EADV Congress 2012

PRAGUE – Off-label use of oral finasteride at 5 mg/day proved safe and effective for the treatment of female pattern hair loss in 43 premenopausal women in an 18-month study.

Treatment effectiveness was assessed in two ways: patient satisfaction scores and two blinded investigators’ evaluation of photographs. As a precondition for study participation, patients needed to have normal serum androgen levels, no clinical signs of hyperandrogenism, and no wish to become pregnant ever again. They also had to go on drospirenone/ethinyl estradiol for oral contraception.

At the 6-month mark, 25 patients (58%) characterized their improvement as "huge" and 14 (33%) as moderate; 4 reported no improvement. These results were stable across time, with the women reporting the same results at 12 and 18 months of follow-up.

The investigators’ blinded assessments of patient photos were less generous: They characterized 19 patients (44%) as very improved, 17 as somewhat improved, and 7 as unimproved.

Diminished libido was reported by 8 patients; 4 had transient nausea or headaches, and 4 reported transient metrorrhagia. One patient had elevated liver function test results and was dropped from the study, Dr. Rui Oliveira-Soares said at the annual congress of the European Academy of Dermatology and Venereology.

"None of us are very pleased with the results we’re having with other drugs," Dr. Oliveira-Soares said. "Sometimes they are unsuccessful or have unacceptable adverse effects. Sometimes there is progression of disease despite every drug we use."

It has been known for more than 15 years that finasteride at 1 mg/day is an effective treatment for male pattern hair loss. It is approved for that indication, as well as for benign prostatic hypertrophy at 5 mg/day.

However, investigators found 12 years ago that finasteride at 1 mg/day is ineffective for female pattern hair loss (J. Am. Acad. Dermatol. 2000;43:768-76). And there have been conflicting reports as to whether the therapy is effective in female androgenetic alopecia at 2.5 mg/day, noted Dr. Oliveira-Soares of Hospital Cuf Descobertas in Lisbon.

Having recently shown in an as-yet-unpublished study that finasteride at a dosage of 5 mg/day was beneficial in postmenopausal women with androgenetic alopecia, Dr. Oliveira-Soares said he sought to learn whether this regimen was safe and effective in premenopausal women affected by the disorder. He reported on 43 patients treated with finasteride at 5 mg/day for 18 months, with formal outcome assessments conducted every 6 months.

Future studies should focus on how to identify likely nonresponders. Also, an 18-month study is not sufficient to draw solid conclusions about the possible long-term risks of extended therapy. An increased risk of breast cancer is a theoretic concern, although there are no clinical data to suggest it is an issue, he said.

The problem in conducting larger, longer-term studies of finasteride at 5 mg/day for female pattern hair loss is that because the drug is available as a relatively inexpensive generic, there is no industry interest in funding such research, he added.

Topical 2% minoxidil is the standard treatment for female pattern hair loss. Among the other drugs used are flutamide and spironolactone, which can have hepatic toxicity, and cyproterone acetate, which can have cardiovascular side effects.

Dr. Oliveira-Soares’ study was supported by hospital research funds. He reported having no relevant financial conflicts.

PRAGUE – Off-label use of oral finasteride at 5 mg/day proved safe and effective for the treatment of female pattern hair loss in 43 premenopausal women in an 18-month study.

Treatment effectiveness was assessed in two ways: patient satisfaction scores and two blinded investigators’ evaluation of photographs. As a precondition for study participation, patients needed to have normal serum androgen levels, no clinical signs of hyperandrogenism, and no wish to become pregnant ever again. They also had to go on drospirenone/ethinyl estradiol for oral contraception.

At the 6-month mark, 25 patients (58%) characterized their improvement as "huge" and 14 (33%) as moderate; 4 reported no improvement. These results were stable across time, with the women reporting the same results at 12 and 18 months of follow-up.

The investigators’ blinded assessments of patient photos were less generous: They characterized 19 patients (44%) as very improved, 17 as somewhat improved, and 7 as unimproved.

Diminished libido was reported by 8 patients; 4 had transient nausea or headaches, and 4 reported transient metrorrhagia. One patient had elevated liver function test results and was dropped from the study, Dr. Rui Oliveira-Soares said at the annual congress of the European Academy of Dermatology and Venereology.

"None of us are very pleased with the results we’re having with other drugs," Dr. Oliveira-Soares said. "Sometimes they are unsuccessful or have unacceptable adverse effects. Sometimes there is progression of disease despite every drug we use."

It has been known for more than 15 years that finasteride at 1 mg/day is an effective treatment for male pattern hair loss. It is approved for that indication, as well as for benign prostatic hypertrophy at 5 mg/day.

However, investigators found 12 years ago that finasteride at 1 mg/day is ineffective for female pattern hair loss (J. Am. Acad. Dermatol. 2000;43:768-76). And there have been conflicting reports as to whether the therapy is effective in female androgenetic alopecia at 2.5 mg/day, noted Dr. Oliveira-Soares of Hospital Cuf Descobertas in Lisbon.

Having recently shown in an as-yet-unpublished study that finasteride at a dosage of 5 mg/day was beneficial in postmenopausal women with androgenetic alopecia, Dr. Oliveira-Soares said he sought to learn whether this regimen was safe and effective in premenopausal women affected by the disorder. He reported on 43 patients treated with finasteride at 5 mg/day for 18 months, with formal outcome assessments conducted every 6 months.

Future studies should focus on how to identify likely nonresponders. Also, an 18-month study is not sufficient to draw solid conclusions about the possible long-term risks of extended therapy. An increased risk of breast cancer is a theoretic concern, although there are no clinical data to suggest it is an issue, he said.

The problem in conducting larger, longer-term studies of finasteride at 5 mg/day for female pattern hair loss is that because the drug is available as a relatively inexpensive generic, there is no industry interest in funding such research, he added.

Topical 2% minoxidil is the standard treatment for female pattern hair loss. Among the other drugs used are flutamide and spironolactone, which can have hepatic toxicity, and cyproterone acetate, which can have cardiovascular side effects.

Dr. Oliveira-Soares’ study was supported by hospital research funds. He reported having no relevant financial conflicts.

PRAGUE – Off-label use of oral finasteride at 5 mg/day proved safe and effective for the treatment of female pattern hair loss in 43 premenopausal women in an 18-month study.

Treatment effectiveness was assessed in two ways: patient satisfaction scores and two blinded investigators’ evaluation of photographs. As a precondition for study participation, patients needed to have normal serum androgen levels, no clinical signs of hyperandrogenism, and no wish to become pregnant ever again. They also had to go on drospirenone/ethinyl estradiol for oral contraception.

At the 6-month mark, 25 patients (58%) characterized their improvement as "huge" and 14 (33%) as moderate; 4 reported no improvement. These results were stable across time, with the women reporting the same results at 12 and 18 months of follow-up.

The investigators’ blinded assessments of patient photos were less generous: They characterized 19 patients (44%) as very improved, 17 as somewhat improved, and 7 as unimproved.

Diminished libido was reported by 8 patients; 4 had transient nausea or headaches, and 4 reported transient metrorrhagia. One patient had elevated liver function test results and was dropped from the study, Dr. Rui Oliveira-Soares said at the annual congress of the European Academy of Dermatology and Venereology.

"None of us are very pleased with the results we’re having with other drugs," Dr. Oliveira-Soares said. "Sometimes they are unsuccessful or have unacceptable adverse effects. Sometimes there is progression of disease despite every drug we use."

It has been known for more than 15 years that finasteride at 1 mg/day is an effective treatment for male pattern hair loss. It is approved for that indication, as well as for benign prostatic hypertrophy at 5 mg/day.

However, investigators found 12 years ago that finasteride at 1 mg/day is ineffective for female pattern hair loss (J. Am. Acad. Dermatol. 2000;43:768-76). And there have been conflicting reports as to whether the therapy is effective in female androgenetic alopecia at 2.5 mg/day, noted Dr. Oliveira-Soares of Hospital Cuf Descobertas in Lisbon.

Having recently shown in an as-yet-unpublished study that finasteride at a dosage of 5 mg/day was beneficial in postmenopausal women with androgenetic alopecia, Dr. Oliveira-Soares said he sought to learn whether this regimen was safe and effective in premenopausal women affected by the disorder. He reported on 43 patients treated with finasteride at 5 mg/day for 18 months, with formal outcome assessments conducted every 6 months.

