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VIDEO: Are those musculoskeletal symptoms psoriatic arthritis?

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WAIKOLOA, HAWAII – Dermatologists are in a unique position to identify psoriatic arthritis in patients with psoriasis whose musculoskeletal symptoms may be too subtle for them to mention to an internist or seek out a rheumatologist, according to Dr. Brian Mandell of the Cleveland Clinic.

Dr. Mandell spoke with us in a video interview at the Hawaii Dermatology Seminar about the key questions to ask patients.

bjancin@frontlinemedcom.com

 

 

 

 

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WAIKOLOA, HAWAII – Dermatologists are in a unique position to identify psoriatic arthritis in patients with psoriasis whose musculoskeletal symptoms may be too subtle for them to mention to an internist or seek out a rheumatologist, according to Dr. Brian Mandell of the Cleveland Clinic.

Dr. Mandell spoke with us in a video interview at the Hawaii Dermatology Seminar about the key questions to ask patients.

bjancin@frontlinemedcom.com

 

 

 

 

WAIKOLOA, HAWAII – Dermatologists are in a unique position to identify psoriatic arthritis in patients with psoriasis whose musculoskeletal symptoms may be too subtle for them to mention to an internist or seek out a rheumatologist, according to Dr. Brian Mandell of the Cleveland Clinic.

Dr. Mandell spoke with us in a video interview at the Hawaii Dermatology Seminar about the key questions to ask patients.

bjancin@frontlinemedcom.com

 

 

 

 

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ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR

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VIDEO: Coffee Break 2: What did you learn at the meeting?

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WAIKOLOA, HAWAII – Our editor, Heidi Splete, catches up with attendees at the Hawaii Dermatology Seminar to find out what they learned at the meeting that they will take back to their practices.

During a coffee break video interview, doctors said they enjoyed presentations on tips to treat fine lines around the eyes and mouth, the link between psoriasis and increased cardiovascular risks, and the "two Cs" of potential leather allergies.

hsplete@frontlinemedcom.com

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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WAIKOLOA, HAWAII – Our editor, Heidi Splete, catches up with attendees at the Hawaii Dermatology Seminar to find out what they learned at the meeting that they will take back to their practices.

During a coffee break video interview, doctors said they enjoyed presentations on tips to treat fine lines around the eyes and mouth, the link between psoriasis and increased cardiovascular risks, and the "two Cs" of potential leather allergies.

hsplete@frontlinemedcom.com

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

WAIKOLOA, HAWAII – Our editor, Heidi Splete, catches up with attendees at the Hawaii Dermatology Seminar to find out what they learned at the meeting that they will take back to their practices.

During a coffee break video interview, doctors said they enjoyed presentations on tips to treat fine lines around the eyes and mouth, the link between psoriasis and increased cardiovascular risks, and the "two Cs" of potential leather allergies.

hsplete@frontlinemedcom.com

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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FROM SDEF HAWAII DERMATOLOGY SYMPOSIUM

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Psoriasis: The Story Worsens

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We have already come a long way from thinking that psoriasis is merely a cutaneous disease caused by a defect in cellular replication; we now recognize that psoriasis is a systemic inflammatory process that has broad health implications. This association is manifested by comorbidities such as the occurrence of the metabolic syndrome and an increased risk for myocardial infarction. An increased incidence of chronic obstructive pulmonary disease also has been demonstrated in patients with psoriasis, especially those who smoke. Unfortunately, recent publications have highlighted investigative work that expands the scope of psoriatic comorbidity into new realms.

Li and colleagues (Ann Rheum Dis. 2013;72:1200-1205) performed a retrospective analysis of 174,476 women enrolled in several large national health studies. They found an increased risk for incident Crohn disease (relative risk [RR], 4.00; 95% confidence interval [CI], 1.72-9.27) among women with psoriasis. This increased risk rose (RR, 6.43; 95% CI, 2.04-20.32) if both psoriasis and psoriatic arthritis were present. Although the risk for those who already have Crohn disease to develop psoriasis has been previously noted, this study provides the first convincing clinical evidence that the converse association also is true, which is is not totally surprising when one considers common genetic and aberrant cytokine profiles between Crohn disease and psoriasis to suggest an overlap in pathogenic mechanisms.

Perhaps more ominous was the recently published work of Wan and associates (BMJ. 2013;347:f5961). In this massive retrospective analysis utilizing detailed British electronic medical records, 136,529 patients with mild psoriasis and 7354 patients with severe psoriasis based on treatment patterns were matched to 689,702 unaffected patients. The investigators found a clear increased risk for chronic renal disease (RR, 1.93; 95% CI, 1.79-2.08) among those with severe psoriasis. The risk was higher in younger patients; for example, among those aged 30 years, the RR rose to 3.82 (95% CI, 3.15-4.64). The risk for developing renal disease was independent of well-known predisposing factors, such as diabetes mellitus and hypertension. The association between severe psoriasis and renal disease also appeared to be independent of medications administered for psoriasis (eg, cyclosporine).

Also alarming was a recently published systematic review and meta-analysis of 1080 publications concerning the potential association between psoriasis and cancer (J Eur Acad Dermatol Venereol. 2013;27[suppl 3]:36-46). Pouplard et al found that there may be an increased risk for the following solid cancers in psoriasis patients: respiratory tract cancer (RR, 1.52; 95% CI, 1.35-1.71), upper aerodigestive tract cancer (RR, 3.05; 95% CI, 1.74-5.32), urinary tract cancer (RR, 1.31; 95% CI, 1.11-1.55), and liver cancer (RR, 1.90; 95% CI, 1.48-2.44). To the authors, the association seemed particularly strong with these neoplasms, which are associated with excessive alcohol ingestion and smoking.

 

What’s the issue?

Why might these comorbidities occur? Perhaps chronic inflammation due to abnormal cytokine production and/or deviant immune defenses may promote these new (or better documented) psoriatic comorbidities. Why are they of importance to dermatologists? Because we are the primary source of care for patients with psoriasis, especially those with severe disease. We cannot stop our historical reviews and physical examination with the skin and joints; rather, we must consider the whole patient. We probably should at least perform a comprehensive history at each visit, being carefully attune to any new concerns that suggest gastrointestinal, pulmonary, and renal disease or internal neoplasia, which places an extra (and perhaps unwanted) burden of care on the dermatologist. However, the way I see it is that our role in early detection of an ever-expanding list of serious psoriatic comorbidities may be crucial to the ultimate long-term health of our patients. Are you ready to accept that intensified and enhanced medical responsibility?

We want to know your views! Tell us what you think.

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We have already come a long way from thinking that psoriasis is merely a cutaneous disease caused by a defect in cellular replication; we now recognize that psoriasis is a systemic inflammatory process that has broad health implications. This association is manifested by comorbidities such as the occurrence of the metabolic syndrome and an increased risk for myocardial infarction. An increased incidence of chronic obstructive pulmonary disease also has been demonstrated in patients with psoriasis, especially those who smoke. Unfortunately, recent publications have highlighted investigative work that expands the scope of psoriatic comorbidity into new realms.

Li and colleagues (Ann Rheum Dis. 2013;72:1200-1205) performed a retrospective analysis of 174,476 women enrolled in several large national health studies. They found an increased risk for incident Crohn disease (relative risk [RR], 4.00; 95% confidence interval [CI], 1.72-9.27) among women with psoriasis. This increased risk rose (RR, 6.43; 95% CI, 2.04-20.32) if both psoriasis and psoriatic arthritis were present. Although the risk for those who already have Crohn disease to develop psoriasis has been previously noted, this study provides the first convincing clinical evidence that the converse association also is true, which is is not totally surprising when one considers common genetic and aberrant cytokine profiles between Crohn disease and psoriasis to suggest an overlap in pathogenic mechanisms.

