Damian McNamara

NEW ORLEANS – Their presentation can be alarming, even for dermatologists accustomed to seeing all kinds of adverse skin manifestations. Widespread necrosis, skin detachment, erythema, large bullae, and more are seen in patients with the life-threatening drug eruption, toxic epidermal necrolysis.

Medical management with intravenous immunoglobulin and a focus on supportive care save lives at the University of Miami, a toxic epidermal necrolysis (TEN) referral center.

"The survival rate is extremely low for this set of patients," Dr. Carlos A. Ricotti said at the annual meeting of the American Academy of Dermatology. But "the outcome at the University of Miami is very good. We see these patients, and we have a good understanding they are going to leave the hospital well."

Medical management is swift and comprehensive. "Assume there will be fluid loss, possible infection, impaired thermal regulation, altered immunity, and increased energy expenditure," Dr. Ricotti said. "Each of these has to be addressed."

In addition, despite a clinical appearance similar to that of burns, recognize that patients with TEN differ from burn patients in important ways, said Dr. Ricotti, who is on the dermatology staff at the University of Miami Hospital. TEN patients typically feature less edema, minimal vascular damage, and less damage to regenerative tissue, leading to faster re-epithelialization, compared with burn patients. "The rate of healing is much faster."

The hospital’s dermatologic medical management of TEN begins with withdrawal of offending medication. Because patients present with a burning sensation, pain control is essential to achieve comfort and to decrease their movement during recovery.

Think in terms of "acute skin failure" when providing supportive care, Dr. Ricotti said. Consider medical ICU or a burn unit admission; an air mattress with pressure ulcer prophylaxis; nonstick sheets and heating blankets; and maintenance of room temperature at 30° C.

"We don’t do debridement," Dr. Ricotti said. Pathology reveals that the entire dermis is not necrotic. The remaining viable tissue can act as a natural biologic dressing that may retake as a graft. "This speeds re-epithelialization ... and we believe this speeds recovery of the patient."

By day 6-10 of admission, most of the skin erosions re-epithelialize (as opposed to second-degree burns, which can take 14 days or longer). Because of this rapid tissue regeneration, patients require high caloric intake, which can include total parenteral nutrition or feeding via a nasogastric tube.

Strict fluid monitoring is essential, Dr. Ricotti said. "We feel very strongly about [fluid management]. We feel this plays an important role in our excellent outcomes." They typically administer IV fluids with half normal saline and 20 mEq KCl. Fluids in and out are monitored with a urine output goal of 40-80 mL/hr.

"We know that in TEN, there is potential for alveolar/epithelial barrier alteration due to the systemic nature of the disease," Dr. Ricotti said. "Our working hypothesis is that by decreasing fluid overload, we can minimize pulmonary involvement and improve outcomes." He recommended reading the results of a prospective clinical trial for more insight into the management of pulmonary complications (Intensive Care Med. 1997;23:1237-44).

Not only is intravenous immunoglobulin (IVIG) therapy important, the total dose makes a difference, Dr. Ricotti said. Survival increases significantly with each 1-g/kg increase in IVIG dose (odds ratio 4.2), according to a review article (Expert Rev. Dermatol. 2007;2:299-303).

A typical IVIG protocol at the hospital is 1 g/kg per day for 4 days, Dr. Ricotti said in response to a meeting attendee’s question. "The higher the dosage, the better the outcome." Although IVIG is essential, so is treatment at a center of excellence with special expertise in treating patients with drug eruptions.

TEN know-how also is important, he said, because "with its low incidence, it’s difficult to perform large, multicenter prospective trials."

Infections can occur. Cutaneous infection, pneumonia, and subsequent life-threatening sepsis are well-recognized complications of TEN. However, "we refrain from using empiric antibiotic therapy," Dr. Ricotti said.

They do routinely provide anticoagulation prophylaxis with heparin to prevent deep vein thrombosis, gastrointestinal prophylaxis with proton pump inhibitors, and eye care with tobramycin and dexamethasone.

TEN is relatively rare, with an estimated incidence of 1 person per million per year. Even so, "we see drug eruptions all the time in inpatient units," Dr. Ricotti said.

In addition to TEN (classified as "with spots" or "without spots" by extent of skin involvement), other drug eruptions include erythema multiforme major, Stevens-Johnson syndrome (SJS), and patients who have an overlap of SJS and TEN. Consider staphylococcal scalded skin syndrome and TEN with drug hypersensitivity syndrome in your differential diagnosis, he added.

Dr. Ricotti said he had no relevant disclosures.

NEW ORLEANS – Their presentation can be alarming, even for dermatologists accustomed to seeing all kinds of adverse skin manifestations. Widespread necrosis, skin detachment, erythema, large bullae, and more are seen in patients with the life-threatening drug eruption, toxic epidermal necrolysis.

Medical management with intravenous immunoglobulin and a focus on supportive care save lives at the University of Miami, a toxic epidermal necrolysis (TEN) referral center.

"The survival rate is extremely low for this set of patients," Dr. Carlos A. Ricotti said at the annual meeting of the American Academy of Dermatology. But "the outcome at the University of Miami is very good. We see these patients, and we have a good understanding they are going to leave the hospital well."

Medical management is swift and comprehensive. "Assume there will be fluid loss, possible infection, impaired thermal regulation, altered immunity, and increased energy expenditure," Dr. Ricotti said. "Each of these has to be addressed."

In addition, despite a clinical appearance similar to that of burns, recognize that patients with TEN differ from burn patients in important ways, said Dr. Ricotti, who is on the dermatology staff at the University of Miami Hospital. TEN patients typically feature less edema, minimal vascular damage, and less damage to regenerative tissue, leading to faster re-epithelialization, compared with burn patients. "The rate of healing is much faster."

The hospital’s dermatologic medical management of TEN begins with withdrawal of offending medication. Because patients present with a burning sensation, pain control is essential to achieve comfort and to decrease their movement during recovery.

Think in terms of "acute skin failure" when providing supportive care, Dr. Ricotti said. Consider medical ICU or a burn unit admission; an air mattress with pressure ulcer prophylaxis; nonstick sheets and heating blankets; and maintenance of room temperature at 30° C.

"We don’t do debridement," Dr. Ricotti said. Pathology reveals that the entire dermis is not necrotic. The remaining viable tissue can act as a natural biologic dressing that may retake as a graft. "This speeds re-epithelialization ... and we believe this speeds recovery of the patient."

By day 6-10 of admission, most of the skin erosions re-epithelialize (as opposed to second-degree burns, which can take 14 days or longer). Because of this rapid tissue regeneration, patients require high caloric intake, which can include total parenteral nutrition or feeding via a nasogastric tube.

Strict fluid monitoring is essential, Dr. Ricotti said. "We feel very strongly about [fluid management]. We feel this plays an important role in our excellent outcomes." They typically administer IV fluids with half normal saline and 20 mEq KCl. Fluids in and out are monitored with a urine output goal of 40-80 mL/hr.

"We know that in TEN, there is potential for alveolar/epithelial barrier alteration due to the systemic nature of the disease," Dr. Ricotti said. "Our working hypothesis is that by decreasing fluid overload, we can minimize pulmonary involvement and improve outcomes." He recommended reading the results of a prospective clinical trial for more insight into the management of pulmonary complications (Intensive Care Med. 1997;23:1237-44).

Not only is intravenous immunoglobulin (IVIG) therapy important, the total dose makes a difference, Dr. Ricotti said. Survival increases significantly with each 1-g/kg increase in IVIG dose (odds ratio 4.2), according to a review article (Expert Rev. Dermatol. 2007;2:299-303).

A typical IVIG protocol at the hospital is 1 g/kg per day for 4 days, Dr. Ricotti said in response to a meeting attendee’s question. "The higher the dosage, the better the outcome." Although IVIG is essential, so is treatment at a center of excellence with special expertise in treating patients with drug eruptions.

TEN know-how also is important, he said, because "with its low incidence, it’s difficult to perform large, multicenter prospective trials."

Infections can occur. Cutaneous infection, pneumonia, and subsequent life-threatening sepsis are well-recognized complications of TEN. However, "we refrain from using empiric antibiotic therapy," Dr. Ricotti said.

They do routinely provide anticoagulation prophylaxis with heparin to prevent deep vein thrombosis, gastrointestinal prophylaxis with proton pump inhibitors, and eye care with tobramycin and dexamethasone.

TEN is relatively rare, with an estimated incidence of 1 person per million per year. Even so, "we see drug eruptions all the time in inpatient units," Dr. Ricotti said.

In addition to TEN (classified as "with spots" or "without spots" by extent of skin involvement), other drug eruptions include erythema multiforme major, Stevens-Johnson syndrome (SJS), and patients who have an overlap of SJS and TEN. Consider staphylococcal scalded skin syndrome and TEN with drug hypersensitivity syndrome in your differential diagnosis, he added.

Dr. Ricotti said he had no relevant disclosures.

NEW ORLEANS – Their presentation can be alarming, even for dermatologists accustomed to seeing all kinds of adverse skin manifestations. Widespread necrosis, skin detachment, erythema, large bullae, and more are seen in patients with the life-threatening drug eruption, toxic epidermal necrolysis.

Medical management with intravenous immunoglobulin and a focus on supportive care save lives at the University of Miami, a toxic epidermal necrolysis (TEN) referral center.

"The survival rate is extremely low for this set of patients," Dr. Carlos A. Ricotti said at the annual meeting of the American Academy of Dermatology. But "the outcome at the University of Miami is very good. We see these patients, and we have a good understanding they are going to leave the hospital well."

Medical management is swift and comprehensive. "Assume there will be fluid loss, possible infection, impaired thermal regulation, altered immunity, and increased energy expenditure," Dr. Ricotti said. "Each of these has to be addressed."

In addition, despite a clinical appearance similar to that of burns, recognize that patients with TEN differ from burn patients in important ways, said Dr. Ricotti, who is on the dermatology staff at the University of Miami Hospital. TEN patients typically feature less edema, minimal vascular damage, and less damage to regenerative tissue, leading to faster re-epithelialization, compared with burn patients. "The rate of healing is much faster."

The hospital’s dermatologic medical management of TEN begins with withdrawal of offending medication. Because patients present with a burning sensation, pain control is essential to achieve comfort and to decrease their movement during recovery.

Think in terms of "acute skin failure" when providing supportive care, Dr. Ricotti said. Consider medical ICU or a burn unit admission; an air mattress with pressure ulcer prophylaxis; nonstick sheets and heating blankets; and maintenance of room temperature at 30° C.

"We don’t do debridement," Dr. Ricotti said. Pathology reveals that the entire dermis is not necrotic. The remaining viable tissue can act as a natural biologic dressing that may retake as a graft. "This speeds re-epithelialization ... and we believe this speeds recovery of the patient."

By day 6-10 of admission, most of the skin erosions re-epithelialize (as opposed to second-degree burns, which can take 14 days or longer). Because of this rapid tissue regeneration, patients require high caloric intake, which can include total parenteral nutrition or feeding via a nasogastric tube.

Strict fluid monitoring is essential, Dr. Ricotti said. "We feel very strongly about [fluid management]. We feel this plays an important role in our excellent outcomes." They typically administer IV fluids with half normal saline and 20 mEq KCl. Fluids in and out are monitored with a urine output goal of 40-80 mL/hr.

"We know that in TEN, there is potential for alveolar/epithelial barrier alteration due to the systemic nature of the disease," Dr. Ricotti said. "Our working hypothesis is that by decreasing fluid overload, we can minimize pulmonary involvement and improve outcomes." He recommended reading the results of a prospective clinical trial for more insight into the management of pulmonary complications (Intensive Care Med. 1997;23:1237-44).

Not only is intravenous immunoglobulin (IVIG) therapy important, the total dose makes a difference, Dr. Ricotti said. Survival increases significantly with each 1-g/kg increase in IVIG dose (odds ratio 4.2), according to a review article (Expert Rev. Dermatol. 2007;2:299-303).

A typical IVIG protocol at the hospital is 1 g/kg per day for 4 days, Dr. Ricotti said in response to a meeting attendee’s question. "The higher the dosage, the better the outcome." Although IVIG is essential, so is treatment at a center of excellence with special expertise in treating patients with drug eruptions.

TEN know-how also is important, he said, because "with its low incidence, it’s difficult to perform large, multicenter prospective trials."

Infections can occur. Cutaneous infection, pneumonia, and subsequent life-threatening sepsis are well-recognized complications of TEN. However, "we refrain from using empiric antibiotic therapy," Dr. Ricotti said.

They do routinely provide anticoagulation prophylaxis with heparin to prevent deep vein thrombosis, gastrointestinal prophylaxis with proton pump inhibitors, and eye care with tobramycin and dexamethasone.

TEN is relatively rare, with an estimated incidence of 1 person per million per year. Even so, "we see drug eruptions all the time in inpatient units," Dr. Ricotti said.

In addition to TEN (classified as "with spots" or "without spots" by extent of skin involvement), other drug eruptions include erythema multiforme major, Stevens-Johnson syndrome (SJS), and patients who have an overlap of SJS and TEN. Consider staphylococcal scalded skin syndrome and TEN with drug hypersensitivity syndrome in your differential diagnosis, he added.

Dr. Ricotti said he had no relevant disclosures.

NAPLES, FLA. – An exponential increase in ambulatory endovascular procedures for peripheral arterial disease is occurring in Florida, and it mirrors a nationwide trend, Dr. Michael S. Hong said at the annual meeting of the Southern Association for Vascular Surgery.

This shift to more ambulatory-based interventions is leading to decreases in open bypass procedures and major amputations, he said. This finding is from a study of discharges for peripheral arterial disease from Florida hospitals since 2000 and from ambulatory centers since 2004.

Approximately four out of five endovascular interventions for claudication, for example, are now performed in an ambulatory setting in Florida (approximately 8,000 vs. 2,000 done in a hospital setting), Dr. Hong said.

"With critical limb ischemia, the number of endovascular ambulatory interventions is much less than [that for] claudication, but we see an increase in the absolute number and in the proportion done in an ambulatory setting over time," said Dr. Hong, a research resident in the department of surgery at the University of Florida, Gainesville.

At the same time, inpatient procedures are still increasing for critical limb ischemia, Dr. Hong said. "Inpatient endovascular procedures are predominantly now for more advanced peripheral arterial disease."

"Interventionists might consider these more dangerous and hence want to perform them more in the hospital," said study discussant Dr. Russell H. Samson, a vascular surgeon at Doctors Hospital of Sarasota (Fla.). In addition, critical limb ischemia repairs "are very equipment intensive and the equipment is expensive."

Importantly, overall patient safety has not been compromised with a move toward more outpatient procedures, Dr. Hong said. "From our data, with only two deaths and 20 transferred, ... this shift to the ambulatory setting has not compromised patient safety."

He and his associates reviewed 10 years of ICD-9 inpatient codes and 6 years of outpatient CPT codes for endovascular angioplasty, atherectomy, and peripheral stent procedures. They also assessed ICD-9 codes for open bypasses.

Among the findings is that lower extremity bypass procedures in the state dropped from 5,294 in 2000 to 3,636 in 2008, a 31% decrease.

In just 5 years (2004-2008), ambulatory endovascular procedures grew from 3,014 to an estimated 6,670, which Dr. Hong described as "an exponential increase." (The 2008 figure is an annual projection based on data available from the first three quarters of that year.)

In 2008, the number of endovascular interventions in both settings exceeded the number of open bypasses by nearly threefold (12,419 vs. 3,636). Although hospital-based endovascular procedures increased from 2,698 to 5,748 in 2008, "inpatient management ... numbers seem to have plateaued over the last several years," Dr. Hong said.

Dr. Samson commented, "There is a shift for performing these procedures from hospitals to outpatient settings. However, only 3% are being done in freestanding facilities and the rest are at centers affiliated with hospitals." Dr. Hong confirmed that 97% of the ambulatory endovascular interventions were performed at hospital-affiliated centers, but added that some were done at freestanding cardiac catheter centers.