Future studies should focus on how to identify likely nonresponders. Also, an 18-month study is not sufficient to draw solid conclusions about the possible long-term risks of extended therapy. An increased risk of breast cancer is a theoretic concern, although there are no clinical data to suggest it is an issue, he said.

The problem in conducting larger, longer-term studies of finasteride at 5 mg/day for female pattern hair loss is that because the drug is available as a relatively inexpensive generic, there is no industry interest in funding such research, he added.

Topical 2% minoxidil is the standard treatment for female pattern hair loss. Among the other drugs used are flutamide and spironolactone, which can have hepatic toxicity, and cyproterone acetate, which can have cardiovascular side effects.

Dr. Oliveira-Soares’ study was supported by hospital research funds. He reported having no relevant financial conflicts.

PRAGUE – Once-daily brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea hit its efficacy and safety end points in a pivotal phase III clinical trial.

The randomized, double-blind, vehicle-controlled, multicenter study totaled 260 patients with persistent moderate to severe facial redness from rosacea. The patients were randomized to once-daily brimonidine tartrate gel 0.5% or a vehicle gel for 4 weeks, with 4 weeks of subsequent off-label follow-up.

The proprietary brimonidine tartrate gel proved faster acting and significantly more effective than the vehicle. Thirty minutes after the first application on study day 1, 28% of patients in the active treatment arm showed at least a 1-grade improvement on both Patient Self-Assessment and Clinician’s Erythema Assessment, compared with 7% of controls, Dr. Y. May Ma reported at the annual congress of the European Academy of Dermatology and Venereology.

The other efficacy end point was maintenance of a 2-grade improvement on both study measures for 12 hours after application on day 29. This was achieved in 23% of patients in the brimonidine tartrate gel cohort and 8% of controls.

No tachyphylaxis or rebound worsening of erythema occurred during the off-treatment follow-up, nor did the brimonidine tartrate group experience aggravation of telangiectasias or inflammatory lesions during that phase of the study, according to Dr. Ma of Galderma Laboratories, Sophia Antipolis, France.

The adverse events were generally mild, transient, and local. The most frequent events in the brimonidine tartrate group were worsening erythema and/or flushing in seven patients, itching in four, and skin irritation in three. No changes in blood pressure or heart rate were noted.

At present no medical therapies are approved for the treatment of persistent facial redness of rosacea. While brimonidine tartrate gel doesn’t tackle the underlying cause of rosacea, the topical vasoconstrictor does improve the appearance of rosacea patients who have persistent erythema. Galderma is preparing to file for U.S. and European marketing approval of the topical agent.

The trial was sponsored by Galderma Laboratories and presented by Dr. Ma, a company employee.

PRAGUE – Once-daily brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea hit its efficacy and safety end points in a pivotal phase III clinical trial.

The randomized, double-blind, vehicle-controlled, multicenter study totaled 260 patients with persistent moderate to severe facial redness from rosacea. The patients were randomized to once-daily brimonidine tartrate gel 0.5% or a vehicle gel for 4 weeks, with 4 weeks of subsequent off-label follow-up.

The proprietary brimonidine tartrate gel proved faster acting and significantly more effective than the vehicle. Thirty minutes after the first application on study day 1, 28% of patients in the active treatment arm showed at least a 1-grade improvement on both Patient Self-Assessment and Clinician’s Erythema Assessment, compared with 7% of controls, Dr. Y. May Ma reported at the annual congress of the European Academy of Dermatology and Venereology.

The other efficacy end point was maintenance of a 2-grade improvement on both study measures for 12 hours after application on day 29. This was achieved in 23% of patients in the brimonidine tartrate gel cohort and 8% of controls.

No tachyphylaxis or rebound worsening of erythema occurred during the off-treatment follow-up, nor did the brimonidine tartrate group experience aggravation of telangiectasias or inflammatory lesions during that phase of the study, according to Dr. Ma of Galderma Laboratories, Sophia Antipolis, France.

The adverse events were generally mild, transient, and local. The most frequent events in the brimonidine tartrate group were worsening erythema and/or flushing in seven patients, itching in four, and skin irritation in three. No changes in blood pressure or heart rate were noted.

At present no medical therapies are approved for the treatment of persistent facial redness of rosacea. While brimonidine tartrate gel doesn’t tackle the underlying cause of rosacea, the topical vasoconstrictor does improve the appearance of rosacea patients who have persistent erythema. Galderma is preparing to file for U.S. and European marketing approval of the topical agent.

The trial was sponsored by Galderma Laboratories and presented by Dr. Ma, a company employee.

PRAGUE – Once-daily brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea hit its efficacy and safety end points in a pivotal phase III clinical trial.

The randomized, double-blind, vehicle-controlled, multicenter study totaled 260 patients with persistent moderate to severe facial redness from rosacea. The patients were randomized to once-daily brimonidine tartrate gel 0.5% or a vehicle gel for 4 weeks, with 4 weeks of subsequent off-label follow-up.

The proprietary brimonidine tartrate gel proved faster acting and significantly more effective than the vehicle. Thirty minutes after the first application on study day 1, 28% of patients in the active treatment arm showed at least a 1-grade improvement on both Patient Self-Assessment and Clinician’s Erythema Assessment, compared with 7% of controls, Dr. Y. May Ma reported at the annual congress of the European Academy of Dermatology and Venereology.

The other efficacy end point was maintenance of a 2-grade improvement on both study measures for 12 hours after application on day 29. This was achieved in 23% of patients in the brimonidine tartrate gel cohort and 8% of controls.

No tachyphylaxis or rebound worsening of erythema occurred during the off-treatment follow-up, nor did the brimonidine tartrate group experience aggravation of telangiectasias or inflammatory lesions during that phase of the study, according to Dr. Ma of Galderma Laboratories, Sophia Antipolis, France.

The adverse events were generally mild, transient, and local. The most frequent events in the brimonidine tartrate group were worsening erythema and/or flushing in seven patients, itching in four, and skin irritation in three. No changes in blood pressure or heart rate were noted.

At present no medical therapies are approved for the treatment of persistent facial redness of rosacea. While brimonidine tartrate gel doesn’t tackle the underlying cause of rosacea, the topical vasoconstrictor does improve the appearance of rosacea patients who have persistent erythema. Galderma is preparing to file for U.S. and European marketing approval of the topical agent.

The trial was sponsored by Galderma Laboratories and presented by Dr. Ma, a company employee.

PRAGUE – Long-term therapy utilizing a pimecrolimus-based strategy for mild to moderate atopic dermatitis beginning in infancy proved as effective and safe as conventional therapy with topical corticosteroids in a 5-year randomized study.

"Given that pimecrolimus cream 1% is not associated with topical corticosteroid-specific side effects, such as hypothalamic-pituitary-adrenal axis suppression or skin atrophy, which can limit their long-term use, pimecrolimus cream may represent the drug of choice for long-term atopic dermatitis management," said Dr. Thomas A. Luger, professor and chairman of the department of dermatology at the University of Müenster (Germany).

Novak, Natalija (2010):Pediatric Allergy

Currently, pimecrolimus is not approved for use in patients under 2 years of age, he noted.

Dr. Luger, who is an investigator on the study’s steering committee, reported on 2,418 infants with mild to moderate atopic dermatitis randomized to daily use of an emollient for their dry skin plus either pimecrolimus cream 1% (Elidel) or low-potency to midpotency topical steroids on an as-needed basis. The participants’ mean age at enrollment was 7 months. Fifty-three percent of infants had moderate atopic dermatitis based on the Investigator’s Global Assessment; the rest had mild disease.

This was a 5-year, international, open-label randomized study designed to reflect real world, as-needed use of topical medications. Patients in the pimecrolimus group applied the topical calcineurin inhibitor at the first sign of an atopic dermatitis flare. If pimecrolimus didn’t control the itching, redness, and/or lesion elevation to the parents’ satisfaction, the child was switched to a low-potency topical steroid. If that didn’t quell the episode, a midpotency topical steroid was used. And if the child’s skin disease worsened despite the midpotency topical steroid, the patient went to the clinic. If the physician determined systemic therapy was needed, the child was removed from the study.

Treatment success was defined as a score of 0 or 1, meaning clear or almost clear, on the Investigator’s Global Assessment. By week 3 of the study, more than 50% of patients in both treatment arms met that standard. The success rate gradually increased over a 5-year period to about 90% overall in both groups and greater than 95% for facial atopic dermatitis.