Perhaps more ominous was the recently published work of Wan and associates (BMJ. 2013;347:f5961). In this massive retrospective analysis utilizing detailed British electronic medical records, 136,529 patients with mild psoriasis and 7354 patients with severe psoriasis based on treatment patterns were matched to 689,702 unaffected patients. The investigators found a clear increased risk for chronic renal disease (RR, 1.93; 95% CI, 1.79-2.08) among those with severe psoriasis. The risk was higher in younger patients; for example, among those aged 30 years, the RR rose to 3.82 (95% CI, 3.15-4.64). The risk for developing renal disease was independent of well-known predisposing factors, such as diabetes mellitus and hypertension. The association between severe psoriasis and renal disease also appeared to be independent of medications administered for psoriasis (eg, cyclosporine).

Also alarming was a recently published systematic review and meta-analysis of 1080 publications concerning the potential association between psoriasis and cancer (J Eur Acad Dermatol Venereol. 2013;27[suppl 3]:36-46). Pouplard et al found that there may be an increased risk for the following solid cancers in psoriasis patients: respiratory tract cancer (RR, 1.52; 95% CI, 1.35-1.71), upper aerodigestive tract cancer (RR, 3.05; 95% CI, 1.74-5.32), urinary tract cancer (RR, 1.31; 95% CI, 1.11-1.55), and liver cancer (RR, 1.90; 95% CI, 1.48-2.44). To the authors, the association seemed particularly strong with these neoplasms, which are associated with excessive alcohol ingestion and smoking.

 

What’s the issue?

Why might these comorbidities occur? Perhaps chronic inflammation due to abnormal cytokine production and/or deviant immune defenses may promote these new (or better documented) psoriatic comorbidities. Why are they of importance to dermatologists? Because we are the primary source of care for patients with psoriasis, especially those with severe disease. We cannot stop our historical reviews and physical examination with the skin and joints; rather, we must consider the whole patient. We probably should at least perform a comprehensive history at each visit, being carefully attune to any new concerns that suggest gastrointestinal, pulmonary, and renal disease or internal neoplasia, which places an extra (and perhaps unwanted) burden of care on the dermatologist. However, the way I see it is that our role in early detection of an ever-expanding list of serious psoriatic comorbidities may be crucial to the ultimate long-term health of our patients. Are you ready to accept that intensified and enhanced medical responsibility?

We want to know your views! Tell us what you think.

We have already come a long way from thinking that psoriasis is merely a cutaneous disease caused by a defect in cellular replication; we now recognize that psoriasis is a systemic inflammatory process that has broad health implications. This association is manifested by comorbidities such as the occurrence of the metabolic syndrome and an increased risk for myocardial infarction. An increased incidence of chronic obstructive pulmonary disease also has been demonstrated in patients with psoriasis, especially those who smoke. Unfortunately, recent publications have highlighted investigative work that expands the scope of psoriatic comorbidity into new realms.

Li and colleagues (Ann Rheum Dis. 2013;72:1200-1205) performed a retrospective analysis of 174,476 women enrolled in several large national health studies. They found an increased risk for incident Crohn disease (relative risk [RR], 4.00; 95% confidence interval [CI], 1.72-9.27) among women with psoriasis. This increased risk rose (RR, 6.43; 95% CI, 2.04-20.32) if both psoriasis and psoriatic arthritis were present. Although the risk for those who already have Crohn disease to develop psoriasis has been previously noted, this study provides the first convincing clinical evidence that the converse association also is true, which is is not totally surprising when one considers common genetic and aberrant cytokine profiles between Crohn disease and psoriasis to suggest an overlap in pathogenic mechanisms.

Perhaps more ominous was the recently published work of Wan and associates (BMJ. 2013;347:f5961). In this massive retrospective analysis utilizing detailed British electronic medical records, 136,529 patients with mild psoriasis and 7354 patients with severe psoriasis based on treatment patterns were matched to 689,702 unaffected patients. The investigators found a clear increased risk for chronic renal disease (RR, 1.93; 95% CI, 1.79-2.08) among those with severe psoriasis. The risk was higher in younger patients; for example, among those aged 30 years, the RR rose to 3.82 (95% CI, 3.15-4.64). The risk for developing renal disease was independent of well-known predisposing factors, such as diabetes mellitus and hypertension. The association between severe psoriasis and renal disease also appeared to be independent of medications administered for psoriasis (eg, cyclosporine).

Also alarming was a recently published systematic review and meta-analysis of 1080 publications concerning the potential association between psoriasis and cancer (J Eur Acad Dermatol Venereol. 2013;27[suppl 3]:36-46). Pouplard et al found that there may be an increased risk for the following solid cancers in psoriasis patients: respiratory tract cancer (RR, 1.52; 95% CI, 1.35-1.71), upper aerodigestive tract cancer (RR, 3.05; 95% CI, 1.74-5.32), urinary tract cancer (RR, 1.31; 95% CI, 1.11-1.55), and liver cancer (RR, 1.90; 95% CI, 1.48-2.44). To the authors, the association seemed particularly strong with these neoplasms, which are associated with excessive alcohol ingestion and smoking.

 

What’s the issue?

Why might these comorbidities occur? Perhaps chronic inflammation due to abnormal cytokine production and/or deviant immune defenses may promote these new (or better documented) psoriatic comorbidities. Why are they of importance to dermatologists? Because we are the primary source of care for patients with psoriasis, especially those with severe disease. We cannot stop our historical reviews and physical examination with the skin and joints; rather, we must consider the whole patient. We probably should at least perform a comprehensive history at each visit, being carefully attune to any new concerns that suggest gastrointestinal, pulmonary, and renal disease or internal neoplasia, which places an extra (and perhaps unwanted) burden of care on the dermatologist. However, the way I see it is that our role in early detection of an ever-expanding list of serious psoriatic comorbidities may be crucial to the ultimate long-term health of our patients. Are you ready to accept that intensified and enhanced medical responsibility?

We want to know your views! Tell us what you think.

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VIDEO: Coffee Break 1: What did you learn at the meeting?

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WAIKOLOA, HAWAII – Our editor, Heidi Splete, catches up with attendees at the SDEF Hawaii Dermatology Seminar to find out what they learned at the meeting that they will take back to their practices.

During a coffee break video interview, doctors said they enjoyed presentations on the need to treat onychomycosis aggressively in patients with diabetes; diet and acne; and recent trends in the use of systemic biologic therapies for psoriasis.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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WAIKOLOA, HAWAII – Our editor, Heidi Splete, catches up with attendees at the SDEF Hawaii Dermatology Seminar to find out what they learned at the meeting that they will take back to their practices.

During a coffee break video interview, doctors said they enjoyed presentations on the need to treat onychomycosis aggressively in patients with diabetes; diet and acne; and recent trends in the use of systemic biologic therapies for psoriasis.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

WAIKOLOA, HAWAII – Our editor, Heidi Splete, catches up with attendees at the SDEF Hawaii Dermatology Seminar to find out what they learned at the meeting that they will take back to their practices.

