Psoriasis

Case Report

A 28-year-old man presented to the dermatology department with cone-shaped, oyster shell–like skin lesions on the scalp, trunk, arms, and legs of 1 month’s duration. He denied any fever, pruritus, pain, joint stiffness, or arthralgia. His family history was remarkable for psoriasis in his paternal grandfather and uncle.

A few years prior to the eruption, the patient developed a rash in the bilateral inguinal area but did not seek medical attention. One month prior to presentation, the rash began to spread to the scalp, trunk, arms, and legs. He was treated in the emergency department with a 5-day course of oral prednisone without any noticeable improvement. At the time of presentation to the dermatology clinic, he was found to have multiple well-demarcated erythematous plaques with conical, oyster shell–like, dirty-appearing, hyperkeratotic crusts (Figure 1). Rapid plasma reagin testing was negative. A 4-mm punch biopsy specimen from the right upper arm demonstrated thick parakeratosis with a remarkable Munro microabscess, regular psoriasiform acanthosis with thin suprapapillary epidermal plates, absent granular layer, and prominent papillary dermal edema (Figure 2). In the stratum corneum, there was seroexudate with numerous red blood cells between the parakeratosis.

Figure 1. Multiple well-demarcated erythematous plaques with hyperkeratotic crust on the back (A). Closer view of erythematous plaques with conical, oyster shell–like, dirty-appearing, hyperkeratotic crust (B).

Figure 2. Thick parakeratosis with a remarkable Munro microabscess, regular psoriasiform acanthosis with thin suprapapillary epidermal plates, absent granular layer, and prominent papillary dermal edema (H&E, original magnification ×100).

The patient was diagnosed with rupioid psoriasis. The lesions dramatically improved with methotrexate 10 mg weekly and topical steroids. Two months following diagnosis the patient presented with persistent hyperkeratotic lesions on the back, as he had difficulty reaching the lesions to apply topical medications; intralesional steroid injections were added. This regimen resulted in near-complete resolution maintained at his most recent follow-up 2 years following diagnosis in our clinic.

Comment

Rupia is based on the Greek word rhupos, which means dirt or filth. The term rupioid has been used to describe well-demarcated, cone-shaped plaques with thick, dark, lamellate, and adherent crusts on the skin somewhat resembling oyster or limpet shells. Histologically, a serosanguineous exudate along with thick skin helps to impart a “dirty” appearance to rupioid lesions. Rupioid manifestations have been clinically observed in a variety of diseases, including rupioid psoriasis,^1-3 reactive arthritis,⁴ disseminated histoplasmosis,⁵ keratotic scabies,⁶ secondary syphilis,⁷ and photosensitive skin lesions in association with aminoaciduria.⁸ To diagnose the underlying infectious or inflammatory diseases beneath the thick crusts, skin biopsy and a blood test for syphilis may be necessary.

Rupioid psoriasis is a morphologic subtype of plaque psoriasis with hyperkeratotic lesions that resemble an oyster or limpet shell. Patients with thick plaque psoriasis are more likely to be male with a higher incidence of nail disease and psoriatic arthritis as well as a greater body surface area affected than patients with thin plaque psoriasis.¹ Although most cases of rupioid psoriasis were associated with psoriatic arthritis,³ our patient showed no evidence of psoriatic arthritis or nail changes.

Reactive arthritis may have a similar appearance to rupioid psoriasis but may be distinguished by a geographic relief map configuration with coalescing, keratotic and desquamating lesions, as well as associated urethritis, arthritis, and conjunctivitis.⁴ A rupioid eruption was reported as a manifestation of disseminated histoplasmosis with dirty-appearing, heaped-up, crusted lesions present on the cheeks, nose, and forehead on clinical examination and several intracellular and extracellular oval structures on histologic examination with periodic acid–Schiff and Gomori methenamine-silver stain.⁵ Malignant or rupioid syphilis refers to the stage in which papulopustules of pustular syphilis undergo central necrosis due to endarteritis obliterans and intravascular thrombosis.⁷

In our case, the patient’s psoriasis could have flared after discontinuation of the prednisone that was administered by the emergency department physician. Most cases have been treated with combined systemic and topical therapy.⁹ For systemic treatment, cyclosporine, intramuscular or oral methotrexate, adalimumab, and ustekinumab³ have been used with remarkable improvement. Hyperkeratotic types of psoriasis are generally thought to be resistant to topical therapy because of poor penetration of applied agents; however, a case of rupioid psoriasis without arthritis was successfully treated with topical steroids without concomitant systemic medications.²

Conclusion

Rupioid psoriasis is a morphological subtype of plaque psoriasis with hyperkeratotic lesions that resemble a limpet shell. Rupioid skin manifestations may be seen in a variety of diseases including rupioid psoriasis, reactive arthritis, disseminated histoplasmosis, keratotic scabies, secondary syphilis, and photosensitive skin lesions associated with aminoaciduria. Diagnosis of rupioid psoriasis often requires additional testing such as skin biopsy, skin scraping, and blood tests, and it typically requires systemic therapy for treatment.

Case Report

A 28-year-old man presented to the dermatology department with cone-shaped, oyster shell–like skin lesions on the scalp, trunk, arms, and legs of 1 month’s duration. He denied any fever, pruritus, pain, joint stiffness, or arthralgia. His family history was remarkable for psoriasis in his paternal grandfather and uncle.

A few years prior to the eruption, the patient developed a rash in the bilateral inguinal area but did not seek medical attention. One month prior to presentation, the rash began to spread to the scalp, trunk, arms, and legs. He was treated in the emergency department with a 5-day course of oral prednisone without any noticeable improvement. At the time of presentation to the dermatology clinic, he was found to have multiple well-demarcated erythematous plaques with conical, oyster shell–like, dirty-appearing, hyperkeratotic crusts (Figure 1). Rapid plasma reagin testing was negative. A 4-mm punch biopsy specimen from the right upper arm demonstrated thick parakeratosis with a remarkable Munro microabscess, regular psoriasiform acanthosis with thin suprapapillary epidermal plates, absent granular layer, and prominent papillary dermal edema (Figure 2). In the stratum corneum, there was seroexudate with numerous red blood cells between the parakeratosis.

Figure 1. Multiple well-demarcated erythematous plaques with hyperkeratotic crust on the back (A). Closer view of erythematous plaques with conical, oyster shell–like, dirty-appearing, hyperkeratotic crust (B).

Figure 2. Thick parakeratosis with a remarkable Munro microabscess, regular psoriasiform acanthosis with thin suprapapillary epidermal plates, absent granular layer, and prominent papillary dermal edema (H&E, original magnification ×100).

The patient was diagnosed with rupioid psoriasis. The lesions dramatically improved with methotrexate 10 mg weekly and topical steroids. Two months following diagnosis the patient presented with persistent hyperkeratotic lesions on the back, as he had difficulty reaching the lesions to apply topical medications; intralesional steroid injections were added. This regimen resulted in near-complete resolution maintained at his most recent follow-up 2 years following diagnosis in our clinic.

Comment

Rupia is based on the Greek word rhupos, which means dirt or filth. The term rupioid has been used to describe well-demarcated, cone-shaped plaques with thick, dark, lamellate, and adherent crusts on the skin somewhat resembling oyster or limpet shells. Histologically, a serosanguineous exudate along with thick skin helps to impart a “dirty” appearance to rupioid lesions. Rupioid manifestations have been clinically observed in a variety of diseases, including rupioid psoriasis,^1-3 reactive arthritis,⁴ disseminated histoplasmosis,⁵ keratotic scabies,⁶ secondary syphilis,⁷ and photosensitive skin lesions in association with aminoaciduria.⁸ To diagnose the underlying infectious or inflammatory diseases beneath the thick crusts, skin biopsy and a blood test for syphilis may be necessary.

Rupioid psoriasis is a morphologic subtype of plaque psoriasis with hyperkeratotic lesions that resemble an oyster or limpet shell. Patients with thick plaque psoriasis are more likely to be male with a higher incidence of nail disease and psoriatic arthritis as well as a greater body surface area affected than patients with thin plaque psoriasis.¹ Although most cases of rupioid psoriasis were associated with psoriatic arthritis,³ our patient showed no evidence of psoriatic arthritis or nail changes.

Reactive arthritis may have a similar appearance to rupioid psoriasis but may be distinguished by a geographic relief map configuration with coalescing, keratotic and desquamating lesions, as well as associated urethritis, arthritis, and conjunctivitis.⁴ A rupioid eruption was reported as a manifestation of disseminated histoplasmosis with dirty-appearing, heaped-up, crusted lesions present on the cheeks, nose, and forehead on clinical examination and several intracellular and extracellular oval structures on histologic examination with periodic acid–Schiff and Gomori methenamine-silver stain.⁵ Malignant or rupioid syphilis refers to the stage in which papulopustules of pustular syphilis undergo central necrosis due to endarteritis obliterans and intravascular thrombosis.⁷

In our case, the patient’s psoriasis could have flared after discontinuation of the prednisone that was administered by the emergency department physician. Most cases have been treated with combined systemic and topical therapy.⁹ For systemic treatment, cyclosporine, intramuscular or oral methotrexate, adalimumab, and ustekinumab³ have been used with remarkable improvement. Hyperkeratotic types of psoriasis are generally thought to be resistant to topical therapy because of poor penetration of applied agents; however, a case of rupioid psoriasis without arthritis was successfully treated with topical steroids without concomitant systemic medications.²

Conclusion

Rupioid psoriasis is a morphological subtype of plaque psoriasis with hyperkeratotic lesions that resemble a limpet shell. Rupioid skin manifestations may be seen in a variety of diseases including rupioid psoriasis, reactive arthritis, disseminated histoplasmosis, keratotic scabies, secondary syphilis, and photosensitive skin lesions associated with aminoaciduria. Diagnosis of rupioid psoriasis often requires additional testing such as skin biopsy, skin scraping, and blood tests, and it typically requires systemic therapy for treatment.

