Bruce Jancin

WAIKOLOA, HAWAII – Joint pain arising in a patient with psoriasis is by no means necessarily due to psoriatic arthritis.

Psoriasis patients can get osteoarthritis or rheumatoid arthritis, just like individuals without the skin disease. The distribution pattern of affected joints provides a useful guide as to which arthropathy is involved.

Bruce Jancin/Elsevier Global Medical News

"When a patient who’s got psoriasis comes to me and says, ‘I have a tremendous amount of joint pain,’ the first place I look is the heel. Heel involvement doesn’t happen very often in rheumatoid arthritis. If the heel hurts, it’s probable that the patient has dactylitis and some form of psoriatic arthritis," according to Dr. Daniel E. Furst, the Carl M. Pearson professor of rheumatology at the University of California, Los Angeles.

Another useful clue: Psoriatic arthritis often affects the distal phalangeal joints of the fingers and toes, with accompanying characteristic psoriatic nail changes, but it spares the metacarpophalangeal (MCP) joints. In contrast, MCP involvement is a typical feature of rheumatoid arthritis, he explained at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

"If only we understood why one joint tends to be affected and not another, we would sure know a whole lot more about psoriatic arthritis, and rheumatoid arthritis for that matter," Dr. Furst observed.

Involvement of the distal interphalangeal (DIP) joints is a common feature in osteoarthritis as well as psoriatic arthritis. However, psoriatic arthritis, unlike osteoarthritis, is an inflammatory arthritis. The affected fingers and toes in a patient with psoriatic arthritis often develop a painful, red, warm, sausage-like swelling of the soft tissue on the entire digit.

"If there’s erythema and squishiness when you push on a painful joint, that’s synovitis, not osteoarthritis," the rheumatologist noted.

Also, osteoarthritis has a strong tendency to involve the carpometacarpal joint of the thumb, a site spared in psoriatic arthritis, he continued.

Psoriatic arthritis often first shows up as a monoarticular, asymmetric arthritis of a larger joint, such as the knee, ankle, or wrist. Rheumatoid arthritis tends to come on much stronger.

"In rheumatoid arthritis, it’s frequently all at once. The patient will say, ‘In a week I went from nothing to pain everywhere.’ Not so in psoriatic arthritis," according to Dr. Furst.

Spondyloarthropathy is common in psoriatic arthritis. It often takes the form of a spondylitis characterized by asymmetric thickening and calcification of the longitudinal ligaments of the spine, resulting in asymmetric syndesmophytes on imaging. The result is a painful and/or stiff low back.

Psoriatic arthritis is widely thought of as a rheumatoid factor–negative disease, but that’s not strictly true. Roughly 15% of psoriatic arthritis patients are rheumatoid factor–positive.

Differentiating psoriatic arthritis from other types of arthritis that occur in psoriasis patients is important from a treatment standpoint. Psoriatic arthritis causes much more bony destruction than recognized until fairly recently, twice as much as rheumatoid arthritis by some measures. The nonbiologic disease-modifying antirheumatic drugs are only marginally effective for joint disease in psoriatic arthritis patients, with the exception of leflunomide (Arava), which has fair benefit for the peripheral arthritis but less for the skin disease.

At present, the tumor necrosis factor (TNF) inhibitors are the most effective agents available for peripheral and axial joint disease in psoriatic arthritis. But the response can be less impressive than in patients with psoriasis-only or rheumatoid arthritis. New therapies on the horizon include agents targeting the inflammatory cytokines interleukins-6, -12, and -15, as well as orally administered small molecules that inhibit Janus kinase, spleen tyrosine kinase, TNF-alpha converting enzyme, or mitogen-activated protein kinase.

"There’s a lot of stuff coming down the pike, including new drugs which have mechanisms of action very different from those most extant in psoriasis. Some of it is going to work. But so far we really don’t know which of it will," Dr. Furst said.

He reported that he serves as a consultant to or recipient of research grants from more than a dozen pharmaceutical companies and the National Institutes of Health.

SDEF and this news organization are owned by Elsevier.

WAIKOLOA, HAWAII – Joint pain arising in a patient with psoriasis is by no means necessarily due to psoriatic arthritis.

Psoriasis patients can get osteoarthritis or rheumatoid arthritis, just like individuals without the skin disease. The distribution pattern of affected joints provides a useful guide as to which arthropathy is involved.

Bruce Jancin/Elsevier Global Medical News

"When a patient who’s got psoriasis comes to me and says, ‘I have a tremendous amount of joint pain,’ the first place I look is the heel. Heel involvement doesn’t happen very often in rheumatoid arthritis. If the heel hurts, it’s probable that the patient has dactylitis and some form of psoriatic arthritis," according to Dr. Daniel E. Furst, the Carl M. Pearson professor of rheumatology at the University of California, Los Angeles.

Another useful clue: Psoriatic arthritis often affects the distal phalangeal joints of the fingers and toes, with accompanying characteristic psoriatic nail changes, but it spares the metacarpophalangeal (MCP) joints. In contrast, MCP involvement is a typical feature of rheumatoid arthritis, he explained at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

"If only we understood why one joint tends to be affected and not another, we would sure know a whole lot more about psoriatic arthritis, and rheumatoid arthritis for that matter," Dr. Furst observed.

Involvement of the distal interphalangeal (DIP) joints is a common feature in osteoarthritis as well as psoriatic arthritis. However, psoriatic arthritis, unlike osteoarthritis, is an inflammatory arthritis. The affected fingers and toes in a patient with psoriatic arthritis often develop a painful, red, warm, sausage-like swelling of the soft tissue on the entire digit.

"If there’s erythema and squishiness when you push on a painful joint, that’s synovitis, not osteoarthritis," the rheumatologist noted.

Also, osteoarthritis has a strong tendency to involve the carpometacarpal joint of the thumb, a site spared in psoriatic arthritis, he continued.

Psoriatic arthritis often first shows up as a monoarticular, asymmetric arthritis of a larger joint, such as the knee, ankle, or wrist. Rheumatoid arthritis tends to come on much stronger.

"In rheumatoid arthritis, it’s frequently all at once. The patient will say, ‘In a week I went from nothing to pain everywhere.’ Not so in psoriatic arthritis," according to Dr. Furst.

Spondyloarthropathy is common in psoriatic arthritis. It often takes the form of a spondylitis characterized by asymmetric thickening and calcification of the longitudinal ligaments of the spine, resulting in asymmetric syndesmophytes on imaging. The result is a painful and/or stiff low back.

Psoriatic arthritis is widely thought of as a rheumatoid factor–negative disease, but that’s not strictly true. Roughly 15% of psoriatic arthritis patients are rheumatoid factor–positive.

Differentiating psoriatic arthritis from other types of arthritis that occur in psoriasis patients is important from a treatment standpoint. Psoriatic arthritis causes much more bony destruction than recognized until fairly recently, twice as much as rheumatoid arthritis by some measures. The nonbiologic disease-modifying antirheumatic drugs are only marginally effective for joint disease in psoriatic arthritis patients, with the exception of leflunomide (Arava), which has fair benefit for the peripheral arthritis but less for the skin disease.

At present, the tumor necrosis factor (TNF) inhibitors are the most effective agents available for peripheral and axial joint disease in psoriatic arthritis. But the response can be less impressive than in patients with psoriasis-only or rheumatoid arthritis. New therapies on the horizon include agents targeting the inflammatory cytokines interleukins-6, -12, and -15, as well as orally administered small molecules that inhibit Janus kinase, spleen tyrosine kinase, TNF-alpha converting enzyme, or mitogen-activated protein kinase.

"There’s a lot of stuff coming down the pike, including new drugs which have mechanisms of action very different from those most extant in psoriasis. Some of it is going to work. But so far we really don’t know which of it will," Dr. Furst said.

He reported that he serves as a consultant to or recipient of research grants from more than a dozen pharmaceutical companies and the National Institutes of Health.

SDEF and this news organization are owned by Elsevier.

WAIKOLOA, HAWAII – Joint pain arising in a patient with psoriasis is by no means necessarily due to psoriatic arthritis.

Psoriasis patients can get osteoarthritis or rheumatoid arthritis, just like individuals without the skin disease. The distribution pattern of affected joints provides a useful guide as to which arthropathy is involved.

Bruce Jancin/Elsevier Global Medical News

"When a patient who’s got psoriasis comes to me and says, ‘I have a tremendous amount of joint pain,’ the first place I look is the heel. Heel involvement doesn’t happen very often in rheumatoid arthritis. If the heel hurts, it’s probable that the patient has dactylitis and some form of psoriatic arthritis," according to Dr. Daniel E. Furst, the Carl M. Pearson professor of rheumatology at the University of California, Los Angeles.

Another useful clue: Psoriatic arthritis often affects the distal phalangeal joints of the fingers and toes, with accompanying characteristic psoriatic nail changes, but it spares the metacarpophalangeal (MCP) joints. In contrast, MCP involvement is a typical feature of rheumatoid arthritis, he explained at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

"If only we understood why one joint tends to be affected and not another, we would sure know a whole lot more about psoriatic arthritis, and rheumatoid arthritis for that matter," Dr. Furst observed.

Involvement of the distal interphalangeal (DIP) joints is a common feature in osteoarthritis as well as psoriatic arthritis. However, psoriatic arthritis, unlike osteoarthritis, is an inflammatory arthritis. The affected fingers and toes in a patient with psoriatic arthritis often develop a painful, red, warm, sausage-like swelling of the soft tissue on the entire digit.

"If there’s erythema and squishiness when you push on a painful joint, that’s synovitis, not osteoarthritis," the rheumatologist noted.

Also, osteoarthritis has a strong tendency to involve the carpometacarpal joint of the thumb, a site spared in psoriatic arthritis, he continued.

Psoriatic arthritis often first shows up as a monoarticular, asymmetric arthritis of a larger joint, such as the knee, ankle, or wrist. Rheumatoid arthritis tends to come on much stronger.

"In rheumatoid arthritis, it’s frequently all at once. The patient will say, ‘In a week I went from nothing to pain everywhere.’ Not so in psoriatic arthritis," according to Dr. Furst.

Spondyloarthropathy is common in psoriatic arthritis. It often takes the form of a spondylitis characterized by asymmetric thickening and calcification of the longitudinal ligaments of the spine, resulting in asymmetric syndesmophytes on imaging. The result is a painful and/or stiff low back.

Psoriatic arthritis is widely thought of as a rheumatoid factor–negative disease, but that’s not strictly true. Roughly 15% of psoriatic arthritis patients are rheumatoid factor–positive.

Differentiating psoriatic arthritis from other types of arthritis that occur in psoriasis patients is important from a treatment standpoint. Psoriatic arthritis causes much more bony destruction than recognized until fairly recently, twice as much as rheumatoid arthritis by some measures. The nonbiologic disease-modifying antirheumatic drugs are only marginally effective for joint disease in psoriatic arthritis patients, with the exception of leflunomide (Arava), which has fair benefit for the peripheral arthritis but less for the skin disease.

At present, the tumor necrosis factor (TNF) inhibitors are the most effective agents available for peripheral and axial joint disease in psoriatic arthritis. But the response can be less impressive than in patients with psoriasis-only or rheumatoid arthritis. New therapies on the horizon include agents targeting the inflammatory cytokines interleukins-6, -12, and -15, as well as orally administered small molecules that inhibit Janus kinase, spleen tyrosine kinase, TNF-alpha converting enzyme, or mitogen-activated protein kinase.

"There’s a lot of stuff coming down the pike, including new drugs which have mechanisms of action very different from those most extant in psoriasis. Some of it is going to work. But so far we really don’t know which of it will," Dr. Furst said.

He reported that he serves as a consultant to or recipient of research grants from more than a dozen pharmaceutical companies and the National Institutes of Health.

SDEF and this news organization are owned by Elsevier.

SNOWMASS, COLO. – The guideline-endorsed demotion of nonsteroidal anti-inflammatory drugs in favor of narcotic analgesics for chronic pain has led to a marked increase in falls, fractures, and other bad outcomes among elderly arthritis patients.

"I think the real take-home message here is that current guidelines for the treatment of pain should be revisited," Dr. Bruce N. Cronstein asserted at a symposium sponsored by the American College of Rheumatology.

Since the cyclo-oxygenase-2 (COX-2)-selective NSAID rofecoxib (Vioxx) was famously taken off the market in late 2004 because of a scandal related to cover-up of an increased risk of myocardial infarction (MI), prescriptions for narcotic analgesics in elderly patients with arthritis have risen sharply. This trend accelerated after the 2007 publication of an American Heart Association (AHA) scientific statement on the treatment of chronic pain in patients with or at increased risk for heart disease (Circulation 2007;115:1634-42). The AHA guidelines elevated short-term use of narcotic analgesics to first-tier status alongside aspirin, acetaminophen, and tramadol, while demoting both COX-2-selective and nonselective NSAIDs to second-tier status.

The AHA recommendations have been embraced by geriatrics groups and other medical societies. Notably, however, the American College of Rheumatology has declined to get on board, observed Dr. Cronstein, Dr. Paul R. Esserman professor of medicine at New York University.

The AHA guidelines, in his view, are poorly done. The problem is one of tunnel vision. The guidelines focus on the evidence of increased cardiovascular risk associated with nearly all NSAIDs without considering how the drugs stack up in terms of overall safety – noncardiovascular as well as cardiovascular – compared with the other major analgesic group: narcotic analgesics. And it turns out that the NSAIDs look pretty good in comparison, the rheumatologist added.

"You’re trading off falls and fractures for MIs – and it turns out that in patients over age 65, the mortality from hip fracture is significantly greater than it is for MI," said Dr. Cronstein, who is also director of the Clinical and Translational Science Institute, which is a partnership between New York University and the New York City Health and Hospitals Corporation.

