Skin Disease Education Foundation (SDEF): Las Vegas Dermatology Seminar

When resurfacing the skin with nonablative, midinfrared fractional lasers, "don’t think you’re just going to set these devices to the highest [density] setting, and get the best results," Dr. Mathew Avram said at the SDEF Las Vegas Dermatology Seminar.

The percentage of skin in the treatment area that receives microscopic thermal wounds doesn’t necessarily translate to better results, said Dr. Avram, director of the dermatology laser and cosmetic center at Massachusetts General Hospital in Boston.

One study randomized 20 patients with hypertrophic scars to either 26% or 14% scar coverage with 40 mJ. Patients in the 14% group rated the results better at 3 months’ follow-up. "Low-density treatment is at least as effective as high-density treatment and [has] fewer side effects," the authors wrote (Lasers Surg. Med. 2011;43:265-72).

"If you did a lower-density [treatment]," Dr. Avram explained, "you got the same improvement as you did with a higher density, which is counterintuitive. You’d think the more damage you do the better, but basically all you get is more side effects" like pain, peeling, and inflammation. "Density is the key in terms of side effects and risk of hyperpigmentation."

Depth of treatment, which is determined by pulse energy, is another major consideration. "The pulse energy should reflect the pathology of the condition being treated," he said. With superficial pathology, photoaging, for instance,"you use a low pulse energy." With deeper pathology, such as deeper rhytides or traumatic scars, "you use higher pulse energy to penetrate more deeply. Adjust the depth of treatment and density for the pathology you are treating," Dr. Avram advised.

"You want to tell patients about procedural discomfort, side effects, and real expectations. It’s going to take multiple treatments, and these treatments will only partially improve fine to moderate wrinkles, pigmentation, and scars about 3 months after the time of treatment," he said.

Cold-air cooling is an option for anesthesia, as are topical lidocaine/tetracaine and locally injected anesthesia. The anesthetized area should be allowed to settle down a bit before the procedure to reduce the risk of ulceration, he said.

To prevent treatment-induced flares, Dr. Avram said he gives patients with histories of herpes labialis 500 mg of valacyclovir twice daily on the day before the procedure and continues this for about a week. Patients should also have been off isotretinoin for at least 6 months before treatment, he noted.

"I treat through skin type 6, but I’m very cautious doing it. I’m not so much worried about how deeply I’m treating, but I really dial back the density to avoid hyperpigmentation, and pretreat with hydroquinone, as well," he said.

For poikiloderma of Civatte, fractional lasers are more effective for pigment than erythema. Pulsed dye lasers are more effective for erythema. "You can do [the pulsed dye treatment] first, and then do the fractional resurfacing," he said.

Dr. Avram is a paid consultant to Zeltiq Aesthetics, Unilever, and Living Proof.

SDEF and this news organization are owned by Frontline Medical Communications.

When resurfacing the skin with nonablative, midinfrared fractional lasers, "don’t think you’re just going to set these devices to the highest [density] setting, and get the best results," Dr. Mathew Avram said at the SDEF Las Vegas Dermatology Seminar.

The percentage of skin in the treatment area that receives microscopic thermal wounds doesn’t necessarily translate to better results, said Dr. Avram, director of the dermatology laser and cosmetic center at Massachusetts General Hospital in Boston.

One study randomized 20 patients with hypertrophic scars to either 26% or 14% scar coverage with 40 mJ. Patients in the 14% group rated the results better at 3 months’ follow-up. "Low-density treatment is at least as effective as high-density treatment and [has] fewer side effects," the authors wrote (Lasers Surg. Med. 2011;43:265-72).

"If you did a lower-density [treatment]," Dr. Avram explained, "you got the same improvement as you did with a higher density, which is counterintuitive. You’d think the more damage you do the better, but basically all you get is more side effects" like pain, peeling, and inflammation. "Density is the key in terms of side effects and risk of hyperpigmentation."

Depth of treatment, which is determined by pulse energy, is another major consideration. "The pulse energy should reflect the pathology of the condition being treated," he said. With superficial pathology, photoaging, for instance,"you use a low pulse energy." With deeper pathology, such as deeper rhytides or traumatic scars, "you use higher pulse energy to penetrate more deeply. Adjust the depth of treatment and density for the pathology you are treating," Dr. Avram advised.

"You want to tell patients about procedural discomfort, side effects, and real expectations. It’s going to take multiple treatments, and these treatments will only partially improve fine to moderate wrinkles, pigmentation, and scars about 3 months after the time of treatment," he said.

Cold-air cooling is an option for anesthesia, as are topical lidocaine/tetracaine and locally injected anesthesia. The anesthetized area should be allowed to settle down a bit before the procedure to reduce the risk of ulceration, he said.

To prevent treatment-induced flares, Dr. Avram said he gives patients with histories of herpes labialis 500 mg of valacyclovir twice daily on the day before the procedure and continues this for about a week. Patients should also have been off isotretinoin for at least 6 months before treatment, he noted.

"I treat through skin type 6, but I’m very cautious doing it. I’m not so much worried about how deeply I’m treating, but I really dial back the density to avoid hyperpigmentation, and pretreat with hydroquinone, as well," he said.

For poikiloderma of Civatte, fractional lasers are more effective for pigment than erythema. Pulsed dye lasers are more effective for erythema. "You can do [the pulsed dye treatment] first, and then do the fractional resurfacing," he said.

Dr. Avram is a paid consultant to Zeltiq Aesthetics, Unilever, and Living Proof.

SDEF and this news organization are owned by Frontline Medical Communications.

When resurfacing the skin with nonablative, midinfrared fractional lasers, "don’t think you’re just going to set these devices to the highest [density] setting, and get the best results," Dr. Mathew Avram said at the SDEF Las Vegas Dermatology Seminar.

The percentage of skin in the treatment area that receives microscopic thermal wounds doesn’t necessarily translate to better results, said Dr. Avram, director of the dermatology laser and cosmetic center at Massachusetts General Hospital in Boston.

One study randomized 20 patients with hypertrophic scars to either 26% or 14% scar coverage with 40 mJ. Patients in the 14% group rated the results better at 3 months’ follow-up. "Low-density treatment is at least as effective as high-density treatment and [has] fewer side effects," the authors wrote (Lasers Surg. Med. 2011;43:265-72).

"If you did a lower-density [treatment]," Dr. Avram explained, "you got the same improvement as you did with a higher density, which is counterintuitive. You’d think the more damage you do the better, but basically all you get is more side effects" like pain, peeling, and inflammation. "Density is the key in terms of side effects and risk of hyperpigmentation."

Depth of treatment, which is determined by pulse energy, is another major consideration. "The pulse energy should reflect the pathology of the condition being treated," he said. With superficial pathology, photoaging, for instance,"you use a low pulse energy." With deeper pathology, such as deeper rhytides or traumatic scars, "you use higher pulse energy to penetrate more deeply. Adjust the depth of treatment and density for the pathology you are treating," Dr. Avram advised.

"You want to tell patients about procedural discomfort, side effects, and real expectations. It’s going to take multiple treatments, and these treatments will only partially improve fine to moderate wrinkles, pigmentation, and scars about 3 months after the time of treatment," he said.

Cold-air cooling is an option for anesthesia, as are topical lidocaine/tetracaine and locally injected anesthesia. The anesthetized area should be allowed to settle down a bit before the procedure to reduce the risk of ulceration, he said.

To prevent treatment-induced flares, Dr. Avram said he gives patients with histories of herpes labialis 500 mg of valacyclovir twice daily on the day before the procedure and continues this for about a week. Patients should also have been off isotretinoin for at least 6 months before treatment, he noted.

"I treat through skin type 6, but I’m very cautious doing it. I’m not so much worried about how deeply I’m treating, but I really dial back the density to avoid hyperpigmentation, and pretreat with hydroquinone, as well," he said.

For poikiloderma of Civatte, fractional lasers are more effective for pigment than erythema. Pulsed dye lasers are more effective for erythema. "You can do [the pulsed dye treatment] first, and then do the fractional resurfacing," he said.

Dr. Avram is a paid consultant to Zeltiq Aesthetics, Unilever, and Living Proof.

SDEF and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – If psoriasis patients don’t improve after 2 months of methotrexate therapy, the drug’s probably not going to work, according to Dr. Bruce Strober, of the University of Connecticut in Farmington.

But "don’t give up" if there’s even a slight improvement at that point. Up to 45% of patients achieve psoriasis area and severity index (PASI) scores of 75 on methotrexate, but "you really have to allow the drug 24 weeks to see that. If you see any hint of efficacy, keep going," he said at the SDEF Las Vegas Dermatology Seminar.

Dr. Strober shared insights about using methotrexate culled from more than a decade of experience. He starts most patients on 15 mg/week, but smaller people at perhaps 10-12.5 mg. He’ll dose down the elderly, as well, if he suspects renal insufficiency.

"I give it all in one dose, except if it’s at 17.5 mg or more per week, then I will divide the dose, either half in the morning, half at night," or a few days apart. "I never do the q [every] 12 hours x 3-day dosing. It’s based on no science, and you don’t have to make your patient’s life so hard," he said.

Not infrequently, Dr. Strober has patients self-inject a subcutaneous formulation in lieu of oral therapy. "It likely has better bioavailability and efficacy, [and] studies suggest avoiding first pass metabolism" is safer for the liver. Liver toxicity will be a problem in up to a quarter of patients, with the obese perhaps facing a higher risk. As with CBC and renal function, monthly liver testing is a must with methotrexate, at least for the first year.

"I don’t do liver biopsies anymore. I think it’s an extremely poor test laden with sampling error, and it has its own risks," he said. Instead, "I use liver function tests pretty exclusively" to look for marked, persistent LFT [liver function test] elevations above baseline, even if patients stay in the normal range. "Not uncommonly, a patient’s LFT could be 15 over 16 AST [aspartate aminotransferase] over ALT [alanine aminotransferase], and then 3 months into methotrexate, 45 over 42. It might be in the normal range, but I think that should give you pause. You caused a threefold increase in the liver tests," he said.

"Liver-induced changes are reversible if you react early enough by reducing the dose or just stopping the drug," Dr. Strober said.

Folate supplementation helps to protect the liver and reduce GI side effects. Dr. Strober often adds folinic acid, three 5 mg-doses per week, if GI side effects persist with folic acid alone. It’s as effective as folic acid, but "folic acid is cheaper. That’s why I start with it," he said.