Case Report

A 28-year-old man presented to the dermatology department with cone-shaped, oyster shell–like skin lesions on the scalp, trunk, arms, and legs of 1 month’s duration. He denied any fever, pruritus, pain, joint stiffness, or arthralgia. His family history was remarkable for psoriasis in his paternal grandfather and uncle.

A few years prior to the eruption, the patient developed a rash in the bilateral inguinal area but did not seek medical attention. One month prior to presentation, the rash began to spread to the scalp, trunk, arms, and legs. He was treated in the emergency department with a 5-day course of oral prednisone without any noticeable improvement. At the time of presentation to the dermatology clinic, he was found to have multiple well-demarcated erythematous plaques with conical, oyster shell–like, dirty-appearing, hyperkeratotic crusts (Figure 1). Rapid plasma reagin testing was negative. A 4-mm punch biopsy specimen from the right upper arm demonstrated thick parakeratosis with a remarkable Munro microabscess, regular psoriasiform acanthosis with thin suprapapillary epidermal plates, absent granular layer, and prominent papillary dermal edema (Figure 2). In the stratum corneum, there was seroexudate with numerous red blood cells between the parakeratosis.

Figure 1. Multiple well-demarcated erythematous plaques with hyperkeratotic crust on the back (A). Closer view of erythematous plaques with conical, oyster shell–like, dirty-appearing, hyperkeratotic crust (B).

Figure 2. Thick parakeratosis with a remarkable Munro microabscess, regular psoriasiform acanthosis with thin suprapapillary epidermal plates, absent granular layer, and prominent papillary dermal edema (H&E, original magnification ×100).

The patient was diagnosed with rupioid psoriasis. The lesions dramatically improved with methotrexate 10 mg weekly and topical steroids. Two months following diagnosis the patient presented with persistent hyperkeratotic lesions on the back, as he had difficulty reaching the lesions to apply topical medications; intralesional steroid injections were added. This regimen resulted in near-complete resolution maintained at his most recent follow-up 2 years following diagnosis in our clinic.

Comment

Rupia is based on the Greek word rhupos, which means dirt or filth. The term rupioid has been used to describe well-demarcated, cone-shaped plaques with thick, dark, lamellate, and adherent crusts on the skin somewhat resembling oyster or limpet shells. Histologically, a serosanguineous exudate along with thick skin helps to impart a “dirty” appearance to rupioid lesions. Rupioid manifestations have been clinically observed in a variety of diseases, including rupioid psoriasis,^1-3 reactive arthritis,⁴ disseminated histoplasmosis,⁵ keratotic scabies,⁶ secondary syphilis,⁷ and photosensitive skin lesions in association with aminoaciduria.⁸ To diagnose the underlying infectious or inflammatory diseases beneath the thick crusts, skin biopsy and a blood test for syphilis may be necessary.

Rupioid psoriasis is a morphologic subtype of plaque psoriasis with hyperkeratotic lesions that resemble an oyster or limpet shell. Patients with thick plaque psoriasis are more likely to be male with a higher incidence of nail disease and psoriatic arthritis as well as a greater body surface area affected than patients with thin plaque psoriasis.¹ Although most cases of rupioid psoriasis were associated with psoriatic arthritis,³ our patient showed no evidence of psoriatic arthritis or nail changes.

Reactive arthritis may have a similar appearance to rupioid psoriasis but may be distinguished by a geographic relief map configuration with coalescing, keratotic and desquamating lesions, as well as associated urethritis, arthritis, and conjunctivitis.⁴ A rupioid eruption was reported as a manifestation of disseminated histoplasmosis with dirty-appearing, heaped-up, crusted lesions present on the cheeks, nose, and forehead on clinical examination and several intracellular and extracellular oval structures on histologic examination with periodic acid–Schiff and Gomori methenamine-silver stain.⁵ Malignant or rupioid syphilis refers to the stage in which papulopustules of pustular syphilis undergo central necrosis due to endarteritis obliterans and intravascular thrombosis.⁷

In our case, the patient’s psoriasis could have flared after discontinuation of the prednisone that was administered by the emergency department physician. Most cases have been treated with combined systemic and topical therapy.⁹ For systemic treatment, cyclosporine, intramuscular or oral methotrexate, adalimumab, and ustekinumab³ have been used with remarkable improvement. Hyperkeratotic types of psoriasis are generally thought to be resistant to topical therapy because of poor penetration of applied agents; however, a case of rupioid psoriasis without arthritis was successfully treated with topical steroids without concomitant systemic medications.²

Conclusion

Rupioid psoriasis is a morphological subtype of plaque psoriasis with hyperkeratotic lesions that resemble a limpet shell. Rupioid skin manifestations may be seen in a variety of diseases including rupioid psoriasis, reactive arthritis, disseminated histoplasmosis, keratotic scabies, secondary syphilis, and photosensitive skin lesions associated with aminoaciduria. Diagnosis of rupioid psoriasis often requires additional testing such as skin biopsy, skin scraping, and blood tests, and it typically requires systemic therapy for treatment.

Psoriasis Associated With Obesity in Adults

The National Health and Nutrition Examination Surveys were reviewed to better understand the burden of psoriasis. Helmick et al (Am J Prev Med. 2014;47:37-45) examined psoriasis prevalence, severity, disparities, health-related quality of life, and selected comorbidities in 10,676 adults aged 20 to 59 years from 2003-2006 and 2009-2010. Related to patient diet and weight, they noted that psoriasis was associated with obesity.

Practice Point: The association between psoriasis and obesity warrants further research, as the disease is a large public health concern.

>>Read more at American Journal of Preventive Medicine

Dietary Plan With Physical Exercise Reduces Psoriasis Severity

Among the risk factors for psoriasis are increased body mass index and weight gain. The prevalence of obesity in patients with psoriasis is higher than in the general population. Naldi et al (Br J Dermatol. 2014;170:634-642) assessed the impact of a dietary intervention combined with physical exercise for weight loss on improving psoriasis in overweight or obese patients. Patients were randomized to receive either a 20-week quantitative and qualitative dietary plan associated with physical exercise for weight loss or simple informative counseling at baseline about the utility of weight loss for clinical control of psoriatic disease. They reported that the median reduction in psoriasis area and severity index scores was significantly higher in the dietary intervention arm compared with the information-only arm (P=.02).

Practice Point: A dietary plan associated with physical exercise for obese or overweight psoriasis patients may help reduce disease severity.

>>Read more at British Journal of Dermatology

Improvement in Psoriasis With a Low-Energy Diet

Psoriasis severity increases with weight gain. Jensen et al (JAMA Dermatol. 2013;149:795-801) sought to measure the effect of weight reduction on the severity of psoriasis in obese patients. The intervention group received a low-energy diet for 8 weeks to induce weight loss, followed by 8 weeks of reintroduction of normal food intake. The control group was instructed to continue eating ordinary healthy foods. Results based on psoriasis area and severity index and dermatology life quality index scores were in favor of the low-energy diet group.

Practice Point: A low-energy diet may improve the severity of psoriasis in obese patients.

>>Read more at JAMA Dermatology

Psoriasis Associated With Obesity in Adults

The National Health and Nutrition Examination Surveys were reviewed to better understand the burden of psoriasis. Helmick et al (Am J Prev Med. 2014;47:37-45) examined psoriasis prevalence, severity, disparities, health-related quality of life, and selected comorbidities in 10,676 adults aged 20 to 59 years from 2003-2006 and 2009-2010. Related to patient diet and weight, they noted that psoriasis was associated with obesity.

Practice Point: The association between psoriasis and obesity warrants further research, as the disease is a large public health concern.

>>Read more at American Journal of Preventive Medicine

Dietary Plan With Physical Exercise Reduces Psoriasis Severity

Among the risk factors for psoriasis are increased body mass index and weight gain. The prevalence of obesity in patients with psoriasis is higher than in the general population. Naldi et al (Br J Dermatol. 2014;170:634-642) assessed the impact of a dietary intervention combined with physical exercise for weight loss on improving psoriasis in overweight or obese patients. Patients were randomized to receive either a 20-week quantitative and qualitative dietary plan associated with physical exercise for weight loss or simple informative counseling at baseline about the utility of weight loss for clinical control of psoriatic disease. They reported that the median reduction in psoriasis area and severity index scores was significantly higher in the dietary intervention arm compared with the information-only arm (P=.02).

Practice Point: A dietary plan associated with physical exercise for obese or overweight psoriasis patients may help reduce disease severity.

>>Read more at British Journal of Dermatology

Improvement in Psoriasis With a Low-Energy Diet

Psoriasis severity increases with weight gain. Jensen et al (JAMA Dermatol. 2013;149:795-801) sought to measure the effect of weight reduction on the severity of psoriasis in obese patients. The intervention group received a low-energy diet for 8 weeks to induce weight loss, followed by 8 weeks of reintroduction of normal food intake. The control group was instructed to continue eating ordinary healthy foods. Results based on psoriasis area and severity index and dermatology life quality index scores were in favor of the low-energy diet group.

Practice Point: A low-energy diet may improve the severity of psoriasis in obese patients.

>>Read more at JAMA Dermatology

Psoriasis Associated With Obesity in Adults

The National Health and Nutrition Examination Surveys were reviewed to better understand the burden of psoriasis. Helmick et al (Am J Prev Med. 2014;47:37-45) examined psoriasis prevalence, severity, disparities, health-related quality of life, and selected comorbidities in 10,676 adults aged 20 to 59 years from 2003-2006 and 2009-2010. Related to patient diet and weight, they noted that psoriasis was associated with obesity.

Practice Point: The association between psoriasis and obesity warrants further research, as the disease is a large public health concern.

