis incidence, a significant drop of –59.7 in Leeds dactylitis instrument median score, and a significant decrease in the proportion of patients with enthesitis (25.7%). However, the median change in enthesitis score was 0.

Response rates did not differ between patients receiving methotrexate 15 mg/week or higher doses, although there was generally a higher proportion who met various response criteria among those taking greater than 15 mg/week. However, the authors noted that there could be an underestimation of the dose effect because the design of the TICOPA study, which randomized patients to a protocol for tight control of psoriatic arthritis disease activity or standard care, introduced a bias by intentionally escalating treatment doses in patients who continue to have active disease.

The investigators advised that the study results be interpreted in the context of the open-label design of the study, and placed alongside the other observational studies that support its use in psoriatic arthritis.

No relevant conflicts of interest were disclosed.

Patients with psoriatic arthritis taking methotrexate demonstrated an improvement in peripheral joint disease, skin disease, enthesitis, dactylitis, and nail disease over 12 weeks in a subanalysis of methotrexate users in the TICOPA (Tight Control of Psoriatic Arthritis) study.

Out of the original 206 patients in the open-label, randomized, controlled TICOPA study, the subanalysis involved 188 who received methotrexate in its first 12 weeks. Substudy authors Dr. Laura C. Coates and Dr. Philip S. Helliwell of the Leeds Institute of Rheumatic and Musculoskeletal Medicine at the University of Leeds (England) verified a maximum dose at 12 weeks of at least 15 mg/week in 175, 20 mg/week in 122, and 25 mg/week in 86 (J Rheumatol. Dec 15. doi: 10.3899/jrheum.150614).

©Thinkstock.com

The proportions of patients achieving American College of Rheumatology (ACR) outcomes at 12 weeks were 40.8% for ACR20, 18.8% for ACR50, and 8.6% for ACR70. A total of 22.4% achieved minimal disease activity, defined as meeting five of these seven criteria: 0-1 tender joints, 0-1 swollen joints, Psoriasis Area and Severity Index (PASI) of 1 or less or body surface area involvement of 3 or less, patient pain visual analog score (VAS) of 15 or less, patient global disease activity VAS of 20 or less, health assessment questionnaire of 0.5 or less, and 0-1 tender entheseal points.

Other improvements that occurred at 12 weeks included 27.2% reaching a PASI75, a 62.7% drop in dactylitis incidence, a significant drop of –59.7 in Leeds dactylitis instrument median score, and a significant decrease in the proportion of patients with enthesitis (25.7%). However, the median change in enthesitis score was 0.

Response rates did not differ between patients receiving methotrexate 15 mg/week or higher doses, although there was generally a higher proportion who met various response criteria among those taking greater than 15 mg/week. However, the authors noted that there could be an underestimation of the dose effect because the design of the TICOPA study, which randomized patients to a protocol for tight control of psoriatic arthritis disease activity or standard care, introduced a bias by intentionally escalating treatment doses in patients who continue to have active disease.

The investigators advised that the study results be interpreted in the context of the open-label design of the study, and placed alongside the other observational studies that support its use in psoriatic arthritis.

No relevant conflicts of interest were disclosed.

Patients with psoriatic arthritis taking methotrexate demonstrated an improvement in peripheral joint disease, skin disease, enthesitis, dactylitis, and nail disease over 12 weeks in a subanalysis of methotrexate users in the TICOPA (Tight Control of Psoriatic Arthritis) study.

Out of the original 206 patients in the open-label, randomized, controlled TICOPA study, the subanalysis involved 188 who received methotrexate in its first 12 weeks. Substudy authors Dr. Laura C. Coates and Dr. Philip S. Helliwell of the Leeds Institute of Rheumatic and Musculoskeletal Medicine at the University of Leeds (England) verified a maximum dose at 12 weeks of at least 15 mg/week in 175, 20 mg/week in 122, and 25 mg/week in 86 (J Rheumatol. Dec 15. doi: 10.3899/jrheum.150614).

©Thinkstock.com

The proportions of patients achieving American College of Rheumatology (ACR) outcomes at 12 weeks were 40.8% for ACR20, 18.8% for ACR50, and 8.6% for ACR70. A total of 22.4% achieved minimal disease activity, defined as meeting five of these seven criteria: 0-1 tender joints, 0-1 swollen joints, Psoriasis Area and Severity Index (PASI) of 1 or less or body surface area involvement of 3 or less, patient pain visual analog score (VAS) of 15 or less, patient global disease activity VAS of 20 or less, health assessment questionnaire of 0.5 or less, and 0-1 tender entheseal points.

Other improvements that occurred at 12 weeks included 27.2% reaching a PASI75, a 62.7% drop in dactylitis incidence, a significant drop of –59.7 in Leeds dactylitis instrument median score, and a significant decrease in the proportion of patients with enthesitis (25.7%). However, the median change in enthesitis score was 0.