Dr. Cronstein cited a large Medicare study conducted by investigators at Brigham and Women’s Hospital, Boston. They examined the comparative safety of analgesics in elderly arthritis patients and concluded that narcotic analgesics come up short.

The investigators sifted through the population of Medicare beneficiaries in Pennsylvania and New Jersey to identify elderly patients with rheumatoid arthritis or osteoarthritis (OA) who were started on a nonselective NSAID, a COX-2-selective NSAID, or a narcotic analgesic during 1999-2005. They came up with 4,280 propensity score–matched patients in each of the three groups. The subjects’ mean age was 80 years, and 85% were women. Patients with prior cancer or nursing-home use were excluded from the study in order to avoid data skewing.

The composite incidence of fractures of the hip, pelvis, humerus, or radius in this National Institutes of Health–funded study was 26 per 1,000 person-years among patients on nonselective NSAIDs, 19 with COX-2-selective NSAIDs, and 101 with opioids.

While it’s not really surprising that opiate analgesics should be associated with increased risk of falls and fractures, another finding in this study proved unexpected: Intriguingly, the composite cardiovascular event rate was 77 per 1,000 person-years with nonselective NSAIDs, 88 per 1,000 with COX-2-selective NSAIDs, and 122 in the narcotic analgesics group.

The patients taking opioids had a 77% greater risk of cardiovascular events and those taking COX-2-selective NSAIDs had a 28% greater risk than did patients on nonselective NSAIDs, according to findings from a multivariate Cox regression analysis. The fracture risk was 4.47-fold greater with narcotic analgesics than with NSAIDs. The gastrointestinal bleeding risk was 40% lower in the COX-2-selective NSAID group than in the other two study arms. The all-cause mortality risk was 87% greater in the narcotic analgesic group than with nonselective NSAIDs, while COX-2-selective NSAIDs were not associated with increased risk (Arch. Intern. Med. 2010; 170: 1968-76).

Dr. Cronstein also presented highlights of a not-yet-published study that documented the changing pattern of analgesic prescriptions for elderly patients with OA since 2005. He conducted the study with coinvestigators at the Geisinger Health Plan in Danville, Pa.

During 2001-2004, 24% of elderly patients with OA in the Geisinger system were on a narcotic-only for pain relief, 15% were on a narcotic analgesic plus a COX-2-selective NSAID, and 13% were on COX-2-selective NSAID monotherapy. But in 2005-2009, 56% of patients were on monotherapy with a narcotic analgesic, 9% were on a narcotic plus a COX-2-selective NSAID, and 2% were on COX-2-selective NSAID monotherapy.

Thus, the use of narcotic analgesics as the sole prescription medication for pain relief in elderly OA patients more than doubled after Vioxx was withdrawn from the market. The patients on narcotic analgesics with or without a COX-2-selective NSAID had a fourfold greater rate of falls or fractures than those on nonselective NSAIDs or COX-2-selective agents.

Dr. Cronstein and his coworkers also conducted a nested case-control study of 3,830 elderly Geisinger OA patients with fractures and 11,490 others matched for age and Charlson Comorbidity Index without fractures. In a multivariate analysis, patients on narcotic analgesics had a threefold greater risk of falls or fractures than those on either COX-2-selective or nonselective NSAIDs.

Dr. Cronstein observed that large studies indicate that the frequency of positive tests for prescription narcotic analgesics in employees involved in workplace accidents has increased significantly since 2005. Meanwhile, prescription narcotic analgesic abuse among younger individuals has ballooned. But while it’s interesting to speculate that these trends might be related to Vioxx going off the market and the general disenchantment with all NSAIDs that followed, there is no concrete evidence of such an association, he conceded.

This work was funded by the National Institutes of Health, the Geisinger Clinic, and the Clinical and Translational Science Institute. Dr. Cronstein reported that he has served as a paid consultant to Allos, Bristol-Myers Squibb, CanFite Biopharmaceuticals, Cypress Laboratories, Gismo Therapeutics, Novartis, Protalex, Regeneron, and Savient. He has received research grants from the National Institutes of Health and numerous pharmaceutical companies.

SNOWMASS, COLO. – The guideline-endorsed demotion of nonsteroidal anti-inflammatory drugs in favor of narcotic analgesics for chronic pain has led to a marked increase in falls, fractures, and other bad outcomes among elderly arthritis patients.

"I think the real take-home message here is that current guidelines for the treatment of pain should be revisited," Dr. Bruce N. Cronstein asserted at a symposium sponsored by the American College of Rheumatology.

Since the cyclo-oxygenase-2 (COX-2)-selective NSAID rofecoxib (Vioxx) was famously taken off the market in late 2004 because of a scandal related to cover-up of an increased risk of myocardial infarction (MI), prescriptions for narcotic analgesics in elderly patients with arthritis have risen sharply. This trend accelerated after the 2007 publication of an American Heart Association (AHA) scientific statement on the treatment of chronic pain in patients with or at increased risk for heart disease (Circulation 2007;115:1634-42). The AHA guidelines elevated short-term use of narcotic analgesics to first-tier status alongside aspirin, acetaminophen, and tramadol, while demoting both COX-2-selective and nonselective NSAIDs to second-tier status.

The AHA recommendations have been embraced by geriatrics groups and other medical societies. Notably, however, the American College of Rheumatology has declined to get on board, observed Dr. Cronstein, Dr. Paul R. Esserman professor of medicine at New York University.

The AHA guidelines, in his view, are poorly done. The problem is one of tunnel vision. The guidelines focus on the evidence of increased cardiovascular risk associated with nearly all NSAIDs without considering how the drugs stack up in terms of overall safety – noncardiovascular as well as cardiovascular – compared with the other major analgesic group: narcotic analgesics. And it turns out that the NSAIDs look pretty good in comparison, the rheumatologist added.

"You’re trading off falls and fractures for MIs – and it turns out that in patients over age 65, the mortality from hip fracture is significantly greater than it is for MI," said Dr. Cronstein, who is also director of the Clinical and Translational Science Institute, which is a partnership between New York University and the New York City Health and Hospitals Corporation.

Dr. Cronstein cited a large Medicare study conducted by investigators at Brigham and Women’s Hospital, Boston. They examined the comparative safety of analgesics in elderly arthritis patients and concluded that narcotic analgesics come up short.

The investigators sifted through the population of Medicare beneficiaries in Pennsylvania and New Jersey to identify elderly patients with rheumatoid arthritis or osteoarthritis (OA) who were started on a nonselective NSAID, a COX-2-selective NSAID, or a narcotic analgesic during 1999-2005. They came up with 4,280 propensity score–matched patients in each of the three groups. The subjects’ mean age was 80 years, and 85% were women. Patients with prior cancer or nursing-home use were excluded from the study in order to avoid data skewing.

The composite incidence of fractures of the hip, pelvis, humerus, or radius in this National Institutes of Health–funded study was 26 per 1,000 person-years among patients on nonselective NSAIDs, 19 with COX-2-selective NSAIDs, and 101 with opioids.

While it’s not really surprising that opiate analgesics should be associated with increased risk of falls and fractures, another finding in this study proved unexpected: Intriguingly, the composite cardiovascular event rate was 77 per 1,000 person-years with nonselective NSAIDs, 88 per 1,000 with COX-2-selective NSAIDs, and 122 in the narcotic analgesics group.

The patients taking opioids had a 77% greater risk of cardiovascular events and those taking COX-2-selective NSAIDs had a 28% greater risk than did patients on nonselective NSAIDs, according to findings from a multivariate Cox regression analysis. The fracture risk was 4.47-fold greater with narcotic analgesics than with NSAIDs. The gastrointestinal bleeding risk was 40% lower in the COX-2-selective NSAID group than in the other two study arms. The all-cause mortality risk was 87% greater in the narcotic analgesic group than with nonselective NSAIDs, while COX-2-selective NSAIDs were not associated with increased risk (Arch. Intern. Med. 2010; 170: 1968-76).

Dr. Cronstein also presented highlights of a not-yet-published study that documented the changing pattern of analgesic prescriptions for elderly patients with OA since 2005. He conducted the study with coinvestigators at the Geisinger Health Plan in Danville, Pa.

During 2001-2004, 24% of elderly patients with OA in the Geisinger system were on a narcotic-only for pain relief, 15% were on a narcotic analgesic plus a COX-2-selective NSAID, and 13% were on COX-2-selective NSAID monotherapy. But in 2005-2009, 56% of patients were on monotherapy with a narcotic analgesic, 9% were on a narcotic plus a COX-2-selective NSAID, and 2% were on COX-2-selective NSAID monotherapy.

Thus, the use of narcotic analgesics as the sole prescription medication for pain relief in elderly OA patients more than doubled after Vioxx was withdrawn from the market. The patients on narcotic analgesics with or without a COX-2-selective NSAID had a fourfold greater rate of falls or fractures than those on nonselective NSAIDs or COX-2-selective agents.

Dr. Cronstein and his coworkers also conducted a nested case-control study of 3,830 elderly Geisinger OA patients with fractures and 11,490 others matched for age and Charlson Comorbidity Index without fractures. In a multivariate analysis, patients on narcotic analgesics had a threefold greater risk of falls or fractures than those on either COX-2-selective or nonselective NSAIDs.

Dr. Cronstein observed that large studies indicate that the frequency of positive tests for prescription narcotic analgesics in employees involved in workplace accidents has increased significantly since 2005. Meanwhile, prescription narcotic analgesic abuse among younger individuals has ballooned. But while it’s interesting to speculate that these trends might be related to Vioxx going off the market and the general disenchantment with all NSAIDs that followed, there is no concrete evidence of such an association, he conceded.

This work was funded by the National Institutes of Health, the Geisinger Clinic, and the Clinical and Translational Science Institute. Dr. Cronstein reported that he has served as a paid consultant to Allos, Bristol-Myers Squibb, CanFite Biopharmaceuticals, Cypress Laboratories, Gismo Therapeutics, Novartis, Protalex, Regeneron, and Savient. He has received research grants from the National Institutes of Health and numerous pharmaceutical companies.

SNOWMASS, COLO. – The guideline-endorsed demotion of nonsteroidal anti-inflammatory drugs in favor of narcotic analgesics for chronic pain has led to a marked increase in falls, fractures, and other bad outcomes among elderly arthritis patients.

"I think the real take-home message here is that current guidelines for the treatment of pain should be revisited," Dr. Bruce N. Cronstein asserted at a symposium sponsored by the American College of Rheumatology.

Since the cyclo-oxygenase-2 (COX-2)-selective NSAID rofecoxib (Vioxx) was famously taken off the market in late 2004 because of a scandal related to cover-up of an increased risk of myocardial infarction (MI), prescriptions for narcotic analgesics in elderly patients with arthritis have risen sharply. This trend accelerated after the 2007 publication of an American Heart Association (AHA) scientific statement on the treatment of chronic pain in patients with or at increased risk for heart disease (Circulation 2007;115:1634-42). The AHA guidelines elevated short-term use of narcotic analgesics to first-tier status alongside aspirin, acetaminophen, and tramadol, while demoting both COX-2-selective and nonselective NSAIDs to second-tier status.

The AHA recommendations have been embraced by geriatrics groups and other medical societies. Notably, however, the American College of Rheumatology has declined to get on board, observed Dr. Cronstein, Dr. Paul R. Esserman professor of medicine at New York University.

The AHA guidelines, in his view, are poorly done. The problem is one of tunnel vision. The guidelines focus on the evidence of increased cardiovascular risk associated with nearly all NSAIDs without considering how the drugs stack up in terms of overall safety – noncardiovascular as well as cardiovascular – compared with the other major analgesic group: narcotic analgesics. And it turns out that the NSAIDs look pretty good in comparison, the rheumatologist added.

"You’re trading off falls and fractures for MIs – and it turns out that in patients over age 65, the mortality from hip fracture is significantly greater than it is for MI," said Dr. Cronstein, who is also director of the Clinical and Translational Science Institute, which is a partnership between New York University and the New York City Health and Hospitals Corporation.

Dr. Cronstein cited a large Medicare study conducted by investigators at Brigham and Women’s Hospital, Boston. They examined the comparative safety of analgesics in elderly arthritis patients and concluded that narcotic analgesics come up short.

The investigators sifted through the population of Medicare beneficiaries in Pennsylvania and New Jersey to identify elderly patients with rheumatoid arthritis or osteoarthritis (OA) who were started on a nonselective NSAID, a COX-2-selective NSAID, or a narcotic analgesic during 1999-2005. They came up with 4,280 propensity score–matched patients in each of the three groups. The subjects’ mean age was 80 years, and 85% were women. Patients with prior cancer or nursing-home use were excluded from the study in order to avoid data skewing.

The composite incidence of fractures of the hip, pelvis, humerus, or radius in this National Institutes of Health–funded study was 26 per 1,000 person-years among patients on nonselective NSAIDs, 19 with COX-2-selective NSAIDs, and 101 with opioids.

While it’s not really surprising that opiate analgesics should be associated with increased risk of falls and fractures, another finding in this study proved unexpected: Intriguingly, the composite cardiovascular event rate was 77 per 1,000 person-years with nonselective NSAIDs, 88 per 1,000 with COX-2-selective NSAIDs, and 122 in the narcotic analgesics group.

The patients taking opioids had a 77% greater risk of cardiovascular events and those taking COX-2-selective NSAIDs had a 28% greater risk than did patients on nonselective NSAIDs, according to findings from a multivariate Cox regression analysis. The fracture risk was 4.47-fold greater with narcotic analgesics than with NSAIDs. The gastrointestinal bleeding risk was 40% lower in the COX-2-selective NSAID group than in the other two study arms. The all-cause mortality risk was 87% greater in the narcotic analgesic group than with nonselective NSAIDs, while COX-2-selective NSAIDs were not associated with increased risk (Arch. Intern. Med. 2010; 170: 1968-76).

