EADV Congress 2012

PRAGUE – A novel self-occlusive topical anesthetic cream newly approved by the Food and Drug Administration for local analgesia in superficial dermatologic procedures displayed persuasive evidence of efficacy in a phase III study highlighted at the annual congress of the European Academy of Dermatology and Venereology.

The topical anesthetic cream, called Pliaglis, incorporates lidocaine and tetracaine at 70 mg/g each. The FDA approved the product in October 2012 for use in conjunction with filler injections, laser-assisted tattoo removal, pulsed dye laser therapy, and other dermatologic procedures.

At the congress, Y. May Ma, Ph.D., presented the results of a multicenter phase III clinical trial involving 50 patients undergoing laser-assisted hair removal. Investigators applied Pliaglis to half of the skin surface scheduled for treatment and a placebo cream to the other half. Thirty minutes later dermatologists peeled off both materials and got to work.

Participants’ mean pain score for the laser procedure on a 0-100 visual analog scale was 23 for the Pliaglis-pretreated areas compared with 32 for hair removal on the control areas. Eighty percent of patients rated the analgesic effect as adequate on Pliaglis-pretreated skin areas, but only 52% did so for placebo-pretreated areas, reported Dr. Ma of Galderma Laboratories in Sophia Antipolis, France.

Blinded investigators rated 44% of patients as having no pain during laser therapy on areas that had been pretreated with Pliaglis, compared with an investigator-judged 22% pain-free procedure rate on placebo-pretreated areas.

Mild, transient stinging, redness, and erythema were fairly common on Pliaglis-treated skin, but quickly resolved without any intervention, Dr. Ma observed.

This study was funded by Galderma and presented by a full-time Galderma employee.

PRAGUE – A novel self-occlusive topical anesthetic cream newly approved by the Food and Drug Administration for local analgesia in superficial dermatologic procedures displayed persuasive evidence of efficacy in a phase III study highlighted at the annual congress of the European Academy of Dermatology and Venereology.

The topical anesthetic cream, called Pliaglis, incorporates lidocaine and tetracaine at 70 mg/g each. The FDA approved the product in October 2012 for use in conjunction with filler injections, laser-assisted tattoo removal, pulsed dye laser therapy, and other dermatologic procedures.

At the congress, Y. May Ma, Ph.D., presented the results of a multicenter phase III clinical trial involving 50 patients undergoing laser-assisted hair removal. Investigators applied Pliaglis to half of the skin surface scheduled for treatment and a placebo cream to the other half. Thirty minutes later dermatologists peeled off both materials and got to work.

Participants’ mean pain score for the laser procedure on a 0-100 visual analog scale was 23 for the Pliaglis-pretreated areas compared with 32 for hair removal on the control areas. Eighty percent of patients rated the analgesic effect as adequate on Pliaglis-pretreated skin areas, but only 52% did so for placebo-pretreated areas, reported Dr. Ma of Galderma Laboratories in Sophia Antipolis, France.

Blinded investigators rated 44% of patients as having no pain during laser therapy on areas that had been pretreated with Pliaglis, compared with an investigator-judged 22% pain-free procedure rate on placebo-pretreated areas.

Mild, transient stinging, redness, and erythema were fairly common on Pliaglis-treated skin, but quickly resolved without any intervention, Dr. Ma observed.

This study was funded by Galderma and presented by a full-time Galderma employee.

PRAGUE – A novel self-occlusive topical anesthetic cream newly approved by the Food and Drug Administration for local analgesia in superficial dermatologic procedures displayed persuasive evidence of efficacy in a phase III study highlighted at the annual congress of the European Academy of Dermatology and Venereology.

The topical anesthetic cream, called Pliaglis, incorporates lidocaine and tetracaine at 70 mg/g each. The FDA approved the product in October 2012 for use in conjunction with filler injections, laser-assisted tattoo removal, pulsed dye laser therapy, and other dermatologic procedures.

At the congress, Y. May Ma, Ph.D., presented the results of a multicenter phase III clinical trial involving 50 patients undergoing laser-assisted hair removal. Investigators applied Pliaglis to half of the skin surface scheduled for treatment and a placebo cream to the other half. Thirty minutes later dermatologists peeled off both materials and got to work.

Participants’ mean pain score for the laser procedure on a 0-100 visual analog scale was 23 for the Pliaglis-pretreated areas compared with 32 for hair removal on the control areas. Eighty percent of patients rated the analgesic effect as adequate on Pliaglis-pretreated skin areas, but only 52% did so for placebo-pretreated areas, reported Dr. Ma of Galderma Laboratories in Sophia Antipolis, France.

Blinded investigators rated 44% of patients as having no pain during laser therapy on areas that had been pretreated with Pliaglis, compared with an investigator-judged 22% pain-free procedure rate on placebo-pretreated areas.

Mild, transient stinging, redness, and erythema were fairly common on Pliaglis-treated skin, but quickly resolved without any intervention, Dr. Ma observed.

This study was funded by Galderma and presented by a full-time Galderma employee.

PRAGUE – Intensified photodynamic therapy assisted by ablative fractional laser resurfacing is a new and more effective way to treat thick actinic keratoses, according to Dr. Merete Haedersdal.

At 3 months’ follow-up, cure rates were significantly better with fractional CO₂ laser-assisted photodynamic therapy (PDT) than with standard PDT in a randomized trial, she reported at the annual congress of the European Academy of Dermatology and Venereology.

"As a side benefit, the combined therapy gives a nice decrease in photoaging. There is photorejuvenation of the skin," noted Dr. Haedersdal of the University of Copenhagen.

Stand-alone PDT gets good results in thinner AKs, Bowen’s lesions, and basal cell carcinomas, both superficial and nodular. But effectiveness drops off considerably for thicker lesions.

That’s why Dr. Haedersdal and her Copenhagen colleagues, together with researchers at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, where she has been a visiting scientist, are developing intensified PDT.

Basically, the dermatologists are using the fractional CO₂ laser at 10,600 nm to drill tiny vertical channels surrounded by areas of unexposed skin. These channels facilitate uptake of the photosensitizing agent, rendering PDT more effective at greater depths. The enhanced uptake of photosensitizer is not merely a hypothesis; it has been documented via a marked increase in fluorescence intensity during illumination, she explained.

Dr. Haedersdal reported on 15 patients with a total of 212 AKs on severely photodamaged skin of the scalp and face. Two symmetrical randomly selected areas were chosen on each patient to receive one fractional CO₂ laser-assisted PDT treatment and one standard PDT treatment. First, however, both treatment areas underwent curettage. Then one site was treated with the UltraPulse laser using the DeepFx handpiece set to 10 mJ per pulse and a single pulse density of 5%. The photosensitizing agent, methyl aminolevulinate cream, was then applied under occlusion for 3 hours at both sites. This was followed by illumination using a red light–emitting diode at 37 J/cm².

At 3 months’ follow-up, the complete response rate of thicker grade II-III AKs was 88% with intensified PDT, compared with 59% with conventional PDT. For thinner grade I lesions, the complete response rates were 100% and 79%, respectively.

Only 3 new lesions arose at the intensified PDT-treated sites within 3 months, compared with 11 new lesions in areas that received standard PDT.

"So there might – in terms of avoiding future treatment procedures – be a benefit in combining the photothermal efficacy of the laser with the photochemical response from the PDT procedure," Dr. Haedersdal noted.

Pain scores were significantly higher during illumination in the intensified PDT areas, with a mean of 6.5 on a 1-10 scale compared with 5.4 on skin sites that got standard PDT. Erythema and crusting were also more intense at intensified PDT sites, and long-term pigmentary changes were more frequent at these sites as well.

"We have to be aware that the clinical reactions that we see from this new procedure are more intense than with conventional PDT. So for now we have to take care that we’re not using it for really large treatment areas because then the patients will have really intense phototoxic reactions," the dermatologist cautioned.

She and her coinvestigators are conducting an ongoing clinical trial combining mild daylight PDT and intensified PDT in organ transplant recipients, who are highly prone to the development of numerous skin cancers.

In pig models, the investigators are able to get the photosensitizing agent to a depth of 1.8 mm with the help of the fractional CO₂ laser. This makes intensified PDT an attractive proposition for the treatment of basal cell carcinomas. Indeed, Dr. Haedersdal and her coinvestigators are now in the middle of a clinical trial of fractional CO₂ laser-assisted PDT in patients with difficult-to-treat basal cell carcinomas.

"It seems very promising so far. We don’t have an evidence base yet, but I believe in it," she said.

The dermatologist reported serving on the advisory boards of Lumenis and Galderma, which are providing financial support for the development of intensified PDT.

PRAGUE – Intensified photodynamic therapy assisted by ablative fractional laser resurfacing is a new and more effective way to treat thick actinic keratoses, according to Dr. Merete Haedersdal.

At 3 months’ follow-up, cure rates were significantly better with fractional CO₂ laser-assisted photodynamic therapy (PDT) than with standard PDT in a randomized trial, she reported at the annual congress of the European Academy of Dermatology and Venereology.

"As a side benefit, the combined therapy gives a nice decrease in photoaging. There is photorejuvenation of the skin," noted Dr. Haedersdal of the University of Copenhagen.

Stand-alone PDT gets good results in thinner AKs, Bowen’s lesions, and basal cell carcinomas, both superficial and nodular. But effectiveness drops off considerably for thicker lesions.

That’s why Dr. Haedersdal and her Copenhagen colleagues, together with researchers at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, where she has been a visiting scientist, are developing intensified PDT.

Basically, the dermatologists are using the fractional CO₂ laser at 10,600 nm to drill tiny vertical channels surrounded by areas of unexposed skin. These channels facilitate uptake of the photosensitizing agent, rendering PDT more effective at greater depths. The enhanced uptake of photosensitizer is not merely a hypothesis; it has been documented via a marked increase in fluorescence intensity during illumination, she explained.

Dr. Haedersdal reported on 15 patients with a total of 212 AKs on severely photodamaged skin of the scalp and face. Two symmetrical randomly selected areas were chosen on each patient to receive one fractional CO₂ laser-assisted PDT treatment and one standard PDT treatment. First, however, both treatment areas underwent curettage. Then one site was treated with the UltraPulse laser using the DeepFx handpiece set to 10 mJ per pulse and a single pulse density of 5%. The photosensitizing agent, methyl aminolevulinate cream, was then applied under occlusion for 3 hours at both sites. This was followed by illumination using a red light–emitting diode at 37 J/cm².

At 3 months’ follow-up, the complete response rate of thicker grade II-III AKs was 88% with intensified PDT, compared with 59% with conventional PDT. For thinner grade I lesions, the complete response rates were 100% and 79%, respectively.

Only 3 new lesions arose at the intensified PDT-treated sites within 3 months, compared with 11 new lesions in areas that received standard PDT.

"So there might – in terms of avoiding future treatment procedures – be a benefit in combining the photothermal efficacy of the laser with the photochemical response from the PDT procedure," Dr. Haedersdal noted.

Pain scores were significantly higher during illumination in the intensified PDT areas, with a mean of 6.5 on a 1-10 scale compared with 5.4 on skin sites that got standard PDT. Erythema and crusting were also more intense at intensified PDT sites, and long-term pigmentary changes were more frequent at these sites as well.

"We have to be aware that the clinical reactions that we see from this new procedure are more intense than with conventional PDT. So for now we have to take care that we’re not using it for really large treatment areas because then the patients will have really intense phototoxic reactions," the dermatologist cautioned.

She and her coinvestigators are conducting an ongoing clinical trial combining mild daylight PDT and intensified PDT in organ transplant recipients, who are highly prone to the development of numerous skin cancers.

In pig models, the investigators are able to get the photosensitizing agent to a depth of 1.8 mm with the help of the fractional CO₂ laser. This makes intensified PDT an attractive proposition for the treatment of basal cell carcinomas. Indeed, Dr. Haedersdal and her coinvestigators are now in the middle of a clinical trial of fractional CO₂ laser-assisted PDT in patients with difficult-to-treat basal cell carcinomas.

"It seems very promising so far. We don’t have an evidence base yet, but I believe in it," she said.

The dermatologist reported serving on the advisory boards of Lumenis and Galderma, which are providing financial support for the development of intensified PDT.

PRAGUE – Intensified photodynamic therapy assisted by ablative fractional laser resurfacing is a new and more effective way to treat thick actinic keratoses, according to Dr. Merete Haedersdal.

At 3 months’ follow-up, cure rates were significantly better with fractional CO₂ laser-assisted photodynamic therapy (PDT) than with standard PDT in a randomized trial, she reported at the annual congress of the European Academy of Dermatology and Venereology.

"As a side benefit, the combined therapy gives a nice decrease in photoaging. There is photorejuvenation of the skin," noted Dr. Haedersdal of the University of Copenhagen.

Stand-alone PDT gets good results in thinner AKs, Bowen’s lesions, and basal cell carcinomas, both superficial and nodular. But effectiveness drops off considerably for thicker lesions.