>>Read more at American Journal of Preventive Medicine

Dietary Plan With Physical Exercise Reduces Psoriasis Severity

Among the risk factors for psoriasis are increased body mass index and weight gain. The prevalence of obesity in patients with psoriasis is higher than in the general population. Naldi et al (Br J Dermatol. 2014;170:634-642) assessed the impact of a dietary intervention combined with physical exercise for weight loss on improving psoriasis in overweight or obese patients. Patients were randomized to receive either a 20-week quantitative and qualitative dietary plan associated with physical exercise for weight loss or simple informative counseling at baseline about the utility of weight loss for clinical control of psoriatic disease. They reported that the median reduction in psoriasis area and severity index scores was significantly higher in the dietary intervention arm compared with the information-only arm (P=.02).

Practice Point: A dietary plan associated with physical exercise for obese or overweight psoriasis patients may help reduce disease severity.

>>Read more at British Journal of Dermatology

Improvement in Psoriasis With a Low-Energy Diet

Psoriasis severity increases with weight gain. Jensen et al (JAMA Dermatol. 2013;149:795-801) sought to measure the effect of weight reduction on the severity of psoriasis in obese patients. The intervention group received a low-energy diet for 8 weeks to induce weight loss, followed by 8 weeks of reintroduction of normal food intake. The control group was instructed to continue eating ordinary healthy foods. Results based on psoriasis area and severity index and dermatology life quality index scores were in favor of the low-energy diet group.

Practice Point: A low-energy diet may improve the severity of psoriasis in obese patients.

>>Read more at JAMA Dermatology

CHICAGO – Malignancy rates in patients with psoriasis outstrip those in the general population, based on data from a retrospective analysis of commercial claims.

Rates for all cancers were similar among patients undergoing different psoriasis treatments, with the exception of nonmelanoma skin cancer and lymphoma.

Rates for these two cancers were more variable across treatment groups, but were still above those in the general public, Dr. Alexa B. Kimball reported at the American Academy of Dermatology summer meeting.

The increased cancer risk may be associated with chronic inflammation, a hallmark of psoriasis, and exposure to some psoriasis therapies such as phototherapy with psoralen plus ultraviolet, cyclosporine, and methotrexate, she noted in the study’s background information.

Previous studies also have suggested that patients with psoriasis may be at increased risk for some cancers such as respiratory tract, urinary tract, and liver cancers, non-Hodgkin’s lymphoma, and skin cancers.

To evaluate the incidence of malignancy, the investigators obtained data from the MarketScan Commercial and Medicare Supplemental claims databases for patients with a diagnosis of psoriasis on or before Dec. 31, 2006, and at least one prescription claim for etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), ustekinumab (Stelara), nonbiologic therapies, or phototherapy.

The general population cohort included patients at least 18 years old as of 2005 or at enrollment in the health care plan. Both cohorts had 12 months’ continuous enrollment in the health care plan from Jan. 1, 2005, through Dec. 31, 2006.

Follow-up for a patient ended at the first cancer event, disenrollment from the health care plan, or after 5 years from the index date.

Patients with psoriasis had a 5-year malignancy rate of 115.5 cases/10,000 person-years, compared with 96/10,000 person-years for the general population, reported Dr. Kimball of Massachusetts General Hospital, Boston.

Excluding nonmelanoma skin cancer and lymphoma, incidence rates were similar across treatment groups: etanercept (100.2/10,000), adalimumab (94.6/10,000), infliximab (138.1/10,000), ustekinumab (100.6/10,000), nonbiologics (116.8/10,000), and phototherapy (117.3/10,000).

"These large database queries continue to be reassuring that most systemic therapies are not changing the risk for common cancers, excluding lymphoma and skin cancer, which we continue to examine separately," Dr. Kimball said in an interview.

Nonmelanoma skin cancer was far and away the most common malignancy in psoriasis patients, occurring at a rate of 147.2/10,000 person-years vs. 94.2/10,000 person-years among the general public. Rates were highest in patients treated with adalimumab (234.2/10,000 person-years) and ustekinumab (233.3/10,000) and lowest in those treated with etanercept (155.9/10,000).

"Even with the large size of the database, the number of skin cancers remains small, so making conclusions about specific therapies may be premature," she said.

Incidence rates of lymphoma were considerably lower, but again higher in psoriasis patients than the general public (11.1/10,000 vs. 6.6/10,000). Rates of this hematologic cancer were highest with ustekinumab (25.1/10,000) and, once again, lowest with etanercept (6.9/10,000), according to the poster.

In all, 5,857 patients received nonbiologic therapies, 6,856 received etanercept, 3,314 adalimumab, 1,044 infliximab, 526 ustekinumab, and 5,156 were treated with phototherapy.

Dr. Kimball is a consultant for several pharmaceutical companies including Amgen, the study sponsor.

[email protected]

CHICAGO – Malignancy rates in patients with psoriasis outstrip those in the general population, based on data from a retrospective analysis of commercial claims.

Rates for all cancers were similar among patients undergoing different psoriasis treatments, with the exception of nonmelanoma skin cancer and lymphoma.

Rates for these two cancers were more variable across treatment groups, but were still above those in the general public, Dr. Alexa B. Kimball reported at the American Academy of Dermatology summer meeting.

The increased cancer risk may be associated with chronic inflammation, a hallmark of psoriasis, and exposure to some psoriasis therapies such as phototherapy with psoralen plus ultraviolet, cyclosporine, and methotrexate, she noted in the study’s background information.

Previous studies also have suggested that patients with psoriasis may be at increased risk for some cancers such as respiratory tract, urinary tract, and liver cancers, non-Hodgkin’s lymphoma, and skin cancers.

To evaluate the incidence of malignancy, the investigators obtained data from the MarketScan Commercial and Medicare Supplemental claims databases for patients with a diagnosis of psoriasis on or before Dec. 31, 2006, and at least one prescription claim for etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), ustekinumab (Stelara), nonbiologic therapies, or phototherapy.

The general population cohort included patients at least 18 years old as of 2005 or at enrollment in the health care plan. Both cohorts had 12 months’ continuous enrollment in the health care plan from Jan. 1, 2005, through Dec. 31, 2006.

Follow-up for a patient ended at the first cancer event, disenrollment from the health care plan, or after 5 years from the index date.

Patients with psoriasis had a 5-year malignancy rate of 115.5 cases/10,000 person-years, compared with 96/10,000 person-years for the general population, reported Dr. Kimball of Massachusetts General Hospital, Boston.

Excluding nonmelanoma skin cancer and lymphoma, incidence rates were similar across treatment groups: etanercept (100.2/10,000), adalimumab (94.6/10,000), infliximab (138.1/10,000), ustekinumab (100.6/10,000), nonbiologics (116.8/10,000), and phototherapy (117.3/10,000).

"These large database queries continue to be reassuring that most systemic therapies are not changing the risk for common cancers, excluding lymphoma and skin cancer, which we continue to examine separately," Dr. Kimball said in an interview.

Nonmelanoma skin cancer was far and away the most common malignancy in psoriasis patients, occurring at a rate of 147.2/10,000 person-years vs. 94.2/10,000 person-years among the general public. Rates were highest in patients treated with adalimumab (234.2/10,000 person-years) and ustekinumab (233.3/10,000) and lowest in those treated with etanercept (155.9/10,000).

"Even with the large size of the database, the number of skin cancers remains small, so making conclusions about specific therapies may be premature," she said.

Incidence rates of lymphoma were considerably lower, but again higher in psoriasis patients than the general public (11.1/10,000 vs. 6.6/10,000). Rates of this hematologic cancer were highest with ustekinumab (25.1/10,000) and, once again, lowest with etanercept (6.9/10,000), according to the poster.

In all, 5,857 patients received nonbiologic therapies, 6,856 received etanercept, 3,314 adalimumab, 1,044 infliximab, 526 ustekinumab, and 5,156 were treated with phototherapy.

Dr. Kimball is a consultant for several pharmaceutical companies including Amgen, the study sponsor.

[email protected]

CHICAGO – Malignancy rates in patients with psoriasis outstrip those in the general population, based on data from a retrospective analysis of commercial claims.

Rates for all cancers were similar among patients undergoing different psoriasis treatments, with the exception of nonmelanoma skin cancer and lymphoma.

Rates for these two cancers were more variable across treatment groups, but were still above those in the general public, Dr. Alexa B. Kimball reported at the American Academy of Dermatology summer meeting.

The increased cancer risk may be associated with chronic inflammation, a hallmark of psoriasis, and exposure to some psoriasis therapies such as phototherapy with psoralen plus ultraviolet, cyclosporine, and methotrexate, she noted in the study’s background information.

Previous studies also have suggested that patients with psoriasis may be at increased risk for some cancers such as respiratory tract, urinary tract, and liver cancers, non-Hodgkin’s lymphoma, and skin cancers.

To evaluate the incidence of malignancy, the investigators obtained data from the MarketScan Commercial and Medicare Supplemental claims databases for patients with a diagnosis of psoriasis on or before Dec. 31, 2006, and at least one prescription claim for etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), ustekinumab (Stelara), nonbiologic therapies, or phototherapy.

The general population cohort included patients at least 18 years old as of 2005 or at enrollment in the health care plan. Both cohorts had 12 months’ continuous enrollment in the health care plan from Jan. 1, 2005, through Dec. 31, 2006.

Follow-up for a patient ended at the first cancer event, disenrollment from the health care plan, or after 5 years from the index date.

Patients with psoriasis had a 5-year malignancy rate of 115.5 cases/10,000 person-years, compared with 96/10,000 person-years for the general population, reported Dr. Kimball of Massachusetts General Hospital, Boston.

Excluding nonmelanoma skin cancer and lymphoma, incidence rates were similar across treatment groups: etanercept (100.2/10,000), adalimumab (94.6/10,000), infliximab (138.1/10,000), ustekinumab (100.6/10,000), nonbiologics (116.8/10,000), and phototherapy (117.3/10,000).