Dr. Cronstein also presented highlights of a not-yet-published study that documented the changing pattern of analgesic prescriptions for elderly patients with OA since 2005. He conducted the study with coinvestigators at the Geisinger Health Plan in Danville, Pa.

During 2001-2004, 24% of elderly patients with OA in the Geisinger system were on a narcotic-only for pain relief, 15% were on a narcotic analgesic plus a COX-2-selective NSAID, and 13% were on COX-2-selective NSAID monotherapy. But in 2005-2009, 56% of patients were on monotherapy with a narcotic analgesic, 9% were on a narcotic plus a COX-2-selective NSAID, and 2% were on COX-2-selective NSAID monotherapy.

Thus, the use of narcotic analgesics as the sole prescription medication for pain relief in elderly OA patients more than doubled after Vioxx was withdrawn from the market. The patients on narcotic analgesics with or without a COX-2-selective NSAID had a fourfold greater rate of falls or fractures than those on nonselective NSAIDs or COX-2-selective agents.

Dr. Cronstein and his coworkers also conducted a nested case-control study of 3,830 elderly Geisinger OA patients with fractures and 11,490 others matched for age and Charlson Comorbidity Index without fractures. In a multivariate analysis, patients on narcotic analgesics had a threefold greater risk of falls or fractures than those on either COX-2-selective or nonselective NSAIDs.

Dr. Cronstein observed that large studies indicate that the frequency of positive tests for prescription narcotic analgesics in employees involved in workplace accidents has increased significantly since 2005. Meanwhile, prescription narcotic analgesic abuse among younger individuals has ballooned. But while it’s interesting to speculate that these trends might be related to Vioxx going off the market and the general disenchantment with all NSAIDs that followed, there is no concrete evidence of such an association, he conceded.

This work was funded by the National Institutes of Health, the Geisinger Clinic, and the Clinical and Translational Science Institute. Dr. Cronstein reported that he has served as a paid consultant to Allos, Bristol-Myers Squibb, CanFite Biopharmaceuticals, Cypress Laboratories, Gismo Therapeutics, Novartis, Protalex, Regeneron, and Savient. He has received research grants from the National Institutes of Health and numerous pharmaceutical companies.

SNOWMASS, COLO. – Unless you’re a dermatologist, you’re likely to need just three topical corticosteroids from the dizzying array of available products.

That’s the contention of Dr. Ruth Ann Vleugels, a dermatologist who is director of the connective tissue disease clinic at Brigham and Women’s Hospital in Boston and codirector of the rheumatology-dermatology clinic at Children’s Hospital Boston. She advises gaining familiarity with the use of desonide, triamcinolone 0.1%, and clobetasol.

"Honestly, this is 90% of what I use. If you have a ‘favorites’ tab on your [electronic health record system] you can plug in these three with their instructions and you’ll never need to use any other topical steroids," she said at the conference.

Clobetasol is a potent steroid, triamcinolone 0.1% is midstrength, and desonide is lower-potency. Clobetasol and triamcinolone 0.1% are generally utilized for skin disease on the body, whereas desonide is the appropriate choice for skin disorders on the face, groin, axillae, and breasts.

Many nondermatologists are leery about long-term topical corticosteroid therapy. But there’s no need for concern as long as the drugs are used with breaks, Dr. Vleugels emphasized.

"You can use topical steroids for life with no issues; we know that from studies in our psoriasis and eczema patients. But we can’t use them without breaks. That’s the most important message in counseling your patients. For the body, it’s 2 weeks on, 1 week off. For the face, it’s 1 week on, 1 week off. If they do that, you won’t see steroid side effects," she said.

The side effects that are seen with uninterrupted topical steroid therapy include skin atrophy, striae, lightening, and telangiectasias.

When desonide is used in treating the groin, breasts, or armpits, the schedule is 1 week on, 1 week off – the same as the facial schedule.

Dr. Vleugels makes an exception to these rules when she’s treating facial lesions related to autoimmune diseases. Because she wants to get rapid clearing, she often turns to a burst of clobetasol in these circumstances. The schedule is 1 week on, 1 week off.

"A typical situation might be when a rheumatologist calls me and says, ‘I have a patient who got a horrible photosensitive malar rash while outdoors last weekend, and she’s already on maximum-dose systemic therapy.’ I’d say, just give her 1 week of clobetasol on her face; she’ll be better in 3-4 days. But you need to carefully tell your patients that if they’re going to put it on their face they have to follow the rule for face disease: 1 week on, 1 week off," she said.

Cream or ointment? For most patients with autoimmune diseases, pick a topical steroid cream; it’ll result in better compliance. A steroid ointment is preferable when skin hydration is a consideration, as in atopic dermatitis. Because ointments are effectively stronger and more deeply penetrating than creams, a steroid ointment is also the best choice in treating disease involving particularly thick skin, such as palmar or plantar psoriasis, where the medication is employed under occlusion with gloves or socks, Dr. Vleugels explained.

To avoid undertreatment, it’s important to specify on the prescription how much medication the pharmacy is to provide. A 60-g tube of a topical steroid won’t last longer than a week in a patient with a full-body skin eruption; Dr. Vleugels generally orders 120-240 g for such patients. For patients treating lesions on the face or other sensitive areas, she cuts the prescription to 30 g with a single refill unless she’s comfortable with that individual’s adherence.

Topical calcineurin inhibitors have a limited role. Dr. Vleugels considers using 0.3% tacrolimus during patients’ week-long topical steroid breaks if their disease isn’t well controlled during those intervals. She also considers tacrolimus in patients with periorbital skin lesions, where steroid atrophy is a particular concern. Topical pimecrolimus is considerably less effective than tacrolimus, and she never uses pimecrolimus in adults.

"I use these agents much less frequently than topical steroids. They’re often low efficacy for the cost [compared with] a topical steroid, used safely," the dermatologist said.

She reported having no financial conflicts.

SNOWMASS, COLO. – Unless you’re a dermatologist, you’re likely to need just three topical corticosteroids from the dizzying array of available products.

That’s the contention of Dr. Ruth Ann Vleugels, a dermatologist who is director of the connective tissue disease clinic at Brigham and Women’s Hospital in Boston and codirector of the rheumatology-dermatology clinic at Children’s Hospital Boston. She advises gaining familiarity with the use of desonide, triamcinolone 0.1%, and clobetasol.

"Honestly, this is 90% of what I use. If you have a ‘favorites’ tab on your [electronic health record system] you can plug in these three with their instructions and you’ll never need to use any other topical steroids," she said at the conference.

Clobetasol is a potent steroid, triamcinolone 0.1% is midstrength, and desonide is lower-potency. Clobetasol and triamcinolone 0.1% are generally utilized for skin disease on the body, whereas desonide is the appropriate choice for skin disorders on the face, groin, axillae, and breasts.

Many nondermatologists are leery about long-term topical corticosteroid therapy. But there’s no need for concern as long as the drugs are used with breaks, Dr. Vleugels emphasized.

"You can use topical steroids for life with no issues; we know that from studies in our psoriasis and eczema patients. But we can’t use them without breaks. That’s the most important message in counseling your patients. For the body, it’s 2 weeks on, 1 week off. For the face, it’s 1 week on, 1 week off. If they do that, you won’t see steroid side effects," she said.

The side effects that are seen with uninterrupted topical steroid therapy include skin atrophy, striae, lightening, and telangiectasias.

When desonide is used in treating the groin, breasts, or armpits, the schedule is 1 week on, 1 week off – the same as the facial schedule.

Dr. Vleugels makes an exception to these rules when she’s treating facial lesions related to autoimmune diseases. Because she wants to get rapid clearing, she often turns to a burst of clobetasol in these circumstances. The schedule is 1 week on, 1 week off.

"A typical situation might be when a rheumatologist calls me and says, ‘I have a patient who got a horrible photosensitive malar rash while outdoors last weekend, and she’s already on maximum-dose systemic therapy.’ I’d say, just give her 1 week of clobetasol on her face; she’ll be better in 3-4 days. But you need to carefully tell your patients that if they’re going to put it on their face they have to follow the rule for face disease: 1 week on, 1 week off," she said.

Cream or ointment? For most patients with autoimmune diseases, pick a topical steroid cream; it’ll result in better compliance. A steroid ointment is preferable when skin hydration is a consideration, as in atopic dermatitis. Because ointments are effectively stronger and more deeply penetrating than creams, a steroid ointment is also the best choice in treating disease involving particularly thick skin, such as palmar or plantar psoriasis, where the medication is employed under occlusion with gloves or socks, Dr. Vleugels explained.

To avoid undertreatment, it’s important to specify on the prescription how much medication the pharmacy is to provide. A 60-g tube of a topical steroid won’t last longer than a week in a patient with a full-body skin eruption; Dr. Vleugels generally orders 120-240 g for such patients. For patients treating lesions on the face or other sensitive areas, she cuts the prescription to 30 g with a single refill unless she’s comfortable with that individual’s adherence.

Topical calcineurin inhibitors have a limited role. Dr. Vleugels considers using 0.3% tacrolimus during patients’ week-long topical steroid breaks if their disease isn’t well controlled during those intervals. She also considers tacrolimus in patients with periorbital skin lesions, where steroid atrophy is a particular concern. Topical pimecrolimus is considerably less effective than tacrolimus, and she never uses pimecrolimus in adults.

"I use these agents much less frequently than topical steroids. They’re often low efficacy for the cost [compared with] a topical steroid, used safely," the dermatologist said.

She reported having no financial conflicts.

SNOWMASS, COLO. – Unless you’re a dermatologist, you’re likely to need just three topical corticosteroids from the dizzying array of available products.

That’s the contention of Dr. Ruth Ann Vleugels, a dermatologist who is director of the connective tissue disease clinic at Brigham and Women’s Hospital in Boston and codirector of the rheumatology-dermatology clinic at Children’s Hospital Boston. She advises gaining familiarity with the use of desonide, triamcinolone 0.1%, and clobetasol.

"Honestly, this is 90% of what I use. If you have a ‘favorites’ tab on your [electronic health record system] you can plug in these three with their instructions and you’ll never need to use any other topical steroids," she said at the conference.

Clobetasol is a potent steroid, triamcinolone 0.1% is midstrength, and desonide is lower-potency. Clobetasol and triamcinolone 0.1% are generally utilized for skin disease on the body, whereas desonide is the appropriate choice for skin disorders on the face, groin, axillae, and breasts.

Many nondermatologists are leery about long-term topical corticosteroid therapy. But there’s no need for concern as long as the drugs are used with breaks, Dr. Vleugels emphasized.

"You can use topical steroids for life with no issues; we know that from studies in our psoriasis and eczema patients. But we can’t use them without breaks. That’s the most important message in counseling your patients. For the body, it’s 2 weeks on, 1 week off. For the face, it’s 1 week on, 1 week off. If they do that, you won’t see steroid side effects," she said.

The side effects that are seen with uninterrupted topical steroid therapy include skin atrophy, striae, lightening, and telangiectasias.

When desonide is used in treating the groin, breasts, or armpits, the schedule is 1 week on, 1 week off – the same as the facial schedule.

Dr. Vleugels makes an exception to these rules when she’s treating facial lesions related to autoimmune diseases. Because she wants to get rapid clearing, she often turns to a burst of clobetasol in these circumstances. The schedule is 1 week on, 1 week off.

"A typical situation might be when a rheumatologist calls me and says, ‘I have a patient who got a horrible photosensitive malar rash while outdoors last weekend, and she’s already on maximum-dose systemic therapy.’ I’d say, just give her 1 week of clobetasol on her face; she’ll be better in 3-4 days. But you need to carefully tell your patients that if they’re going to put it on their face they have to follow the rule for face disease: 1 week on, 1 week off," she said.

Cream or ointment? For most patients with autoimmune diseases, pick a topical steroid cream; it’ll result in better compliance. A steroid ointment is preferable when skin hydration is a consideration, as in atopic dermatitis. Because ointments are effectively stronger and more deeply penetrating than creams, a steroid ointment is also the best choice in treating disease involving particularly thick skin, such as palmar or plantar psoriasis, where the medication is employed under occlusion with gloves or socks, Dr. Vleugels explained.

To avoid undertreatment, it’s important to specify on the prescription how much medication the pharmacy is to provide. A 60-g tube of a topical steroid won’t last longer than a week in a patient with a full-body skin eruption; Dr. Vleugels generally orders 120-240 g for such patients. For patients treating lesions on the face or other sensitive areas, she cuts the prescription to 30 g with a single refill unless she’s comfortable with that individual’s adherence.

Topical calcineurin inhibitors have a limited role. Dr. Vleugels considers using 0.3% tacrolimus during patients’ week-long topical steroid breaks if their disease isn’t well controlled during those intervals. She also considers tacrolimus in patients with periorbital skin lesions, where steroid atrophy is a particular concern. Topical pimecrolimus is considerably less effective than tacrolimus, and she never uses pimecrolimus in adults.

"I use these agents much less frequently than topical steroids. They’re often low efficacy for the cost [compared with] a topical steroid, used safely," the dermatologist said.

She reported having no financial conflicts.

WAIKOLOA, HAWAII – Topical cyclosporine 0.05% ophthalmic emulsion significantly outperformed artificial tears for the treatment of ocular rosacea in a double-blind, randomized, multicenter study.

"It’s a fairly small study, but I think it gives us some valuable information. This gives us a new option topically," Dr. Julie C. Harper said in highlighting the study at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

She referred to a clinical trial conducted by Florida ophthalmologists who randomized 37 patients with ocular rosacea to twice-daily topical cyclosporine 0.05% (Restasis) or artificial tears for 3 months.

The outcome that most impressed Dr. Harper was the topical cyclosporine group’s mean 11.5-point improvement from a baseline of 14.1 on the Ocular Surface Disease Index, a validated patient questionnaire assessing the eye disease’s impact on quality of life. Patients who received artificial tears – a widely prescribed treatment for ocular rosacea – had a significantly lesser mean 2.9-point improvement.