The risk of pancytopenia is increased with poor renal function or use of sulfonamide-based antibiotics. "Monitor the CBC closely in the first few visits. You need folinic acid for rescue if it becomes a problem," he said.

Dr. Strober is on the advisory board of or a consultant to several pharmaceutical companies, including Janssen, Abbott, Pfizer, and Amgen. SDEF and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – If psoriasis patients don’t improve after 2 months of methotrexate therapy, the drug’s probably not going to work, according to Dr. Bruce Strober, of the University of Connecticut in Farmington.

But "don’t give up" if there’s even a slight improvement at that point. Up to 45% of patients achieve psoriasis area and severity index (PASI) scores of 75 on methotrexate, but "you really have to allow the drug 24 weeks to see that. If you see any hint of efficacy, keep going," he said at the SDEF Las Vegas Dermatology Seminar.

Dr. Strober shared insights about using methotrexate culled from more than a decade of experience. He starts most patients on 15 mg/week, but smaller people at perhaps 10-12.5 mg. He’ll dose down the elderly, as well, if he suspects renal insufficiency.

"I give it all in one dose, except if it’s at 17.5 mg or more per week, then I will divide the dose, either half in the morning, half at night," or a few days apart. "I never do the q [every] 12 hours x 3-day dosing. It’s based on no science, and you don’t have to make your patient’s life so hard," he said.

Not infrequently, Dr. Strober has patients self-inject a subcutaneous formulation in lieu of oral therapy. "It likely has better bioavailability and efficacy, [and] studies suggest avoiding first pass metabolism" is safer for the liver. Liver toxicity will be a problem in up to a quarter of patients, with the obese perhaps facing a higher risk. As with CBC and renal function, monthly liver testing is a must with methotrexate, at least for the first year.

"I don’t do liver biopsies anymore. I think it’s an extremely poor test laden with sampling error, and it has its own risks," he said. Instead, "I use liver function tests pretty exclusively" to look for marked, persistent LFT [liver function test] elevations above baseline, even if patients stay in the normal range. "Not uncommonly, a patient’s LFT could be 15 over 16 AST [aspartate aminotransferase] over ALT [alanine aminotransferase], and then 3 months into methotrexate, 45 over 42. It might be in the normal range, but I think that should give you pause. You caused a threefold increase in the liver tests," he said.

"Liver-induced changes are reversible if you react early enough by reducing the dose or just stopping the drug," Dr. Strober said.

Folate supplementation helps to protect the liver and reduce GI side effects. Dr. Strober often adds folinic acid, three 5 mg-doses per week, if GI side effects persist with folic acid alone. It’s as effective as folic acid, but "folic acid is cheaper. That’s why I start with it," he said.

The risk of pancytopenia is increased with poor renal function or use of sulfonamide-based antibiotics. "Monitor the CBC closely in the first few visits. You need folinic acid for rescue if it becomes a problem," he said.

Dr. Strober is on the advisory board of or a consultant to several pharmaceutical companies, including Janssen, Abbott, Pfizer, and Amgen. SDEF and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – If psoriasis patients don’t improve after 2 months of methotrexate therapy, the drug’s probably not going to work, according to Dr. Bruce Strober, of the University of Connecticut in Farmington.

But "don’t give up" if there’s even a slight improvement at that point. Up to 45% of patients achieve psoriasis area and severity index (PASI) scores of 75 on methotrexate, but "you really have to allow the drug 24 weeks to see that. If you see any hint of efficacy, keep going," he said at the SDEF Las Vegas Dermatology Seminar.

Dr. Strober shared insights about using methotrexate culled from more than a decade of experience. He starts most patients on 15 mg/week, but smaller people at perhaps 10-12.5 mg. He’ll dose down the elderly, as well, if he suspects renal insufficiency.

"I give it all in one dose, except if it’s at 17.5 mg or more per week, then I will divide the dose, either half in the morning, half at night," or a few days apart. "I never do the q [every] 12 hours x 3-day dosing. It’s based on no science, and you don’t have to make your patient’s life so hard," he said.

Not infrequently, Dr. Strober has patients self-inject a subcutaneous formulation in lieu of oral therapy. "It likely has better bioavailability and efficacy, [and] studies suggest avoiding first pass metabolism" is safer for the liver. Liver toxicity will be a problem in up to a quarter of patients, with the obese perhaps facing a higher risk. As with CBC and renal function, monthly liver testing is a must with methotrexate, at least for the first year.

"I don’t do liver biopsies anymore. I think it’s an extremely poor test laden with sampling error, and it has its own risks," he said. Instead, "I use liver function tests pretty exclusively" to look for marked, persistent LFT [liver function test] elevations above baseline, even if patients stay in the normal range. "Not uncommonly, a patient’s LFT could be 15 over 16 AST [aspartate aminotransferase] over ALT [alanine aminotransferase], and then 3 months into methotrexate, 45 over 42. It might be in the normal range, but I think that should give you pause. You caused a threefold increase in the liver tests," he said.

"Liver-induced changes are reversible if you react early enough by reducing the dose or just stopping the drug," Dr. Strober said.

Folate supplementation helps to protect the liver and reduce GI side effects. Dr. Strober often adds folinic acid, three 5 mg-doses per week, if GI side effects persist with folic acid alone. It’s as effective as folic acid, but "folic acid is cheaper. That’s why I start with it," he said.

The risk of pancytopenia is increased with poor renal function or use of sulfonamide-based antibiotics. "Monitor the CBC closely in the first few visits. You need folinic acid for rescue if it becomes a problem," he said.

Dr. Strober is on the advisory board of or a consultant to several pharmaceutical companies, including Janssen, Abbott, Pfizer, and Amgen. SDEF and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – To prevent immunogenicity to biologics, it’s best to have psoriasis patients on methotrexate at baseline, according to Dr. Bruce Strober of the University of Connecticut, Farmington.

Once patients develop antibodies to a biologic, “the horse is already out of the barn. It may be too late to recover efficacy by adding methotrexate,” Dr. Strober said. “Add the biologic to the methotrexate, not visa versa” (Br. J. Dermatol. 2012;167:649-57).

Anti–tumor necrosis factors and other biologics often lose their effects as patients build antibodies to the foreign proteins they contain. “Drug levels fall off a cliff when you have a lot of immunogenicity. The major challenge [is] making sure patients 1-3 years out see the response they got in the first 6 months,” Dr. Strober said at the SDEF Las Vegas Dermatology Seminar.

Methotrexate is thought to diminish the antibody response, blocking immunogenicity. “Biologics invariably show greater and more durable efficacy” with methotrexate “even when methotrexate is ineffective on its own,” he said. When oral therapy is indicated, Dr. Strober said he starts most of his psoriasis patients on about 15 mg/wk and waits 8-12 weeks to see whether this works. If there is no response, he will add a biologic and continue the methotrexate.

The dose of methotrexate needed to tame the antibody response remains unclear. “The consensus in the rheumatology world is somewhere around 15 mg weekly, but I don’t always use that dose. I will go down to 7.5 mg to 12.5 mg in many patients,” said Dr. Strober. “It appears anecdotally that there’s good protection of the [biologic] response with those doses. It’s something you might vary based on the size of the patient,” he said. “Episodic dosing gives you the greatest percent of patients getting antibodies, [so] dose biologics without interruption if you can,” he added (J. Am. Acad. Dermatol. 2007;56:31.e1-15).

Immunogenicity to one biologic does not necessarily translate to immunogenicity to another. Also, increasing infusion frequency can help recapture a biologic’s effect, he noted.

SDEF and this news organization are owned by Frontline Medical Communications. Dr. Strober is on the advisory board of or a consultant to several pharmaceutical companies, including Janssen, Abbott, Pfizer, and Amgen.

LAS VEGAS – To prevent immunogenicity to biologics, it’s best to have psoriasis patients on methotrexate at baseline, according to Dr. Bruce Strober of the University of Connecticut, Farmington.

Once patients develop antibodies to a biologic, “the horse is already out of the barn. It may be too late to recover efficacy by adding methotrexate,” Dr. Strober said. “Add the biologic to the methotrexate, not visa versa” (Br. J. Dermatol. 2012;167:649-57).

Anti–tumor necrosis factors and other biologics often lose their effects as patients build antibodies to the foreign proteins they contain. “Drug levels fall off a cliff when you have a lot of immunogenicity. The major challenge [is] making sure patients 1-3 years out see the response they got in the first 6 months,” Dr. Strober said at the SDEF Las Vegas Dermatology Seminar.

Methotrexate is thought to diminish the antibody response, blocking immunogenicity. “Biologics invariably show greater and more durable efficacy” with methotrexate “even when methotrexate is ineffective on its own,” he said. When oral therapy is indicated, Dr. Strober said he starts most of his psoriasis patients on about 15 mg/wk and waits 8-12 weeks to see whether this works. If there is no response, he will add a biologic and continue the methotrexate.

The dose of methotrexate needed to tame the antibody response remains unclear. “The consensus in the rheumatology world is somewhere around 15 mg weekly, but I don’t always use that dose. I will go down to 7.5 mg to 12.5 mg in many patients,” said Dr. Strober. “It appears anecdotally that there’s good protection of the [biologic] response with those doses. It’s something you might vary based on the size of the patient,” he said. “Episodic dosing gives you the greatest percent of patients getting antibodies, [so] dose biologics without interruption if you can,” he added (J. Am. Acad. Dermatol. 2007;56:31.e1-15).

Immunogenicity to one biologic does not necessarily translate to immunogenicity to another. Also, increasing infusion frequency can help recapture a biologic’s effect, he noted.

SDEF and this news organization are owned by Frontline Medical Communications. Dr. Strober is on the advisory board of or a consultant to several pharmaceutical companies, including Janssen, Abbott, Pfizer, and Amgen.

LAS VEGAS – To prevent immunogenicity to biologics, it’s best to have psoriasis patients on methotrexate at baseline, according to Dr. Bruce Strober of the University of Connecticut, Farmington.

Once patients develop antibodies to a biologic, “the horse is already out of the barn. It may be too late to recover efficacy by adding methotrexate,” Dr. Strober said. “Add the biologic to the methotrexate, not visa versa” (Br. J. Dermatol. 2012;167:649-57).