At baseline, the participants’ mean total body surface area affected by atopic dermatitis was 17%, and 22% of infants had a total body surface area of 30% or greater. By week 3, however, the mean total body surface area had dropped below 5% in both groups. The total body surface area progressively improved, reaching a mean of 0% at week 78 and staying that way for the remainder of the 5-year study, Dr. Luger reported at the annual congress of the European Academy of Dermatology and Venereology.

Of children in the pimecrolimus cohort, 70% completed the 5-year study, as did 72% in the topical steroid arm. During the course of the study, 38% of completers in the pimecrolimus arm used a low-potency topical steroid, and 41% used a midpotency topical steroid.

The two treatment strategies proved similarly well tolerated. The rate of discontinuation because of adverse events was 0.6% in the pimecrolimus cohort and 1.1% in the topical steroids group. The incidence and time to onset of all adverse events were similar in the two study arms. Serious adverse events, the majority of which were infections, occurred in 20% of the pimecrolimus group and 17% of the topical steroids group.

The study was funded by Novartis, which markets Elidel. Dr. Luger is a consultant to and a paid speaker for the pharmaceutical company.

PRAGUE – Long-term therapy utilizing a pimecrolimus-based strategy for mild to moderate atopic dermatitis beginning in infancy proved as effective and safe as conventional therapy with topical corticosteroids in a 5-year randomized study.

"Given that pimecrolimus cream 1% is not associated with topical corticosteroid-specific side effects, such as hypothalamic-pituitary-adrenal axis suppression or skin atrophy, which can limit their long-term use, pimecrolimus cream may represent the drug of choice for long-term atopic dermatitis management," said Dr. Thomas A. Luger, professor and chairman of the department of dermatology at the University of Müenster (Germany).

Novak, Natalija (2010):Pediatric Allergy

Currently, pimecrolimus is not approved for use in patients under 2 years of age, he noted.

Dr. Luger, who is an investigator on the study’s steering committee, reported on 2,418 infants with mild to moderate atopic dermatitis randomized to daily use of an emollient for their dry skin plus either pimecrolimus cream 1% (Elidel) or low-potency to midpotency topical steroids on an as-needed basis. The participants’ mean age at enrollment was 7 months. Fifty-three percent of infants had moderate atopic dermatitis based on the Investigator’s Global Assessment; the rest had mild disease.

This was a 5-year, international, open-label randomized study designed to reflect real world, as-needed use of topical medications. Patients in the pimecrolimus group applied the topical calcineurin inhibitor at the first sign of an atopic dermatitis flare. If pimecrolimus didn’t control the itching, redness, and/or lesion elevation to the parents’ satisfaction, the child was switched to a low-potency topical steroid. If that didn’t quell the episode, a midpotency topical steroid was used. And if the child’s skin disease worsened despite the midpotency topical steroid, the patient went to the clinic. If the physician determined systemic therapy was needed, the child was removed from the study.

Treatment success was defined as a score of 0 or 1, meaning clear or almost clear, on the Investigator’s Global Assessment. By week 3 of the study, more than 50% of patients in both treatment arms met that standard. The success rate gradually increased over a 5-year period to about 90% overall in both groups and greater than 95% for facial atopic dermatitis.

At baseline, the participants’ mean total body surface area affected by atopic dermatitis was 17%, and 22% of infants had a total body surface area of 30% or greater. By week 3, however, the mean total body surface area had dropped below 5% in both groups. The total body surface area progressively improved, reaching a mean of 0% at week 78 and staying that way for the remainder of the 5-year study, Dr. Luger reported at the annual congress of the European Academy of Dermatology and Venereology.

Of children in the pimecrolimus cohort, 70% completed the 5-year study, as did 72% in the topical steroid arm. During the course of the study, 38% of completers in the pimecrolimus arm used a low-potency topical steroid, and 41% used a midpotency topical steroid.

The two treatment strategies proved similarly well tolerated. The rate of discontinuation because of adverse events was 0.6% in the pimecrolimus cohort and 1.1% in the topical steroids group. The incidence and time to onset of all adverse events were similar in the two study arms. Serious adverse events, the majority of which were infections, occurred in 20% of the pimecrolimus group and 17% of the topical steroids group.

The study was funded by Novartis, which markets Elidel. Dr. Luger is a consultant to and a paid speaker for the pharmaceutical company.

PRAGUE – Long-term therapy utilizing a pimecrolimus-based strategy for mild to moderate atopic dermatitis beginning in infancy proved as effective and safe as conventional therapy with topical corticosteroids in a 5-year randomized study.

"Given that pimecrolimus cream 1% is not associated with topical corticosteroid-specific side effects, such as hypothalamic-pituitary-adrenal axis suppression or skin atrophy, which can limit their long-term use, pimecrolimus cream may represent the drug of choice for long-term atopic dermatitis management," said Dr. Thomas A. Luger, professor and chairman of the department of dermatology at the University of Müenster (Germany).

Novak, Natalija (2010):Pediatric Allergy

Currently, pimecrolimus is not approved for use in patients under 2 years of age, he noted.

Dr. Luger, who is an investigator on the study’s steering committee, reported on 2,418 infants with mild to moderate atopic dermatitis randomized to daily use of an emollient for their dry skin plus either pimecrolimus cream 1% (Elidel) or low-potency to midpotency topical steroids on an as-needed basis. The participants’ mean age at enrollment was 7 months. Fifty-three percent of infants had moderate atopic dermatitis based on the Investigator’s Global Assessment; the rest had mild disease.

This was a 5-year, international, open-label randomized study designed to reflect real world, as-needed use of topical medications. Patients in the pimecrolimus group applied the topical calcineurin inhibitor at the first sign of an atopic dermatitis flare. If pimecrolimus didn’t control the itching, redness, and/or lesion elevation to the parents’ satisfaction, the child was switched to a low-potency topical steroid. If that didn’t quell the episode, a midpotency topical steroid was used. And if the child’s skin disease worsened despite the midpotency topical steroid, the patient went to the clinic. If the physician determined systemic therapy was needed, the child was removed from the study.

Treatment success was defined as a score of 0 or 1, meaning clear or almost clear, on the Investigator’s Global Assessment. By week 3 of the study, more than 50% of patients in both treatment arms met that standard. The success rate gradually increased over a 5-year period to about 90% overall in both groups and greater than 95% for facial atopic dermatitis.

At baseline, the participants’ mean total body surface area affected by atopic dermatitis was 17%, and 22% of infants had a total body surface area of 30% or greater. By week 3, however, the mean total body surface area had dropped below 5% in both groups. The total body surface area progressively improved, reaching a mean of 0% at week 78 and staying that way for the remainder of the 5-year study, Dr. Luger reported at the annual congress of the European Academy of Dermatology and Venereology.

Of children in the pimecrolimus cohort, 70% completed the 5-year study, as did 72% in the topical steroid arm. During the course of the study, 38% of completers in the pimecrolimus arm used a low-potency topical steroid, and 41% used a midpotency topical steroid.

The two treatment strategies proved similarly well tolerated. The rate of discontinuation because of adverse events was 0.6% in the pimecrolimus cohort and 1.1% in the topical steroids group. The incidence and time to onset of all adverse events were similar in the two study arms. Serious adverse events, the majority of which were infections, occurred in 20% of the pimecrolimus group and 17% of the topical steroids group.

The study was funded by Novartis, which markets Elidel. Dr. Luger is a consultant to and a paid speaker for the pharmaceutical company.

PRAGUE – Patients with diabetes and psoriasis are significantly more likely to develop new-onset, diabetes-related microvascular and macrovascular complications than are psoriasis-free patients with diabetes, according to the results of a large study.

"In view of this greater likelihood of developing microvascular and macrovascular complications, clinicians may wish to consider closer disease management of diabetic patients with psoriasis," said Dr. April W. Armstrong, director of clinical research and teledermatology for the department of dermatology at the University of California Davis Health System. The study is the first to examine the impact of comorbid psoriasis and diabetes – two diseases characterized by systemic inflammation – on the risk of diabetic vascular complications.

She and her coinvestigators identified 6,164 adult patients with psoriasis and diabetes in the Thomson Reuters MarketScan medical records database covering 2000-2006. A limitation of the database is its lack of information regarding how well the participants’ diabetes was controlled, Dr. Armstrong noted.