"These large database queries continue to be reassuring that most systemic therapies are not changing the risk for common cancers, excluding lymphoma and skin cancer, which we continue to examine separately," Dr. Kimball said in an interview.

Nonmelanoma skin cancer was far and away the most common malignancy in psoriasis patients, occurring at a rate of 147.2/10,000 person-years vs. 94.2/10,000 person-years among the general public. Rates were highest in patients treated with adalimumab (234.2/10,000 person-years) and ustekinumab (233.3/10,000) and lowest in those treated with etanercept (155.9/10,000).

"Even with the large size of the database, the number of skin cancers remains small, so making conclusions about specific therapies may be premature," she said.

Incidence rates of lymphoma were considerably lower, but again higher in psoriasis patients than the general public (11.1/10,000 vs. 6.6/10,000). Rates of this hematologic cancer were highest with ustekinumab (25.1/10,000) and, once again, lowest with etanercept (6.9/10,000), according to the poster.

In all, 5,857 patients received nonbiologic therapies, 6,856 received etanercept, 3,314 adalimumab, 1,044 infliximab, 526 ustekinumab, and 5,156 were treated with phototherapy.

Dr. Kimball is a consultant for several pharmaceutical companies including Amgen, the study sponsor.

[email protected]

Psoriatic arthritis patients with detectable anti-adalimumab antibodies have significantly lower serum adalimumab concentrations and poorer clinical outcomes at 28 weeks and 52 weeks of treatment, than did patients without antibodies in a prospective cohort study of 103 patients.

At week 52, the 23 patients with detectable anti-adalimumab antibodies had a median adalimumab concentration of 0.9 mg/L, compared with 9.4 mg/L in the 80 patients without detectable antibodies, as well as significantly higher C-reactive protein, Psoriasis Area Severity Index score, and 28-joint Disease Activity Score.

The researchers, led by Erik H. Vogelzang of the Jan van Breemen Research Institute/Reade in Amsterdam, also found that patients on adalimumab monotherapy had significantly lower median adalimumab concentrations at 28 and 52 weeks, compared with patients taking adalimumab and concomitant methotrexate (Ann. Rheum. Dis. 2014 [doi:10.1136/annrheumdis-2014-205554]).

"Further studies regarding measuring drug concentrations would be relevant, since this could give more insight on the cause of inadequate response, especially since treatment options in PsA [psoriatic arthritis] are limited," the investigators wrote.

The study was partly supported by AbbVie and Pfizer. The authors declared a range of consultancies, lecture fees, and research grants from the pharmaceutical industry.

Psoriatic arthritis patients with detectable anti-adalimumab antibodies have significantly lower serum adalimumab concentrations and poorer clinical outcomes at 28 weeks and 52 weeks of treatment, than did patients without antibodies in a prospective cohort study of 103 patients.

At week 52, the 23 patients with detectable anti-adalimumab antibodies had a median adalimumab concentration of 0.9 mg/L, compared with 9.4 mg/L in the 80 patients without detectable antibodies, as well as significantly higher C-reactive protein, Psoriasis Area Severity Index score, and 28-joint Disease Activity Score.

The researchers, led by Erik H. Vogelzang of the Jan van Breemen Research Institute/Reade in Amsterdam, also found that patients on adalimumab monotherapy had significantly lower median adalimumab concentrations at 28 and 52 weeks, compared with patients taking adalimumab and concomitant methotrexate (Ann. Rheum. Dis. 2014 [doi:10.1136/annrheumdis-2014-205554]).

"Further studies regarding measuring drug concentrations would be relevant, since this could give more insight on the cause of inadequate response, especially since treatment options in PsA [psoriatic arthritis] are limited," the investigators wrote.

The study was partly supported by AbbVie and Pfizer. The authors declared a range of consultancies, lecture fees, and research grants from the pharmaceutical industry.

Psoriatic arthritis patients with detectable anti-adalimumab antibodies have significantly lower serum adalimumab concentrations and poorer clinical outcomes at 28 weeks and 52 weeks of treatment, than did patients without antibodies in a prospective cohort study of 103 patients.

At week 52, the 23 patients with detectable anti-adalimumab antibodies had a median adalimumab concentration of 0.9 mg/L, compared with 9.4 mg/L in the 80 patients without detectable antibodies, as well as significantly higher C-reactive protein, Psoriasis Area Severity Index score, and 28-joint Disease Activity Score.

The researchers, led by Erik H. Vogelzang of the Jan van Breemen Research Institute/Reade in Amsterdam, also found that patients on adalimumab monotherapy had significantly lower median adalimumab concentrations at 28 and 52 weeks, compared with patients taking adalimumab and concomitant methotrexate (Ann. Rheum. Dis. 2014 [doi:10.1136/annrheumdis-2014-205554]).

"Further studies regarding measuring drug concentrations would be relevant, since this could give more insight on the cause of inadequate response, especially since treatment options in PsA [psoriatic arthritis] are limited," the investigators wrote.

The study was partly supported by AbbVie and Pfizer. The authors declared a range of consultancies, lecture fees, and research grants from the pharmaceutical industry.

COEUR D’ALENE, IDAHO – Long-term use of methotrexate has a lot going for it as first-line therapy for active juvenile localized scleroderma, according to Dr. Francesco Zulian, chief of pediatric rheumatology at the University of Padua (Italy).

"It’s a drug that’s very old, it’s not expensive, it’s used in many dermatologic and rheumatologic conditions – and it is very useful in patients with scleroderma," he observed in his Sidney Hurwitz Memorial Lecture at the annual meeting of the Society for Pediatric Dermatology.

The initial studies of methotrexate in scleroderma were conducted in adults. Dr. Zulian and colleagues are credited with performing the first randomized, double-blind, prospective clinical trial in pediatric patients, building upon other investigators’ favorable earlier nonrandomized results.

Based upon the randomized trial findings and the subsequent long-term follow-up study, his recommendation for patients with active juvenile localized scleroderma – whether of the linear, pansclerotic, or generalized morphea subtype – is 3 months of initial bridging therapy with a combination of methotrexate plus systemic corticosteroids, followed by at least 24 months of methotrexate without systemic steroids.

In the long-term follow-up study involving 65 patients, treatment was associated with a 74% clinical remission rate. This broke down as approximately a 54% complete remission rate maintained for at least 6 months without treatment, and a 20% clinical remission rate on treatment. Treatment for less than 24 months yielded lesser long-term benefit. Adverse effects were seen in nearly half of patients; however, they were typically mild, and no patients discontinued treatment as a result (J. Am. Acad. Dermatol. 2012;67:1151-6).

"This study shows there is a large group of patients who get better with a relatively mild treatment," Dr. Zulian noted.

The bridging therapy regimen employed in the landmark double-blind, placebo-controlled trial involved oral methotrexate at 15 mg/m² or a maximum of 20 mg per week, along with prednisone at 1 mg/kg/day or a maximum of 50 mg daily for 3 months (Arthritis Rheum. 2011;63:1998-2006).

In his own clinical practice, Dr. Zulian said, he turns to mycophenolate mofetil (CellCept) in the minority of cases in which bridging therapy with methotrexate and prednisone proves inadequate.

In patients with circumscribed morphea as defined in the international Padua consensus conference guidelines, subsequently formalized by the American College of Rheumatology, the European League Against Rheumatism, and the Pediatric Rheumatism European Society (Arthritis Rheum. 2007;203-12), his recommended treatment is topical corticosteroids, calcipotriol, or phototherapy.

While scleroderma is a rare condition in children, it is nonetheless the third most frequent condition within pediatric rheumatology. For physicians with affected patients who are interested in collaborative research to advance the treatment and understanding of this disease, Dr. Zulian recommended contacting the Juvenile Scleroderma International Network (www.jusinet.org).

Dr. Zulian reported having no financial conflicts with regard to his presentation.

[email protected]

COEUR D’ALENE, IDAHO – Long-term use of methotrexate has a lot going for it as first-line therapy for active juvenile localized scleroderma, according to Dr. Francesco Zulian, chief of pediatric rheumatology at the University of Padua (Italy).

"It’s a drug that’s very old, it’s not expensive, it’s used in many dermatologic and rheumatologic conditions – and it is very useful in patients with scleroderma," he observed in his Sidney Hurwitz Memorial Lecture at the annual meeting of the Society for Pediatric Dermatology.

The initial studies of methotrexate in scleroderma were conducted in adults. Dr. Zulian and colleagues are credited with performing the first randomized, double-blind, prospective clinical trial in pediatric patients, building upon other investigators’ favorable earlier nonrandomized results.

Based upon the randomized trial findings and the subsequent long-term follow-up study, his recommendation for patients with active juvenile localized scleroderma – whether of the linear, pansclerotic, or generalized morphea subtype – is 3 months of initial bridging therapy with a combination of methotrexate plus systemic corticosteroids, followed by at least 24 months of methotrexate without systemic steroids.

In the long-term follow-up study involving 65 patients, treatment was associated with a 74% clinical remission rate. This broke down as approximately a 54% complete remission rate maintained for at least 6 months without treatment, and a 20% clinical remission rate on treatment. Treatment for less than 24 months yielded lesser long-term benefit. Adverse effects were seen in nearly half of patients; however, they were typically mild, and no patients discontinued treatment as a result (J. Am. Acad. Dermatol. 2012;67:1151-6).

"This study shows there is a large group of patients who get better with a relatively mild treatment," Dr. Zulian noted.

The bridging therapy regimen employed in the landmark double-blind, placebo-controlled trial involved oral methotrexate at 15 mg/m² or a maximum of 20 mg per week, along with prednisone at 1 mg/kg/day or a maximum of 50 mg daily for 3 months (Arthritis Rheum. 2011;63:1998-2006).