During a coffee break video interview, doctors said they enjoyed presentations on the need to treat onychomycosis aggressively in patients with diabetes; diet and acne; and recent trends in the use of systemic biologic therapies for psoriasis.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR

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Calcipotriene/ betamethasone dipropionate for psoriasis cut health care costs

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Calcipotriene/ betamethasone dipropionate for psoriasis cut health care costs

WAIKOLOA, HAWAII – Topical calcipotriene/betamethasone diproprionate combination products as first-line therapy for newly diagnosed plaque psoriasis result in significantly fewer office visits and lower total health care costs than any other topical psoriasis medications.

That’s the central finding of a retrospective analysis of the MarketScan insurance claims database that included 1 year of follow-up of 7,307 patients placed on calcipotriene/betamethasone dipropionate combination products immediately after diagnosis of plaque psoriasis and 9,670 others who received prescriptions for other topical agents.

Dr. Steven R. Feldman

During that first year of treatment, patients on various formulations of calcipotriene/betamethasone dipropionate had a mean of 2.79 psoriasis-related office visits and 13.36 total office visits, compared with 4.25 and 16.08 visits, respectively, for patients on other topical psoriasis medications (P less than .0001), Dr. Steven R. Feldman reported in a poster at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Mean total health care costs per patient, including pharmacy costs and inpatient and outpatient care, also were significantly lower in the group on calcipotriene/betamethasone dipropionate at $7,786, compared with $11,757, according to Dr. Feldman, professor of dermatology, pathology, and public health sciences and director of the Center for Dermatology Research at Wake Forest University in Winston-Salem, N.C.

There were important baseline differences between the two groups. Of the patients treated with calcipotriene/betamethasone dipropionate, 88% had mild psoriasis, as did only 62% of the patients on other topicals. Psoriatic arthritis was present in 3% of patients on calcipotriene/betamethasone diproprionate, compared with 8% on other topical medications. In a statistical model that adjusted for these and other differences, health care costs during 1 year of follow-up remained significantly lower in the calcipotriene/betamethasone dipropionate group.

The study was funded by LEO Pharma. Dr. Feldman reported receiving research grants from LEO and a couple of dozen other pharmaceutical companies. He also serves as a consultant to 10 pharmaceutical companies.

SDEF and this news organization are owned by the same parent company.

bjancin@frontlinemedcom.com

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WAIKOLOA, HAWAII – Topical calcipotriene/betamethasone diproprionate combination products as first-line therapy for newly diagnosed plaque psoriasis result in significantly fewer office visits and lower total health care costs than any other topical psoriasis medications.

That’s the central finding of a retrospective analysis of the MarketScan insurance claims database that included 1 year of follow-up of 7,307 patients placed on calcipotriene/betamethasone dipropionate combination products immediately after diagnosis of plaque psoriasis and 9,670 others who received prescriptions for other topical agents.

Dr. Steven R. Feldman

During that first year of treatment, patients on various formulations of calcipotriene/betamethasone dipropionate had a mean of 2.79 psoriasis-related office visits and 13.36 total office visits, compared with 4.25 and 16.08 visits, respectively, for patients on other topical psoriasis medications (P less than .0001), Dr. Steven R. Feldman reported in a poster at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Mean total health care costs per patient, including pharmacy costs and inpatient and outpatient care, also were significantly lower in the group on calcipotriene/betamethasone dipropionate at $7,786, compared with $11,757, according to Dr. Feldman, professor of dermatology, pathology, and public health sciences and director of the Center for Dermatology Research at Wake Forest University in Winston-Salem, N.C.

There were important baseline differences between the two groups. Of the patients treated with calcipotriene/betamethasone dipropionate, 88% had mild psoriasis, as did only 62% of the patients on other topicals. Psoriatic arthritis was present in 3% of patients on calcipotriene/betamethasone diproprionate, compared with 8% on other topical medications. In a statistical model that adjusted for these and other differences, health care costs during 1 year of follow-up remained significantly lower in the calcipotriene/betamethasone dipropionate group.

The study was funded by LEO Pharma. Dr. Feldman reported receiving research grants from LEO and a couple of dozen other pharmaceutical companies. He also serves as a consultant to 10 pharmaceutical companies.

SDEF and this news organization are owned by the same parent company.

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Topical calcipotriene/betamethasone diproprionate combination products as first-line therapy for newly diagnosed plaque psoriasis result in significantly fewer office visits and lower total health care costs than any other topical psoriasis medications.

That’s the central finding of a retrospective analysis of the MarketScan insurance claims database that included 1 year of follow-up of 7,307 patients placed on calcipotriene/betamethasone dipropionate combination products immediately after diagnosis of plaque psoriasis and 9,670 others who received prescriptions for other topical agents.

Dr. Steven R. Feldman

During that first year of treatment, patients on various formulations of calcipotriene/betamethasone dipropionate had a mean of 2.79 psoriasis-related office visits and 13.36 total office visits, compared with 4.25 and 16.08 visits, respectively, for patients on other topical psoriasis medications (P less than .0001), Dr. Steven R. Feldman reported in a poster at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Mean total health care costs per patient, including pharmacy costs and inpatient and outpatient care, also were significantly lower in the group on calcipotriene/betamethasone dipropionate at $7,786, compared with $11,757, according to Dr. Feldman, professor of dermatology, pathology, and public health sciences and director of the Center for Dermatology Research at Wake Forest University in Winston-Salem, N.C.

There were important baseline differences between the two groups. Of the patients treated with calcipotriene/betamethasone dipropionate, 88% had mild psoriasis, as did only 62% of the patients on other topicals. Psoriatic arthritis was present in 3% of patients on calcipotriene/betamethasone diproprionate, compared with 8% on other topical medications. In a statistical model that adjusted for these and other differences, health care costs during 1 year of follow-up remained significantly lower in the calcipotriene/betamethasone dipropionate group.

The study was funded by LEO Pharma. Dr. Feldman reported receiving research grants from LEO and a couple of dozen other pharmaceutical companies. He also serves as a consultant to 10 pharmaceutical companies.

SDEF and this news organization are owned by the same parent company.

bjancin@frontlinemedcom.com

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Topical treatments for psoriasis: Molecules to watch

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Though it’s been more than a decade since a new class of topical medication has been approved for psoriasis, there are several promising new anti-inflammatory compounds to keep an eye on, says Dr. Linda Stein Gold.

Dr. Stein Gold, director of dermatology clinical research and division head of dermatology in the Henry Ford Health System in Detroit and West Bloomfield, Mich., highlighted several molecules first developed as oral therapies that are now under clinical investigation as topical treatments for psoriasis. If successful in phase III trials, these could offer important alternatives to topical steroids and vitamin D analogues, she said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Steroids can cause skin atrophy, among other adverse effects, when used long term, and vitamin D analogues can cause irritation.

Dr. Linda Stein Gold

The topical treatments in development, if successful, could fill an important need for patients whose disease is not severe enough to require systemic treatments, or as add-on therapies for patients whose psoriasis is not adequately controlled with systemic treatments.

Dr. Stein Gold named Janus kinase (JAK) inhibitors as a key group of medicines that block cytokine signaling in receptors involved in psoriasis. One topical formulation containing JAK 1 and 2 inhibitor was shown in a 2012 phase II trial (n = 29) to be well tolerated and to improve lesion thickness, scaling, and total area, with few and mild adverse events (J. Am. Acad. Dermatol. 2012;67:658-64).