"People definitely felt better with this product than with artificial tears," observed Dr. Harper, a dermatologist at the University of Alabama at Birmingham.

In addition, the topical cyclosporine group fared significantly better in the other study end points, which focused on eye dryness and tear production. For example, mean scores on Schirmer\'s test (a measure of eye-surface wetness) improved by 2.7 mm over the course of 3 months of treatment, from a baseline of 8.3, compared with a 1.4-mm deterioration in the artificial tears group.

Also, tear break-up time (a measure of how quickly an eye becomes dry) increased by a mean of 3.56 seconds in the cyclosporine group, a significantly more favorable effect than the 0.04-second decrease in the artificial tears arm (Adv. Ther. 2009;26:651-9).

The investigators speculated that topical cyclosporine’s clinical benefits in ocular rosacea are due to the drug’s anti-inflammatory effects, including a cyclosporine-mediated reduction in the number of activated lymphocytes in the conjunctiva, in combination with stimulation of increased tear production

The ophthalmologists emphasized that ocular rosacea can be a serious and potentially even a blinding condition. They noted that in one classic study, 13 of 131 patients had corneal complications resulting in visual acuity loss at the time they presented to ophthalmology. Of those 13 patients, 7 were left with worse than 20/400 eyesight, and 6 of the 13 required penetrating keratoplasty during the course of their disease (Ophthalmology 1997;104:1863-7).

Dr. Harper said that since she learned of the randomized trial, she has tried using topical cyclosporine for ocular rosacea but doesn’t yet have enough experience to say how well it works in her own hands. Usually, she gives the topical agent in combination with an oral tetracycline in patients whose ocular disease isn’t responding adequately to oral therapy alone.

Her preferred oral agent is delayed-release doxycycline (Oracea) at the anti-inflammatory but subantimicrobial dose of 40 mg once daily, a dosage that is Food and Drug Administration approved for treatment of rosacea. She favors this regimen because it doesn’t contribute to the worsening, global, antibiotic-resistance public health problem, and the once-daily aspect is a real plus from the patient adherence standpoint.

For patients who don’t have insurance coverage for this relatively costly drug, her second-favorite option is generic doxycycline at 20 mg BID, which is also an anti-inflammatory yet subantimicrobial dosage. It’s important to recognize, however, that bumping up the dosage of generic doxycycline to 50 mg/day would cross the threshold into the antibacterial range that could contribute to the resistance problem, the dermatologist added.

Topical cyclosporine for ocular rosacea is off-label therapy. The drug’s approved indication is in treating chronic dry eyes. Conference codirector Dr. Joseph F. Fowler Jr. predicted that the product may never gain an indication for ocular rosacea. That’s because ophthalmologists have a difficult time in quantifying the severity of ocular rosacea for research purposes, and even in distinguishing it from dry eye.

"My own crude approach is that if you’ve got rosacea on the skin and you’ve got itchy, gritty eyes, then I generally assume you’ve got ocular rosacea," explained Dr. Fowler, a dermatologist at the University of Louisville (Ky.).

Like Dr. Harper, he typically prescribes topical cyclosporine for ocular rosacea in combination with oral doxycycline.

"I find it very useful," he added.

Dr. Fowler disclosed that he has received research grants from Allergan, which markets Restasis. He also serves as a consultant to Galderma, which markets Oracea, as well as to numerous other pharmaceutical companies. Dr. Harper is on the speakers bureaus for Allergan, Galderma, and a handful of other companies.

The SDEF and this news organization are owned by Elsevier.

WAIKOLOA, HAWAII – Topical cyclosporine 0.05% ophthalmic emulsion significantly outperformed artificial tears for the treatment of ocular rosacea in a double-blind, randomized, multicenter study.

"It’s a fairly small study, but I think it gives us some valuable information. This gives us a new option topically," Dr. Julie C. Harper said in highlighting the study at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

She referred to a clinical trial conducted by Florida ophthalmologists who randomized 37 patients with ocular rosacea to twice-daily topical cyclosporine 0.05% (Restasis) or artificial tears for 3 months.

The outcome that most impressed Dr. Harper was the topical cyclosporine group’s mean 11.5-point improvement from a baseline of 14.1 on the Ocular Surface Disease Index, a validated patient questionnaire assessing the eye disease’s impact on quality of life. Patients who received artificial tears – a widely prescribed treatment for ocular rosacea – had a significantly lesser mean 2.9-point improvement.

"People definitely felt better with this product than with artificial tears," observed Dr. Harper, a dermatologist at the University of Alabama at Birmingham.

In addition, the topical cyclosporine group fared significantly better in the other study end points, which focused on eye dryness and tear production. For example, mean scores on Schirmer\'s test (a measure of eye-surface wetness) improved by 2.7 mm over the course of 3 months of treatment, from a baseline of 8.3, compared with a 1.4-mm deterioration in the artificial tears group.

Also, tear break-up time (a measure of how quickly an eye becomes dry) increased by a mean of 3.56 seconds in the cyclosporine group, a significantly more favorable effect than the 0.04-second decrease in the artificial tears arm (Adv. Ther. 2009;26:651-9).

The investigators speculated that topical cyclosporine’s clinical benefits in ocular rosacea are due to the drug’s anti-inflammatory effects, including a cyclosporine-mediated reduction in the number of activated lymphocytes in the conjunctiva, in combination with stimulation of increased tear production

The ophthalmologists emphasized that ocular rosacea can be a serious and potentially even a blinding condition. They noted that in one classic study, 13 of 131 patients had corneal complications resulting in visual acuity loss at the time they presented to ophthalmology. Of those 13 patients, 7 were left with worse than 20/400 eyesight, and 6 of the 13 required penetrating keratoplasty during the course of their disease (Ophthalmology 1997;104:1863-7).

Dr. Harper said that since she learned of the randomized trial, she has tried using topical cyclosporine for ocular rosacea but doesn’t yet have enough experience to say how well it works in her own hands. Usually, she gives the topical agent in combination with an oral tetracycline in patients whose ocular disease isn’t responding adequately to oral therapy alone.

Her preferred oral agent is delayed-release doxycycline (Oracea) at the anti-inflammatory but subantimicrobial dose of 40 mg once daily, a dosage that is Food and Drug Administration approved for treatment of rosacea. She favors this regimen because it doesn’t contribute to the worsening, global, antibiotic-resistance public health problem, and the once-daily aspect is a real plus from the patient adherence standpoint.

For patients who don’t have insurance coverage for this relatively costly drug, her second-favorite option is generic doxycycline at 20 mg BID, which is also an anti-inflammatory yet subantimicrobial dosage. It’s important to recognize, however, that bumping up the dosage of generic doxycycline to 50 mg/day would cross the threshold into the antibacterial range that could contribute to the resistance problem, the dermatologist added.

Topical cyclosporine for ocular rosacea is off-label therapy. The drug’s approved indication is in treating chronic dry eyes. Conference codirector Dr. Joseph F. Fowler Jr. predicted that the product may never gain an indication for ocular rosacea. That’s because ophthalmologists have a difficult time in quantifying the severity of ocular rosacea for research purposes, and even in distinguishing it from dry eye.

"My own crude approach is that if you’ve got rosacea on the skin and you’ve got itchy, gritty eyes, then I generally assume you’ve got ocular rosacea," explained Dr. Fowler, a dermatologist at the University of Louisville (Ky.).

Like Dr. Harper, he typically prescribes topical cyclosporine for ocular rosacea in combination with oral doxycycline.

"I find it very useful," he added.

Dr. Fowler disclosed that he has received research grants from Allergan, which markets Restasis. He also serves as a consultant to Galderma, which markets Oracea, as well as to numerous other pharmaceutical companies. Dr. Harper is on the speakers bureaus for Allergan, Galderma, and a handful of other companies.

The SDEF and this news organization are owned by Elsevier.

WAIKOLOA, HAWAII – Topical cyclosporine 0.05% ophthalmic emulsion significantly outperformed artificial tears for the treatment of ocular rosacea in a double-blind, randomized, multicenter study.

"It’s a fairly small study, but I think it gives us some valuable information. This gives us a new option topically," Dr. Julie C. Harper said in highlighting the study at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

She referred to a clinical trial conducted by Florida ophthalmologists who randomized 37 patients with ocular rosacea to twice-daily topical cyclosporine 0.05% (Restasis) or artificial tears for 3 months.

The outcome that most impressed Dr. Harper was the topical cyclosporine group’s mean 11.5-point improvement from a baseline of 14.1 on the Ocular Surface Disease Index, a validated patient questionnaire assessing the eye disease’s impact on quality of life. Patients who received artificial tears – a widely prescribed treatment for ocular rosacea – had a significantly lesser mean 2.9-point improvement.

"People definitely felt better with this product than with artificial tears," observed Dr. Harper, a dermatologist at the University of Alabama at Birmingham.

In addition, the topical cyclosporine group fared significantly better in the other study end points, which focused on eye dryness and tear production. For example, mean scores on Schirmer\'s test (a measure of eye-surface wetness) improved by 2.7 mm over the course of 3 months of treatment, from a baseline of 8.3, compared with a 1.4-mm deterioration in the artificial tears group.

Also, tear break-up time (a measure of how quickly an eye becomes dry) increased by a mean of 3.56 seconds in the cyclosporine group, a significantly more favorable effect than the 0.04-second decrease in the artificial tears arm (Adv. Ther. 2009;26:651-9).

The investigators speculated that topical cyclosporine’s clinical benefits in ocular rosacea are due to the drug’s anti-inflammatory effects, including a cyclosporine-mediated reduction in the number of activated lymphocytes in the conjunctiva, in combination with stimulation of increased tear production

The ophthalmologists emphasized that ocular rosacea can be a serious and potentially even a blinding condition. They noted that in one classic study, 13 of 131 patients had corneal complications resulting in visual acuity loss at the time they presented to ophthalmology. Of those 13 patients, 7 were left with worse than 20/400 eyesight, and 6 of the 13 required penetrating keratoplasty during the course of their disease (Ophthalmology 1997;104:1863-7).

Dr. Harper said that since she learned of the randomized trial, she has tried using topical cyclosporine for ocular rosacea but doesn’t yet have enough experience to say how well it works in her own hands. Usually, she gives the topical agent in combination with an oral tetracycline in patients whose ocular disease isn’t responding adequately to oral therapy alone.

Her preferred oral agent is delayed-release doxycycline (Oracea) at the anti-inflammatory but subantimicrobial dose of 40 mg once daily, a dosage that is Food and Drug Administration approved for treatment of rosacea. She favors this regimen because it doesn’t contribute to the worsening, global, antibiotic-resistance public health problem, and the once-daily aspect is a real plus from the patient adherence standpoint.

For patients who don’t have insurance coverage for this relatively costly drug, her second-favorite option is generic doxycycline at 20 mg BID, which is also an anti-inflammatory yet subantimicrobial dosage. It’s important to recognize, however, that bumping up the dosage of generic doxycycline to 50 mg/day would cross the threshold into the antibacterial range that could contribute to the resistance problem, the dermatologist added.

Topical cyclosporine for ocular rosacea is off-label therapy. The drug’s approved indication is in treating chronic dry eyes. Conference codirector Dr. Joseph F. Fowler Jr. predicted that the product may never gain an indication for ocular rosacea. That’s because ophthalmologists have a difficult time in quantifying the severity of ocular rosacea for research purposes, and even in distinguishing it from dry eye.

"My own crude approach is that if you’ve got rosacea on the skin and you’ve got itchy, gritty eyes, then I generally assume you’ve got ocular rosacea," explained Dr. Fowler, a dermatologist at the University of Louisville (Ky.).

Like Dr. Harper, he typically prescribes topical cyclosporine for ocular rosacea in combination with oral doxycycline.

"I find it very useful," he added.

Dr. Fowler disclosed that he has received research grants from Allergan, which markets Restasis. He also serves as a consultant to Galderma, which markets Oracea, as well as to numerous other pharmaceutical companies. Dr. Harper is on the speakers bureaus for Allergan, Galderma, and a handful of other companies.

The SDEF and this news organization are owned by Elsevier.

STEAMBOAT SPRINGS, COLO. – The thing parents need to understand about the age-based suitability ratings prominently displayed on video game packaging is they are bestowed by raters with no training in child development who are paid by an organization founded by the video game industry itself.

"What the ratings are telling us is not what’s good or bad for kids, it’s telling us what society will accept – what the industry can get away without getting people pissed off at them," Dr. Michael Rich said at a meeting on practical pediatrics, sponsored by the American Academy of Pediatrics.

mennovandijk/iStockphoto.com

The Entertainment Software Rating Board (ESRB) raters don’t even get to actually play the games before making their determinations. Instead, they are provided with a manufacturer-edited video sample of part of the game being played by someone else. In other words, they receive only part of the content, explained Dr. Rich, director of the center on media and child health at Children’s Hospital, Boston.

The video game industry’s ratings are based on the self-regulating rating system developed by the movie industry, with which Dr. Rich said he is intimately familiar. He began his career in adolescent medicine after a dozen years as a Hollywood filmmaker, a highlight of which was serving as the assistant director to the legendary Akira Kurosawa on the making of Kagemusha, which means "shadow warrior."

"We have a system in place to ensure a safe food supply so that when we walk down a grocery store aisle we can read labels and know what we’re putting in our kids’ bodies. Because of the way we approach media ratings, we’ve got no idea, really, what we’re putting into kids’ minds," he said.

The arbitrary age cutoffs used in the ESRB rating system are just plain silly, as not all 13-year-olds or 17-year-olds are developmentally equal, Dr. Rich noted. He said he favors instead a descriptive rating system that tells what happens in a video game.

"You really want to know whether you’re going to be killing hookers or building a farm," the pediatrician continued.

