Psoriasis

BUDAPEST — Rituximab for the treatment of severe pemphigus continued to demonstrate positive results in the 2-year extension of a landmark 3-year multicenter trial.

After 5 years of follow-up, 19 of 22 rituximab-treated patients (86%) were in complete or near-complete remission, including 8 who were off all therapies, Dr. Pascal Joly reported at the annual congress of the European Society for Dermatological Research.

Also noteworthy was the finding that no new rituximab-related side effects emerged during years 4 and 5. The only serious side effects over the course of 5 years were a case of pyelonephritis 12 months after a single cycle of rituximab (Rituxan) and a fatal septicemia at 18 months in a patient taking etanercept for comorbid rheumatoid arthritis, both of which were detailed in the initial 3-year report (N. Engl. J. Med. 2007;357:545-52), said Dr. Joly of Rouen (France) University Hospital.

Five of the eight patients in complete remission off all treatment at 5 years achieved their remission several months after their first and only cycle of rituximab and never experienced a relapse in the intervening years, he said.

Based upon these encouraging results, a new randomized trial is underway to evaluate an expanded use of rituximab in treating pemphigus.

Instead of reserving the biologic therapy for patients with severe pemphigus who are corticosteroid refractory or have contraindications to high-dose steroids, as was the case in the original 5-year French study, the new multicenter study is testing rituximab as first-line treatment. The investigators also are enrolling patients with moderate as well as severe pemphigus vulgaris or foliaceous, he added.

Fourteen patients in the 5-year trial had pemphigus vulgaris, seven had pemphigus foliaceous, and one had paraneoplastic pemphigus.

Thirteen of the 22 patients experienced relapse after a mean delay of 28.2 months. The 2-, 3-, and 5-year relapse rates were 33%, 43%, and 59%, respectively.

Relapse in six patients was treated with a second cycle of rituximab; five of the six achieved complete remission once again. The other seven patients had their relapse treated with stepped-up doses of corticosteroids.

The mean dose of prednisone used by participants dropped from 55 mg/day at baseline to 6 mg/day after 5 years. The decrease was even more impressive in the five patients who entered the trial with steroid-refractory disease; their corticosteroid use went from a mean of 94 mg/day at baseline to 6 mg/day 5 years later, Dr. Joly continued.

The rituximab regimen consisted of four weekly infusions at 375 mg/m

Rituximab is a monoclonal antibody directed against the CD20 antigen of B lymphocytes. Beginning 3 weeks after rituximab administration, peripheral B cells became undetectable. B cells remained suppressed for 6 months to 2 years. When they reappeared they displayed a naive phenotype similar to that found in neonatal cord blood.

No changes were detected in levels of T cells, total IgG, or titers of antibodies against tetanus toxoid or pneumococcal capsule polysaccharide in response to rituximab. The pathogenic autoantibodies anti-desmoglein-1 and −3, which are produced by activated B cells, responded to rituximab differentially. Anti-desmoglein-1 titers dropped steeply in all patients with a complete response and increased when patients experienced relapse. In contrast, five patients in prolonged remission maintained high titers of anti-desmoglein-3 throughout and four other patients relapsed despite persistently low anti-desmoglein-3.

In the new randomized trial of rituximab as first-line therapy in moderate to severe pemphigus, the rituximab group receives low-dose prednisone at 0.5-0.75 mg/kg per day for the first 2-3 months of the study.

“Of course, the absence of corticosteroids would make for more spectacular results. However, rituximab typically has a 2- to 3-month delay in action, and it's difficult not to treat patients during this delay. This is why we're using low-dose corticosteroids, especially to treat the pain in our patients with mucosal lesions. A dose of 0.5 mg/kg per day of prednisone is not sufficient to lead to clearance in these patients, but it's a dose that has an anti-inflammatory effect and will decrease their pain,” Dr. Joly explained.

In light of the timing of relapses in the original 5-year study, the new trial incorporates maintenance rituximab at 500 mg given at 12 months and again at 18 months in an effort to avoid relapses in the second and third year. The dose and timing of the maintenance therapy were chosen in consultation with rheumatologists, who have the most experience with rituximab. The biologic agent's approved indications are for treatment of rheumatoid arthritis unresponsive to anti–tumor necrosis factor therapy and in B-cell lymphomas.

The study was supported by the French Society of Dermatology and Roche.

BUDAPEST — Rituximab for the treatment of severe pemphigus continued to demonstrate positive results in the 2-year extension of a landmark 3-year multicenter trial.

After 5 years of follow-up, 19 of 22 rituximab-treated patients (86%) were in complete or near-complete remission, including 8 who were off all therapies, Dr. Pascal Joly reported at the annual congress of the European Society for Dermatological Research.