Anti–tumor necrosis factors and other biologics often lose their effects as patients build antibodies to the foreign proteins they contain. “Drug levels fall off a cliff when you have a lot of immunogenicity. The major challenge [is] making sure patients 1-3 years out see the response they got in the first 6 months,” Dr. Strober said at the SDEF Las Vegas Dermatology Seminar.

Methotrexate is thought to diminish the antibody response, blocking immunogenicity. “Biologics invariably show greater and more durable efficacy” with methotrexate “even when methotrexate is ineffective on its own,” he said. When oral therapy is indicated, Dr. Strober said he starts most of his psoriasis patients on about 15 mg/wk and waits 8-12 weeks to see whether this works. If there is no response, he will add a biologic and continue the methotrexate.

The dose of methotrexate needed to tame the antibody response remains unclear. “The consensus in the rheumatology world is somewhere around 15 mg weekly, but I don’t always use that dose. I will go down to 7.5 mg to 12.5 mg in many patients,” said Dr. Strober. “It appears anecdotally that there’s good protection of the [biologic] response with those doses. It’s something you might vary based on the size of the patient,” he said. “Episodic dosing gives you the greatest percent of patients getting antibodies, [so] dose biologics without interruption if you can,” he added (J. Am. Acad. Dermatol. 2007;56:31.e1-15).

Immunogenicity to one biologic does not necessarily translate to immunogenicity to another. Also, increasing infusion frequency can help recapture a biologic’s effect, he noted.

SDEF and this news organization are owned by Frontline Medical Communications. Dr. Strober is on the advisory board of or a consultant to several pharmaceutical companies, including Janssen, Abbott, Pfizer, and Amgen.

LAS VEGAS – It’s probably best to treat one area during an initial cryolipolysis session and wait "2-3 months to see what clinical benefits you have" before the next treatment, according to Dr. Mathew Avram.

"If patients are going to get another treatment, I want them to be happy with the first one," he said. Cryolipolysis is expensive, and "there are definitely patients who do not respond."

Also, "you’ll get down a little deeper to cells that weren’t reached" during the first treatment if inflammation and dead fat cells are given a chance to dissipate before the next treatment. "If you wait 2 or 3 months, I think you’ll get a better end-result," said Dr. Avram, director of the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital in Boston.

Most patients can expect a small but noticeable difference with the procedure. "It’s not a home run," but it’s helpful for areas "that you can’t really get rid of with diet and exercise," he said at the SDEF Las Vegas Dermatology Seminar.

The study that earned cryolipolysis (CoolSculpting – Zeltiq Aesthetics Inc.) Food and Drug Administration clearance found that one session decreased love-handle fat layer thickness by 22.7% in 32 patients. One side was treated in each patient, with the other side used as a control. Results were assessed by high-resolution ultrasound and histology at 4 months.

"Most people come in for a little bit of protrusion in the lower abdomen. Two to three months later, they’ll see a small but noticeable decrease," said Dr. Avram, who’s also treated gynecomastia, the upper back, and other areas over the past 3 years.

But "this does not compare to liposuction. This is a much more modest amount of fat removal," he said.

CoolSculpting takes about 1-3 hours and does not require close supervision once the cooling device is placed. The procedure is thought to crystalize lipids in subcutaneous fat cells at near-freezing temperatures, causing their death without damaging the skin. Fat "feels like slush underneath the skin" after treatment, and patients can expect some redness, numbness, and bruising where the device was applied.

Overall, it’s "typically very mild – not a very painful treatment." Postprocedure massage may improve clinical results [although] "there are no hard data to show that," Dr. Avram said.

The areas that respond best are "grabbable areas of fat" because the cooling applicator is not contoured to curved areas like the buttocks, though Zeltiq is working to address the problem, he said.

"The posterior upper arms don’t do as well either. Typically both laxity and fat are involved, and sometimes you can get a little problem with the nerve root there," he said.

The procedure does not change skin pigmentation, but rarely patients can experience significant pain 3-7 days following treatment that resolves with no sequelae. Even more rarely, there can be a paradoxical fat increase in the treated area 3-5 months later, Dr. Avram said.

Cold-air urticaria, cryoglobulinemia, and hernia are all contraindications.

SDEF and this news organization are owned by Frontline Medical Communications. Dr. Avram is on the scientific advisory board of Zeltiq and is a paid consultant to the company.

LAS VEGAS – It’s probably best to treat one area during an initial cryolipolysis session and wait "2-3 months to see what clinical benefits you have" before the next treatment, according to Dr. Mathew Avram.

"If patients are going to get another treatment, I want them to be happy with the first one," he said. Cryolipolysis is expensive, and "there are definitely patients who do not respond."

Also, "you’ll get down a little deeper to cells that weren’t reached" during the first treatment if inflammation and dead fat cells are given a chance to dissipate before the next treatment. "If you wait 2 or 3 months, I think you’ll get a better end-result," said Dr. Avram, director of the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital in Boston.

Most patients can expect a small but noticeable difference with the procedure. "It’s not a home run," but it’s helpful for areas "that you can’t really get rid of with diet and exercise," he said at the SDEF Las Vegas Dermatology Seminar.

The study that earned cryolipolysis (CoolSculpting – Zeltiq Aesthetics Inc.) Food and Drug Administration clearance found that one session decreased love-handle fat layer thickness by 22.7% in 32 patients. One side was treated in each patient, with the other side used as a control. Results were assessed by high-resolution ultrasound and histology at 4 months.

"Most people come in for a little bit of protrusion in the lower abdomen. Two to three months later, they’ll see a small but noticeable decrease," said Dr. Avram, who’s also treated gynecomastia, the upper back, and other areas over the past 3 years.

But "this does not compare to liposuction. This is a much more modest amount of fat removal," he said.

CoolSculpting takes about 1-3 hours and does not require close supervision once the cooling device is placed. The procedure is thought to crystalize lipids in subcutaneous fat cells at near-freezing temperatures, causing their death without damaging the skin. Fat "feels like slush underneath the skin" after treatment, and patients can expect some redness, numbness, and bruising where the device was applied.

Overall, it’s "typically very mild – not a very painful treatment." Postprocedure massage may improve clinical results [although] "there are no hard data to show that," Dr. Avram said.

The areas that respond best are "grabbable areas of fat" because the cooling applicator is not contoured to curved areas like the buttocks, though Zeltiq is working to address the problem, he said.

"The posterior upper arms don’t do as well either. Typically both laxity and fat are involved, and sometimes you can get a little problem with the nerve root there," he said.

The procedure does not change skin pigmentation, but rarely patients can experience significant pain 3-7 days following treatment that resolves with no sequelae. Even more rarely, there can be a paradoxical fat increase in the treated area 3-5 months later, Dr. Avram said.

Cold-air urticaria, cryoglobulinemia, and hernia are all contraindications.

SDEF and this news organization are owned by Frontline Medical Communications. Dr. Avram is on the scientific advisory board of Zeltiq and is a paid consultant to the company.

LAS VEGAS – It’s probably best to treat one area during an initial cryolipolysis session and wait "2-3 months to see what clinical benefits you have" before the next treatment, according to Dr. Mathew Avram.

"If patients are going to get another treatment, I want them to be happy with the first one," he said. Cryolipolysis is expensive, and "there are definitely patients who do not respond."

Also, "you’ll get down a little deeper to cells that weren’t reached" during the first treatment if inflammation and dead fat cells are given a chance to dissipate before the next treatment. "If you wait 2 or 3 months, I think you’ll get a better end-result," said Dr. Avram, director of the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital in Boston.

Most patients can expect a small but noticeable difference with the procedure. "It’s not a home run," but it’s helpful for areas "that you can’t really get rid of with diet and exercise," he said at the SDEF Las Vegas Dermatology Seminar.

The study that earned cryolipolysis (CoolSculpting – Zeltiq Aesthetics Inc.) Food and Drug Administration clearance found that one session decreased love-handle fat layer thickness by 22.7% in 32 patients. One side was treated in each patient, with the other side used as a control. Results were assessed by high-resolution ultrasound and histology at 4 months.

"Most people come in for a little bit of protrusion in the lower abdomen. Two to three months later, they’ll see a small but noticeable decrease," said Dr. Avram, who’s also treated gynecomastia, the upper back, and other areas over the past 3 years.

But "this does not compare to liposuction. This is a much more modest amount of fat removal," he said.

CoolSculpting takes about 1-3 hours and does not require close supervision once the cooling device is placed. The procedure is thought to crystalize lipids in subcutaneous fat cells at near-freezing temperatures, causing their death without damaging the skin. Fat "feels like slush underneath the skin" after treatment, and patients can expect some redness, numbness, and bruising where the device was applied.

Overall, it’s "typically very mild – not a very painful treatment." Postprocedure massage may improve clinical results [although] "there are no hard data to show that," Dr. Avram said.

The areas that respond best are "grabbable areas of fat" because the cooling applicator is not contoured to curved areas like the buttocks, though Zeltiq is working to address the problem, he said.

"The posterior upper arms don’t do as well either. Typically both laxity and fat are involved, and sometimes you can get a little problem with the nerve root there," he said.

The procedure does not change skin pigmentation, but rarely patients can experience significant pain 3-7 days following treatment that resolves with no sequelae. Even more rarely, there can be a paradoxical fat increase in the treated area 3-5 months later, Dr. Avram said.

Cold-air urticaria, cryoglobulinemia, and hernia are all contraindications.

SDEF and this news organization are owned by Frontline Medical Communications. Dr. Avram is on the scientific advisory board of Zeltiq and is a paid consultant to the company.

LAS VEGAS – Acne patients need to know it’s a bad idea to spot-treat comedones with topical retinoids, according to Dr. Linda F. Stein Gold.

"We have to educate our patients that if they spot treat, they’re going to have acne indefinitely until their body decides it’s done having acne," she said. "You have to educate them that they have to treat the entire acne-prone area and [keep treating it] to maintain remission. Their skin may look clear, but they are not cured."

Topical retinoids remain the gold standard for acne treatment. They clear and prevent comedones, help clindamycin and other antibiotics penetrate the skin, and calm inflammation, which is probably the initial step in acne’s development, noted Dr. Stein Gold, director of dermatology research at Henry Ford Hospital, Detroit.

