Psoriasis Collection

To the Editor:

Both alopecia areata (AA) and psoriasis vulgaris are chronic relapsing autoimmune diseases, with AA causing nonscarring hair loss in approximately 0.1% to 0.2%¹ of the population with a lifetime risk of 1.7%,² and psoriasis more broadly impacting 1.5% to 2% of the population.³ The helper T cell (T_H1) cytokine milieu is pathogenic in both conditions.^4-6 IFN-γ knockout mice, unlike their wild-type counterparts, do not exhibit AA.⁷ Psoriasis is notably improved by IL-10 injections, which dampen the T_H1 response.⁸ Distinct from AA, T_H17 and T_H22 cells have been implicated as key players in psoriasis pathogenesis, along with the associated IL-17 and IL-22 cytokines.^9-12

Few cases of patients with concurrent AA and psoriasis have been described. Interestingly, these cases document normal hair regrowth in the areas of psoriasis.^13-16 These cases may offer unique insight into the immune factors driving each disease. We describe a case of a man with both alopecia universalis (AU) and psoriasis who developed hair regrowth in some of the psoriatic plaques.

A 34-year-old man with concurrent AU and psoriasis who had not used any systemic or topical medication for either condition in the last year presented to our clinic seeking treatment. The patient had a history of alopecia totalis as a toddler that completely resolved by 4 years of age with the use of squaric acid dibutylester (SADBE). At 31 years of age, the alopecia recurred and was localized to the scalp. It was partially responsive to intralesional triamcinolone acetonide. The patient’s alopecia worsened over the 2 years following recurrence, ultimately progressing to AU. Two months after the alopecia recurrence, he developed the first psoriatic plaques. As the plaque psoriasis progressed, systemic therapy was initiated, first methotrexate and then etanercept. Shortly after developing AU, he lost his health insurance and discontinued all therapy. The patient’s psoriasis began to recur approximately 3 months after stopping etanercept. He was not using any other psoriasis medications. At that time, he noted terminal hair regrowth within some of the psoriatic plaques. No terminal hairs grew outside of the psoriatic plaques, and all regions with growth had previously been without hair for an extended period of time. The patient presented to our clinic approximately 1 year later. He had no other medical conditions and no relevant family history.

On initial physical examination, he had nonscarring hair loss involving nearly 100% of the body with psoriatic plaques on approximately 30% of the body surface area. Regions of terminal hair growth were confined to some but not all of the psoriatic plaques (Figure). Interestingly, the terminal hairs were primarily localized to the thickest central regions of the plaques. The patient’s psoriasis was treated with a combination of topical clobetasol and calcipotriene. In addition, he was started on tacrolimus ointment to the face and eyebrows for the AA. Maintenance of terminal hair within a region of topically treated psoriasis on the forearm persisted at the 2-month follow-up despite complete clearance of the corresponding psoriatic plaque. A small psoriatic plaque on the scalp cleared early with topical therapy without noticeable hair regrowth. The patient subsequently was started on contact immunotherapy with SADBE and intralesional triamcinolone acetonide for the scalp alopecia without satisfactory response. He decided to discontinue further attempts at treating the alopecia and requested to be restarted on etanercept therapy for recalcitrant psoriatic plaques. His psoriasis responded well to this therapy and he continues to be followed in our psoriasis clinic. One year after clearance of the treated psoriatic plaques, the corresponding terminal hairs persist.

Contact immunotherapy, most commonly with diphenylcyclopropenone or SADBE, is reported to have a 50% to 60% success rate in extensive AA, with a broad range of 9% to 87%¹⁷; however, randomized controlled trials testing the efficacy of contact immunotherapy are lacking. Although the mechanism of action of these topical sensitizers is not clearly delineated, it has been postulated that by inducing a new type of inflammatory response in the region, the immunologic milieu is changed, allowing the hair to grow. Some proposed mechanisms include promoting perifollicular lymphocyte apoptosis, preventing new recruitment of autoreactive lymphocytes, and allowing for the correction of aberrant major histocompatibility complex expression on the hair matrix epithelium to regain follicle immune privilege.^18-20

Iatrogenic immunotherapy may work analogously to the natural immune system deviation demonstrated in our patient. Psoriasis and AA are believed to form competing immune cells and cytokine milieus, thus explaining how an individual with AA could regain normal hair growth in areas of psoriasis.^15,16 The Renbök phenomenon, or reverse Köbner phenomenon, coined by Happle et al¹³ can be used to describe both the iatrogenic and natural cases of dermatologic disease improvement in response to secondary insults.¹⁴

A complex cascade of immune cells and cytokines coordinate AA pathogenesis. In the acute stage of AA, an inflammatory infiltrate of CD4⁺ T cells, CD8⁺ T cells, and antigen-presenting cells target anagen phase follicles, with a higher CD4⁺:CD8⁺ ratio in clinically active disease.^21-23 Subcutaneous injections of either CD4⁺ or CD8⁺ lymphocyte subsets from mice with AA into normal-haired mice induces disease. However, CD8⁺ T cell injections rapidly produce apparent hair loss, whereas CD4⁺ T cells cause hair loss after several weeks, suggesting that CD8⁺ T cells directly modulate AA hair loss and CD4⁺ T cells act as an aide.²⁴ The growth, differentiation, and survival of CD8⁺ T cells are stimulated by IL-2 and IFN-γ. Alopecia areata biopsies demonstrate a prevalence of T_H1 cytokines, and patients with localized AA, alopecia totalis, and AU have notably higher serum IFN-γ levels compared to controls.²⁵ In murine models, IL-1α and IL-1β increase during the catagen phase of the hair cycle and peak during the telogen phase.²⁶ Excessive IL-1β expression is detected in the early stages of human disease, and certain IL-1β polymorphisms are associated with severe forms of AA.²⁶ The role of tumor necrosis factor (TNF) α in AA is not well understood. In vitro studies show it inhibits hair growth, suggesting the cytokine may play a role in AA.²⁷ However, anti–TNF-α therapy is not effective in AA, and case reports propose these therapies rarely induce AA.^28-31

The T_H1 response is likewise critical to psoriatic plaque development. IFN-γ and TNF-α are overexpressed in psoriatic plaques.³² IFN-γ has an antiproliferative and differentiation-inducing effect on normal keratinocytes, but psoriatic epithelial cells in vitro respond differently to the cytokine with a notably diminished growth inhibition.^33,34 One explanation for the role of IFN-γ is that it stimulates dendritic cells to produce IL-1 and IL-23.³⁵ IL-23 activates T_H17 cells³⁶; T_H1 and T_H17 conditions produce IL-22 whose serum level correlates with disease severity.^37-39 IL-22 induces keratinocyte proliferation and migration and inhibits keratinocyte differentiation, helping account for hallmarks of the disease.⁴⁰ Patients with psoriasis have increased levels of T_H1, T_H17, and T_H22 cells, as well as their associated cytokines, in the skin and blood compared to controls.^{4,11,32,39,41}

Alopecia areata and psoriasis are regulated by complex and still not entirely understood immune interactions. The fact that many of the same therapies are used to treat both diseases emphasizes both their overlapping characteristics and the lack of targeted therapy. It is unclear if and how the topical or systemic therapies used in our patient to treat one disease affected the natural history of the other condition. It is important to highlight, however, that the patient had not been treated for months when he developed the psoriatic plaques with hair regrowth. Other case reports also document hair regrowth in untreated plaques,^13,16 making it unlikely to be a side effect of the medication regimen. For both psoriasis and AA, the immune cell composition and cytokine levels in the skin or serum vary throughout a patient’s disease course depending on severity of disease or response to treatment.^6,39,42,43 Therefore, we hypothesize that the 2 conditions interact in a similarly distinct manner based on each disease’s stage and intensity in the patient. Both our patient’s course thus far and the various presentations described by other groups support this hypothesis. Our patient had a small region of psoriasis on the scalp that cleared without any terminal hair growth. He also had larger plaques on the forearms that developed hair growth most predominantly within the thicker regions of the plaques. His unique presentation highlights the fluidity of the immune factors driving psoriasis vulgaris and AA.

To the Editor:

Both alopecia areata (AA) and psoriasis vulgaris are chronic relapsing autoimmune diseases, with AA causing nonscarring hair loss in approximately 0.1% to 0.2%¹ of the population with a lifetime risk of 1.7%,² and psoriasis more broadly impacting 1.5% to 2% of the population.³ The helper T cell (T_H1) cytokine milieu is pathogenic in both conditions.^4-6 IFN-γ knockout mice, unlike their wild-type counterparts, do not exhibit AA.⁷ Psoriasis is notably improved by IL-10 injections, which dampen the T_H1 response.⁸ Distinct from AA, T_H17 and T_H22 cells have been implicated as key players in psoriasis pathogenesis, along with the associated IL-17 and IL-22 cytokines.^9-12

Few cases of patients with concurrent AA and psoriasis have been described. Interestingly, these cases document normal hair regrowth in the areas of psoriasis.^13-16 These cases may offer unique insight into the immune factors driving each disease. We describe a case of a man with both alopecia universalis (AU) and psoriasis who developed hair regrowth in some of the psoriatic plaques.

A 34-year-old man with concurrent AU and psoriasis who had not used any systemic or topical medication for either condition in the last year presented to our clinic seeking treatment. The patient had a history of alopecia totalis as a toddler that completely resolved by 4 years of age with the use of squaric acid dibutylester (SADBE). At 31 years of age, the alopecia recurred and was localized to the scalp. It was partially responsive to intralesional triamcinolone acetonide. The patient’s alopecia worsened over the 2 years following recurrence, ultimately progressing to AU. Two months after the alopecia recurrence, he developed the first psoriatic plaques. As the plaque psoriasis progressed, systemic therapy was initiated, first methotrexate and then etanercept. Shortly after developing AU, he lost his health insurance and discontinued all therapy. The patient’s psoriasis began to recur approximately 3 months after stopping etanercept. He was not using any other psoriasis medications. At that time, he noted terminal hair regrowth within some of the psoriatic plaques. No terminal hairs grew outside of the psoriatic plaques, and all regions with growth had previously been without hair for an extended period of time. The patient presented to our clinic approximately 1 year later. He had no other medical conditions and no relevant family history.