He said he recommends that parents disregard the ESRB ratings in favor of a more trustworthy rating system developed independently of the video game industry, such as Common Sense Media. Kids-in-Mind rates movies.

"While they are also fairly subjective, at least they’re coming from the position of a parent who cares, who’s seen it and rates it for you and tells you exactly what you’re going to find if you’re worried about violence or nudity or language," Dr. Rich said.

Patricia Vance, president of the ESRB, said, “The age ratings we assign serve as a reference point by which parents may make their own determination about a game’s suitability for their child, and the content descriptors give a clear and unmistakable warning about the type of material that contributed to that rating, and which a parent might reasonably want to know about. As a supplemental resource, we also offer ‘rating summaries’ via our website and a free mobile app. These provide brief but detailed descriptions of a game’s content, including specific examples.

We do not pretend to be perfect, nor do we believe that a rating can ever objectively represent the sensibilities of every single parent. But we do take seriously the obligation we have to provide them with trustworthy guidance about video game content," she said in a written statement.*

He reported that he had no relevant financial disclosures.

* Updated 2/29/2012 to include additional information.

STEAMBOAT SPRINGS, COLO. – The thing parents need to understand about the age-based suitability ratings prominently displayed on video game packaging is they are bestowed by raters with no training in child development who are paid by an organization founded by the video game industry itself.

"What the ratings are telling us is not what’s good or bad for kids, it’s telling us what society will accept – what the industry can get away without getting people pissed off at them," Dr. Michael Rich said at a meeting on practical pediatrics, sponsored by the American Academy of Pediatrics.

mennovandijk/iStockphoto.com

The Entertainment Software Rating Board (ESRB) raters don’t even get to actually play the games before making their determinations. Instead, they are provided with a manufacturer-edited video sample of part of the game being played by someone else. In other words, they receive only part of the content, explained Dr. Rich, director of the center on media and child health at Children’s Hospital, Boston.

The video game industry’s ratings are based on the self-regulating rating system developed by the movie industry, with which Dr. Rich said he is intimately familiar. He began his career in adolescent medicine after a dozen years as a Hollywood filmmaker, a highlight of which was serving as the assistant director to the legendary Akira Kurosawa on the making of Kagemusha, which means "shadow warrior."

"We have a system in place to ensure a safe food supply so that when we walk down a grocery store aisle we can read labels and know what we’re putting in our kids’ bodies. Because of the way we approach media ratings, we’ve got no idea, really, what we’re putting into kids’ minds," he said.

The arbitrary age cutoffs used in the ESRB rating system are just plain silly, as not all 13-year-olds or 17-year-olds are developmentally equal, Dr. Rich noted. He said he favors instead a descriptive rating system that tells what happens in a video game.

"You really want to know whether you’re going to be killing hookers or building a farm," the pediatrician continued.

He said he recommends that parents disregard the ESRB ratings in favor of a more trustworthy rating system developed independently of the video game industry, such as Common Sense Media. Kids-in-Mind rates movies.

"While they are also fairly subjective, at least they’re coming from the position of a parent who cares, who’s seen it and rates it for you and tells you exactly what you’re going to find if you’re worried about violence or nudity or language," Dr. Rich said.

Patricia Vance, president of the ESRB, said, “The age ratings we assign serve as a reference point by which parents may make their own determination about a game’s suitability for their child, and the content descriptors give a clear and unmistakable warning about the type of material that contributed to that rating, and which a parent might reasonably want to know about. As a supplemental resource, we also offer ‘rating summaries’ via our website and a free mobile app. These provide brief but detailed descriptions of a game’s content, including specific examples.

We do not pretend to be perfect, nor do we believe that a rating can ever objectively represent the sensibilities of every single parent. But we do take seriously the obligation we have to provide them with trustworthy guidance about video game content," she said in a written statement.*

He reported that he had no relevant financial disclosures.

* Updated 2/29/2012 to include additional information.

STEAMBOAT SPRINGS, COLO. – The thing parents need to understand about the age-based suitability ratings prominently displayed on video game packaging is they are bestowed by raters with no training in child development who are paid by an organization founded by the video game industry itself.

"What the ratings are telling us is not what’s good or bad for kids, it’s telling us what society will accept – what the industry can get away without getting people pissed off at them," Dr. Michael Rich said at a meeting on practical pediatrics, sponsored by the American Academy of Pediatrics.

mennovandijk/iStockphoto.com

The Entertainment Software Rating Board (ESRB) raters don’t even get to actually play the games before making their determinations. Instead, they are provided with a manufacturer-edited video sample of part of the game being played by someone else. In other words, they receive only part of the content, explained Dr. Rich, director of the center on media and child health at Children’s Hospital, Boston.

The video game industry’s ratings are based on the self-regulating rating system developed by the movie industry, with which Dr. Rich said he is intimately familiar. He began his career in adolescent medicine after a dozen years as a Hollywood filmmaker, a highlight of which was serving as the assistant director to the legendary Akira Kurosawa on the making of Kagemusha, which means "shadow warrior."

"We have a system in place to ensure a safe food supply so that when we walk down a grocery store aisle we can read labels and know what we’re putting in our kids’ bodies. Because of the way we approach media ratings, we’ve got no idea, really, what we’re putting into kids’ minds," he said.

The arbitrary age cutoffs used in the ESRB rating system are just plain silly, as not all 13-year-olds or 17-year-olds are developmentally equal, Dr. Rich noted. He said he favors instead a descriptive rating system that tells what happens in a video game.

"You really want to know whether you’re going to be killing hookers or building a farm," the pediatrician continued.

He said he recommends that parents disregard the ESRB ratings in favor of a more trustworthy rating system developed independently of the video game industry, such as Common Sense Media. Kids-in-Mind rates movies.

"While they are also fairly subjective, at least they’re coming from the position of a parent who cares, who’s seen it and rates it for you and tells you exactly what you’re going to find if you’re worried about violence or nudity or language," Dr. Rich said.

Patricia Vance, president of the ESRB, said, “The age ratings we assign serve as a reference point by which parents may make their own determination about a game’s suitability for their child, and the content descriptors give a clear and unmistakable warning about the type of material that contributed to that rating, and which a parent might reasonably want to know about. As a supplemental resource, we also offer ‘rating summaries’ via our website and a free mobile app. These provide brief but detailed descriptions of a game’s content, including specific examples.

We do not pretend to be perfect, nor do we believe that a rating can ever objectively represent the sensibilities of every single parent. But we do take seriously the obligation we have to provide them with trustworthy guidance about video game content," she said in a written statement.*

He reported that he had no relevant financial disclosures.

* Updated 2/29/2012 to include additional information.

SNOWMASS, COLO. - Low-dose methotrexate is highly effective for treatment of antimalarial-resistant discoid lupus or subacute cutaneous lupus erythematosus.

"If you have to pick one thing past Plaquenil [hydroxychloroquine], I’d say try methotrexate," declared Dr. Ruth Ann Vleugels at a symposium sponsored by the American College of Rheumatology. "At our institution, methotrexate is by far the next agent we choose for cutaneous lupus if the patient is able to tolerate it. We have really good luck with it, and it’s easy to prescribe," she said.

Dr. Vleugels has amassed what is believed to be the largest U.S. case series of patients treated with methotrexate for refractory cutaneous lupus erythematosus (LE). The as-yet unpublished series consists of 20 patients, most of whom received between 20 mg/week and 25 mg/week. Most were on oral methotrexate, but, if they experienced troublesome side effects, they were switched to the subcutaneous formulation.

Seventeen of the 20 patients (85%) experienced significant improvement on methotrexate. The drug was steroid sparing in 10 of 12 patients (83%). The response time was typically 8-12 weeks, according to Dr. Vleugels, a dermatologist who is director of the connective tissue disease clinic at Brigham and Women’s Hospital and codirector of the rheumatology-dermatology clinic at Children’s Hospital, both in Boston.

Although cutaneous LE is not a systemic disease, it’s essential to treat it aggressively from the get-go in order to halt the disease process and prevent irreversible scarring in discoid LE and disfiguring pigment contrast in subacute cutaneous LE, she emphasized.

The first question patients ask upon receiving the diagnosis of discoid LE is, how likely am I to develop systemic lupus erythematosus? The best available data suggest a 5%-10% risk overall, and less than that if the lesions are confined to the head and neck, she said. About one-third of discoid LE patients are antinuclear antibody–positive; this has no bearing on their risk of future systemic lupus erythematosus.

When a patient comes in with mild cutaneous LE that’s not adequately controlled with photoprotection, topical agents, and hydroxychloroquine, Dr. Vleugels may opt for combination antimalarial therapy, adding on quinacrine at 100 mg/day. Quinacrine is not immunosuppressive and has essentially no ocular toxicity. Its two downsides are that it can be obtained only at a compounding pharmacy, and it causes many patients to turn yellow. The yellow hue is more noticeable on light-skinned patients. Fortunately, the color change is completely reversible upon drug discontinuation.

If a patient’s cutaneous LE is a little more serious and it isn’t reined in using hydroxychloroquine as sole systemic therapy, Dr. Vleugels will bypass the add-on quinacrine and go straight to methotrexate because the results are so good.

Not all patients are good candidates for methotrexate, however. And some just don’t want to take an immunosuppressive medication. Under those circumstances, her second-choice option is thalidomide. It’s typically dosed at 25-100 mg once at night because it’s sedating. This is a highly effective drug with Food and Drug Administration approval for multiple myeloma and erythema nodosum leprosum, so cutaneous LE is off-label therapy.

Thalidomide is somewhat difficult to give because it is category X, and cutaneous LE occurs most commonly in young women. Physician participation in the FDA’s System for Thalidomide Education and Prescribing Safety (STEPS) program is mandatory. Pregnancy testing is required. Still, "the paperwork is actually pretty simple," according to Dr. Vleugels.

Thromboembolism is a side effect that seems to be largely confined to cancer patients. The chief limiting side effect in lupus patients is peripheral neuropathy, which has occurred in 25%-33% of treated patients in various series.

"That’s the main reason we have to take patients off this drug. That’s a pretty good chunk of patients, but the other patients do extremely well," the dermatologist noted.

Because thalidomide is not immunosuppressive, it can be added to virtually any other therapies without causing problems.

When thalidomide is not an option, her next choice is mycophenolate mofetil. It’s easier to prescribe, but definitely less effective than thalidomide in cutaneous LE.

Backup add-on systemic agents include dapsone, which is most effective in bullous LE, and acitretin, a potent retinoid with efficacy in cutaneous LE comparable to that of hydroxychloroquine. However, acitretin has a major drawback: It is stored in fat for 3 years and is category X. That means a young woman can’t get pregnant for 3 years after stopping the drug. For this reason, Dr. Vleugels reserves acitretin for men and older women.

Although she is quick to turn to systemic therapy for cutaneous LE, all of her patients start out with a message underscoring the importance of photoprotection, smoking cessation, and – living in Boston – vitamin D supplementation at 2,000 IU/day.

Topical therapy with corticosteroids and tacrolimus, a calcineurin inhibitor which is useful as a break from steroids, is also in place before she considers the introduction of systemic therapy starting with antimalarials.

To prevent lasting scarring in discoid LE patients with scalp involvement, Dr. Vleugels moves beyond systemic therapy, adding intralesional steroid injections. She typically takes triamcinolone (Kenalog) that comes in a concentration of 10 mg/cc, and dilutes it 1-to-1 with normal saline, for a final concentration of 5 mg/cc. She uses 0.1 cc of the diluted product per injection through a 30- or 31-gauge needle, picking the most inflamed areas of the scalp and placing the injections about 1 cm apart.

"One patient can tolerate only about 25 injections per day, sometimes fewer than that," Dr. Vleugels said, eliciting audience gasps. "You’d be surprised: Even our kids with scalp disease can tolerate injections fairly well because of the very small needle we use."

She has the patient return for another series of scalp injections in 5-6 weeks.

Dr. Vleugels reported having no financial conflicts.

SNOWMASS, COLO. - Low-dose methotrexate is highly effective for treatment of antimalarial-resistant discoid lupus or subacute cutaneous lupus erythematosus.

"If you have to pick one thing past Plaquenil [hydroxychloroquine], I’d say try methotrexate," declared Dr. Ruth Ann Vleugels at a symposium sponsored by the American College of Rheumatology. "At our institution, methotrexate is by far the next agent we choose for cutaneous lupus if the patient is able to tolerate it. We have really good luck with it, and it’s easy to prescribe," she said.

Dr. Vleugels has amassed what is believed to be the largest U.S. case series of patients treated with methotrexate for refractory cutaneous lupus erythematosus (LE). The as-yet unpublished series consists of 20 patients, most of whom received between 20 mg/week and 25 mg/week. Most were on oral methotrexate, but, if they experienced troublesome side effects, they were switched to the subcutaneous formulation.

Seventeen of the 20 patients (85%) experienced significant improvement on methotrexate. The drug was steroid sparing in 10 of 12 patients (83%). The response time was typically 8-12 weeks, according to Dr. Vleugels, a dermatologist who is director of the connective tissue disease clinic at Brigham and Women’s Hospital and codirector of the rheumatology-dermatology clinic at Children’s Hospital, both in Boston.

Although cutaneous LE is not a systemic disease, it’s essential to treat it aggressively from the get-go in order to halt the disease process and prevent irreversible scarring in discoid LE and disfiguring pigment contrast in subacute cutaneous LE, she emphasized.

The first question patients ask upon receiving the diagnosis of discoid LE is, how likely am I to develop systemic lupus erythematosus? The best available data suggest a 5%-10% risk overall, and less than that if the lesions are confined to the head and neck, she said. About one-third of discoid LE patients are antinuclear antibody–positive; this has no bearing on their risk of future systemic lupus erythematosus.