A different JAK inhibitor, tofacitinib, which has also been studied in oral formulations as a treatment for psoriasis, was also recently shown to be effective as a topical formulation, improving clinical signs of plaque psoriasis in a 2013 phase IIa trial (Br. J. Dermatol. 2013;169:137-45)

Finally, Dr. Stein Gold talked about AN2728, a boron-containing molecule that works by inhibiting phosphodiesterase 4. Topical treatment with AN2728 was seen in a 2011 manufacturer-sponsored phase II study (n = 140) to show significant reductions in thickness and clinical improvement in the psoriatic plaque without dermal irritation. (41st ESDR, Barcelona, poster 244)

Dr. Stein Gold stressed the validity of complementary treatment with both topical corticosteroids and vitamin D analogues in psoriasis – and even topical tazarotene and tar – but said there was an "active future" for the new molecules.

Dr. Stein Gold disclosed relationships with Leo, Medicis, Stiefel, Galderma, Novartis, and Taro. SDEF and this news organization are owned by the same parent company.

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Though it’s been more than a decade since a new class of topical medication has been approved for psoriasis, there are several promising new anti-inflammatory compounds to keep an eye on, says Dr. Linda Stein Gold.

Dr. Stein Gold, director of dermatology clinical research and division head of dermatology in the Henry Ford Health System in Detroit and West Bloomfield, Mich., highlighted several molecules first developed as oral therapies that are now under clinical investigation as topical treatments for psoriasis. If successful in phase III trials, these could offer important alternatives to topical steroids and vitamin D analogues, she said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Steroids can cause skin atrophy, among other adverse effects, when used long term, and vitamin D analogues can cause irritation.

Dr. Linda Stein Gold

The topical treatments in development, if successful, could fill an important need for patients whose disease is not severe enough to require systemic treatments, or as add-on therapies for patients whose psoriasis is not adequately controlled with systemic treatments.

Dr. Stein Gold named Janus kinase (JAK) inhibitors as a key group of medicines that block cytokine signaling in receptors involved in psoriasis. One topical formulation containing JAK 1 and 2 inhibitor was shown in a 2012 phase II trial (n = 29) to be well tolerated and to improve lesion thickness, scaling, and total area, with few and mild adverse events (J. Am. Acad. Dermatol. 2012;67:658-64).

A different JAK inhibitor, tofacitinib, which has also been studied in oral formulations as a treatment for psoriasis, was also recently shown to be effective as a topical formulation, improving clinical signs of plaque psoriasis in a 2013 phase IIa trial (Br. J. Dermatol. 2013;169:137-45)

Finally, Dr. Stein Gold talked about AN2728, a boron-containing molecule that works by inhibiting phosphodiesterase 4. Topical treatment with AN2728 was seen in a 2011 manufacturer-sponsored phase II study (n = 140) to show significant reductions in thickness and clinical improvement in the psoriatic plaque without dermal irritation. (41st ESDR, Barcelona, poster 244)

Dr. Stein Gold stressed the validity of complementary treatment with both topical corticosteroids and vitamin D analogues in psoriasis – and even topical tazarotene and tar – but said there was an "active future" for the new molecules.

Dr. Stein Gold disclosed relationships with Leo, Medicis, Stiefel, Galderma, Novartis, and Taro. SDEF and this news organization are owned by the same parent company.

Though it’s been more than a decade since a new class of topical medication has been approved for psoriasis, there are several promising new anti-inflammatory compounds to keep an eye on, says Dr. Linda Stein Gold.

Dr. Stein Gold, director of dermatology clinical research and division head of dermatology in the Henry Ford Health System in Detroit and West Bloomfield, Mich., highlighted several molecules first developed as oral therapies that are now under clinical investigation as topical treatments for psoriasis. If successful in phase III trials, these could offer important alternatives to topical steroids and vitamin D analogues, she said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Steroids can cause skin atrophy, among other adverse effects, when used long term, and vitamin D analogues can cause irritation.

Dr. Linda Stein Gold

The topical treatments in development, if successful, could fill an important need for patients whose disease is not severe enough to require systemic treatments, or as add-on therapies for patients whose psoriasis is not adequately controlled with systemic treatments.

Dr. Stein Gold named Janus kinase (JAK) inhibitors as a key group of medicines that block cytokine signaling in receptors involved in psoriasis. One topical formulation containing JAK 1 and 2 inhibitor was shown in a 2012 phase II trial (n = 29) to be well tolerated and to improve lesion thickness, scaling, and total area, with few and mild adverse events (J. Am. Acad. Dermatol. 2012;67:658-64).

A different JAK inhibitor, tofacitinib, which has also been studied in oral formulations as a treatment for psoriasis, was also recently shown to be effective as a topical formulation, improving clinical signs of plaque psoriasis in a 2013 phase IIa trial (Br. J. Dermatol. 2013;169:137-45)

Finally, Dr. Stein Gold talked about AN2728, a boron-containing molecule that works by inhibiting phosphodiesterase 4. Topical treatment with AN2728 was seen in a 2011 manufacturer-sponsored phase II study (n = 140) to show significant reductions in thickness and clinical improvement in the psoriatic plaque without dermal irritation. (41st ESDR, Barcelona, poster 244)

Dr. Stein Gold stressed the validity of complementary treatment with both topical corticosteroids and vitamin D analogues in psoriasis – and even topical tazarotene and tar – but said there was an "active future" for the new molecules.

Dr. Stein Gold disclosed relationships with Leo, Medicis, Stiefel, Galderma, Novartis, and Taro. SDEF and this news organization are owned by the same parent company.

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SNOWMASS, COLO. – Total knee replacement surgery rates in patients with systemic lupus erythematosus jumped sixfold nationally during a recent 15-year span – and buried within this statistic is some very good news.

The sharp rise in total knee replacement (TKR) among systemic lupus erythematosus (SLE) patients has been driven by a hefty increase in operations performed for osteoarthritis, while TKR for active SLE in the knee has declined. These trends reflect the increased longevity of patients with SLE resulting from improved medical management. For the first time, large numbers of SLE patients are surviving to an age when they, like other Americans, are more vulnerable to osteoarthritis, Dr. Susan M. Goodman explained at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.

Dr. Susan M. Goodman

"Lupus is no longer the highly mortal disease that it was," she observed. "Clearly, patients are surviving and – I don’t know how else to put it – they’ve become middle-aged women who are having knee replacements, which is kind of a success."

She presented highlights of a soon-to-be-published study involving analysis of 10 state databases including nearly 2.8 million arthroplasties performed during 1991-2005. The rate of TKR in SLE patients climbed sixfold from 0.03 per 100,000 population in 1991 to 0.18 per 100,000 in 2005. Meanwhile, total hip replacement (THR) in SLE patients showed a modest but statistically significant increase from 0.11 to 0.18 cases per 100,000.

The proportion of lupus patients undergoing arthroplasty for avascular necrosis fell from 53% in 1991 to 24% in 2005, while the proportion undergoing arthroplasty because they developed osteoarthritis went from 23% to 61%.

Virtually all of the increase in total arthroplasties among SLE patients occurred in women aged 45 years and older. Their rate more than tripled during the study years, going from 0.076 to 0.271 cases per 100,000. Rates in female SLE patients aged 44 years and younger actually took a significant drop from 0.073 to 0.067 per 100,000. Rates in males aged 44 and younger remained flat over time, while men aged 45 and up showed a modest increase from a low baseline rate of 0.009 cases per 100,000 in 1991 to 0.034 per 100,000 in 2005, according to Dr. Goodman, a rheumatologist at the Hospital for Special Surgery and Cornell University, New York.

The proportion of TKRs among all arthroplasties performed in SLE patients increased from 16% in 1991 to 48% in 2005. Meanwhile, THRs decreased from 66% of all arthroplasties to 40%. Other joint replacements didn’t change much over time.