On initial physical examination, he had nonscarring hair loss involving nearly 100% of the body with psoriatic plaques on approximately 30% of the body surface area. Regions of terminal hair growth were confined to some but not all of the psoriatic plaques (Figure). Interestingly, the terminal hairs were primarily localized to the thickest central regions of the plaques. The patient’s psoriasis was treated with a combination of topical clobetasol and calcipotriene. In addition, he was started on tacrolimus ointment to the face and eyebrows for the AA. Maintenance of terminal hair within a region of topically treated psoriasis on the forearm persisted at the 2-month follow-up despite complete clearance of the corresponding psoriatic plaque. A small psoriatic plaque on the scalp cleared early with topical therapy without noticeable hair regrowth. The patient subsequently was started on contact immunotherapy with SADBE and intralesional triamcinolone acetonide for the scalp alopecia without satisfactory response. He decided to discontinue further attempts at treating the alopecia and requested to be restarted on etanercept therapy for recalcitrant psoriatic plaques. His psoriasis responded well to this therapy and he continues to be followed in our psoriasis clinic. One year after clearance of the treated psoriatic plaques, the corresponding terminal hairs persist.

Contact immunotherapy, most commonly with diphenylcyclopropenone or SADBE, is reported to have a 50% to 60% success rate in extensive AA, with a broad range of 9% to 87%¹⁷; however, randomized controlled trials testing the efficacy of contact immunotherapy are lacking. Although the mechanism of action of these topical sensitizers is not clearly delineated, it has been postulated that by inducing a new type of inflammatory response in the region, the immunologic milieu is changed, allowing the hair to grow. Some proposed mechanisms include promoting perifollicular lymphocyte apoptosis, preventing new recruitment of autoreactive lymphocytes, and allowing for the correction of aberrant major histocompatibility complex expression on the hair matrix epithelium to regain follicle immune privilege.^18-20

Iatrogenic immunotherapy may work analogously to the natural immune system deviation demonstrated in our patient. Psoriasis and AA are believed to form competing immune cells and cytokine milieus, thus explaining how an individual with AA could regain normal hair growth in areas of psoriasis.^15,16 The Renbök phenomenon, or reverse Köbner phenomenon, coined by Happle et al¹³ can be used to describe both the iatrogenic and natural cases of dermatologic disease improvement in response to secondary insults.¹⁴

A complex cascade of immune cells and cytokines coordinate AA pathogenesis. In the acute stage of AA, an inflammatory infiltrate of CD4⁺ T cells, CD8⁺ T cells, and antigen-presenting cells target anagen phase follicles, with a higher CD4⁺:CD8⁺ ratio in clinically active disease.^21-23 Subcutaneous injections of either CD4⁺ or CD8⁺ lymphocyte subsets from mice with AA into normal-haired mice induces disease. However, CD8⁺ T cell injections rapidly produce apparent hair loss, whereas CD4⁺ T cells cause hair loss after several weeks, suggesting that CD8⁺ T cells directly modulate AA hair loss and CD4⁺ T cells act as an aide.²⁴ The growth, differentiation, and survival of CD8⁺ T cells are stimulated by IL-2 and IFN-γ. Alopecia areata biopsies demonstrate a prevalence of T_H1 cytokines, and patients with localized AA, alopecia totalis, and AU have notably higher serum IFN-γ levels compared to controls.²⁵ In murine models, IL-1α and IL-1β increase during the catagen phase of the hair cycle and peak during the telogen phase.²⁶ Excessive IL-1β expression is detected in the early stages of human disease, and certain IL-1β polymorphisms are associated with severe forms of AA.²⁶ The role of tumor necrosis factor (TNF) α in AA is not well understood. In vitro studies show it inhibits hair growth, suggesting the cytokine may play a role in AA.²⁷ However, anti–TNF-α therapy is not effective in AA, and case reports propose these therapies rarely induce AA.^28-31

The T_H1 response is likewise critical to psoriatic plaque development. IFN-γ and TNF-α are overexpressed in psoriatic plaques.³² IFN-γ has an antiproliferative and differentiation-inducing effect on normal keratinocytes, but psoriatic epithelial cells in vitro respond differently to the cytokine with a notably diminished growth inhibition.^33,34 One explanation for the role of IFN-γ is that it stimulates dendritic cells to produce IL-1 and IL-23.³⁵ IL-23 activates T_H17 cells³⁶; T_H1 and T_H17 conditions produce IL-22 whose serum level correlates with disease severity.^37-39 IL-22 induces keratinocyte proliferation and migration and inhibits keratinocyte differentiation, helping account for hallmarks of the disease.⁴⁰ Patients with psoriasis have increased levels of T_H1, T_H17, and T_H22 cells, as well as their associated cytokines, in the skin and blood compared to controls.^{4,11,32,39,41}

Alopecia areata and psoriasis are regulated by complex and still not entirely understood immune interactions. The fact that many of the same therapies are used to treat both diseases emphasizes both their overlapping characteristics and the lack of targeted therapy. It is unclear if and how the topical or systemic therapies used in our patient to treat one disease affected the natural history of the other condition. It is important to highlight, however, that the patient had not been treated for months when he developed the psoriatic plaques with hair regrowth. Other case reports also document hair regrowth in untreated plaques,^13,16 making it unlikely to be a side effect of the medication regimen. For both psoriasis and AA, the immune cell composition and cytokine levels in the skin or serum vary throughout a patient’s disease course depending on severity of disease or response to treatment.^6,39,42,43 Therefore, we hypothesize that the 2 conditions interact in a similarly distinct manner based on each disease’s stage and intensity in the patient. Both our patient’s course thus far and the various presentations described by other groups support this hypothesis. Our patient had a small region of psoriasis on the scalp that cleared without any terminal hair growth. He also had larger plaques on the forearms that developed hair growth most predominantly within the thicker regions of the plaques. His unique presentation highlights the fluidity of the immune factors driving psoriasis vulgaris and AA.

To the Editor:

Both alopecia areata (AA) and psoriasis vulgaris are chronic relapsing autoimmune diseases, with AA causing nonscarring hair loss in approximately 0.1% to 0.2%¹ of the population with a lifetime risk of 1.7%,² and psoriasis more broadly impacting 1.5% to 2% of the population.³ The helper T cell (T_H1) cytokine milieu is pathogenic in both conditions.^4-6 IFN-γ knockout mice, unlike their wild-type counterparts, do not exhibit AA.⁷ Psoriasis is notably improved by IL-10 injections, which dampen the T_H1 response.⁸ Distinct from AA, T_H17 and T_H22 cells have been implicated as key players in psoriasis pathogenesis, along with the associated IL-17 and IL-22 cytokines.^9-12

Few cases of patients with concurrent AA and psoriasis have been described. Interestingly, these cases document normal hair regrowth in the areas of psoriasis.^13-16 These cases may offer unique insight into the immune factors driving each disease. We describe a case of a man with both alopecia universalis (AU) and psoriasis who developed hair regrowth in some of the psoriatic plaques.

A 34-year-old man with concurrent AU and psoriasis who had not used any systemic or topical medication for either condition in the last year presented to our clinic seeking treatment. The patient had a history of alopecia totalis as a toddler that completely resolved by 4 years of age with the use of squaric acid dibutylester (SADBE). At 31 years of age, the alopecia recurred and was localized to the scalp. It was partially responsive to intralesional triamcinolone acetonide. The patient’s alopecia worsened over the 2 years following recurrence, ultimately progressing to AU. Two months after the alopecia recurrence, he developed the first psoriatic plaques. As the plaque psoriasis progressed, systemic therapy was initiated, first methotrexate and then etanercept. Shortly after developing AU, he lost his health insurance and discontinued all therapy. The patient’s psoriasis began to recur approximately 3 months after stopping etanercept. He was not using any other psoriasis medications. At that time, he noted terminal hair regrowth within some of the psoriatic plaques. No terminal hairs grew outside of the psoriatic plaques, and all regions with growth had previously been without hair for an extended period of time. The patient presented to our clinic approximately 1 year later. He had no other medical conditions and no relevant family history.

On initial physical examination, he had nonscarring hair loss involving nearly 100% of the body with psoriatic plaques on approximately 30% of the body surface area. Regions of terminal hair growth were confined to some but not all of the psoriatic plaques (Figure). Interestingly, the terminal hairs were primarily localized to the thickest central regions of the plaques. The patient’s psoriasis was treated with a combination of topical clobetasol and calcipotriene. In addition, he was started on tacrolimus ointment to the face and eyebrows for the AA. Maintenance of terminal hair within a region of topically treated psoriasis on the forearm persisted at the 2-month follow-up despite complete clearance of the corresponding psoriatic plaque. A small psoriatic plaque on the scalp cleared early with topical therapy without noticeable hair regrowth. The patient subsequently was started on contact immunotherapy with SADBE and intralesional triamcinolone acetonide for the scalp alopecia without satisfactory response. He decided to discontinue further attempts at treating the alopecia and requested to be restarted on etanercept therapy for recalcitrant psoriatic plaques. His psoriasis responded well to this therapy and he continues to be followed in our psoriasis clinic. One year after clearance of the treated psoriatic plaques, the corresponding terminal hairs persist.

Contact immunotherapy, most commonly with diphenylcyclopropenone or SADBE, is reported to have a 50% to 60% success rate in extensive AA, with a broad range of 9% to 87%¹⁷; however, randomized controlled trials testing the efficacy of contact immunotherapy are lacking. Although the mechanism of action of these topical sensitizers is not clearly delineated, it has been postulated that by inducing a new type of inflammatory response in the region, the immunologic milieu is changed, allowing the hair to grow. Some proposed mechanisms include promoting perifollicular lymphocyte apoptosis, preventing new recruitment of autoreactive lymphocytes, and allowing for the correction of aberrant major histocompatibility complex expression on the hair matrix epithelium to regain follicle immune privilege.^18-20

Iatrogenic immunotherapy may work analogously to the natural immune system deviation demonstrated in our patient. Psoriasis and AA are believed to form competing immune cells and cytokine milieus, thus explaining how an individual with AA could regain normal hair growth in areas of psoriasis.^15,16 The Renbök phenomenon, or reverse Köbner phenomenon, coined by Happle et al¹³ can be used to describe both the iatrogenic and natural cases of dermatologic disease improvement in response to secondary insults.¹⁴

A complex cascade of immune cells and cytokines coordinate AA pathogenesis. In the acute stage of AA, an inflammatory infiltrate of CD4⁺ T cells, CD8⁺ T cells, and antigen-presenting cells target anagen phase follicles, with a higher CD4⁺:CD8⁺ ratio in clinically active disease.^21-23 Subcutaneous injections of either CD4⁺ or CD8⁺ lymphocyte subsets from mice with AA into normal-haired mice induces disease. However, CD8⁺ T cell injections rapidly produce apparent hair loss, whereas CD4⁺ T cells cause hair loss after several weeks, suggesting that CD8⁺ T cells directly modulate AA hair loss and CD4⁺ T cells act as an aide.²⁴ The growth, differentiation, and survival of CD8⁺ T cells are stimulated by IL-2 and IFN-γ. Alopecia areata biopsies demonstrate a prevalence of T_H1 cytokines, and patients with localized AA, alopecia totalis, and AU have notably higher serum IFN-γ levels compared to controls.²⁵ In murine models, IL-1α and IL-1β increase during the catagen phase of the hair cycle and peak during the telogen phase.²⁶ Excessive IL-1β expression is detected in the early stages of human disease, and certain IL-1β polymorphisms are associated with severe forms of AA.²⁶ The role of tumor necrosis factor (TNF) α in AA is not well understood. In vitro studies show it inhibits hair growth, suggesting the cytokine may play a role in AA.²⁷ However, anti–TNF-α therapy is not effective in AA, and case reports propose these therapies rarely induce AA.^28-31