In his own clinical practice, Dr. Zulian said, he turns to mycophenolate mofetil (CellCept) in the minority of cases in which bridging therapy with methotrexate and prednisone proves inadequate.

In patients with circumscribed morphea as defined in the international Padua consensus conference guidelines, subsequently formalized by the American College of Rheumatology, the European League Against Rheumatism, and the Pediatric Rheumatism European Society (Arthritis Rheum. 2007;203-12), his recommended treatment is topical corticosteroids, calcipotriol, or phototherapy.

While scleroderma is a rare condition in children, it is nonetheless the third most frequent condition within pediatric rheumatology. For physicians with affected patients who are interested in collaborative research to advance the treatment and understanding of this disease, Dr. Zulian recommended contacting the Juvenile Scleroderma International Network (www.jusinet.org).

Dr. Zulian reported having no financial conflicts with regard to his presentation.

[email protected]

COEUR D’ALENE, IDAHO – Long-term use of methotrexate has a lot going for it as first-line therapy for active juvenile localized scleroderma, according to Dr. Francesco Zulian, chief of pediatric rheumatology at the University of Padua (Italy).

"It’s a drug that’s very old, it’s not expensive, it’s used in many dermatologic and rheumatologic conditions – and it is very useful in patients with scleroderma," he observed in his Sidney Hurwitz Memorial Lecture at the annual meeting of the Society for Pediatric Dermatology.

The initial studies of methotrexate in scleroderma were conducted in adults. Dr. Zulian and colleagues are credited with performing the first randomized, double-blind, prospective clinical trial in pediatric patients, building upon other investigators’ favorable earlier nonrandomized results.

Based upon the randomized trial findings and the subsequent long-term follow-up study, his recommendation for patients with active juvenile localized scleroderma – whether of the linear, pansclerotic, or generalized morphea subtype – is 3 months of initial bridging therapy with a combination of methotrexate plus systemic corticosteroids, followed by at least 24 months of methotrexate without systemic steroids.

In the long-term follow-up study involving 65 patients, treatment was associated with a 74% clinical remission rate. This broke down as approximately a 54% complete remission rate maintained for at least 6 months without treatment, and a 20% clinical remission rate on treatment. Treatment for less than 24 months yielded lesser long-term benefit. Adverse effects were seen in nearly half of patients; however, they were typically mild, and no patients discontinued treatment as a result (J. Am. Acad. Dermatol. 2012;67:1151-6).

"This study shows there is a large group of patients who get better with a relatively mild treatment," Dr. Zulian noted.

The bridging therapy regimen employed in the landmark double-blind, placebo-controlled trial involved oral methotrexate at 15 mg/m² or a maximum of 20 mg per week, along with prednisone at 1 mg/kg/day or a maximum of 50 mg daily for 3 months (Arthritis Rheum. 2011;63:1998-2006).

In his own clinical practice, Dr. Zulian said, he turns to mycophenolate mofetil (CellCept) in the minority of cases in which bridging therapy with methotrexate and prednisone proves inadequate.

In patients with circumscribed morphea as defined in the international Padua consensus conference guidelines, subsequently formalized by the American College of Rheumatology, the European League Against Rheumatism, and the Pediatric Rheumatism European Society (Arthritis Rheum. 2007;203-12), his recommended treatment is topical corticosteroids, calcipotriol, or phototherapy.

While scleroderma is a rare condition in children, it is nonetheless the third most frequent condition within pediatric rheumatology. For physicians with affected patients who are interested in collaborative research to advance the treatment and understanding of this disease, Dr. Zulian recommended contacting the Juvenile Scleroderma International Network (www.jusinet.org).

Dr. Zulian reported having no financial conflicts with regard to his presentation.

[email protected]

Patch testing is one of the major diagnostic tools in the evaluation of allergic contact dermatitis. One limitation of patch testing is the use of steroids prior to testing. Because steroids may suppress a positive test reaction, the use of topical steroids on the test site or oral steroids should be discontinued for at least 2 weeks prior to testing. Therefore, it is interesting to consider the effect of biologics on the reliability of patch testing.

Kim et al (Dermatitis. 2014;25:182-190) evaluated the prevalence of positive patch tests in psoriasis patients receiving biologics and whether these results differed from those of psoriasis patients who were not receiving biologics. An institutional review board–approved retrospective chart review was performed for individuals with psoriasis who were patch tested from January 2002 to 2012 at Tufts Medical Center in Boston, Massachusetts. Patients were selected if they had a history of psoriasis, psoriatic arthritis, and patch testing as identified by International Classification of Diseases, Ninth Revision, codes 696.1, 696.0, and 95044, respectively, in their medical records. Patients were patch tested using a modified North American Contact Dermatitis Group standard and cosmetics series. Readings were performed at 48 hours and 72 to 96 hours. The North American Contact Dermatitis Group grading system was used to grade reactions. 

The chart review included 15 psoriasis patients who were on biologics (cases) and 16 psoriasis patients who were not on biologics (control subjects). The biologics used were ustekinumab (n=7), etanercept (n=4), adalimumab (n=3), and infliximab (n=1). The authors determined that 80% (12/15) of cases had at least 1 positive reaction compared with 81% (13/16) of control subjects, 67% (10/15) of cases had 2+ positive reactions compared with 63% (10/16) of control subjects, and 27% (4/15) of cases had 3+ positive reactions compared with 38% (6/16) of control subjects. These differences were not statistically significant.

Given the limitation of the small number of patients evaluated, the authors concluded that biologics do not appear to influence the abilities of patients with psoriasis to mount a positive patch test.

What’s the issue?

This study is small, but the findings do give an indication that the biologic agents utilized for psoriasis do not suppress patch test reactions. These data are not typically what we collect in this population, but it is nice to know. What has been your experience in patch testing patients on biologic therapy?

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

Patch testing is one of the major diagnostic tools in the evaluation of allergic contact dermatitis. One limitation of patch testing is the use of steroids prior to testing. Because steroids may suppress a positive test reaction, the use of topical steroids on the test site or oral steroids should be discontinued for at least 2 weeks prior to testing. Therefore, it is interesting to consider the effect of biologics on the reliability of patch testing.

Kim et al (Dermatitis. 2014;25:182-190) evaluated the prevalence of positive patch tests in psoriasis patients receiving biologics and whether these results differed from those of psoriasis patients who were not receiving biologics. An institutional review board–approved retrospective chart review was performed for individuals with psoriasis who were patch tested from January 2002 to 2012 at Tufts Medical Center in Boston, Massachusetts. Patients were selected if they had a history of psoriasis, psoriatic arthritis, and patch testing as identified by International Classification of Diseases, Ninth Revision, codes 696.1, 696.0, and 95044, respectively, in their medical records. Patients were patch tested using a modified North American Contact Dermatitis Group standard and cosmetics series. Readings were performed at 48 hours and 72 to 96 hours. The North American Contact Dermatitis Group grading system was used to grade reactions. 

The chart review included 15 psoriasis patients who were on biologics (cases) and 16 psoriasis patients who were not on biologics (control subjects). The biologics used were ustekinumab (n=7), etanercept (n=4), adalimumab (n=3), and infliximab (n=1). The authors determined that 80% (12/15) of cases had at least 1 positive reaction compared with 81% (13/16) of control subjects, 67% (10/15) of cases had 2+ positive reactions compared with 63% (10/16) of control subjects, and 27% (4/15) of cases had 3+ positive reactions compared with 38% (6/16) of control subjects. These differences were not statistically significant.

Given the limitation of the small number of patients evaluated, the authors concluded that biologics do not appear to influence the abilities of patients with psoriasis to mount a positive patch test.

What’s the issue?

This study is small, but the findings do give an indication that the biologic agents utilized for psoriasis do not suppress patch test reactions. These data are not typically what we collect in this population, but it is nice to know. What has been your experience in patch testing patients on biologic therapy?

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

Patch testing is one of the major diagnostic tools in the evaluation of allergic contact dermatitis. One limitation of patch testing is the use of steroids prior to testing. Because steroids may suppress a positive test reaction, the use of topical steroids on the test site or oral steroids should be discontinued for at least 2 weeks prior to testing. Therefore, it is interesting to consider the effect of biologics on the reliability of patch testing.

Kim et al (Dermatitis. 2014;25:182-190) evaluated the prevalence of positive patch tests in psoriasis patients receiving biologics and whether these results differed from those of psoriasis patients who were not receiving biologics. An institutional review board–approved retrospective chart review was performed for individuals with psoriasis who were patch tested from January 2002 to 2012 at Tufts Medical Center in Boston, Massachusetts. Patients were selected if they had a history of psoriasis, psoriatic arthritis, and patch testing as identified by International Classification of Diseases, Ninth Revision, codes 696.1, 696.0, and 95044, respectively, in their medical records. Patients were patch tested using a modified North American Contact Dermatitis Group standard and cosmetics series. Readings were performed at 48 hours and 72 to 96 hours. The North American Contact Dermatitis Group grading system was used to grade reactions. 

The chart review included 15 psoriasis patients who were on biologics (cases) and 16 psoriasis patients who were not on biologics (control subjects). The biologics used were ustekinumab (n=7), etanercept (n=4), adalimumab (n=3), and infliximab (n=1). The authors determined that 80% (12/15) of cases had at least 1 positive reaction compared with 81% (13/16) of control subjects, 67% (10/15) of cases had 2+ positive reactions compared with 63% (10/16) of control subjects, and 27% (4/15) of cases had 3+ positive reactions compared with 38% (6/16) of control subjects. These differences were not statistically significant.

Given the limitation of the small number of patients evaluated, the authors concluded that biologics do not appear to influence the abilities of patients with psoriasis to mount a positive patch test.

What’s the issue?