When a patient comes in with mild cutaneous LE that’s not adequately controlled with photoprotection, topical agents, and hydroxychloroquine, Dr. Vleugels may opt for combination antimalarial therapy, adding on quinacrine at 100 mg/day. Quinacrine is not immunosuppressive and has essentially no ocular toxicity. Its two downsides are that it can be obtained only at a compounding pharmacy, and it causes many patients to turn yellow. The yellow hue is more noticeable on light-skinned patients. Fortunately, the color change is completely reversible upon drug discontinuation.

If a patient’s cutaneous LE is a little more serious and it isn’t reined in using hydroxychloroquine as sole systemic therapy, Dr. Vleugels will bypass the add-on quinacrine and go straight to methotrexate because the results are so good.

Not all patients are good candidates for methotrexate, however. And some just don’t want to take an immunosuppressive medication. Under those circumstances, her second-choice option is thalidomide. It’s typically dosed at 25-100 mg once at night because it’s sedating. This is a highly effective drug with Food and Drug Administration approval for multiple myeloma and erythema nodosum leprosum, so cutaneous LE is off-label therapy.

Thalidomide is somewhat difficult to give because it is category X, and cutaneous LE occurs most commonly in young women. Physician participation in the FDA’s System for Thalidomide Education and Prescribing Safety (STEPS) program is mandatory. Pregnancy testing is required. Still, "the paperwork is actually pretty simple," according to Dr. Vleugels.

Thromboembolism is a side effect that seems to be largely confined to cancer patients. The chief limiting side effect in lupus patients is peripheral neuropathy, which has occurred in 25%-33% of treated patients in various series.

"That’s the main reason we have to take patients off this drug. That’s a pretty good chunk of patients, but the other patients do extremely well," the dermatologist noted.

Because thalidomide is not immunosuppressive, it can be added to virtually any other therapies without causing problems.

When thalidomide is not an option, her next choice is mycophenolate mofetil. It’s easier to prescribe, but definitely less effective than thalidomide in cutaneous LE.

Backup add-on systemic agents include dapsone, which is most effective in bullous LE, and acitretin, a potent retinoid with efficacy in cutaneous LE comparable to that of hydroxychloroquine. However, acitretin has a major drawback: It is stored in fat for 3 years and is category X. That means a young woman can’t get pregnant for 3 years after stopping the drug. For this reason, Dr. Vleugels reserves acitretin for men and older women.

Although she is quick to turn to systemic therapy for cutaneous LE, all of her patients start out with a message underscoring the importance of photoprotection, smoking cessation, and – living in Boston – vitamin D supplementation at 2,000 IU/day.

Topical therapy with corticosteroids and tacrolimus, a calcineurin inhibitor which is useful as a break from steroids, is also in place before she considers the introduction of systemic therapy starting with antimalarials.

To prevent lasting scarring in discoid LE patients with scalp involvement, Dr. Vleugels moves beyond systemic therapy, adding intralesional steroid injections. She typically takes triamcinolone (Kenalog) that comes in a concentration of 10 mg/cc, and dilutes it 1-to-1 with normal saline, for a final concentration of 5 mg/cc. She uses 0.1 cc of the diluted product per injection through a 30- or 31-gauge needle, picking the most inflamed areas of the scalp and placing the injections about 1 cm apart.

"One patient can tolerate only about 25 injections per day, sometimes fewer than that," Dr. Vleugels said, eliciting audience gasps. "You’d be surprised: Even our kids with scalp disease can tolerate injections fairly well because of the very small needle we use."

She has the patient return for another series of scalp injections in 5-6 weeks.

Dr. Vleugels reported having no financial conflicts.

SNOWMASS, COLO. - Low-dose methotrexate is highly effective for treatment of antimalarial-resistant discoid lupus or subacute cutaneous lupus erythematosus.

"If you have to pick one thing past Plaquenil [hydroxychloroquine], I’d say try methotrexate," declared Dr. Ruth Ann Vleugels at a symposium sponsored by the American College of Rheumatology. "At our institution, methotrexate is by far the next agent we choose for cutaneous lupus if the patient is able to tolerate it. We have really good luck with it, and it’s easy to prescribe," she said.

Dr. Vleugels has amassed what is believed to be the largest U.S. case series of patients treated with methotrexate for refractory cutaneous lupus erythematosus (LE). The as-yet unpublished series consists of 20 patients, most of whom received between 20 mg/week and 25 mg/week. Most were on oral methotrexate, but, if they experienced troublesome side effects, they were switched to the subcutaneous formulation.

Seventeen of the 20 patients (85%) experienced significant improvement on methotrexate. The drug was steroid sparing in 10 of 12 patients (83%). The response time was typically 8-12 weeks, according to Dr. Vleugels, a dermatologist who is director of the connective tissue disease clinic at Brigham and Women’s Hospital and codirector of the rheumatology-dermatology clinic at Children’s Hospital, both in Boston.

Although cutaneous LE is not a systemic disease, it’s essential to treat it aggressively from the get-go in order to halt the disease process and prevent irreversible scarring in discoid LE and disfiguring pigment contrast in subacute cutaneous LE, she emphasized.

The first question patients ask upon receiving the diagnosis of discoid LE is, how likely am I to develop systemic lupus erythematosus? The best available data suggest a 5%-10% risk overall, and less than that if the lesions are confined to the head and neck, she said. About one-third of discoid LE patients are antinuclear antibody–positive; this has no bearing on their risk of future systemic lupus erythematosus.

When a patient comes in with mild cutaneous LE that’s not adequately controlled with photoprotection, topical agents, and hydroxychloroquine, Dr. Vleugels may opt for combination antimalarial therapy, adding on quinacrine at 100 mg/day. Quinacrine is not immunosuppressive and has essentially no ocular toxicity. Its two downsides are that it can be obtained only at a compounding pharmacy, and it causes many patients to turn yellow. The yellow hue is more noticeable on light-skinned patients. Fortunately, the color change is completely reversible upon drug discontinuation.

If a patient’s cutaneous LE is a little more serious and it isn’t reined in using hydroxychloroquine as sole systemic therapy, Dr. Vleugels will bypass the add-on quinacrine and go straight to methotrexate because the results are so good.

Not all patients are good candidates for methotrexate, however. And some just don’t want to take an immunosuppressive medication. Under those circumstances, her second-choice option is thalidomide. It’s typically dosed at 25-100 mg once at night because it’s sedating. This is a highly effective drug with Food and Drug Administration approval for multiple myeloma and erythema nodosum leprosum, so cutaneous LE is off-label therapy.

Thalidomide is somewhat difficult to give because it is category X, and cutaneous LE occurs most commonly in young women. Physician participation in the FDA’s System for Thalidomide Education and Prescribing Safety (STEPS) program is mandatory. Pregnancy testing is required. Still, "the paperwork is actually pretty simple," according to Dr. Vleugels.

Thromboembolism is a side effect that seems to be largely confined to cancer patients. The chief limiting side effect in lupus patients is peripheral neuropathy, which has occurred in 25%-33% of treated patients in various series.

"That’s the main reason we have to take patients off this drug. That’s a pretty good chunk of patients, but the other patients do extremely well," the dermatologist noted.

Because thalidomide is not immunosuppressive, it can be added to virtually any other therapies without causing problems.

When thalidomide is not an option, her next choice is mycophenolate mofetil. It’s easier to prescribe, but definitely less effective than thalidomide in cutaneous LE.

Backup add-on systemic agents include dapsone, which is most effective in bullous LE, and acitretin, a potent retinoid with efficacy in cutaneous LE comparable to that of hydroxychloroquine. However, acitretin has a major drawback: It is stored in fat for 3 years and is category X. That means a young woman can’t get pregnant for 3 years after stopping the drug. For this reason, Dr. Vleugels reserves acitretin for men and older women.

Although she is quick to turn to systemic therapy for cutaneous LE, all of her patients start out with a message underscoring the importance of photoprotection, smoking cessation, and – living in Boston – vitamin D supplementation at 2,000 IU/day.

Topical therapy with corticosteroids and tacrolimus, a calcineurin inhibitor which is useful as a break from steroids, is also in place before she considers the introduction of systemic therapy starting with antimalarials.

To prevent lasting scarring in discoid LE patients with scalp involvement, Dr. Vleugels moves beyond systemic therapy, adding intralesional steroid injections. She typically takes triamcinolone (Kenalog) that comes in a concentration of 10 mg/cc, and dilutes it 1-to-1 with normal saline, for a final concentration of 5 mg/cc. She uses 0.1 cc of the diluted product per injection through a 30- or 31-gauge needle, picking the most inflamed areas of the scalp and placing the injections about 1 cm apart.

"One patient can tolerate only about 25 injections per day, sometimes fewer than that," Dr. Vleugels said, eliciting audience gasps. "You’d be surprised: Even our kids with scalp disease can tolerate injections fairly well because of the very small needle we use."

She has the patient return for another series of scalp injections in 5-6 weeks.

Dr. Vleugels reported having no financial conflicts.

STEAMBOAT SPRINGS, COLO. – The good news for pediatricians on the malpractice front is they get sued far less often than other specialists.

The bad news? When a pediatrician does have an indemnity payout, it’s a whopper, according to Dr. Steven M. Selbst, professor and vice chair of pediatrics at Jefferson Medical College, Philadelphia, and author of a textbook on preventing malpractice lawsuits in pediatric emergency medicine.

© BanksPhotos/iStockphoto

He pointed to the findings of a landmark study of medical malpractice which concluded that pediatricians had the highest average indemnity payouts out of any of the 25 specialties scrutinized. The mean payment in successful lawsuits involving pediatricians was $520,924, nearly twice the average of $274,887 for physicians overall, he said at a meeting on practical pediatrics sponsored by the American Academy of Pediatrics.

Indeed, the average indemnity payment for pediatricians was, surprisingly, substantially greater than for neurosurgeons or cardiothoracic surgeons, widely considered to be the highest-risk practitioners.

On the plus side, pediatricians had the second-lowest risk of being sued among all physician specialties. A mere 3.1% of pediatricians per year faced a malpractice claim, compared with 19.1% of all neurosurgeons, 18.9% of cardiothoracic surgeons, and 15.3% of general surgeons. Only psychiatrists had a lower annual risk of being sued than pediatricians, he said.

The study, funded by the RAND Institute for Civil Justice and the National Institute on Aging, encompassed one large insurance company’s malpractice lawsuit data for 1991-2005. It included nearly 41,000 insured physicians in all 50 states, among whom were 1,616 pediatricians. Each year, on average 7.4% of all physicians were the subject of a malpractice claim, and 1.6% of physicians had a claim resulting in a payout. In other words, 78% of malpractice claims did not result in payment to the claimant. The investigators calculated that by age 65 years, 75% of physicians in pediatrics and other low-risk specialties would face a malpractice claim, as would 99% of neurosurgeons and other high-risk practitioners (N. Engl. J. Med. 2011;365:629-36).

Dr. Selbst said that among the reasons lawsuit payouts are so large in pediatrics is that juries tend to be extremely sympathetic to plaintiffs injured in childhood. And, when damages are calculated in such cases, the tally will include potential lost income for the rest of that child’s life.

"We’re also at great risk because the statute of limitations is longer in pediatrics. For most other patients, it’s 2 years after the injury. But in pediatrics it can take a long time to recognize the injury. If a patient has developmental delay, it may not be recognized until they’re in school, so it could be 5-10 years later. And even if the family didn’t want to file a lawsuit, when the child becomes 18 years old he or she can file," explained Dr. Selbst.

"There are lawsuits out there dating from an injury at the time the child was a neonate, and he’s now 18 years old. So the statute of limitations in pediatrics can be 20 years. I think that’s a reminder that you have to keep your medical records, somehow, some way, pretty much forever, but at least for 21 years. You can be named in a lawsuit many, many years later," he emphasized.

Dr. Selbst reported having no financial conflicts.

STEAMBOAT SPRINGS, COLO. – The good news for pediatricians on the malpractice front is they get sued far less often than other specialists.

The bad news? When a pediatrician does have an indemnity payout, it’s a whopper, according to Dr. Steven M. Selbst, professor and vice chair of pediatrics at Jefferson Medical College, Philadelphia, and author of a textbook on preventing malpractice lawsuits in pediatric emergency medicine.

© BanksPhotos/iStockphoto

He pointed to the findings of a landmark study of medical malpractice which concluded that pediatricians had the highest average indemnity payouts out of any of the 25 specialties scrutinized. The mean payment in successful lawsuits involving pediatricians was $520,924, nearly twice the average of $274,887 for physicians overall, he said at a meeting on practical pediatrics sponsored by the American Academy of Pediatrics.

Indeed, the average indemnity payment for pediatricians was, surprisingly, substantially greater than for neurosurgeons or cardiothoracic surgeons, widely considered to be the highest-risk practitioners.

On the plus side, pediatricians had the second-lowest risk of being sued among all physician specialties. A mere 3.1% of pediatricians per year faced a malpractice claim, compared with 19.1% of all neurosurgeons, 18.9% of cardiothoracic surgeons, and 15.3% of general surgeons. Only psychiatrists had a lower annual risk of being sued than pediatricians, he said.

The study, funded by the RAND Institute for Civil Justice and the National Institute on Aging, encompassed one large insurance company’s malpractice lawsuit data for 1991-2005. It included nearly 41,000 insured physicians in all 50 states, among whom were 1,616 pediatricians. Each year, on average 7.4% of all physicians were the subject of a malpractice claim, and 1.6% of physicians had a claim resulting in a payout. In other words, 78% of malpractice claims did not result in payment to the claimant. The investigators calculated that by age 65 years, 75% of physicians in pediatrics and other low-risk specialties would face a malpractice claim, as would 99% of neurosurgeons and other high-risk practitioners (N. Engl. J. Med. 2011;365:629-36).