The researchers also assessed amputation numbers and trends. They found a 43% decrease in major amputations (defined as above knee to the ankle), from 2,833 in 2000 to 1,609 in 2008. At the same time, the number of minor amputations (from the forefoot to toe) remained relatively stable, from 1,354 to 1,362. "If you put them together with major amputations, the overall rate is down," Dr. Hong said.

Not surprisingly, the overall shift to ambulatory interventions was associated with "substantially lower charges overall," Dr. Hong said. The total mean charge for open bypass was $62,946, compared with $57,995 for hospital-based endovascular interventions and $32,719 for ambulatory endovascular procedures. Total charges increased each year by approximately 21% in the hospital setting and by 10% in the ambulatory setting, he added.

One potential study limitation is the reliance on coder input into the AHCA (Agency for Health Care Administration) database. "But there is nothing here to suggest any significant adverse problems so far," Dr. Hong said.

Another limitation of the study is that cost-to-charge ratios vary by hospital, Dr. Hong said. He added, however, that "a comparison between procedures still provides a good estimate of relative costs." Because AHCA is an administrative database, there was no clinical information on ankle brachial index or TASC (TransAtlantic Inter-Society Consensus) lesion classification. Also, it is unknown if the deidentified data included patients who underwent multiple procedures.

Dr. Hong and Dr. Samson said that they had no relevant disclosures.

NAPLES, FLA. – An exponential increase in ambulatory endovascular procedures for peripheral arterial disease is occurring in Florida, and it mirrors a nationwide trend, Dr. Michael S. Hong said at the annual meeting of the Southern Association for Vascular Surgery.

This shift to more ambulatory-based interventions is leading to decreases in open bypass procedures and major amputations, he said. This finding is from a study of discharges for peripheral arterial disease from Florida hospitals since 2000 and from ambulatory centers since 2004.

Approximately four out of five endovascular interventions for claudication, for example, are now performed in an ambulatory setting in Florida (approximately 8,000 vs. 2,000 done in a hospital setting), Dr. Hong said.

"With critical limb ischemia, the number of endovascular ambulatory interventions is much less than [that for] claudication, but we see an increase in the absolute number and in the proportion done in an ambulatory setting over time," said Dr. Hong, a research resident in the department of surgery at the University of Florida, Gainesville.

At the same time, inpatient procedures are still increasing for critical limb ischemia, Dr. Hong said. "Inpatient endovascular procedures are predominantly now for more advanced peripheral arterial disease."

"Interventionists might consider these more dangerous and hence want to perform them more in the hospital," said study discussant Dr. Russell H. Samson, a vascular surgeon at Doctors Hospital of Sarasota (Fla.). In addition, critical limb ischemia repairs "are very equipment intensive and the equipment is expensive."

Importantly, overall patient safety has not been compromised with a move toward more outpatient procedures, Dr. Hong said. "From our data, with only two deaths and 20 transferred, ... this shift to the ambulatory setting has not compromised patient safety."

He and his associates reviewed 10 years of ICD-9 inpatient codes and 6 years of outpatient CPT codes for endovascular angioplasty, atherectomy, and peripheral stent procedures. They also assessed ICD-9 codes for open bypasses.

Among the findings is that lower extremity bypass procedures in the state dropped from 5,294 in 2000 to 3,636 in 2008, a 31% decrease.

In just 5 years (2004-2008), ambulatory endovascular procedures grew from 3,014 to an estimated 6,670, which Dr. Hong described as "an exponential increase." (The 2008 figure is an annual projection based on data available from the first three quarters of that year.)

In 2008, the number of endovascular interventions in both settings exceeded the number of open bypasses by nearly threefold (12,419 vs. 3,636). Although hospital-based endovascular procedures increased from 2,698 to 5,748 in 2008, "inpatient management ... numbers seem to have plateaued over the last several years," Dr. Hong said.

Dr. Samson commented, "There is a shift for performing these procedures from hospitals to outpatient settings. However, only 3% are being done in freestanding facilities and the rest are at centers affiliated with hospitals." Dr. Hong confirmed that 97% of the ambulatory endovascular interventions were performed at hospital-affiliated centers, but added that some were done at freestanding cardiac catheter centers.

The researchers also assessed amputation numbers and trends. They found a 43% decrease in major amputations (defined as above knee to the ankle), from 2,833 in 2000 to 1,609 in 2008. At the same time, the number of minor amputations (from the forefoot to toe) remained relatively stable, from 1,354 to 1,362. "If you put them together with major amputations, the overall rate is down," Dr. Hong said.

Not surprisingly, the overall shift to ambulatory interventions was associated with "substantially lower charges overall," Dr. Hong said. The total mean charge for open bypass was $62,946, compared with $57,995 for hospital-based endovascular interventions and $32,719 for ambulatory endovascular procedures. Total charges increased each year by approximately 21% in the hospital setting and by 10% in the ambulatory setting, he added.

One potential study limitation is the reliance on coder input into the AHCA (Agency for Health Care Administration) database. "But there is nothing here to suggest any significant adverse problems so far," Dr. Hong said.

Another limitation of the study is that cost-to-charge ratios vary by hospital, Dr. Hong said. He added, however, that "a comparison between procedures still provides a good estimate of relative costs." Because AHCA is an administrative database, there was no clinical information on ankle brachial index or TASC (TransAtlantic Inter-Society Consensus) lesion classification. Also, it is unknown if the deidentified data included patients who underwent multiple procedures.

Dr. Hong and Dr. Samson said that they had no relevant disclosures.

NAPLES, FLA. – An exponential increase in ambulatory endovascular procedures for peripheral arterial disease is occurring in Florida, and it mirrors a nationwide trend, Dr. Michael S. Hong said at the annual meeting of the Southern Association for Vascular Surgery.

This shift to more ambulatory-based interventions is leading to decreases in open bypass procedures and major amputations, he said. This finding is from a study of discharges for peripheral arterial disease from Florida hospitals since 2000 and from ambulatory centers since 2004.

Approximately four out of five endovascular interventions for claudication, for example, are now performed in an ambulatory setting in Florida (approximately 8,000 vs. 2,000 done in a hospital setting), Dr. Hong said.

"With critical limb ischemia, the number of endovascular ambulatory interventions is much less than [that for] claudication, but we see an increase in the absolute number and in the proportion done in an ambulatory setting over time," said Dr. Hong, a research resident in the department of surgery at the University of Florida, Gainesville.

At the same time, inpatient procedures are still increasing for critical limb ischemia, Dr. Hong said. "Inpatient endovascular procedures are predominantly now for more advanced peripheral arterial disease."

"Interventionists might consider these more dangerous and hence want to perform them more in the hospital," said study discussant Dr. Russell H. Samson, a vascular surgeon at Doctors Hospital of Sarasota (Fla.). In addition, critical limb ischemia repairs "are very equipment intensive and the equipment is expensive."

Importantly, overall patient safety has not been compromised with a move toward more outpatient procedures, Dr. Hong said. "From our data, with only two deaths and 20 transferred, ... this shift to the ambulatory setting has not compromised patient safety."

He and his associates reviewed 10 years of ICD-9 inpatient codes and 6 years of outpatient CPT codes for endovascular angioplasty, atherectomy, and peripheral stent procedures. They also assessed ICD-9 codes for open bypasses.

Among the findings is that lower extremity bypass procedures in the state dropped from 5,294 in 2000 to 3,636 in 2008, a 31% decrease.

In just 5 years (2004-2008), ambulatory endovascular procedures grew from 3,014 to an estimated 6,670, which Dr. Hong described as "an exponential increase." (The 2008 figure is an annual projection based on data available from the first three quarters of that year.)

In 2008, the number of endovascular interventions in both settings exceeded the number of open bypasses by nearly threefold (12,419 vs. 3,636). Although hospital-based endovascular procedures increased from 2,698 to 5,748 in 2008, "inpatient management ... numbers seem to have plateaued over the last several years," Dr. Hong said.

Dr. Samson commented, "There is a shift for performing these procedures from hospitals to outpatient settings. However, only 3% are being done in freestanding facilities and the rest are at centers affiliated with hospitals." Dr. Hong confirmed that 97% of the ambulatory endovascular interventions were performed at hospital-affiliated centers, but added that some were done at freestanding cardiac catheter centers.

The researchers also assessed amputation numbers and trends. They found a 43% decrease in major amputations (defined as above knee to the ankle), from 2,833 in 2000 to 1,609 in 2008. At the same time, the number of minor amputations (from the forefoot to toe) remained relatively stable, from 1,354 to 1,362. "If you put them together with major amputations, the overall rate is down," Dr. Hong said.

Not surprisingly, the overall shift to ambulatory interventions was associated with "substantially lower charges overall," Dr. Hong said. The total mean charge for open bypass was $62,946, compared with $57,995 for hospital-based endovascular interventions and $32,719 for ambulatory endovascular procedures. Total charges increased each year by approximately 21% in the hospital setting and by 10% in the ambulatory setting, he added.

One potential study limitation is the reliance on coder input into the AHCA (Agency for Health Care Administration) database. "But there is nothing here to suggest any significant adverse problems so far," Dr. Hong said.

Another limitation of the study is that cost-to-charge ratios vary by hospital, Dr. Hong said. He added, however, that "a comparison between procedures still provides a good estimate of relative costs." Because AHCA is an administrative database, there was no clinical information on ankle brachial index or TASC (TransAtlantic Inter-Society Consensus) lesion classification. Also, it is unknown if the deidentified data included patients who underwent multiple procedures.

Dr. Hong and Dr. Samson said that they had no relevant disclosures.

NEW ORLEANS – The numbers can be daunting: juries awarding more than $56 million to patients so far, approximately 1,000 federal and state lawsuits pending, and an excess of 2,500 individuals filing claims in New Jersey State courts alone.

Add to that frequent TV ads from attorneys about inflammatory bowel disease risk with isotretinoin, and you’re bound to encounter fear and confusion from your teenage patients and their parents when you suggest this acne-fighting agent.

"Patients have the idea that this drug is just no longer available because it’s too dangerous," Dr. Julie Harper said at this year’s annual meeting of the American Academy of Dermatology. "It is still out there, as we all know."

So how do you counsel patients in this climate of fear? Dr. Harper counters with some numbers of her own. "This is a real risk in a small percentage of patients, probably occurring at a rate of 1 per 10,000. This is what I tell my patients," said Dr. Harper, a dermatologist in private practice in Birmingham, Ala.

Dr. Harper estimated writing more than 1,000 isotretinoin prescriptions during her dermatology career. "So it’s possible I may never reach 10,000 prescriptions and see this adverse event, but it’s possible."

Isotretinoin is not the only acne fighter implicated in risk for inflammatory bowel disease (IBD), Dr. Harper said. Patients taking tetracyclines, doxycycline in particular, were more likely to develop IBD in a retrospective study of 94,487 individuals with acne (Am. J. Gastroenterol. 2010;105:2610-16). This report generated a lot of attention at the AAD meeting.

"Keep this in mind when we consider isotretinoin and IBD," Dr. Harper said. "There can be a confounding factor."

Dr. Harper highlighted the salient studies from the gastroenterology researchers who assessed a link between isotretinoin and IBD. It all started with a first case report (Gastroenterology. 1987;93:606-9)."It was a suggestive case, but had an ‘n’ of one."

Almost 20 years later came a review article. Researchers identified 85 reports of IBD signs/symptoms associated with isotretinoin in the U.S. Food and Drug Administration MedWatch database between 1997 and 2002 (Am. J. Gastroenterol. 2006:101:1569-73). They also reviewed clinical trial data from isotretinoin manufacturer Hoffman-LaRoche for any de novo cases of IBD not reported to the FDA. "There were none," Dr. Harper said.

The investigators scored the MedWatch reports for strength of causation. Of the 85 reports, 4 were in the "highly probable" range; 58 were in the "probable" range; 23 were "possible," and zero were "doubtful." Three of these reported cases included documented improvement when isotretinoin was withdrawn, and worsening when isotretinoin was reintroduced, Dr. Harper said.

Researchers Dr. Seth D. Crockett and associates reviewed 12 case reports and one case series published in the literature and determined there was insufficient evidence to support or refute a casual relationship between isotretinoin and IBD (Am. J. Gastroenterol. 2009;104:2387-93).

"But we’re seeing what the juries are awarding, so there is a disconnect there," Dr. Harper said.

The following year, the same lead researcher and his associates reported their own case-control study (Am. J. Gastroenterol. 2010;105:1986-93). They assessed an insurance company database with 8,189 people with IBD (3,664 with Crohn’s disease, 4,428 with ulcerative colitis, and 97 with unspecified IBD) and 21,832 controls. They identified 60 people (24 cases, 36 controls) who had exposure to isotretinoin.

"That is not to say it’s not real, but we’re talking big denominators and a low number of cases," Dr. Harper said.

Interestingly, Dr. Crockett’s research team did not find an association between isotretinoin exposure and Crohn’s disease (odds ratio, 0.68) but reported a positive association with ulcerative colitis (OR, 4.36).

During the question-and-answer period, Dr. Bruce Thiers, a meeting attendee who has been working on behalf of Hoffman-La Roche on the lawsuits, commented on the risk. "If you look at the incidence of IBD, the highest incidence is in teenagers and adults. You are treating the age group that gets IBD.

"Right now if you watch television more than 10 minutes you see an advertisement," Dr. Thiers said. "Roche is being sued for people who developed IBD 6 months to 2 years [after isotretinoin]. Some had symptomatology beforehand, so it could also be the drug suppressed the disease and then it recurred." Dr. Thiers is professor and chair of dermatology at the Medical University of South Carolina in Charleston.

"We don’t have hard, fast information on a lot of what we prescribe," Dr. James Q. Del Rosso, a private practice dermatologist in Las Vegas, said before starting his subsequent presentation at the meeting."There is really nothing we can prescribe that has no risk, and patients have to accept some risk. I tell patients that there is always a chance you can get something very rare [but] that is very unlikely. I cannot reassure you that will not happen, but I can tell you the majority of people do very well."

Dr. Del Rosso added: "Oral isotretinoin can significantly reduce night vision. I am actually more concerned about that that is something that will happen to everyone. I document telling them they should not drive at night."

Inhibition of bone growth and an increased likelihood of depression are other major fears of patients and parents regarding isotretinoin that are not fully supported by evidence in the literature.

With respect to bone growth, Dr. Harper said: "There is not a lot of data out there." On the basis of a report of three cases, Dr. Harper said that premature closure of the epiphyses might be possible with a long duration of high doses of isotretinoin (JAAD 2001:45:S176-82).

"I have one [adolescent] patient who is very tall, a star basketball player, who could benefit from isotretinoin. His mom and dad heard about this [risk] and will not let him take it," Dr. Harper said.

Regarding isotretinoin and depression, Dr. Harper said, "Most of what we have out there are case reports, ‘n’s of 1 or small series." One notable exception is a large, population-based study where researchers assessed risk for depression and suicidality among 21,911 people prescribed isotretinoin or an antibiotic for acne (Arch. Dermatol. 2000;136:1231-6). "In summary, there was no difference between isotretinoin and minocycline [with respect to] development of depression," Dr. Harper said.

"When it comes to isotretinoin and depression, evidence is weak, but we have to be vigilant," Dr. Harper said. "Most of us have seen some cases where there is a change in mood – I’m not sure it’s depression – but it’s a small number [of patients]."

Dr. Harper and Dr. Del Rosso are consultants for and receive honoraria from Ranbaxy, which makes a generic form of isotretinoin. Dr. Thiers has supported Hoffman-La Roche in lawsuits concerning isotretinoin.

NEW ORLEANS – The numbers can be daunting: juries awarding more than $56 million to patients so far, approximately 1,000 federal and state lawsuits pending, and an excess of 2,500 individuals filing claims in New Jersey State courts alone.