A particularly striking finding in the study was that the mean age at the time of arthroplasty in SLE patients increased by nearly a decade – 47.3 years in 1991 to 56.8 years in 2005. In contrast, the mean age at arthroplasty for osteoarthritis patients without SLE decreased from 71.5 to 69.0 years.

Dr. Goodman turned to additional studies by her research group and other investigators to provide a picture of arthroplasty outcomes in SLE patients.

In-hospital postoperative mortality was found to be increased in SLE patients, compared with rheumatoid arthritis patients or controls undergoing TKR or THR in a study of more than 1.5 million TKRs and THRs included in the Nationwide Inpatient Sample for 1993-2006. The Nationwide Inpatient Sample is the largest all-payer inpatient health care database in the United States.

In a multivariate logistic regression analysis adjusted for comorbidities, hospital type, and other potential confounders, investigators at Stanford (Calif.) University found that SLE patients undergoing THR had a 3.5-fold increased risk of death, compared with controls. This was driven by a 4.9-fold increased death risk in SLE patients undergoing nonelective THR or TKR, typically because of a fracture. In contrast, the rate of in-hospital death following TKR or THR in rheumatoid arthritis patients wasn’t significantly different from controls. The one comorbidity present on admission that was associated with markedly increased postoperative mortality was renal disease in SLE patients (J. Rheumatol. 2010;37:1467-72).

"Baseline renal dysfunction really seems to be a marker in lupus patients for bad perioperative outcome," Dr. Goodman observed, adding that there is a need for "increased vigilance" regarding this comorbidity.

A study of 57 SLE patients and 107 age-matched osteoarthritis patients who underwent THR at the Hospital for Special Surgery demonstrated that the lupus patients had more baseline comorbidities as reflected in their mean Charlson Comorbidity Index of 1.9, compared with 0.3 in the osteoarthritis group. Seventy-nine percent of the SLE patients, but none of the osteoarthritis patients, were on immunosuppressant therapy. The lupus patients had a 19% incidence of postoperative major adverse events, including deep vein thrombosis, arrhythmia, acute renal insufficiency, or additional surgery, compared with a 6% rate in the osteoarthritis group. The 6-day mean length of stay in the SLE group was a full day longer than that of the osteoarthritis patients, according to Dr. Goodman.

 

 

Another Hospital for Special Surgery study included 56 SLE patients undergoing THR and 45 with TKR, as well as 108 age-matched controls undergoing THR and 89 with TKR. The SLE patients had significantly worse baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores than did the osteoarthritis patients. At 2 years of follow-up, however, all four groups ended up with very good pain and function outcomes, with WOMAC scores in the 80-92 range.

Yet despite these excellent outcomes, the SLE patients still felt more limited by their chronic disease. This was reflected in their lower health-related quality of life on the SF-36 physical component summary score at 2 years of follow-up: 39 in the SLE THR patients, compared with 50.1 in the osteoarthritis THR group, and 38 in the SLE TKR patients, compared with 48.4 in the osteoarthritis controls.

This and other studies paint a picture of contemporary SLE patients undergoing TKR as more closely resembling osteoarthritis patients with TKR than SLE patients undergoing THR. The average age of the SLE TKR patients, at 62.4 years, was 8 years older than the SLE THR group. The SLE TKR group’s mean body mass index of 31.5 kg/m2 was 5 kg/m2 greater than in the SLE THR group. And none of the SLE TKR patients had avascular necrosis, compared with one-third of those undergoing THR.

Dr. Goodman reported having no relevant financial relationships.

bjancin@frontlinemedcom.com

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SNOWMASS, COLO. – Total knee replacement surgery rates in patients with systemic lupus erythematosus jumped sixfold nationally during a recent 15-year span – and buried within this statistic is some very good news.

The sharp rise in total knee replacement (TKR) among systemic lupus erythematosus (SLE) patients has been driven by a hefty increase in operations performed for osteoarthritis, while TKR for active SLE in the knee has declined. These trends reflect the increased longevity of patients with SLE resulting from improved medical management. For the first time, large numbers of SLE patients are surviving to an age when they, like other Americans, are more vulnerable to osteoarthritis, Dr. Susan M. Goodman explained at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.

Dr. Susan M. Goodman

"Lupus is no longer the highly mortal disease that it was," she observed. "Clearly, patients are surviving and – I don’t know how else to put it – they’ve become middle-aged women who are having knee replacements, which is kind of a success."

She presented highlights of a soon-to-be-published study involving analysis of 10 state databases including nearly 2.8 million arthroplasties performed during 1991-2005. The rate of TKR in SLE patients climbed sixfold from 0.03 per 100,000 population in 1991 to 0.18 per 100,000 in 2005. Meanwhile, total hip replacement (THR) in SLE patients showed a modest but statistically significant increase from 0.11 to 0.18 cases per 100,000.

The proportion of lupus patients undergoing arthroplasty for avascular necrosis fell from 53% in 1991 to 24% in 2005, while the proportion undergoing arthroplasty because they developed osteoarthritis went from 23% to 61%.

Virtually all of the increase in total arthroplasties among SLE patients occurred in women aged 45 years and older. Their rate more than tripled during the study years, going from 0.076 to 0.271 cases per 100,000. Rates in female SLE patients aged 44 years and younger actually took a significant drop from 0.073 to 0.067 per 100,000. Rates in males aged 44 and younger remained flat over time, while men aged 45 and up showed a modest increase from a low baseline rate of 0.009 cases per 100,000 in 1991 to 0.034 per 100,000 in 2005, according to Dr. Goodman, a rheumatologist at the Hospital for Special Surgery and Cornell University, New York.

The proportion of TKRs among all arthroplasties performed in SLE patients increased from 16% in 1991 to 48% in 2005. Meanwhile, THRs decreased from 66% of all arthroplasties to 40%. Other joint replacements didn’t change much over time.

A particularly striking finding in the study was that the mean age at the time of arthroplasty in SLE patients increased by nearly a decade – 47.3 years in 1991 to 56.8 years in 2005. In contrast, the mean age at arthroplasty for osteoarthritis patients without SLE decreased from 71.5 to 69.0 years.

Dr. Goodman turned to additional studies by her research group and other investigators to provide a picture of arthroplasty outcomes in SLE patients.

In-hospital postoperative mortality was found to be increased in SLE patients, compared with rheumatoid arthritis patients or controls undergoing TKR or THR in a study of more than 1.5 million TKRs and THRs included in the Nationwide Inpatient Sample for 1993-2006. The Nationwide Inpatient Sample is the largest all-payer inpatient health care database in the United States.

In a multivariate logistic regression analysis adjusted for comorbidities, hospital type, and other potential confounders, investigators at Stanford (Calif.) University found that SLE patients undergoing THR had a 3.5-fold increased risk of death, compared with controls. This was driven by a 4.9-fold increased death risk in SLE patients undergoing nonelective THR or TKR, typically because of a fracture. In contrast, the rate of in-hospital death following TKR or THR in rheumatoid arthritis patients wasn’t significantly different from controls. The one comorbidity present on admission that was associated with markedly increased postoperative mortality was renal disease in SLE patients (J. Rheumatol. 2010;37:1467-72).

"Baseline renal dysfunction really seems to be a marker in lupus patients for bad perioperative outcome," Dr. Goodman observed, adding that there is a need for "increased vigilance" regarding this comorbidity.