Dr. Selbst said that among the reasons lawsuit payouts are so large in pediatrics is that juries tend to be extremely sympathetic to plaintiffs injured in childhood. And, when damages are calculated in such cases, the tally will include potential lost income for the rest of that child’s life.

"We’re also at great risk because the statute of limitations is longer in pediatrics. For most other patients, it’s 2 years after the injury. But in pediatrics it can take a long time to recognize the injury. If a patient has developmental delay, it may not be recognized until they’re in school, so it could be 5-10 years later. And even if the family didn’t want to file a lawsuit, when the child becomes 18 years old he or she can file," explained Dr. Selbst.

"There are lawsuits out there dating from an injury at the time the child was a neonate, and he’s now 18 years old. So the statute of limitations in pediatrics can be 20 years. I think that’s a reminder that you have to keep your medical records, somehow, some way, pretty much forever, but at least for 21 years. You can be named in a lawsuit many, many years later," he emphasized.

Dr. Selbst reported having no financial conflicts.

STEAMBOAT SPRINGS, COLO. – The good news for pediatricians on the malpractice front is they get sued far less often than other specialists.

The bad news? When a pediatrician does have an indemnity payout, it’s a whopper, according to Dr. Steven M. Selbst, professor and vice chair of pediatrics at Jefferson Medical College, Philadelphia, and author of a textbook on preventing malpractice lawsuits in pediatric emergency medicine.

© BanksPhotos/iStockphoto

He pointed to the findings of a landmark study of medical malpractice which concluded that pediatricians had the highest average indemnity payouts out of any of the 25 specialties scrutinized. The mean payment in successful lawsuits involving pediatricians was $520,924, nearly twice the average of $274,887 for physicians overall, he said at a meeting on practical pediatrics sponsored by the American Academy of Pediatrics.

Indeed, the average indemnity payment for pediatricians was, surprisingly, substantially greater than for neurosurgeons or cardiothoracic surgeons, widely considered to be the highest-risk practitioners.

On the plus side, pediatricians had the second-lowest risk of being sued among all physician specialties. A mere 3.1% of pediatricians per year faced a malpractice claim, compared with 19.1% of all neurosurgeons, 18.9% of cardiothoracic surgeons, and 15.3% of general surgeons. Only psychiatrists had a lower annual risk of being sued than pediatricians, he said.

The study, funded by the RAND Institute for Civil Justice and the National Institute on Aging, encompassed one large insurance company’s malpractice lawsuit data for 1991-2005. It included nearly 41,000 insured physicians in all 50 states, among whom were 1,616 pediatricians. Each year, on average 7.4% of all physicians were the subject of a malpractice claim, and 1.6% of physicians had a claim resulting in a payout. In other words, 78% of malpractice claims did not result in payment to the claimant. The investigators calculated that by age 65 years, 75% of physicians in pediatrics and other low-risk specialties would face a malpractice claim, as would 99% of neurosurgeons and other high-risk practitioners (N. Engl. J. Med. 2011;365:629-36).

Dr. Selbst said that among the reasons lawsuit payouts are so large in pediatrics is that juries tend to be extremely sympathetic to plaintiffs injured in childhood. And, when damages are calculated in such cases, the tally will include potential lost income for the rest of that child’s life.

"We’re also at great risk because the statute of limitations is longer in pediatrics. For most other patients, it’s 2 years after the injury. But in pediatrics it can take a long time to recognize the injury. If a patient has developmental delay, it may not be recognized until they’re in school, so it could be 5-10 years later. And even if the family didn’t want to file a lawsuit, when the child becomes 18 years old he or she can file," explained Dr. Selbst.

"There are lawsuits out there dating from an injury at the time the child was a neonate, and he’s now 18 years old. So the statute of limitations in pediatrics can be 20 years. I think that’s a reminder that you have to keep your medical records, somehow, some way, pretty much forever, but at least for 21 years. You can be named in a lawsuit many, many years later," he emphasized.

Dr. Selbst reported having no financial conflicts.

STEAMBOAT SPRINGS, COLO. – When Dr. Michael Rich, a.k.a. "The Mediatrician," recently visited the University of Michigan, Ann Arbor, and met with a group who had won a grant to develop a protocol for teaching pediatric residents how to use e-mail with patients effectively, he had a simple word of advice: "Don’t."

"I said ‘Don’t do it’ because not only are there all kinds of problems with liability and not being able to read the situation well, but where’s the time going to come from? ... You can’t bill for e-mail with patients, you’re not doing an assessment. So why torture yourself by getting involved in all that?" said Dr. Rich, director of the Center on Media and Child Health at Children’s Hospital of Boston.

E-mail is several steps worse than the telephone as a tool for patient communication – and the telephone has plenty of shortcomings in its own right. "E-mail has lots and lots of problems. You don’t know what the assessment of the mom is. You can tell a lot more even on the telephone just from the tone of her voice. Think about the number of times you’ve gotten an e-mail from a friend, and you attributed a nuance to it that wasn’t there," Dr. Rich noted.

Regarding the telephone, another speaker, Dr. Steven M. Selbst, said that while pediatricians can’t manage a practice without giving advice over the phone, they need to understand there are inherent liability risks in doing so.

"A lot of taking a good history is guided by our physical exam, and obviously you can’t do a physical exam by telephone. Instructions given during telephone management are more likely to be misunderstood, and documentation for the medical record is difficult," observed Dr. Selbst, professor and vice chair of pediatrics at Jefferson Medical College, Philadelphia.

His own policy is not to give advice by phone. However, if it’s a life-threatening emergency, such as a poisoning, he’ll take the phone call and tell the family to get straightaway to the hospital.

Dr. Charlotte M. Boney took issue with Dr. Rich regarding e-mail with patients. She makes extensive use of it, albeit within a narrowly defined scope.

"Those of us who take care of a lot of patients with diabetes can all remember the cumbersome phone calls where they provided their blood sugar data. Things got better when they started faxing me their blood sugars. Now, we have lots of patients who send us their blood sugars by e-mail. I think it does have a place in patient care. The families really want to use it, and it’s more convenient than fax," commented Dr. Boney, chief of pediatric endocrinology and metabolism at Brown University in Providence, R.I.

Sure, Dr. Rich replied. "But these are patients you know and have trained well, and you’re asking for objective, measurable information," he pointed out.

As an example of how not to do e-mail, he mentioned that a physician he knows came back from a vacation and found a 5-day-old email from a patient expressing suicidality. The lesson? If you’re going to use e-mail with patients, there needs to be a built-in protocol for accessing and responding to e-mails in timely fashion from remote locations. There also should be an outgoing message stating when the physician won’t be able to respond.

Dr. Beth A. Vogt, a pediatric nephrologist at Case Western Reserve University in Cleveland, said she uses e-mail to manage her patients’ blood pressure.

"It’s an enormous time-saver compared to writing all the figures down. But I educate patients that they can’t e-mail a blood pressure of 180/110 mm Hg; that requires a phone call," she said.

Also, as a matter of hospital policy, Dr. Vogt had to get a signed parental consent authorizing e-mail communication with everyone in her office: her medical assistant, nurse, and secretary.

An audience show of hands indicated fewer than 10% now utilize e-mail as a means of communicating with their patients.

Dr. Rich and Dr. Selbst reported having no relevant financial conflicts.

STEAMBOAT SPRINGS, COLO. – When Dr. Michael Rich, a.k.a. "The Mediatrician," recently visited the University of Michigan, Ann Arbor, and met with a group who had won a grant to develop a protocol for teaching pediatric residents how to use e-mail with patients effectively, he had a simple word of advice: "Don’t."

"I said ‘Don’t do it’ because not only are there all kinds of problems with liability and not being able to read the situation well, but where’s the time going to come from? ... You can’t bill for e-mail with patients, you’re not doing an assessment. So why torture yourself by getting involved in all that?" said Dr. Rich, director of the Center on Media and Child Health at Children’s Hospital of Boston.

E-mail is several steps worse than the telephone as a tool for patient communication – and the telephone has plenty of shortcomings in its own right. "E-mail has lots and lots of problems. You don’t know what the assessment of the mom is. You can tell a lot more even on the telephone just from the tone of her voice. Think about the number of times you’ve gotten an e-mail from a friend, and you attributed a nuance to it that wasn’t there," Dr. Rich noted.

Regarding the telephone, another speaker, Dr. Steven M. Selbst, said that while pediatricians can’t manage a practice without giving advice over the phone, they need to understand there are inherent liability risks in doing so.

"A lot of taking a good history is guided by our physical exam, and obviously you can’t do a physical exam by telephone. Instructions given during telephone management are more likely to be misunderstood, and documentation for the medical record is difficult," observed Dr. Selbst, professor and vice chair of pediatrics at Jefferson Medical College, Philadelphia.

His own policy is not to give advice by phone. However, if it’s a life-threatening emergency, such as a poisoning, he’ll take the phone call and tell the family to get straightaway to the hospital.

Dr. Charlotte M. Boney took issue with Dr. Rich regarding e-mail with patients. She makes extensive use of it, albeit within a narrowly defined scope.

"Those of us who take care of a lot of patients with diabetes can all remember the cumbersome phone calls where they provided their blood sugar data. Things got better when they started faxing me their blood sugars. Now, we have lots of patients who send us their blood sugars by e-mail. I think it does have a place in patient care. The families really want to use it, and it’s more convenient than fax," commented Dr. Boney, chief of pediatric endocrinology and metabolism at Brown University in Providence, R.I.

Sure, Dr. Rich replied. "But these are patients you know and have trained well, and you’re asking for objective, measurable information," he pointed out.

As an example of how not to do e-mail, he mentioned that a physician he knows came back from a vacation and found a 5-day-old email from a patient expressing suicidality. The lesson? If you’re going to use e-mail with patients, there needs to be a built-in protocol for accessing and responding to e-mails in timely fashion from remote locations. There also should be an outgoing message stating when the physician won’t be able to respond.

Dr. Beth A. Vogt, a pediatric nephrologist at Case Western Reserve University in Cleveland, said she uses e-mail to manage her patients’ blood pressure.

"It’s an enormous time-saver compared to writing all the figures down. But I educate patients that they can’t e-mail a blood pressure of 180/110 mm Hg; that requires a phone call," she said.

Also, as a matter of hospital policy, Dr. Vogt had to get a signed parental consent authorizing e-mail communication with everyone in her office: her medical assistant, nurse, and secretary.

An audience show of hands indicated fewer than 10% now utilize e-mail as a means of communicating with their patients.

Dr. Rich and Dr. Selbst reported having no relevant financial conflicts.

STEAMBOAT SPRINGS, COLO. – When Dr. Michael Rich, a.k.a. "The Mediatrician," recently visited the University of Michigan, Ann Arbor, and met with a group who had won a grant to develop a protocol for teaching pediatric residents how to use e-mail with patients effectively, he had a simple word of advice: "Don’t."

"I said ‘Don’t do it’ because not only are there all kinds of problems with liability and not being able to read the situation well, but where’s the time going to come from? ... You can’t bill for e-mail with patients, you’re not doing an assessment. So why torture yourself by getting involved in all that?" said Dr. Rich, director of the Center on Media and Child Health at Children’s Hospital of Boston.

E-mail is several steps worse than the telephone as a tool for patient communication – and the telephone has plenty of shortcomings in its own right. "E-mail has lots and lots of problems. You don’t know what the assessment of the mom is. You can tell a lot more even on the telephone just from the tone of her voice. Think about the number of times you’ve gotten an e-mail from a friend, and you attributed a nuance to it that wasn’t there," Dr. Rich noted.

Regarding the telephone, another speaker, Dr. Steven M. Selbst, said that while pediatricians can’t manage a practice without giving advice over the phone, they need to understand there are inherent liability risks in doing so.

"A lot of taking a good history is guided by our physical exam, and obviously you can’t do a physical exam by telephone. Instructions given during telephone management are more likely to be misunderstood, and documentation for the medical record is difficult," observed Dr. Selbst, professor and vice chair of pediatrics at Jefferson Medical College, Philadelphia.

His own policy is not to give advice by phone. However, if it’s a life-threatening emergency, such as a poisoning, he’ll take the phone call and tell the family to get straightaway to the hospital.

Dr. Charlotte M. Boney took issue with Dr. Rich regarding e-mail with patients. She makes extensive use of it, albeit within a narrowly defined scope.

"Those of us who take care of a lot of patients with diabetes can all remember the cumbersome phone calls where they provided their blood sugar data. Things got better when they started faxing me their blood sugars. Now, we have lots of patients who send us their blood sugars by e-mail. I think it does have a place in patient care. The families really want to use it, and it’s more convenient than fax," commented Dr. Boney, chief of pediatric endocrinology and metabolism at Brown University in Providence, R.I.

Sure, Dr. Rich replied. "But these are patients you know and have trained well, and you’re asking for objective, measurable information," he pointed out.

As an example of how not to do e-mail, he mentioned that a physician he knows came back from a vacation and found a 5-day-old email from a patient expressing suicidality. The lesson? If you’re going to use e-mail with patients, there needs to be a built-in protocol for accessing and responding to e-mails in timely fashion from remote locations. There also should be an outgoing message stating when the physician won’t be able to respond.

Dr. Beth A. Vogt, a pediatric nephrologist at Case Western Reserve University in Cleveland, said she uses e-mail to manage her patients’ blood pressure.

"It’s an enormous time-saver compared to writing all the figures down. But I educate patients that they can’t e-mail a blood pressure of 180/110 mm Hg; that requires a phone call," she said.

Also, as a matter of hospital policy, Dr. Vogt had to get a signed parental consent authorizing e-mail communication with everyone in her office: her medical assistant, nurse, and secretary.

An audience show of hands indicated fewer than 10% now utilize e-mail as a means of communicating with their patients.

Dr. Rich and Dr. Selbst reported having no relevant financial conflicts.