Add to that frequent TV ads from attorneys about inflammatory bowel disease risk with isotretinoin, and you’re bound to encounter fear and confusion from your teenage patients and their parents when you suggest this acne-fighting agent.

"Patients have the idea that this drug is just no longer available because it’s too dangerous," Dr. Julie Harper said at this year’s annual meeting of the American Academy of Dermatology. "It is still out there, as we all know."

So how do you counsel patients in this climate of fear? Dr. Harper counters with some numbers of her own. "This is a real risk in a small percentage of patients, probably occurring at a rate of 1 per 10,000. This is what I tell my patients," said Dr. Harper, a dermatologist in private practice in Birmingham, Ala.

Dr. Harper estimated writing more than 1,000 isotretinoin prescriptions during her dermatology career. "So it’s possible I may never reach 10,000 prescriptions and see this adverse event, but it’s possible."

Isotretinoin is not the only acne fighter implicated in risk for inflammatory bowel disease (IBD), Dr. Harper said. Patients taking tetracyclines, doxycycline in particular, were more likely to develop IBD in a retrospective study of 94,487 individuals with acne (Am. J. Gastroenterol. 2010;105:2610-16). This report generated a lot of attention at the AAD meeting.

"Keep this in mind when we consider isotretinoin and IBD," Dr. Harper said. "There can be a confounding factor."

Dr. Harper highlighted the salient studies from the gastroenterology researchers who assessed a link between isotretinoin and IBD. It all started with a first case report (Gastroenterology. 1987;93:606-9)."It was a suggestive case, but had an ‘n’ of one."

Almost 20 years later came a review article. Researchers identified 85 reports of IBD signs/symptoms associated with isotretinoin in the U.S. Food and Drug Administration MedWatch database between 1997 and 2002 (Am. J. Gastroenterol. 2006:101:1569-73). They also reviewed clinical trial data from isotretinoin manufacturer Hoffman-LaRoche for any de novo cases of IBD not reported to the FDA. "There were none," Dr. Harper said.

The investigators scored the MedWatch reports for strength of causation. Of the 85 reports, 4 were in the "highly probable" range; 58 were in the "probable" range; 23 were "possible," and zero were "doubtful." Three of these reported cases included documented improvement when isotretinoin was withdrawn, and worsening when isotretinoin was reintroduced, Dr. Harper said.

Researchers Dr. Seth D. Crockett and associates reviewed 12 case reports and one case series published in the literature and determined there was insufficient evidence to support or refute a casual relationship between isotretinoin and IBD (Am. J. Gastroenterol. 2009;104:2387-93).

"But we’re seeing what the juries are awarding, so there is a disconnect there," Dr. Harper said.

The following year, the same lead researcher and his associates reported their own case-control study (Am. J. Gastroenterol. 2010;105:1986-93). They assessed an insurance company database with 8,189 people with IBD (3,664 with Crohn’s disease, 4,428 with ulcerative colitis, and 97 with unspecified IBD) and 21,832 controls. They identified 60 people (24 cases, 36 controls) who had exposure to isotretinoin.

"That is not to say it’s not real, but we’re talking big denominators and a low number of cases," Dr. Harper said.

Interestingly, Dr. Crockett’s research team did not find an association between isotretinoin exposure and Crohn’s disease (odds ratio, 0.68) but reported a positive association with ulcerative colitis (OR, 4.36).

During the question-and-answer period, Dr. Bruce Thiers, a meeting attendee who has been working on behalf of Hoffman-La Roche on the lawsuits, commented on the risk. "If you look at the incidence of IBD, the highest incidence is in teenagers and adults. You are treating the age group that gets IBD.

"Right now if you watch television more than 10 minutes you see an advertisement," Dr. Thiers said. "Roche is being sued for people who developed IBD 6 months to 2 years [after isotretinoin]. Some had symptomatology beforehand, so it could also be the drug suppressed the disease and then it recurred." Dr. Thiers is professor and chair of dermatology at the Medical University of South Carolina in Charleston.

"We don’t have hard, fast information on a lot of what we prescribe," Dr. James Q. Del Rosso, a private practice dermatologist in Las Vegas, said before starting his subsequent presentation at the meeting."There is really nothing we can prescribe that has no risk, and patients have to accept some risk. I tell patients that there is always a chance you can get something very rare [but] that is very unlikely. I cannot reassure you that will not happen, but I can tell you the majority of people do very well."

Dr. Del Rosso added: "Oral isotretinoin can significantly reduce night vision. I am actually more concerned about that that is something that will happen to everyone. I document telling them they should not drive at night."

Inhibition of bone growth and an increased likelihood of depression are other major fears of patients and parents regarding isotretinoin that are not fully supported by evidence in the literature.

With respect to bone growth, Dr. Harper said: "There is not a lot of data out there." On the basis of a report of three cases, Dr. Harper said that premature closure of the epiphyses might be possible with a long duration of high doses of isotretinoin (JAAD 2001:45:S176-82).

"I have one [adolescent] patient who is very tall, a star basketball player, who could benefit from isotretinoin. His mom and dad heard about this [risk] and will not let him take it," Dr. Harper said.

Regarding isotretinoin and depression, Dr. Harper said, "Most of what we have out there are case reports, ‘n’s of 1 or small series." One notable exception is a large, population-based study where researchers assessed risk for depression and suicidality among 21,911 people prescribed isotretinoin or an antibiotic for acne (Arch. Dermatol. 2000;136:1231-6). "In summary, there was no difference between isotretinoin and minocycline [with respect to] development of depression," Dr. Harper said.

"When it comes to isotretinoin and depression, evidence is weak, but we have to be vigilant," Dr. Harper said. "Most of us have seen some cases where there is a change in mood – I’m not sure it’s depression – but it’s a small number [of patients]."

Dr. Harper and Dr. Del Rosso are consultants for and receive honoraria from Ranbaxy, which makes a generic form of isotretinoin. Dr. Thiers has supported Hoffman-La Roche in lawsuits concerning isotretinoin.

NEW ORLEANS – The numbers can be daunting: juries awarding more than $56 million to patients so far, approximately 1,000 federal and state lawsuits pending, and an excess of 2,500 individuals filing claims in New Jersey State courts alone.

Add to that frequent TV ads from attorneys about inflammatory bowel disease risk with isotretinoin, and you’re bound to encounter fear and confusion from your teenage patients and their parents when you suggest this acne-fighting agent.

"Patients have the idea that this drug is just no longer available because it’s too dangerous," Dr. Julie Harper said at this year’s annual meeting of the American Academy of Dermatology. "It is still out there, as we all know."

So how do you counsel patients in this climate of fear? Dr. Harper counters with some numbers of her own. "This is a real risk in a small percentage of patients, probably occurring at a rate of 1 per 10,000. This is what I tell my patients," said Dr. Harper, a dermatologist in private practice in Birmingham, Ala.

Dr. Harper estimated writing more than 1,000 isotretinoin prescriptions during her dermatology career. "So it’s possible I may never reach 10,000 prescriptions and see this adverse event, but it’s possible."

Isotretinoin is not the only acne fighter implicated in risk for inflammatory bowel disease (IBD), Dr. Harper said. Patients taking tetracyclines, doxycycline in particular, were more likely to develop IBD in a retrospective study of 94,487 individuals with acne (Am. J. Gastroenterol. 2010;105:2610-16). This report generated a lot of attention at the AAD meeting.

"Keep this in mind when we consider isotretinoin and IBD," Dr. Harper said. "There can be a confounding factor."

Dr. Harper highlighted the salient studies from the gastroenterology researchers who assessed a link between isotretinoin and IBD. It all started with a first case report (Gastroenterology. 1987;93:606-9)."It was a suggestive case, but had an ‘n’ of one."

Almost 20 years later came a review article. Researchers identified 85 reports of IBD signs/symptoms associated with isotretinoin in the U.S. Food and Drug Administration MedWatch database between 1997 and 2002 (Am. J. Gastroenterol. 2006:101:1569-73). They also reviewed clinical trial data from isotretinoin manufacturer Hoffman-LaRoche for any de novo cases of IBD not reported to the FDA. "There were none," Dr. Harper said.

The investigators scored the MedWatch reports for strength of causation. Of the 85 reports, 4 were in the "highly probable" range; 58 were in the "probable" range; 23 were "possible," and zero were "doubtful." Three of these reported cases included documented improvement when isotretinoin was withdrawn, and worsening when isotretinoin was reintroduced, Dr. Harper said.

Researchers Dr. Seth D. Crockett and associates reviewed 12 case reports and one case series published in the literature and determined there was insufficient evidence to support or refute a casual relationship between isotretinoin and IBD (Am. J. Gastroenterol. 2009;104:2387-93).

"But we’re seeing what the juries are awarding, so there is a disconnect there," Dr. Harper said.

The following year, the same lead researcher and his associates reported their own case-control study (Am. J. Gastroenterol. 2010;105:1986-93). They assessed an insurance company database with 8,189 people with IBD (3,664 with Crohn’s disease, 4,428 with ulcerative colitis, and 97 with unspecified IBD) and 21,832 controls. They identified 60 people (24 cases, 36 controls) who had exposure to isotretinoin.

"That is not to say it’s not real, but we’re talking big denominators and a low number of cases," Dr. Harper said.

Interestingly, Dr. Crockett’s research team did not find an association between isotretinoin exposure and Crohn’s disease (odds ratio, 0.68) but reported a positive association with ulcerative colitis (OR, 4.36).

During the question-and-answer period, Dr. Bruce Thiers, a meeting attendee who has been working on behalf of Hoffman-La Roche on the lawsuits, commented on the risk. "If you look at the incidence of IBD, the highest incidence is in teenagers and adults. You are treating the age group that gets IBD.

"Right now if you watch television more than 10 minutes you see an advertisement," Dr. Thiers said. "Roche is being sued for people who developed IBD 6 months to 2 years [after isotretinoin]. Some had symptomatology beforehand, so it could also be the drug suppressed the disease and then it recurred." Dr. Thiers is professor and chair of dermatology at the Medical University of South Carolina in Charleston.

"We don’t have hard, fast information on a lot of what we prescribe," Dr. James Q. Del Rosso, a private practice dermatologist in Las Vegas, said before starting his subsequent presentation at the meeting."There is really nothing we can prescribe that has no risk, and patients have to accept some risk. I tell patients that there is always a chance you can get something very rare [but] that is very unlikely. I cannot reassure you that will not happen, but I can tell you the majority of people do very well."

Dr. Del Rosso added: "Oral isotretinoin can significantly reduce night vision. I am actually more concerned about that that is something that will happen to everyone. I document telling them they should not drive at night."

Inhibition of bone growth and an increased likelihood of depression are other major fears of patients and parents regarding isotretinoin that are not fully supported by evidence in the literature.

With respect to bone growth, Dr. Harper said: "There is not a lot of data out there." On the basis of a report of three cases, Dr. Harper said that premature closure of the epiphyses might be possible with a long duration of high doses of isotretinoin (JAAD 2001:45:S176-82).

"I have one [adolescent] patient who is very tall, a star basketball player, who could benefit from isotretinoin. His mom and dad heard about this [risk] and will not let him take it," Dr. Harper said.

Regarding isotretinoin and depression, Dr. Harper said, "Most of what we have out there are case reports, ‘n’s of 1 or small series." One notable exception is a large, population-based study where researchers assessed risk for depression and suicidality among 21,911 people prescribed isotretinoin or an antibiotic for acne (Arch. Dermatol. 2000;136:1231-6). "In summary, there was no difference between isotretinoin and minocycline [with respect to] development of depression," Dr. Harper said.

"When it comes to isotretinoin and depression, evidence is weak, but we have to be vigilant," Dr. Harper said. "Most of us have seen some cases where there is a change in mood – I’m not sure it’s depression – but it’s a small number [of patients]."

Dr. Harper and Dr. Del Rosso are consultants for and receive honoraria from Ranbaxy, which makes a generic form of isotretinoin. Dr. Thiers has supported Hoffman-La Roche in lawsuits concerning isotretinoin.

NEW ORLEANS – Although the American Medical Association recently updated recommendations for office-based screening of older adults for driving impairment, little guidance is available on screening hospitalized patients before discharge, Dr. Linda Hill said at the annual meeting of the Gerontological Society of America.

So Dr. Hill and her associates performed two studies. In one, they screened 755 patients, who were older than 60 years and in hospital and affiliated outpatient settings, for driving disorders. About one in six (17%) failed the screening, meaning that they did not pass one or more tests for visual acuity, visual fields, clock drawing, range of motion, timed gait, strength, or the Trail Making Test.

"We’ve been working on trying to educate health professionals. There has been less uptake than would be ideal, since the AMA said this should be done routinely," said Dr. Hill of the department of family and preventive medicine at the University of California, San Diego.

Their second study indicated that few physicians implement screening of older, office-based patients for age-related driving disorders (ARDDs), as outlined in the AMA 2003 and 2010 Physicians Guide to Assessing and Counseling Older Drivers. However, a training program improved practitioner awareness and willingness to screen in this study of 492 providers, 81% of whom were physicians. Confidence about performing ARDD screening rose from 19% before training to 73% afterward. Intent to screen surpassed 90% after the activity.

"We think the doctors could take a much more proactive role." Dr. Hill said. For example, "hospitalists are seeing the highest-risk elderly population and should be aware if their patients are high-risk drivers."

Dr. Hill acknowledged that physicians have a lot of competing priorities for their time, and added, "Our other message is that it does not have to be the doctor doing the screening, just the interpretation."

Also, if screening uncovers some impairment, a physician can refer the patient. "There is a whole group of occupational therapists who do driving assessments," Dr. Hill said.

In the first study, the mean age of the 755 adults was 72 years, and 56% were men. They were screened from January 2008 to October 2009 using the AMA guidelines, followed by a satisfaction survey and 1-month follow-up.

Older age, male sex, self-restrictions on driving, and inpatient status predicted failing at least one of the ARDD tests adapted to the inpatient setting. A total of 74% passed screening, 17% failed (11% of these cases were reported to the department of motor vehicles), and 9% had incomplete testing.

In all, 537 older patients (71%) completed the satisfaction survey. The majority (71%) indicated that the screening was useful; 75% would recommend the screening, and 78% were not surprised by their results.

At 1 month post screening, 49% of the patients who failed and 14% of those who passed said they were not driving. Another 37% of those who failed and 24% of those who passed had restricted their driving.

The primary care physician ordered additional testing to assess driving ability in 16% of participants who failed screening and 6% of those who passed, Dr. Hill said.

The studies showed that screening for driving impairment is feasible in both inpatient and outpatient settings, Dr. Hill said.

The research was funded by the California Office of Traffic Safety through the National Highway Traffic Safety Administration. Dr. Hill said she had no relevant financial disclosures.

NEW ORLEANS – Although the American Medical Association recently updated recommendations for office-based screening of older adults for driving impairment, little guidance is available on screening hospitalized patients before discharge, Dr. Linda Hill said at the annual meeting of the Gerontological Society of America.

So Dr. Hill and her associates performed two studies. In one, they screened 755 patients, who were older than 60 years and in hospital and affiliated outpatient settings, for driving disorders. About one in six (17%) failed the screening, meaning that they did not pass one or more tests for visual acuity, visual fields, clock drawing, range of motion, timed gait, strength, or the Trail Making Test.

"We’ve been working on trying to educate health professionals. There has been less uptake than would be ideal, since the AMA said this should be done routinely," said Dr. Hill of the department of family and preventive medicine at the University of California, San Diego.

Their second study indicated that few physicians implement screening of older, office-based patients for age-related driving disorders (ARDDs), as outlined in the AMA 2003 and 2010 Physicians Guide to Assessing and Counseling Older Drivers. However, a training program improved practitioner awareness and willingness to screen in this study of 492 providers, 81% of whom were physicians. Confidence about performing ARDD screening rose from 19% before training to 73% afterward. Intent to screen surpassed 90% after the activity.