Response rates did not differ between patients receiving methotrexate 15 mg/week or higher doses, although there was generally a higher proportion who met various response criteria among those taking greater than 15 mg/week. However, the authors noted that there could be an underestimation of the dose effect because the design of the TICOPA study, which randomized patients to a protocol for tight control of psoriatic arthritis disease activity or standard care, introduced a bias by intentionally escalating treatment doses in patients who continue to have active disease.

The investigators advised that the study results be interpreted in the context of the open-label design of the study, and placed alongside the other observational studies that support its use in psoriatic arthritis.

No relevant conflicts of interest were disclosed.

Psoriatic arthritis in patients with spondyloarthritis conveys an increased risk of comorbidities, especially cardiovascular and metabolic diseases, as compared with spondyloarthritis alone.

The association persisted even after adjusting for demographic factors, disease duration, and length of treatment, Dr. Naba Haque of the University of Leuven (Belgium) and associates wrote in the Journal of Rheumatology (2015 Dec 15. doi: 10.3899/jrheum.141359).

In an analysis of 518 patients in the spondyloarthritis database at the university, over half (54%) had comorbidities, and those with psoriatic spondyloarthropathy had significantly more comorbidities than those without psoriatic arthropathy (P less than .001). Cardiovascular comorbidities were most common, with an increased prevalence of hypertension, coronary artery disease, and hyperlipidemia in the patients with psoriatic spondyloarthropathy (odds ratios, 1.81, 1.39, and 1.60, respectively; P less than .001). The differences persisted after adjusting for confounders such as age, sex, disease duration, and treatment.

Twice as many patients with spondyloarthritis and psoriatic arthropathy met the criteria for metabolic syndrome as did patients without psoriatric arthropathy (10% vs. 5%, P = .03). The regression model showed a significant difference in the prevalence of diabetes in the PsA patients (OR, 1.35; 95% confidence interval, 1.17-1.56; P less than .001). Psoriatic arthropathy also was linked to an increased risk of cancer (12% vs. 6%; P less than .05); however, the authors wrote that “we can only state a possible positive association … this observation needs to be studied in further detail.”

The study was supported by an unrestricted grant from the Abbvie Chair for psoriatic arthritis research (Dr. Rik J. Lories and Dr. Kurt de Vlam).

Psoriatic arthritis in patients with spondyloarthritis conveys an increased risk of comorbidities, especially cardiovascular and metabolic diseases, as compared with spondyloarthritis alone.

The association persisted even after adjusting for demographic factors, disease duration, and length of treatment, Dr. Naba Haque of the University of Leuven (Belgium) and associates wrote in the Journal of Rheumatology (2015 Dec 15. doi: 10.3899/jrheum.141359).

In an analysis of 518 patients in the spondyloarthritis database at the university, over half (54%) had comorbidities, and those with psoriatic spondyloarthropathy had significantly more comorbidities than those without psoriatic arthropathy (P less than .001). Cardiovascular comorbidities were most common, with an increased prevalence of hypertension, coronary artery disease, and hyperlipidemia in the patients with psoriatic spondyloarthropathy (odds ratios, 1.81, 1.39, and 1.60, respectively; P less than .001). The differences persisted after adjusting for confounders such as age, sex, disease duration, and treatment.

Twice as many patients with spondyloarthritis and psoriatic arthropathy met the criteria for metabolic syndrome as did patients without psoriatric arthropathy (10% vs. 5%, P = .03). The regression model showed a significant difference in the prevalence of diabetes in the PsA patients (OR, 1.35; 95% confidence interval, 1.17-1.56; P less than .001). Psoriatic arthropathy also was linked to an increased risk of cancer (12% vs. 6%; P less than .05); however, the authors wrote that “we can only state a possible positive association … this observation needs to be studied in further detail.”

The study was supported by an unrestricted grant from the Abbvie Chair for psoriatic arthritis research (Dr. Rik J. Lories and Dr. Kurt de Vlam).

Psoriatic arthritis in patients with spondyloarthritis conveys an increased risk of comorbidities, especially cardiovascular and metabolic diseases, as compared with spondyloarthritis alone.

The association persisted even after adjusting for demographic factors, disease duration, and length of treatment, Dr. Naba Haque of the University of Leuven (Belgium) and associates wrote in the Journal of Rheumatology (2015 Dec 15. doi: 10.3899/jrheum.141359).

In an analysis of 518 patients in the spondyloarthritis database at the university, over half (54%) had comorbidities, and those with psoriatic spondyloarthropathy had significantly more comorbidities than those without psoriatic arthropathy (P less than .001). Cardiovascular comorbidities were most common, with an increased prevalence of hypertension, coronary artery disease, and hyperlipidemia in the patients with psoriatic spondyloarthropathy (odds ratios, 1.81, 1.39, and 1.60, respectively; P less than .001). The differences persisted after adjusting for confounders such as age, sex, disease duration, and treatment.