Microsphere and micronized tretinoin gel formulations are less irritating than generic topical tretinoin, and they’re less apt to be deactivated by benzoyl peroxide and ultraviolet light, she said at SDEF Las Vegas Dermatology Seminar.

One of the newer topicals combines benzoyl peroxide and a retinoid stable in its presence, adapalene. One study found about a 70% reduction in lesions after 4 months of use (J. Drugs Dermatol. 2007;6:899-905). With that topical combination and other acne treatments, patients should be told that it may take a while to see maximal improvements, she said.

With any retinoid treatment, patients should also expect flare-ups of redness, irritation, and dryness in the first 2 weeks. "If I’m concerned about irritation, I’ll ask them to go every other night for the first 2 weeks until they adjust to the medication, and then titrate up to every night," Dr. Stein Gold noted. "I also have them use a moisturizer and general cleanser." But she tells them not to use facial scrubs, because scrubbing does "more harm than good."

Benzoil peroxide also remains important, either alone or in combination, because Propionibacterium acnes bacteria do not develop resistance to it, and it helps prevent resistance when used with antibiotics.

"You get a nice reduction both in inflammatory and noninflammatory lesions with benzoil peroxide," she said, but patients should be warned about possible skin bleaching.

The concentration of benzoyl peroxide isn’t that important, Dr. Stein Gold explained. "We know that 2.5% and 10% gels have fairly similar efficacy," she added (Int. J. Dermatol. 1986;25:664-7).

Benzoil peroxide gels are known to work well, although foams and cleansers are available for patients who find them too irritating. Cleansers appear most effective at reducing P. acnes on the face, as long as patients wait 20 seconds before rinsing. One study found foams effective on the back when massaged into dry skin for 20 seconds and patients waited 2 minutes before showering (J. Drugs Dermatol. 2012;11:830-3).

Whatever the treatment, Dr. Stein Gold noted, "stress compliance. My first question is, ‘Did you get a chance to fill your medicine?’ and then, ‘How many times do you think you got a chance to use it?’ "

She cautioned physicians to "have no expectations" – that way, patients won’t be afraid to admit that they only used it once or twice. Whatever their usage, "you say, ‘Great. Good for you. Keep on going.’ "

In addition, "the simpler you make the regimen, the more likely it is your patients are going to" stick with it, Dr. Stein Gold explained.

Dr. Stein Gold is a consultant or researcher for Galderma, Leo, Medicis, Novartis, and Stiefel. SDEF and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Acne patients need to know it’s a bad idea to spot-treat comedones with topical retinoids, according to Dr. Linda F. Stein Gold.

"We have to educate our patients that if they spot treat, they’re going to have acne indefinitely until their body decides it’s done having acne," she said. "You have to educate them that they have to treat the entire acne-prone area and [keep treating it] to maintain remission. Their skin may look clear, but they are not cured."

Topical retinoids remain the gold standard for acne treatment. They clear and prevent comedones, help clindamycin and other antibiotics penetrate the skin, and calm inflammation, which is probably the initial step in acne’s development, noted Dr. Stein Gold, director of dermatology research at Henry Ford Hospital, Detroit.

Microsphere and micronized tretinoin gel formulations are less irritating than generic topical tretinoin, and they’re less apt to be deactivated by benzoyl peroxide and ultraviolet light, she said at SDEF Las Vegas Dermatology Seminar.

One of the newer topicals combines benzoyl peroxide and a retinoid stable in its presence, adapalene. One study found about a 70% reduction in lesions after 4 months of use (J. Drugs Dermatol. 2007;6:899-905). With that topical combination and other acne treatments, patients should be told that it may take a while to see maximal improvements, she said.

With any retinoid treatment, patients should also expect flare-ups of redness, irritation, and dryness in the first 2 weeks. "If I’m concerned about irritation, I’ll ask them to go every other night for the first 2 weeks until they adjust to the medication, and then titrate up to every night," Dr. Stein Gold noted. "I also have them use a moisturizer and general cleanser." But she tells them not to use facial scrubs, because scrubbing does "more harm than good."

Benzoil peroxide also remains important, either alone or in combination, because Propionibacterium acnes bacteria do not develop resistance to it, and it helps prevent resistance when used with antibiotics.

"You get a nice reduction both in inflammatory and noninflammatory lesions with benzoil peroxide," she said, but patients should be warned about possible skin bleaching.

The concentration of benzoyl peroxide isn’t that important, Dr. Stein Gold explained. "We know that 2.5% and 10% gels have fairly similar efficacy," she added (Int. J. Dermatol. 1986;25:664-7).

Benzoil peroxide gels are known to work well, although foams and cleansers are available for patients who find them too irritating. Cleansers appear most effective at reducing P. acnes on the face, as long as patients wait 20 seconds before rinsing. One study found foams effective on the back when massaged into dry skin for 20 seconds and patients waited 2 minutes before showering (J. Drugs Dermatol. 2012;11:830-3).

Whatever the treatment, Dr. Stein Gold noted, "stress compliance. My first question is, ‘Did you get a chance to fill your medicine?’ and then, ‘How many times do you think you got a chance to use it?’ "

She cautioned physicians to "have no expectations" – that way, patients won’t be afraid to admit that they only used it once or twice. Whatever their usage, "you say, ‘Great. Good for you. Keep on going.’ "

In addition, "the simpler you make the regimen, the more likely it is your patients are going to" stick with it, Dr. Stein Gold explained.

Dr. Stein Gold is a consultant or researcher for Galderma, Leo, Medicis, Novartis, and Stiefel. SDEF and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Acne patients need to know it’s a bad idea to spot-treat comedones with topical retinoids, according to Dr. Linda F. Stein Gold.

"We have to educate our patients that if they spot treat, they’re going to have acne indefinitely until their body decides it’s done having acne," she said. "You have to educate them that they have to treat the entire acne-prone area and [keep treating it] to maintain remission. Their skin may look clear, but they are not cured."

Topical retinoids remain the gold standard for acne treatment. They clear and prevent comedones, help clindamycin and other antibiotics penetrate the skin, and calm inflammation, which is probably the initial step in acne’s development, noted Dr. Stein Gold, director of dermatology research at Henry Ford Hospital, Detroit.

Microsphere and micronized tretinoin gel formulations are less irritating than generic topical tretinoin, and they’re less apt to be deactivated by benzoyl peroxide and ultraviolet light, she said at SDEF Las Vegas Dermatology Seminar.

One of the newer topicals combines benzoyl peroxide and a retinoid stable in its presence, adapalene. One study found about a 70% reduction in lesions after 4 months of use (J. Drugs Dermatol. 2007;6:899-905). With that topical combination and other acne treatments, patients should be told that it may take a while to see maximal improvements, she said.

With any retinoid treatment, patients should also expect flare-ups of redness, irritation, and dryness in the first 2 weeks. "If I’m concerned about irritation, I’ll ask them to go every other night for the first 2 weeks until they adjust to the medication, and then titrate up to every night," Dr. Stein Gold noted. "I also have them use a moisturizer and general cleanser." But she tells them not to use facial scrubs, because scrubbing does "more harm than good."

Benzoil peroxide also remains important, either alone or in combination, because Propionibacterium acnes bacteria do not develop resistance to it, and it helps prevent resistance when used with antibiotics.

"You get a nice reduction both in inflammatory and noninflammatory lesions with benzoil peroxide," she said, but patients should be warned about possible skin bleaching.

The concentration of benzoyl peroxide isn’t that important, Dr. Stein Gold explained. "We know that 2.5% and 10% gels have fairly similar efficacy," she added (Int. J. Dermatol. 1986;25:664-7).

Benzoil peroxide gels are known to work well, although foams and cleansers are available for patients who find them too irritating. Cleansers appear most effective at reducing P. acnes on the face, as long as patients wait 20 seconds before rinsing. One study found foams effective on the back when massaged into dry skin for 20 seconds and patients waited 2 minutes before showering (J. Drugs Dermatol. 2012;11:830-3).

Whatever the treatment, Dr. Stein Gold noted, "stress compliance. My first question is, ‘Did you get a chance to fill your medicine?’ and then, ‘How many times do you think you got a chance to use it?’ "

She cautioned physicians to "have no expectations" – that way, patients won’t be afraid to admit that they only used it once or twice. Whatever their usage, "you say, ‘Great. Good for you. Keep on going.’ "

In addition, "the simpler you make the regimen, the more likely it is your patients are going to" stick with it, Dr. Stein Gold explained.

Dr. Stein Gold is a consultant or researcher for Galderma, Leo, Medicis, Novartis, and Stiefel. SDEF and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Acne patients treated with oral antibiotics don’t necessarily need to stay on them for more than 3 months, according to Dr. Joshua Zeichner.

"Even if you are initially treating them with an oral antibiotic for severe acne, you can maintain them after about 12 weeks just on a topical therapy like tazarotene, explained Dr. Zeichner, director of cosmetic and clinical research in the dermatology department at Mt. Sinai Medical Center in New York. "You don’t necessarily need to keep your patients on oral antibiotics for long periods of time."

To prevent resistance and other problems, "try to limit use to about 3 months, and think about maintenance using just a topical therapy," he said at the Las Vegas Dermatology seminar, sponsored by the Skin Disease Education Foundation.

Several studies prove the point. In one, 189 patients with severe acne received 0.1% tazarotene gel each evening and 100 mg minocycline twice daily for 12 weeks. The 110 (58%) with at least a 75% global improvement were then assigned to 12 weeks of maintenance with tazarotene gel, minocycline, or tazarotene plus minocycline.

Keeping the antibiotic onboard past 12 weeks made no difference. All three groups – including the tazarotene-only group – did equally well. At week 24, more than 80% of the patients had at least a 50% global improvement from baseline, and 50% had at least a 75% improvement (Arch. Dermatol. 2006;142:605-12).

In his own practice, Dr. Zeichner said he often puts patients on oral antibiotics with topical therapies while they wait a month for their oral isotretinoin prescriptions to come through. "There are a lot of cases where patients don’t even end up going on isotretinoin because they are doing well," he said.

The approach also offers an alternative for severe acne patients who, for whatever reason, can’t take isotretinoin.

Another combination that’s been shown to work is minocycline extended release (Solodyn) about 1 mg/kg daily, daily clindamycin phosphate 1.2%/tretinoin 0.025% gel, and benzoil peroxide 6% foaming cloths. There’s an excellent chance isotretinoin candidates will no longer be candidates after 12 weeks of treatment, Dr. Zeichner said.