A study of 57 SLE patients and 107 age-matched osteoarthritis patients who underwent THR at the Hospital for Special Surgery demonstrated that the lupus patients had more baseline comorbidities as reflected in their mean Charlson Comorbidity Index of 1.9, compared with 0.3 in the osteoarthritis group. Seventy-nine percent of the SLE patients, but none of the osteoarthritis patients, were on immunosuppressant therapy. The lupus patients had a 19% incidence of postoperative major adverse events, including deep vein thrombosis, arrhythmia, acute renal insufficiency, or additional surgery, compared with a 6% rate in the osteoarthritis group. The 6-day mean length of stay in the SLE group was a full day longer than that of the osteoarthritis patients, according to Dr. Goodman.

 

 

Another Hospital for Special Surgery study included 56 SLE patients undergoing THR and 45 with TKR, as well as 108 age-matched controls undergoing THR and 89 with TKR. The SLE patients had significantly worse baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores than did the osteoarthritis patients. At 2 years of follow-up, however, all four groups ended up with very good pain and function outcomes, with WOMAC scores in the 80-92 range.

Yet despite these excellent outcomes, the SLE patients still felt more limited by their chronic disease. This was reflected in their lower health-related quality of life on the SF-36 physical component summary score at 2 years of follow-up: 39 in the SLE THR patients, compared with 50.1 in the osteoarthritis THR group, and 38 in the SLE TKR patients, compared with 48.4 in the osteoarthritis controls.

This and other studies paint a picture of contemporary SLE patients undergoing TKR as more closely resembling osteoarthritis patients with TKR than SLE patients undergoing THR. The average age of the SLE TKR patients, at 62.4 years, was 8 years older than the SLE THR group. The SLE TKR group’s mean body mass index of 31.5 kg/m2 was 5 kg/m2 greater than in the SLE THR group. And none of the SLE TKR patients had avascular necrosis, compared with one-third of those undergoing THR.

Dr. Goodman reported having no relevant financial relationships.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – Total knee replacement surgery rates in patients with systemic lupus erythematosus jumped sixfold nationally during a recent 15-year span – and buried within this statistic is some very good news.

The sharp rise in total knee replacement (TKR) among systemic lupus erythematosus (SLE) patients has been driven by a hefty increase in operations performed for osteoarthritis, while TKR for active SLE in the knee has declined. These trends reflect the increased longevity of patients with SLE resulting from improved medical management. For the first time, large numbers of SLE patients are surviving to an age when they, like other Americans, are more vulnerable to osteoarthritis, Dr. Susan M. Goodman explained at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.

Dr. Susan M. Goodman

"Lupus is no longer the highly mortal disease that it was," she observed. "Clearly, patients are surviving and – I don’t know how else to put it – they’ve become middle-aged women who are having knee replacements, which is kind of a success."

She presented highlights of a soon-to-be-published study involving analysis of 10 state databases including nearly 2.8 million arthroplasties performed during 1991-2005. The rate of TKR in SLE patients climbed sixfold from 0.03 per 100,000 population in 1991 to 0.18 per 100,000 in 2005. Meanwhile, total hip replacement (THR) in SLE patients showed a modest but statistically significant increase from 0.11 to 0.18 cases per 100,000.

The proportion of lupus patients undergoing arthroplasty for avascular necrosis fell from 53% in 1991 to 24% in 2005, while the proportion undergoing arthroplasty because they developed osteoarthritis went from 23% to 61%.

Virtually all of the increase in total arthroplasties among SLE patients occurred in women aged 45 years and older. Their rate more than tripled during the study years, going from 0.076 to 0.271 cases per 100,000. Rates in female SLE patients aged 44 years and younger actually took a significant drop from 0.073 to 0.067 per 100,000. Rates in males aged 44 and younger remained flat over time, while men aged 45 and up showed a modest increase from a low baseline rate of 0.009 cases per 100,000 in 1991 to 0.034 per 100,000 in 2005, according to Dr. Goodman, a rheumatologist at the Hospital for Special Surgery and Cornell University, New York.

The proportion of TKRs among all arthroplasties performed in SLE patients increased from 16% in 1991 to 48% in 2005. Meanwhile, THRs decreased from 66% of all arthroplasties to 40%. Other joint replacements didn’t change much over time.

A particularly striking finding in the study was that the mean age at the time of arthroplasty in SLE patients increased by nearly a decade – 47.3 years in 1991 to 56.8 years in 2005. In contrast, the mean age at arthroplasty for osteoarthritis patients without SLE decreased from 71.5 to 69.0 years.

Dr. Goodman turned to additional studies by her research group and other investigators to provide a picture of arthroplasty outcomes in SLE patients.

In-hospital postoperative mortality was found to be increased in SLE patients, compared with rheumatoid arthritis patients or controls undergoing TKR or THR in a study of more than 1.5 million TKRs and THRs included in the Nationwide Inpatient Sample for 1993-2006. The Nationwide Inpatient Sample is the largest all-payer inpatient health care database in the United States.

In a multivariate logistic regression analysis adjusted for comorbidities, hospital type, and other potential confounders, investigators at Stanford (Calif.) University found that SLE patients undergoing THR had a 3.5-fold increased risk of death, compared with controls. This was driven by a 4.9-fold increased death risk in SLE patients undergoing nonelective THR or TKR, typically because of a fracture. In contrast, the rate of in-hospital death following TKR or THR in rheumatoid arthritis patients wasn’t significantly different from controls. The one comorbidity present on admission that was associated with markedly increased postoperative mortality was renal disease in SLE patients (J. Rheumatol. 2010;37:1467-72).

"Baseline renal dysfunction really seems to be a marker in lupus patients for bad perioperative outcome," Dr. Goodman observed, adding that there is a need for "increased vigilance" regarding this comorbidity.

A study of 57 SLE patients and 107 age-matched osteoarthritis patients who underwent THR at the Hospital for Special Surgery demonstrated that the lupus patients had more baseline comorbidities as reflected in their mean Charlson Comorbidity Index of 1.9, compared with 0.3 in the osteoarthritis group. Seventy-nine percent of the SLE patients, but none of the osteoarthritis patients, were on immunosuppressant therapy. The lupus patients had a 19% incidence of postoperative major adverse events, including deep vein thrombosis, arrhythmia, acute renal insufficiency, or additional surgery, compared with a 6% rate in the osteoarthritis group. The 6-day mean length of stay in the SLE group was a full day longer than that of the osteoarthritis patients, according to Dr. Goodman.

 

 

Another Hospital for Special Surgery study included 56 SLE patients undergoing THR and 45 with TKR, as well as 108 age-matched controls undergoing THR and 89 with TKR. The SLE patients had significantly worse baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores than did the osteoarthritis patients. At 2 years of follow-up, however, all four groups ended up with very good pain and function outcomes, with WOMAC scores in the 80-92 range.

Yet despite these excellent outcomes, the SLE patients still felt more limited by their chronic disease. This was reflected in their lower health-related quality of life on the SF-36 physical component summary score at 2 years of follow-up: 39 in the SLE THR patients, compared with 50.1 in the osteoarthritis THR group, and 38 in the SLE TKR patients, compared with 48.4 in the osteoarthritis controls.

This and other studies paint a picture of contemporary SLE patients undergoing TKR as more closely resembling osteoarthritis patients with TKR than SLE patients undergoing THR. The average age of the SLE TKR patients, at 62.4 years, was 8 years older than the SLE THR group. The SLE TKR group’s mean body mass index of 31.5 kg/m2 was 5 kg/m2 greater than in the SLE THR group. And none of the SLE TKR patients had avascular necrosis, compared with one-third of those undergoing THR.