This study is small, but the findings do give an indication that the biologic agents utilized for psoriasis do not suppress patch test reactions. These data are not typically what we collect in this population, but it is nice to know. What has been your experience in patch testing patients on biologic therapy?

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

CHICAGO – Patients with psoriasis treated with infliximab had the highest incidence of serious infections in a retrospective analysis of commercial claims data.

After 5 years of follow-up among 22,753 patients, there were 554.7 hospitalized infectious events (HIEs) per 10,000 patient-years of exposure to infliximab (Remicade).

Among the other treatment groups, the incidence of HIEs varied within a comparatively narrow range of 261.2 for phototherapy to 341.4 per 10,000 patient-years of exposure to nonbiologic therapies, Dr. Alexa B. Kimball reported at the American Academy of Dermatology summer meeting.

The biologics etanercept (Enbrel), ustekinumab (Stelara), and adalimumab (Humira) fell somewhere in between with HIE incidence rates of 261.5, 287.1, and 321.9 per 10,000 patient years, respectively.

"It is reassuring that some of the rates we reported for patients on biologics were similar to that found in the phototherapy-treated population, which is not expected to have a reduced immune response to infection," Dr. Kimball of Massachusetts General Hospital, Boston, said in an interview. "Still, in any given patient, individual risk and benefits are important to assess when starting or continuing therapy."

In one other study evaluating the safety of anti–tumor necrosis factor agents, rates of serious infections and lymphoma were higher among patients with psoriasis and psoriatic arthritis treated with infliximab and adalimumab, compared with etanercept (Immunopharmacol. Immunotoxicol. 2012;34:548-60).

In the current analysis, hospitalizations for an infectious event were also higher in patients on concomitant corticosteroid therapy at baseline, Dr. Kimball reported.

Five-year HIE incidence rates were higher in patients with systemic corticosteroid exposure versus those without, regardless of treatment group: nonbiologics (649.2 vs. 251.6); etanercept (676.9 vs. 198.1); adalimumab (424.5 vs. 260.9); infliximab (990.2 vs. 443.3); ustekinumab (542.4 vs. 201.2); and phototherapy (320.3 vs. 235.3).

"This finding reinforces that combination therapy, especially with systemic steroids, may confer additional risk," Dr. Kimball said. "Patients on infliximab were also more likely to have psoriatic arthritis and may have a different underlying level of disease severity and risk, which we could not ascertain from these data."

The retrospective analysis was based on data obtained from the MarketScan Commercial Claims and Encounters and Medicare Supplemental and COB databases for patients with a diagnosis of psoriasis on or before Dec. 31, 2006, and at least one prescription claim for one of the above-mentioned therapies. Patients could belong to more than one treatment group.

A new HIE was defined as at least one overnight hospitalization with an ICD-9 infection code. Patients hospitalized in the previous 3 months for the same ICD-9 code were not eligible.

In all, there were 5,857 patients with any exposure to nonbiologics, 6,856 to etanercept, 3,314 to adalimumab, 1,044 to infliximab, 526 to ustekinumab, and 5,156 to phototherapy.

Unique exposures to these agents totaled 2,700; 3,433; 719; 301; 0; and 3,482, respectively, according to the poster.

Amgen sponsored the study. Dr. Kimball is a consultant for Amgen and several other pharmaceutical companies.

[email protected]

CHICAGO – Patients with psoriasis treated with infliximab had the highest incidence of serious infections in a retrospective analysis of commercial claims data.

After 5 years of follow-up among 22,753 patients, there were 554.7 hospitalized infectious events (HIEs) per 10,000 patient-years of exposure to infliximab (Remicade).

Among the other treatment groups, the incidence of HIEs varied within a comparatively narrow range of 261.2 for phototherapy to 341.4 per 10,000 patient-years of exposure to nonbiologic therapies, Dr. Alexa B. Kimball reported at the American Academy of Dermatology summer meeting.

The biologics etanercept (Enbrel), ustekinumab (Stelara), and adalimumab (Humira) fell somewhere in between with HIE incidence rates of 261.5, 287.1, and 321.9 per 10,000 patient years, respectively.

"It is reassuring that some of the rates we reported for patients on biologics were similar to that found in the phototherapy-treated population, which is not expected to have a reduced immune response to infection," Dr. Kimball of Massachusetts General Hospital, Boston, said in an interview. "Still, in any given patient, individual risk and benefits are important to assess when starting or continuing therapy."

In one other study evaluating the safety of anti–tumor necrosis factor agents, rates of serious infections and lymphoma were higher among patients with psoriasis and psoriatic arthritis treated with infliximab and adalimumab, compared with etanercept (Immunopharmacol. Immunotoxicol. 2012;34:548-60).

In the current analysis, hospitalizations for an infectious event were also higher in patients on concomitant corticosteroid therapy at baseline, Dr. Kimball reported.

Five-year HIE incidence rates were higher in patients with systemic corticosteroid exposure versus those without, regardless of treatment group: nonbiologics (649.2 vs. 251.6); etanercept (676.9 vs. 198.1); adalimumab (424.5 vs. 260.9); infliximab (990.2 vs. 443.3); ustekinumab (542.4 vs. 201.2); and phototherapy (320.3 vs. 235.3).

"This finding reinforces that combination therapy, especially with systemic steroids, may confer additional risk," Dr. Kimball said. "Patients on infliximab were also more likely to have psoriatic arthritis and may have a different underlying level of disease severity and risk, which we could not ascertain from these data."

The retrospective analysis was based on data obtained from the MarketScan Commercial Claims and Encounters and Medicare Supplemental and COB databases for patients with a diagnosis of psoriasis on or before Dec. 31, 2006, and at least one prescription claim for one of the above-mentioned therapies. Patients could belong to more than one treatment group.

A new HIE was defined as at least one overnight hospitalization with an ICD-9 infection code. Patients hospitalized in the previous 3 months for the same ICD-9 code were not eligible.

In all, there were 5,857 patients with any exposure to nonbiologics, 6,856 to etanercept, 3,314 to adalimumab, 1,044 to infliximab, 526 to ustekinumab, and 5,156 to phototherapy.

Unique exposures to these agents totaled 2,700; 3,433; 719; 301; 0; and 3,482, respectively, according to the poster.

Amgen sponsored the study. Dr. Kimball is a consultant for Amgen and several other pharmaceutical companies.

[email protected]

CHICAGO – Patients with psoriasis treated with infliximab had the highest incidence of serious infections in a retrospective analysis of commercial claims data.

After 5 years of follow-up among 22,753 patients, there were 554.7 hospitalized infectious events (HIEs) per 10,000 patient-years of exposure to infliximab (Remicade).

Among the other treatment groups, the incidence of HIEs varied within a comparatively narrow range of 261.2 for phototherapy to 341.4 per 10,000 patient-years of exposure to nonbiologic therapies, Dr. Alexa B. Kimball reported at the American Academy of Dermatology summer meeting.

The biologics etanercept (Enbrel), ustekinumab (Stelara), and adalimumab (Humira) fell somewhere in between with HIE incidence rates of 261.5, 287.1, and 321.9 per 10,000 patient years, respectively.

"It is reassuring that some of the rates we reported for patients on biologics were similar to that found in the phototherapy-treated population, which is not expected to have a reduced immune response to infection," Dr. Kimball of Massachusetts General Hospital, Boston, said in an interview. "Still, in any given patient, individual risk and benefits are important to assess when starting or continuing therapy."

In one other study evaluating the safety of anti–tumor necrosis factor agents, rates of serious infections and lymphoma were higher among patients with psoriasis and psoriatic arthritis treated with infliximab and adalimumab, compared with etanercept (Immunopharmacol. Immunotoxicol. 2012;34:548-60).

In the current analysis, hospitalizations for an infectious event were also higher in patients on concomitant corticosteroid therapy at baseline, Dr. Kimball reported.

Five-year HIE incidence rates were higher in patients with systemic corticosteroid exposure versus those without, regardless of treatment group: nonbiologics (649.2 vs. 251.6); etanercept (676.9 vs. 198.1); adalimumab (424.5 vs. 260.9); infliximab (990.2 vs. 443.3); ustekinumab (542.4 vs. 201.2); and phototherapy (320.3 vs. 235.3).

"This finding reinforces that combination therapy, especially with systemic steroids, may confer additional risk," Dr. Kimball said. "Patients on infliximab were also more likely to have psoriatic arthritis and may have a different underlying level of disease severity and risk, which we could not ascertain from these data."

The retrospective analysis was based on data obtained from the MarketScan Commercial Claims and Encounters and Medicare Supplemental and COB databases for patients with a diagnosis of psoriasis on or before Dec. 31, 2006, and at least one prescription claim for one of the above-mentioned therapies. Patients could belong to more than one treatment group.

A new HIE was defined as at least one overnight hospitalization with an ICD-9 infection code. Patients hospitalized in the previous 3 months for the same ICD-9 code were not eligible.

In all, there were 5,857 patients with any exposure to nonbiologics, 6,856 to etanercept, 3,314 to adalimumab, 1,044 to infliximab, 526 to ustekinumab, and 5,156 to phototherapy.

Unique exposures to these agents totaled 2,700; 3,433; 719; 301; 0; and 3,482, respectively, according to the poster.

Amgen sponsored the study. Dr. Kimball is a consultant for Amgen and several other pharmaceutical companies.

[email protected]

CHICAGO – The data are still being developed, but evidence of a direct link between stress and inflammatory skin conditions continues to mount.

The research is especially compelling for psoriasis; experimental data suggest that stress triggers the nerves to release elevated levels of neuropeptides and neurotransmitters, which in turn affect the nervous system.

Dr. Richard Granstein, chairman of the dermatology department at Weill Cornell Medical College in New York, gave an exclusive interview to Frontline Medical News in which he described studies of how calming the nerves clearly interrupts psoriatic and other inflammatory skin conditions. Dr. Granstein discussed the implications of this new, and still controversial, line of research, and what this means for clinicians: Should they prescribe stress management programs to their patients with these skin conditions?