That’s why Dr. Haedersdal and her Copenhagen colleagues, together with researchers at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, where she has been a visiting scientist, are developing intensified PDT.

Basically, the dermatologists are using the fractional CO₂ laser at 10,600 nm to drill tiny vertical channels surrounded by areas of unexposed skin. These channels facilitate uptake of the photosensitizing agent, rendering PDT more effective at greater depths. The enhanced uptake of photosensitizer is not merely a hypothesis; it has been documented via a marked increase in fluorescence intensity during illumination, she explained.

Dr. Haedersdal reported on 15 patients with a total of 212 AKs on severely photodamaged skin of the scalp and face. Two symmetrical randomly selected areas were chosen on each patient to receive one fractional CO₂ laser-assisted PDT treatment and one standard PDT treatment. First, however, both treatment areas underwent curettage. Then one site was treated with the UltraPulse laser using the DeepFx handpiece set to 10 mJ per pulse and a single pulse density of 5%. The photosensitizing agent, methyl aminolevulinate cream, was then applied under occlusion for 3 hours at both sites. This was followed by illumination using a red light–emitting diode at 37 J/cm².

At 3 months’ follow-up, the complete response rate of thicker grade II-III AKs was 88% with intensified PDT, compared with 59% with conventional PDT. For thinner grade I lesions, the complete response rates were 100% and 79%, respectively.

Only 3 new lesions arose at the intensified PDT-treated sites within 3 months, compared with 11 new lesions in areas that received standard PDT.

"So there might – in terms of avoiding future treatment procedures – be a benefit in combining the photothermal efficacy of the laser with the photochemical response from the PDT procedure," Dr. Haedersdal noted.

Pain scores were significantly higher during illumination in the intensified PDT areas, with a mean of 6.5 on a 1-10 scale compared with 5.4 on skin sites that got standard PDT. Erythema and crusting were also more intense at intensified PDT sites, and long-term pigmentary changes were more frequent at these sites as well.

"We have to be aware that the clinical reactions that we see from this new procedure are more intense than with conventional PDT. So for now we have to take care that we’re not using it for really large treatment areas because then the patients will have really intense phototoxic reactions," the dermatologist cautioned.

She and her coinvestigators are conducting an ongoing clinical trial combining mild daylight PDT and intensified PDT in organ transplant recipients, who are highly prone to the development of numerous skin cancers.

In pig models, the investigators are able to get the photosensitizing agent to a depth of 1.8 mm with the help of the fractional CO₂ laser. This makes intensified PDT an attractive proposition for the treatment of basal cell carcinomas. Indeed, Dr. Haedersdal and her coinvestigators are now in the middle of a clinical trial of fractional CO₂ laser-assisted PDT in patients with difficult-to-treat basal cell carcinomas.

"It seems very promising so far. We don’t have an evidence base yet, but I believe in it," she said.

The dermatologist reported serving on the advisory boards of Lumenis and Galderma, which are providing financial support for the development of intensified PDT.

PRAGUE – Tacrolimus 0.03% ointment has earned first-line, treatment-of-choice status in atopic blepharoconjunctivitis, the most common ocular complication of atopic dermatitis, Dr. Ville Kiiski said at the annual congress of the European Academy of Dermatology and Venereology.

In a 10-year, single-center review of 338 patients on long-term topical therapy for atopic blepharoconjunctivitis with either tacrolimus (Protopic), pimecrolimus 1% cream (Elidel), or topical corticosteroids, tacrolimus displayed the best efficacy and tolerability, according to Dr. Kiiski of Helsinki University Central Hospital.

Tacrolimus ointment was the primary therapy in 297 patients as young as 2 years old. Thirty-three patients were on pimecrolimus, while just eight patients were treated mainly with topical steroids. Most Finnish physicians are reluctant to prescribe topical steroids for long-term use in the eyelid area because of the well-known associated increased risks of cataracts, elevated intraocular pressure, and skin atrophy, the dermatologist noted.

The mean follow-up was 1.5 years for treatment efficacy and 5.8 years for malignancy risk.

The treatment discontinuation rate because of intolerance of side effects was 33% with pimecrolimus and 9.1% for tacrolimus. Twenty-two percent of patients placed on pimecrolimus discontinued the drug because of insufficient efficacy, compared with 1.6% on tacrolimus.

The blepharitis response rate was 90% in tacrolimus-treated patients, 79% with pimecrolimus, and 88% in the handful of patients on topical steroids. The conjunctivitis response rates were 80%, 55%, and 50% with tacrolimus, pimecrolimus, and topical steroids, respectively.

Tacrolimus-treated patients were an adjusted 2.37-fold more likely to experience significant improvement in their blepharitis than patients on pimecrolimus and 2.34-fold more likely to see improvement in their conjunctivitis.

Intraocular pressure dropped over time by a mean of 0.6 mm Hg in patients on either of the topical calcineurin inhibitors. None of the three topical therapies was associated with adverse effects on vision, lens, or cornea, nor were there adverse trends in terms of bacterial infections or malignancies.

Atopic blepharoconjunctivitis occurs when inflammatory disease activity at the eyelid margins traumatizes the ocular surface, aggravating keratitis and conjunctivitis.

The study was free of commercial sponsorship or investigator financial conflicts.

PRAGUE – Tacrolimus 0.03% ointment has earned first-line, treatment-of-choice status in atopic blepharoconjunctivitis, the most common ocular complication of atopic dermatitis, Dr. Ville Kiiski said at the annual congress of the European Academy of Dermatology and Venereology.

In a 10-year, single-center review of 338 patients on long-term topical therapy for atopic blepharoconjunctivitis with either tacrolimus (Protopic), pimecrolimus 1% cream (Elidel), or topical corticosteroids, tacrolimus displayed the best efficacy and tolerability, according to Dr. Kiiski of Helsinki University Central Hospital.

Tacrolimus ointment was the primary therapy in 297 patients as young as 2 years old. Thirty-three patients were on pimecrolimus, while just eight patients were treated mainly with topical steroids. Most Finnish physicians are reluctant to prescribe topical steroids for long-term use in the eyelid area because of the well-known associated increased risks of cataracts, elevated intraocular pressure, and skin atrophy, the dermatologist noted.

The mean follow-up was 1.5 years for treatment efficacy and 5.8 years for malignancy risk.

The treatment discontinuation rate because of intolerance of side effects was 33% with pimecrolimus and 9.1% for tacrolimus. Twenty-two percent of patients placed on pimecrolimus discontinued the drug because of insufficient efficacy, compared with 1.6% on tacrolimus.

The blepharitis response rate was 90% in tacrolimus-treated patients, 79% with pimecrolimus, and 88% in the handful of patients on topical steroids. The conjunctivitis response rates were 80%, 55%, and 50% with tacrolimus, pimecrolimus, and topical steroids, respectively.

Tacrolimus-treated patients were an adjusted 2.37-fold more likely to experience significant improvement in their blepharitis than patients on pimecrolimus and 2.34-fold more likely to see improvement in their conjunctivitis.

Intraocular pressure dropped over time by a mean of 0.6 mm Hg in patients on either of the topical calcineurin inhibitors. None of the three topical therapies was associated with adverse effects on vision, lens, or cornea, nor were there adverse trends in terms of bacterial infections or malignancies.

Atopic blepharoconjunctivitis occurs when inflammatory disease activity at the eyelid margins traumatizes the ocular surface, aggravating keratitis and conjunctivitis.

The study was free of commercial sponsorship or investigator financial conflicts.

PRAGUE – Tacrolimus 0.03% ointment has earned first-line, treatment-of-choice status in atopic blepharoconjunctivitis, the most common ocular complication of atopic dermatitis, Dr. Ville Kiiski said at the annual congress of the European Academy of Dermatology and Venereology.

In a 10-year, single-center review of 338 patients on long-term topical therapy for atopic blepharoconjunctivitis with either tacrolimus (Protopic), pimecrolimus 1% cream (Elidel), or topical corticosteroids, tacrolimus displayed the best efficacy and tolerability, according to Dr. Kiiski of Helsinki University Central Hospital.

Tacrolimus ointment was the primary therapy in 297 patients as young as 2 years old. Thirty-three patients were on pimecrolimus, while just eight patients were treated mainly with topical steroids. Most Finnish physicians are reluctant to prescribe topical steroids for long-term use in the eyelid area because of the well-known associated increased risks of cataracts, elevated intraocular pressure, and skin atrophy, the dermatologist noted.

The mean follow-up was 1.5 years for treatment efficacy and 5.8 years for malignancy risk.

The treatment discontinuation rate because of intolerance of side effects was 33% with pimecrolimus and 9.1% for tacrolimus. Twenty-two percent of patients placed on pimecrolimus discontinued the drug because of insufficient efficacy, compared with 1.6% on tacrolimus.

The blepharitis response rate was 90% in tacrolimus-treated patients, 79% with pimecrolimus, and 88% in the handful of patients on topical steroids. The conjunctivitis response rates were 80%, 55%, and 50% with tacrolimus, pimecrolimus, and topical steroids, respectively.

Tacrolimus-treated patients were an adjusted 2.37-fold more likely to experience significant improvement in their blepharitis than patients on pimecrolimus and 2.34-fold more likely to see improvement in their conjunctivitis.

Intraocular pressure dropped over time by a mean of 0.6 mm Hg in patients on either of the topical calcineurin inhibitors. None of the three topical therapies was associated with adverse effects on vision, lens, or cornea, nor were there adverse trends in terms of bacterial infections or malignancies.

Atopic blepharoconjunctivitis occurs when inflammatory disease activity at the eyelid margins traumatizes the ocular surface, aggravating keratitis and conjunctivitis.

The study was free of commercial sponsorship or investigator financial conflicts.

PRAGUE – It has been a big year for dermatologic laser therapy.

Among the major advances in the field seen during 2012 has been introduction of novel techniques for remodeling mature burn scars and removing tattoos, as well as welcome, albeit preliminary, data supporting laser therapy of onychomycosis, and – finally – some long-overdue first persuasive evidence of the effectiveness of a home-use, light-based device for unwanted hair removal, Dr. Merete Haedersdal said in a keynote year-in-review laser lecture at the annual congress of the European Academy of Dermatology and Venereology.

• Tattoos. Based upon the concept of selective photothermolysis coupled with recognition that tattoo pigment particles are really tiny – a mere 40-300 nm in size – dermatologists at SkinCare Physicians in Chestnut Hill (Mass.) treated 12 patients using a novel picosecond 755-nm alexandrite laser.

After an average of 4.2 treatment sessions spaced roughly 6 weeks apart, all 12 patients showed greater than 75% clearance upon blinded physician assessment. All 12 declared themselves either satisfied or extremely satisfied with their results (Arch. Dermatol. 2012;17:1-4).

This picosecond alexandrite laser delivers pulses 100 times shorter than the familiar nanosecond lasers. It’s not yet commercially available, but is expected to be quite soon, according to Dr. Haedersdal of the University of Copenhagen.

Meanwhile, Greek dermatologists have pioneered a laser technique for tattoo removal that entails four treatment passes separated by 20-minute intervals, all delivered in a single lengthy session. The underlying concept is that the downtime between passes allows the treated skin to relax and shed treatment-induced air bubbles. In an 18-patient study, the clinical results were demonstrably better with the four-pass technique than with conventional single-treatment sessions (J. Am. Acad. Dermatol. 2012;66:271-7).

Dr. Haedersdal said that she’s heard some colleagues who’ve tried the four-pass-in-a-session technique say they’re not convinced it really does work better than the standard approach. She has tweaked the technique somewhat to good effect in her own practice: She starts out removing a tattoo using the standard single-treatment-per-session method and sticks with it until there is no further improvement. Then she switches to the four-pass-per-session technique.

"I would say it works very nicely when we add it on," the dermatologist commented.

• Home-use hair-removal device effectiveness. The home-device market has been on fire in the United States for more than 5 years and in Europe for the last couple. It is a field that’s been long on claims and short on evidence of meaningful efficacy and safety – until 2012. Just in September, Dr. Ronald G. Wheeland, professor of dermatology and chief of dermatologic surgery at the University of Missouri, Columbia, published a case-controlled study that Dr. Haedersdal considers most welcome.

Thirteen patients underwent eight hair removal treatment sessions at monthly intervals using an 810-nm home-use diode laser marketed as the Tria Hair Removal Laser. Untreated areas of unwanted hair growth served as controls. At 1 year of follow-up after completing the eighth and final treatment, the mean hair count reduction was 44%, 49%, and 65%, respectively, in areas treated at fluences of 7, 12, and 20 J/cm² compared with controls (Lasers Surg. Med. 2012;44:550-7).

In addition, Dr. Haedersdal coauthored a systematic literature review of the two approved diode laser devices and nine intense pulsed light devices marketed for home use for hair removal. The cumulative supporting evidence isn’t super strong: six prospective uncontrolled studies and one controlled study (J. Eur. Acad. Dermatol. Venereol. 2012;26:545-53).