The T_H1 response is likewise critical to psoriatic plaque development. IFN-γ and TNF-α are overexpressed in psoriatic plaques.³² IFN-γ has an antiproliferative and differentiation-inducing effect on normal keratinocytes, but psoriatic epithelial cells in vitro respond differently to the cytokine with a notably diminished growth inhibition.^33,34 One explanation for the role of IFN-γ is that it stimulates dendritic cells to produce IL-1 and IL-23.³⁵ IL-23 activates T_H17 cells³⁶; T_H1 and T_H17 conditions produce IL-22 whose serum level correlates with disease severity.^37-39 IL-22 induces keratinocyte proliferation and migration and inhibits keratinocyte differentiation, helping account for hallmarks of the disease.⁴⁰ Patients with psoriasis have increased levels of T_H1, T_H17, and T_H22 cells, as well as their associated cytokines, in the skin and blood compared to controls.^{4,11,32,39,41}

Alopecia areata and psoriasis are regulated by complex and still not entirely understood immune interactions. The fact that many of the same therapies are used to treat both diseases emphasizes both their overlapping characteristics and the lack of targeted therapy. It is unclear if and how the topical or systemic therapies used in our patient to treat one disease affected the natural history of the other condition. It is important to highlight, however, that the patient had not been treated for months when he developed the psoriatic plaques with hair regrowth. Other case reports also document hair regrowth in untreated plaques,^13,16 making it unlikely to be a side effect of the medication regimen. For both psoriasis and AA, the immune cell composition and cytokine levels in the skin or serum vary throughout a patient’s disease course depending on severity of disease or response to treatment.^6,39,42,43 Therefore, we hypothesize that the 2 conditions interact in a similarly distinct manner based on each disease’s stage and intensity in the patient. Both our patient’s course thus far and the various presentations described by other groups support this hypothesis. Our patient had a small region of psoriasis on the scalp that cleared without any terminal hair growth. He also had larger plaques on the forearms that developed hair growth most predominantly within the thicker regions of the plaques. His unique presentation highlights the fluidity of the immune factors driving psoriasis vulgaris and AA.

Patients with psoriasis may be at a greater risk of melanoma and hematologic cancers, compared with the general population, but treatments do not appear to increase risk, according to Shivani P. Reddy of the University of Illinois at Chicago, and associates.

In a retrospective cohort study, they identified 815,765 patients at Kaiser Permanente Southern California who had at least one medical encounter from January 2004 through December 2013. Of these patients, 8,161 (1%) met the diagnostic and inclusion criteria for psoriasis, and there were 7,167 (0.89%) cases of melanoma and 5,399 (0.66%) cases of lymphoma or leukemia.

Among the patients with psoriasis, there were 62 (0.87%) melanoma cases and 47 (0.87%) cases of lymphoma or leukemia.

Of the 109 patients with psoriasis who went on to develop melanoma or lymphoma, the time to diagnosis of melanoma or hematologic cancers was significantly less for patients with psoriasis than for patients without psoriasis (P = .01). The patients with psoriasis had a 1.53 times higher risk of developing a malignancy compared with patients without psoriasis (P less than .01) in the multivariable Cox proportional hazards model.

“There were no differences between patients with melanoma and hematologic cancer by treatment type,” which were phototherapy, tumor necrosis factor inhibitor therapy, and topical medications, they wrote.

“Our study demonstrates that the risk of hematologic cancer and melanoma is increased in patients with psoriasis over time, although this risk is not impacted by psoriasis therapies,” the researchers concluded. “Defining the risk of malignancy in these patients is important for proper workup and management.”

Read the study in the Journal of the American Academy of Dermatology (doi: 10.1016/j.jaad.2016.09.047).
 

[email protected]

Patients with psoriasis may be at a greater risk of melanoma and hematologic cancers, compared with the general population, but treatments do not appear to increase risk, according to Shivani P. Reddy of the University of Illinois at Chicago, and associates.

In a retrospective cohort study, they identified 815,765 patients at Kaiser Permanente Southern California who had at least one medical encounter from January 2004 through December 2013. Of these patients, 8,161 (1%) met the diagnostic and inclusion criteria for psoriasis, and there were 7,167 (0.89%) cases of melanoma and 5,399 (0.66%) cases of lymphoma or leukemia.

Among the patients with psoriasis, there were 62 (0.87%) melanoma cases and 47 (0.87%) cases of lymphoma or leukemia.

Of the 109 patients with psoriasis who went on to develop melanoma or lymphoma, the time to diagnosis of melanoma or hematologic cancers was significantly less for patients with psoriasis than for patients without psoriasis (P = .01). The patients with psoriasis had a 1.53 times higher risk of developing a malignancy compared with patients without psoriasis (P less than .01) in the multivariable Cox proportional hazards model.

“There were no differences between patients with melanoma and hematologic cancer by treatment type,” which were phototherapy, tumor necrosis factor inhibitor therapy, and topical medications, they wrote.

“Our study demonstrates that the risk of hematologic cancer and melanoma is increased in patients with psoriasis over time, although this risk is not impacted by psoriasis therapies,” the researchers concluded. “Defining the risk of malignancy in these patients is important for proper workup and management.”

Read the study in the Journal of the American Academy of Dermatology (doi: 10.1016/j.jaad.2016.09.047).
 

[email protected]

Patients with psoriasis may be at a greater risk of melanoma and hematologic cancers, compared with the general population, but treatments do not appear to increase risk, according to Shivani P. Reddy of the University of Illinois at Chicago, and associates.

In a retrospective cohort study, they identified 815,765 patients at Kaiser Permanente Southern California who had at least one medical encounter from January 2004 through December 2013. Of these patients, 8,161 (1%) met the diagnostic and inclusion criteria for psoriasis, and there were 7,167 (0.89%) cases of melanoma and 5,399 (0.66%) cases of lymphoma or leukemia.

Among the patients with psoriasis, there were 62 (0.87%) melanoma cases and 47 (0.87%) cases of lymphoma or leukemia.

Of the 109 patients with psoriasis who went on to develop melanoma or lymphoma, the time to diagnosis of melanoma or hematologic cancers was significantly less for patients with psoriasis than for patients without psoriasis (P = .01). The patients with psoriasis had a 1.53 times higher risk of developing a malignancy compared with patients without psoriasis (P less than .01) in the multivariable Cox proportional hazards model.

“There were no differences between patients with melanoma and hematologic cancer by treatment type,” which were phototherapy, tumor necrosis factor inhibitor therapy, and topical medications, they wrote.

“Our study demonstrates that the risk of hematologic cancer and melanoma is increased in patients with psoriasis over time, although this risk is not impacted by psoriasis therapies,” the researchers concluded. “Defining the risk of malignancy in these patients is important for proper workup and management.”

Read the study in the Journal of the American Academy of Dermatology (doi: 10.1016/j.jaad.2016.09.047).
 

[email protected]

At 12 weeks, 77% of psoriasis patients treated with risankizumab showed a 90% or greater reduction in Psoriasis Area and Severity Index (PASI) score, compared with 40% of ustekinumab patients, in a phase II randomized trial.

The results were published April 19 in the New England Journal of Medicine.

Ustekinumab (Stelara), approved by the Food and Drug Administration in 2009, blocks interleukin-12 and interleukin-23 and has demonstrated effectiveness in psoriasis patients. However, the humanized IgG1 monoclonal antibody risankizumab goes farther and “selectively inhibits interleukin-23 by specifically targeting p19,” wrote Kim A. Papp, MD, PhD, of K. Papp Clinical Research and Probity Medical Research, Waterloo, Ont., and associates (N. Engl. J. Med. 2017;376:1551-60. doi: 10.1056/NEJMoa1607017).

To compare clinical response and safety, the researchers enrolled 166 adults aged 18-75 years with moderate to severe plaque psoriasis, in the phase II study. Patients were randomized to subcutaneous injections of risankizumab at one of three doses, or ustekinumab at one of two doses. Risankizumab patients received a single 18-mg dose at week 0, or 90-mg or 180-mg doses at weeks 0, 4, and 16. Ustekinumab patients weighing 100 kg or less received 45 mg at weeks 0, 4, and 16; those weighing more than 100 kg received 90 mg at weeks 0, 4, and 16. Demographics were similar among the treatment groups.

The primary end point was a 90% or greater reduction in the PASI score at week 12, compared with baseline.

In pooled results of the risankizumab 90-mg and 180-mg groups, 77% of patients achieved a PASI 90 at 12 weeks (73% of the 90-mg group and 81% of the 180-mg group), vs. 40% of ustekinumab patients (P less than .001). Complete clearance of lesions (PASI 100) occurred among risankizumab patients in 14% of the 18-mg group, 41% of the 90-mg group, and 48% of the 180-mg group, compared with 18% of the ustekinumab group.

Among risankizumab patients, the rates of adverse events through 48 weeks were 81% in the 180-mg group, 80% in the 90-mg group, and 69% in the 180-mg group, compared with 72% in those on ustekinumab, with nasopharyngitis the most commonly reported adverse event in all the treatment groups. The rates of serious adverse events were 12% and 15% among those in the 18-mg and 90-mg risankizumab groups, respectively; 0% among those on the 180-mg dose, and 8% among those on ustekinumab.

The study was not large or long enough to provide conclusive safety data on risankizumab, and additional studies are needed to review psoriasis lesions over a longer time period and include both placebo and active comparators, researchers noted. However, the results suggest that “the selective blockade of interleukin-23 through the inhibition of the p19 subunit rather than p40 provides a more complete inhibition of interleukin-23 activity, potentially resulting in a greater efficacy in the treatment of plaque psoriasis at the doses used,” they said.

The study was supported by Boehringer Ingelheim. Several study coauthors, including lead author Dr. Papp, disclosed relationships with Boehringer Ingelheim and other companies. Several authors are Boehringer Ingelheim employees.
 

[email protected]

At 12 weeks, 77% of psoriasis patients treated with risankizumab showed a 90% or greater reduction in Psoriasis Area and Severity Index (PASI) score, compared with 40% of ustekinumab patients, in a phase II randomized trial.

The results were published April 19 in the New England Journal of Medicine.