Dr. Granstein disclosed he has financial relationships with Velius and Clinique.

[email protected]

On Twitter @whitneymcknight

CHICAGO – The data are still being developed, but evidence of a direct link between stress and inflammatory skin conditions continues to mount.

The research is especially compelling for psoriasis; experimental data suggest that stress triggers the nerves to release elevated levels of neuropeptides and neurotransmitters, which in turn affect the nervous system.

Dr. Richard Granstein, chairman of the dermatology department at Weill Cornell Medical College in New York, gave an exclusive interview to Frontline Medical News in which he described studies of how calming the nerves clearly interrupts psoriatic and other inflammatory skin conditions. Dr. Granstein discussed the implications of this new, and still controversial, line of research, and what this means for clinicians: Should they prescribe stress management programs to their patients with these skin conditions?

Dr. Granstein disclosed he has financial relationships with Velius and Clinique.

[email protected]

On Twitter @whitneymcknight

CHICAGO – The data are still being developed, but evidence of a direct link between stress and inflammatory skin conditions continues to mount.

The research is especially compelling for psoriasis; experimental data suggest that stress triggers the nerves to release elevated levels of neuropeptides and neurotransmitters, which in turn affect the nervous system.

Dr. Richard Granstein, chairman of the dermatology department at Weill Cornell Medical College in New York, gave an exclusive interview to Frontline Medical News in which he described studies of how calming the nerves clearly interrupts psoriatic and other inflammatory skin conditions. Dr. Granstein discussed the implications of this new, and still controversial, line of research, and what this means for clinicians: Should they prescribe stress management programs to their patients with these skin conditions?

Dr. Granstein disclosed he has financial relationships with Velius and Clinique.

[email protected]

On Twitter @whitneymcknight

COEUR D’ALENE, IDAHO – The psoriasiform eruptions that occur in a subgroup of patients with Kawasaki disease during the acute or subacute phase may be a red flag for more severe coronary artery involvement, according to a retrospective, case-control study.

Another striking feature of these psoriasiform lesions is that they go into remission. No recurrences were seen in the study population during up to 13 years of follow-up, in marked contrast to classic psoriasis, a chronic disease, Dr. Wynnis L. Tom observed at the annual meeting of the Society for Pediatric Dermatology.

She presented what she believes to be the first study to formally compare the psoriasiform lesions arising in a minority of Kawasaki disease (KD) patients with the lesions of classic psoriasis. The study population consisted of 11 KD patients with psoriasiform eruptions whose median age was 1.9 years, 22 matched controls with KD and no psoriasiform lesions, and another 22 matched controls with psoriasis but not KD.

Kawasaki disease patients who developed psoriasiform eruptions had significantly more dilated coronary arteries than did those who did not, as reflected in their median maximal echocardiographic z-score of 2.7, compared with 1.8 in controls. A z-score greater than 2.5 is deemed to indicate clinically significant coronary artery dilation, noted Dr. Tom, a pediatric dermatologist at Rady Children’s Hospital and the University of California, San Diego.

The psoriasiform eruptions resolved within 13 months in all 11 affected KD patients, with no recurrences. In contrast, only 5 of 22 controls with classic psoriasis experienced remission during follow-up of up to 6 years.

The cutaneous distribution of the psoriasiform lesions in patients with KD was also distinctive. The eruptions were significantly less common in the head, neck, and diaper area than is the case in classic psoriasis. In addition, patients with KD and psoriasiform eruptions were significantly less likely to be overweight or obese than were controls with classic psoriasis.

Skin biopsies read by a blinded dermatopathologist showed that the psoriasiform lesions that arose during KD demonstrated suprabasilar staining of keratin 16 and increased expression of Ki-67 antigen. They differed from classic psoriasis lesions in that they displayed more crusting, serum, and an increased prevalence of bacteria at the epidermis.

There was no significant difference between KD patients with and without psoriasiform eruptions in terms of maximum levels of C-reactive protein, erythrocyte sedimentation rate, and other inflammatory markers. However, patients with psoriasiform lesions required significantly more time for their gamma-glutamyl transferase level and platelet count to return to normal.

One possible explanation for the distinct phenotype of these psoriasiform eruptions is that KD brings forth the skin lesions in patients who are predisposed to psoriasis, but without causing typical chronic psoriasis because the underlying KD is self-limited. But further study with larger numbers of patients is required for clarification, according to Dr. Tom.

Her work is supported by a career development award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. She reported having no financial conflicts regarding this study.

[email protected]

COEUR D’ALENE, IDAHO – The psoriasiform eruptions that occur in a subgroup of patients with Kawasaki disease during the acute or subacute phase may be a red flag for more severe coronary artery involvement, according to a retrospective, case-control study.

Another striking feature of these psoriasiform lesions is that they go into remission. No recurrences were seen in the study population during up to 13 years of follow-up, in marked contrast to classic psoriasis, a chronic disease, Dr. Wynnis L. Tom observed at the annual meeting of the Society for Pediatric Dermatology.

She presented what she believes to be the first study to formally compare the psoriasiform lesions arising in a minority of Kawasaki disease (KD) patients with the lesions of classic psoriasis. The study population consisted of 11 KD patients with psoriasiform eruptions whose median age was 1.9 years, 22 matched controls with KD and no psoriasiform lesions, and another 22 matched controls with psoriasis but not KD.

Kawasaki disease patients who developed psoriasiform eruptions had significantly more dilated coronary arteries than did those who did not, as reflected in their median maximal echocardiographic z-score of 2.7, compared with 1.8 in controls. A z-score greater than 2.5 is deemed to indicate clinically significant coronary artery dilation, noted Dr. Tom, a pediatric dermatologist at Rady Children’s Hospital and the University of California, San Diego.

The psoriasiform eruptions resolved within 13 months in all 11 affected KD patients, with no recurrences. In contrast, only 5 of 22 controls with classic psoriasis experienced remission during follow-up of up to 6 years.

The cutaneous distribution of the psoriasiform lesions in patients with KD was also distinctive. The eruptions were significantly less common in the head, neck, and diaper area than is the case in classic psoriasis. In addition, patients with KD and psoriasiform eruptions were significantly less likely to be overweight or obese than were controls with classic psoriasis.

Skin biopsies read by a blinded dermatopathologist showed that the psoriasiform lesions that arose during KD demonstrated suprabasilar staining of keratin 16 and increased expression of Ki-67 antigen. They differed from classic psoriasis lesions in that they displayed more crusting, serum, and an increased prevalence of bacteria at the epidermis.

There was no significant difference between KD patients with and without psoriasiform eruptions in terms of maximum levels of C-reactive protein, erythrocyte sedimentation rate, and other inflammatory markers. However, patients with psoriasiform lesions required significantly more time for their gamma-glutamyl transferase level and platelet count to return to normal.

One possible explanation for the distinct phenotype of these psoriasiform eruptions is that KD brings forth the skin lesions in patients who are predisposed to psoriasis, but without causing typical chronic psoriasis because the underlying KD is self-limited. But further study with larger numbers of patients is required for clarification, according to Dr. Tom.

Her work is supported by a career development award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. She reported having no financial conflicts regarding this study.

[email protected]

COEUR D’ALENE, IDAHO – The psoriasiform eruptions that occur in a subgroup of patients with Kawasaki disease during the acute or subacute phase may be a red flag for more severe coronary artery involvement, according to a retrospective, case-control study.

Another striking feature of these psoriasiform lesions is that they go into remission. No recurrences were seen in the study population during up to 13 years of follow-up, in marked contrast to classic psoriasis, a chronic disease, Dr. Wynnis L. Tom observed at the annual meeting of the Society for Pediatric Dermatology.

She presented what she believes to be the first study to formally compare the psoriasiform lesions arising in a minority of Kawasaki disease (KD) patients with the lesions of classic psoriasis. The study population consisted of 11 KD patients with psoriasiform eruptions whose median age was 1.9 years, 22 matched controls with KD and no psoriasiform lesions, and another 22 matched controls with psoriasis but not KD.

Kawasaki disease patients who developed psoriasiform eruptions had significantly more dilated coronary arteries than did those who did not, as reflected in their median maximal echocardiographic z-score of 2.7, compared with 1.8 in controls. A z-score greater than 2.5 is deemed to indicate clinically significant coronary artery dilation, noted Dr. Tom, a pediatric dermatologist at Rady Children’s Hospital and the University of California, San Diego.

The psoriasiform eruptions resolved within 13 months in all 11 affected KD patients, with no recurrences. In contrast, only 5 of 22 controls with classic psoriasis experienced remission during follow-up of up to 6 years.

The cutaneous distribution of the psoriasiform lesions in patients with KD was also distinctive. The eruptions were significantly less common in the head, neck, and diaper area than is the case in classic psoriasis. In addition, patients with KD and psoriasiform eruptions were significantly less likely to be overweight or obese than were controls with classic psoriasis.

Skin biopsies read by a blinded dermatopathologist showed that the psoriasiform lesions that arose during KD demonstrated suprabasilar staining of keratin 16 and increased expression of Ki-67 antigen. They differed from classic psoriasis lesions in that they displayed more crusting, serum, and an increased prevalence of bacteria at the epidermis.

There was no significant difference between KD patients with and without psoriasiform eruptions in terms of maximum levels of C-reactive protein, erythrocyte sedimentation rate, and other inflammatory markers. However, patients with psoriasiform lesions required significantly more time for their gamma-glutamyl transferase level and platelet count to return to normal.

One possible explanation for the distinct phenotype of these psoriasiform eruptions is that KD brings forth the skin lesions in patients who are predisposed to psoriasis, but without causing typical chronic psoriasis because the underlying KD is self-limited. But further study with larger numbers of patients is required for clarification, according to Dr. Tom.