"Clearly, there is something to this home therapy based on the Wheeland study and our systematic review. We really need some randomized comparative trials, though," she said.

• Home-device safety. This is an area of such great concern that she and her colleagues in the European Society for Laser Dermatology recently published hair-removal home-device safety guidelines (J. Eur. Acad. Dermatol. Venereol. 2012;26: 799-811).

"People just aren’t being trained in the safe use of these devices," she cautioned.

The risks associated with improper use include ocular injury, skin burns, and paradoxical hair growth, as is the case with devices used in physicians’ offices.

The paradoxical hair growth risk in untreated areas close by treated skin is an issue that has been largely beneath dermatologists’ radar prior to the European guidelines. The reported risk with professional devices used by dermatologists is 0.6%-10%. With home devices, who knows?

"It’s a real matter of concern these days. When you lower the fluences, the incidence of paradoxical hair growth may be even higher. There’s nothing in the literature yet, but I’m sure there will be in the next few years," Dr. Haedersdal said.

Patients at increased risk for paradoxical hair regrowth are women with darker skin types, typically with polycystic ovarian syndrome, who are undergoing facial treatment. The mechanism of paradoxical hair regrowth is unknown. Two leading possibilities are light-driven triggering of inflammatory mediators or stimulation of the hair cycle secondary to subtherapeutic thermal injury, she continued.

• Burn scars. A solid body of evidence has accrued regarding the efficacy and safety of both ablative and nonablative fractional lasers to remodel mature burn scars.

Particularly noteworthy was a recent prospective, single-arm, blinded-evaluator study in which a 1,550-nm nonablative fractional erbium laser was employed to treat burn scars in 10 patients. Ninety percent of patients showed improved skin texture and 80% demonstrated improvement in dyschromia, something that hasn’t previously been reported with laser therapy (Lasers Surg. Med. 2012;44:441-6).

The 13 published studies of nonablative fractional laser therapy for burn scars show 26%-50% improvement. That’s slightly less than the 26%-83% improvement reported in the 13 studies of ablative fractional lasers. On the other hand, nonablative fractional laser therapy entails fewer side effects: 1-3 days of erythema and a postinflammatory hyperpigmentation rate of up to 13%, compared with 3-14 days of erythema with ablative fractional laser therapy and a postinflammatory hyperpigmentation rate of up to 92%. As yet, though, there have been no head-to-head comparative studies of the two types of devices.

• Onychomycosis. This is a brand-new area for laser therapy. A recent review noted that, while the Food and Drug Administration has approved four YAG lasers for treatment of onychomycosis, the regulatory standards for device approval don’t require persuasive evidence of efficacy, unlike for drugs (J. Am. Podiatr. Med. Assoc. 2012;102:428-30). Although it’s a promising technology, the authors stated that there are as yet no data showing how laser therapy stacks up against existing standard treatments for onychomycosis in terms of efficacy.

Nevertheless, Dr. Haedersdal noted, attention-getting cure rates were seen in a recent Chinese study involving 154 laser-treated nails in 33 patients. The week-24 complete cure rate, both mycologic and clinical, was 51% after eight weekly treatments and 53% after four weekly treatments (Chin. Med. J. 2012;125:3288-91).

Dr. Haedersdal reported serving on the scientific advisory boards for Galderma, LEO Pharma, and Procter & Gamble.

PRAGUE – It has been a big year for dermatologic laser therapy.

Among the major advances in the field seen during 2012 has been introduction of novel techniques for remodeling mature burn scars and removing tattoos, as well as welcome, albeit preliminary, data supporting laser therapy of onychomycosis, and – finally – some long-overdue first persuasive evidence of the effectiveness of a home-use, light-based device for unwanted hair removal, Dr. Merete Haedersdal said in a keynote year-in-review laser lecture at the annual congress of the European Academy of Dermatology and Venereology.

• Tattoos. Based upon the concept of selective photothermolysis coupled with recognition that tattoo pigment particles are really tiny – a mere 40-300 nm in size – dermatologists at SkinCare Physicians in Chestnut Hill (Mass.) treated 12 patients using a novel picosecond 755-nm alexandrite laser.

After an average of 4.2 treatment sessions spaced roughly 6 weeks apart, all 12 patients showed greater than 75% clearance upon blinded physician assessment. All 12 declared themselves either satisfied or extremely satisfied with their results (Arch. Dermatol. 2012;17:1-4).

This picosecond alexandrite laser delivers pulses 100 times shorter than the familiar nanosecond lasers. It’s not yet commercially available, but is expected to be quite soon, according to Dr. Haedersdal of the University of Copenhagen.

Meanwhile, Greek dermatologists have pioneered a laser technique for tattoo removal that entails four treatment passes separated by 20-minute intervals, all delivered in a single lengthy session. The underlying concept is that the downtime between passes allows the treated skin to relax and shed treatment-induced air bubbles. In an 18-patient study, the clinical results were demonstrably better with the four-pass technique than with conventional single-treatment sessions (J. Am. Acad. Dermatol. 2012;66:271-7).

Dr. Haedersdal said that she’s heard some colleagues who’ve tried the four-pass-in-a-session technique say they’re not convinced it really does work better than the standard approach. She has tweaked the technique somewhat to good effect in her own practice: She starts out removing a tattoo using the standard single-treatment-per-session method and sticks with it until there is no further improvement. Then she switches to the four-pass-per-session technique.

"I would say it works very nicely when we add it on," the dermatologist commented.

• Home-use hair-removal device effectiveness. The home-device market has been on fire in the United States for more than 5 years and in Europe for the last couple. It is a field that’s been long on claims and short on evidence of meaningful efficacy and safety – until 2012. Just in September, Dr. Ronald G. Wheeland, professor of dermatology and chief of dermatologic surgery at the University of Missouri, Columbia, published a case-controlled study that Dr. Haedersdal considers most welcome.

Thirteen patients underwent eight hair removal treatment sessions at monthly intervals using an 810-nm home-use diode laser marketed as the Tria Hair Removal Laser. Untreated areas of unwanted hair growth served as controls. At 1 year of follow-up after completing the eighth and final treatment, the mean hair count reduction was 44%, 49%, and 65%, respectively, in areas treated at fluences of 7, 12, and 20 J/cm² compared with controls (Lasers Surg. Med. 2012;44:550-7).

In addition, Dr. Haedersdal coauthored a systematic literature review of the two approved diode laser devices and nine intense pulsed light devices marketed for home use for hair removal. The cumulative supporting evidence isn’t super strong: six prospective uncontrolled studies and one controlled study (J. Eur. Acad. Dermatol. Venereol. 2012;26:545-53).

"Clearly, there is something to this home therapy based on the Wheeland study and our systematic review. We really need some randomized comparative trials, though," she said.

• Home-device safety. This is an area of such great concern that she and her colleagues in the European Society for Laser Dermatology recently published hair-removal home-device safety guidelines (J. Eur. Acad. Dermatol. Venereol. 2012;26: 799-811).

"People just aren’t being trained in the safe use of these devices," she cautioned.

The risks associated with improper use include ocular injury, skin burns, and paradoxical hair growth, as is the case with devices used in physicians’ offices.

The paradoxical hair growth risk in untreated areas close by treated skin is an issue that has been largely beneath dermatologists’ radar prior to the European guidelines. The reported risk with professional devices used by dermatologists is 0.6%-10%. With home devices, who knows?

"It’s a real matter of concern these days. When you lower the fluences, the incidence of paradoxical hair growth may be even higher. There’s nothing in the literature yet, but I’m sure there will be in the next few years," Dr. Haedersdal said.

Patients at increased risk for paradoxical hair regrowth are women with darker skin types, typically with polycystic ovarian syndrome, who are undergoing facial treatment. The mechanism of paradoxical hair regrowth is unknown. Two leading possibilities are light-driven triggering of inflammatory mediators or stimulation of the hair cycle secondary to subtherapeutic thermal injury, she continued.

• Burn scars. A solid body of evidence has accrued regarding the efficacy and safety of both ablative and nonablative fractional lasers to remodel mature burn scars.

Particularly noteworthy was a recent prospective, single-arm, blinded-evaluator study in which a 1,550-nm nonablative fractional erbium laser was employed to treat burn scars in 10 patients. Ninety percent of patients showed improved skin texture and 80% demonstrated improvement in dyschromia, something that hasn’t previously been reported with laser therapy (Lasers Surg. Med. 2012;44:441-6).

The 13 published studies of nonablative fractional laser therapy for burn scars show 26%-50% improvement. That’s slightly less than the 26%-83% improvement reported in the 13 studies of ablative fractional lasers. On the other hand, nonablative fractional laser therapy entails fewer side effects: 1-3 days of erythema and a postinflammatory hyperpigmentation rate of up to 13%, compared with 3-14 days of erythema with ablative fractional laser therapy and a postinflammatory hyperpigmentation rate of up to 92%. As yet, though, there have been no head-to-head comparative studies of the two types of devices.

• Onychomycosis. This is a brand-new area for laser therapy. A recent review noted that, while the Food and Drug Administration has approved four YAG lasers for treatment of onychomycosis, the regulatory standards for device approval don’t require persuasive evidence of efficacy, unlike for drugs (J. Am. Podiatr. Med. Assoc. 2012;102:428-30). Although it’s a promising technology, the authors stated that there are as yet no data showing how laser therapy stacks up against existing standard treatments for onychomycosis in terms of efficacy.

Nevertheless, Dr. Haedersdal noted, attention-getting cure rates were seen in a recent Chinese study involving 154 laser-treated nails in 33 patients. The week-24 complete cure rate, both mycologic and clinical, was 51% after eight weekly treatments and 53% after four weekly treatments (Chin. Med. J. 2012;125:3288-91).

Dr. Haedersdal reported serving on the scientific advisory boards for Galderma, LEO Pharma, and Procter & Gamble.

PRAGUE – It has been a big year for dermatologic laser therapy.

Among the major advances in the field seen during 2012 has been introduction of novel techniques for remodeling mature burn scars and removing tattoos, as well as welcome, albeit preliminary, data supporting laser therapy of onychomycosis, and – finally – some long-overdue first persuasive evidence of the effectiveness of a home-use, light-based device for unwanted hair removal, Dr. Merete Haedersdal said in a keynote year-in-review laser lecture at the annual congress of the European Academy of Dermatology and Venereology.

• Tattoos. Based upon the concept of selective photothermolysis coupled with recognition that tattoo pigment particles are really tiny – a mere 40-300 nm in size – dermatologists at SkinCare Physicians in Chestnut Hill (Mass.) treated 12 patients using a novel picosecond 755-nm alexandrite laser.

After an average of 4.2 treatment sessions spaced roughly 6 weeks apart, all 12 patients showed greater than 75% clearance upon blinded physician assessment. All 12 declared themselves either satisfied or extremely satisfied with their results (Arch. Dermatol. 2012;17:1-4).

This picosecond alexandrite laser delivers pulses 100 times shorter than the familiar nanosecond lasers. It’s not yet commercially available, but is expected to be quite soon, according to Dr. Haedersdal of the University of Copenhagen.

Meanwhile, Greek dermatologists have pioneered a laser technique for tattoo removal that entails four treatment passes separated by 20-minute intervals, all delivered in a single lengthy session. The underlying concept is that the downtime between passes allows the treated skin to relax and shed treatment-induced air bubbles. In an 18-patient study, the clinical results were demonstrably better with the four-pass technique than with conventional single-treatment sessions (J. Am. Acad. Dermatol. 2012;66:271-7).

Dr. Haedersdal said that she’s heard some colleagues who’ve tried the four-pass-in-a-session technique say they’re not convinced it really does work better than the standard approach. She has tweaked the technique somewhat to good effect in her own practice: She starts out removing a tattoo using the standard single-treatment-per-session method and sticks with it until there is no further improvement. Then she switches to the four-pass-per-session technique.

"I would say it works very nicely when we add it on," the dermatologist commented.

• Home-use hair-removal device effectiveness. The home-device market has been on fire in the United States for more than 5 years and in Europe for the last couple. It is a field that’s been long on claims and short on evidence of meaningful efficacy and safety – until 2012. Just in September, Dr. Ronald G. Wheeland, professor of dermatology and chief of dermatologic surgery at the University of Missouri, Columbia, published a case-controlled study that Dr. Haedersdal considers most welcome.

Thirteen patients underwent eight hair removal treatment sessions at monthly intervals using an 810-nm home-use diode laser marketed as the Tria Hair Removal Laser. Untreated areas of unwanted hair growth served as controls. At 1 year of follow-up after completing the eighth and final treatment, the mean hair count reduction was 44%, 49%, and 65%, respectively, in areas treated at fluences of 7, 12, and 20 J/cm² compared with controls (Lasers Surg. Med. 2012;44:550-7).