Ustekinumab (Stelara), approved by the Food and Drug Administration in 2009, blocks interleukin-12 and interleukin-23 and has demonstrated effectiveness in psoriasis patients. However, the humanized IgG1 monoclonal antibody risankizumab goes farther and “selectively inhibits interleukin-23 by specifically targeting p19,” wrote Kim A. Papp, MD, PhD, of K. Papp Clinical Research and Probity Medical Research, Waterloo, Ont., and associates (N. Engl. J. Med. 2017;376:1551-60. doi: 10.1056/NEJMoa1607017).

To compare clinical response and safety, the researchers enrolled 166 adults aged 18-75 years with moderate to severe plaque psoriasis, in the phase II study. Patients were randomized to subcutaneous injections of risankizumab at one of three doses, or ustekinumab at one of two doses. Risankizumab patients received a single 18-mg dose at week 0, or 90-mg or 180-mg doses at weeks 0, 4, and 16. Ustekinumab patients weighing 100 kg or less received 45 mg at weeks 0, 4, and 16; those weighing more than 100 kg received 90 mg at weeks 0, 4, and 16. Demographics were similar among the treatment groups.

The primary end point was a 90% or greater reduction in the PASI score at week 12, compared with baseline.

In pooled results of the risankizumab 90-mg and 180-mg groups, 77% of patients achieved a PASI 90 at 12 weeks (73% of the 90-mg group and 81% of the 180-mg group), vs. 40% of ustekinumab patients (P less than .001). Complete clearance of lesions (PASI 100) occurred among risankizumab patients in 14% of the 18-mg group, 41% of the 90-mg group, and 48% of the 180-mg group, compared with 18% of the ustekinumab group.

Among risankizumab patients, the rates of adverse events through 48 weeks were 81% in the 180-mg group, 80% in the 90-mg group, and 69% in the 180-mg group, compared with 72% in those on ustekinumab, with nasopharyngitis the most commonly reported adverse event in all the treatment groups. The rates of serious adverse events were 12% and 15% among those in the 18-mg and 90-mg risankizumab groups, respectively; 0% among those on the 180-mg dose, and 8% among those on ustekinumab.

The study was not large or long enough to provide conclusive safety data on risankizumab, and additional studies are needed to review psoriasis lesions over a longer time period and include both placebo and active comparators, researchers noted. However, the results suggest that “the selective blockade of interleukin-23 through the inhibition of the p19 subunit rather than p40 provides a more complete inhibition of interleukin-23 activity, potentially resulting in a greater efficacy in the treatment of plaque psoriasis at the doses used,” they said.

The study was supported by Boehringer Ingelheim. Several study coauthors, including lead author Dr. Papp, disclosed relationships with Boehringer Ingelheim and other companies. Several authors are Boehringer Ingelheim employees.
 

[email protected]

At 12 weeks, 77% of psoriasis patients treated with risankizumab showed a 90% or greater reduction in Psoriasis Area and Severity Index (PASI) score, compared with 40% of ustekinumab patients, in a phase II randomized trial.

The results were published April 19 in the New England Journal of Medicine.

Ustekinumab (Stelara), approved by the Food and Drug Administration in 2009, blocks interleukin-12 and interleukin-23 and has demonstrated effectiveness in psoriasis patients. However, the humanized IgG1 monoclonal antibody risankizumab goes farther and “selectively inhibits interleukin-23 by specifically targeting p19,” wrote Kim A. Papp, MD, PhD, of K. Papp Clinical Research and Probity Medical Research, Waterloo, Ont., and associates (N. Engl. J. Med. 2017;376:1551-60. doi: 10.1056/NEJMoa1607017).

To compare clinical response and safety, the researchers enrolled 166 adults aged 18-75 years with moderate to severe plaque psoriasis, in the phase II study. Patients were randomized to subcutaneous injections of risankizumab at one of three doses, or ustekinumab at one of two doses. Risankizumab patients received a single 18-mg dose at week 0, or 90-mg or 180-mg doses at weeks 0, 4, and 16. Ustekinumab patients weighing 100 kg or less received 45 mg at weeks 0, 4, and 16; those weighing more than 100 kg received 90 mg at weeks 0, 4, and 16. Demographics were similar among the treatment groups.

The primary end point was a 90% or greater reduction in the PASI score at week 12, compared with baseline.

In pooled results of the risankizumab 90-mg and 180-mg groups, 77% of patients achieved a PASI 90 at 12 weeks (73% of the 90-mg group and 81% of the 180-mg group), vs. 40% of ustekinumab patients (P less than .001). Complete clearance of lesions (PASI 100) occurred among risankizumab patients in 14% of the 18-mg group, 41% of the 90-mg group, and 48% of the 180-mg group, compared with 18% of the ustekinumab group.

Among risankizumab patients, the rates of adverse events through 48 weeks were 81% in the 180-mg group, 80% in the 90-mg group, and 69% in the 180-mg group, compared with 72% in those on ustekinumab, with nasopharyngitis the most commonly reported adverse event in all the treatment groups. The rates of serious adverse events were 12% and 15% among those in the 18-mg and 90-mg risankizumab groups, respectively; 0% among those on the 180-mg dose, and 8% among those on ustekinumab.

The study was not large or long enough to provide conclusive safety data on risankizumab, and additional studies are needed to review psoriasis lesions over a longer time period and include both placebo and active comparators, researchers noted. However, the results suggest that “the selective blockade of interleukin-23 through the inhibition of the p19 subunit rather than p40 provides a more complete inhibition of interleukin-23 activity, potentially resulting in a greater efficacy in the treatment of plaque psoriasis at the doses used,” they said.

The study was supported by Boehringer Ingelheim. Several study coauthors, including lead author Dr. Papp, disclosed relationships with Boehringer Ingelheim and other companies. Several authors are Boehringer Ingelheim employees.
 

[email protected]

WAILEA, HAWAII – In an era when affordable health insurance could become increasingly tough to come by, it’s worth emphasizing that methotrexate is the most cost-effective way to manage extensive psoriasis – and the liquid formulation designed for intramuscular injection can be taken orally to reduce the cost even further, according to Craig L. Leonardi, MD.

“The absolute cheapest way to manage the patient who has no insurance and has bad psoriasis is to put him on methotrexate and teach him how to draw the liquid solution up in a syringe, dump it in a cup of juice, and drink it,” Dr. Leonardi said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Research Foundation. “The bioavailability is equivalent to [that of] the tablets, and it’s only about one-tenth the cost.”

He urged his fellow dermatologists not to forget about methotrexate in the current flashy era of highly effective – and very expensive – biologic therapies for psoriasis.

“I was thinking methotrexate was going to go away, but it turns out I rely more on that drug than ever before. It’s very useful, and it’s safe if used correctly,” said Dr. Leonardi, a dermatologist at Saint Louis University and a prominent clinical trialist.

He highlighted numerous clinical scenarios in which methotrexate remains a valuable treatment in patients with moderate to severe psoriasis. He also touched on patient monitoring requirements, adverse events, and common reasons he receives referrals from physicians whose patients seem to be having problems on methotrexate – referrals that, in most cases, could be avoided, he said, if the referring physician had a fuller understanding of the drug.

“Patients are referred to me all the time for methotrexate intolerance,” Dr. Leonardi said. “When you take methotrexate, you get a brief, dramatic spike in transaminase levels that peaks within a day and then drops off. But, when you get lab tests in these patients, you want to look at trough levels. You want to see the best liver function test values for the week.

“That means you have to tell the patient what day to take the drug and what day to get labs drawn,” he continued. “I’m here to tell you that the vast majority of issues that I see where patients have elevated liver function tests involves them getting their testing done in the first 4 days after taking methotrexate. Take the time to ask about this, and I think you’ll be pleasantly surprised.

“If you just make an adjustment and get them on the right schedule, you’ll discover that the patient is tolerating the drug just fine,” Dr. Leonardi added. “We like getting labs on Monday and dosing on Tuesday.”

Methotrexate’s half-life is 3-15 hours. Psoriasis is often controlled at a methotrexate dose of about 15 mg/week.

Methotrexate’s advantages include ease of use. It’s a straightforward matter to start and stop the drug and to make small dose adjustments. Methotrexate comes in a variety of formulations: the 2.5-mg tablets, the 25 mg/mL solution for IM injection, and prefilled autoinjector devices for subcutaneous administration.

These preloaded pens for subcutaneous injection are just as effective as IM therapy, Dr. Leonardi said. Methotrexate is also better absorbed subcutaneously than it is orally. The bioavailability of oral methotrexate plateaus at a dose of about 22 mg/week, while subcutaneously delivered methotrexate does not. So, if a patient’s psoriasis isn’t adequately controlled on higher-dose oral therapy, it’s worth considering a switch to the preloaded pens.

“It’s a very simple injection, very cost-effective, and your patients may get more bang for the buck by doing that,” according to the dermatologist.

Also, nausea, vomiting, diarrhea, and abdominal pain have been shown to be significantly less frequent and intense with subcutaneous methotrexate than with the tablets. So, if a patient is experiencing limiting gastrointestinal issues on methotrexate tablets, a shift to subcutaneous therapy is often the solution.

What kind of efficacy can physicians expect with methotrexate monotherapy?

Dr. Leonardi cited the results of the European randomized, open-label RESTORE-1 trial (Br J Dermatol. 2011 Nov;165[5]:1109-17) as being consistent with his own extensive clinical experience: a week-16 PASI (Psoriasis Area and Severity Index ) 75 response rate of 42% with methotrexate, compared with 78% for infliximab (Remicade).

Of course, some patients can’t receive a biologic agent because of their age, lack of insurance coverage, or medical contraindications.

“I use methotrexate a lot in Medicare patients, where, with Part D, it’s hard to get access to biologics without really good coinsurance. I think all of us who prescribe biologics understand that,” he observed.

In pediatric patients with extensive psoriasis, he turns to methotrexate as first-line systemic therapy. After 3 months, if the young patient hasn’t responded satisfactorily, Dr. Leonardi asks the insurance company for access to a biologic agent and usually gets it.

Methotrexate really shines in combination with a biologic agent. It inhibits formation of antibiologic antibodies, an important cause of loss of effectiveness of monoclonal antibody therapy.

In one study, 28% of patients on adalimumab (Humira) developed antiadalimumab antibodies during the first 3 years of therapy. These patients were more likely to drop out of therapy for lack of effectiveness.

A key finding in this study was that two-thirds of patients who developed antiadalimumab antibodies did so during the first 28 weeks of therapy (JAMA. 2011 Apr 13;305[14]:1460-8). This time line has influenced Dr. Leonardi’s own clinical practice. He routinely keeps patients on methotrexate for their first 28-36 weeks on a biologic, then tapers the methotrexate in favor of biologic monotherapy.

Other benefits and guidelines

Methotrexate is also a boon in managing psoriasis flares in patients on a biologic.