Her work is supported by a career development award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. She reported having no financial conflicts regarding this study.

[email protected]

BELLEVUE, WASH. – Women with autoimmune diseases who take corticosteroids and disease-modifying antirheumatic drugs later in pregnancy have an increased risk of preterm birth, but this association is largely explained by confounding with sociodemographic and clinical factors and disease severity, a study showed.

Researchers prospectively studied 678 pregnant women from the MotherToBaby database who had rheumatoid arthritis, psoriasis or psoriatic arthritis, ankylosing spondylitis, or Crohn’s disease. They focused on steroid use and disease-modifying antirheumatic drug (DMARD) use in the 16 weeks before delivery.

The results presented at the annual meeting of the Teratology Society showed that the incidence of preterm birth (birth before 37 weeks of gestation) was 19.2% among women using only steroids, 11.9% among those using only DMARDs, and 25.0% among those using both, compared with 11.2% among women who used neither throughout pregnancy.

In unadjusted analyses, women taking both steroids and DMARDs had significantly higher odds of preterm birth relative to peers who took neither (relative risk, 2.23), reported lead author Kristin Palmsten, Sc.D., of the University of California, San Diego.

But this risk was attenuated and no longer significant after adjustment for sociodemographic and clinical factors, such as age, race/ethnicity, parity, prior preterm birth, twin pregnancy, prepregnancy hypertension, depression, and use of nonsteroidal anti-inflammatory drugs.

It was attenuated further still after additional adjustment for the severity of autoimmune disease earlier in pregnancy, as assessed with the Health Assessment Questionnaire Disability Index (HAQ-DI) in analyses that excluded patients with Crohn’s disease (because they were not asked about disease severity).

The use of steroids alone and the use of DMARDs alone were not associated with a significantly elevated risk of preterm birth in either unadjusted or adjusted analyses.

The findings showed that confounders at least partially explain the heightened risk of preterm birth associated with autoimmune therapy, according to Dr. Palmsten.

A major study strength was exposure ascertainment, as the women were directly asked about their medication use several times during pregnancy, she noted. A limitation was the potential lack of generalizability, as the women studied were predominantly white and had higher socioeconomic status and lower disease severity.

In ongoing analyses, the investigators are looking at the proportions of preterm births that were spontaneous and medically indicated, and at the specific gestational age of the preterm births.

"I’d like to confirm the results in a different population; I’d like to look at this association in the Medicaid population, which is a low-income population," Dr. Palmsten added. "And I think preterm birth subtypes should be considered in further investigation. I’d also like to explore the timing of exposure and dose as well."

Session attendee Dr. Jan M. Friedman of the University of British Columbia in Vancouver noted the wide confidence intervals seen in analyses. "Obviously, that’s partially a function of the fact that the groups are fairly small. Is this an ongoing study? Will you have more data, more patients to look at in a year or something?" he asked.

"It is ongoing," Dr. Palmsten replied. "I don’t think that we’ll have 500 women exposed even after a year. But I do hope to address that with the Medicaid data because that would have a very large population."

Dr. Palmsten disclosed no relevant conflicts of interest. The MotherToBaby Pregnancy Study is sponsored by AbbVie, Amgen, Sanofi-Aventis, Apotex, Barr, Par Pharmaceutical, Sandoz, Teva, Bristol-Myers Squibb, Roche/Genentech, UCB Pharma, Pfizer, and Janssen.

BELLEVUE, WASH. – Women with autoimmune diseases who take corticosteroids and disease-modifying antirheumatic drugs later in pregnancy have an increased risk of preterm birth, but this association is largely explained by confounding with sociodemographic and clinical factors and disease severity, a study showed.

Researchers prospectively studied 678 pregnant women from the MotherToBaby database who had rheumatoid arthritis, psoriasis or psoriatic arthritis, ankylosing spondylitis, or Crohn’s disease. They focused on steroid use and disease-modifying antirheumatic drug (DMARD) use in the 16 weeks before delivery.

The results presented at the annual meeting of the Teratology Society showed that the incidence of preterm birth (birth before 37 weeks of gestation) was 19.2% among women using only steroids, 11.9% among those using only DMARDs, and 25.0% among those using both, compared with 11.2% among women who used neither throughout pregnancy.

In unadjusted analyses, women taking both steroids and DMARDs had significantly higher odds of preterm birth relative to peers who took neither (relative risk, 2.23), reported lead author Kristin Palmsten, Sc.D., of the University of California, San Diego.

But this risk was attenuated and no longer significant after adjustment for sociodemographic and clinical factors, such as age, race/ethnicity, parity, prior preterm birth, twin pregnancy, prepregnancy hypertension, depression, and use of nonsteroidal anti-inflammatory drugs.

It was attenuated further still after additional adjustment for the severity of autoimmune disease earlier in pregnancy, as assessed with the Health Assessment Questionnaire Disability Index (HAQ-DI) in analyses that excluded patients with Crohn’s disease (because they were not asked about disease severity).

The use of steroids alone and the use of DMARDs alone were not associated with a significantly elevated risk of preterm birth in either unadjusted or adjusted analyses.

The findings showed that confounders at least partially explain the heightened risk of preterm birth associated with autoimmune therapy, according to Dr. Palmsten.

A major study strength was exposure ascertainment, as the women were directly asked about their medication use several times during pregnancy, she noted. A limitation was the potential lack of generalizability, as the women studied were predominantly white and had higher socioeconomic status and lower disease severity.

In ongoing analyses, the investigators are looking at the proportions of preterm births that were spontaneous and medically indicated, and at the specific gestational age of the preterm births.

"I’d like to confirm the results in a different population; I’d like to look at this association in the Medicaid population, which is a low-income population," Dr. Palmsten added. "And I think preterm birth subtypes should be considered in further investigation. I’d also like to explore the timing of exposure and dose as well."

Session attendee Dr. Jan M. Friedman of the University of British Columbia in Vancouver noted the wide confidence intervals seen in analyses. "Obviously, that’s partially a function of the fact that the groups are fairly small. Is this an ongoing study? Will you have more data, more patients to look at in a year or something?" he asked.

"It is ongoing," Dr. Palmsten replied. "I don’t think that we’ll have 500 women exposed even after a year. But I do hope to address that with the Medicaid data because that would have a very large population."

Dr. Palmsten disclosed no relevant conflicts of interest. The MotherToBaby Pregnancy Study is sponsored by AbbVie, Amgen, Sanofi-Aventis, Apotex, Barr, Par Pharmaceutical, Sandoz, Teva, Bristol-Myers Squibb, Roche/Genentech, UCB Pharma, Pfizer, and Janssen.

BELLEVUE, WASH. – Women with autoimmune diseases who take corticosteroids and disease-modifying antirheumatic drugs later in pregnancy have an increased risk of preterm birth, but this association is largely explained by confounding with sociodemographic and clinical factors and disease severity, a study showed.

Researchers prospectively studied 678 pregnant women from the MotherToBaby database who had rheumatoid arthritis, psoriasis or psoriatic arthritis, ankylosing spondylitis, or Crohn’s disease. They focused on steroid use and disease-modifying antirheumatic drug (DMARD) use in the 16 weeks before delivery.

The results presented at the annual meeting of the Teratology Society showed that the incidence of preterm birth (birth before 37 weeks of gestation) was 19.2% among women using only steroids, 11.9% among those using only DMARDs, and 25.0% among those using both, compared with 11.2% among women who used neither throughout pregnancy.

In unadjusted analyses, women taking both steroids and DMARDs had significantly higher odds of preterm birth relative to peers who took neither (relative risk, 2.23), reported lead author Kristin Palmsten, Sc.D., of the University of California, San Diego.

But this risk was attenuated and no longer significant after adjustment for sociodemographic and clinical factors, such as age, race/ethnicity, parity, prior preterm birth, twin pregnancy, prepregnancy hypertension, depression, and use of nonsteroidal anti-inflammatory drugs.

It was attenuated further still after additional adjustment for the severity of autoimmune disease earlier in pregnancy, as assessed with the Health Assessment Questionnaire Disability Index (HAQ-DI) in analyses that excluded patients with Crohn’s disease (because they were not asked about disease severity).

The use of steroids alone and the use of DMARDs alone were not associated with a significantly elevated risk of preterm birth in either unadjusted or adjusted analyses.

The findings showed that confounders at least partially explain the heightened risk of preterm birth associated with autoimmune therapy, according to Dr. Palmsten.

A major study strength was exposure ascertainment, as the women were directly asked about their medication use several times during pregnancy, she noted. A limitation was the potential lack of generalizability, as the women studied were predominantly white and had higher socioeconomic status and lower disease severity.

In ongoing analyses, the investigators are looking at the proportions of preterm births that were spontaneous and medically indicated, and at the specific gestational age of the preterm births.

"I’d like to confirm the results in a different population; I’d like to look at this association in the Medicaid population, which is a low-income population," Dr. Palmsten added. "And I think preterm birth subtypes should be considered in further investigation. I’d also like to explore the timing of exposure and dose as well."

Session attendee Dr. Jan M. Friedman of the University of British Columbia in Vancouver noted the wide confidence intervals seen in analyses. "Obviously, that’s partially a function of the fact that the groups are fairly small. Is this an ongoing study? Will you have more data, more patients to look at in a year or something?" he asked.

"It is ongoing," Dr. Palmsten replied. "I don’t think that we’ll have 500 women exposed even after a year. But I do hope to address that with the Medicaid data because that would have a very large population."

Dr. Palmsten disclosed no relevant conflicts of interest. The MotherToBaby Pregnancy Study is sponsored by AbbVie, Amgen, Sanofi-Aventis, Apotex, Barr, Par Pharmaceutical, Sandoz, Teva, Bristol-Myers Squibb, Roche/Genentech, UCB Pharma, Pfizer, and Janssen.