Twice as many patients with spondyloarthritis and psoriatic arthropathy met the criteria for metabolic syndrome as did patients without psoriatric arthropathy (10% vs. 5%, P = .03). The regression model showed a significant difference in the prevalence of diabetes in the PsA patients (OR, 1.35; 95% confidence interval, 1.17-1.56; P less than .001). Psoriatic arthropathy also was linked to an increased risk of cancer (12% vs. 6%; P less than .05); however, the authors wrote that “we can only state a possible positive association … this observation needs to be studied in further detail.”

The study was supported by an unrestricted grant from the Abbvie Chair for psoriatic arthritis research (Dr. Rik J. Lories and Dr. Kurt de Vlam).

An alcohol-free aerosol foam that contains a fixed combination of calcipotriene 0.005% plus betamethasone dipropionate 0.064% provided rapid itch relief and was well tolerated in patients with psoriasis vulgaris, according to results from a randomized, phase III study.

In earlier phase II studies, the product, which is being developed by Denmark-based LEO Pharma, was shown to be effective and had a safe tolerability profile, with no clinically relevant impact on the hypothalamic-pituitary-adrenal axis or on calcium metabolism. In an effort to confirm the efficacy and safety profile seen in the phase II trials, researchers led by Dr. Craig Leonardi, a dermatologist at Saint Louis (Mo.) University, performed the phase III study to compare the aerosol foam product with vehicle when applied once daily for up to 4 weeks in patients with psoriasis vulgaris.

Reporting in the December 2015 issue of the Journal of Drugs in Dermatology, Dr. Leonardi and his associates at 27 outpatient sites enrolled 426 patients aged 18 years and older between June and October of 2013 in a trial known as PSO-FAST (Cal/BD Foam in Psoriasis Vulgaris, a Four-Week, Vehicle-Controlled, Efficacy, and Safety Trial). The primary outcome was the proportion of patients who achieved treatment success at week 4, based on the physician’s global assessment, which was defined as clear or almost clear (for patients with at least moderate disease at baseline) or clear (for patients who had mild disease at baseline). Secondary outcomes included a modified (excluding head) Psoriasis Area and Severity Index (mPASI) and patient’s assessment of itch based on a visual analog scale(J. Drugs Dermatol. 2015;14[12]:1468-77).

Of the 426 patients, 323 received the aerosol foam product, while 103 received the vehicle. Their median age was 51 years, 59% were male, and their mean body mass index was 32.3 kg/m^2. At week 4, the researchers found that significantly more patients in the aerosol foam group achieved treatment success, compared with those in the vehicle group (53.3% vs. 4.8%, respectively; odds ratio 30.3; P less than .001).

In addition, the mean mPASI score was significantly lower among patients in the aerosol foam group, compared with those in the vehicle group (a score of 2.0 vs. 5.5, for an adjusted difference of –3.3; P less than .001).

Among the 96% of patients who reported any level of itch at baseline, 36.8% in the aerosol foam group reported a 70% reduction in itch at day 3, compared with 24% of those in the vehicle group (OR 1.9; P = .018).

“This trial also demonstrated itch alleviation led to significant reductions in sleep loss, with 70.8% of patients using Cal/BD aerosol foam reporting a 70% reduction in itch-related sleep loss by week 4,” the researchers wrote.

No clinically significant changes in mean albumin-corrected serum calcium or urinary calcium to creatinine ratio was observed in either group. The researchers concluded that the Cal/DB aerosol foam product “may be a beneficial treatment option for those patients who are candidates for therapy with a superpotent steroid, but desire a therapeutic safety profile similar to that of a less potent steroid.”

[email protected]

An alcohol-free aerosol foam that contains a fixed combination of calcipotriene 0.005% plus betamethasone dipropionate 0.064% provided rapid itch relief and was well tolerated in patients with psoriasis vulgaris, according to results from a randomized, phase III study.

In earlier phase II studies, the product, which is being developed by Denmark-based LEO Pharma, was shown to be effective and had a safe tolerability profile, with no clinically relevant impact on the hypothalamic-pituitary-adrenal axis or on calcium metabolism. In an effort to confirm the efficacy and safety profile seen in the phase II trials, researchers led by Dr. Craig Leonardi, a dermatologist at Saint Louis (Mo.) University, performed the phase III study to compare the aerosol foam product with vehicle when applied once daily for up to 4 weeks in patients with psoriasis vulgaris.