In addition, Dr. Haedersdal coauthored a systematic literature review of the two approved diode laser devices and nine intense pulsed light devices marketed for home use for hair removal. The cumulative supporting evidence isn’t super strong: six prospective uncontrolled studies and one controlled study (J. Eur. Acad. Dermatol. Venereol. 2012;26:545-53).

"Clearly, there is something to this home therapy based on the Wheeland study and our systematic review. We really need some randomized comparative trials, though," she said.

• Home-device safety. This is an area of such great concern that she and her colleagues in the European Society for Laser Dermatology recently published hair-removal home-device safety guidelines (J. Eur. Acad. Dermatol. Venereol. 2012;26: 799-811).

"People just aren’t being trained in the safe use of these devices," she cautioned.

The risks associated with improper use include ocular injury, skin burns, and paradoxical hair growth, as is the case with devices used in physicians’ offices.

The paradoxical hair growth risk in untreated areas close by treated skin is an issue that has been largely beneath dermatologists’ radar prior to the European guidelines. The reported risk with professional devices used by dermatologists is 0.6%-10%. With home devices, who knows?

"It’s a real matter of concern these days. When you lower the fluences, the incidence of paradoxical hair growth may be even higher. There’s nothing in the literature yet, but I’m sure there will be in the next few years," Dr. Haedersdal said.

Patients at increased risk for paradoxical hair regrowth are women with darker skin types, typically with polycystic ovarian syndrome, who are undergoing facial treatment. The mechanism of paradoxical hair regrowth is unknown. Two leading possibilities are light-driven triggering of inflammatory mediators or stimulation of the hair cycle secondary to subtherapeutic thermal injury, she continued.

• Burn scars. A solid body of evidence has accrued regarding the efficacy and safety of both ablative and nonablative fractional lasers to remodel mature burn scars.

Particularly noteworthy was a recent prospective, single-arm, blinded-evaluator study in which a 1,550-nm nonablative fractional erbium laser was employed to treat burn scars in 10 patients. Ninety percent of patients showed improved skin texture and 80% demonstrated improvement in dyschromia, something that hasn’t previously been reported with laser therapy (Lasers Surg. Med. 2012;44:441-6).

The 13 published studies of nonablative fractional laser therapy for burn scars show 26%-50% improvement. That’s slightly less than the 26%-83% improvement reported in the 13 studies of ablative fractional lasers. On the other hand, nonablative fractional laser therapy entails fewer side effects: 1-3 days of erythema and a postinflammatory hyperpigmentation rate of up to 13%, compared with 3-14 days of erythema with ablative fractional laser therapy and a postinflammatory hyperpigmentation rate of up to 92%. As yet, though, there have been no head-to-head comparative studies of the two types of devices.

• Onychomycosis. This is a brand-new area for laser therapy. A recent review noted that, while the Food and Drug Administration has approved four YAG lasers for treatment of onychomycosis, the regulatory standards for device approval don’t require persuasive evidence of efficacy, unlike for drugs (J. Am. Podiatr. Med. Assoc. 2012;102:428-30). Although it’s a promising technology, the authors stated that there are as yet no data showing how laser therapy stacks up against existing standard treatments for onychomycosis in terms of efficacy.

Nevertheless, Dr. Haedersdal noted, attention-getting cure rates were seen in a recent Chinese study involving 154 laser-treated nails in 33 patients. The week-24 complete cure rate, both mycologic and clinical, was 51% after eight weekly treatments and 53% after four weekly treatments (Chin. Med. J. 2012;125:3288-91).

Dr. Haedersdal reported serving on the scientific advisory boards for Galderma, LEO Pharma, and Procter & Gamble.

PRAGUE – Add Merkel cell carcinoma to the seemingly ever-growing list of malignancies linked to vitamin D deficiency.

A multicenter French study involving 89 patients with histologically confirmed Merkel cell carcinoma indicates that individuals with this rare and often aggressive neuroendocrine skin malignancy have an increased prevalence of vitamin D deficiency. Moreover, the vitamin D–deficient subgroup had a greater mean tumor size at diagnosis and sharply worse outcomes, Dr. Mahtab Samimi reported at the annual congress of the European Academy of Dermatology and Venereology.

© Kaspri/Fotolia.com

Fifty-eight of the 89 (65%) Merkel cell carcinoma patients were vitamin D deficient as defined by a serum level below 50 nmol/L. During follow-up, 33 patients developed nodal and/or distant metastases and 19 died of Merkel cell carcinoma. The 4-year Merkel cell carcinoma–free survival rate was 40% in the vitamin D deficient group and more than 90% in patients with normal-range vitamin D. The metastasis-free survival rate at 4 years was 20% in vitamin D–deficient patients and 70% in those without serum vitamin D deficiency.

In a multivariate regression analysis, low vitamin D was independently associated with an adjusted 2.89-fold increased risk of developing nodal and/or distant metastases and a 5.28-fold increased risk for death from their malignancy, reported Dr. Samimi of Francois Rabelais University in Tours, France.

The multivariate analysis was adjusted for age, gender, immune status, tumor location, time of year of the serum vitamin D measurement, and Merkel cell polyomavirus DNA levels.

It’s biologically plausible that a patient’s vitamin D status influences Merkel cell carcinoma behavior, according to Dr. Samimi. She and her coworkers analyzed 19 primary tumor specimens and 9 nodal metastases and found every single one strongly expressed the vitamin D receptor.

"The active metabolites of vitamin D bind to the vitamin D receptor, which is able to regulate genes involved in cell cycle control and others that have anti-inflammatory effects," the dermatologist explained.

Other investigators have shown that melanoma, too, is affected by a patient’s vitamin D status. Vitamin D deficiency is associated with thicker melanomas at diagnosis and reduced survival, she noted.

Dr. Samimi stressed that the newly shown association that she and her coworkers have found between vitamin D deficiency and worse-prognosis Merkel cell carcinoma must be considered hypothesis-generating rather than proof of causality. Serum vitamin D wasn’t measured until an average of 3 months after cancer diagnosis.

Asked by the audience if she screens her patients with Merkel cell carcinoma or melanoma for vitamin D deficiency, Dr. Samimi replied affirmatively. And if they’re deficient, as is so often the case, she puts them on vitamin D supplementation.

"The protective role of doing this in terms of cancer prognosis is not proven, but at the very least the supplementation has beneficial effects on skeletal and muscle health, so it’s a good thing," she said.

In a separate study, Dr. Nicolas Kluger of the University of Helsinki presented national Finnish data showing a predisposition of Merkel cell carcinoma for the left side of affected patients.

The comprehensive Finnish Cancer Registry is thought to have captured all 177 Finns diagnosed with Merkel cell carcinoma in a recent 20-year period. Fifty-six percent of the tumors were on the left, 37% on the right, and 7% occurred on the midline.

Tumors located on the trunk were equally likely to be left or right sided, but tumors on the head and neck were 3.2-fold more likely to be on the left side. Merkel cell carcinomas arising on the forearm or hand were fourfold more likely to occur on the left than the right side. On the leg and foot, the left-sided excess was 2.4-fold. Tumors located on the face were 1.5-fold more likely to occur on the left side.

These Finnish data confirm an earlier U.S. study involving a much larger patient population: 2,384 individuals with Merkel cell carcinoma included the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) database, Dr. Kluger noted. In the U.S. study, 52.7% of the cancers occurred on the left side. On the arm it was 55%, while on the face it was 52%, but there was no difference in lateral distribution of the tumors on the legs (J. Am. Acad. Dermatol. 2011;65:35-9).

The same large U.S. study also showed an excess of left-sidedness in the distribution of melanomas among 82,587 affected patients in the SEER registry.

Since ultraviolet light exposure figures in the pathogenesis of both of these serious skin cancers, one leading theory regarding the explanation for the left-sided predominance of Merkel cell carcinoma and melanoma involves increased driver-side UV exposure while operating motor vehicles. Dr. Kluger finds this explanation unlikely. Although steering wheels are placed on the left side of vehicles in Finland, as in the United States, left-side predominance of these skin cancers also has been reported in countries such as Scotland, where drivers stick to the left side of the road and the steering wheel is on the right, he noted.

In Finland, there was a significant excess of Merkel cell carcinomas on the left side in nearly every year of the 20-year study. That means if the skewed lateral distribution of the tumors is due to some as-yet-unidentified environmental factor, it’s a factor that hasn’t changed in 20 years, Dr. Kluger observed.

"For now it’s an interesting curiosity," he commented.

Both Dr. Kluger and Dr. Samimi reported having no financial conflicts.

PRAGUE – Add Merkel cell carcinoma to the seemingly ever-growing list of malignancies linked to vitamin D deficiency.

A multicenter French study involving 89 patients with histologically confirmed Merkel cell carcinoma indicates that individuals with this rare and often aggressive neuroendocrine skin malignancy have an increased prevalence of vitamin D deficiency. Moreover, the vitamin D–deficient subgroup had a greater mean tumor size at diagnosis and sharply worse outcomes, Dr. Mahtab Samimi reported at the annual congress of the European Academy of Dermatology and Venereology.

© Kaspri/Fotolia.com

Fifty-eight of the 89 (65%) Merkel cell carcinoma patients were vitamin D deficient as defined by a serum level below 50 nmol/L. During follow-up, 33 patients developed nodal and/or distant metastases and 19 died of Merkel cell carcinoma. The 4-year Merkel cell carcinoma–free survival rate was 40% in the vitamin D deficient group and more than 90% in patients with normal-range vitamin D. The metastasis-free survival rate at 4 years was 20% in vitamin D–deficient patients and 70% in those without serum vitamin D deficiency.

In a multivariate regression analysis, low vitamin D was independently associated with an adjusted 2.89-fold increased risk of developing nodal and/or distant metastases and a 5.28-fold increased risk for death from their malignancy, reported Dr. Samimi of Francois Rabelais University in Tours, France.

The multivariate analysis was adjusted for age, gender, immune status, tumor location, time of year of the serum vitamin D measurement, and Merkel cell polyomavirus DNA levels.

It’s biologically plausible that a patient’s vitamin D status influences Merkel cell carcinoma behavior, according to Dr. Samimi. She and her coworkers analyzed 19 primary tumor specimens and 9 nodal metastases and found every single one strongly expressed the vitamin D receptor.

"The active metabolites of vitamin D bind to the vitamin D receptor, which is able to regulate genes involved in cell cycle control and others that have anti-inflammatory effects," the dermatologist explained.

Other investigators have shown that melanoma, too, is affected by a patient’s vitamin D status. Vitamin D deficiency is associated with thicker melanomas at diagnosis and reduced survival, she noted.

Dr. Samimi stressed that the newly shown association that she and her coworkers have found between vitamin D deficiency and worse-prognosis Merkel cell carcinoma must be considered hypothesis-generating rather than proof of causality. Serum vitamin D wasn’t measured until an average of 3 months after cancer diagnosis.

Asked by the audience if she screens her patients with Merkel cell carcinoma or melanoma for vitamin D deficiency, Dr. Samimi replied affirmatively. And if they’re deficient, as is so often the case, she puts them on vitamin D supplementation.

"The protective role of doing this in terms of cancer prognosis is not proven, but at the very least the supplementation has beneficial effects on skeletal and muscle health, so it’s a good thing," she said.

In a separate study, Dr. Nicolas Kluger of the University of Helsinki presented national Finnish data showing a predisposition of Merkel cell carcinoma for the left side of affected patients.

The comprehensive Finnish Cancer Registry is thought to have captured all 177 Finns diagnosed with Merkel cell carcinoma in a recent 20-year period. Fifty-six percent of the tumors were on the left, 37% on the right, and 7% occurred on the midline.

Tumors located on the trunk were equally likely to be left or right sided, but tumors on the head and neck were 3.2-fold more likely to be on the left side. Merkel cell carcinomas arising on the forearm or hand were fourfold more likely to occur on the left than the right side. On the leg and foot, the left-sided excess was 2.4-fold. Tumors located on the face were 1.5-fold more likely to occur on the left side.

These Finnish data confirm an earlier U.S. study involving a much larger patient population: 2,384 individuals with Merkel cell carcinoma included the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) database, Dr. Kluger noted. In the U.S. study, 52.7% of the cancers occurred on the left side. On the arm it was 55%, while on the face it was 52%, but there was no difference in lateral distribution of the tumors on the legs (J. Am. Acad. Dermatol. 2011;65:35-9).

The same large U.S. study also showed an excess of left-sidedness in the distribution of melanomas among 82,587 affected patients in the SEER registry.

Since ultraviolet light exposure figures in the pathogenesis of both of these serious skin cancers, one leading theory regarding the explanation for the left-sided predominance of Merkel cell carcinoma and melanoma involves increased driver-side UV exposure while operating motor vehicles. Dr. Kluger finds this explanation unlikely. Although steering wheels are placed on the left side of vehicles in Finland, as in the United States, left-side predominance of these skin cancers also has been reported in countries such as Scotland, where drivers stick to the left side of the road and the steering wheel is on the right, he noted.