“We’ve all had patients who are doing well on a biologic, they’re cruising along at 140 weeks, then they get strep throat or another infection, and, next thing you know, you have destabilized psoriasis,” Dr. Leonardi noted.

“One thing I’ll do is add methotrexate to the mix, try to get things under control, and, if we do, then we’ll try to taper the methotrexate,” he continued. “That whole episode might take 4-6 months to resolve before the patient might be able to tolerate biologic monotherapy, though. If they can’t at that point, you might consider rotating to another biologic.”

Current American Academy of Dermatology guidelines recommend that women on methotrexate limit their alcohol intake to one drink per day, two drinks for men. British Society for Rheumatology guidelines recommend a ceiling of 32 g to 64 g of ethanol per week.

“We don’t insist on abstinence. There’s no good evidence that it’s needed,” Dr. Leonardi noted. “If you dose this drug on Tuesday, you can be sure that it’s eliminated from the body on Friday, and that’s when I’ll generally green-light patients to socialize over the weekend. If you can make life a little more tolerable for your patients and they’re willing to follow your instructions, I think it’s a better deal all the way around.”

Prior to initiating methotrexate, he obtains a CBC with platelet count, liver function tests, serum urea nitrogen, creatinine, and screens for latent tuberculosis. In terms of on-treatment monitoring, he gets a CBC and liver function tests every 4-12 weeks and keeps an eye on renal function, especially in older patients, because methotrexate is eliminated renally.

“The guidelines have relaxed regarding the need for liver biopsies,” Dr. Leonardi said. “Most of us are not getting liver biopsies anymore, as is true of our friends in rheumatology.”

He reported having financial relationships with more than a dozen pharmaceutical companies. The SDEF and this news organization are owned by the same parent company.

[email protected]

WAILEA, HAWAII – In an era when affordable health insurance could become increasingly tough to come by, it’s worth emphasizing that methotrexate is the most cost-effective way to manage extensive psoriasis – and the liquid formulation designed for intramuscular injection can be taken orally to reduce the cost even further, according to Craig L. Leonardi, MD.

“The absolute cheapest way to manage the patient who has no insurance and has bad psoriasis is to put him on methotrexate and teach him how to draw the liquid solution up in a syringe, dump it in a cup of juice, and drink it,” Dr. Leonardi said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Research Foundation. “The bioavailability is equivalent to [that of] the tablets, and it’s only about one-tenth the cost.”

He urged his fellow dermatologists not to forget about methotrexate in the current flashy era of highly effective – and very expensive – biologic therapies for psoriasis.

“I was thinking methotrexate was going to go away, but it turns out I rely more on that drug than ever before. It’s very useful, and it’s safe if used correctly,” said Dr. Leonardi, a dermatologist at Saint Louis University and a prominent clinical trialist.

He highlighted numerous clinical scenarios in which methotrexate remains a valuable treatment in patients with moderate to severe psoriasis. He also touched on patient monitoring requirements, adverse events, and common reasons he receives referrals from physicians whose patients seem to be having problems on methotrexate – referrals that, in most cases, could be avoided, he said, if the referring physician had a fuller understanding of the drug.

“Patients are referred to me all the time for methotrexate intolerance,” Dr. Leonardi said. “When you take methotrexate, you get a brief, dramatic spike in transaminase levels that peaks within a day and then drops off. But, when you get lab tests in these patients, you want to look at trough levels. You want to see the best liver function test values for the week.

“That means you have to tell the patient what day to take the drug and what day to get labs drawn,” he continued. “I’m here to tell you that the vast majority of issues that I see where patients have elevated liver function tests involves them getting their testing done in the first 4 days after taking methotrexate. Take the time to ask about this, and I think you’ll be pleasantly surprised.

“If you just make an adjustment and get them on the right schedule, you’ll discover that the patient is tolerating the drug just fine,” Dr. Leonardi added. “We like getting labs on Monday and dosing on Tuesday.”

Methotrexate’s half-life is 3-15 hours. Psoriasis is often controlled at a methotrexate dose of about 15 mg/week.

Methotrexate’s advantages include ease of use. It’s a straightforward matter to start and stop the drug and to make small dose adjustments. Methotrexate comes in a variety of formulations: the 2.5-mg tablets, the 25 mg/mL solution for IM injection, and prefilled autoinjector devices for subcutaneous administration.

These preloaded pens for subcutaneous injection are just as effective as IM therapy, Dr. Leonardi said. Methotrexate is also better absorbed subcutaneously than it is orally. The bioavailability of oral methotrexate plateaus at a dose of about 22 mg/week, while subcutaneously delivered methotrexate does not. So, if a patient’s psoriasis isn’t adequately controlled on higher-dose oral therapy, it’s worth considering a switch to the preloaded pens.

“It’s a very simple injection, very cost-effective, and your patients may get more bang for the buck by doing that,” according to the dermatologist.

Also, nausea, vomiting, diarrhea, and abdominal pain have been shown to be significantly less frequent and intense with subcutaneous methotrexate than with the tablets. So, if a patient is experiencing limiting gastrointestinal issues on methotrexate tablets, a shift to subcutaneous therapy is often the solution.

What kind of efficacy can physicians expect with methotrexate monotherapy?

Dr. Leonardi cited the results of the European randomized, open-label RESTORE-1 trial (Br J Dermatol. 2011 Nov;165[5]:1109-17) as being consistent with his own extensive clinical experience: a week-16 PASI (Psoriasis Area and Severity Index ) 75 response rate of 42% with methotrexate, compared with 78% for infliximab (Remicade).

Of course, some patients can’t receive a biologic agent because of their age, lack of insurance coverage, or medical contraindications.

“I use methotrexate a lot in Medicare patients, where, with Part D, it’s hard to get access to biologics without really good coinsurance. I think all of us who prescribe biologics understand that,” he observed.

In pediatric patients with extensive psoriasis, he turns to methotrexate as first-line systemic therapy. After 3 months, if the young patient hasn’t responded satisfactorily, Dr. Leonardi asks the insurance company for access to a biologic agent and usually gets it.

Methotrexate really shines in combination with a biologic agent. It inhibits formation of antibiologic antibodies, an important cause of loss of effectiveness of monoclonal antibody therapy.

In one study, 28% of patients on adalimumab (Humira) developed antiadalimumab antibodies during the first 3 years of therapy. These patients were more likely to drop out of therapy for lack of effectiveness.

A key finding in this study was that two-thirds of patients who developed antiadalimumab antibodies did so during the first 28 weeks of therapy (JAMA. 2011 Apr 13;305[14]:1460-8). This time line has influenced Dr. Leonardi’s own clinical practice. He routinely keeps patients on methotrexate for their first 28-36 weeks on a biologic, then tapers the methotrexate in favor of biologic monotherapy.

Other benefits and guidelines

Methotrexate is also a boon in managing psoriasis flares in patients on a biologic.

“We’ve all had patients who are doing well on a biologic, they’re cruising along at 140 weeks, then they get strep throat or another infection, and, next thing you know, you have destabilized psoriasis,” Dr. Leonardi noted.

“One thing I’ll do is add methotrexate to the mix, try to get things under control, and, if we do, then we’ll try to taper the methotrexate,” he continued. “That whole episode might take 4-6 months to resolve before the patient might be able to tolerate biologic monotherapy, though. If they can’t at that point, you might consider rotating to another biologic.”

Current American Academy of Dermatology guidelines recommend that women on methotrexate limit their alcohol intake to one drink per day, two drinks for men. British Society for Rheumatology guidelines recommend a ceiling of 32 g to 64 g of ethanol per week.

“We don’t insist on abstinence. There’s no good evidence that it’s needed,” Dr. Leonardi noted. “If you dose this drug on Tuesday, you can be sure that it’s eliminated from the body on Friday, and that’s when I’ll generally green-light patients to socialize over the weekend. If you can make life a little more tolerable for your patients and they’re willing to follow your instructions, I think it’s a better deal all the way around.”

Prior to initiating methotrexate, he obtains a CBC with platelet count, liver function tests, serum urea nitrogen, creatinine, and screens for latent tuberculosis. In terms of on-treatment monitoring, he gets a CBC and liver function tests every 4-12 weeks and keeps an eye on renal function, especially in older patients, because methotrexate is eliminated renally.

“The guidelines have relaxed regarding the need for liver biopsies,” Dr. Leonardi said. “Most of us are not getting liver biopsies anymore, as is true of our friends in rheumatology.”

He reported having financial relationships with more than a dozen pharmaceutical companies. The SDEF and this news organization are owned by the same parent company.

[email protected]

WAILEA, HAWAII – In an era when affordable health insurance could become increasingly tough to come by, it’s worth emphasizing that methotrexate is the most cost-effective way to manage extensive psoriasis – and the liquid formulation designed for intramuscular injection can be taken orally to reduce the cost even further, according to Craig L. Leonardi, MD.

“The absolute cheapest way to manage the patient who has no insurance and has bad psoriasis is to put him on methotrexate and teach him how to draw the liquid solution up in a syringe, dump it in a cup of juice, and drink it,” Dr. Leonardi said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Research Foundation. “The bioavailability is equivalent to [that of] the tablets, and it’s only about one-tenth the cost.”

He urged his fellow dermatologists not to forget about methotrexate in the current flashy era of highly effective – and very expensive – biologic therapies for psoriasis.

“I was thinking methotrexate was going to go away, but it turns out I rely more on that drug than ever before. It’s very useful, and it’s safe if used correctly,” said Dr. Leonardi, a dermatologist at Saint Louis University and a prominent clinical trialist.

He highlighted numerous clinical scenarios in which methotrexate remains a valuable treatment in patients with moderate to severe psoriasis. He also touched on patient monitoring requirements, adverse events, and common reasons he receives referrals from physicians whose patients seem to be having problems on methotrexate – referrals that, in most cases, could be avoided, he said, if the referring physician had a fuller understanding of the drug.

“Patients are referred to me all the time for methotrexate intolerance,” Dr. Leonardi said. “When you take methotrexate, you get a brief, dramatic spike in transaminase levels that peaks within a day and then drops off. But, when you get lab tests in these patients, you want to look at trough levels. You want to see the best liver function test values for the week.

“That means you have to tell the patient what day to take the drug and what day to get labs drawn,” he continued. “I’m here to tell you that the vast majority of issues that I see where patients have elevated liver function tests involves them getting their testing done in the first 4 days after taking methotrexate. Take the time to ask about this, and I think you’ll be pleasantly surprised.

“If you just make an adjustment and get them on the right schedule, you’ll discover that the patient is tolerating the drug just fine,” Dr. Leonardi added. “We like getting labs on Monday and dosing on Tuesday.”

Methotrexate’s half-life is 3-15 hours. Psoriasis is often controlled at a methotrexate dose of about 15 mg/week.