"We think the doctors could take a much more proactive role." Dr. Hill said. For example, "hospitalists are seeing the highest-risk elderly population and should be aware if their patients are high-risk drivers."

Dr. Hill acknowledged that physicians have a lot of competing priorities for their time, and added, "Our other message is that it does not have to be the doctor doing the screening, just the interpretation."

Also, if screening uncovers some impairment, a physician can refer the patient. "There is a whole group of occupational therapists who do driving assessments," Dr. Hill said.

In the first study, the mean age of the 755 adults was 72 years, and 56% were men. They were screened from January 2008 to October 2009 using the AMA guidelines, followed by a satisfaction survey and 1-month follow-up.

Older age, male sex, self-restrictions on driving, and inpatient status predicted failing at least one of the ARDD tests adapted to the inpatient setting. A total of 74% passed screening, 17% failed (11% of these cases were reported to the department of motor vehicles), and 9% had incomplete testing.

In all, 537 older patients (71%) completed the satisfaction survey. The majority (71%) indicated that the screening was useful; 75% would recommend the screening, and 78% were not surprised by their results.

At 1 month post screening, 49% of the patients who failed and 14% of those who passed said they were not driving. Another 37% of those who failed and 24% of those who passed had restricted their driving.

The primary care physician ordered additional testing to assess driving ability in 16% of participants who failed screening and 6% of those who passed, Dr. Hill said.

The studies showed that screening for driving impairment is feasible in both inpatient and outpatient settings, Dr. Hill said.

The research was funded by the California Office of Traffic Safety through the National Highway Traffic Safety Administration. Dr. Hill said she had no relevant financial disclosures.

NEW ORLEANS – Although the American Medical Association recently updated recommendations for office-based screening of older adults for driving impairment, little guidance is available on screening hospitalized patients before discharge, Dr. Linda Hill said at the annual meeting of the Gerontological Society of America.

So Dr. Hill and her associates performed two studies. In one, they screened 755 patients, who were older than 60 years and in hospital and affiliated outpatient settings, for driving disorders. About one in six (17%) failed the screening, meaning that they did not pass one or more tests for visual acuity, visual fields, clock drawing, range of motion, timed gait, strength, or the Trail Making Test.

"We’ve been working on trying to educate health professionals. There has been less uptake than would be ideal, since the AMA said this should be done routinely," said Dr. Hill of the department of family and preventive medicine at the University of California, San Diego.

Their second study indicated that few physicians implement screening of older, office-based patients for age-related driving disorders (ARDDs), as outlined in the AMA 2003 and 2010 Physicians Guide to Assessing and Counseling Older Drivers. However, a training program improved practitioner awareness and willingness to screen in this study of 492 providers, 81% of whom were physicians. Confidence about performing ARDD screening rose from 19% before training to 73% afterward. Intent to screen surpassed 90% after the activity.

"We think the doctors could take a much more proactive role." Dr. Hill said. For example, "hospitalists are seeing the highest-risk elderly population and should be aware if their patients are high-risk drivers."

Dr. Hill acknowledged that physicians have a lot of competing priorities for their time, and added, "Our other message is that it does not have to be the doctor doing the screening, just the interpretation."

Also, if screening uncovers some impairment, a physician can refer the patient. "There is a whole group of occupational therapists who do driving assessments," Dr. Hill said.

In the first study, the mean age of the 755 adults was 72 years, and 56% were men. They were screened from January 2008 to October 2009 using the AMA guidelines, followed by a satisfaction survey and 1-month follow-up.

Older age, male sex, self-restrictions on driving, and inpatient status predicted failing at least one of the ARDD tests adapted to the inpatient setting. A total of 74% passed screening, 17% failed (11% of these cases were reported to the department of motor vehicles), and 9% had incomplete testing.

In all, 537 older patients (71%) completed the satisfaction survey. The majority (71%) indicated that the screening was useful; 75% would recommend the screening, and 78% were not surprised by their results.

At 1 month post screening, 49% of the patients who failed and 14% of those who passed said they were not driving. Another 37% of those who failed and 24% of those who passed had restricted their driving.

The primary care physician ordered additional testing to assess driving ability in 16% of participants who failed screening and 6% of those who passed, Dr. Hill said.

The studies showed that screening for driving impairment is feasible in both inpatient and outpatient settings, Dr. Hill said.

The research was funded by the California Office of Traffic Safety through the National Highway Traffic Safety Administration. Dr. Hill said she had no relevant financial disclosures.

NEW ORLEANS – Although the American Medical Association recently updated recommendations for office-based screening of older adults for driving impairment, little guidance is available on screening hospitalized patients before discharge, Dr. Linda Hill said at the annual meeting of the Gerontological Society of America.

So Dr. Hill and her associates performed two studies. In one, they screened 755 patients, who were older than 60 years and in hospital and affiliated outpatient settings, for driving disorders. About one in six (17%) failed the screening, meaning that they did not pass one or more tests for visual acuity, visual fields, clock drawing, range of motion, timed gait, strength, or the Trail Making Test.

"We’ve been working on trying to educate health professionals. There has been less uptake than would be ideal, since the AMA said this should be done routinely," said Dr. Hill of the department of family and preventive medicine at the University of California, San Diego.

Their second study indicated that few physicians implement screening of older, office-based patients for age-related driving disorders (ARDDs), as outlined in the AMA 2003 and 2010 Physicians Guide to Assessing and Counseling Older Drivers. However, a training program improved practitioner awareness and willingness to screen in this study of 492 providers, 81% of whom were physicians. Confidence about performing ARDD screening rose from 19% before training to 73% afterward. Intent to screen surpassed 90% after the activity.

"We think the doctors could take a much more proactive role." Dr. Hill said. For example, "hospitalists are seeing the highest-risk elderly population and should be aware if their patients are high-risk drivers."

Dr. Hill acknowledged that physicians have a lot of competing priorities for their time, and added, "Our other message is that it does not have to be the doctor doing the screening, just the interpretation."

Also, if screening uncovers some impairment, a physician can refer the patient. "There is a whole group of occupational therapists who do driving assessments," Dr. Hill said.

In the first study, the mean age of the 755 adults was 72 years, and 56% were men. They were screened from January 2008 to October 2009 using the AMA guidelines, followed by a satisfaction survey and 1-month follow-up.

Older age, male sex, self-restrictions on driving, and inpatient status predicted failing at least one of the ARDD tests adapted to the inpatient setting. A total of 74% passed screening, 17% failed (11% of these cases were reported to the department of motor vehicles), and 9% had incomplete testing.

In all, 537 older patients (71%) completed the satisfaction survey. The majority (71%) indicated that the screening was useful; 75% would recommend the screening, and 78% were not surprised by their results.

At 1 month post screening, 49% of the patients who failed and 14% of those who passed said they were not driving. Another 37% of those who failed and 24% of those who passed had restricted their driving.

The primary care physician ordered additional testing to assess driving ability in 16% of participants who failed screening and 6% of those who passed, Dr. Hill said.

The studies showed that screening for driving impairment is feasible in both inpatient and outpatient settings, Dr. Hill said.

The research was funded by the California Office of Traffic Safety through the National Highway Traffic Safety Administration. Dr. Hill said she had no relevant financial disclosures.

NEW ORLEANS – Although the American Medical Association recently updated recommendations for office-based screening of older adults for driving impairment, little guidance is available on screening hospitalized patients before discharge, Dr. Linda Hill said at the annual meeting of the Gerontological Society of America.

So Dr. Hill and her associates performed two studies. In one, they screened 755 patients, who were older than 60 years and in hospital and affiliated outpatient settings, for driving disorders. About one in six (17%) failed the screening, meaning that they did not pass one or more tests for visual acuity, visual fields, clock drawing, range of motion, timed gait, strength, or the Trail Making Test.

"We’ve been working on trying to educate health professionals. There has been less uptake than would be ideal, since the AMA said this should be done routinely," said Dr. Hill of the department of family and preventive medicine at the University of California, San Diego.

Their second study indicated that few physicians implement screening of older, office-based patients for age-related driving disorders (ARDDs), as outlined in the AMA 2003 and 2010 Physicians Guide to Assessing and Counseling Older Drivers. However, a training program improved practitioner awareness and willingness to screen in this study of 492 providers, 81% of whom were physicians. Confidence about performing ARDD screening rose from 19% before training to 73% afterward. Intent to screen surpassed 90% after the activity.

"We think the doctors could take a much more proactive role." Dr. Hill said. For example, "hospitalists are seeing the highest-risk elderly population and should be aware if their patients are high-risk drivers."

Dr. Hill acknowledged that physicians have a lot of competing priorities for their time, and added, "Our other message is that it does not have to be the doctor doing the screening, just the interpretation."

Also, if screening uncovers some impairment, a physician can refer the patient. "There is a whole group of occupational therapists who do driving assessments," Dr. Hill said.

In the first study, the mean age of the 755 adults was 72 years, and 56% were men. They were screened from January 2008 to October 2009 using the AMA guidelines, followed by a satisfaction survey and 1-month follow-up.

Older age, male sex, self-restrictions on driving, and inpatient status predicted failing at least one of the ARDD tests adapted to the inpatient setting. A total of 74% passed screening, 17% failed (11% of these cases were reported to the department of motor vehicles), and 9% had incomplete testing.

In all, 537 older patients (71%) completed the satisfaction survey. The majority (71%) indicated that the screening was useful; 75% would recommend the screening, and 78% were not surprised by their results.

At 1 month post screening, 49% of the patients who failed and 14% of those who passed said they were not driving. Another 37% of those who failed and 24% of those who passed had restricted their driving.

The primary care physician ordered additional testing to assess driving ability in 16% of participants who failed screening and 6% of those who passed, Dr. Hill said.

The studies showed that screening for driving impairment is feasible in both inpatient and outpatient settings, Dr. Hill said.

The research was funded by the California Office of Traffic Safety through the National Highway Traffic Safety Administration. Dr. Hill said she had no relevant financial disclosures.

NEW ORLEANS – Although the American Medical Association recently updated recommendations for office-based screening of older adults for driving impairment, little guidance is available on screening hospitalized patients before discharge, Dr. Linda Hill said at the annual meeting of the Gerontological Society of America.

So Dr. Hill and her associates performed two studies. In one, they screened 755 patients, who were older than 60 years and in hospital and affiliated outpatient settings, for driving disorders. About one in six (17%) failed the screening, meaning that they did not pass one or more tests for visual acuity, visual fields, clock drawing, range of motion, timed gait, strength, or the Trail Making Test.

"We’ve been working on trying to educate health professionals. There has been less uptake than would be ideal, since the AMA said this should be done routinely," said Dr. Hill of the department of family and preventive medicine at the University of California, San Diego.

Their second study indicated that few physicians implement screening of older, office-based patients for age-related driving disorders (ARDDs), as outlined in the AMA 2003 and 2010 Physicians Guide to Assessing and Counseling Older Drivers. However, a training program improved practitioner awareness and willingness to screen in this study of 492 providers, 81% of whom were physicians. Confidence about performing ARDD screening rose from 19% before training to 73% afterward. Intent to screen surpassed 90% after the activity.

"We think the doctors could take a much more proactive role." Dr. Hill said. For example, "hospitalists are seeing the highest-risk elderly population and should be aware if their patients are high-risk drivers."

Dr. Hill acknowledged that physicians have a lot of competing priorities for their time, and added, "Our other message is that it does not have to be the doctor doing the screening, just the interpretation."

Also, if screening uncovers some impairment, a physician can refer the patient. "There is a whole group of occupational therapists who do driving assessments," Dr. Hill said.

In the first study, the mean age of the 755 adults was 72 years, and 56% were men. They were screened from January 2008 to October 2009 using the AMA guidelines, followed by a satisfaction survey and 1-month follow-up.

Older age, male sex, self-restrictions on driving, and inpatient status predicted failing at least one of the ARDD tests adapted to the inpatient setting. A total of 74% passed screening, 17% failed (11% of these cases were reported to the department of motor vehicles), and 9% had incomplete testing.

In all, 537 older patients (71%) completed the satisfaction survey. The majority (71%) indicated that the screening was useful; 75% would recommend the screening, and 78% were not surprised by their results.

At 1 month post screening, 49% of the patients who failed and 14% of those who passed said they were not driving. Another 37% of those who failed and 24% of those who passed had restricted their driving.

The primary care physician ordered additional testing to assess driving ability in 16% of participants who failed screening and 6% of those who passed, Dr. Hill said.

The studies showed that screening for driving impairment is feasible in both inpatient and outpatient settings, Dr. Hill said.

The research was funded by the California Office of Traffic Safety through the National Highway Traffic Safety Administration. Dr. Hill said she had no relevant financial disclosures.

NEW ORLEANS – Topical immunomodulators did not increase overall risk for lymphoma in a large retrospective study of patients with atopic dermatitis.

Researchers identified 760 cases of lymphoma in a claims database of 625,915 atopic patients. They assessed risk of lymphoma associated with pimecrolimus cream 1%, tacrolimus ointment 0.1% or 0.3%, and topical corticosteroid treatment, compared with patients not treated with the agents. They also looked at a group of 3,040 atopic dermatitis patients to control for age and gender in each lymphoma case.

"This study found no increased risk of overall lymphoma in atopic dermatitis patients treated with topical corticosteroids or topical calcineurin inhibitors," said Dr. Alejandro Arana, a researcher in Zaragoza, Spain.

Compared with lymphoma risk in the control group of atopic dermatitis patients who did not use any of the agents in the study (odds ratio, 1), risk was lower with pimecrolimus (OR, 0.76) and topical corticosteroids (OR, 0.90). In contrast, risk was increased for patients treated with tacrolimus (OR, 1.24).

"The lower risk of lymphoma appears to be reassuring," said session moderator Dr. Jan Izakovic, a dermatologist at the University of Miami.

Because of specific concerns about elevated risk for lymphoma associated with topical immunomodulators in children and adolescents, Dr. Arana and his associates separately assessed the 186 atopic patients with lymphoma and 741 atopic controls younger than 20 years.

"The results were similar," said Dr. Arana.

In the younger population 186 atopic patients with lymphoma and 741 atopic controls all risks for lymphoma were lower: with pimecrolimus (OR, 0.64); topical corticosteroids (OR, 0.72); and tacrolimus (OR, 0.96).

"Among those younger than 20, we feel very reassured," Dr. Arana said. "We didn’t find any risk."

All atopic dermatitis and lymphoma cases were identified using ICD-9 codes in the PharMetrics Integrated Database between July 1995 and March 2009. Mean age was 38 years, and 43% of patients were male.

The researchers also looked at subtypes of lymphoma. Of the 760 cases, 106 were Hodgkin's lymphoma. The 200 cases of non-Hodgkin's lymphoma included 118 T-cell lymphomas, 30 B-cell lymphomas, and 52 indeterminate types. The remaining 454 cases (60%) were not classified by subtype, a potential limitation of the study.

"We also looked at exposure to immunomodulators and risk of T-cell lymphoma, the subtype we are most concerned about," Dr. Arana said.

Dr. Arana and his associates assessed this risk in patients of all ages. Compared with a reference group of 45 cases with T-cell lymphoma and 228 controls not exposed to any of the medications (OR, 1.0), risk was lower with pimecrolimus (OR, 0.85); slightly increased with corticosteroids (OR, 1.16); and greater with tacrolimus (OR, 4.95).

"We should be very, very careful with these results," Dr. Arana said. The results are only suggestive, he added, because of the small number of cases of T-cell lymphoma, and the researchers' inability to determine lymphoma subtype in a majority of cases. In addition, cases with more severe atopic dermatitis could have confounded the results.

Nevertheless, the study size was sufficient to precisely estimate the association between overall lymphoma risk and use of topical calcineurin inhibitors, Dr. Arana said.