In Finland, there was a significant excess of Merkel cell carcinomas on the left side in nearly every year of the 20-year study. That means if the skewed lateral distribution of the tumors is due to some as-yet-unidentified environmental factor, it’s a factor that hasn’t changed in 20 years, Dr. Kluger observed.

"For now it’s an interesting curiosity," he commented.

Both Dr. Kluger and Dr. Samimi reported having no financial conflicts.

PRAGUE – Add Merkel cell carcinoma to the seemingly ever-growing list of malignancies linked to vitamin D deficiency.

A multicenter French study involving 89 patients with histologically confirmed Merkel cell carcinoma indicates that individuals with this rare and often aggressive neuroendocrine skin malignancy have an increased prevalence of vitamin D deficiency. Moreover, the vitamin D–deficient subgroup had a greater mean tumor size at diagnosis and sharply worse outcomes, Dr. Mahtab Samimi reported at the annual congress of the European Academy of Dermatology and Venereology.

© Kaspri/Fotolia.com

Fifty-eight of the 89 (65%) Merkel cell carcinoma patients were vitamin D deficient as defined by a serum level below 50 nmol/L. During follow-up, 33 patients developed nodal and/or distant metastases and 19 died of Merkel cell carcinoma. The 4-year Merkel cell carcinoma–free survival rate was 40% in the vitamin D deficient group and more than 90% in patients with normal-range vitamin D. The metastasis-free survival rate at 4 years was 20% in vitamin D–deficient patients and 70% in those without serum vitamin D deficiency.

In a multivariate regression analysis, low vitamin D was independently associated with an adjusted 2.89-fold increased risk of developing nodal and/or distant metastases and a 5.28-fold increased risk for death from their malignancy, reported Dr. Samimi of Francois Rabelais University in Tours, France.

The multivariate analysis was adjusted for age, gender, immune status, tumor location, time of year of the serum vitamin D measurement, and Merkel cell polyomavirus DNA levels.

It’s biologically plausible that a patient’s vitamin D status influences Merkel cell carcinoma behavior, according to Dr. Samimi. She and her coworkers analyzed 19 primary tumor specimens and 9 nodal metastases and found every single one strongly expressed the vitamin D receptor.

"The active metabolites of vitamin D bind to the vitamin D receptor, which is able to regulate genes involved in cell cycle control and others that have anti-inflammatory effects," the dermatologist explained.

Other investigators have shown that melanoma, too, is affected by a patient’s vitamin D status. Vitamin D deficiency is associated with thicker melanomas at diagnosis and reduced survival, she noted.

Dr. Samimi stressed that the newly shown association that she and her coworkers have found between vitamin D deficiency and worse-prognosis Merkel cell carcinoma must be considered hypothesis-generating rather than proof of causality. Serum vitamin D wasn’t measured until an average of 3 months after cancer diagnosis.

Asked by the audience if she screens her patients with Merkel cell carcinoma or melanoma for vitamin D deficiency, Dr. Samimi replied affirmatively. And if they’re deficient, as is so often the case, she puts them on vitamin D supplementation.

"The protective role of doing this in terms of cancer prognosis is not proven, but at the very least the supplementation has beneficial effects on skeletal and muscle health, so it’s a good thing," she said.

In a separate study, Dr. Nicolas Kluger of the University of Helsinki presented national Finnish data showing a predisposition of Merkel cell carcinoma for the left side of affected patients.

The comprehensive Finnish Cancer Registry is thought to have captured all 177 Finns diagnosed with Merkel cell carcinoma in a recent 20-year period. Fifty-six percent of the tumors were on the left, 37% on the right, and 7% occurred on the midline.

Tumors located on the trunk were equally likely to be left or right sided, but tumors on the head and neck were 3.2-fold more likely to be on the left side. Merkel cell carcinomas arising on the forearm or hand were fourfold more likely to occur on the left than the right side. On the leg and foot, the left-sided excess was 2.4-fold. Tumors located on the face were 1.5-fold more likely to occur on the left side.

These Finnish data confirm an earlier U.S. study involving a much larger patient population: 2,384 individuals with Merkel cell carcinoma included the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) database, Dr. Kluger noted. In the U.S. study, 52.7% of the cancers occurred on the left side. On the arm it was 55%, while on the face it was 52%, but there was no difference in lateral distribution of the tumors on the legs (J. Am. Acad. Dermatol. 2011;65:35-9).

The same large U.S. study also showed an excess of left-sidedness in the distribution of melanomas among 82,587 affected patients in the SEER registry.

Since ultraviolet light exposure figures in the pathogenesis of both of these serious skin cancers, one leading theory regarding the explanation for the left-sided predominance of Merkel cell carcinoma and melanoma involves increased driver-side UV exposure while operating motor vehicles. Dr. Kluger finds this explanation unlikely. Although steering wheels are placed on the left side of vehicles in Finland, as in the United States, left-side predominance of these skin cancers also has been reported in countries such as Scotland, where drivers stick to the left side of the road and the steering wheel is on the right, he noted.

In Finland, there was a significant excess of Merkel cell carcinomas on the left side in nearly every year of the 20-year study. That means if the skewed lateral distribution of the tumors is due to some as-yet-unidentified environmental factor, it’s a factor that hasn’t changed in 20 years, Dr. Kluger observed.

"For now it’s an interesting curiosity," he commented.

Both Dr. Kluger and Dr. Samimi reported having no financial conflicts.

PRAGUE – Everolimus significantly improved the skin lesions of tuberous sclerosis complex in two phase-III clinical trials, Dr. Sergiusz Jozwiak reported at the annual congress of the European Academy of Dermatology and Venereology.

Tuberous sclerosis is a genetic disorder characterized by the growth of numerous nonmalignant tumors in various organs including the brain, kidneys, heart, and skin.

The most devastating skin lesions associated with tuberous sclerosis complex are facial angiofibromas. Hypopigmented spots are also common, said Dr. Jozwiak, a pediatric neurologist at the Children’s Memorial Health Institute of Warsaw.

In the first study, Examining Everolimus in a Study of Tuberous Sclerosis Complex (EXIST-1), about 100 patients with subependymal giant cell astrocytoma (SEGA) were randomized 2:1 to receive everolimus or placebo. In EXIST-2, approximately 100 patients with renal angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis were randomized to receive either everolimus or placebo. EXIST-1 participants averaged about 8 years of age; those in EXIST-2 had an average age of 30 years.

Both studies met their primary end points, with favorable effects documented in patients with SEGA and renal angiomyolipoma. This led the Food and Drug Administration to approve everolimus (Afinitor), an oral inhibitor of the mammalian target of rapamycin (mTOR), for the treatment of both conditions.

Dr. Jozwiak reported on the skin lesion response to everolimus, a prespecified secondary end point in EXIST-1 and -2.

Close to 95% of all participants – 224 subjects in the two trials – had skin lesions at baseline. Of those on everolimus, 42% in EXIST-1 and 26% in EXIST-2 had significant improvements in their skin lesions, compared with 11% and 0%, respectively, of those on placebo.

The skin response was partial in all cases as judged on a 7-point scale, but the response, when it occurred, was durable: All patients with a partial response to everolimus maintained that response at last follow-up, ranging from 2 to 20 months. Thus, the median duration of skin response has yet to be determined, Dr. Jozwiak noted.

Mouth ulcers were the most common and troublesome everolimus side effect, seen intermittently in 70% of the patients in the two phase-III trials. The side effect was managed by temporary reductions in dosing or suspension of therapy for a week.

"We were able to reinstitute full-dose therapy in all patients," he said.

There were no other serious treatment-related adverse events. The incidence of infections was similar in the everolimus and placebo arms of the studies.

Everolimus was dosed starting at 4.5 mg/m² per day, with a target trough level of 5-15 ng/mL in EXIST-1. In EXIST-2, which was limited to an adult patient population, the drug was dosed at 10 mg/day.

The EXIST trials were sponsored by Novartis. Dr. Jozwiak is a consultant to the company.

PRAGUE – Everolimus significantly improved the skin lesions of tuberous sclerosis complex in two phase-III clinical trials, Dr. Sergiusz Jozwiak reported at the annual congress of the European Academy of Dermatology and Venereology.

Tuberous sclerosis is a genetic disorder characterized by the growth of numerous nonmalignant tumors in various organs including the brain, kidneys, heart, and skin.

The most devastating skin lesions associated with tuberous sclerosis complex are facial angiofibromas. Hypopigmented spots are also common, said Dr. Jozwiak, a pediatric neurologist at the Children’s Memorial Health Institute of Warsaw.

In the first study, Examining Everolimus in a Study of Tuberous Sclerosis Complex (EXIST-1), about 100 patients with subependymal giant cell astrocytoma (SEGA) were randomized 2:1 to receive everolimus or placebo. In EXIST-2, approximately 100 patients with renal angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis were randomized to receive either everolimus or placebo. EXIST-1 participants averaged about 8 years of age; those in EXIST-2 had an average age of 30 years.

Both studies met their primary end points, with favorable effects documented in patients with SEGA and renal angiomyolipoma. This led the Food and Drug Administration to approve everolimus (Afinitor), an oral inhibitor of the mammalian target of rapamycin (mTOR), for the treatment of both conditions.

Dr. Jozwiak reported on the skin lesion response to everolimus, a prespecified secondary end point in EXIST-1 and -2.

Close to 95% of all participants – 224 subjects in the two trials – had skin lesions at baseline. Of those on everolimus, 42% in EXIST-1 and 26% in EXIST-2 had significant improvements in their skin lesions, compared with 11% and 0%, respectively, of those on placebo.

The skin response was partial in all cases as judged on a 7-point scale, but the response, when it occurred, was durable: All patients with a partial response to everolimus maintained that response at last follow-up, ranging from 2 to 20 months. Thus, the median duration of skin response has yet to be determined, Dr. Jozwiak noted.

Mouth ulcers were the most common and troublesome everolimus side effect, seen intermittently in 70% of the patients in the two phase-III trials. The side effect was managed by temporary reductions in dosing or suspension of therapy for a week.

"We were able to reinstitute full-dose therapy in all patients," he said.

There were no other serious treatment-related adverse events. The incidence of infections was similar in the everolimus and placebo arms of the studies.

Everolimus was dosed starting at 4.5 mg/m² per day, with a target trough level of 5-15 ng/mL in EXIST-1. In EXIST-2, which was limited to an adult patient population, the drug was dosed at 10 mg/day.

The EXIST trials were sponsored by Novartis. Dr. Jozwiak is a consultant to the company.

PRAGUE – Everolimus significantly improved the skin lesions of tuberous sclerosis complex in two phase-III clinical trials, Dr. Sergiusz Jozwiak reported at the annual congress of the European Academy of Dermatology and Venereology.

Tuberous sclerosis is a genetic disorder characterized by the growth of numerous nonmalignant tumors in various organs including the brain, kidneys, heart, and skin.

The most devastating skin lesions associated with tuberous sclerosis complex are facial angiofibromas. Hypopigmented spots are also common, said Dr. Jozwiak, a pediatric neurologist at the Children’s Memorial Health Institute of Warsaw.

In the first study, Examining Everolimus in a Study of Tuberous Sclerosis Complex (EXIST-1), about 100 patients with subependymal giant cell astrocytoma (SEGA) were randomized 2:1 to receive everolimus or placebo. In EXIST-2, approximately 100 patients with renal angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis were randomized to receive either everolimus or placebo. EXIST-1 participants averaged about 8 years of age; those in EXIST-2 had an average age of 30 years.

Both studies met their primary end points, with favorable effects documented in patients with SEGA and renal angiomyolipoma. This led the Food and Drug Administration to approve everolimus (Afinitor), an oral inhibitor of the mammalian target of rapamycin (mTOR), for the treatment of both conditions.

Dr. Jozwiak reported on the skin lesion response to everolimus, a prespecified secondary end point in EXIST-1 and -2.

Close to 95% of all participants – 224 subjects in the two trials – had skin lesions at baseline. Of those on everolimus, 42% in EXIST-1 and 26% in EXIST-2 had significant improvements in their skin lesions, compared with 11% and 0%, respectively, of those on placebo.

The skin response was partial in all cases as judged on a 7-point scale, but the response, when it occurred, was durable: All patients with a partial response to everolimus maintained that response at last follow-up, ranging from 2 to 20 months. Thus, the median duration of skin response has yet to be determined, Dr. Jozwiak noted.

Mouth ulcers were the most common and troublesome everolimus side effect, seen intermittently in 70% of the patients in the two phase-III trials. The side effect was managed by temporary reductions in dosing or suspension of therapy for a week.

"We were able to reinstitute full-dose therapy in all patients," he said.

There were no other serious treatment-related adverse events. The incidence of infections was similar in the everolimus and placebo arms of the studies.

Everolimus was dosed starting at 4.5 mg/m² per day, with a target trough level of 5-15 ng/mL in EXIST-1. In EXIST-2, which was limited to an adult patient population, the drug was dosed at 10 mg/day.