Dr. Goodman reported having no relevant financial relationships.

bjancin@frontlinemedcom.com

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EXPERT ANALYSIS FROM THE WINTER RHEUMATOLOGY SYMPOSIUM

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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:

  1. the biosimilar has been designated by the Food and Drug Administration as interchangeable with the prescribed biologic for the specified indicated use;
  2. 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;
  3. the biosimilar product follows the same route of administration and dosage form as the reference product;
  4. the pharmacist notifies the prescriber in writing or electronic communication of the intention to substitute at least 24 hours prior to the substitution;
  5. if explicit permission from prescribing physician and patient is not obtained within 24 hours, then the original prescription must be filled;
  6. the patient (or patient's authorized representative) must be informed and educated about a biosimilar substitution at the point of sale; and
  7. 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?

We want to know your views. Tell us what you think.

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Dr. Weinberg is from the Icahn School of Medicine at Mount Sinai, New York, New York.

Dr. Weinberg is a member of the medical board for the National Psoriasis Foundation; is a speaker for Abbott Laboratories and Amgen Inc; and has received research grants from Amgen Inc, Celgene Corporation, and LEO Pharma.

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Dr. Weinberg is a member of the medical board for the National Psoriasis Foundation; is a speaker for Abbott Laboratories and Amgen Inc; and has received research grants from Amgen Inc, Celgene Corporation, and LEO Pharma.

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Dr. Weinberg is from the Icahn School of Medicine at Mount Sinai, New York, New York.

Dr. Weinberg is a member of the medical board for the National Psoriasis Foundation; is a speaker for Abbott Laboratories and Amgen Inc; and has received research grants from Amgen Inc, Celgene Corporation, and LEO Pharma.

Related Articles

 

 

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:

  1. the biosimilar has been designated by the Food and Drug Administration as interchangeable with the prescribed biologic for the specified indicated use;
  2. 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;
  3. the biosimilar product follows the same route of administration and dosage form as the reference product;
  4. the pharmacist notifies the prescriber in writing or electronic communication of the intention to substitute at least 24 hours prior to the substitution;
  5. if explicit permission from prescribing physician and patient is not obtained within 24 hours, then the original prescription must be filled;
  6. the patient (or patient's authorized representative) must be informed and educated about a biosimilar substitution at the point of sale; and
  7. 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?

We want to know your views. Tell us what you think.

 

 

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:

  1. the biosimilar has been designated by the Food and Drug Administration as interchangeable with the prescribed biologic for the specified indicated use;
  2. 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;
  3. the biosimilar product follows the same route of administration and dosage form as the reference product;
  4. the pharmacist notifies the prescriber in writing or electronic communication of the intention to substitute at least 24 hours prior to the substitution;
  5. if explicit permission from prescribing physician and patient is not obtained within 24 hours, then the original prescription must be filled;
  6. the patient (or patient's authorized representative) must be informed and educated about a biosimilar substitution at the point of sale; and
  7. 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?

We want to know your views. Tell us what you think.

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AAD identifies important knowledge gaps for psoriasis

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The three most important gaps in current understanding of psoriasis are the need to fully elucidate the genetic underpinnings of the disease, delineate in more detail its natural history and prognostic factors, and better characterize and treat its associated comorbidities, according to an article in the Journal of the American Academy of Dermatology.

The academy recently issued guidelines for the management of psoriasis and psoriatic arthritis, which included a section concerning the most prominent deficiencies in knowledge about the disease. In the current article (J. Am. Acad. Dermatol. 2014;70:146-67), the expert panel that wrote the guidelines now details some of those gaps and suggests how future research should address them.

Advances in genetic research have allowed considerable progress in our understanding of the pathogenesis of psoriasis, including the identification of genetic susceptibility regions and nucleotide polymorphisms that are significantly associated with immune pathways, skin barrier function, and epidermal proliferation. Future research should "explore whether the genetic basis of psoriasis stems from a primary defect in immunologic function, a defect in keratinocyte function, or a complex interaction of both," wrote Dr. Caitriona Ryan of the Psoriasis Research Center, Baylor University Medical Center, Dallas, and her associates on the expert panel.

In particular, genetic research should help elucidate the correlation between psoriasis genotype and phenotype, determining whether psoriasis and psoriatic arthritis are genetically distinct diseases, as well as the genetic differences underlying guttate, erythrodermic, inverse, palmoplantar, and pustular forms of the disease.

Immunologic studies are needed to define the roles of various inflammatory cells in patients’ skin and blood, and to assist the development of targeted immunotherapies that will correct immunologic dysfunction without causing adverse immunosuppression. Similarly, the role of angiogenesis and the vascular bed in the pathogenesis of psoriasis requires more research attention, because topical or systemic inhibition of this process appears to be beneficial.

Additionally, the environmental factors that predispose to the development of psoriasis or contribute to disease exacerbations are still poorly defined. Research into lifestyle factors and the role of bacterial and viral infections should be especially revealing, Dr. Ryan and her associates said.

Research to determine the prevalence and natural history of psoriasis across different populations also is critical. Robust, long-term, prospective epidemiology studies at the population level are key.

Several subpopulations of psoriasis patients also deserve special attention. There is a dearth of both clinical and basic scientific data on pediatric psoriasis, when children are the very patients most likely to suffer the adverse psychosocial effects of psoriasis and the most vulnerable to the adverse physical and developmental effects of treatments, the investigators noted.

Women who are pregnant or breastfeeding constitute another important subgroup of psoriasis patients. Studies are urgently needed to examine the effects of the disease itself and of its therapies on pregnancy outcomes. Similarly, the elderly are a subgroup of patients that requires special attention to adverse medication effects, because they have a high prevalence of comorbid conditions, greater use of concomitant medications, diminished renal function, and age-related changes in pharmacokinetics and pharmacodynamics.

Finally, future research must more closely examine several comorbidities now known to accompany psoriasis, including diabetes, obesity, the metabolic syndrome, and, most importantly, cardiovascular disease.

Severe psoriasis now should be considered an independent cardiovascular risk factor. "As physicians, it is our responsibility to counsel patients with psoriasis regarding the increased risk of cardiometabolic conditions and the need for lifestyle modifications, including smoking cessation, weight reduction, and regular screening for diabetes and hypertension," Dr. Ryan and her colleagues said.

Determining whether systemic treatment of psoriasis mitigates cardiometabolic risk, especially if it entails newer biologic agents, also is important, they added.

Psychological comorbidities should not be overlooked. Patients with psoriasis are known to have high rates of anxiety, depression, and alexithymia—the inability to recognize or discuss feelings or emotional states. Relaxation techniques, meditation, and cognitive-behavioral therapy have shown efficacy and need further assessment.

Sexual functioning also should be studied in greater detail, since psoriasis can have a significant impact on sexuality, particularly if the disease affects the genitals.

Dr. Ryan reported ties to Janssen-Cilag, Pfizer, Galderma, and Abbott, and her associates reported ties to numerous industry sources.

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The three most important gaps in current understanding of psoriasis are the need to fully elucidate the genetic underpinnings of the disease, delineate in more detail its natural history and prognostic factors, and better characterize and treat its associated comorbidities, according to an article in the Journal of the American Academy of Dermatology.

The academy recently issued guidelines for the management of psoriasis and psoriatic arthritis, which included a section concerning the most prominent deficiencies in knowledge about the disease. In the current article (J. Am. Acad. Dermatol. 2014;70:146-67), the expert panel that wrote the guidelines now details some of those gaps and suggests how future research should address them.