The patients were matched to an equal number of control patients (psoriasis-free patients with diabetes) based on sex, diabetes type, prior diabetic complications, diabetic complications, and a vascular complications propensity score. Then, the researchers analyzed the risk of incident diabetes-related microvascular and macrovascular complications over the subsequent 1, 3, and 5 years.

At 12 months’ follow-up, 18.3% of the patients with diabetes and psoriasis had developed new-onset diabetic microvascular complications – that is, retinopathy, neuropathy, or nephropathy – compared with 16.5% of controls. Similarly, 18.6% of patients with diabetes and psoriasis developed microvascular complications within this time frame, compared with 15.9% of controls.

Over the full 5 years of follow-up, 29.2% of the patients with diabetes and psoriasis experienced incident microvascular and 28.6% developed macrovascular complications, compared with 26.0% and 25.7% of control patients. This translated to a highly significant adjusted 14% increased relative risk of incident microvascular complications in the cohort with comorbid diabetes and psoriasis, as well as a 13% increased incidence of macrovascular complications such as MI, heart failure, or stroke, Dr. Armstrong reported at the annual congress of the European Academy of Dermatology and Venereology.

At baseline, investigators classified 73% of the 6,164 psoriasis patients who also had diabetes as having mild psoriasis based on their use of topical therapies only, while the remaining 27% had moderate to severe psoriasis defined by their use of systemic medications or phototherapy.

Next, the researchers sought to find out whether the risk of diabetic vascular complications in patients with comorbid psoriasis climbed with increasing severity of their dermatologic disease. The answer turned out to be "sort of," noted Dr. Armstrong.

That is, the adjusted 5-year risk of incident diabetic microvascular complications was 13% greater in patients with mild psoriasis than in psoriasis-free patients with diabetes, and 16% greater in those with moderate to severe psoriasis. The results were consistent with the notion that more severe psoriasis, with its greater attendant systemic inflammation, spells greater vascular risk.

However, the risk for macrovascular complications wasn’t as clear cut. While the risk of diabetic macrovascular complications was increased 16% in patients with diabetes and mild psoriasis, the relative risk in those with moderate to severe psoriasis was only 10% more than in psoriasis-free patients with diabetes – and that degree of elevation didn’t achieve statistical significance.

One plausible explanation for this discordant finding, according to Dr. Armstrong, is that the use of systemic therapies in the cohort with moderate to severe psoriasis quelled their systemic inflammation, which dampened their risk for macrovascular disease to a level similar to that seen in patients with diabetes without psoriasis, which, it must be emphasized, is still significantly greater than in the general population without diabetes.

Dr. Armstrong reported being the recipient of psoriasis research grants from Abbott Laboratories, which sponsored this study, as well as from Amgen and Janssen Pharmaceuticals.

PRAGUE – Patients with diabetes and psoriasis are significantly more likely to develop new-onset, diabetes-related microvascular and macrovascular complications than are psoriasis-free patients with diabetes, according to the results of a large study.

"In view of this greater likelihood of developing microvascular and macrovascular complications, clinicians may wish to consider closer disease management of diabetic patients with psoriasis," said Dr. April W. Armstrong, director of clinical research and teledermatology for the department of dermatology at the University of California Davis Health System. The study is the first to examine the impact of comorbid psoriasis and diabetes – two diseases characterized by systemic inflammation – on the risk of diabetic vascular complications.

She and her coinvestigators identified 6,164 adult patients with psoriasis and diabetes in the Thomson Reuters MarketScan medical records database covering 2000-2006. A limitation of the database is its lack of information regarding how well the participants’ diabetes was controlled, Dr. Armstrong noted.

The patients were matched to an equal number of control patients (psoriasis-free patients with diabetes) based on sex, diabetes type, prior diabetic complications, diabetic complications, and a vascular complications propensity score. Then, the researchers analyzed the risk of incident diabetes-related microvascular and macrovascular complications over the subsequent 1, 3, and 5 years.

At 12 months’ follow-up, 18.3% of the patients with diabetes and psoriasis had developed new-onset diabetic microvascular complications – that is, retinopathy, neuropathy, or nephropathy – compared with 16.5% of controls. Similarly, 18.6% of patients with diabetes and psoriasis developed microvascular complications within this time frame, compared with 15.9% of controls.

Over the full 5 years of follow-up, 29.2% of the patients with diabetes and psoriasis experienced incident microvascular and 28.6% developed macrovascular complications, compared with 26.0% and 25.7% of control patients. This translated to a highly significant adjusted 14% increased relative risk of incident microvascular complications in the cohort with comorbid diabetes and psoriasis, as well as a 13% increased incidence of macrovascular complications such as MI, heart failure, or stroke, Dr. Armstrong reported at the annual congress of the European Academy of Dermatology and Venereology.

At baseline, investigators classified 73% of the 6,164 psoriasis patients who also had diabetes as having mild psoriasis based on their use of topical therapies only, while the remaining 27% had moderate to severe psoriasis defined by their use of systemic medications or phototherapy.

Next, the researchers sought to find out whether the risk of diabetic vascular complications in patients with comorbid psoriasis climbed with increasing severity of their dermatologic disease. The answer turned out to be "sort of," noted Dr. Armstrong.

That is, the adjusted 5-year risk of incident diabetic microvascular complications was 13% greater in patients with mild psoriasis than in psoriasis-free patients with diabetes, and 16% greater in those with moderate to severe psoriasis. The results were consistent with the notion that more severe psoriasis, with its greater attendant systemic inflammation, spells greater vascular risk.

However, the risk for macrovascular complications wasn’t as clear cut. While the risk of diabetic macrovascular complications was increased 16% in patients with diabetes and mild psoriasis, the relative risk in those with moderate to severe psoriasis was only 10% more than in psoriasis-free patients with diabetes – and that degree of elevation didn’t achieve statistical significance.

One plausible explanation for this discordant finding, according to Dr. Armstrong, is that the use of systemic therapies in the cohort with moderate to severe psoriasis quelled their systemic inflammation, which dampened their risk for macrovascular disease to a level similar to that seen in patients with diabetes without psoriasis, which, it must be emphasized, is still significantly greater than in the general population without diabetes.

Dr. Armstrong reported being the recipient of psoriasis research grants from Abbott Laboratories, which sponsored this study, as well as from Amgen and Janssen Pharmaceuticals.

PRAGUE – Patients with diabetes and psoriasis are significantly more likely to develop new-onset, diabetes-related microvascular and macrovascular complications than are psoriasis-free patients with diabetes, according to the results of a large study.

"In view of this greater likelihood of developing microvascular and macrovascular complications, clinicians may wish to consider closer disease management of diabetic patients with psoriasis," said Dr. April W. Armstrong, director of clinical research and teledermatology for the department of dermatology at the University of California Davis Health System. The study is the first to examine the impact of comorbid psoriasis and diabetes – two diseases characterized by systemic inflammation – on the risk of diabetic vascular complications.

She and her coinvestigators identified 6,164 adult patients with psoriasis and diabetes in the Thomson Reuters MarketScan medical records database covering 2000-2006. A limitation of the database is its lack of information regarding how well the participants’ diabetes was controlled, Dr. Armstrong noted.

The patients were matched to an equal number of control patients (psoriasis-free patients with diabetes) based on sex, diabetes type, prior diabetic complications, diabetic complications, and a vascular complications propensity score. Then, the researchers analyzed the risk of incident diabetes-related microvascular and macrovascular complications over the subsequent 1, 3, and 5 years.

At 12 months’ follow-up, 18.3% of the patients with diabetes and psoriasis had developed new-onset diabetic microvascular complications – that is, retinopathy, neuropathy, or nephropathy – compared with 16.5% of controls. Similarly, 18.6% of patients with diabetes and psoriasis developed microvascular complications within this time frame, compared with 15.9% of controls.

Over the full 5 years of follow-up, 29.2% of the patients with diabetes and psoriasis experienced incident microvascular and 28.6% developed macrovascular complications, compared with 26.0% and 25.7% of control patients. This translated to a highly significant adjusted 14% increased relative risk of incident microvascular complications in the cohort with comorbid diabetes and psoriasis, as well as a 13% increased incidence of macrovascular complications such as MI, heart failure, or stroke, Dr. Armstrong reported at the annual congress of the European Academy of Dermatology and Venereology.