SNOWMASS, COLO. – The risk of herpes zoster isn’t raised in rheumatoid arthritis patients who are on a tumor necrosis factor inhibitor, compared with those on nonbiologic disease-modifying antirheumatic drugs, according to a preliminary analysis from by far the largest study to examine the question.

Findings from the same study also suggested that TNF–inhibiting therapy may actually protect against zoster in patients with psoriasis, psoriatic arthritis, ankylosing spondylitis, or inflammatory bowel disease.

Data from two previous, large, population-based studies looking at the risk of herpes zoster in RA patients on anti-TNF biologics reveal discordant conclusions. These conflicting findings prompted Dr. Kevin L. Winthrop and his coinvestigators in the SABER (Safety Assessment of Biologic Therapy) collaboration to examine the issue in their very large data set.

SABER is a retrospective cohort study involving four large U.S. automated health databases. The as-yet-unpublished SABER herpes zoster analysis included more than 35,000 patients with diseases for which TNF inhibitors are indicated.

During 22,215 person-years of follow-up, the crude rate of herpes zoster among RA patients who were new first-time users of an anti-TNF agent was 12.1 cases per 1,000 person-years, which wasn’t significantly different from the 12.8 per 1,000 rate during 7,165 person-years of follow-up in the control group, which comprised RA patients who were failing on methotrexate and adding another conventional DMARD, usually hydroxychloroquine (Plaquenil).

There were no significant differences in zoster rates among the various anti-TNF agents, Dr. Winthrop said at the symposium, which was sponsored by the American College of Rheumatology.

Intriguingly, going on an anti-TNF agent actually appeared to protect against herpes zoster in SABER participants with psoriasis, psoriatic arthritis, or ankylosing spondylitis. During 4,106 person-years of follow-up, their crude rate of zoster was 4.4 cases per 1,000 person-years, an adjusted 36% lower risk than that in patients on a nonbiologic DMARD, whose rate was 6.8 cases per 1,000 person-years during 3,950 person-years of follow-up, according to Dr. Winthrop, an infectious diseases specialist at Oregon Health and Science University, Portland.

Moreover, new users of infliximab or adalimumab for inflammatory bowel disease had an adjusted 20% reduction in risk of zoster, compared with those on azathioprine or 6-mercaptopurine, he added.

An earlier retrospective cohort study involving 20,357 RA patients in the Veterans Affairs health care system found that patients on adalimumab had an adjusted 47% lower risk of zoster, and those on etanercept had a 38% reduction in risk, compared with patients on conventional DMARDs. Patients on infliximab had a 30% increased risk; however, this trend didn’t reach statistical significance (Clin. Infect. Dis. 2009;48:1364-71).

In sharp contrast, investigators from the prospective German RABBIT registry involving 5,040 RA patients reported that adalimumab was associated with a 3-fold increased risk of herpes zoster compared to nonbiologic DMARD therapy. Infliximab had an adjusted 2.4-fold increased risk, which wasn’t statistically significant. Etanercept wasn’t associated with increased risk (JAMA 2009;301:737-44).

The explanation for the discordant findings in RABBIT and the VA study is unclear. The studies did use somewhat different methodologies. Regardless, it’s worth noting that the number of subjects included in the new SABER analysis was larger than for both of the earlier studies put together.

"Look how robust this is," Dr. Winthrop observed. "We have good, good power. Our interpretation is there is no increased risk of zoster with anti-TNF drugs."

Nonetheless, this is a preliminary analysis. The SABER investigators plan to look next at what happened to prednisone dosing when the RA patients went on anti-TNF therapy or an additional nonbiologic DMARD, something they can do with this cohort but couldn’t do in an earlier SABER publication. Dr. Winthrop said he suspects that the prednisone dose was more likely to be reduced or eliminated in the TNF-inhibitor users, and that this might account for the finding that anti-TNF therapy didn’t increase zoster risk. A half-dozen studies have shown that prednisone therapy is associated with an increased risk of herpes zoster.

Dr. Winthrop said it’s his impression that patients who develop herpes zoster while on anti-TNF therapy don’t have a higher rate of disseminated disease or worse outcomes than do those who are not. In the SABER analysis, the rate of hospitalization for zoster was similarly very low in the biologic and nonbiologic treatment groups.

In response to audience questions, he said he believes it makes sense to give herpes zoster vaccine to RA patients starting at 50 years of age. RA per se is a risk factor for zoster, as is prednisone therapy. There is no evidence of any safety issues in vaccinating patients who take any of the standard DMARDs or anti-TNF agents, although there are no definitive data on that score. It’s possible that pharmacologic immunosuppression blunts the vaccine’s efficacy, but that hasn’t been studied.

Dr. Winthrop reported having no financial conflicts.

SNOWMASS, COLO. – The risk of herpes zoster isn’t raised in rheumatoid arthritis patients who are on a tumor necrosis factor inhibitor, compared with those on nonbiologic disease-modifying antirheumatic drugs, according to a preliminary analysis from by far the largest study to examine the question.

Findings from the same study also suggested that TNF–inhibiting therapy may actually protect against zoster in patients with psoriasis, psoriatic arthritis, ankylosing spondylitis, or inflammatory bowel disease.

Data from two previous, large, population-based studies looking at the risk of herpes zoster in RA patients on anti-TNF biologics reveal discordant conclusions. These conflicting findings prompted Dr. Kevin L. Winthrop and his coinvestigators in the SABER (Safety Assessment of Biologic Therapy) collaboration to examine the issue in their very large data set.

SABER is a retrospective cohort study involving four large U.S. automated health databases. The as-yet-unpublished SABER herpes zoster analysis included more than 35,000 patients with diseases for which TNF inhibitors are indicated.

During 22,215 person-years of follow-up, the crude rate of herpes zoster among RA patients who were new first-time users of an anti-TNF agent was 12.1 cases per 1,000 person-years, which wasn’t significantly different from the 12.8 per 1,000 rate during 7,165 person-years of follow-up in the control group, which comprised RA patients who were failing on methotrexate and adding another conventional DMARD, usually hydroxychloroquine (Plaquenil).

There were no significant differences in zoster rates among the various anti-TNF agents, Dr. Winthrop said at the symposium, which was sponsored by the American College of Rheumatology.

Intriguingly, going on an anti-TNF agent actually appeared to protect against herpes zoster in SABER participants with psoriasis, psoriatic arthritis, or ankylosing spondylitis. During 4,106 person-years of follow-up, their crude rate of zoster was 4.4 cases per 1,000 person-years, an adjusted 36% lower risk than that in patients on a nonbiologic DMARD, whose rate was 6.8 cases per 1,000 person-years during 3,950 person-years of follow-up, according to Dr. Winthrop, an infectious diseases specialist at Oregon Health and Science University, Portland.

Moreover, new users of infliximab or adalimumab for inflammatory bowel disease had an adjusted 20% reduction in risk of zoster, compared with those on azathioprine or 6-mercaptopurine, he added.

An earlier retrospective cohort study involving 20,357 RA patients in the Veterans Affairs health care system found that patients on adalimumab had an adjusted 47% lower risk of zoster, and those on etanercept had a 38% reduction in risk, compared with patients on conventional DMARDs. Patients on infliximab had a 30% increased risk; however, this trend didn’t reach statistical significance (Clin. Infect. Dis. 2009;48:1364-71).

In sharp contrast, investigators from the prospective German RABBIT registry involving 5,040 RA patients reported that adalimumab was associated with a 3-fold increased risk of herpes zoster compared to nonbiologic DMARD therapy. Infliximab had an adjusted 2.4-fold increased risk, which wasn’t statistically significant. Etanercept wasn’t associated with increased risk (JAMA 2009;301:737-44).

The explanation for the discordant findings in RABBIT and the VA study is unclear. The studies did use somewhat different methodologies. Regardless, it’s worth noting that the number of subjects included in the new SABER analysis was larger than for both of the earlier studies put together.

"Look how robust this is," Dr. Winthrop observed. "We have good, good power. Our interpretation is there is no increased risk of zoster with anti-TNF drugs."

Nonetheless, this is a preliminary analysis. The SABER investigators plan to look next at what happened to prednisone dosing when the RA patients went on anti-TNF therapy or an additional nonbiologic DMARD, something they can do with this cohort but couldn’t do in an earlier SABER publication. Dr. Winthrop said he suspects that the prednisone dose was more likely to be reduced or eliminated in the TNF-inhibitor users, and that this might account for the finding that anti-TNF therapy didn’t increase zoster risk. A half-dozen studies have shown that prednisone therapy is associated with an increased risk of herpes zoster.

Dr. Winthrop said it’s his impression that patients who develop herpes zoster while on anti-TNF therapy don’t have a higher rate of disseminated disease or worse outcomes than do those who are not. In the SABER analysis, the rate of hospitalization for zoster was similarly very low in the biologic and nonbiologic treatment groups.

In response to audience questions, he said he believes it makes sense to give herpes zoster vaccine to RA patients starting at 50 years of age. RA per se is a risk factor for zoster, as is prednisone therapy. There is no evidence of any safety issues in vaccinating patients who take any of the standard DMARDs or anti-TNF agents, although there are no definitive data on that score. It’s possible that pharmacologic immunosuppression blunts the vaccine’s efficacy, but that hasn’t been studied.

Dr. Winthrop reported having no financial conflicts.

SNOWMASS, COLO. – The risk of herpes zoster isn’t raised in rheumatoid arthritis patients who are on a tumor necrosis factor inhibitor, compared with those on nonbiologic disease-modifying antirheumatic drugs, according to a preliminary analysis from by far the largest study to examine the question.

Findings from the same study also suggested that TNF–inhibiting therapy may actually protect against zoster in patients with psoriasis, psoriatic arthritis, ankylosing spondylitis, or inflammatory bowel disease.

Data from two previous, large, population-based studies looking at the risk of herpes zoster in RA patients on anti-TNF biologics reveal discordant conclusions. These conflicting findings prompted Dr. Kevin L. Winthrop and his coinvestigators in the SABER (Safety Assessment of Biologic Therapy) collaboration to examine the issue in their very large data set.

SABER is a retrospective cohort study involving four large U.S. automated health databases. The as-yet-unpublished SABER herpes zoster analysis included more than 35,000 patients with diseases for which TNF inhibitors are indicated.

During 22,215 person-years of follow-up, the crude rate of herpes zoster among RA patients who were new first-time users of an anti-TNF agent was 12.1 cases per 1,000 person-years, which wasn’t significantly different from the 12.8 per 1,000 rate during 7,165 person-years of follow-up in the control group, which comprised RA patients who were failing on methotrexate and adding another conventional DMARD, usually hydroxychloroquine (Plaquenil).

There were no significant differences in zoster rates among the various anti-TNF agents, Dr. Winthrop said at the symposium, which was sponsored by the American College of Rheumatology.

Intriguingly, going on an anti-TNF agent actually appeared to protect against herpes zoster in SABER participants with psoriasis, psoriatic arthritis, or ankylosing spondylitis. During 4,106 person-years of follow-up, their crude rate of zoster was 4.4 cases per 1,000 person-years, an adjusted 36% lower risk than that in patients on a nonbiologic DMARD, whose rate was 6.8 cases per 1,000 person-years during 3,950 person-years of follow-up, according to Dr. Winthrop, an infectious diseases specialist at Oregon Health and Science University, Portland.

Moreover, new users of infliximab or adalimumab for inflammatory bowel disease had an adjusted 20% reduction in risk of zoster, compared with those on azathioprine or 6-mercaptopurine, he added.

An earlier retrospective cohort study involving 20,357 RA patients in the Veterans Affairs health care system found that patients on adalimumab had an adjusted 47% lower risk of zoster, and those on etanercept had a 38% reduction in risk, compared with patients on conventional DMARDs. Patients on infliximab had a 30% increased risk; however, this trend didn’t reach statistical significance (Clin. Infect. Dis. 2009;48:1364-71).

In sharp contrast, investigators from the prospective German RABBIT registry involving 5,040 RA patients reported that adalimumab was associated with a 3-fold increased risk of herpes zoster compared to nonbiologic DMARD therapy. Infliximab had an adjusted 2.4-fold increased risk, which wasn’t statistically significant. Etanercept wasn’t associated with increased risk (JAMA 2009;301:737-44).

The explanation for the discordant findings in RABBIT and the VA study is unclear. The studies did use somewhat different methodologies. Regardless, it’s worth noting that the number of subjects included in the new SABER analysis was larger than for both of the earlier studies put together.

"Look how robust this is," Dr. Winthrop observed. "We have good, good power. Our interpretation is there is no increased risk of zoster with anti-TNF drugs."

Nonetheless, this is a preliminary analysis. The SABER investigators plan to look next at what happened to prednisone dosing when the RA patients went on anti-TNF therapy or an additional nonbiologic DMARD, something they can do with this cohort but couldn’t do in an earlier SABER publication. Dr. Winthrop said he suspects that the prednisone dose was more likely to be reduced or eliminated in the TNF-inhibitor users, and that this might account for the finding that anti-TNF therapy didn’t increase zoster risk. A half-dozen studies have shown that prednisone therapy is associated with an increased risk of herpes zoster.

Dr. Winthrop said it’s his impression that patients who develop herpes zoster while on anti-TNF therapy don’t have a higher rate of disseminated disease or worse outcomes than do those who are not. In the SABER analysis, the rate of hospitalization for zoster was similarly very low in the biologic and nonbiologic treatment groups.

In response to audience questions, he said he believes it makes sense to give herpes zoster vaccine to RA patients starting at 50 years of age. RA per se is a risk factor for zoster, as is prednisone therapy. There is no evidence of any safety issues in vaccinating patients who take any of the standard DMARDs or anti-TNF agents, although there are no definitive data on that score. It’s possible that pharmacologic immunosuppression blunts the vaccine’s efficacy, but that hasn’t been studied.

Dr. Winthrop reported having no financial conflicts.