Methotrexate’s advantages include ease of use. It’s a straightforward matter to start and stop the drug and to make small dose adjustments. Methotrexate comes in a variety of formulations: the 2.5-mg tablets, the 25 mg/mL solution for IM injection, and prefilled autoinjector devices for subcutaneous administration.

These preloaded pens for subcutaneous injection are just as effective as IM therapy, Dr. Leonardi said. Methotrexate is also better absorbed subcutaneously than it is orally. The bioavailability of oral methotrexate plateaus at a dose of about 22 mg/week, while subcutaneously delivered methotrexate does not. So, if a patient’s psoriasis isn’t adequately controlled on higher-dose oral therapy, it’s worth considering a switch to the preloaded pens.

“It’s a very simple injection, very cost-effective, and your patients may get more bang for the buck by doing that,” according to the dermatologist.

Also, nausea, vomiting, diarrhea, and abdominal pain have been shown to be significantly less frequent and intense with subcutaneous methotrexate than with the tablets. So, if a patient is experiencing limiting gastrointestinal issues on methotrexate tablets, a shift to subcutaneous therapy is often the solution.

What kind of efficacy can physicians expect with methotrexate monotherapy?

Dr. Leonardi cited the results of the European randomized, open-label RESTORE-1 trial (Br J Dermatol. 2011 Nov;165[5]:1109-17) as being consistent with his own extensive clinical experience: a week-16 PASI (Psoriasis Area and Severity Index ) 75 response rate of 42% with methotrexate, compared with 78% for infliximab (Remicade).

Of course, some patients can’t receive a biologic agent because of their age, lack of insurance coverage, or medical contraindications.

“I use methotrexate a lot in Medicare patients, where, with Part D, it’s hard to get access to biologics without really good coinsurance. I think all of us who prescribe biologics understand that,” he observed.

In pediatric patients with extensive psoriasis, he turns to methotrexate as first-line systemic therapy. After 3 months, if the young patient hasn’t responded satisfactorily, Dr. Leonardi asks the insurance company for access to a biologic agent and usually gets it.

Methotrexate really shines in combination with a biologic agent. It inhibits formation of antibiologic antibodies, an important cause of loss of effectiveness of monoclonal antibody therapy.

In one study, 28% of patients on adalimumab (Humira) developed antiadalimumab antibodies during the first 3 years of therapy. These patients were more likely to drop out of therapy for lack of effectiveness.

A key finding in this study was that two-thirds of patients who developed antiadalimumab antibodies did so during the first 28 weeks of therapy (JAMA. 2011 Apr 13;305[14]:1460-8). This time line has influenced Dr. Leonardi’s own clinical practice. He routinely keeps patients on methotrexate for their first 28-36 weeks on a biologic, then tapers the methotrexate in favor of biologic monotherapy.

Other benefits and guidelines

Methotrexate is also a boon in managing psoriasis flares in patients on a biologic.

“We’ve all had patients who are doing well on a biologic, they’re cruising along at 140 weeks, then they get strep throat or another infection, and, next thing you know, you have destabilized psoriasis,” Dr. Leonardi noted.

“One thing I’ll do is add methotrexate to the mix, try to get things under control, and, if we do, then we’ll try to taper the methotrexate,” he continued. “That whole episode might take 4-6 months to resolve before the patient might be able to tolerate biologic monotherapy, though. If they can’t at that point, you might consider rotating to another biologic.”

Current American Academy of Dermatology guidelines recommend that women on methotrexate limit their alcohol intake to one drink per day, two drinks for men. British Society for Rheumatology guidelines recommend a ceiling of 32 g to 64 g of ethanol per week.

“We don’t insist on abstinence. There’s no good evidence that it’s needed,” Dr. Leonardi noted. “If you dose this drug on Tuesday, you can be sure that it’s eliminated from the body on Friday, and that’s when I’ll generally green-light patients to socialize over the weekend. If you can make life a little more tolerable for your patients and they’re willing to follow your instructions, I think it’s a better deal all the way around.”

Prior to initiating methotrexate, he obtains a CBC with platelet count, liver function tests, serum urea nitrogen, creatinine, and screens for latent tuberculosis. In terms of on-treatment monitoring, he gets a CBC and liver function tests every 4-12 weeks and keeps an eye on renal function, especially in older patients, because methotrexate is eliminated renally.

“The guidelines have relaxed regarding the need for liver biopsies,” Dr. Leonardi said. “Most of us are not getting liver biopsies anymore, as is true of our friends in rheumatology.”

He reported having financial relationships with more than a dozen pharmaceutical companies. The SDEF and this news organization are owned by the same parent company.

[email protected]

Compared with etanercept, secukinumab was associated with significantly faster and greater improvements in skin-specific quality of life among adults with moderate to severe psoriasis, according to a pooled analysis of data from the randomized, multicenter phase III ERASURE and FIXTURE trials.

The findings confirm the clinical superiority of secukinumab and extend prior head-to-head comparisons of this IL-17A inhibitor and etanercept, said Bruce E. Strober, MD, PhD, of the University of Connecticut in Farmington, Conn.

[email protected]

Compared with etanercept, secukinumab was associated with significantly faster and greater improvements in skin-specific quality of life among adults with moderate to severe psoriasis, according to a pooled analysis of data from the randomized, multicenter phase III ERASURE and FIXTURE trials.

The findings confirm the clinical superiority of secukinumab and extend prior head-to-head comparisons of this IL-17A inhibitor and etanercept, said Bruce E. Strober, MD, PhD, of the University of Connecticut in Farmington, Conn.

[email protected]

Compared with etanercept, secukinumab was associated with significantly faster and greater improvements in skin-specific quality of life among adults with moderate to severe psoriasis, according to a pooled analysis of data from the randomized, multicenter phase III ERASURE and FIXTURE trials.

The findings confirm the clinical superiority of secukinumab and extend prior head-to-head comparisons of this IL-17A inhibitor and etanercept, said Bruce E. Strober, MD, PhD, of the University of Connecticut in Farmington, Conn.

[email protected]

Myth: Psoriasis Therapies Can Cause Suicidal Ideation in Psoriasis Patients

Psoriasis takes a toll on patients, both physically and emotionally. Depression is one of the comorbidities of psoriasis due to biological changes that cause psoriasis as well as the stigma of visible psoriasis. Severe depression and suicidal ideation have been perceived to be features of life-threatening medical disorders, but dermatologists need to be aware of the relationship between depressive symptoms, suicidal ideation, and psoriasis severity.

A 2010 United Kingdom study of 916,948 patients with mild psoriasis, severe psoriasis, or controls without psoriasis indicated that patients with psoriasis have an increased risk for depression, anxiety, and suicidality. The relative risk of these outcomes is elevated in younger patients with psoriasis, with the greatest relative risk being for depression in patients with severe psoriasis.

Kimball et al conducted a study in the United States of 7404 patients with psoriasis and 37,020 controls without psoriasis (age, <18 years). They reported that pediatric patients with psoriasis were significantly more at risk of developing psychiatric disorders versus controls (P=.0001), especially depression (P=.0036) and anxiety (P=.0048).

In February 2017, the US Food and Drug Administration (FDA) announced approval of brodalumab for use in adults with moderate to severe plaque psoriasis. It is intended for patients who are candidates for systemic therapy or phototherapy but have failed to respond or have stopped responding to other systemic therapies. Lebwohl et al published the results of the phase 3 clinical trials, which showed that brodalumab was highly effective in reducing plaque psoriasis, even compared to ustekinumab. In fact, psoriasis area and severity index scores of 100 were significantly higher in the brodalumab 210-mg group versus ustekinumab group by week 12 (P<.001).

However, the approval is accompanied with a strict warning from the FDA and tightly regulated access to the drug, as suicidal ideation and behavior, including 4 suicides, occurred in patients treated with brodalumab during clinical trials, particularly patients with a history of depression or suicidality. According to the FDA, "[a] causal association between treatment with [brodalumab] and increased risk of suicidal ideation and behavior has not been established." The label includes a black box warning and the drug will only be available through a restricted Risk Evaluation and Mitigation Strategy program, which has the following requirements from the FDA:

• Prescribers must be certified with the program and counsel patients about this risk. Patients with new or worsening symptoms of depression or suicidality should be referred to a mental health professional, as appropriate.
• Patients must sign a Patient-Prescriber Agreement Form and be made aware of the need to seek medical attention should they experience new or worsening suicidal thoughts or behavior, feelings of depression, anxiety, or other mood changes.
• Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive the drug.

A medication guide is available for patients to inform them of the risk for suicidal ideation and behavior. The benefit of treatment must be weighed carefully against the seriousness of the risks associated with use.

Regardless of the therapy prescribed, dermatologists should be aware of the symptoms of depression. The National Psoriasis Foundation suggests you ask patients how they dress: Do they always wear long-sleeved shirts when they leave the house? Do they wear black? These questions can help determine if patients feel socially isolated or stigmatized by the disease. The National Psoriasis Foundation offers a Patient Navigation Center to help patients find a psychologist who specializes in issues related to psoriatic disease. Antidepressants and seeing a mental health professional can help, but ultimately taking control of the disease is the best way to improve depression.

Expert Commentary

According to the prescribing information for brodalumab, "Eight of the 10 subjects who attempted or completed suicide had a history of depression and/or suicidal ideation or behavior." Thus, 80% of these cases were at risk even before receiving 1 injection of brodalumab. Long-term registries will determine if there is truly an increased risk for suicidal ideation or behavior when taking brodalumab. 

Brodalumab will be commercially available around the fall 2017. Before prescribing brodalumab, I will counsel patients about this potential increased risk of suicidal ideation or behavior as noted in the prescribing information, but I will tell them that a true risk has not yet been determined in long-term registries. I will mention to patients that if they really do feel depressed or experience suicidal ideation or behavior after starting brodalumab, they should stop taking brodalumab and contact me or a mental health professional.

—Jashin J. Wu, MD (Los Angeles, California)

Myth: Psoriasis Therapies Can Cause Suicidal Ideation in Psoriasis Patients

Psoriasis takes a toll on patients, both physically and emotionally. Depression is one of the comorbidities of psoriasis due to biological changes that cause psoriasis as well as the stigma of visible psoriasis. Severe depression and suicidal ideation have been perceived to be features of life-threatening medical disorders, but dermatologists need to be aware of the relationship between depressive symptoms, suicidal ideation, and psoriasis severity.

A 2010 United Kingdom study of 916,948 patients with mild psoriasis, severe psoriasis, or controls without psoriasis indicated that patients with psoriasis have an increased risk for depression, anxiety, and suicidality. The relative risk of these outcomes is elevated in younger patients with psoriasis, with the greatest relative risk being for depression in patients with severe psoriasis.