The EXIST trials were sponsored by Novartis. Dr. Jozwiak is a consultant to the company.

PRAGUE – Recognizing the slim chances of a direct comparison study of two biologics for treatment of psoriasis, Dr. Kristian Reich and his coworkers have done the next best thing: they’ve conducted an indirect comparison study.

They used existing data from four randomized trials to compare two biologics adalimumab (Humira) and etanercept (Enbrel) and adjusted for between-trial differences in baseline patient demographics, treatment history, and numerous measures of psoriasis severity.

The analysis was supported by Abbott, the maker of adalimumab. The drug had a significantly better benefit-risk profile as measured by the number of days patients spent with at least a 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores while also remaining free of study drug–related adverse events, Dr. Reich reported at the annual congress of the European Academy of Dermatology and Venereology.

The four phase III, double-blind, randomized, placebo-controlled, 12-week clinical trials included REVEAL (J. Am. Acad. Dermatol. 2008;56:106-15) and CHAMPION (Br. J. Dermatol. 2008;158:558-66), studies that pitted adalimumab against placebo in 1,302 subjects. The analysis also included the M10-114 and M10-315 trials, which included 390 patients randomized to briakinumab (Abbott), etanercept, or placebo.

Prior to propensity score weighting, participants in the adalimumab studies differed from those in the etanercept trials in terms of disease duration, percent body surface area involvement, extent of prior medication use, PASI scores, and other important variables. After matching, however, the two groups were closely similar across the board, explained Dr. Reich of the Hamburg (Germany) Dermatology Clinic.

Through 12 weeks of study participation, adalimumab-treated patients spent an average of 22.4 more days at PASI 75 with no study drug–related side effects than did those on placebo in the same two studies. In contrast, etanercept-treated patients spent 11.5 more days than did controls in this optimal state.

At week 4, the proportion of biologic-treated subjects who were PASI 75 responders free of moderate-to-severe study drug–related adverse events was 15.7% in the adalimumab group compared with 5.5% with etanercept. At week 8, these rates climbed to 46.3% in the adalimumab-treated patients and 16.2% in the etanercept group. By week 12, the figures were 58% for adalimumab compared with 39.4% with etanercept.

An obvious limitation of this indirect comparison is the potential for confounding due to unobserved baseline differences. But Dr. Reich said he and his coinvestigators adjusted and balanced for everything they could think of.

"To further adjust for potential differences between trials, outcomes were compared relative to the corresponding placebo arms after applying propensity weights and before comparing across trials. Thus, unobserved factors that equally impact outcomes on the drug and placebo arms would not bias this comparison of adalimumab and etanercept," the dermatologist said.

Dr. Reich has received research grants from and serves as a consultant to Abbott, which supported this analysis, as well as to numerous other pharmaceutical companies.

PRAGUE – Recognizing the slim chances of a direct comparison study of two biologics for treatment of psoriasis, Dr. Kristian Reich and his coworkers have done the next best thing: they’ve conducted an indirect comparison study.

They used existing data from four randomized trials to compare two biologics adalimumab (Humira) and etanercept (Enbrel) and adjusted for between-trial differences in baseline patient demographics, treatment history, and numerous measures of psoriasis severity.

The analysis was supported by Abbott, the maker of adalimumab. The drug had a significantly better benefit-risk profile as measured by the number of days patients spent with at least a 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores while also remaining free of study drug–related adverse events, Dr. Reich reported at the annual congress of the European Academy of Dermatology and Venereology.

The four phase III, double-blind, randomized, placebo-controlled, 12-week clinical trials included REVEAL (J. Am. Acad. Dermatol. 2008;56:106-15) and CHAMPION (Br. J. Dermatol. 2008;158:558-66), studies that pitted adalimumab against placebo in 1,302 subjects. The analysis also included the M10-114 and M10-315 trials, which included 390 patients randomized to briakinumab (Abbott), etanercept, or placebo.

Prior to propensity score weighting, participants in the adalimumab studies differed from those in the etanercept trials in terms of disease duration, percent body surface area involvement, extent of prior medication use, PASI scores, and other important variables. After matching, however, the two groups were closely similar across the board, explained Dr. Reich of the Hamburg (Germany) Dermatology Clinic.

Through 12 weeks of study participation, adalimumab-treated patients spent an average of 22.4 more days at PASI 75 with no study drug–related side effects than did those on placebo in the same two studies. In contrast, etanercept-treated patients spent 11.5 more days than did controls in this optimal state.

At week 4, the proportion of biologic-treated subjects who were PASI 75 responders free of moderate-to-severe study drug–related adverse events was 15.7% in the adalimumab group compared with 5.5% with etanercept. At week 8, these rates climbed to 46.3% in the adalimumab-treated patients and 16.2% in the etanercept group. By week 12, the figures were 58% for adalimumab compared with 39.4% with etanercept.

An obvious limitation of this indirect comparison is the potential for confounding due to unobserved baseline differences. But Dr. Reich said he and his coinvestigators adjusted and balanced for everything they could think of.

"To further adjust for potential differences between trials, outcomes were compared relative to the corresponding placebo arms after applying propensity weights and before comparing across trials. Thus, unobserved factors that equally impact outcomes on the drug and placebo arms would not bias this comparison of adalimumab and etanercept," the dermatologist said.

Dr. Reich has received research grants from and serves as a consultant to Abbott, which supported this analysis, as well as to numerous other pharmaceutical companies.

PRAGUE – Recognizing the slim chances of a direct comparison study of two biologics for treatment of psoriasis, Dr. Kristian Reich and his coworkers have done the next best thing: they’ve conducted an indirect comparison study.

They used existing data from four randomized trials to compare two biologics adalimumab (Humira) and etanercept (Enbrel) and adjusted for between-trial differences in baseline patient demographics, treatment history, and numerous measures of psoriasis severity.

The analysis was supported by Abbott, the maker of adalimumab. The drug had a significantly better benefit-risk profile as measured by the number of days patients spent with at least a 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores while also remaining free of study drug–related adverse events, Dr. Reich reported at the annual congress of the European Academy of Dermatology and Venereology.

The four phase III, double-blind, randomized, placebo-controlled, 12-week clinical trials included REVEAL (J. Am. Acad. Dermatol. 2008;56:106-15) and CHAMPION (Br. J. Dermatol. 2008;158:558-66), studies that pitted adalimumab against placebo in 1,302 subjects. The analysis also included the M10-114 and M10-315 trials, which included 390 patients randomized to briakinumab (Abbott), etanercept, or placebo.

Prior to propensity score weighting, participants in the adalimumab studies differed from those in the etanercept trials in terms of disease duration, percent body surface area involvement, extent of prior medication use, PASI scores, and other important variables. After matching, however, the two groups were closely similar across the board, explained Dr. Reich of the Hamburg (Germany) Dermatology Clinic.

Through 12 weeks of study participation, adalimumab-treated patients spent an average of 22.4 more days at PASI 75 with no study drug–related side effects than did those on placebo in the same two studies. In contrast, etanercept-treated patients spent 11.5 more days than did controls in this optimal state.

At week 4, the proportion of biologic-treated subjects who were PASI 75 responders free of moderate-to-severe study drug–related adverse events was 15.7% in the adalimumab group compared with 5.5% with etanercept. At week 8, these rates climbed to 46.3% in the adalimumab-treated patients and 16.2% in the etanercept group. By week 12, the figures were 58% for adalimumab compared with 39.4% with etanercept.

An obvious limitation of this indirect comparison is the potential for confounding due to unobserved baseline differences. But Dr. Reich said he and his coinvestigators adjusted and balanced for everything they could think of.

"To further adjust for potential differences between trials, outcomes were compared relative to the corresponding placebo arms after applying propensity weights and before comparing across trials. Thus, unobserved factors that equally impact outcomes on the drug and placebo arms would not bias this comparison of adalimumab and etanercept," the dermatologist said.

Dr. Reich has received research grants from and serves as a consultant to Abbott, which supported this analysis, as well as to numerous other pharmaceutical companies.

PRAGUE  – More than half of patients who undergo surgical treatment for hidradenitis suppurativa experience one or more indicators of unmet treatment needs – in other words, a suboptimal result – during the subsequent 12 months, according to Dr. Gregor B. Jemec of the University of Copenhagen.

"Very often hidradenitis suppurativa is considered a disease that is treatable only surgically. This study highlights the need for development of effective nonsurgical treatment options for people with hidradenitis suppurativa," he said at the annual congress of the European Academy of Dermatology and Venereology.

Several medical therapies for hidradenitis suppurativa (HS) are backed by reasonably good evidence, but all of them are off label. No approved therapy exists for this chronic, recurrent, scarring, inflammatory skin disease that affects 1%-4% of U.S. adults.

Dr. Jemec presented a retrospective claims-based analysis of the economic burden of failed HS surgery in the United States.

He and his coinvestigators identified 2,668 patients in the Ingenix Employer Solutions database who underwent surgery for HS within 6 months after being diagnosed with the skin disease. The researchers came up with a list of indicators of unmet needs following surgery: development of surgical complications such as scarring, abscess, fistulization, or septicemia; an inpatient stay, office visit, or emergency department visit for HS; or another HS skin surgery. The investigators asked two questions: How many patients experienced one or more of these adverse outcome indicators within 12 months following surgery, and what was the associated economic cost?

Fifty-one percent of patients experienced one or more of the indicators of unmet needs. Fifty-seven percent of this cohort underwent one or more subsequent skin surgeries, mostly excisions. Twenty-three percent of patients in the unmet needs cohort developed abscesses, 15% had septicemia, 5% had an HS hospitalization, and 4% had an emergency department visit for HS.

Patients with unmet needs following HS surgery were significantly older by a mean of 3 years. They also had more comorbid conditions as reflected in their significantly higher mean Charlson Comorbidity Index score. After adjustment for these and other potential confounding variables in a multivariate analysis, the group with indicators of unmet needs had a 63% greater incidence of hospital admission for HS during follow-up than did those without. They also had a 59% greater rate of emergency department visits for HS and a 35% increase in office visits for the skin disease.

Total health care costs during the 12 months following HS surgery averaged $13,235 for patients with indicators of unmet needs, compared with $8,193 for those who were trouble free after surgery. After multivariate adjustment, costs in the unmet needs group were an average of $3,109 higher, with the bulk of this difference being driven by the increased rate of inpatient stays for HS.

This study was funded by Abbott Laboratories, which is developing its tumor necrosis factor inhibitor adalimumab (Humira) as a therapy for HS. Abbott has two pivotal 36-week, randomized, double-blind, placebo-controlled, multinational phase III clinical trials underway. Dr. Jemec is a consultant to the company and has received research grants from and/or serves as a consultant to multiple other pharmaceutical companies.

PRAGUE  – More than half of patients who undergo surgical treatment for hidradenitis suppurativa experience one or more indicators of unmet treatment needs – in other words, a suboptimal result – during the subsequent 12 months, according to Dr. Gregor B. Jemec of the University of Copenhagen.

"Very often hidradenitis suppurativa is considered a disease that is treatable only surgically. This study highlights the need for development of effective nonsurgical treatment options for people with hidradenitis suppurativa," he said at the annual congress of the European Academy of Dermatology and Venereology.

Several medical therapies for hidradenitis suppurativa (HS) are backed by reasonably good evidence, but all of them are off label. No approved therapy exists for this chronic, recurrent, scarring, inflammatory skin disease that affects 1%-4% of U.S. adults.

Dr. Jemec presented a retrospective claims-based analysis of the economic burden of failed HS surgery in the United States.

He and his coinvestigators identified 2,668 patients in the Ingenix Employer Solutions database who underwent surgery for HS within 6 months after being diagnosed with the skin disease. The researchers came up with a list of indicators of unmet needs following surgery: development of surgical complications such as scarring, abscess, fistulization, or septicemia; an inpatient stay, office visit, or emergency department visit for HS; or another HS skin surgery. The investigators asked two questions: How many patients experienced one or more of these adverse outcome indicators within 12 months following surgery, and what was the associated economic cost?

Fifty-one percent of patients experienced one or more of the indicators of unmet needs. Fifty-seven percent of this cohort underwent one or more subsequent skin surgeries, mostly excisions. Twenty-three percent of patients in the unmet needs cohort developed abscesses, 15% had septicemia, 5% had an HS hospitalization, and 4% had an emergency department visit for HS.

Patients with unmet needs following HS surgery were significantly older by a mean of 3 years. They also had more comorbid conditions as reflected in their significantly higher mean Charlson Comorbidity Index score. After adjustment for these and other potential confounding variables in a multivariate analysis, the group with indicators of unmet needs had a 63% greater incidence of hospital admission for HS during follow-up than did those without. They also had a 59% greater rate of emergency department visits for HS and a 35% increase in office visits for the skin disease.