Some patients will need to stay on oral antibiotics a bit longer than 3 months. Even so, "try to get them off the antibiotic as early as possible. If they flare up again, [you can always] give them another course," he said.

Although the antibiotic may be stopped, Dr. Zeichner cautioned, it’s important to continue topical treatment to keep acne from coming back.

"I’d much rather see women on hormonal-type therapies than on oral antibiotics. I feel it gets a little more to the root of the issue," he noted.

Dr. Zeichner is a consultant, an investigator, or an advisory board member for several pharmaceutical companies, including Allergan, Beiersdorf, Galderma, Medicis, and Valeant. The SDEF and this publication are owned by Frontline Medical Communications.

LAS VEGAS – Acne patients treated with oral antibiotics don’t necessarily need to stay on them for more than 3 months, according to Dr. Joshua Zeichner.

"Even if you are initially treating them with an oral antibiotic for severe acne, you can maintain them after about 12 weeks just on a topical therapy like tazarotene, explained Dr. Zeichner, director of cosmetic and clinical research in the dermatology department at Mt. Sinai Medical Center in New York. "You don’t necessarily need to keep your patients on oral antibiotics for long periods of time."

To prevent resistance and other problems, "try to limit use to about 3 months, and think about maintenance using just a topical therapy," he said at the Las Vegas Dermatology seminar, sponsored by the Skin Disease Education Foundation.

Several studies prove the point. In one, 189 patients with severe acne received 0.1% tazarotene gel each evening and 100 mg minocycline twice daily for 12 weeks. The 110 (58%) with at least a 75% global improvement were then assigned to 12 weeks of maintenance with tazarotene gel, minocycline, or tazarotene plus minocycline.

Keeping the antibiotic onboard past 12 weeks made no difference. All three groups – including the tazarotene-only group – did equally well. At week 24, more than 80% of the patients had at least a 50% global improvement from baseline, and 50% had at least a 75% improvement (Arch. Dermatol. 2006;142:605-12).

In his own practice, Dr. Zeichner said he often puts patients on oral antibiotics with topical therapies while they wait a month for their oral isotretinoin prescriptions to come through. "There are a lot of cases where patients don’t even end up going on isotretinoin because they are doing well," he said.

The approach also offers an alternative for severe acne patients who, for whatever reason, can’t take isotretinoin.

Another combination that’s been shown to work is minocycline extended release (Solodyn) about 1 mg/kg daily, daily clindamycin phosphate 1.2%/tretinoin 0.025% gel, and benzoil peroxide 6% foaming cloths. There’s an excellent chance isotretinoin candidates will no longer be candidates after 12 weeks of treatment, Dr. Zeichner said.

Some patients will need to stay on oral antibiotics a bit longer than 3 months. Even so, "try to get them off the antibiotic as early as possible. If they flare up again, [you can always] give them another course," he said.

Although the antibiotic may be stopped, Dr. Zeichner cautioned, it’s important to continue topical treatment to keep acne from coming back.

"I’d much rather see women on hormonal-type therapies than on oral antibiotics. I feel it gets a little more to the root of the issue," he noted.

Dr. Zeichner is a consultant, an investigator, or an advisory board member for several pharmaceutical companies, including Allergan, Beiersdorf, Galderma, Medicis, and Valeant. The SDEF and this publication are owned by Frontline Medical Communications.

LAS VEGAS – Acne patients treated with oral antibiotics don’t necessarily need to stay on them for more than 3 months, according to Dr. Joshua Zeichner.

"Even if you are initially treating them with an oral antibiotic for severe acne, you can maintain them after about 12 weeks just on a topical therapy like tazarotene, explained Dr. Zeichner, director of cosmetic and clinical research in the dermatology department at Mt. Sinai Medical Center in New York. "You don’t necessarily need to keep your patients on oral antibiotics for long periods of time."

To prevent resistance and other problems, "try to limit use to about 3 months, and think about maintenance using just a topical therapy," he said at the Las Vegas Dermatology seminar, sponsored by the Skin Disease Education Foundation.

Several studies prove the point. In one, 189 patients with severe acne received 0.1% tazarotene gel each evening and 100 mg minocycline twice daily for 12 weeks. The 110 (58%) with at least a 75% global improvement were then assigned to 12 weeks of maintenance with tazarotene gel, minocycline, or tazarotene plus minocycline.

Keeping the antibiotic onboard past 12 weeks made no difference. All three groups – including the tazarotene-only group – did equally well. At week 24, more than 80% of the patients had at least a 50% global improvement from baseline, and 50% had at least a 75% improvement (Arch. Dermatol. 2006;142:605-12).

In his own practice, Dr. Zeichner said he often puts patients on oral antibiotics with topical therapies while they wait a month for their oral isotretinoin prescriptions to come through. "There are a lot of cases where patients don’t even end up going on isotretinoin because they are doing well," he said.

The approach also offers an alternative for severe acne patients who, for whatever reason, can’t take isotretinoin.

Another combination that’s been shown to work is minocycline extended release (Solodyn) about 1 mg/kg daily, daily clindamycin phosphate 1.2%/tretinoin 0.025% gel, and benzoil peroxide 6% foaming cloths. There’s an excellent chance isotretinoin candidates will no longer be candidates after 12 weeks of treatment, Dr. Zeichner said.

Some patients will need to stay on oral antibiotics a bit longer than 3 months. Even so, "try to get them off the antibiotic as early as possible. If they flare up again, [you can always] give them another course," he said.

Although the antibiotic may be stopped, Dr. Zeichner cautioned, it’s important to continue topical treatment to keep acne from coming back.

"I’d much rather see women on hormonal-type therapies than on oral antibiotics. I feel it gets a little more to the root of the issue," he noted.

Dr. Zeichner is a consultant, an investigator, or an advisory board member for several pharmaceutical companies, including Allergan, Beiersdorf, Galderma, Medicis, and Valeant. The SDEF and this publication are owned by Frontline Medical Communications.

LAS VEGAS – Cardiovascular event rates in patients treated with ustekinumab have been found to remain stable over time, according to 5-year follow-up data from the manufacturer.

"The overall safety profile of ustekinumab [Stelara] remained stable in adults with moderate to severe plaque psoriasis receiving up to 5 years of ustekinumab treatment," noted the manufacturer of Stelara, Janssen Pharmaceuticals, in a statement. "There was no dose-response or cumulative effect of increasing duration of exposure to ustekinumab on the rates of overall and targeted adverse events after up to 5 years of treatment."

The cardiovascular safety of the plaque psoriasis treatment has been a concern because early testing detected a slightly higher incidence of events in patients treated with ustekinumab, compared with placebo.

But among 3,117 patients – 838 of whom were on the biologic for 5 years – and after a cumulative total of 8,998 patient-years, the rate of major adverse cardiovascular events (MACEs) held largely steady at 0.47 per 100 patient-years at year 1, 0.44 at year 5, and comparable numbers in between. The data were pooled from one phase II and three phase III trials, with MACE defined as stroke, myocardial infarction, or cardiovascular death.

The MACE rate at 5-year follow-up was 0.56 per 100 patient-years (95% confidence interval, 0.35-0.85) among patients receiving the 45-mg dose of the injectable and 0.36 per 100 patient-years (95% CI, 0.22-0.57) in patients receiving 90 mg.

In comparable 4-year follow-up data, researchers found that MACE and other serious adverse event rates among ustekinumab users "were consistent with those in the general and psoriasis populations" (J. Drugs Dermatol. 2012;11:300-12).

"The cardiovascular events over time seem to be stable," said Dr. Craig Leonardi, of the dermatology department at St. Louis University, who summarized the 5-year findings during a talk about the drug.

Even so, Dr. Leonardi, who presented the study results at a seminar sponsored by Skin Disease Education Foundation (SDEF), said that he remains concerned, noting that follow-up studies select for patients who do well on a drug and have minimal adverse events.

It’s possible that patients susceptible to MACEs – those with preexisting cardiac risk factors or, perhaps, an as-yet unrecognized genetic predisposition – dropped out early due to angina or other problems.

Dr. Leonardi also noted a recent meta-analysis that found a higher risk of MACEs in patients treated with ustekinumab or briakinumab – another interleukin-12/23 antibody no longer under development – compared with those on placebo (J. Eur. Acad. Dermatol. Venereol. 2012 March 8 [doi: 10.1111/j.1468-3083.2012.04500]).

It followed an earlier meta-analysis, conducted by Dr. Leonardi and his colleagues, of 22 trials that found 10 MACEs among 3,179 patients on ustekinumab or briakinumab but none among 1,474 placebo patients (JAMA 2011;306:864-71). Even though the results were not statistically significant, "there was a trend, and we are concerned about it. It seems to correspond to peak levels of the drug. We are awaiting further analysis," Dr. Leonardi said.

There’s "no question [ustekinumab] is a high-performance drug with a durable response," but in the meantime, "I am putting all my ustekinumab patients on aspirin, 81 mg/day," he said.

Patients with multiple cardiovascular risk factors should start with a tumor necrosis factor antagonist instead, according to Dr. Leonardi. "These are drugs with proven cardiovascular friendliness," he added. It is also probably wise to start out with the lower 45-mg dose of ustekinumab when initiating treatment.

Dr. Leonardi is a consultant, investigator, and speaker for Abbott, Amgen, and other companies. SDEF and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Cardiovascular event rates in patients treated with ustekinumab have been found to remain stable over time, according to 5-year follow-up data from the manufacturer.

"The overall safety profile of ustekinumab [Stelara] remained stable in adults with moderate to severe plaque psoriasis receiving up to 5 years of ustekinumab treatment," noted the manufacturer of Stelara, Janssen Pharmaceuticals, in a statement. "There was no dose-response or cumulative effect of increasing duration of exposure to ustekinumab on the rates of overall and targeted adverse events after up to 5 years of treatment."

The cardiovascular safety of the plaque psoriasis treatment has been a concern because early testing detected a slightly higher incidence of events in patients treated with ustekinumab, compared with placebo.

But among 3,117 patients – 838 of whom were on the biologic for 5 years – and after a cumulative total of 8,998 patient-years, the rate of major adverse cardiovascular events (MACEs) held largely steady at 0.47 per 100 patient-years at year 1, 0.44 at year 5, and comparable numbers in between. The data were pooled from one phase II and three phase III trials, with MACE defined as stroke, myocardial infarction, or cardiovascular death.