At baseline, investigators classified 73% of the 6,164 psoriasis patients who also had diabetes as having mild psoriasis based on their use of topical therapies only, while the remaining 27% had moderate to severe psoriasis defined by their use of systemic medications or phototherapy.

Next, the researchers sought to find out whether the risk of diabetic vascular complications in patients with comorbid psoriasis climbed with increasing severity of their dermatologic disease. The answer turned out to be "sort of," noted Dr. Armstrong.

That is, the adjusted 5-year risk of incident diabetic microvascular complications was 13% greater in patients with mild psoriasis than in psoriasis-free patients with diabetes, and 16% greater in those with moderate to severe psoriasis. The results were consistent with the notion that more severe psoriasis, with its greater attendant systemic inflammation, spells greater vascular risk.

However, the risk for macrovascular complications wasn’t as clear cut. While the risk of diabetic macrovascular complications was increased 16% in patients with diabetes and mild psoriasis, the relative risk in those with moderate to severe psoriasis was only 10% more than in psoriasis-free patients with diabetes – and that degree of elevation didn’t achieve statistical significance.

One plausible explanation for this discordant finding, according to Dr. Armstrong, is that the use of systemic therapies in the cohort with moderate to severe psoriasis quelled their systemic inflammation, which dampened their risk for macrovascular disease to a level similar to that seen in patients with diabetes without psoriasis, which, it must be emphasized, is still significantly greater than in the general population without diabetes.

Dr. Armstrong reported being the recipient of psoriasis research grants from Abbott Laboratories, which sponsored this study, as well as from Amgen and Janssen Pharmaceuticals.

PRAGUE – Maggot debridement of wounds proved significantly faster, less painful, and less labor intensive than surgical debridement and conventional dressings in a randomized, multicenter clinical trial.

"There was quite an amazing debridement after 7 days of maggot therapy," Dr. Kristina Opletalova said of the phase III study findings presented at the annual congress of the European Academy of Dermatology and Venereology.

Courtesy National Institutes of Health

She reported on 119 patients hospitalized for 2 weeks for treatment of nonhealing sloughy wounds, most of which were venous ulcers on the lower limbs. Participants were randomized to maggot therapy or to thrice-weekly surgical debridement with topical anesthesia and conventional dressings.

The maggot therapy was administered via a novel delivery system: 80 maggots of Lucilia sericata were bagged in a special two-layer dressing, known as a Vitapad (BioMonde Laboratories), which allowed the critters to move and feed on the wound surface and kept them from escaping. The dressing was changed twice weekly.

Patients were blindfolded for all dressing changes so they didn’t know which study arm they were in. Wound sloughing was analyzed using computerized planimetry software, and other end points were assessed by an investigator blinded to treatment arm.

After 7 days of therapy, the wound status was significantly better in the maggot debridement group. The mean percentage of slough in wounds was 54.5%, compared with 66.5% in controls, but the significantly faster debridement didn’t boost the final healing rate. The day 15 percentage of slough in the wounds didn’t differ significantly between the two groups: 55.4% with maggot therapy and 53.8% in controls.

"So we think maggot debridement therapy should be stopped after 1 week and other types of dressings should then be used," said Dr. Opletalova, a dermatologist at the University of Caen (France).

Pain scores, which were assessed on a weekly basis, were similarly low in the two groups, but it must be noted that the control group received topical anesthetic and the maggot therapy group did not. Nursing time was four-fold greater in the control group. The study didn’t include a formal cost analysis, but the markedly reduced nursing time in the maggot therapy group is likely to spell cost savings, she said.

Maggot therapy was well tolerated. Patients expressed no reticence about it. A similar number of patients in both study arms reported a crawling sensation on their wounds.

Dr. Opletalova said that maggot therapy is likely to be particularly useful in patients with wounds that need rapid debridement, such as those with diabetes, or to prepare a wound for skin grafting or when there is an increased risk for infection.

Further details of the recently published randomized trial can be found in the Archives of Dermatology (2012;148:432-8).

The study was supported by university hospital research funding and by a grant from the French Society of Dermatology. Dr. Opletalova reported having no financial conflicts.

PRAGUE – Maggot debridement of wounds proved significantly faster, less painful, and less labor intensive than surgical debridement and conventional dressings in a randomized, multicenter clinical trial.

"There was quite an amazing debridement after 7 days of maggot therapy," Dr. Kristina Opletalova said of the phase III study findings presented at the annual congress of the European Academy of Dermatology and Venereology.

Courtesy National Institutes of Health

She reported on 119 patients hospitalized for 2 weeks for treatment of nonhealing sloughy wounds, most of which were venous ulcers on the lower limbs. Participants were randomized to maggot therapy or to thrice-weekly surgical debridement with topical anesthesia and conventional dressings.

The maggot therapy was administered via a novel delivery system: 80 maggots of Lucilia sericata were bagged in a special two-layer dressing, known as a Vitapad (BioMonde Laboratories), which allowed the critters to move and feed on the wound surface and kept them from escaping. The dressing was changed twice weekly.

Patients were blindfolded for all dressing changes so they didn’t know which study arm they were in. Wound sloughing was analyzed using computerized planimetry software, and other end points were assessed by an investigator blinded to treatment arm.

After 7 days of therapy, the wound status was significantly better in the maggot debridement group. The mean percentage of slough in wounds was 54.5%, compared with 66.5% in controls, but the significantly faster debridement didn’t boost the final healing rate. The day 15 percentage of slough in the wounds didn’t differ significantly between the two groups: 55.4% with maggot therapy and 53.8% in controls.

"So we think maggot debridement therapy should be stopped after 1 week and other types of dressings should then be used," said Dr. Opletalova, a dermatologist at the University of Caen (France).

Pain scores, which were assessed on a weekly basis, were similarly low in the two groups, but it must be noted that the control group received topical anesthetic and the maggot therapy group did not. Nursing time was four-fold greater in the control group. The study didn’t include a formal cost analysis, but the markedly reduced nursing time in the maggot therapy group is likely to spell cost savings, she said.

Maggot therapy was well tolerated. Patients expressed no reticence about it. A similar number of patients in both study arms reported a crawling sensation on their wounds.

Dr. Opletalova said that maggot therapy is likely to be particularly useful in patients with wounds that need rapid debridement, such as those with diabetes, or to prepare a wound for skin grafting or when there is an increased risk for infection.

Further details of the recently published randomized trial can be found in the Archives of Dermatology (2012;148:432-8).

The study was supported by university hospital research funding and by a grant from the French Society of Dermatology. Dr. Opletalova reported having no financial conflicts.

PRAGUE – Maggot debridement of wounds proved significantly faster, less painful, and less labor intensive than surgical debridement and conventional dressings in a randomized, multicenter clinical trial.

"There was quite an amazing debridement after 7 days of maggot therapy," Dr. Kristina Opletalova said of the phase III study findings presented at the annual congress of the European Academy of Dermatology and Venereology.

Courtesy National Institutes of Health

She reported on 119 patients hospitalized for 2 weeks for treatment of nonhealing sloughy wounds, most of which were venous ulcers on the lower limbs. Participants were randomized to maggot therapy or to thrice-weekly surgical debridement with topical anesthesia and conventional dressings.

The maggot therapy was administered via a novel delivery system: 80 maggots of Lucilia sericata were bagged in a special two-layer dressing, known as a Vitapad (BioMonde Laboratories), which allowed the critters to move and feed on the wound surface and kept them from escaping. The dressing was changed twice weekly.

Patients were blindfolded for all dressing changes so they didn’t know which study arm they were in. Wound sloughing was analyzed using computerized planimetry software, and other end points were assessed by an investigator blinded to treatment arm.

After 7 days of therapy, the wound status was significantly better in the maggot debridement group. The mean percentage of slough in wounds was 54.5%, compared with 66.5% in controls, but the significantly faster debridement didn’t boost the final healing rate. The day 15 percentage of slough in the wounds didn’t differ significantly between the two groups: 55.4% with maggot therapy and 53.8% in controls.

"So we think maggot debridement therapy should be stopped after 1 week and other types of dressings should then be used," said Dr. Opletalova, a dermatologist at the University of Caen (France).

Pain scores, which were assessed on a weekly basis, were similarly low in the two groups, but it must be noted that the control group received topical anesthetic and the maggot therapy group did not. Nursing time was four-fold greater in the control group. The study didn’t include a formal cost analysis, but the markedly reduced nursing time in the maggot therapy group is likely to spell cost savings, she said.