Kimball et al conducted a study in the United States of 7404 patients with psoriasis and 37,020 controls without psoriasis (age, <18 years). They reported that pediatric patients with psoriasis were significantly more at risk of developing psychiatric disorders versus controls (P=.0001), especially depression (P=.0036) and anxiety (P=.0048).

In February 2017, the US Food and Drug Administration (FDA) announced approval of brodalumab for use in adults with moderate to severe plaque psoriasis. It is intended for patients who are candidates for systemic therapy or phototherapy but have failed to respond or have stopped responding to other systemic therapies. Lebwohl et al published the results of the phase 3 clinical trials, which showed that brodalumab was highly effective in reducing plaque psoriasis, even compared to ustekinumab. In fact, psoriasis area and severity index scores of 100 were significantly higher in the brodalumab 210-mg group versus ustekinumab group by week 12 (P<.001).

However, the approval is accompanied with a strict warning from the FDA and tightly regulated access to the drug, as suicidal ideation and behavior, including 4 suicides, occurred in patients treated with brodalumab during clinical trials, particularly patients with a history of depression or suicidality. According to the FDA, "[a] causal association between treatment with [brodalumab] and increased risk of suicidal ideation and behavior has not been established." The label includes a black box warning and the drug will only be available through a restricted Risk Evaluation and Mitigation Strategy program, which has the following requirements from the FDA:

• Prescribers must be certified with the program and counsel patients about this risk. Patients with new or worsening symptoms of depression or suicidality should be referred to a mental health professional, as appropriate.
• Patients must sign a Patient-Prescriber Agreement Form and be made aware of the need to seek medical attention should they experience new or worsening suicidal thoughts or behavior, feelings of depression, anxiety, or other mood changes.
• Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive the drug.

A medication guide is available for patients to inform them of the risk for suicidal ideation and behavior. The benefit of treatment must be weighed carefully against the seriousness of the risks associated with use.

Regardless of the therapy prescribed, dermatologists should be aware of the symptoms of depression. The National Psoriasis Foundation suggests you ask patients how they dress: Do they always wear long-sleeved shirts when they leave the house? Do they wear black? These questions can help determine if patients feel socially isolated or stigmatized by the disease. The National Psoriasis Foundation offers a Patient Navigation Center to help patients find a psychologist who specializes in issues related to psoriatic disease. Antidepressants and seeing a mental health professional can help, but ultimately taking control of the disease is the best way to improve depression.

Expert Commentary

According to the prescribing information for brodalumab, "Eight of the 10 subjects who attempted or completed suicide had a history of depression and/or suicidal ideation or behavior." Thus, 80% of these cases were at risk even before receiving 1 injection of brodalumab. Long-term registries will determine if there is truly an increased risk for suicidal ideation or behavior when taking brodalumab. 

Brodalumab will be commercially available around the fall 2017. Before prescribing brodalumab, I will counsel patients about this potential increased risk of suicidal ideation or behavior as noted in the prescribing information, but I will tell them that a true risk has not yet been determined in long-term registries. I will mention to patients that if they really do feel depressed or experience suicidal ideation or behavior after starting brodalumab, they should stop taking brodalumab and contact me or a mental health professional.

—Jashin J. Wu, MD (Los Angeles, California)

Myth: Psoriasis Therapies Can Cause Suicidal Ideation in Psoriasis Patients

Psoriasis takes a toll on patients, both physically and emotionally. Depression is one of the comorbidities of psoriasis due to biological changes that cause psoriasis as well as the stigma of visible psoriasis. Severe depression and suicidal ideation have been perceived to be features of life-threatening medical disorders, but dermatologists need to be aware of the relationship between depressive symptoms, suicidal ideation, and psoriasis severity.

A 2010 United Kingdom study of 916,948 patients with mild psoriasis, severe psoriasis, or controls without psoriasis indicated that patients with psoriasis have an increased risk for depression, anxiety, and suicidality. The relative risk of these outcomes is elevated in younger patients with psoriasis, with the greatest relative risk being for depression in patients with severe psoriasis.

Kimball et al conducted a study in the United States of 7404 patients with psoriasis and 37,020 controls without psoriasis (age, <18 years). They reported that pediatric patients with psoriasis were significantly more at risk of developing psychiatric disorders versus controls (P=.0001), especially depression (P=.0036) and anxiety (P=.0048).

In February 2017, the US Food and Drug Administration (FDA) announced approval of brodalumab for use in adults with moderate to severe plaque psoriasis. It is intended for patients who are candidates for systemic therapy or phototherapy but have failed to respond or have stopped responding to other systemic therapies. Lebwohl et al published the results of the phase 3 clinical trials, which showed that brodalumab was highly effective in reducing plaque psoriasis, even compared to ustekinumab. In fact, psoriasis area and severity index scores of 100 were significantly higher in the brodalumab 210-mg group versus ustekinumab group by week 12 (P<.001).

However, the approval is accompanied with a strict warning from the FDA and tightly regulated access to the drug, as suicidal ideation and behavior, including 4 suicides, occurred in patients treated with brodalumab during clinical trials, particularly patients with a history of depression or suicidality. According to the FDA, "[a] causal association between treatment with [brodalumab] and increased risk of suicidal ideation and behavior has not been established." The label includes a black box warning and the drug will only be available through a restricted Risk Evaluation and Mitigation Strategy program, which has the following requirements from the FDA:

• Prescribers must be certified with the program and counsel patients about this risk. Patients with new or worsening symptoms of depression or suicidality should be referred to a mental health professional, as appropriate.
• Patients must sign a Patient-Prescriber Agreement Form and be made aware of the need to seek medical attention should they experience new or worsening suicidal thoughts or behavior, feelings of depression, anxiety, or other mood changes.
• Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive the drug.

A medication guide is available for patients to inform them of the risk for suicidal ideation and behavior. The benefit of treatment must be weighed carefully against the seriousness of the risks associated with use.

Regardless of the therapy prescribed, dermatologists should be aware of the symptoms of depression. The National Psoriasis Foundation suggests you ask patients how they dress: Do they always wear long-sleeved shirts when they leave the house? Do they wear black? These questions can help determine if patients feel socially isolated or stigmatized by the disease. The National Psoriasis Foundation offers a Patient Navigation Center to help patients find a psychologist who specializes in issues related to psoriatic disease. Antidepressants and seeing a mental health professional can help, but ultimately taking control of the disease is the best way to improve depression.

Expert Commentary

According to the prescribing information for brodalumab, "Eight of the 10 subjects who attempted or completed suicide had a history of depression and/or suicidal ideation or behavior." Thus, 80% of these cases were at risk even before receiving 1 injection of brodalumab. Long-term registries will determine if there is truly an increased risk for suicidal ideation or behavior when taking brodalumab. 

Brodalumab will be commercially available around the fall 2017. Before prescribing brodalumab, I will counsel patients about this potential increased risk of suicidal ideation or behavior as noted in the prescribing information, but I will tell them that a true risk has not yet been determined in long-term registries. I will mention to patients that if they really do feel depressed or experience suicidal ideation or behavior after starting brodalumab, they should stop taking brodalumab and contact me or a mental health professional.

—Jashin J. Wu, MD (Los Angeles, California)

WAILEA, HAWAII – A fixed combination of halobetasol and tazarotene formulated as a once-daily lotion proved safe and effective for patients with moderate or severe plaque psoriasis in a phase II randomized clinical trial, Linda Stein Gold, MD, reported at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

The rationale for developing this product is that it should provide the efficacy of a class 1 superpotent topical corticosteroid, albeit with the topical retinoid lessening concern about the possibility of steroid-induced skin atrophy and other long-term safety issues, explained Dr. Stein Gold, director of dermatology research at Henry Ford Health System in Detroit.

Bruce Jancni/Frontline Medical News

[email protected]

WAILEA, HAWAII – A fixed combination of halobetasol and tazarotene formulated as a once-daily lotion proved safe and effective for patients with moderate or severe plaque psoriasis in a phase II randomized clinical trial, Linda Stein Gold, MD, reported at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

The rationale for developing this product is that it should provide the efficacy of a class 1 superpotent topical corticosteroid, albeit with the topical retinoid lessening concern about the possibility of steroid-induced skin atrophy and other long-term safety issues, explained Dr. Stein Gold, director of dermatology research at Henry Ford Health System in Detroit.

Bruce Jancni/Frontline Medical News

[email protected]

WAILEA, HAWAII – A fixed combination of halobetasol and tazarotene formulated as a once-daily lotion proved safe and effective for patients with moderate or severe plaque psoriasis in a phase II randomized clinical trial, Linda Stein Gold, MD, reported at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

The rationale for developing this product is that it should provide the efficacy of a class 1 superpotent topical corticosteroid, albeit with the topical retinoid lessening concern about the possibility of steroid-induced skin atrophy and other long-term safety issues, explained Dr. Stein Gold, director of dermatology research at Henry Ford Health System in Detroit.

Bruce Jancni/Frontline Medical News

[email protected]

Flaking/scaling and itching, followed by dry cracked skin that may bleed, pain or soreness, and burning/stinging were noted by psoriasis patients as the symptoms with the most significant impact on daily life in a public meeting hosted by the US Food and Drug Administration (FDA) to hear patient perspectives on psoriasis. Approximately 70 psoriasis patients or patient representatives attended the meeting in person and others attended through a live webcast.

More than two-thirds of respondents identified flaking/scaling as one of their most significant symptoms of psoriasis, either localized to psoriasis-prone areas such as the elbows and knees or more widespread. Patients reported that this symptom is constant, leaving them to absentmindedly rub certain areas of the skin.

A similar number of respondents indicated that itching was their most significant symptom. One patient called it “an intense subcutaneous itch… deep down in the skin,” a description that resonated with other patients in the room.

Nearly 40% identified dry cracked skin that may bleed as a significant symptom, noting that areas where skin is thinner are affected more, such as the folds of the body. Patients described this symptom as interrelated with other symptoms such as itching. “The thicker the scales get on my skin, the more they itch, and the more they itch, the more I am likely to scratch them, and the more I scratch them, the more they start to crack, and then more come back and it keeps going and going,” one patient said.

More than one-quarter of respondents indicated that pain, soreness, or burning/stinging were the most significant symptoms. Patients indicated that the stinging/burning was more episodic, while the pain was more constant, with the pain being under the skin.

Triggers of these symptoms included stress (primary trigger), changes in weather, hormonal changes, diet, lotions, prolonged exposure to sunlight, sweat, aging, and other medical conditions.

Dermatologists may use these patient insights to prescribe therapies that target these symptoms.

The psoriasis public meeting in March 2016 was the FDA’s 18th patient-focused drug development meeting. The FDA sought this information to have a greater understanding of the burden of psoriasis on patients and the treatments currently used to treat psoriasis and its symptoms. This information will help guide the FDA as they consider future drug approvals.