The MACE rate at 5-year follow-up was 0.56 per 100 patient-years (95% confidence interval, 0.35-0.85) among patients receiving the 45-mg dose of the injectable and 0.36 per 100 patient-years (95% CI, 0.22-0.57) in patients receiving 90 mg.

In comparable 4-year follow-up data, researchers found that MACE and other serious adverse event rates among ustekinumab users "were consistent with those in the general and psoriasis populations" (J. Drugs Dermatol. 2012;11:300-12).

"The cardiovascular events over time seem to be stable," said Dr. Craig Leonardi, of the dermatology department at St. Louis University, who summarized the 5-year findings during a talk about the drug.

Even so, Dr. Leonardi, who presented the study results at a seminar sponsored by Skin Disease Education Foundation (SDEF), said that he remains concerned, noting that follow-up studies select for patients who do well on a drug and have minimal adverse events.

It’s possible that patients susceptible to MACEs – those with preexisting cardiac risk factors or, perhaps, an as-yet unrecognized genetic predisposition – dropped out early due to angina or other problems.

Dr. Leonardi also noted a recent meta-analysis that found a higher risk of MACEs in patients treated with ustekinumab or briakinumab – another interleukin-12/23 antibody no longer under development – compared with those on placebo (J. Eur. Acad. Dermatol. Venereol. 2012 March 8 [doi: 10.1111/j.1468-3083.2012.04500]).

It followed an earlier meta-analysis, conducted by Dr. Leonardi and his colleagues, of 22 trials that found 10 MACEs among 3,179 patients on ustekinumab or briakinumab but none among 1,474 placebo patients (JAMA 2011;306:864-71). Even though the results were not statistically significant, "there was a trend, and we are concerned about it. It seems to correspond to peak levels of the drug. We are awaiting further analysis," Dr. Leonardi said.

There’s "no question [ustekinumab] is a high-performance drug with a durable response," but in the meantime, "I am putting all my ustekinumab patients on aspirin, 81 mg/day," he said.

Patients with multiple cardiovascular risk factors should start with a tumor necrosis factor antagonist instead, according to Dr. Leonardi. "These are drugs with proven cardiovascular friendliness," he added. It is also probably wise to start out with the lower 45-mg dose of ustekinumab when initiating treatment.

Dr. Leonardi is a consultant, investigator, and speaker for Abbott, Amgen, and other companies. SDEF and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Cardiovascular event rates in patients treated with ustekinumab have been found to remain stable over time, according to 5-year follow-up data from the manufacturer.

"The overall safety profile of ustekinumab [Stelara] remained stable in adults with moderate to severe plaque psoriasis receiving up to 5 years of ustekinumab treatment," noted the manufacturer of Stelara, Janssen Pharmaceuticals, in a statement. "There was no dose-response or cumulative effect of increasing duration of exposure to ustekinumab on the rates of overall and targeted adverse events after up to 5 years of treatment."

The cardiovascular safety of the plaque psoriasis treatment has been a concern because early testing detected a slightly higher incidence of events in patients treated with ustekinumab, compared with placebo.

But among 3,117 patients – 838 of whom were on the biologic for 5 years – and after a cumulative total of 8,998 patient-years, the rate of major adverse cardiovascular events (MACEs) held largely steady at 0.47 per 100 patient-years at year 1, 0.44 at year 5, and comparable numbers in between. The data were pooled from one phase II and three phase III trials, with MACE defined as stroke, myocardial infarction, or cardiovascular death.

The MACE rate at 5-year follow-up was 0.56 per 100 patient-years (95% confidence interval, 0.35-0.85) among patients receiving the 45-mg dose of the injectable and 0.36 per 100 patient-years (95% CI, 0.22-0.57) in patients receiving 90 mg.

In comparable 4-year follow-up data, researchers found that MACE and other serious adverse event rates among ustekinumab users "were consistent with those in the general and psoriasis populations" (J. Drugs Dermatol. 2012;11:300-12).

"The cardiovascular events over time seem to be stable," said Dr. Craig Leonardi, of the dermatology department at St. Louis University, who summarized the 5-year findings during a talk about the drug.

Even so, Dr. Leonardi, who presented the study results at a seminar sponsored by Skin Disease Education Foundation (SDEF), said that he remains concerned, noting that follow-up studies select for patients who do well on a drug and have minimal adverse events.

It’s possible that patients susceptible to MACEs – those with preexisting cardiac risk factors or, perhaps, an as-yet unrecognized genetic predisposition – dropped out early due to angina or other problems.

Dr. Leonardi also noted a recent meta-analysis that found a higher risk of MACEs in patients treated with ustekinumab or briakinumab – another interleukin-12/23 antibody no longer under development – compared with those on placebo (J. Eur. Acad. Dermatol. Venereol. 2012 March 8 [doi: 10.1111/j.1468-3083.2012.04500]).

It followed an earlier meta-analysis, conducted by Dr. Leonardi and his colleagues, of 22 trials that found 10 MACEs among 3,179 patients on ustekinumab or briakinumab but none among 1,474 placebo patients (JAMA 2011;306:864-71). Even though the results were not statistically significant, "there was a trend, and we are concerned about it. It seems to correspond to peak levels of the drug. We are awaiting further analysis," Dr. Leonardi said.

There’s "no question [ustekinumab] is a high-performance drug with a durable response," but in the meantime, "I am putting all my ustekinumab patients on aspirin, 81 mg/day," he said.

Patients with multiple cardiovascular risk factors should start with a tumor necrosis factor antagonist instead, according to Dr. Leonardi. "These are drugs with proven cardiovascular friendliness," he added. It is also probably wise to start out with the lower 45-mg dose of ustekinumab when initiating treatment.

Dr. Leonardi is a consultant, investigator, and speaker for Abbott, Amgen, and other companies. SDEF and this news organization are owned by Frontline Medical Communications.

For more than 2 decades, dermatologists have tackled tattoo removal with Q-switched lasers, which work by heating and destroying the target chromophore, allowing pigment to be released into the extracellular space.

But Q-switched laser treatments, while effective, also are time consuming and costly, with eight or more clinical visits needed, spaced a month or more apart, before treatment is complete, according to Dr. Nazanin Saedi, director of laser surgery and cosmetic dermatology at Jefferson Medical College in Philadelphia.

New methods can help optimize clinical results from Q-switched treatments, allowing for fewer visits before the removal is complete, said Dr. Saedi. Picosecond technology – or "pico," as it is commonly called for short – is also promising.

Picosecond lasers pulse at a trillionth of a second (compared with the billionth of a second pulsed by Q-switched lasers). By delivering the energy in a shorter amount of time, picosecond lasers require less energy to clear pigment, and damage to surrounding tissue may be minimized, Dr. Saedi said in an interview.

Dr. Saedi was an investigator on one recent nonrandomized clinical trial enrolling 15 patients with dark tattoos. Using a picosecond laser, the investigators produced tattoo clearance of 75% or greater in an average of 4.25 sessions, or about half the time associated with Q-switched lasers (Arch. Dermatol. 2012;148:820-3).

Further studies are now attempting to determine whether pico is "color blind," and therefore could work on different colors of tattoo ink, Dr. Saedi said. This would represent another advantage, because with conventional Q-switched lasers, wavelengths need to be changed for each targeted color.

Because the pico laser is still being studied and has not yet been approved by the Food and Drug Administration, clinicians may want to know how they can maximize use of currently approved technologies.

Dr. Saedi said that combining Q-switched lasers with a fractionated ablative or nonablative device offers some promise, citing a small, nonrandomized study that showed less blistering, shortened recovery time, and less treatment-induced hypopigmentation, compared with published results from standard treatment (Dermatol. Surg. 2011;37:97-9).

Other options for optimizing results include offering up to four consecutive treatments with Q-switched lasers, spaced 20 minutes apart. But realistically, Dr. Saedi said, "what works in a study may not be practical in the clinic."

SDEF and this news organization are owned by Frontline Medical Communications.

Dr. Saedi did not declare any financial conflicts related to her talk.

For more than 2 decades, dermatologists have tackled tattoo removal with Q-switched lasers, which work by heating and destroying the target chromophore, allowing pigment to be released into the extracellular space.

But Q-switched laser treatments, while effective, also are time consuming and costly, with eight or more clinical visits needed, spaced a month or more apart, before treatment is complete, according to Dr. Nazanin Saedi, director of laser surgery and cosmetic dermatology at Jefferson Medical College in Philadelphia.

New methods can help optimize clinical results from Q-switched treatments, allowing for fewer visits before the removal is complete, said Dr. Saedi. Picosecond technology – or "pico," as it is commonly called for short – is also promising.

Picosecond lasers pulse at a trillionth of a second (compared with the billionth of a second pulsed by Q-switched lasers). By delivering the energy in a shorter amount of time, picosecond lasers require less energy to clear pigment, and damage to surrounding tissue may be minimized, Dr. Saedi said in an interview.

Dr. Saedi was an investigator on one recent nonrandomized clinical trial enrolling 15 patients with dark tattoos. Using a picosecond laser, the investigators produced tattoo clearance of 75% or greater in an average of 4.25 sessions, or about half the time associated with Q-switched lasers (Arch. Dermatol. 2012;148:820-3).

Further studies are now attempting to determine whether pico is "color blind," and therefore could work on different colors of tattoo ink, Dr. Saedi said. This would represent another advantage, because with conventional Q-switched lasers, wavelengths need to be changed for each targeted color.

Because the pico laser is still being studied and has not yet been approved by the Food and Drug Administration, clinicians may want to know how they can maximize use of currently approved technologies.

Dr. Saedi said that combining Q-switched lasers with a fractionated ablative or nonablative device offers some promise, citing a small, nonrandomized study that showed less blistering, shortened recovery time, and less treatment-induced hypopigmentation, compared with published results from standard treatment (Dermatol. Surg. 2011;37:97-9).

Other options for optimizing results include offering up to four consecutive treatments with Q-switched lasers, spaced 20 minutes apart. But realistically, Dr. Saedi said, "what works in a study may not be practical in the clinic."

SDEF and this news organization are owned by Frontline Medical Communications.

Dr. Saedi did not declare any financial conflicts related to her talk.