Total health care costs during the 12 months following HS surgery averaged $13,235 for patients with indicators of unmet needs, compared with $8,193 for those who were trouble free after surgery. After multivariate adjustment, costs in the unmet needs group were an average of $3,109 higher, with the bulk of this difference being driven by the increased rate of inpatient stays for HS.

This study was funded by Abbott Laboratories, which is developing its tumor necrosis factor inhibitor adalimumab (Humira) as a therapy for HS. Abbott has two pivotal 36-week, randomized, double-blind, placebo-controlled, multinational phase III clinical trials underway. Dr. Jemec is a consultant to the company and has received research grants from and/or serves as a consultant to multiple other pharmaceutical companies.

PRAGUE  – More than half of patients who undergo surgical treatment for hidradenitis suppurativa experience one or more indicators of unmet treatment needs – in other words, a suboptimal result – during the subsequent 12 months, according to Dr. Gregor B. Jemec of the University of Copenhagen.

"Very often hidradenitis suppurativa is considered a disease that is treatable only surgically. This study highlights the need for development of effective nonsurgical treatment options for people with hidradenitis suppurativa," he said at the annual congress of the European Academy of Dermatology and Venereology.

Several medical therapies for hidradenitis suppurativa (HS) are backed by reasonably good evidence, but all of them are off label. No approved therapy exists for this chronic, recurrent, scarring, inflammatory skin disease that affects 1%-4% of U.S. adults.

Dr. Jemec presented a retrospective claims-based analysis of the economic burden of failed HS surgery in the United States.

He and his coinvestigators identified 2,668 patients in the Ingenix Employer Solutions database who underwent surgery for HS within 6 months after being diagnosed with the skin disease. The researchers came up with a list of indicators of unmet needs following surgery: development of surgical complications such as scarring, abscess, fistulization, or septicemia; an inpatient stay, office visit, or emergency department visit for HS; or another HS skin surgery. The investigators asked two questions: How many patients experienced one or more of these adverse outcome indicators within 12 months following surgery, and what was the associated economic cost?

Fifty-one percent of patients experienced one or more of the indicators of unmet needs. Fifty-seven percent of this cohort underwent one or more subsequent skin surgeries, mostly excisions. Twenty-three percent of patients in the unmet needs cohort developed abscesses, 15% had septicemia, 5% had an HS hospitalization, and 4% had an emergency department visit for HS.

Patients with unmet needs following HS surgery were significantly older by a mean of 3 years. They also had more comorbid conditions as reflected in their significantly higher mean Charlson Comorbidity Index score. After adjustment for these and other potential confounding variables in a multivariate analysis, the group with indicators of unmet needs had a 63% greater incidence of hospital admission for HS during follow-up than did those without. They also had a 59% greater rate of emergency department visits for HS and a 35% increase in office visits for the skin disease.

Total health care costs during the 12 months following HS surgery averaged $13,235 for patients with indicators of unmet needs, compared with $8,193 for those who were trouble free after surgery. After multivariate adjustment, costs in the unmet needs group were an average of $3,109 higher, with the bulk of this difference being driven by the increased rate of inpatient stays for HS.

This study was funded by Abbott Laboratories, which is developing its tumor necrosis factor inhibitor adalimumab (Humira) as a therapy for HS. Abbott has two pivotal 36-week, randomized, double-blind, placebo-controlled, multinational phase III clinical trials underway. Dr. Jemec is a consultant to the company and has received research grants from and/or serves as a consultant to multiple other pharmaceutical companies.

PRAGUE – Adding short courses of clobetasol propionate foam to etanercept resulted in improved outcomes compared with etanercept alone in patients with moderate to severe plaque psoriasis in a large, multicenter phase III randomized trial.

Moreover, the boost in efficacy that resulted from add-on short-course therapy with the potent topical steroid came at no cost in terms of additional side effects, according to Dr. Mark G. Lebwohl, professor and chair of dermatology at Mount Sinai School of Medicine, New York.

He reported on 592 psoriasis patients who were randomized to etanercept at 50 mg twice weekly for 12 weeks alone or with the option of using clobetasol propionate foam twice daily for up to 2 weeks during weeks 11-12 as needed to clear lesions. Of patients with the opportunity to resort to short-course topical steroid therapy, 85% did so during week 11 and 82% exercised that option in week 12.

The primary end point was a 75% improvement in the Psoriasis Area and Severity Index score, or PASI 75, at week 12 compared with baseline as determined by blinded investigators. This occurred in 65% of patients in the dual-therapy group vs. 48% of those on etanercept alone.

The incremental improvement in PASI 90 seen in the etanercept plus clobetasol propionate group was similarly impressive: a 30% PASI 90 rate compared with 19% with etanercept alone, Dr. Lebwohl noted at the annual congress of the European Academy of Dermatology and Venereology.

Patient satisfaction scores were significantly higher in the dual-therapy arm as well. Of patients randomized to etanercept plus clobetasol propionate, 87% said they were satisfied or very satisfied with their therapy, vs. 78% on etanercept alone.

The rate of treatment-related adverse events leading to discontinuation of therapy was low in both study arms: 0.7% with etanercept plus short-course topical steroid therapy and 1.3% with etanercept alone. No serious treatment-related adverse events occurred in the dual-therapy group, and there was only one in patients assigned to etanercept alone.

This phase III study was sponsored by Amgen. Dr. Lebwohl reported that he serves as a consultant to Amgen as well as numerous other pharmaceutical companies involved in developing dermatologic drugs.

PRAGUE – Adding short courses of clobetasol propionate foam to etanercept resulted in improved outcomes compared with etanercept alone in patients with moderate to severe plaque psoriasis in a large, multicenter phase III randomized trial.

Moreover, the boost in efficacy that resulted from add-on short-course therapy with the potent topical steroid came at no cost in terms of additional side effects, according to Dr. Mark G. Lebwohl, professor and chair of dermatology at Mount Sinai School of Medicine, New York.

He reported on 592 psoriasis patients who were randomized to etanercept at 50 mg twice weekly for 12 weeks alone or with the option of using clobetasol propionate foam twice daily for up to 2 weeks during weeks 11-12 as needed to clear lesions. Of patients with the opportunity to resort to short-course topical steroid therapy, 85% did so during week 11 and 82% exercised that option in week 12.

The primary end point was a 75% improvement in the Psoriasis Area and Severity Index score, or PASI 75, at week 12 compared with baseline as determined by blinded investigators. This occurred in 65% of patients in the dual-therapy group vs. 48% of those on etanercept alone.

The incremental improvement in PASI 90 seen in the etanercept plus clobetasol propionate group was similarly impressive: a 30% PASI 90 rate compared with 19% with etanercept alone, Dr. Lebwohl noted at the annual congress of the European Academy of Dermatology and Venereology.

Patient satisfaction scores were significantly higher in the dual-therapy arm as well. Of patients randomized to etanercept plus clobetasol propionate, 87% said they were satisfied or very satisfied with their therapy, vs. 78% on etanercept alone.

The rate of treatment-related adverse events leading to discontinuation of therapy was low in both study arms: 0.7% with etanercept plus short-course topical steroid therapy and 1.3% with etanercept alone. No serious treatment-related adverse events occurred in the dual-therapy group, and there was only one in patients assigned to etanercept alone.

This phase III study was sponsored by Amgen. Dr. Lebwohl reported that he serves as a consultant to Amgen as well as numerous other pharmaceutical companies involved in developing dermatologic drugs.

PRAGUE – Adding short courses of clobetasol propionate foam to etanercept resulted in improved outcomes compared with etanercept alone in patients with moderate to severe plaque psoriasis in a large, multicenter phase III randomized trial.

Moreover, the boost in efficacy that resulted from add-on short-course therapy with the potent topical steroid came at no cost in terms of additional side effects, according to Dr. Mark G. Lebwohl, professor and chair of dermatology at Mount Sinai School of Medicine, New York.

He reported on 592 psoriasis patients who were randomized to etanercept at 50 mg twice weekly for 12 weeks alone or with the option of using clobetasol propionate foam twice daily for up to 2 weeks during weeks 11-12 as needed to clear lesions. Of patients with the opportunity to resort to short-course topical steroid therapy, 85% did so during week 11 and 82% exercised that option in week 12.

The primary end point was a 75% improvement in the Psoriasis Area and Severity Index score, or PASI 75, at week 12 compared with baseline as determined by blinded investigators. This occurred in 65% of patients in the dual-therapy group vs. 48% of those on etanercept alone.

The incremental improvement in PASI 90 seen in the etanercept plus clobetasol propionate group was similarly impressive: a 30% PASI 90 rate compared with 19% with etanercept alone, Dr. Lebwohl noted at the annual congress of the European Academy of Dermatology and Venereology.

Patient satisfaction scores were significantly higher in the dual-therapy arm as well. Of patients randomized to etanercept plus clobetasol propionate, 87% said they were satisfied or very satisfied with their therapy, vs. 78% on etanercept alone.

The rate of treatment-related adverse events leading to discontinuation of therapy was low in both study arms: 0.7% with etanercept plus short-course topical steroid therapy and 1.3% with etanercept alone. No serious treatment-related adverse events occurred in the dual-therapy group, and there was only one in patients assigned to etanercept alone.

This phase III study was sponsored by Amgen. Dr. Lebwohl reported that he serves as a consultant to Amgen as well as numerous other pharmaceutical companies involved in developing dermatologic drugs.

PRAGUE – Patients with the common chronic inflammatory skin disease hidradenitis suppurativa have a sharply increased prevalence of metabolic syndrome, according to the results of three recent case-control studies.

"I think we can say that we have a uniform pattern from three studies showing hidradenitis suppurativa patients have increased risk for the metabolic syndrome, with odds ratios up to 5.8," Dr. Iben M. Miller said at the annual congress of the European Academy of Dermatology and Venereology.

"The implication is that we need to consider screening our hidradenitis suppurativa patients for cardiovascular risk factors, and – perhaps the most important and difficult thing – to help these patients with lifestyle interventions," added Dr. Miller, a dermatologist at the University of Copenhagen.

She presented updates on two case-control studies, which she is conducting in Denmark, as well as highlights from a third study recently published by dermatologists from the University Hospital Charitè in Berlin.

One of her studies included 374 patients with hidradenitis suppurativa and 15,000 controls drawn from the Danish General Suburban Population Study (GESUS), an ongoing study of the adults initiated in 2010, with enrollment at 15,500 and climbing. Participants are evaluated via detailed questionnaires, periodic physical examinations, and blood work.

All of the hidradenitis suppurativa study patients were adjusted for age, smoking status, and sex because patients with hidradenitis suppurativa are considerably younger, more likely to be female, and have a far greater prevalence of smoking than do control patients.

The hidradenitis suppurativa patients in GESUS proved to have an adjusted 2.35-fold greater likelihood of meeting criteria for metabolic syndrome than do control patients. They had a 2.79-fold increased odds of carrying the diagnosis of diabetes mellitus. They were also 2.36 times more likely to be obese and 2.33-fold more likely to have an increased waist circumference. The hidradenitis suppurativa group also was saddled with increased rates of hypertriglyceridemia and low HDL, with a mean serum triglyceride of 159 mg/dL, compared with 142 mg/dL in control patients, and a mean HDL of 51 mg/dL vs. 57 mg/dL in control patients.

The sole component of metabolic syndrome that was not more prominent in the hidradenitis suppurativa group was hypertension; the 16% increased prevalence of high blood pressure among patients with hidradenitis suppurativa didn’t achieve statistical significance, Dr. Miller noted.

The hidradenitis suppurativa group had an adjusted 1.69-fold greater prevalence of ischemic heart disease and a 1.14-fold greater likelihood of a history of stroke.

Dr. Miller’s second case-control study involved 31 Danish adults hospitalized for surgical treatment of hidradenitis suppurativa and the same 15,000 controls from GESUS. Of note, they were also significantly younger, with a mean age of 40.3 years, compared with 45.9 years in the population-based hidradenitis suppurativa cohort and 54.5 years in control patients. They were also more likely to be female and smokers than the 374 hidradenitis suppurativa patients drawn from GESUS.

The hospitalized hidradenitis suppurativa patients were an adjusted 5.8 times more likely to fulfill the criteria for metabolic syndrome than control patients. They also had a 5.47-fold increased risk of being diagnosed with diabetes. Their rates of all the other metabolic syndrome components were higher than in the GESUS hidradenitis suppurativa patients, as well. "I think that’s probably because the hospital cases have a greater degree of disease severity," said Dr. Miller.

The recently published German case-control study (PLoS ONE 7: e31810. [doi:10.1371/journal.pone.0031810]) included 80 patients hospitalized for surgical treatment of hidradenitis suppurativa and 100 age- and sex-matched controls. The prevalence of metabolic syndrome was 40% among the hidradenitis suppurativa cohort, compared with 13% in controls. The adjusted odds ratio was 4.46%.