The researchers also looked at overall risk of lymphoma in all patients by dose. For example, they looked at pimecrolimus doses less than 0.3 g; 0.3 g to less than 0.6 g; 0.6 g to less than 1.0 g; and 1.0 g or greater. They also looked at tacrolimus doses of less than 0.03 g; 0.03 g to less than 0.06 g; 0.06 g to less than 0.10 g; and 0.10 g or greater.

"We didn't see any dose response for any corticosteroids or pimecrolimus, and a slightly increased risk for tacrolimus of 0.10 g or greater, with an odds ratio of 2.08," Dr. Arana said.

The study was funded through an unrestricted grant from Novartis. Dr. Arana had no relevant disclosures, but said two of the study coauthors are Novartis employees.

NEW ORLEANS – Topical immunomodulators did not increase overall risk for lymphoma in a large retrospective study of patients with atopic dermatitis.

Researchers identified 760 cases of lymphoma in a claims database of 625,915 atopic patients. They assessed risk of lymphoma associated with pimecrolimus cream 1%, tacrolimus ointment 0.1% or 0.3%, and topical corticosteroid treatment, compared with patients not treated with the agents. They also looked at a group of 3,040 atopic dermatitis patients to control for age and gender in each lymphoma case.

"This study found no increased risk of overall lymphoma in atopic dermatitis patients treated with topical corticosteroids or topical calcineurin inhibitors," said Dr. Alejandro Arana, a researcher in Zaragoza, Spain.

Compared with lymphoma risk in the control group of atopic dermatitis patients who did not use any of the agents in the study (odds ratio, 1), risk was lower with pimecrolimus (OR, 0.76) and topical corticosteroids (OR, 0.90). In contrast, risk was increased for patients treated with tacrolimus (OR, 1.24).

"The lower risk of lymphoma appears to be reassuring," said session moderator Dr. Jan Izakovic, a dermatologist at the University of Miami.

Because of specific concerns about elevated risk for lymphoma associated with topical immunomodulators in children and adolescents, Dr. Arana and his associates separately assessed the 186 atopic patients with lymphoma and 741 atopic controls younger than 20 years.

"The results were similar," said Dr. Arana.

In the younger population 186 atopic patients with lymphoma and 741 atopic controls all risks for lymphoma were lower: with pimecrolimus (OR, 0.64); topical corticosteroids (OR, 0.72); and tacrolimus (OR, 0.96).

"Among those younger than 20, we feel very reassured," Dr. Arana said. "We didn’t find any risk."

All atopic dermatitis and lymphoma cases were identified using ICD-9 codes in the PharMetrics Integrated Database between July 1995 and March 2009. Mean age was 38 years, and 43% of patients were male.

The researchers also looked at subtypes of lymphoma. Of the 760 cases, 106 were Hodgkin's lymphoma. The 200 cases of non-Hodgkin's lymphoma included 118 T-cell lymphomas, 30 B-cell lymphomas, and 52 indeterminate types. The remaining 454 cases (60%) were not classified by subtype, a potential limitation of the study.

"We also looked at exposure to immunomodulators and risk of T-cell lymphoma, the subtype we are most concerned about," Dr. Arana said.

Dr. Arana and his associates assessed this risk in patients of all ages. Compared with a reference group of 45 cases with T-cell lymphoma and 228 controls not exposed to any of the medications (OR, 1.0), risk was lower with pimecrolimus (OR, 0.85); slightly increased with corticosteroids (OR, 1.16); and greater with tacrolimus (OR, 4.95).

"We should be very, very careful with these results," Dr. Arana said. The results are only suggestive, he added, because of the small number of cases of T-cell lymphoma, and the researchers' inability to determine lymphoma subtype in a majority of cases. In addition, cases with more severe atopic dermatitis could have confounded the results.

Nevertheless, the study size was sufficient to precisely estimate the association between overall lymphoma risk and use of topical calcineurin inhibitors, Dr. Arana said.

The researchers also looked at overall risk of lymphoma in all patients by dose. For example, they looked at pimecrolimus doses less than 0.3 g; 0.3 g to less than 0.6 g; 0.6 g to less than 1.0 g; and 1.0 g or greater. They also looked at tacrolimus doses of less than 0.03 g; 0.03 g to less than 0.06 g; 0.06 g to less than 0.10 g; and 0.10 g or greater.

"We didn't see any dose response for any corticosteroids or pimecrolimus, and a slightly increased risk for tacrolimus of 0.10 g or greater, with an odds ratio of 2.08," Dr. Arana said.

The study was funded through an unrestricted grant from Novartis. Dr. Arana had no relevant disclosures, but said two of the study coauthors are Novartis employees.

NEW ORLEANS – Topical immunomodulators did not increase overall risk for lymphoma in a large retrospective study of patients with atopic dermatitis.

Researchers identified 760 cases of lymphoma in a claims database of 625,915 atopic patients. They assessed risk of lymphoma associated with pimecrolimus cream 1%, tacrolimus ointment 0.1% or 0.3%, and topical corticosteroid treatment, compared with patients not treated with the agents. They also looked at a group of 3,040 atopic dermatitis patients to control for age and gender in each lymphoma case.

"This study found no increased risk of overall lymphoma in atopic dermatitis patients treated with topical corticosteroids or topical calcineurin inhibitors," said Dr. Alejandro Arana, a researcher in Zaragoza, Spain.

Compared with lymphoma risk in the control group of atopic dermatitis patients who did not use any of the agents in the study (odds ratio, 1), risk was lower with pimecrolimus (OR, 0.76) and topical corticosteroids (OR, 0.90). In contrast, risk was increased for patients treated with tacrolimus (OR, 1.24).

"The lower risk of lymphoma appears to be reassuring," said session moderator Dr. Jan Izakovic, a dermatologist at the University of Miami.

Because of specific concerns about elevated risk for lymphoma associated with topical immunomodulators in children and adolescents, Dr. Arana and his associates separately assessed the 186 atopic patients with lymphoma and 741 atopic controls younger than 20 years.

"The results were similar," said Dr. Arana.

In the younger population 186 atopic patients with lymphoma and 741 atopic controls all risks for lymphoma were lower: with pimecrolimus (OR, 0.64); topical corticosteroids (OR, 0.72); and tacrolimus (OR, 0.96).

"Among those younger than 20, we feel very reassured," Dr. Arana said. "We didn’t find any risk."

All atopic dermatitis and lymphoma cases were identified using ICD-9 codes in the PharMetrics Integrated Database between July 1995 and March 2009. Mean age was 38 years, and 43% of patients were male.

The researchers also looked at subtypes of lymphoma. Of the 760 cases, 106 were Hodgkin's lymphoma. The 200 cases of non-Hodgkin's lymphoma included 118 T-cell lymphomas, 30 B-cell lymphomas, and 52 indeterminate types. The remaining 454 cases (60%) were not classified by subtype, a potential limitation of the study.

"We also looked at exposure to immunomodulators and risk of T-cell lymphoma, the subtype we are most concerned about," Dr. Arana said.

Dr. Arana and his associates assessed this risk in patients of all ages. Compared with a reference group of 45 cases with T-cell lymphoma and 228 controls not exposed to any of the medications (OR, 1.0), risk was lower with pimecrolimus (OR, 0.85); slightly increased with corticosteroids (OR, 1.16); and greater with tacrolimus (OR, 4.95).

"We should be very, very careful with these results," Dr. Arana said. The results are only suggestive, he added, because of the small number of cases of T-cell lymphoma, and the researchers' inability to determine lymphoma subtype in a majority of cases. In addition, cases with more severe atopic dermatitis could have confounded the results.

Nevertheless, the study size was sufficient to precisely estimate the association between overall lymphoma risk and use of topical calcineurin inhibitors, Dr. Arana said.

The researchers also looked at overall risk of lymphoma in all patients by dose. For example, they looked at pimecrolimus doses less than 0.3 g; 0.3 g to less than 0.6 g; 0.6 g to less than 1.0 g; and 1.0 g or greater. They also looked at tacrolimus doses of less than 0.03 g; 0.03 g to less than 0.06 g; 0.06 g to less than 0.10 g; and 0.10 g or greater.

"We didn't see any dose response for any corticosteroids or pimecrolimus, and a slightly increased risk for tacrolimus of 0.10 g or greater, with an odds ratio of 2.08," Dr. Arana said.

The study was funded through an unrestricted grant from Novartis. Dr. Arana had no relevant disclosures, but said two of the study coauthors are Novartis employees.

NEW ORLEANS – Topical immunomodulators did not increase overall risk for lymphoma in a large retrospective study of patients with atopic dermatitis.

Researchers identified 760 cases of lymphoma in a claims database of 625,915 atopic patients. They assessed risk of lymphoma associated with pimecrolimus cream 1%, tacrolimus ointment 0.1% or 0.3%, and topical corticosteroid treatment, compared with patients not treated with the agents. They also looked at a group of 3,040 atopic dermatitis patients to control for age and gender in each lymphoma case.

"This study found no increased risk of overall lymphoma in atopic dermatitis patients treated with topical corticosteroids or topical calcineurin inhibitors," said Dr. Alejandro Arana, a researcher in Zaragoza, Spain, at the annual meeting of the American Academy of Dermatology.

Compared with lymphoma risk in the control group of atopic dermatitis patients who did not use any of the agents in the study (odds ratio, 1), risk was lower with pimecrolimus (OR, 0.76) and topical corticosteroids (OR, 0.90). In contrast, risk was increased for patients treated with tacrolimus (OR, 1.24).

"The lower risk of lymphoma appears to be reassuring," said session moderator Dr. Jan Izakovic, a dermatologist at the University of Miami.

Because of specific concerns about elevated risk for lymphoma associated with topical immunomodulators in children and adolescents, Dr. Arana and his associates separately assessed the 186 atopic patients with lymphoma and 741 atopic controls younger than 20 years.

"The results were similar," said Dr. Arana.

In the younger population 186 atopic patients with lymphoma and 741 atopic controls all risks for lymphoma were lower: with pimecrolimus (OR, 0.64); topical corticosteroids (OR, 0.72); and tacrolimus (OR, 0.96).

"Among those younger than 20, we feel very reassured," Dr. Arana said. "We didn’t find any risk."

All atopic dermatitis and lymphoma cases were identified using ICD-9 codes in the PharMetrics Integrated Database between July 1995 and March 2009. Mean age was 38 years, and 43% of patients were male.

The researchers also looked at subtypes of lymphoma. Of the 760 cases, 106 were Hodgkin's lymphoma. The 200 cases of non-Hodgkin's lymphoma included 118 T-cell lymphomas, 30 B-cell lymphomas, and 52 indeterminate types. The remaining 454 cases (60%) were not classified by subtype, a potential limitation of the study.

"We also looked at exposure to immunomodulators and risk of T-cell lymphoma, the subtype we are most concerned about," Dr. Arana said.

Dr. Arana and his associates assessed this risk in patients of all ages. Compared with a reference group of 45 cases with T-cell lymphoma and 228 controls not exposed to any of the medications (OR, 1.0), risk was lower with pimecrolimus (OR, 0.85); slightly increased with corticosteroids (OR, 1.16); and greater with tacrolimus (OR, 4.95).

"We should be very, very careful with these results," Dr. Arana said. The results are only suggestive, he added, because of the small number of cases of T-cell lymphoma, and the researchers' inability to determine lymphoma subtype in a majority of cases. In addition, cases with more severe atopic dermatitis could have confounded the results.

Nevertheless, the study size was sufficient to precisely estimate the association between overall lymphoma risk and use of topical calcineurin inhibitors, Dr. Arana said.

The researchers also looked at overall risk of lymphoma in all patients by dose. For example, they looked at pimecrolimus doses less than 0.3 g; 0.3 g to less than 0.6 g; 0.6 g to less than 1.0 g; and 1.0 g or greater. They also looked at tacrolimus doses of less than 0.03 g; 0.03 g to less than 0.06 g; 0.06 g to less than 0.10 g; and 0.10 g or greater.

"We didn't see any dose response for any corticosteroids or pimecrolimus, and a slightly increased risk for tacrolimus of 0.10 g or greater, with an odds ratio of 2.08," Dr. Arana said.

The study was funded through an unrestricted grant from Novartis. Dr. Arana had no relevant disclosures, but said two of the study coauthors are Novartis employees.

NEW ORLEANS – Topical immunomodulators did not increase overall risk for lymphoma in a large retrospective study of patients with atopic dermatitis.

Researchers identified 760 cases of lymphoma in a claims database of 625,915 atopic patients. They assessed risk of lymphoma associated with pimecrolimus cream 1%, tacrolimus ointment 0.1% or 0.3%, and topical corticosteroid treatment, compared with patients not treated with the agents. They also looked at a group of 3,040 atopic dermatitis patients to control for age and gender in each lymphoma case.

"This study found no increased risk of overall lymphoma in atopic dermatitis patients treated with topical corticosteroids or topical calcineurin inhibitors," said Dr. Alejandro Arana, a researcher in Zaragoza, Spain, at the annual meeting of the American Academy of Dermatology.

Compared with lymphoma risk in the control group of atopic dermatitis patients who did not use any of the agents in the study (odds ratio, 1), risk was lower with pimecrolimus (OR, 0.76) and topical corticosteroids (OR, 0.90). In contrast, risk was increased for patients treated with tacrolimus (OR, 1.24).

"The lower risk of lymphoma appears to be reassuring," said session moderator Dr. Jan Izakovic, a dermatologist at the University of Miami.

Because of specific concerns about elevated risk for lymphoma associated with topical immunomodulators in children and adolescents, Dr. Arana and his associates separately assessed the 186 atopic patients with lymphoma and 741 atopic controls younger than 20 years.

"The results were similar," said Dr. Arana.

In the younger population 186 atopic patients with lymphoma and 741 atopic controls all risks for lymphoma were lower: with pimecrolimus (OR, 0.64); topical corticosteroids (OR, 0.72); and tacrolimus (OR, 0.96).

"Among those younger than 20, we feel very reassured," Dr. Arana said. "We didn’t find any risk."

All atopic dermatitis and lymphoma cases were identified using ICD-9 codes in the PharMetrics Integrated Database between July 1995 and March 2009. Mean age was 38 years, and 43% of patients were male.

The researchers also looked at subtypes of lymphoma. Of the 760 cases, 106 were Hodgkin's lymphoma. The 200 cases of non-Hodgkin's lymphoma included 118 T-cell lymphomas, 30 B-cell lymphomas, and 52 indeterminate types. The remaining 454 cases (60%) were not classified by subtype, a potential limitation of the study.

"We also looked at exposure to immunomodulators and risk of T-cell lymphoma, the subtype we are most concerned about," Dr. Arana said.

Dr. Arana and his associates assessed this risk in patients of all ages. Compared with a reference group of 45 cases with T-cell lymphoma and 228 controls not exposed to any of the medications (OR, 1.0), risk was lower with pimecrolimus (OR, 0.85); slightly increased with corticosteroids (OR, 1.16); and greater with tacrolimus (OR, 4.95).

"We should be very, very careful with these results," Dr. Arana said. The results are only suggestive, he added, because of the small number of cases of T-cell lymphoma, and the researchers' inability to determine lymphoma subtype in a majority of cases. In addition, cases with more severe atopic dermatitis could have confounded the results.

Nevertheless, the study size was sufficient to precisely estimate the association between overall lymphoma risk and use of topical calcineurin inhibitors, Dr. Arana said.

The researchers also looked at overall risk of lymphoma in all patients by dose. For example, they looked at pimecrolimus doses less than 0.3 g; 0.3 g to less than 0.6 g; 0.6 g to less than 1.0 g; and 1.0 g or greater. They also looked at tacrolimus doses of less than 0.03 g; 0.03 g to less than 0.06 g; 0.06 g to less than 0.10 g; and 0.10 g or greater.

"We didn't see any dose response for any corticosteroids or pimecrolimus, and a slightly increased risk for tacrolimus of 0.10 g or greater, with an odds ratio of 2.08," Dr. Arana said.