For more than 2 decades, dermatologists have tackled tattoo removal with Q-switched lasers, which work by heating and destroying the target chromophore, allowing pigment to be released into the extracellular space.

But Q-switched laser treatments, while effective, also are time consuming and costly, with eight or more clinical visits needed, spaced a month or more apart, before treatment is complete, according to Dr. Nazanin Saedi, director of laser surgery and cosmetic dermatology at Jefferson Medical College in Philadelphia.

New methods can help optimize clinical results from Q-switched treatments, allowing for fewer visits before the removal is complete, said Dr. Saedi. Picosecond technology – or "pico," as it is commonly called for short – is also promising.

Picosecond lasers pulse at a trillionth of a second (compared with the billionth of a second pulsed by Q-switched lasers). By delivering the energy in a shorter amount of time, picosecond lasers require less energy to clear pigment, and damage to surrounding tissue may be minimized, Dr. Saedi said in an interview.

Dr. Saedi was an investigator on one recent nonrandomized clinical trial enrolling 15 patients with dark tattoos. Using a picosecond laser, the investigators produced tattoo clearance of 75% or greater in an average of 4.25 sessions, or about half the time associated with Q-switched lasers (Arch. Dermatol. 2012;148:820-3).

Further studies are now attempting to determine whether pico is "color blind," and therefore could work on different colors of tattoo ink, Dr. Saedi said. This would represent another advantage, because with conventional Q-switched lasers, wavelengths need to be changed for each targeted color.

Because the pico laser is still being studied and has not yet been approved by the Food and Drug Administration, clinicians may want to know how they can maximize use of currently approved technologies.

Dr. Saedi said that combining Q-switched lasers with a fractionated ablative or nonablative device offers some promise, citing a small, nonrandomized study that showed less blistering, shortened recovery time, and less treatment-induced hypopigmentation, compared with published results from standard treatment (Dermatol. Surg. 2011;37:97-9).

Other options for optimizing results include offering up to four consecutive treatments with Q-switched lasers, spaced 20 minutes apart. But realistically, Dr. Saedi said, "what works in a study may not be practical in the clinic."

SDEF and this news organization are owned by Frontline Medical Communications.

Dr. Saedi did not declare any financial conflicts related to her talk.

Patients often ask their dermatologists for recommendations on over-the-counter moisturizers, said Dr. Joshua Zeichner.

The trouble is that "many dermatologists don’t really know what makes a good moisturizer, and are unfamiliar with the latest advances in moisturizing technology," he said at SDEF Las Vegas Dermatology Seminar.

While the purpose of all moisturizers is simple enough – to boost and maintain the water content of the skin – their formulations and the manner of their activity vary widely. Some work by increasing the expression of aquaporins, the water channels in the skin cell membrane; others by replacing skin lipids, temporarily repairing the skin’s barrier function and improving appearance.

Any high-quality moisturizer will contain a mixture of humectant, emollient, and occlusive ingredients, said Dr. Zeichner, director of cosmetic and clinical research in dermatology at Mount Sinai Medical Center in New York.

Among the novel humectants being incorporated into moisturizers today are natural moisturizing factors (NMF), an umbrella term for the naturally occurring humectants glycerol, urea, and lactic acid, along with the amino acids urocanic acid (UCA) and pyrrolidone carboxylic acid (PCA), which are produced by the breakdown of filaggrin.

Many moisturizers contain ceramides, the major lipids that make up the "mortar" between skin-cell "bricks" in the stratum corneum; moisturizers also may contain ceramide precursors.

"Applying a moisturizer with [the ceramide precursor] pseudoceramide 5 has been shown to lead to an increase in ceramide levels in the stratum corneum," Dr. Zeichner said. "However, it’s unclear whether the ingredient is directly incorporated into those ceramides. Regardless, you can see the clinical improvement."

Generally with all moisturizers, he said, "we need more studies to evaluate the long-term effects to the skin beyond just the immediate effect."

Glyceryl glucoside, a modified glycerin molecule that enhances the activity of aquaporin channels, shows promise as a humectant, Dr. Zeichner said.

He described glyceryl glucoside as a "super humectant" whose effect on skin may last longer than that of other humectants.

Dr. Zeichner also tipped his hat to an old school moisturizer ingredient – colloidal oatmeal.

"There’s a lot of talk about all of these exciting new technologies but you don’t want to forget about tried and true colloidal oatmeal," he said. Oatmeal, which has occlusive, humectant, and emollient properties, "serves as the backbone for many skin brands and works very well. Advances in cosmetic chemistry have made oatmeal formulations much more elegant now – they’re not your grandmother’s oatmeal anymore."

Dr. Zeichner disclosed financial relationships with Allergan, Bayer, Beiersdorf, Galderma, Johnson and Johnson, L’Oreal, Medicis, Onset, Pharmaderm, Procter and Gamble, and Valeant.

SDEF and this news organization are owned by Frontline Medical Communications.

Patients often ask their dermatologists for recommendations on over-the-counter moisturizers, said Dr. Joshua Zeichner.

The trouble is that "many dermatologists don’t really know what makes a good moisturizer, and are unfamiliar with the latest advances in moisturizing technology," he said at SDEF Las Vegas Dermatology Seminar.

While the purpose of all moisturizers is simple enough – to boost and maintain the water content of the skin – their formulations and the manner of their activity vary widely. Some work by increasing the expression of aquaporins, the water channels in the skin cell membrane; others by replacing skin lipids, temporarily repairing the skin’s barrier function and improving appearance.

Any high-quality moisturizer will contain a mixture of humectant, emollient, and occlusive ingredients, said Dr. Zeichner, director of cosmetic and clinical research in dermatology at Mount Sinai Medical Center in New York.

Among the novel humectants being incorporated into moisturizers today are natural moisturizing factors (NMF), an umbrella term for the naturally occurring humectants glycerol, urea, and lactic acid, along with the amino acids urocanic acid (UCA) and pyrrolidone carboxylic acid (PCA), which are produced by the breakdown of filaggrin.

Many moisturizers contain ceramides, the major lipids that make up the "mortar" between skin-cell "bricks" in the stratum corneum; moisturizers also may contain ceramide precursors.

"Applying a moisturizer with [the ceramide precursor] pseudoceramide 5 has been shown to lead to an increase in ceramide levels in the stratum corneum," Dr. Zeichner said. "However, it’s unclear whether the ingredient is directly incorporated into those ceramides. Regardless, you can see the clinical improvement."

Generally with all moisturizers, he said, "we need more studies to evaluate the long-term effects to the skin beyond just the immediate effect."

Glyceryl glucoside, a modified glycerin molecule that enhances the activity of aquaporin channels, shows promise as a humectant, Dr. Zeichner said.

He described glyceryl glucoside as a "super humectant" whose effect on skin may last longer than that of other humectants.

Dr. Zeichner also tipped his hat to an old school moisturizer ingredient – colloidal oatmeal.

"There’s a lot of talk about all of these exciting new technologies but you don’t want to forget about tried and true colloidal oatmeal," he said. Oatmeal, which has occlusive, humectant, and emollient properties, "serves as the backbone for many skin brands and works very well. Advances in cosmetic chemistry have made oatmeal formulations much more elegant now – they’re not your grandmother’s oatmeal anymore."

Dr. Zeichner disclosed financial relationships with Allergan, Bayer, Beiersdorf, Galderma, Johnson and Johnson, L’Oreal, Medicis, Onset, Pharmaderm, Procter and Gamble, and Valeant.

SDEF and this news organization are owned by Frontline Medical Communications.

Patients often ask their dermatologists for recommendations on over-the-counter moisturizers, said Dr. Joshua Zeichner.

The trouble is that "many dermatologists don’t really know what makes a good moisturizer, and are unfamiliar with the latest advances in moisturizing technology," he said at SDEF Las Vegas Dermatology Seminar.

While the purpose of all moisturizers is simple enough – to boost and maintain the water content of the skin – their formulations and the manner of their activity vary widely. Some work by increasing the expression of aquaporins, the water channels in the skin cell membrane; others by replacing skin lipids, temporarily repairing the skin’s barrier function and improving appearance.

Any high-quality moisturizer will contain a mixture of humectant, emollient, and occlusive ingredients, said Dr. Zeichner, director of cosmetic and clinical research in dermatology at Mount Sinai Medical Center in New York.

Among the novel humectants being incorporated into moisturizers today are natural moisturizing factors (NMF), an umbrella term for the naturally occurring humectants glycerol, urea, and lactic acid, along with the amino acids urocanic acid (UCA) and pyrrolidone carboxylic acid (PCA), which are produced by the breakdown of filaggrin.

Many moisturizers contain ceramides, the major lipids that make up the "mortar" between skin-cell "bricks" in the stratum corneum; moisturizers also may contain ceramide precursors.

"Applying a moisturizer with [the ceramide precursor] pseudoceramide 5 has been shown to lead to an increase in ceramide levels in the stratum corneum," Dr. Zeichner said. "However, it’s unclear whether the ingredient is directly incorporated into those ceramides. Regardless, you can see the clinical improvement."

Generally with all moisturizers, he said, "we need more studies to evaluate the long-term effects to the skin beyond just the immediate effect."

Glyceryl glucoside, a modified glycerin molecule that enhances the activity of aquaporin channels, shows promise as a humectant, Dr. Zeichner said.

He described glyceryl glucoside as a "super humectant" whose effect on skin may last longer than that of other humectants.

Dr. Zeichner also tipped his hat to an old school moisturizer ingredient – colloidal oatmeal.

"There’s a lot of talk about all of these exciting new technologies but you don’t want to forget about tried and true colloidal oatmeal," he said. Oatmeal, which has occlusive, humectant, and emollient properties, "serves as the backbone for many skin brands and works very well. Advances in cosmetic chemistry have made oatmeal formulations much more elegant now – they’re not your grandmother’s oatmeal anymore."

Dr. Zeichner disclosed financial relationships with Allergan, Bayer, Beiersdorf, Galderma, Johnson and Johnson, L’Oreal, Medicis, Onset, Pharmaderm, Procter and Gamble, and Valeant.

SDEF and this news organization are owned by Frontline Medical Communications.

A coming, branded formulation of isotretinoin will offer compliance and efficacy advantages not previously available to U.S. dermatologists.