The hidradenitis suppurativa group had a 5.88-fold increased likelihood of central obesity, a 4.09-fold greater rate of hyperglycemia, a 2.24-fold increase in hypertriglyceridemia, and 4.56-fold greater odds of low HDL.

An increased prevalence of metabolic syndrome has previously been shown in patients having other chronic inflammatory diseases, including psoriasis and rheumatoid arthritis. The German study provides the first published evidence that the same is true for hidradenitis suppurativa, a disease that affects up to 4% of the adult population, noted Dr. Miller.

The German dermatologists noted in their study results that the prevalence of metabolic syndrome and degree of metabolic derangement appear to be even greater among hidradenitis suppurativa patients than in those with psoriasis, particularly in light of the fact that patients with hidradenitis suppurativa tend to develop metabolic syndrome at a younger age.

As to the mechanism, the investigators reported that chronic inflammation may not be the driving force behind development of metabolic syndrome in patients with hidradenitis suppurativa. Just the opposite: They speculated that metabolic abnormalities may actually trigger hidradenitis suppurativa. Dr. Miller deemed that an intriguing hypothesis that’s far from proven.

Audience members said these cross-sectional case-control studies can’t demonstrate causality, which would require prospective studies. Dr. Miller agreed. "I think we should be careful about saying what causes what. We’ve shown an association. It could all be due to patient lifestyle. These patients do get depressed, and maybe they sit around at home and get obese, and those fat cells do make inflammatory cytokines," she said.

However, the GESUS study contains information on participants’ physical activity and diet that Dr. Miller is now analyzing. She believes the results will shed light on the mechanism underlying the association between hidradenitis suppurativa and metabolic syndrome.

Hidradenitis suppurativa manifests as extremely painful, chronic, scarring abscesses, cysts, nonhealing tracts, and localized infections affecting mostly intertriginous sites including the underarms, groin, and buttocks.

The GESUS study is funded by the Danish Agency for Science, Technology and Innovation. Dr. Miller reported having no financial conflicts. The German study was unsponsored.

PRAGUE – Patients with the common chronic inflammatory skin disease hidradenitis suppurativa have a sharply increased prevalence of metabolic syndrome, according to the results of three recent case-control studies.

"I think we can say that we have a uniform pattern from three studies showing hidradenitis suppurativa patients have increased risk for the metabolic syndrome, with odds ratios up to 5.8," Dr. Iben M. Miller said at the annual congress of the European Academy of Dermatology and Venereology.

"The implication is that we need to consider screening our hidradenitis suppurativa patients for cardiovascular risk factors, and – perhaps the most important and difficult thing – to help these patients with lifestyle interventions," added Dr. Miller, a dermatologist at the University of Copenhagen.

She presented updates on two case-control studies, which she is conducting in Denmark, as well as highlights from a third study recently published by dermatologists from the University Hospital Charitè in Berlin.

One of her studies included 374 patients with hidradenitis suppurativa and 15,000 controls drawn from the Danish General Suburban Population Study (GESUS), an ongoing study of the adults initiated in 2010, with enrollment at 15,500 and climbing. Participants are evaluated via detailed questionnaires, periodic physical examinations, and blood work.

All of the hidradenitis suppurativa study patients were adjusted for age, smoking status, and sex because patients with hidradenitis suppurativa are considerably younger, more likely to be female, and have a far greater prevalence of smoking than do control patients.

The hidradenitis suppurativa patients in GESUS proved to have an adjusted 2.35-fold greater likelihood of meeting criteria for metabolic syndrome than do control patients. They had a 2.79-fold increased odds of carrying the diagnosis of diabetes mellitus. They were also 2.36 times more likely to be obese and 2.33-fold more likely to have an increased waist circumference. The hidradenitis suppurativa group also was saddled with increased rates of hypertriglyceridemia and low HDL, with a mean serum triglyceride of 159 mg/dL, compared with 142 mg/dL in control patients, and a mean HDL of 51 mg/dL vs. 57 mg/dL in control patients.

The sole component of metabolic syndrome that was not more prominent in the hidradenitis suppurativa group was hypertension; the 16% increased prevalence of high blood pressure among patients with hidradenitis suppurativa didn’t achieve statistical significance, Dr. Miller noted.

The hidradenitis suppurativa group had an adjusted 1.69-fold greater prevalence of ischemic heart disease and a 1.14-fold greater likelihood of a history of stroke.

Dr. Miller’s second case-control study involved 31 Danish adults hospitalized for surgical treatment of hidradenitis suppurativa and the same 15,000 controls from GESUS. Of note, they were also significantly younger, with a mean age of 40.3 years, compared with 45.9 years in the population-based hidradenitis suppurativa cohort and 54.5 years in control patients. They were also more likely to be female and smokers than the 374 hidradenitis suppurativa patients drawn from GESUS.

The hospitalized hidradenitis suppurativa patients were an adjusted 5.8 times more likely to fulfill the criteria for metabolic syndrome than control patients. They also had a 5.47-fold increased risk of being diagnosed with diabetes. Their rates of all the other metabolic syndrome components were higher than in the GESUS hidradenitis suppurativa patients, as well. "I think that’s probably because the hospital cases have a greater degree of disease severity," said Dr. Miller.

The recently published German case-control study (PLoS ONE 7: e31810. [doi:10.1371/journal.pone.0031810]) included 80 patients hospitalized for surgical treatment of hidradenitis suppurativa and 100 age- and sex-matched controls. The prevalence of metabolic syndrome was 40% among the hidradenitis suppurativa cohort, compared with 13% in controls. The adjusted odds ratio was 4.46%.

The hidradenitis suppurativa group had a 5.88-fold increased likelihood of central obesity, a 4.09-fold greater rate of hyperglycemia, a 2.24-fold increase in hypertriglyceridemia, and 4.56-fold greater odds of low HDL.

An increased prevalence of metabolic syndrome has previously been shown in patients having other chronic inflammatory diseases, including psoriasis and rheumatoid arthritis. The German study provides the first published evidence that the same is true for hidradenitis suppurativa, a disease that affects up to 4% of the adult population, noted Dr. Miller.

The German dermatologists noted in their study results that the prevalence of metabolic syndrome and degree of metabolic derangement appear to be even greater among hidradenitis suppurativa patients than in those with psoriasis, particularly in light of the fact that patients with hidradenitis suppurativa tend to develop metabolic syndrome at a younger age.

As to the mechanism, the investigators reported that chronic inflammation may not be the driving force behind development of metabolic syndrome in patients with hidradenitis suppurativa. Just the opposite: They speculated that metabolic abnormalities may actually trigger hidradenitis suppurativa. Dr. Miller deemed that an intriguing hypothesis that’s far from proven.

Audience members said these cross-sectional case-control studies can’t demonstrate causality, which would require prospective studies. Dr. Miller agreed. "I think we should be careful about saying what causes what. We’ve shown an association. It could all be due to patient lifestyle. These patients do get depressed, and maybe they sit around at home and get obese, and those fat cells do make inflammatory cytokines," she said.

However, the GESUS study contains information on participants’ physical activity and diet that Dr. Miller is now analyzing. She believes the results will shed light on the mechanism underlying the association between hidradenitis suppurativa and metabolic syndrome.

Hidradenitis suppurativa manifests as extremely painful, chronic, scarring abscesses, cysts, nonhealing tracts, and localized infections affecting mostly intertriginous sites including the underarms, groin, and buttocks.

The GESUS study is funded by the Danish Agency for Science, Technology and Innovation. Dr. Miller reported having no financial conflicts. The German study was unsponsored.

PRAGUE – Patients with the common chronic inflammatory skin disease hidradenitis suppurativa have a sharply increased prevalence of metabolic syndrome, according to the results of three recent case-control studies.

"I think we can say that we have a uniform pattern from three studies showing hidradenitis suppurativa patients have increased risk for the metabolic syndrome, with odds ratios up to 5.8," Dr. Iben M. Miller said at the annual congress of the European Academy of Dermatology and Venereology.

"The implication is that we need to consider screening our hidradenitis suppurativa patients for cardiovascular risk factors, and – perhaps the most important and difficult thing – to help these patients with lifestyle interventions," added Dr. Miller, a dermatologist at the University of Copenhagen.

She presented updates on two case-control studies, which she is conducting in Denmark, as well as highlights from a third study recently published by dermatologists from the University Hospital Charitè in Berlin.

One of her studies included 374 patients with hidradenitis suppurativa and 15,000 controls drawn from the Danish General Suburban Population Study (GESUS), an ongoing study of the adults initiated in 2010, with enrollment at 15,500 and climbing. Participants are evaluated via detailed questionnaires, periodic physical examinations, and blood work.

All of the hidradenitis suppurativa study patients were adjusted for age, smoking status, and sex because patients with hidradenitis suppurativa are considerably younger, more likely to be female, and have a far greater prevalence of smoking than do control patients.

The hidradenitis suppurativa patients in GESUS proved to have an adjusted 2.35-fold greater likelihood of meeting criteria for metabolic syndrome than do control patients. They had a 2.79-fold increased odds of carrying the diagnosis of diabetes mellitus. They were also 2.36 times more likely to be obese and 2.33-fold more likely to have an increased waist circumference. The hidradenitis suppurativa group also was saddled with increased rates of hypertriglyceridemia and low HDL, with a mean serum triglyceride of 159 mg/dL, compared with 142 mg/dL in control patients, and a mean HDL of 51 mg/dL vs. 57 mg/dL in control patients.

The sole component of metabolic syndrome that was not more prominent in the hidradenitis suppurativa group was hypertension; the 16% increased prevalence of high blood pressure among patients with hidradenitis suppurativa didn’t achieve statistical significance, Dr. Miller noted.

The hidradenitis suppurativa group had an adjusted 1.69-fold greater prevalence of ischemic heart disease and a 1.14-fold greater likelihood of a history of stroke.

Dr. Miller’s second case-control study involved 31 Danish adults hospitalized for surgical treatment of hidradenitis suppurativa and the same 15,000 controls from GESUS. Of note, they were also significantly younger, with a mean age of 40.3 years, compared with 45.9 years in the population-based hidradenitis suppurativa cohort and 54.5 years in control patients. They were also more likely to be female and smokers than the 374 hidradenitis suppurativa patients drawn from GESUS.

The hospitalized hidradenitis suppurativa patients were an adjusted 5.8 times more likely to fulfill the criteria for metabolic syndrome than control patients. They also had a 5.47-fold increased risk of being diagnosed with diabetes. Their rates of all the other metabolic syndrome components were higher than in the GESUS hidradenitis suppurativa patients, as well. "I think that’s probably because the hospital cases have a greater degree of disease severity," said Dr. Miller.

The recently published German case-control study (PLoS ONE 7: e31810. [doi:10.1371/journal.pone.0031810]) included 80 patients hospitalized for surgical treatment of hidradenitis suppurativa and 100 age- and sex-matched controls. The prevalence of metabolic syndrome was 40% among the hidradenitis suppurativa cohort, compared with 13% in controls. The adjusted odds ratio was 4.46%.

The hidradenitis suppurativa group had a 5.88-fold increased likelihood of central obesity, a 4.09-fold greater rate of hyperglycemia, a 2.24-fold increase in hypertriglyceridemia, and 4.56-fold greater odds of low HDL.

An increased prevalence of metabolic syndrome has previously been shown in patients having other chronic inflammatory diseases, including psoriasis and rheumatoid arthritis. The German study provides the first published evidence that the same is true for hidradenitis suppurativa, a disease that affects up to 4% of the adult population, noted Dr. Miller.

The German dermatologists noted in their study results that the prevalence of metabolic syndrome and degree of metabolic derangement appear to be even greater among hidradenitis suppurativa patients than in those with psoriasis, particularly in light of the fact that patients with hidradenitis suppurativa tend to develop metabolic syndrome at a younger age.

As to the mechanism, the investigators reported that chronic inflammation may not be the driving force behind development of metabolic syndrome in patients with hidradenitis suppurativa. Just the opposite: They speculated that metabolic abnormalities may actually trigger hidradenitis suppurativa. Dr. Miller deemed that an intriguing hypothesis that’s far from proven.

Audience members said these cross-sectional case-control studies can’t demonstrate causality, which would require prospective studies. Dr. Miller agreed. "I think we should be careful about saying what causes what. We’ve shown an association. It could all be due to patient lifestyle. These patients do get depressed, and maybe they sit around at home and get obese, and those fat cells do make inflammatory cytokines," she said.

However, the GESUS study contains information on participants’ physical activity and diet that Dr. Miller is now analyzing. She believes the results will shed light on the mechanism underlying the association between hidradenitis suppurativa and metabolic syndrome.

Hidradenitis suppurativa manifests as extremely painful, chronic, scarring abscesses, cysts, nonhealing tracts, and localized infections affecting mostly intertriginous sites including the underarms, groin, and buttocks.

The GESUS study is funded by the Danish Agency for Science, Technology and Innovation. Dr. Miller reported having no financial conflicts. The German study was unsponsored.