Maggot therapy was well tolerated. Patients expressed no reticence about it. A similar number of patients in both study arms reported a crawling sensation on their wounds.

Dr. Opletalova said that maggot therapy is likely to be particularly useful in patients with wounds that need rapid debridement, such as those with diabetes, or to prepare a wound for skin grafting or when there is an increased risk for infection.

Further details of the recently published randomized trial can be found in the Archives of Dermatology (2012;148:432-8).

The study was supported by university hospital research funding and by a grant from the French Society of Dermatology. Dr. Opletalova reported having no financial conflicts.

PRAGUE – Oral isotretinoin dosed at 5 mg per day proved to be highly effective, fast acting, and well tolerated for persistent, low-grade, adult acne in a randomized, double-blind clinical trial.

Results of this study provide physicians with evidence supporting the use of low-dose isotretinoin in the management of adult acne, Dr. Marius Rademaker said at the annual congress of the European Academy of Dermatology and Venereology.

"There’s a high degree of dissatisfaction with treatment among adult acne sufferers because of their usual slow response to the traditional acne therapies, the poor clearance, and the very high relapse rate when you stop treatment. The standards of a woman of 35 with adult acne are quite different from those of a 15-year-old. I think people no longer want 70% improvement, they want 100% clearance," said Dr. Rademaker, a dermatologist at Waikato Hospital in Hamilton, New Zealand.

There have been few randomized, controlled studies focusing on treatment of adult acne, he reported, adding that he could find no studies involving systemic antibiotics for acne in adults. He found a few studies on topical retinoid trials, but they only included a minority of adults. And, he found no studies assessing the effectiveness of low dose isotretinoin for adults.

Therefore, he conducted a randomized trial of isotretinoin at 5 mg/day to determine if a lower dose would be as effective and would have fewer adverse events than the standard dose of 0.5-1.0 mg/kg per day. Avoiding relapse upon discontinuation of isotretinoin appears to be more a function of the duration of sebaceous gland suppression – longer is better – than of cumulative dose, he added.

He reported on 58 adults aged 25-55 with low-grade, indolent acne that had persisted since adolescence. Nearly 90% were women. Participants were randomized double-blind to 16 weeks of isotretinoin 5 mg/day or placebo, followed by an additional 16 weeks of open-label isotretinoin in both study arms. The primary end point was the change in the number of facial acne lesions between baseline and week 16.

The acne lesion count in the isotretinoin group was reduced by half within the first 4 weeks of the study, from a mean baseline of 10.6 lesions. By week 16, the group’s mean acne lesion count had dropped to 3.2. After a further 16 weeks of open-label therapy, it had fallen to 1.3.

In contrast, the mean acne lesion count in the control group didn’t change significantly over the first 16 weeks from a baseline of 9.7 lesions. After a subsequent 16 weeks of open-label isotretinoin, acne count dropped to 3.9.

A secondary outcome measure was change in Dermatology Life Quality Index (DLQI) scores. From a mean baseline score of 4.8, indicative of moderate skin disease–related disability, the score fell to 1.3 after 16 weeks of double-blind isotretinoin and to 1.2 after another 16 weeks of open-label therapy. The mean DLQI score of 4.9 was unchanged in the control group after 16 weeks of placebo, but dropped to 2.3 after 16 weeks of open-label isotretinoin.

In an interview, Dr. Neil S. Goldberg, a dermatologist in Bronxville, N.Y, questioned the blindness of any study involving isotretinoin. "No isotretinoin study can be blinded. The side effects of isotretinoin, even low dose, are just too obvious."

The most common side effect in the study was dry lips, which nearly two-thirds of patients reported while on isotretinoin. Dry skin, musculoskeletal aches and pains, dry eyes, and fatigue were less frequently reported. One patient withdrew from the study because of anxiety and mood changes that may or may not have been treatment related, Dr. Rademaker said.

He added that in his experience, after a year of treatment at 5 mg/day, virtually all patients with persistent low-grade adult acne no longer have any acne. He is pursing the possibilities of conducting a long-term, follow-up study.

"Isotretinoin seems to me to be just as valuable a treatment in adults as in teenagers," said Dr. Steven R. Feldman, professor of dermatology at Wake Forest Baptist Medical Center in Winston-Salem, N.C. "My standard approach is to use it in the same way, though using it in lower doses for longer periods of time is reasonable and often effective with fewer side effects." Caution is warranted, however, when prescribing isotretinoin to women of childbearing potential because of the drug’s known teratogenicity.

In response to audience questions about restrictions placed upon isotretinoin prescribing in New Zealand, Dr. Rademaker replied that his country’s pregnancy prevention plan requires patient education but not mandatory pregnancy tests. "And our pregnancy rates [for females on isotretinoin] are lower than in Europe or the U.S.," he said.

"iPledge makes everything harder. It inhibits flexibility. In Australia – where my two nieces and nephew live – when they started isotretinoin, the doctor just gave them 6 months of isotretinoin and sent them on their way," said Dr. Goldberg.

Clinical acne is present in 45% of women aged 21-30 years, 26% of women aged 31-40, and 12% of women aged 41-50, according to the results of a recent cross-sectional study of 2,895 U.S. females aged 10-70 years (J. Womens Health [Larchmt] 2012;21:223-30).

Dr. Rademaker’s investigator-initiated study was sponsored by Douglas Pharmaceuticals (an isotretinoin manufacturer in New Zealand). He had no other conflicts of interest. Dr. Feldman reported significant financial relationships with several pharmaceutical companies. Dr. Goldberg had no financial conflicts to report.

PRAGUE – Oral isotretinoin dosed at 5 mg per day proved to be highly effective, fast acting, and well tolerated for persistent, low-grade, adult acne in a randomized, double-blind clinical trial.

Results of this study provide physicians with evidence supporting the use of low-dose isotretinoin in the management of adult acne, Dr. Marius Rademaker said at the annual congress of the European Academy of Dermatology and Venereology.

"There’s a high degree of dissatisfaction with treatment among adult acne sufferers because of their usual slow response to the traditional acne therapies, the poor clearance, and the very high relapse rate when you stop treatment. The standards of a woman of 35 with adult acne are quite different from those of a 15-year-old. I think people no longer want 70% improvement, they want 100% clearance," said Dr. Rademaker, a dermatologist at Waikato Hospital in Hamilton, New Zealand.

There have been few randomized, controlled studies focusing on treatment of adult acne, he reported, adding that he could find no studies involving systemic antibiotics for acne in adults. He found a few studies on topical retinoid trials, but they only included a minority of adults. And, he found no studies assessing the effectiveness of low dose isotretinoin for adults.

Therefore, he conducted a randomized trial of isotretinoin at 5 mg/day to determine if a lower dose would be as effective and would have fewer adverse events than the standard dose of 0.5-1.0 mg/kg per day. Avoiding relapse upon discontinuation of isotretinoin appears to be more a function of the duration of sebaceous gland suppression – longer is better – than of cumulative dose, he added.

He reported on 58 adults aged 25-55 with low-grade, indolent acne that had persisted since adolescence. Nearly 90% were women. Participants were randomized double-blind to 16 weeks of isotretinoin 5 mg/day or placebo, followed by an additional 16 weeks of open-label isotretinoin in both study arms. The primary end point was the change in the number of facial acne lesions between baseline and week 16.

The acne lesion count in the isotretinoin group was reduced by half within the first 4 weeks of the study, from a mean baseline of 10.6 lesions. By week 16, the group’s mean acne lesion count had dropped to 3.2. After a further 16 weeks of open-label therapy, it had fallen to 1.3.

In contrast, the mean acne lesion count in the control group didn’t change significantly over the first 16 weeks from a baseline of 9.7 lesions. After a subsequent 16 weeks of open-label isotretinoin, acne count dropped to 3.9.

A secondary outcome measure was change in Dermatology Life Quality Index (DLQI) scores. From a mean baseline score of 4.8, indicative of moderate skin disease–related disability, the score fell to 1.3 after 16 weeks of double-blind isotretinoin and to 1.2 after another 16 weeks of open-label therapy. The mean DLQI score of 4.9 was unchanged in the control group after 16 weeks of placebo, but dropped to 2.3 after 16 weeks of open-label isotretinoin.