Absorica is a novel, patented brand formulation of isotretinoin marketed in the United States by Ranbaxy Pharmaceuticals Inc. *It will be available by the end of 2012 for the treatment of severe recalcitrant nodular acne.

The new drug, approved by the Food and Drug Administration in May, isn’t just another therapeutic option for dermatologists looking to treat acne – it’s a potential game changer in terms of improving efficacy and preventing relapse, according to Dr. Eric "Billy" Baum of the University of Alabama, Birmingham, who is a member of the speakers’ bureau for Ranbaxy.

Absorica is not rated as A-B equivalent to Accutane and the other isotretinoins, Dr. Baum said.

"I think that this is going to be a great advantage to dermatologists today," he said in an interview. "They’ll be able to have a type of isotretinoin that they know they are going to see really good results with. They are going to get the high blood levels that they need in order to get the maximum improvement, maximum absorption, and maximum efficacy."

Absorption is the key difference between how Absorica works and how other isotretinoins work, Dr. Baum explained at the meeting sponsored by Skin Disease Education Foundation. 

Isotretinoin is highly lipophilic and is a poorly solubilized molecule. As a result, patients don’t get the maximum benefit of the drug unless they take it with a high-fat meal, ideally about 50 grams of fat, according to Dr. Baum. That’s the equivalent of a breakfast of two fried eggs in butter, two strips of bacon, two slices of toast with butter, 4 ounces of hash brown potatoes, and 8 ounces of whole milk, he said. Since isotretinoin is taken twice daily, patients should also eat another high-fat meal at dinnertime, he said.

But most adolescent patients taking isotretinoin don’t eat that type of high-fat diet – in fact, about a third of adolescents don’t eat breakfast at all, he said.

With the traditional form of isotretinoin, only about 40% of the drug was absorbed when patients were fasting. In contrast, with Absorica nearly 70% is absorbed, Dr. Baum said. "There is now a greater likelihood for patients to achieve cumulative targeted doses of isotretinoin in the 20 weeks of treatment, thereby increasing success of treatment and lowering the risk of relapse."

The better absorption with Absorica is due to a patented drug delivery system, which delivers isotretinoin along with fatty molecules, optimizing absorption in the small intestine, Dr. Baum explained.

A phase III trial with more than 900 patients showed no statistical difference in efficacy at 20 weeks between Absorica and Accutane when patients have eaten a high-fat meal. "You get the results that were achieved with the original Accutane under fed conditions with less concern about what patients will actually eat," Dr. Baum said.

There was also no notable difference in psychiatric, gastrointestinal, vascular, cardiac, or ophthalmic side effects between the two formulations, Dr. Baum said, adding that like all isotretinoins, Absorica patients and prescribers are obligated to participate in the iPLEDGE risk management program.

"This is a medication that’s been very highly studied, the largest clinical study on isotretinoin ever completed," he said.

The better rate of absorption is this formulation’s big clinical advantage, which should result in fewer relapses, Dr. Baum said. That could also make the drug more cost effective, because it would cut down on subsequent treatments in the event of relapse.

"It is important to treat isotretinoin patients most effectively in one cycle, if possible," Dr. Baum said. "This is the time where the patient is most motivated and has the most family support to comply with the complicated instructions of isotretinoin and iPLEDGE."

SDEF and this news organization are owned by Frontline Medical Communications.

*CORRECTION (11/07/12): A previous version of this story incorrectly reported when Absorica will be available in the U.S. This version has been updated.

A coming, branded formulation of isotretinoin will offer compliance and efficacy advantages not previously available to U.S. dermatologists.

Absorica is a novel, patented brand formulation of isotretinoin marketed in the United States by Ranbaxy Pharmaceuticals Inc. *It will be available by the end of 2012 for the treatment of severe recalcitrant nodular acne.

The new drug, approved by the Food and Drug Administration in May, isn’t just another therapeutic option for dermatologists looking to treat acne – it’s a potential game changer in terms of improving efficacy and preventing relapse, according to Dr. Eric "Billy" Baum of the University of Alabama, Birmingham, who is a member of the speakers’ bureau for Ranbaxy.

Absorica is not rated as A-B equivalent to Accutane and the other isotretinoins, Dr. Baum said.

"I think that this is going to be a great advantage to dermatologists today," he said in an interview. "They’ll be able to have a type of isotretinoin that they know they are going to see really good results with. They are going to get the high blood levels that they need in order to get the maximum improvement, maximum absorption, and maximum efficacy."

Absorption is the key difference between how Absorica works and how other isotretinoins work, Dr. Baum explained at the meeting sponsored by Skin Disease Education Foundation. 

Isotretinoin is highly lipophilic and is a poorly solubilized molecule. As a result, patients don’t get the maximum benefit of the drug unless they take it with a high-fat meal, ideally about 50 grams of fat, according to Dr. Baum. That’s the equivalent of a breakfast of two fried eggs in butter, two strips of bacon, two slices of toast with butter, 4 ounces of hash brown potatoes, and 8 ounces of whole milk, he said. Since isotretinoin is taken twice daily, patients should also eat another high-fat meal at dinnertime, he said.

But most adolescent patients taking isotretinoin don’t eat that type of high-fat diet – in fact, about a third of adolescents don’t eat breakfast at all, he said.

With the traditional form of isotretinoin, only about 40% of the drug was absorbed when patients were fasting. In contrast, with Absorica nearly 70% is absorbed, Dr. Baum said. "There is now a greater likelihood for patients to achieve cumulative targeted doses of isotretinoin in the 20 weeks of treatment, thereby increasing success of treatment and lowering the risk of relapse."

The better absorption with Absorica is due to a patented drug delivery system, which delivers isotretinoin along with fatty molecules, optimizing absorption in the small intestine, Dr. Baum explained.

A phase III trial with more than 900 patients showed no statistical difference in efficacy at 20 weeks between Absorica and Accutane when patients have eaten a high-fat meal. "You get the results that were achieved with the original Accutane under fed conditions with less concern about what patients will actually eat," Dr. Baum said.

There was also no notable difference in psychiatric, gastrointestinal, vascular, cardiac, or ophthalmic side effects between the two formulations, Dr. Baum said, adding that like all isotretinoins, Absorica patients and prescribers are obligated to participate in the iPLEDGE risk management program.

"This is a medication that’s been very highly studied, the largest clinical study on isotretinoin ever completed," he said.

The better rate of absorption is this formulation’s big clinical advantage, which should result in fewer relapses, Dr. Baum said. That could also make the drug more cost effective, because it would cut down on subsequent treatments in the event of relapse.

"It is important to treat isotretinoin patients most effectively in one cycle, if possible," Dr. Baum said. "This is the time where the patient is most motivated and has the most family support to comply with the complicated instructions of isotretinoin and iPLEDGE."

SDEF and this news organization are owned by Frontline Medical Communications.

*CORRECTION (11/07/12): A previous version of this story incorrectly reported when Absorica will be available in the U.S. This version has been updated.

A coming, branded formulation of isotretinoin will offer compliance and efficacy advantages not previously available to U.S. dermatologists.

Absorica is a novel, patented brand formulation of isotretinoin marketed in the United States by Ranbaxy Pharmaceuticals Inc. *It will be available by the end of 2012 for the treatment of severe recalcitrant nodular acne.

The new drug, approved by the Food and Drug Administration in May, isn’t just another therapeutic option for dermatologists looking to treat acne – it’s a potential game changer in terms of improving efficacy and preventing relapse, according to Dr. Eric "Billy" Baum of the University of Alabama, Birmingham, who is a member of the speakers’ bureau for Ranbaxy.

Absorica is not rated as A-B equivalent to Accutane and the other isotretinoins, Dr. Baum said.

"I think that this is going to be a great advantage to dermatologists today," he said in an interview. "They’ll be able to have a type of isotretinoin that they know they are going to see really good results with. They are going to get the high blood levels that they need in order to get the maximum improvement, maximum absorption, and maximum efficacy."

Absorption is the key difference between how Absorica works and how other isotretinoins work, Dr. Baum explained at the meeting sponsored by Skin Disease Education Foundation. 

Isotretinoin is highly lipophilic and is a poorly solubilized molecule. As a result, patients don’t get the maximum benefit of the drug unless they take it with a high-fat meal, ideally about 50 grams of fat, according to Dr. Baum. That’s the equivalent of a breakfast of two fried eggs in butter, two strips of bacon, two slices of toast with butter, 4 ounces of hash brown potatoes, and 8 ounces of whole milk, he said. Since isotretinoin is taken twice daily, patients should also eat another high-fat meal at dinnertime, he said.

But most adolescent patients taking isotretinoin don’t eat that type of high-fat diet – in fact, about a third of adolescents don’t eat breakfast at all, he said.

With the traditional form of isotretinoin, only about 40% of the drug was absorbed when patients were fasting. In contrast, with Absorica nearly 70% is absorbed, Dr. Baum said. "There is now a greater likelihood for patients to achieve cumulative targeted doses of isotretinoin in the 20 weeks of treatment, thereby increasing success of treatment and lowering the risk of relapse."

The better absorption with Absorica is due to a patented drug delivery system, which delivers isotretinoin along with fatty molecules, optimizing absorption in the small intestine, Dr. Baum explained.

A phase III trial with more than 900 patients showed no statistical difference in efficacy at 20 weeks between Absorica and Accutane when patients have eaten a high-fat meal. "You get the results that were achieved with the original Accutane under fed conditions with less concern about what patients will actually eat," Dr. Baum said.

There was also no notable difference in psychiatric, gastrointestinal, vascular, cardiac, or ophthalmic side effects between the two formulations, Dr. Baum said, adding that like all isotretinoins, Absorica patients and prescribers are obligated to participate in the iPLEDGE risk management program.

"This is a medication that’s been very highly studied, the largest clinical study on isotretinoin ever completed," he said.

The better rate of absorption is this formulation’s big clinical advantage, which should result in fewer relapses, Dr. Baum said. That could also make the drug more cost effective, because it would cut down on subsequent treatments in the event of relapse.

"It is important to treat isotretinoin patients most effectively in one cycle, if possible," Dr. Baum said. "This is the time where the patient is most motivated and has the most family support to comply with the complicated instructions of isotretinoin and iPLEDGE."

SDEF and this news organization are owned by Frontline Medical Communications.

*CORRECTION (11/07/12): A previous version of this story incorrectly reported when Absorica will be available in the U.S. This version has been updated.