The study was funded through an unrestricted grant from Novartis. Dr. Arana had no relevant disclosures, but said two of the study coauthors are Novartis employees.

NEW ORLEANS – Topical immunomodulators did not increase overall risk for lymphoma in a large retrospective study of patients with atopic dermatitis.

Researchers identified 760 cases of lymphoma in a claims database of 625,915 atopic patients. They assessed risk of lymphoma associated with pimecrolimus cream 1%, tacrolimus ointment 0.1% or 0.3%, and topical corticosteroid treatment, compared with patients not treated with the agents. They also looked at a group of 3,040 atopic dermatitis patients to control for age and gender in each lymphoma case.

"This study found no increased risk of overall lymphoma in atopic dermatitis patients treated with topical corticosteroids or topical calcineurin inhibitors," said Dr. Alejandro Arana, a researcher in Zaragoza, Spain, at the annual meeting of the American Academy of Dermatology.

Compared with lymphoma risk in the control group of atopic dermatitis patients who did not use any of the agents in the study (odds ratio, 1), risk was lower with pimecrolimus (OR, 0.76) and topical corticosteroids (OR, 0.90). In contrast, risk was increased for patients treated with tacrolimus (OR, 1.24).

"The lower risk of lymphoma appears to be reassuring," said session moderator Dr. Jan Izakovic, a dermatologist at the University of Miami.

Because of specific concerns about elevated risk for lymphoma associated with topical immunomodulators in children and adolescents, Dr. Arana and his associates separately assessed the 186 atopic patients with lymphoma and 741 atopic controls younger than 20 years.

"The results were similar," said Dr. Arana.

In the younger population 186 atopic patients with lymphoma and 741 atopic controls all risks for lymphoma were lower: with pimecrolimus (OR, 0.64); topical corticosteroids (OR, 0.72); and tacrolimus (OR, 0.96).

"Among those younger than 20, we feel very reassured," Dr. Arana said. "We didn’t find any risk."

All atopic dermatitis and lymphoma cases were identified using ICD-9 codes in the PharMetrics Integrated Database between July 1995 and March 2009. Mean age was 38 years, and 43% of patients were male.

The researchers also looked at subtypes of lymphoma. Of the 760 cases, 106 were Hodgkin's lymphoma. The 200 cases of non-Hodgkin's lymphoma included 118 T-cell lymphomas, 30 B-cell lymphomas, and 52 indeterminate types. The remaining 454 cases (60%) were not classified by subtype, a potential limitation of the study.

"We also looked at exposure to immunomodulators and risk of T-cell lymphoma, the subtype we are most concerned about," Dr. Arana said.

Dr. Arana and his associates assessed this risk in patients of all ages. Compared with a reference group of 45 cases with T-cell lymphoma and 228 controls not exposed to any of the medications (OR, 1.0), risk was lower with pimecrolimus (OR, 0.85); slightly increased with corticosteroids (OR, 1.16); and greater with tacrolimus (OR, 4.95).

"We should be very, very careful with these results," Dr. Arana said. The results are only suggestive, he added, because of the small number of cases of T-cell lymphoma, and the researchers' inability to determine lymphoma subtype in a majority of cases. In addition, cases with more severe atopic dermatitis could have confounded the results.

Nevertheless, the study size was sufficient to precisely estimate the association between overall lymphoma risk and use of topical calcineurin inhibitors, Dr. Arana said.

The researchers also looked at overall risk of lymphoma in all patients by dose. For example, they looked at pimecrolimus doses less than 0.3 g; 0.3 g to less than 0.6 g; 0.6 g to less than 1.0 g; and 1.0 g or greater. They also looked at tacrolimus doses of less than 0.03 g; 0.03 g to less than 0.06 g; 0.06 g to less than 0.10 g; and 0.10 g or greater.

"We didn't see any dose response for any corticosteroids or pimecrolimus, and a slightly increased risk for tacrolimus of 0.10 g or greater, with an odds ratio of 2.08," Dr. Arana said.

The study was funded through an unrestricted grant from Novartis. Dr. Arana had no relevant disclosures, but said two of the study coauthors are Novartis employees.

NEW ORLEANS - Treatment for melasma can be effective, although the search continues for the ideal clinical strategy that yields optimal outcomes with minimal adverse effects, according to Dr. Amit G. Pandya.

The first challenge is to get patients into treatment. "There is a huge number of people out there with melasma who we are not seeing. A lot are being treated with over-the-counter products or are not being treated [at all]," he said at the annual meeting of the American Academy of Dermatology.

Melasma is a common condition. For example, Dr. Pandya and his colleagues found in a telephone survey that 8.8% of Latino women in the Dallas and Fort Worth, Texas, areas reported melasma (Arch. Dermatol. 2007;143:424-5).

"If I had a buck for each case of melasma, I could retire already," said session moderator Dr. Harvey Lui, professor and chair of dermatology and skin science at the University of British Columbia, Vancouver. "I just don’t know what to do with these patients."

Much of the treatment and management of melasma rely on physicians' clinical expertise. "The evidence we have out there is not huge," Dr. Pandya said. He is professor of dermatology at the University of Texas Southwestern Medical Center at Dallas.

The differential diagnosis includes ruling out postinflammatory hyperpigmentation and drug-induced photosensitivity. Also, "with the growing obesity epidemic, we also see more acanthosis nigricans on the face," Dr. Pandya said.

Treatment of melasma is important – whether it be with a hydroquinone preparation, a chemical peel, or microdermabrasion – because it improves quality of life for patients living with melasma, Dr. Pandya said. Multiple studies have demonstrated that melasma can have a significant negative effect on a person's social life, recreation and leisure activities, and emotional well-being (Brit. J. Dermatol. 2003;149:572-7; J. Am. Acad. Dermatol. 2006;55:59-66).

Dioic acid is a new treatment showing promise in the treatment of melasma, Dr. Pandya said. He cited results of a study of 96 Mexican females treated with 1% dioic acid cream twice daily vs. 2% hydroquinone cream twice daily (Int. J. Dermatol. 2009:48:893-5). After 12 weeks, both treatments were associated with significant decreases in Melasma Area Severity Index (MASI) scores. There were no significant differences in efficacy. and adverse events were similar, except for more pruritus associated with hydroquinone treatment. "This may be an agent we can use in the future," Dr. Pandya said.

Oral antioxidants for melasma also showed promise in a randomized, double-blind, placebo-controlled trial (Int. J. Dermatol. 2009;48:896-901). Researchers assessed a combination of oral procyanidin (a component of pine bark) plus vitamins A, C, and E in 60 women with bilateral epidermal melasma. Study participants took either the oral treatment or a placebo twice daily with meals for 8 weeks. Clinicians observed significant reductions, compared with baseline in pigmentation and significant improvements in MASI scores in the malar regions of faces treated with the antioxidants vs. placebo. The investigators said the combination was well tolerated with minimal side effects.

"This may be something else we can use in the future," Dr. Pandya said.

The tyrosine inhibitor hydroquinone remains a mainstay of melasma treatment, Dr. Pandya said. "Hydroquinone remains the most effective depigmentation agent." There are nine marketed products that contain hydroquinone 4%. Although higher concentrations might be more effective, skin irritation and tolerance become an important consideration.

Monitor patients for development of exogenous ochronosis, a rare but important adverse effect, Dr. Pandya advised. Also, some patients can develop telangiectasias after prolonged use.

Hydroquinone 4% is often found in combination products designed to balance efficacy and tolerability. For example, Tri-Luma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%, Galderma) is a triple combination product that was "shown to be better than any two components in the largest study done so far in melasma," Dr. Pandya said (Cutis 2003;72:67-72). Researchers in this study found a 75% reduction in melasma at 8 weeks in more than 70% of patients, compared with 30% of participants treated with a dual-ingredient product.

A majority "seem to do well, but the problem is irritation, especially in skin of color," Dr. Pandya said. "I usually start patients on this product every other day and then try to increase it, but in some cases, I cannot because of irritation." He emphasized the importance of monitoring patients closely to ensure they do not develop erythema or postinflammatory hypopigmentation.

Evidence on the efficacy of chemical peels in treating melasma is mixed, Dr. Pandya said. In one study of 40 women in India, glycolic acid and a modified Kligman's formula peel showed "some improvement, but it took six glycolic acid peels," Dr. Pandya said (Derm. Surg. 2002;28:828-32).

In his own study, Dr. Pandya and his associates compared a glycolic acid peel and hydroquinone to hydroquinone treatment alone in a split-face study of 21 women (Arch. Dermatol. 2002;138:1578-82). "The peel did not make a difference versus the side of face treated with hydroquinone only," Dr. Pandya said.

Although there are no published studies supporting or not supporting microdermabrasion in melasma, caution is advised when this approach is used, Dr. Pandya said. "If you are too aggressive, you can induce hyperpigmentation."

One of the biggest challenges for dermatologists may be convincing patients of the importance of using sunscreen for UV protection, not only while outside but if they remain indoors as well. "Visible light can also induce melanocyte formation, not just UVA or UVB," Dr. Pandya said. "That's bad news, because how many companies at this convention center will have a product that says 'This blocks visible light?’ The only thing we have is the thick stuff lifeguards put on their noses."

Dr. Pandya said, "Frequent application of broad spectrum and physical sunscreens, as well as avoidance of UV and visible light, are critical for long-term success."

Dr. Pandya said that he is a consultant for Galderma.

NEW ORLEANS - Treatment for melasma can be effective, although the search continues for the ideal clinical strategy that yields optimal outcomes with minimal adverse effects, according to Dr. Amit G. Pandya.

The first challenge is to get patients into treatment. "There is a huge number of people out there with melasma who we are not seeing. A lot are being treated with over-the-counter products or are not being treated [at all]," he said at the annual meeting of the American Academy of Dermatology.

Melasma is a common condition. For example, Dr. Pandya and his colleagues found in a telephone survey that 8.8% of Latino women in the Dallas and Fort Worth, Texas, areas reported melasma (Arch. Dermatol. 2007;143:424-5).

"If I had a buck for each case of melasma, I could retire already," said session moderator Dr. Harvey Lui, professor and chair of dermatology and skin science at the University of British Columbia, Vancouver. "I just don’t know what to do with these patients."

Much of the treatment and management of melasma rely on physicians' clinical expertise. "The evidence we have out there is not huge," Dr. Pandya said. He is professor of dermatology at the University of Texas Southwestern Medical Center at Dallas.

The differential diagnosis includes ruling out postinflammatory hyperpigmentation and drug-induced photosensitivity. Also, "with the growing obesity epidemic, we also see more acanthosis nigricans on the face," Dr. Pandya said.

Treatment of melasma is important – whether it be with a hydroquinone preparation, a chemical peel, or microdermabrasion – because it improves quality of life for patients living with melasma, Dr. Pandya said. Multiple studies have demonstrated that melasma can have a significant negative effect on a person's social life, recreation and leisure activities, and emotional well-being (Brit. J. Dermatol. 2003;149:572-7; J. Am. Acad. Dermatol. 2006;55:59-66).

Dioic acid is a new treatment showing promise in the treatment of melasma, Dr. Pandya said. He cited results of a study of 96 Mexican females treated with 1% dioic acid cream twice daily vs. 2% hydroquinone cream twice daily (Int. J. Dermatol. 2009:48:893-5). After 12 weeks, both treatments were associated with significant decreases in Melasma Area Severity Index (MASI) scores. There were no significant differences in efficacy. and adverse events were similar, except for more pruritus associated with hydroquinone treatment. "This may be an agent we can use in the future," Dr. Pandya said.

Oral antioxidants for melasma also showed promise in a randomized, double-blind, placebo-controlled trial (Int. J. Dermatol. 2009;48:896-901). Researchers assessed a combination of oral procyanidin (a component of pine bark) plus vitamins A, C, and E in 60 women with bilateral epidermal melasma. Study participants took either the oral treatment or a placebo twice daily with meals for 8 weeks. Clinicians observed significant reductions, compared with baseline in pigmentation and significant improvements in MASI scores in the malar regions of faces treated with the antioxidants vs. placebo. The investigators said the combination was well tolerated with minimal side effects.

"This may be something else we can use in the future," Dr. Pandya said.

The tyrosine inhibitor hydroquinone remains a mainstay of melasma treatment, Dr. Pandya said. "Hydroquinone remains the most effective depigmentation agent." There are nine marketed products that contain hydroquinone 4%. Although higher concentrations might be more effective, skin irritation and tolerance become an important consideration.

Monitor patients for development of exogenous ochronosis, a rare but important adverse effect, Dr. Pandya advised. Also, some patients can develop telangiectasias after prolonged use.

Hydroquinone 4% is often found in combination products designed to balance efficacy and tolerability. For example, Tri-Luma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%, Galderma) is a triple combination product that was "shown to be better than any two components in the largest study done so far in melasma," Dr. Pandya said (Cutis 2003;72:67-72). Researchers in this study found a 75% reduction in melasma at 8 weeks in more than 70% of patients, compared with 30% of participants treated with a dual-ingredient product.

A majority "seem to do well, but the problem is irritation, especially in skin of color," Dr. Pandya said. "I usually start patients on this product every other day and then try to increase it, but in some cases, I cannot because of irritation." He emphasized the importance of monitoring patients closely to ensure they do not develop erythema or postinflammatory hypopigmentation.

Evidence on the efficacy of chemical peels in treating melasma is mixed, Dr. Pandya said. In one study of 40 women in India, glycolic acid and a modified Kligman's formula peel showed "some improvement, but it took six glycolic acid peels," Dr. Pandya said (Derm. Surg. 2002;28:828-32).

In his own study, Dr. Pandya and his associates compared a glycolic acid peel and hydroquinone to hydroquinone treatment alone in a split-face study of 21 women (Arch. Dermatol. 2002;138:1578-82). "The peel did not make a difference versus the side of face treated with hydroquinone only," Dr. Pandya said.

Although there are no published studies supporting or not supporting microdermabrasion in melasma, caution is advised when this approach is used, Dr. Pandya said. "If you are too aggressive, you can induce hyperpigmentation."

One of the biggest challenges for dermatologists may be convincing patients of the importance of using sunscreen for UV protection, not only while outside but if they remain indoors as well. "Visible light can also induce melanocyte formation, not just UVA or UVB," Dr. Pandya said. "That's bad news, because how many companies at this convention center will have a product that says 'This blocks visible light?’ The only thing we have is the thick stuff lifeguards put on their noses."

Dr. Pandya said, "Frequent application of broad spectrum and physical sunscreens, as well as avoidance of UV and visible light, are critical for long-term success."

Dr. Pandya said that he is a consultant for Galderma.

NEW ORLEANS - Treatment for melasma can be effective, although the search continues for the ideal clinical strategy that yields optimal outcomes with minimal adverse effects, according to Dr. Amit G. Pandya.

The first challenge is to get patients into treatment. "There is a huge number of people out there with melasma who we are not seeing. A lot are being treated with over-the-counter products or are not being treated [at all]," he said at the annual meeting of the American Academy of Dermatology.

Melasma is a common condition. For example, Dr. Pandya and his colleagues found in a telephone survey that 8.8% of Latino women in the Dallas and Fort Worth, Texas, areas reported melasma (Arch. Dermatol. 2007;143:424-5).

"If I had a buck for each case of melasma, I could retire already," said session moderator Dr. Harvey Lui, professor and chair of dermatology and skin science at the University of British Columbia, Vancouver. "I just don’t know what to do with these patients."

Much of the treatment and management of melasma rely on physicians' clinical expertise. "The evidence we have out there is not huge," Dr. Pandya said. He is professor of dermatology at the University of Texas Southwestern Medical Center at Dallas.

The differential diagnosis includes ruling out postinflammatory hyperpigmentation and drug-induced photosensitivity. Also, "with the growing obesity epidemic, we also see more acanthosis nigricans on the face," Dr. Pandya said.