In an interview, Dr. Neil S. Goldberg, a dermatologist in Bronxville, N.Y, questioned the blindness of any study involving isotretinoin. "No isotretinoin study can be blinded. The side effects of isotretinoin, even low dose, are just too obvious."

The most common side effect in the study was dry lips, which nearly two-thirds of patients reported while on isotretinoin. Dry skin, musculoskeletal aches and pains, dry eyes, and fatigue were less frequently reported. One patient withdrew from the study because of anxiety and mood changes that may or may not have been treatment related, Dr. Rademaker said.

He added that in his experience, after a year of treatment at 5 mg/day, virtually all patients with persistent low-grade adult acne no longer have any acne. He is pursing the possibilities of conducting a long-term, follow-up study.

"Isotretinoin seems to me to be just as valuable a treatment in adults as in teenagers," said Dr. Steven R. Feldman, professor of dermatology at Wake Forest Baptist Medical Center in Winston-Salem, N.C. "My standard approach is to use it in the same way, though using it in lower doses for longer periods of time is reasonable and often effective with fewer side effects." Caution is warranted, however, when prescribing isotretinoin to women of childbearing potential because of the drug’s known teratogenicity.

In response to audience questions about restrictions placed upon isotretinoin prescribing in New Zealand, Dr. Rademaker replied that his country’s pregnancy prevention plan requires patient education but not mandatory pregnancy tests. "And our pregnancy rates [for females on isotretinoin] are lower than in Europe or the U.S.," he said.

"iPledge makes everything harder. It inhibits flexibility. In Australia – where my two nieces and nephew live – when they started isotretinoin, the doctor just gave them 6 months of isotretinoin and sent them on their way," said Dr. Goldberg.

Clinical acne is present in 45% of women aged 21-30 years, 26% of women aged 31-40, and 12% of women aged 41-50, according to the results of a recent cross-sectional study of 2,895 U.S. females aged 10-70 years (J. Womens Health [Larchmt] 2012;21:223-30).

Dr. Rademaker’s investigator-initiated study was sponsored by Douglas Pharmaceuticals (an isotretinoin manufacturer in New Zealand). He had no other conflicts of interest. Dr. Feldman reported significant financial relationships with several pharmaceutical companies. Dr. Goldberg had no financial conflicts to report.

PRAGUE – Oral isotretinoin dosed at 5 mg per day proved to be highly effective, fast acting, and well tolerated for persistent, low-grade, adult acne in a randomized, double-blind clinical trial.

Results of this study provide physicians with evidence supporting the use of low-dose isotretinoin in the management of adult acne, Dr. Marius Rademaker said at the annual congress of the European Academy of Dermatology and Venereology.

"There’s a high degree of dissatisfaction with treatment among adult acne sufferers because of their usual slow response to the traditional acne therapies, the poor clearance, and the very high relapse rate when you stop treatment. The standards of a woman of 35 with adult acne are quite different from those of a 15-year-old. I think people no longer want 70% improvement, they want 100% clearance," said Dr. Rademaker, a dermatologist at Waikato Hospital in Hamilton, New Zealand.

There have been few randomized, controlled studies focusing on treatment of adult acne, he reported, adding that he could find no studies involving systemic antibiotics for acne in adults. He found a few studies on topical retinoid trials, but they only included a minority of adults. And, he found no studies assessing the effectiveness of low dose isotretinoin for adults.

Therefore, he conducted a randomized trial of isotretinoin at 5 mg/day to determine if a lower dose would be as effective and would have fewer adverse events than the standard dose of 0.5-1.0 mg/kg per day. Avoiding relapse upon discontinuation of isotretinoin appears to be more a function of the duration of sebaceous gland suppression – longer is better – than of cumulative dose, he added.

He reported on 58 adults aged 25-55 with low-grade, indolent acne that had persisted since adolescence. Nearly 90% were women. Participants were randomized double-blind to 16 weeks of isotretinoin 5 mg/day or placebo, followed by an additional 16 weeks of open-label isotretinoin in both study arms. The primary end point was the change in the number of facial acne lesions between baseline and week 16.

The acne lesion count in the isotretinoin group was reduced by half within the first 4 weeks of the study, from a mean baseline of 10.6 lesions. By week 16, the group’s mean acne lesion count had dropped to 3.2. After a further 16 weeks of open-label therapy, it had fallen to 1.3.

In contrast, the mean acne lesion count in the control group didn’t change significantly over the first 16 weeks from a baseline of 9.7 lesions. After a subsequent 16 weeks of open-label isotretinoin, acne count dropped to 3.9.

A secondary outcome measure was change in Dermatology Life Quality Index (DLQI) scores. From a mean baseline score of 4.8, indicative of moderate skin disease–related disability, the score fell to 1.3 after 16 weeks of double-blind isotretinoin and to 1.2 after another 16 weeks of open-label therapy. The mean DLQI score of 4.9 was unchanged in the control group after 16 weeks of placebo, but dropped to 2.3 after 16 weeks of open-label isotretinoin.

In an interview, Dr. Neil S. Goldberg, a dermatologist in Bronxville, N.Y, questioned the blindness of any study involving isotretinoin. "No isotretinoin study can be blinded. The side effects of isotretinoin, even low dose, are just too obvious."

The most common side effect in the study was dry lips, which nearly two-thirds of patients reported while on isotretinoin. Dry skin, musculoskeletal aches and pains, dry eyes, and fatigue were less frequently reported. One patient withdrew from the study because of anxiety and mood changes that may or may not have been treatment related, Dr. Rademaker said.

He added that in his experience, after a year of treatment at 5 mg/day, virtually all patients with persistent low-grade adult acne no longer have any acne. He is pursing the possibilities of conducting a long-term, follow-up study.

"Isotretinoin seems to me to be just as valuable a treatment in adults as in teenagers," said Dr. Steven R. Feldman, professor of dermatology at Wake Forest Baptist Medical Center in Winston-Salem, N.C. "My standard approach is to use it in the same way, though using it in lower doses for longer periods of time is reasonable and often effective with fewer side effects." Caution is warranted, however, when prescribing isotretinoin to women of childbearing potential because of the drug’s known teratogenicity.

In response to audience questions about restrictions placed upon isotretinoin prescribing in New Zealand, Dr. Rademaker replied that his country’s pregnancy prevention plan requires patient education but not mandatory pregnancy tests. "And our pregnancy rates [for females on isotretinoin] are lower than in Europe or the U.S.," he said.

"iPledge makes everything harder. It inhibits flexibility. In Australia – where my two nieces and nephew live – when they started isotretinoin, the doctor just gave them 6 months of isotretinoin and sent them on their way," said Dr. Goldberg.

Clinical acne is present in 45% of women aged 21-30 years, 26% of women aged 31-40, and 12% of women aged 41-50, according to the results of a recent cross-sectional study of 2,895 U.S. females aged 10-70 years (J. Womens Health [Larchmt] 2012;21:223-30).

Dr. Rademaker’s investigator-initiated study was sponsored by Douglas Pharmaceuticals (an isotretinoin manufacturer in New Zealand). He had no other conflicts of interest. Dr. Feldman reported significant financial relationships with several pharmaceutical companies. Dr. Goldberg had no financial conflicts to report.

PRAGUE – In a 48-week, phase-II study of brodalumab – a novel selective interleukin-17 inhibitor – 60% of psoriasis patients achieved a Psoriasis Area and Severity Index score of 100, reported Dr. Kim A. Papp.

There were 181 patients with moderate to severe plaque psoriasis in the multicenter, open-label study, and nearly 100% achieved at least a PASI 75 response, 80% achieved at least a PASI 90 response, and 60% achieved a PASI 100, Dr. Papp said at the annual congress of the European Academy of Dermatology and Venereology. Equally important, responses were maintained through week 48, essentially undiminished, he said.

Dr. Papp, director of research at Probity Medical Research, Waterloo, Ont., presented the results of the open-label extension of a previously published phase II, 12-week study (N. Engl. J. Med. 2012;366:1181-9). At the end of the 12-week study, participants were observed off therapy until their psoriasis relapsed, defined as a 50% loss of therapeutic benefit. At that point, they were treated with 210 mg of brodalumab administered subcutaneously every 2 weeks for 48 weeks. The peak response was achieved between weeks 8 and 12 or 16; few study dropouts occurred.