Reporting in the December 2015 issue of the Journal of Drugs in Dermatology, Dr. Leonardi and his associates at 27 outpatient sites enrolled 426 patients aged 18 years and older between June and October of 2013 in a trial known as PSO-FAST (Cal/BD Foam in Psoriasis Vulgaris, a Four-Week, Vehicle-Controlled, Efficacy, and Safety Trial). The primary outcome was the proportion of patients who achieved treatment success at week 4, based on the physician’s global assessment, which was defined as clear or almost clear (for patients with at least moderate disease at baseline) or clear (for patients who had mild disease at baseline). Secondary outcomes included a modified (excluding head) Psoriasis Area and Severity Index (mPASI) and patient’s assessment of itch based on a visual analog scale(J. Drugs Dermatol. 2015;14[12]:1468-77).

Of the 426 patients, 323 received the aerosol foam product, while 103 received the vehicle. Their median age was 51 years, 59% were male, and their mean body mass index was 32.3 kg/m^2. At week 4, the researchers found that significantly more patients in the aerosol foam group achieved treatment success, compared with those in the vehicle group (53.3% vs. 4.8%, respectively; odds ratio 30.3; P less than .001).

In addition, the mean mPASI score was significantly lower among patients in the aerosol foam group, compared with those in the vehicle group (a score of 2.0 vs. 5.5, for an adjusted difference of –3.3; P less than .001).

Among the 96% of patients who reported any level of itch at baseline, 36.8% in the aerosol foam group reported a 70% reduction in itch at day 3, compared with 24% of those in the vehicle group (OR 1.9; P = .018).

“This trial also demonstrated itch alleviation led to significant reductions in sleep loss, with 70.8% of patients using Cal/BD aerosol foam reporting a 70% reduction in itch-related sleep loss by week 4,” the researchers wrote.

No clinically significant changes in mean albumin-corrected serum calcium or urinary calcium to creatinine ratio was observed in either group. The researchers concluded that the Cal/DB aerosol foam product “may be a beneficial treatment option for those patients who are candidates for therapy with a superpotent steroid, but desire a therapeutic safety profile similar to that of a less potent steroid.”

[email protected]

An alcohol-free aerosol foam that contains a fixed combination of calcipotriene 0.005% plus betamethasone dipropionate 0.064% provided rapid itch relief and was well tolerated in patients with psoriasis vulgaris, according to results from a randomized, phase III study.

In earlier phase II studies, the product, which is being developed by Denmark-based LEO Pharma, was shown to be effective and had a safe tolerability profile, with no clinically relevant impact on the hypothalamic-pituitary-adrenal axis or on calcium metabolism. In an effort to confirm the efficacy and safety profile seen in the phase II trials, researchers led by Dr. Craig Leonardi, a dermatologist at Saint Louis (Mo.) University, performed the phase III study to compare the aerosol foam product with vehicle when applied once daily for up to 4 weeks in patients with psoriasis vulgaris.

Reporting in the December 2015 issue of the Journal of Drugs in Dermatology, Dr. Leonardi and his associates at 27 outpatient sites enrolled 426 patients aged 18 years and older between June and October of 2013 in a trial known as PSO-FAST (Cal/BD Foam in Psoriasis Vulgaris, a Four-Week, Vehicle-Controlled, Efficacy, and Safety Trial). The primary outcome was the proportion of patients who achieved treatment success at week 4, based on the physician’s global assessment, which was defined as clear or almost clear (for patients with at least moderate disease at baseline) or clear (for patients who had mild disease at baseline). Secondary outcomes included a modified (excluding head) Psoriasis Area and Severity Index (mPASI) and patient’s assessment of itch based on a visual analog scale(J. Drugs Dermatol. 2015;14[12]:1468-77).

Of the 426 patients, 323 received the aerosol foam product, while 103 received the vehicle. Their median age was 51 years, 59% were male, and their mean body mass index was 32.3 kg/m^2. At week 4, the researchers found that significantly more patients in the aerosol foam group achieved treatment success, compared with those in the vehicle group (53.3% vs. 4.8%, respectively; odds ratio 30.3; P less than .001).

In addition, the mean mPASI score was significantly lower among patients in the aerosol foam group, compared with those in the vehicle group (a score of 2.0 vs. 5.5, for an adjusted difference of –3.3; P less than .001).

Among the 96% of patients who reported any level of itch at baseline, 36.8% in the aerosol foam group reported a 70% reduction in itch at day 3, compared with 24% of those in the vehicle group (OR 1.9; P = .018).

“This trial also demonstrated itch alleviation led to significant reductions in sleep loss, with 70.8% of patients using Cal/BD aerosol foam reporting a 70% reduction in itch-related sleep loss by week 4,” the researchers wrote.

No clinically significant changes in mean albumin-corrected serum calcium or urinary calcium to creatinine ratio was observed in either group. The researchers concluded that the Cal/DB aerosol foam product “may be a beneficial treatment option for those patients who are candidates for therapy with a superpotent steroid, but desire a therapeutic safety profile similar to that of a less potent steroid.”

[email protected]