Advances in genetic research have allowed considerable progress in our understanding of the pathogenesis of psoriasis, including the identification of genetic susceptibility regions and nucleotide polymorphisms that are significantly associated with immune pathways, skin barrier function, and epidermal proliferation. Future research should "explore whether the genetic basis of psoriasis stems from a primary defect in immunologic function, a defect in keratinocyte function, or a complex interaction of both," wrote Dr. Caitriona Ryan of the Psoriasis Research Center, Baylor University Medical Center, Dallas, and her associates on the expert panel.

In particular, genetic research should help elucidate the correlation between psoriasis genotype and phenotype, determining whether psoriasis and psoriatic arthritis are genetically distinct diseases, as well as the genetic differences underlying guttate, erythrodermic, inverse, palmoplantar, and pustular forms of the disease.

Immunologic studies are needed to define the roles of various inflammatory cells in patients’ skin and blood, and to assist the development of targeted immunotherapies that will correct immunologic dysfunction without causing adverse immunosuppression. Similarly, the role of angiogenesis and the vascular bed in the pathogenesis of psoriasis requires more research attention, because topical or systemic inhibition of this process appears to be beneficial.

Additionally, the environmental factors that predispose to the development of psoriasis or contribute to disease exacerbations are still poorly defined. Research into lifestyle factors and the role of bacterial and viral infections should be especially revealing, Dr. Ryan and her associates said.

Research to determine the prevalence and natural history of psoriasis across different populations also is critical. Robust, long-term, prospective epidemiology studies at the population level are key.

Several subpopulations of psoriasis patients also deserve special attention. There is a dearth of both clinical and basic scientific data on pediatric psoriasis, when children are the very patients most likely to suffer the adverse psychosocial effects of psoriasis and the most vulnerable to the adverse physical and developmental effects of treatments, the investigators noted.

Women who are pregnant or breastfeeding constitute another important subgroup of psoriasis patients. Studies are urgently needed to examine the effects of the disease itself and of its therapies on pregnancy outcomes. Similarly, the elderly are a subgroup of patients that requires special attention to adverse medication effects, because they have a high prevalence of comorbid conditions, greater use of concomitant medications, diminished renal function, and age-related changes in pharmacokinetics and pharmacodynamics.

Finally, future research must more closely examine several comorbidities now known to accompany psoriasis, including diabetes, obesity, the metabolic syndrome, and, most importantly, cardiovascular disease.

Severe psoriasis now should be considered an independent cardiovascular risk factor. "As physicians, it is our responsibility to counsel patients with psoriasis regarding the increased risk of cardiometabolic conditions and the need for lifestyle modifications, including smoking cessation, weight reduction, and regular screening for diabetes and hypertension," Dr. Ryan and her colleagues said.

Determining whether systemic treatment of psoriasis mitigates cardiometabolic risk, especially if it entails newer biologic agents, also is important, they added.

Psychological comorbidities should not be overlooked. Patients with psoriasis are known to have high rates of anxiety, depression, and alexithymia—the inability to recognize or discuss feelings or emotional states. Relaxation techniques, meditation, and cognitive-behavioral therapy have shown efficacy and need further assessment.

Sexual functioning also should be studied in greater detail, since psoriasis can have a significant impact on sexuality, particularly if the disease affects the genitals.

Dr. Ryan reported ties to Janssen-Cilag, Pfizer, Galderma, and Abbott, and her associates reported ties to numerous industry sources.

The three most important gaps in current understanding of psoriasis are the need to fully elucidate the genetic underpinnings of the disease, delineate in more detail its natural history and prognostic factors, and better characterize and treat its associated comorbidities, according to an article in the Journal of the American Academy of Dermatology.

The academy recently issued guidelines for the management of psoriasis and psoriatic arthritis, which included a section concerning the most prominent deficiencies in knowledge about the disease. In the current article (J. Am. Acad. Dermatol. 2014;70:146-67), the expert panel that wrote the guidelines now details some of those gaps and suggests how future research should address them.

Advances in genetic research have allowed considerable progress in our understanding of the pathogenesis of psoriasis, including the identification of genetic susceptibility regions and nucleotide polymorphisms that are significantly associated with immune pathways, skin barrier function, and epidermal proliferation. Future research should "explore whether the genetic basis of psoriasis stems from a primary defect in immunologic function, a defect in keratinocyte function, or a complex interaction of both," wrote Dr. Caitriona Ryan of the Psoriasis Research Center, Baylor University Medical Center, Dallas, and her associates on the expert panel.

In particular, genetic research should help elucidate the correlation between psoriasis genotype and phenotype, determining whether psoriasis and psoriatic arthritis are genetically distinct diseases, as well as the genetic differences underlying guttate, erythrodermic, inverse, palmoplantar, and pustular forms of the disease.

Immunologic studies are needed to define the roles of various inflammatory cells in patients’ skin and blood, and to assist the development of targeted immunotherapies that will correct immunologic dysfunction without causing adverse immunosuppression. Similarly, the role of angiogenesis and the vascular bed in the pathogenesis of psoriasis requires more research attention, because topical or systemic inhibition of this process appears to be beneficial.

Additionally, the environmental factors that predispose to the development of psoriasis or contribute to disease exacerbations are still poorly defined. Research into lifestyle factors and the role of bacterial and viral infections should be especially revealing, Dr. Ryan and her associates said.

Research to determine the prevalence and natural history of psoriasis across different populations also is critical. Robust, long-term, prospective epidemiology studies at the population level are key.

Several subpopulations of psoriasis patients also deserve special attention. There is a dearth of both clinical and basic scientific data on pediatric psoriasis, when children are the very patients most likely to suffer the adverse psychosocial effects of psoriasis and the most vulnerable to the adverse physical and developmental effects of treatments, the investigators noted.

Women who are pregnant or breastfeeding constitute another important subgroup of psoriasis patients. Studies are urgently needed to examine the effects of the disease itself and of its therapies on pregnancy outcomes. Similarly, the elderly are a subgroup of patients that requires special attention to adverse medication effects, because they have a high prevalence of comorbid conditions, greater use of concomitant medications, diminished renal function, and age-related changes in pharmacokinetics and pharmacodynamics.

Finally, future research must more closely examine several comorbidities now known to accompany psoriasis, including diabetes, obesity, the metabolic syndrome, and, most importantly, cardiovascular disease.

Severe psoriasis now should be considered an independent cardiovascular risk factor. "As physicians, it is our responsibility to counsel patients with psoriasis regarding the increased risk of cardiometabolic conditions and the need for lifestyle modifications, including smoking cessation, weight reduction, and regular screening for diabetes and hypertension," Dr. Ryan and her colleagues said.

Determining whether systemic treatment of psoriasis mitigates cardiometabolic risk, especially if it entails newer biologic agents, also is important, they added.

Psychological comorbidities should not be overlooked. Patients with psoriasis are known to have high rates of anxiety, depression, and alexithymia—the inability to recognize or discuss feelings or emotional states. Relaxation techniques, meditation, and cognitive-behavioral therapy have shown efficacy and need further assessment.

Sexual functioning also should be studied in greater detail, since psoriasis can have a significant impact on sexuality, particularly if the disease affects the genitals.

Dr. Ryan reported ties to Janssen-Cilag, Pfizer, Galderma, and Abbott, and her associates reported ties to numerous industry sources.

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AAD identifies important knowledge gaps for psoriasis
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