"The side effect profile was varied and included a mix of serious infections and development of atrial fibrillation and other cardiac disorders. Certainly, there were no obvious signals to suggest that we should have undue concerns going into the planned phase III program," said Dr. Papp.

Session cochair Dr. Peter van de Kerkhof was enthusiastic about the brodalumab data. "These are absolutely fabulous results. It’s really very impressive. This study gives us a lead as to where we’re going: to a new phase in biologic therapy where we get an efficacy which we couldn’t have dreamed of 10 years ago. A new bar is set," said Dr. van de Kerkhof, professor and chairman of the department of dermatology at Radboud University in Nijmegen, the Netherlands.

Brodalumab (Amgen) is a human monoclonal antibody directed against the interleukin-17A receptor as a means of quelling inflammatory cytokines. Another humanized monoclonal antibody that neutralizes interleukin-17, ixekizumab (Eli Lilly), was also the subject of a recently published, encouraging phase II study (N. Engl. J. Med. 2012;366:1190-9). Secukinumab (Novartis) is another fully-human monoclonal antibody directed against IL-17A, which has completed several successful phase II studies. These anti-IL-17 biologics are being considered as possible new therapies for other inflammatory diseases, including psoriatic arthritis and rheumatoid arthritis.

Dr. van de Kerkhof cautioned that from a safety standpoint, it will be important to scrutinize the upcoming large, definitive phase III clinical trials of these agents for evidence of an increase in infections, particularly Staphylococcus aureus and Candida albicans.

Interleukin-17A and IL-17F play roles in the normal host-immune defenses against microorganisms. Patients with genetic defects in IL-17 tend to have problems with recurrent chronic mucocutaneous candidiasis. Moreover, individuals with chronic mucocutaneous candidiasis have been shown to have antibodies to IL-17A, IL-17F, and IL-22, he noted.

The study was sponsored by Amgen. Dr. Papp reported receiving research funds from and serving as a consultant to Amgen and numerous other pharmaceutical companies. Dr. van de Kerkhof has received research funding and consultancy fees from more than a dozen pharmaceutical companies.

PRAGUE – In a 48-week, phase-II study of brodalumab – a novel selective interleukin-17 inhibitor – 60% of psoriasis patients achieved a Psoriasis Area and Severity Index score of 100, reported Dr. Kim A. Papp.

There were 181 patients with moderate to severe plaque psoriasis in the multicenter, open-label study, and nearly 100% achieved at least a PASI 75 response, 80% achieved at least a PASI 90 response, and 60% achieved a PASI 100, Dr. Papp said at the annual congress of the European Academy of Dermatology and Venereology. Equally important, responses were maintained through week 48, essentially undiminished, he said.

Dr. Papp, director of research at Probity Medical Research, Waterloo, Ont., presented the results of the open-label extension of a previously published phase II, 12-week study (N. Engl. J. Med. 2012;366:1181-9). At the end of the 12-week study, participants were observed off therapy until their psoriasis relapsed, defined as a 50% loss of therapeutic benefit. At that point, they were treated with 210 mg of brodalumab administered subcutaneously every 2 weeks for 48 weeks. The peak response was achieved between weeks 8 and 12 or 16; few study dropouts occurred.

"The side effect profile was varied and included a mix of serious infections and development of atrial fibrillation and other cardiac disorders. Certainly, there were no obvious signals to suggest that we should have undue concerns going into the planned phase III program," said Dr. Papp.

Session cochair Dr. Peter van de Kerkhof was enthusiastic about the brodalumab data. "These are absolutely fabulous results. It’s really very impressive. This study gives us a lead as to where we’re going: to a new phase in biologic therapy where we get an efficacy which we couldn’t have dreamed of 10 years ago. A new bar is set," said Dr. van de Kerkhof, professor and chairman of the department of dermatology at Radboud University in Nijmegen, the Netherlands.

Brodalumab (Amgen) is a human monoclonal antibody directed against the interleukin-17A receptor as a means of quelling inflammatory cytokines. Another humanized monoclonal antibody that neutralizes interleukin-17, ixekizumab (Eli Lilly), was also the subject of a recently published, encouraging phase II study (N. Engl. J. Med. 2012;366:1190-9). Secukinumab (Novartis) is another fully-human monoclonal antibody directed against IL-17A, which has completed several successful phase II studies. These anti-IL-17 biologics are being considered as possible new therapies for other inflammatory diseases, including psoriatic arthritis and rheumatoid arthritis.

Dr. van de Kerkhof cautioned that from a safety standpoint, it will be important to scrutinize the upcoming large, definitive phase III clinical trials of these agents for evidence of an increase in infections, particularly Staphylococcus aureus and Candida albicans.

Interleukin-17A and IL-17F play roles in the normal host-immune defenses against microorganisms. Patients with genetic defects in IL-17 tend to have problems with recurrent chronic mucocutaneous candidiasis. Moreover, individuals with chronic mucocutaneous candidiasis have been shown to have antibodies to IL-17A, IL-17F, and IL-22, he noted.

The study was sponsored by Amgen. Dr. Papp reported receiving research funds from and serving as a consultant to Amgen and numerous other pharmaceutical companies. Dr. van de Kerkhof has received research funding and consultancy fees from more than a dozen pharmaceutical companies.

PRAGUE – In a 48-week, phase-II study of brodalumab – a novel selective interleukin-17 inhibitor – 60% of psoriasis patients achieved a Psoriasis Area and Severity Index score of 100, reported Dr. Kim A. Papp.

There were 181 patients with moderate to severe plaque psoriasis in the multicenter, open-label study, and nearly 100% achieved at least a PASI 75 response, 80% achieved at least a PASI 90 response, and 60% achieved a PASI 100, Dr. Papp said at the annual congress of the European Academy of Dermatology and Venereology. Equally important, responses were maintained through week 48, essentially undiminished, he said.

Dr. Papp, director of research at Probity Medical Research, Waterloo, Ont., presented the results of the open-label extension of a previously published phase II, 12-week study (N. Engl. J. Med. 2012;366:1181-9). At the end of the 12-week study, participants were observed off therapy until their psoriasis relapsed, defined as a 50% loss of therapeutic benefit. At that point, they were treated with 210 mg of brodalumab administered subcutaneously every 2 weeks for 48 weeks. The peak response was achieved between weeks 8 and 12 or 16; few study dropouts occurred.

"The side effect profile was varied and included a mix of serious infections and development of atrial fibrillation and other cardiac disorders. Certainly, there were no obvious signals to suggest that we should have undue concerns going into the planned phase III program," said Dr. Papp.

Session cochair Dr. Peter van de Kerkhof was enthusiastic about the brodalumab data. "These are absolutely fabulous results. It’s really very impressive. This study gives us a lead as to where we’re going: to a new phase in biologic therapy where we get an efficacy which we couldn’t have dreamed of 10 years ago. A new bar is set," said Dr. van de Kerkhof, professor and chairman of the department of dermatology at Radboud University in Nijmegen, the Netherlands.

Brodalumab (Amgen) is a human monoclonal antibody directed against the interleukin-17A receptor as a means of quelling inflammatory cytokines. Another humanized monoclonal antibody that neutralizes interleukin-17, ixekizumab (Eli Lilly), was also the subject of a recently published, encouraging phase II study (N. Engl. J. Med. 2012;366:1190-9). Secukinumab (Novartis) is another fully-human monoclonal antibody directed against IL-17A, which has completed several successful phase II studies. These anti-IL-17 biologics are being considered as possible new therapies for other inflammatory diseases, including psoriatic arthritis and rheumatoid arthritis.

Dr. van de Kerkhof cautioned that from a safety standpoint, it will be important to scrutinize the upcoming large, definitive phase III clinical trials of these agents for evidence of an increase in infections, particularly Staphylococcus aureus and Candida albicans.

Interleukin-17A and IL-17F play roles in the normal host-immune defenses against microorganisms. Patients with genetic defects in IL-17 tend to have problems with recurrent chronic mucocutaneous candidiasis. Moreover, individuals with chronic mucocutaneous candidiasis have been shown to have antibodies to IL-17A, IL-17F, and IL-22, he noted.

The study was sponsored by Amgen. Dr. Papp reported receiving research funds from and serving as a consultant to Amgen and numerous other pharmaceutical companies. Dr. van de Kerkhof has received research funding and consultancy fees from more than a dozen pharmaceutical companies.