Treatment of melasma is important – whether it be with a hydroquinone preparation, a chemical peel, or microdermabrasion – because it improves quality of life for patients living with melasma, Dr. Pandya said. Multiple studies have demonstrated that melasma can have a significant negative effect on a person's social life, recreation and leisure activities, and emotional well-being (Brit. J. Dermatol. 2003;149:572-7; J. Am. Acad. Dermatol. 2006;55:59-66).

Dioic acid is a new treatment showing promise in the treatment of melasma, Dr. Pandya said. He cited results of a study of 96 Mexican females treated with 1% dioic acid cream twice daily vs. 2% hydroquinone cream twice daily (Int. J. Dermatol. 2009:48:893-5). After 12 weeks, both treatments were associated with significant decreases in Melasma Area Severity Index (MASI) scores. There were no significant differences in efficacy. and adverse events were similar, except for more pruritus associated with hydroquinone treatment. "This may be an agent we can use in the future," Dr. Pandya said.

Oral antioxidants for melasma also showed promise in a randomized, double-blind, placebo-controlled trial (Int. J. Dermatol. 2009;48:896-901). Researchers assessed a combination of oral procyanidin (a component of pine bark) plus vitamins A, C, and E in 60 women with bilateral epidermal melasma. Study participants took either the oral treatment or a placebo twice daily with meals for 8 weeks. Clinicians observed significant reductions, compared with baseline in pigmentation and significant improvements in MASI scores in the malar regions of faces treated with the antioxidants vs. placebo. The investigators said the combination was well tolerated with minimal side effects.

"This may be something else we can use in the future," Dr. Pandya said.

The tyrosine inhibitor hydroquinone remains a mainstay of melasma treatment, Dr. Pandya said. "Hydroquinone remains the most effective depigmentation agent." There are nine marketed products that contain hydroquinone 4%. Although higher concentrations might be more effective, skin irritation and tolerance become an important consideration.

Monitor patients for development of exogenous ochronosis, a rare but important adverse effect, Dr. Pandya advised. Also, some patients can develop telangiectasias after prolonged use.

Hydroquinone 4% is often found in combination products designed to balance efficacy and tolerability. For example, Tri-Luma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%, Galderma) is a triple combination product that was "shown to be better than any two components in the largest study done so far in melasma," Dr. Pandya said (Cutis 2003;72:67-72). Researchers in this study found a 75% reduction in melasma at 8 weeks in more than 70% of patients, compared with 30% of participants treated with a dual-ingredient product.

A majority "seem to do well, but the problem is irritation, especially in skin of color," Dr. Pandya said. "I usually start patients on this product every other day and then try to increase it, but in some cases, I cannot because of irritation." He emphasized the importance of monitoring patients closely to ensure they do not develop erythema or postinflammatory hypopigmentation.

Evidence on the efficacy of chemical peels in treating melasma is mixed, Dr. Pandya said. In one study of 40 women in India, glycolic acid and a modified Kligman's formula peel showed "some improvement, but it took six glycolic acid peels," Dr. Pandya said (Derm. Surg. 2002;28:828-32).

In his own study, Dr. Pandya and his associates compared a glycolic acid peel and hydroquinone to hydroquinone treatment alone in a split-face study of 21 women (Arch. Dermatol. 2002;138:1578-82). "The peel did not make a difference versus the side of face treated with hydroquinone only," Dr. Pandya said.

Although there are no published studies supporting or not supporting microdermabrasion in melasma, caution is advised when this approach is used, Dr. Pandya said. "If you are too aggressive, you can induce hyperpigmentation."

One of the biggest challenges for dermatologists may be convincing patients of the importance of using sunscreen for UV protection, not only while outside but if they remain indoors as well. "Visible light can also induce melanocyte formation, not just UVA or UVB," Dr. Pandya said. "That's bad news, because how many companies at this convention center will have a product that says 'This blocks visible light?’ The only thing we have is the thick stuff lifeguards put on their noses."

Dr. Pandya said, "Frequent application of broad spectrum and physical sunscreens, as well as avoidance of UV and visible light, are critical for long-term success."

Dr. Pandya said that he is a consultant for Galderma.

NEW ORLEANS - Treatment for melasma can be effective, although the search continues for the ideal clinical strategy that yields optimal outcomes with minimal adverse effects, according to Dr. Amit G. Pandya.

The first challenge is to get patients into treatment. "There is a huge number of people out there with melasma who we are not seeing. A lot are being treated with over-the-counter products or are not being treated [at all]," he said at the annual meeting of the American Academy of Dermatology.

Melasma is a common condition. For example, Dr. Pandya and his colleagues found in a telephone survey that 8.8% of Latino women in the Dallas and Fort Worth, Texas, areas reported melasma (Arch. Dermatol. 2007;143:424-5).

"If I had a buck for each case of melasma, I could retire already," said session moderator Dr. Harvey Lui, professor and chair of dermatology and skin science at the University of British Columbia, Vancouver. "I just don't know what to do with these patients."

Much of the treatment and management of melasma rely on physicians' clinical expertise. "The evidence we have out there is not huge," Dr. Pandya said. He is professor of dermatology at the University of Texas Southwestern Medical Center at Dallas.

The differential diagnosis includes ruling out postinflammatory hyperpigmentation and drug-induced photosensitivity. Also, "with the growing obesity epidemic, we also see more acanthosis nigricans on the face," Dr. Pandya said.

Treatment of melasma is important – whether it be with a hydroquinone preparation, a chemical peel, or microdermabrasion – because it improves quality of life for patients living with melasma, Dr. Pandya said. Multiple studies have demonstrated that melasma can have a significant negative effect on a person's social life, recreation and leisure activities, and emotional well-being (Brit. J. Dermatol. 2003;149:572-7; J. Am. Acad. Dermatol. 2006;55:59-66).

Dioic acid is a new treatment showing promise in the treatment of melasma, Dr. Pandya said. He cited results of a study of 96 Mexican females treated with 1% dioic acid cream twice daily vs. 2% hydroquinone cream twice daily (Int. J. Dermatol. 2009;48:893-5). After 12 weeks, both treatments were associated with significant decreases in Melasma Area Severity Index (MASI) scores. There were no significant differences in efficacy, and adverse events were similar, except for more pruritus associated with hydroquinone treatment. "This may be an agent we can use in the future," Dr. Pandya said.

Oral antioxidants for melasma also showed promise in a randomized, double-blind, placebo-controlled trial (Int. J. Dermatol. 2009;48:896-901). Researchers assessed a combination of oral procyanidin (a component of pine bark) plus vitamins A, C, and E in 60 women with bilateral epidermal melasma. Study participants took either the oral treatment or a placebo twice daily with meals for 8 weeks. Clinicians observed significant reductions, compared with baseline in pigmentation and significant improvements in MASI scores in the malar regions of faces treated with the antioxidants vs. placebo. The investigators said the combination was well tolerated with minimal side effects.

"This may be something else we can use in the future," Dr. Pandya said.

The tyrosine inhibitor hydroquinone remains a mainstay of melasma treatment, Dr. Pandya said. "Hydroquinone remains the most effective depigmentation agent." There are nine marketed products that contain hydroquinone 4%. Although higher concentrations might be more effective, skin irritation and tolerance become an important consideration.

Monitor patients for development of exogenous ochronosis, a rare but important adverse effect, Dr. Pandya advised. Also, some patients can develop telangiectasias after prolonged use.

Hydroquinone 4% is often found in combination products designed to balance efficacy and tolerability. For example, Tri-Luma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%, Galderma) is a triple combination product that was "shown to be better than any two components in the largest study done so far in melasma," Dr. Pandya said (Cutis 2003;72:67-72). Researchers in this study found a 75% reduction in melasma at 8 weeks in more than 70% of patients, compared with 30% of participants treated with a dual-ingredient product.

A majority "seem to do well, but the problem is irritation, especially in skin of color," Dr. Pandya said. "I usually start patients on this product every other day and then try to increase it, but in some cases, I cannot because of irritation." He emphasized the importance of monitoring patients closely to ensure they do not develop erythema or postinflammatory hypopigmentation.

Evidence on the efficacy of chemical peels in treating melasma is mixed, Dr. Pandya said. In one study of 40 women in India, glycolic acid and a modified Kligman's formula peel showed "some improvement, but it took six glycolic acid peels," Dr. Pandya said (Derm. Surg. 2002;28:828-32).

In his own study, Dr. Pandya and his associates compared a glycolic acid peel and hydroquinone to hydroquinone treatment alone in a split-face study of 21 women (Arch. Dermatol. 2002;138:1578-82). "The peel did not make a difference versus the side of face treated with hydroquinone only," Dr. Pandya said.

Although there are no published studies supporting or not supporting microdermabrasion in melasma, caution is advised when this approach is used, Dr. Pandya said. "If you are too aggressive, you can induce hyperpigmentation."

One of the biggest challenges for dermatologists may be convincing patients of the importance of using sunscreen for UV protection, not only while outside but if they remain indoors as well. "Visible light can also induce melanocyte formation, not just UVA or UVB," Dr. Pandya said. "That's bad news, because how many companies at this convention center will have a product that says 'This blocks visible light?’ The only thing we have is the thick stuff lifeguards put on their noses."

Dr. Pandya said, "Frequent application of broad spectrum and physical sunscreens, as well as avoidance of UV and visible light, are critical for long-term success."

Dr. Pandya said that he is a consultant for Galderma.

NEW ORLEANS - Treatment for melasma can be effective, although the search continues for the ideal clinical strategy that yields optimal outcomes with minimal adverse effects, according to Dr. Amit G. Pandya.

The first challenge is to get patients into treatment. "There is a huge number of people out there with melasma who we are not seeing. A lot are being treated with over-the-counter products or are not being treated [at all]," he said at the annual meeting of the American Academy of Dermatology.

Melasma is a common condition. For example, Dr. Pandya and his colleagues found in a telephone survey that 8.8% of Latino women in the Dallas and Fort Worth, Texas, areas reported melasma (Arch. Dermatol. 2007;143:424-5).

"If I had a buck for each case of melasma, I could retire already," said session moderator Dr. Harvey Lui, professor and chair of dermatology and skin science at the University of British Columbia, Vancouver. "I just don't know what to do with these patients."

Much of the treatment and management of melasma rely on physicians' clinical expertise. "The evidence we have out there is not huge," Dr. Pandya said. He is professor of dermatology at the University of Texas Southwestern Medical Center at Dallas.

The differential diagnosis includes ruling out postinflammatory hyperpigmentation and drug-induced photosensitivity. Also, "with the growing obesity epidemic, we also see more acanthosis nigricans on the face," Dr. Pandya said.

Treatment of melasma is important – whether it be with a hydroquinone preparation, a chemical peel, or microdermabrasion – because it improves quality of life for patients living with melasma, Dr. Pandya said. Multiple studies have demonstrated that melasma can have a significant negative effect on a person's social life, recreation and leisure activities, and emotional well-being (Brit. J. Dermatol. 2003;149:572-7; J. Am. Acad. Dermatol. 2006;55:59-66).

Dioic acid is a new treatment showing promise in the treatment of melasma, Dr. Pandya said. He cited results of a study of 96 Mexican females treated with 1% dioic acid cream twice daily vs. 2% hydroquinone cream twice daily (Int. J. Dermatol. 2009;48:893-5). After 12 weeks, both treatments were associated with significant decreases in Melasma Area Severity Index (MASI) scores. There were no significant differences in efficacy, and adverse events were similar, except for more pruritus associated with hydroquinone treatment. "This may be an agent we can use in the future," Dr. Pandya said.

Oral antioxidants for melasma also showed promise in a randomized, double-blind, placebo-controlled trial (Int. J. Dermatol. 2009;48:896-901). Researchers assessed a combination of oral procyanidin (a component of pine bark) plus vitamins A, C, and E in 60 women with bilateral epidermal melasma. Study participants took either the oral treatment or a placebo twice daily with meals for 8 weeks. Clinicians observed significant reductions, compared with baseline in pigmentation and significant improvements in MASI scores in the malar regions of faces treated with the antioxidants vs. placebo. The investigators said the combination was well tolerated with minimal side effects.

"This may be something else we can use in the future," Dr. Pandya said.

The tyrosine inhibitor hydroquinone remains a mainstay of melasma treatment, Dr. Pandya said. "Hydroquinone remains the most effective depigmentation agent." There are nine marketed products that contain hydroquinone 4%. Although higher concentrations might be more effective, skin irritation and tolerance become an important consideration.

Monitor patients for development of exogenous ochronosis, a rare but important adverse effect, Dr. Pandya advised. Also, some patients can develop telangiectasias after prolonged use.

Hydroquinone 4% is often found in combination products designed to balance efficacy and tolerability. For example, Tri-Luma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%, Galderma) is a triple combination product that was "shown to be better than any two components in the largest study done so far in melasma," Dr. Pandya said (Cutis 2003;72:67-72). Researchers in this study found a 75% reduction in melasma at 8 weeks in more than 70% of patients, compared with 30% of participants treated with a dual-ingredient product.

A majority "seem to do well, but the problem is irritation, especially in skin of color," Dr. Pandya said. "I usually start patients on this product every other day and then try to increase it, but in some cases, I cannot because of irritation." He emphasized the importance of monitoring patients closely to ensure they do not develop erythema or postinflammatory hypopigmentation.

Evidence on the efficacy of chemical peels in treating melasma is mixed, Dr. Pandya said. In one study of 40 women in India, glycolic acid and a modified Kligman's formula peel showed "some improvement, but it took six glycolic acid peels," Dr. Pandya said (Derm. Surg. 2002;28:828-32).

In his own study, Dr. Pandya and his associates compared a glycolic acid peel and hydroquinone to hydroquinone treatment alone in a split-face study of 21 women (Arch. Dermatol. 2002;138:1578-82). "The peel did not make a difference versus the side of face treated with hydroquinone only," Dr. Pandya said.

Although there are no published studies supporting or not supporting microdermabrasion in melasma, caution is advised when this approach is used, Dr. Pandya said. "If you are too aggressive, you can induce hyperpigmentation."

One of the biggest challenges for dermatologists may be convincing patients of the importance of using sunscreen for UV protection, not only while outside but if they remain indoors as well. "Visible light can also induce melanocyte formation, not just UVA or UVB," Dr. Pandya said. "That's bad news, because how many companies at this convention center will have a product that says 'This blocks visible light?’ The only thing we have is the thick stuff lifeguards put on their noses."

Dr. Pandya said, "Frequent application of broad spectrum and physical sunscreens, as well as avoidance of UV and visible light, are critical for long-term success."

Dr. Pandya said that he is a consultant for Galderma.

NEW ORLEANS - Treatment for melasma can be effective, although the search continues for the ideal clinical strategy that yields optimal outcomes with minimal adverse effects, according to Dr. Amit G. Pandya.

The first challenge is to get patients into treatment. "There is a huge number of people out there with melasma who we are not seeing. A lot are being treated with over-the-counter products or are not being treated [at all]," he said at the annual meeting of the American Academy of Dermatology.

Melasma is a common condition. For example, Dr. Pandya and his colleagues found in a telephone survey that 8.8% of Latino women in the Dallas and Fort Worth, Texas, areas reported melasma (Arch. Dermatol. 2007;143:424-5).

"If I had a buck for each case of melasma, I could retire already," said session moderator Dr. Harvey Lui, professor and chair of dermatology and skin science at the University of British Columbia, Vancouver. "I just don't know what to do with these patients."

Much of the treatment and management of melasma rely on physicians' clinical expertise. "The evidence we have out there is not huge," Dr. Pandya said. He is professor of dermatology at the University of Texas Southwestern Medical Center at Dallas.

The differential diagnosis includes ruling out postinflammatory hyperpigmentation and drug-induced photosensitivity. Also, "with the growing obesity epidemic, we also see more acanthosis nigricans on the face," Dr. Pandya said.