Flaking/scaling and itching, followed by dry cracked skin that may bleed, pain or soreness, and burning/stinging were noted by psoriasis patients as the symptoms with the most significant impact on daily life in a public meeting hosted by the US Food and Drug Administration (FDA) to hear patient perspectives on psoriasis. Approximately 70 psoriasis patients or patient representatives attended the meeting in person and others attended through a live webcast.

More than two-thirds of respondents identified flaking/scaling as one of their most significant symptoms of psoriasis, either localized to psoriasis-prone areas such as the elbows and knees or more widespread. Patients reported that this symptom is constant, leaving them to absentmindedly rub certain areas of the skin.

A similar number of respondents indicated that itching was their most significant symptom. One patient called it “an intense subcutaneous itch… deep down in the skin,” a description that resonated with other patients in the room.

Nearly 40% identified dry cracked skin that may bleed as a significant symptom, noting that areas where skin is thinner are affected more, such as the folds of the body. Patients described this symptom as interrelated with other symptoms such as itching. “The thicker the scales get on my skin, the more they itch, and the more they itch, the more I am likely to scratch them, and the more I scratch them, the more they start to crack, and then more come back and it keeps going and going,” one patient said.

More than one-quarter of respondents indicated that pain, soreness, or burning/stinging were the most significant symptoms. Patients indicated that the stinging/burning was more episodic, while the pain was more constant, with the pain being under the skin.

Triggers of these symptoms included stress (primary trigger), changes in weather, hormonal changes, diet, lotions, prolonged exposure to sunlight, sweat, aging, and other medical conditions.

Dermatologists may use these patient insights to prescribe therapies that target these symptoms.

The psoriasis public meeting in March 2016 was the FDA’s 18th patient-focused drug development meeting. The FDA sought this information to have a greater understanding of the burden of psoriasis on patients and the treatments currently used to treat psoriasis and its symptoms. This information will help guide the FDA as they consider future drug approvals.

Flaking/scaling and itching, followed by dry cracked skin that may bleed, pain or soreness, and burning/stinging were noted by psoriasis patients as the symptoms with the most significant impact on daily life in a public meeting hosted by the US Food and Drug Administration (FDA) to hear patient perspectives on psoriasis. Approximately 70 psoriasis patients or patient representatives attended the meeting in person and others attended through a live webcast.

More than two-thirds of respondents identified flaking/scaling as one of their most significant symptoms of psoriasis, either localized to psoriasis-prone areas such as the elbows and knees or more widespread. Patients reported that this symptom is constant, leaving them to absentmindedly rub certain areas of the skin.

A similar number of respondents indicated that itching was their most significant symptom. One patient called it “an intense subcutaneous itch… deep down in the skin,” a description that resonated with other patients in the room.

Nearly 40% identified dry cracked skin that may bleed as a significant symptom, noting that areas where skin is thinner are affected more, such as the folds of the body. Patients described this symptom as interrelated with other symptoms such as itching. “The thicker the scales get on my skin, the more they itch, and the more they itch, the more I am likely to scratch them, and the more I scratch them, the more they start to crack, and then more come back and it keeps going and going,” one patient said.

More than one-quarter of respondents indicated that pain, soreness, or burning/stinging were the most significant symptoms. Patients indicated that the stinging/burning was more episodic, while the pain was more constant, with the pain being under the skin.

Triggers of these symptoms included stress (primary trigger), changes in weather, hormonal changes, diet, lotions, prolonged exposure to sunlight, sweat, aging, and other medical conditions.

Dermatologists may use these patient insights to prescribe therapies that target these symptoms.

The psoriasis public meeting in March 2016 was the FDA’s 18th patient-focused drug development meeting. The FDA sought this information to have a greater understanding of the burden of psoriasis on patients and the treatments currently used to treat psoriasis and its symptoms. This information will help guide the FDA as they consider future drug approvals.

What does your patient need to know at the first visit?

Patients with this condition need to avoid friction and excessive moisture. They should be counseled to use gloves for excessive wet work. I recommend they use cotton gloves on the hands, and then cover those with rubber gloves. Patients should use a hand emollient regularly, including after each time they wash their hands or have exposure to water. If the patient lifts weights, I recommend he/she use weight-lifting gloves to reduce friction.

What are your go to treatments? What are the side effects?

The first line of therapy for hand and foot psoriasis is a topical agent. I most often use a combination of topical steroids and a topical vitamin D analogue. If insurance is amenable, I may use a fixed combination of topical steroid and vitamin D analogue.

If topical therapies are not successful, I often consider using excimer laser therapy, which requires the patient to come to the office twice weekly, so it is important to determine if this therapy is compatible with the patient's schedule. Other options include oral and biological therapies. Apremilast is a reasonable first-line systemic therapy given that it is an oral therapy, requires no laboratory monitoring, and has a favorable safety profile. Alternatively, biologic agents can be utilized. There are several analyses available looking at the efficacy of different biologics in hand and foot psoriasis, but at this point there is no consensus first choice for a biologic in this condition. Many available biologics may have a notable impact though.

The side effects of therapies for psoriasis are well established. Topical therapies and excimer laser are relatively safe choices. Apremilast has been associated with early gastrointestinal tract side effects that tend to resolve over time. Each biologic has a unique safety profile, with a rare incidence of side effects that should be reviewed carefully with any prospective patients before starting therapy.

How do you keep patients compliant with treatment?

It is important to reinforce gentle hand care and foot care. Patients need to understand that lack of compliance with treatment will lead to recurrence of disease.

What do you do if patients refuse treatment? 

I try to educate them as best as possible, and ask them to return and reconsider therapy if they find that this condition affects their quality of life.

What does your patient need to know at the first visit?

Patients with this condition need to avoid friction and excessive moisture. They should be counseled to use gloves for excessive wet work. I recommend they use cotton gloves on the hands, and then cover those with rubber gloves. Patients should use a hand emollient regularly, including after each time they wash their hands or have exposure to water. If the patient lifts weights, I recommend he/she use weight-lifting gloves to reduce friction.

What are your go to treatments? What are the side effects?

The first line of therapy for hand and foot psoriasis is a topical agent. I most often use a combination of topical steroids and a topical vitamin D analogue. If insurance is amenable, I may use a fixed combination of topical steroid and vitamin D analogue.

If topical therapies are not successful, I often consider using excimer laser therapy, which requires the patient to come to the office twice weekly, so it is important to determine if this therapy is compatible with the patient's schedule. Other options include oral and biological therapies. Apremilast is a reasonable first-line systemic therapy given that it is an oral therapy, requires no laboratory monitoring, and has a favorable safety profile. Alternatively, biologic agents can be utilized. There are several analyses available looking at the efficacy of different biologics in hand and foot psoriasis, but at this point there is no consensus first choice for a biologic in this condition. Many available biologics may have a notable impact though.

The side effects of therapies for psoriasis are well established. Topical therapies and excimer laser are relatively safe choices. Apremilast has been associated with early gastrointestinal tract side effects that tend to resolve over time. Each biologic has a unique safety profile, with a rare incidence of side effects that should be reviewed carefully with any prospective patients before starting therapy.

How do you keep patients compliant with treatment?

It is important to reinforce gentle hand care and foot care. Patients need to understand that lack of compliance with treatment will lead to recurrence of disease.

What do you do if patients refuse treatment? 

I try to educate them as best as possible, and ask them to return and reconsider therapy if they find that this condition affects their quality of life.

What does your patient need to know at the first visit?

Patients with this condition need to avoid friction and excessive moisture. They should be counseled to use gloves for excessive wet work. I recommend they use cotton gloves on the hands, and then cover those with rubber gloves. Patients should use a hand emollient regularly, including after each time they wash their hands or have exposure to water. If the patient lifts weights, I recommend he/she use weight-lifting gloves to reduce friction.

What are your go to treatments? What are the side effects?

The first line of therapy for hand and foot psoriasis is a topical agent. I most often use a combination of topical steroids and a topical vitamin D analogue. If insurance is amenable, I may use a fixed combination of topical steroid and vitamin D analogue.

If topical therapies are not successful, I often consider using excimer laser therapy, which requires the patient to come to the office twice weekly, so it is important to determine if this therapy is compatible with the patient's schedule. Other options include oral and biological therapies. Apremilast is a reasonable first-line systemic therapy given that it is an oral therapy, requires no laboratory monitoring, and has a favorable safety profile. Alternatively, biologic agents can be utilized. There are several analyses available looking at the efficacy of different biologics in hand and foot psoriasis, but at this point there is no consensus first choice for a biologic in this condition. Many available biologics may have a notable impact though.

The side effects of therapies for psoriasis are well established. Topical therapies and excimer laser are relatively safe choices. Apremilast has been associated with early gastrointestinal tract side effects that tend to resolve over time. Each biologic has a unique safety profile, with a rare incidence of side effects that should be reviewed carefully with any prospective patients before starting therapy.

How do you keep patients compliant with treatment?

It is important to reinforce gentle hand care and foot care. Patients need to understand that lack of compliance with treatment will lead to recurrence of disease.

What do you do if patients refuse treatment? 

I try to educate them as best as possible, and ask them to return and reconsider therapy if they find that this condition affects their quality of life.

ORLANDO – The interleukin-17A inhibitor ixekizumab was associated with superior efficacy and safety when compared with ustekinumab at 24 weeks, a head-to-head trial of the two monoclonal antibodies in plaque psoriasis has shown.

The 24-week data from the IXORA-S trial were presented during a late-breaking clinical trial session at the annual meeting of the American Academy of Dermatology by Kristian Reich, MD, PhD, a founder of SCIderm in Hamburg, Germany.

[email protected]

On Twitter @whitneymcknight

ORLANDO – The interleukin-17A inhibitor ixekizumab was associated with superior efficacy and safety when compared with ustekinumab at 24 weeks, a head-to-head trial of the two monoclonal antibodies in plaque psoriasis has shown.

The 24-week data from the IXORA-S trial were presented during a late-breaking clinical trial session at the annual meeting of the American Academy of Dermatology by Kristian Reich, MD, PhD, a founder of SCIderm in Hamburg, Germany.

[email protected]

On Twitter @whitneymcknight

ORLANDO – The interleukin-17A inhibitor ixekizumab was associated with superior efficacy and safety when compared with ustekinumab at 24 weeks, a head-to-head trial of the two monoclonal antibodies in plaque psoriasis has shown.

The 24-week data from the IXORA-S trial were presented during a late-breaking clinical trial session at the annual meeting of the American Academy of Dermatology by Kristian Reich, MD, PhD, a founder of SCIderm in Hamburg, Germany.

[email protected]

On Twitter @whitneymcknight