Treatment of melasma is important – whether it be with a hydroquinone preparation, a chemical peel, or microdermabrasion – because it improves quality of life for patients living with melasma, Dr. Pandya said. Multiple studies have demonstrated that melasma can have a significant negative effect on a person's social life, recreation and leisure activities, and emotional well-being (Brit. J. Dermatol. 2003;149:572-7; J. Am. Acad. Dermatol. 2006;55:59-66).

Dioic acid is a new treatment showing promise in the treatment of melasma, Dr. Pandya said. He cited results of a study of 96 Mexican females treated with 1% dioic acid cream twice daily vs. 2% hydroquinone cream twice daily (Int. J. Dermatol. 2009;48:893-5). After 12 weeks, both treatments were associated with significant decreases in Melasma Area Severity Index (MASI) scores. There were no significant differences in efficacy, and adverse events were similar, except for more pruritus associated with hydroquinone treatment. "This may be an agent we can use in the future," Dr. Pandya said.

Oral antioxidants for melasma also showed promise in a randomized, double-blind, placebo-controlled trial (Int. J. Dermatol. 2009;48:896-901). Researchers assessed a combination of oral procyanidin (a component of pine bark) plus vitamins A, C, and E in 60 women with bilateral epidermal melasma. Study participants took either the oral treatment or a placebo twice daily with meals for 8 weeks. Clinicians observed significant reductions, compared with baseline in pigmentation and significant improvements in MASI scores in the malar regions of faces treated with the antioxidants vs. placebo. The investigators said the combination was well tolerated with minimal side effects.

"This may be something else we can use in the future," Dr. Pandya said.

The tyrosine inhibitor hydroquinone remains a mainstay of melasma treatment, Dr. Pandya said. "Hydroquinone remains the most effective depigmentation agent." There are nine marketed products that contain hydroquinone 4%. Although higher concentrations might be more effective, skin irritation and tolerance become an important consideration.

Monitor patients for development of exogenous ochronosis, a rare but important adverse effect, Dr. Pandya advised. Also, some patients can develop telangiectasias after prolonged use.

Hydroquinone 4% is often found in combination products designed to balance efficacy and tolerability. For example, Tri-Luma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%, Galderma) is a triple combination product that was "shown to be better than any two components in the largest study done so far in melasma," Dr. Pandya said (Cutis 2003;72:67-72). Researchers in this study found a 75% reduction in melasma at 8 weeks in more than 70% of patients, compared with 30% of participants treated with a dual-ingredient product.

A majority "seem to do well, but the problem is irritation, especially in skin of color," Dr. Pandya said. "I usually start patients on this product every other day and then try to increase it, but in some cases, I cannot because of irritation." He emphasized the importance of monitoring patients closely to ensure they do not develop erythema or postinflammatory hypopigmentation.

Evidence on the efficacy of chemical peels in treating melasma is mixed, Dr. Pandya said. In one study of 40 women in India, glycolic acid and a modified Kligman's formula peel showed "some improvement, but it took six glycolic acid peels," Dr. Pandya said (Derm. Surg. 2002;28:828-32).

In his own study, Dr. Pandya and his associates compared a glycolic acid peel and hydroquinone to hydroquinone treatment alone in a split-face study of 21 women (Arch. Dermatol. 2002;138:1578-82). "The peel did not make a difference versus the side of face treated with hydroquinone only," Dr. Pandya said.

Although there are no published studies supporting or not supporting microdermabrasion in melasma, caution is advised when this approach is used, Dr. Pandya said. "If you are too aggressive, you can induce hyperpigmentation."

One of the biggest challenges for dermatologists may be convincing patients of the importance of using sunscreen for UV protection, not only while outside but if they remain indoors as well. "Visible light can also induce melanocyte formation, not just UVA or UVB," Dr. Pandya said. "That's bad news, because how many companies at this convention center will have a product that says 'This blocks visible light?’ The only thing we have is the thick stuff lifeguards put on their noses."

Dr. Pandya said, "Frequent application of broad spectrum and physical sunscreens, as well as avoidance of UV and visible light, are critical for long-term success."

Dr. Pandya said that he is a consultant for Galderma.

ORLANDO – Despite a paucity of recently approved treatments for squamous cell carcinoma, you can use study findings from the past few years to refine your clinical approach, Dr. Suzanne Olbricht said.

"It would be nice if I had some new treatments to discuss, but I don't. So let's go through some recent studies," Dr. Olbricht said at the annual meeting of the Florida Society of Dermatologic Surgeons.

Photodynamic Therapy

Investigators, for example, found methyl aminolevulinate photodynamic therapy (MAL-PDT) superior to 5-fluorouracil and cryosurgery for squamous cell carcinoma in situ. In addition, ophthalmologists might start using more imiquimod to treat periorbital skin cancers based on outcomes of a recent case series, Dr. Olbricht said. Other findings support promise for the oral medications cetuximab and capecitabine.

The prospective, randomized study that bolsters use of MAL-PDT included 225 patients with biopsy-confirmed squamous cell carcinoma in situ (Arch. Dermatol. 2006;142:729-35). Researchers found an 80% complete response rate in the MAL-PDT–treated patients at 12 months, compared with a 69% rate with 5-fluorouracil and a 67% rate in patients treated with cryotherapy.

"MAL-PDT was judged [to have the] most acceptable cosmetic outcome," Dr. Olbricht said. She added that 5-fluorouracil is "still a good therapy if some patients prefer to do things at home."

This is a "large study that is worth thinking about," said Dr. Olbricht, chair of the department of dermatology at the Lahey Clinic in Burlington, Mass., and a member of the dermatology faculty at Harvard Medical School, Boston.

Photodynamic therapy (PDT) was associated with a 72% complete response in a smaller study of 30 patients with recurrent tumors of the head and neck (J. Drugs Dermatol. 2010;9:122-6).

These investigators described PDT as effective, tolerable, and associated with good cosmetic results for recurrent squamous cell carcinoma or basal cell carcinoma. One concern, Dr. Olbricht said, is "they did not describe how they did the PDT."

Imiquimod Therapy

Another noteworthy study supports imiquimod for periorbital skin lesions (Orbit 2010;29:83-7). Two patients in this case series had basal cell carcinoma of the eyelid, one had actinic keratosis, and another had intraepidermal squamous cell carcinoma (Bowen’s disease). A fifth patient presented with concomitant squamous cell carcinoma and intraepidermal squamous cell carcinoma. All tumors regressed with a clinical cure at 6-9 months.

"It’s a short follow-up, but your ophthalmologic colleagues will be using imiquimod," Dr. Olbricht said.

Cetuximab and Capecitabine

Oral cetuximab (Erbitux, Imclone) was associated with a complete clinical response for a patient with organ metastases from cutaneous squamous cell carcinoma (Dermatol. Surg. 2010;36:2069-74). Keep two caveats in mind with a cetuximab treatment strategy, Dr. Olbricht said. First, it's expensive – costing approximately $30,000 for an 8-week series of infusions. Second, cetuximab is effective only for skin cancer patients who do not have a KRAS mutation.

Another treatment showing promise is capecitabine (Xeloda, Hoffmann La Roche), an oral 5-fluorouracil precursor. New lesion development was halted within 6 months for three patients with a history of more than one new squamous cell carcinoma occurrence per month for more than 3 years (Dermatol. Surg. 2009;35:1657-72). Dr. Olbricht noted that hand and foot erythema occurred, which "is supposedly well known with this oral medication."

A meeting attendee asked how Dr. Olbricht manages patients with chronic, multiple squamous cell carcinomas. "I probably have six or seven people for years who come in at least once a month for skin cancer," she replied. "I try to take care of what they have at that moment."

For example, she recently treated a man whose biggest clinical concern is skin cancer 7 years post kidney transplant. "We sent 12 specimens to pathology. We did two Mohs procedures on his face, two excisions on his legs, and the rest were probably electrodesiccation and curettage on his trunk."

"I know I would make more money if I treated each lesion at individual sessions ... but I think this is best approach to this kind of patient," Dr. Olbricht said.

Dr. Olbricht said she had no relevant disclosures.

ORLANDO – Despite a paucity of recently approved treatments for squamous cell carcinoma, you can use study findings from the past few years to refine your clinical approach, Dr. Suzanne Olbricht said.

"It would be nice if I had some new treatments to discuss, but I don't. So let's go through some recent studies," Dr. Olbricht said at the annual meeting of the Florida Society of Dermatologic Surgeons.

Photodynamic Therapy

Investigators, for example, found methyl aminolevulinate photodynamic therapy (MAL-PDT) superior to 5-fluorouracil and cryosurgery for squamous cell carcinoma in situ. In addition, ophthalmologists might start using more imiquimod to treat periorbital skin cancers based on outcomes of a recent case series, Dr. Olbricht said. Other findings support promise for the oral medications cetuximab and capecitabine.

The prospective, randomized study that bolsters use of MAL-PDT included 225 patients with biopsy-confirmed squamous cell carcinoma in situ (Arch. Dermatol. 2006;142:729-35). Researchers found an 80% complete response rate in the MAL-PDT–treated patients at 12 months, compared with a 69% rate with 5-fluorouracil and a 67% rate in patients treated with cryotherapy.

"MAL-PDT was judged [to have the] most acceptable cosmetic outcome," Dr. Olbricht said. She added that 5-fluorouracil is "still a good therapy if some patients prefer to do things at home."

This is a "large study that is worth thinking about," said Dr. Olbricht, chair of the department of dermatology at the Lahey Clinic in Burlington, Mass., and a member of the dermatology faculty at Harvard Medical School, Boston.

Photodynamic therapy (PDT) was associated with a 72% complete response in a smaller study of 30 patients with recurrent tumors of the head and neck (J. Drugs Dermatol. 2010;9:122-6).

These investigators described PDT as effective, tolerable, and associated with good cosmetic results for recurrent squamous cell carcinoma or basal cell carcinoma. One concern, Dr. Olbricht said, is "they did not describe how they did the PDT."

Imiquimod Therapy

Another noteworthy study supports imiquimod for periorbital skin lesions (Orbit 2010;29:83-7). Two patients in this case series had basal cell carcinoma of the eyelid, one had actinic keratosis, and another had intraepidermal squamous cell carcinoma (Bowen’s disease). A fifth patient presented with concomitant squamous cell carcinoma and intraepidermal squamous cell carcinoma. All tumors regressed with a clinical cure at 6-9 months.

"It’s a short follow-up, but your ophthalmologic colleagues will be using imiquimod," Dr. Olbricht said.

Cetuximab and Capecitabine

Oral cetuximab (Erbitux, Imclone) was associated with a complete clinical response for a patient with organ metastases from cutaneous squamous cell carcinoma (Dermatol. Surg. 2010;36:2069-74). Keep two caveats in mind with a cetuximab treatment strategy, Dr. Olbricht said. First, it's expensive – costing approximately $30,000 for an 8-week series of infusions. Second, cetuximab is effective only for skin cancer patients who do not have a KRAS mutation.

Another treatment showing promise is capecitabine (Xeloda, Hoffmann La Roche), an oral 5-fluorouracil precursor. New lesion development was halted within 6 months for three patients with a history of more than one new squamous cell carcinoma occurrence per month for more than 3 years (Dermatol. Surg. 2009;35:1657-72). Dr. Olbricht noted that hand and foot erythema occurred, which "is supposedly well known with this oral medication."

A meeting attendee asked how Dr. Olbricht manages patients with chronic, multiple squamous cell carcinomas. "I probably have six or seven people for years who come in at least once a month for skin cancer," she replied. "I try to take care of what they have at that moment."

For example, she recently treated a man whose biggest clinical concern is skin cancer 7 years post kidney transplant. "We sent 12 specimens to pathology. We did two Mohs procedures on his face, two excisions on his legs, and the rest were probably electrodesiccation and curettage on his trunk."

"I know I would make more money if I treated each lesion at individual sessions ... but I think this is best approach to this kind of patient," Dr. Olbricht said.

Dr. Olbricht said she had no relevant disclosures.

ORLANDO – Despite a paucity of recently approved treatments for squamous cell carcinoma, you can use study findings from the past few years to refine your clinical approach, Dr. Suzanne Olbricht said.

"It would be nice if I had some new treatments to discuss, but I don't. So let's go through some recent studies," Dr. Olbricht said at the annual meeting of the Florida Society of Dermatologic Surgeons.

Photodynamic Therapy

Investigators, for example, found methyl aminolevulinate photodynamic therapy (MAL-PDT) superior to 5-fluorouracil and cryosurgery for squamous cell carcinoma in situ. In addition, ophthalmologists might start using more imiquimod to treat periorbital skin cancers based on outcomes of a recent case series, Dr. Olbricht said. Other findings support promise for the oral medications cetuximab and capecitabine.

The prospective, randomized study that bolsters use of MAL-PDT included 225 patients with biopsy-confirmed squamous cell carcinoma in situ (Arch. Dermatol. 2006;142:729-35). Researchers found an 80% complete response rate in the MAL-PDT–treated patients at 12 months, compared with a 69% rate with 5-fluorouracil and a 67% rate in patients treated with cryotherapy.

"MAL-PDT was judged [to have the] most acceptable cosmetic outcome," Dr. Olbricht said. She added that 5-fluorouracil is "still a good therapy if some patients prefer to do things at home."

This is a "large study that is worth thinking about," said Dr. Olbricht, chair of the department of dermatology at the Lahey Clinic in Burlington, Mass., and a member of the dermatology faculty at Harvard Medical School, Boston.

Photodynamic therapy (PDT) was associated with a 72% complete response in a smaller study of 30 patients with recurrent tumors of the head and neck (J. Drugs Dermatol. 2010;9:122-6).

These investigators described PDT as effective, tolerable, and associated with good cosmetic results for recurrent squamous cell carcinoma or basal cell carcinoma. One concern, Dr. Olbricht said, is "they did not describe how they did the PDT."

Imiquimod Therapy

Another noteworthy study supports imiquimod for periorbital skin lesions (Orbit 2010;29:83-7). Two patients in this case series had basal cell carcinoma of the eyelid, one had actinic keratosis, and another had intraepidermal squamous cell carcinoma (Bowen’s disease). A fifth patient presented with concomitant squamous cell carcinoma and intraepidermal squamous cell carcinoma. All tumors regressed with a clinical cure at 6-9 months.

"It’s a short follow-up, but your ophthalmologic colleagues will be using imiquimod," Dr. Olbricht said.

Cetuximab and Capecitabine

Oral cetuximab (Erbitux, Imclone) was associated with a complete clinical response for a patient with organ metastases from cutaneous squamous cell carcinoma (Dermatol. Surg. 2010;36:2069-74). Keep two caveats in mind with a cetuximab treatment strategy, Dr. Olbricht said. First, it's expensive – costing approximately $30,000 for an 8-week series of infusions. Second, cetuximab is effective only for skin cancer patients who do not have a KRAS mutation.

Another treatment showing promise is capecitabine (Xeloda, Hoffmann La Roche), an oral 5-fluorouracil precursor. New lesion development was halted within 6 months for three patients with a history of more than one new squamous cell carcinoma occurrence per month for more than 3 years (Dermatol. Surg. 2009;35:1657-72). Dr. Olbricht noted that hand and foot erythema occurred, which "is supposedly well known with this oral medication."

A meeting attendee asked how Dr. Olbricht manages patients with chronic, multiple squamous cell carcinomas. "I probably have six or seven people for years who come in at least once a month for skin cancer," she replied. "I try to take care of what they have at that moment."

For example, she recently treated a man whose biggest clinical concern is skin cancer 7 years post kidney transplant. "We sent 12 specimens to pathology. We did two Mohs procedures on his face, two excisions on his legs, and the rest were probably electrodesiccation and curettage on his trunk."

"I know I would make more money if I treated each lesion at individual sessions ... but I think this is best approach to this kind of patient," Dr. Olbricht said.

Dr. Olbricht said she had no relevant disclosures.