Also noteworthy was the finding that no new rituximab-related side effects emerged during years 4 and 5. The only serious side effects over the course of 5 years were a case of pyelonephritis 12 months after a single cycle of rituximab (Rituxan) and a fatal septicemia at 18 months in a patient taking etanercept for comorbid rheumatoid arthritis, both of which were detailed in the initial 3-year report (N. Engl. J. Med. 2007;357:545-52), said Dr. Joly of Rouen (France) University Hospital.

Five of the eight patients in complete remission off all treatment at 5 years achieved their remission several months after their first and only cycle of rituximab and never experienced a relapse in the intervening years, he said.

Based upon these encouraging results, a new randomized trial is underway to evaluate an expanded use of rituximab in treating pemphigus.

Instead of reserving the biologic therapy for patients with severe pemphigus who are corticosteroid refractory or have contraindications to high-dose steroids, as was the case in the original 5-year French study, the new multicenter study is testing rituximab as first-line treatment. The investigators also are enrolling patients with moderate as well as severe pemphigus vulgaris or foliaceous, he added.

Fourteen patients in the 5-year trial had pemphigus vulgaris, seven had pemphigus foliaceous, and one had paraneoplastic pemphigus.

Thirteen of the 22 patients experienced relapse after a mean delay of 28.2 months. The 2-, 3-, and 5-year relapse rates were 33%, 43%, and 59%, respectively.

Relapse in six patients was treated with a second cycle of rituximab; five of the six achieved complete remission once again. The other seven patients had their relapse treated with stepped-up doses of corticosteroids.

The mean dose of prednisone used by participants dropped from 55 mg/day at baseline to 6 mg/day after 5 years. The decrease was even more impressive in the five patients who entered the trial with steroid-refractory disease; their corticosteroid use went from a mean of 94 mg/day at baseline to 6 mg/day 5 years later, Dr. Joly continued.

The rituximab regimen consisted of four weekly infusions at 375 mg/m

Rituximab is a monoclonal antibody directed against the CD20 antigen of B lymphocytes. Beginning 3 weeks after rituximab administration, peripheral B cells became undetectable. B cells remained suppressed for 6 months to 2 years. When they reappeared they displayed a naive phenotype similar to that found in neonatal cord blood.

No changes were detected in levels of T cells, total IgG, or titers of antibodies against tetanus toxoid or pneumococcal capsule polysaccharide in response to rituximab. The pathogenic autoantibodies anti-desmoglein-1 and −3, which are produced by activated B cells, responded to rituximab differentially. Anti-desmoglein-1 titers dropped steeply in all patients with a complete response and increased when patients experienced relapse. In contrast, five patients in prolonged remission maintained high titers of anti-desmoglein-3 throughout and four other patients relapsed despite persistently low anti-desmoglein-3.

In the new randomized trial of rituximab as first-line therapy in moderate to severe pemphigus, the rituximab group receives low-dose prednisone at 0.5-0.75 mg/kg per day for the first 2-3 months of the study.

“Of course, the absence of corticosteroids would make for more spectacular results. However, rituximab typically has a 2- to 3-month delay in action, and it's difficult not to treat patients during this delay. This is why we're using low-dose corticosteroids, especially to treat the pain in our patients with mucosal lesions. A dose of 0.5 mg/kg per day of prednisone is not sufficient to lead to clearance in these patients, but it's a dose that has an anti-inflammatory effect and will decrease their pain,” Dr. Joly explained.

In light of the timing of relapses in the original 5-year study, the new trial incorporates maintenance rituximab at 500 mg given at 12 months and again at 18 months in an effort to avoid relapses in the second and third year. The dose and timing of the maintenance therapy were chosen in consultation with rheumatologists, who have the most experience with rituximab. The biologic agent's approved indications are for treatment of rheumatoid arthritis unresponsive to anti–tumor necrosis factor therapy and in B-cell lymphomas.

The study was supported by the French Society of Dermatology and Roche.

BUDAPEST — Rituximab for the treatment of severe pemphigus continued to demonstrate positive results in the 2-year extension of a landmark 3-year multicenter trial.

After 5 years of follow-up, 19 of 22 rituximab-treated patients (86%) were in complete or near-complete remission, including 8 who were off all therapies, Dr. Pascal Joly reported at the annual congress of the European Society for Dermatological Research.

Also noteworthy was the finding that no new rituximab-related side effects emerged during years 4 and 5. The only serious side effects over the course of 5 years were a case of pyelonephritis 12 months after a single cycle of rituximab (Rituxan) and a fatal septicemia at 18 months in a patient taking etanercept for comorbid rheumatoid arthritis, both of which were detailed in the initial 3-year report (N. Engl. J. Med. 2007;357:545-52), said Dr. Joly of Rouen (France) University Hospital.

Five of the eight patients in complete remission off all treatment at 5 years achieved their remission several months after their first and only cycle of rituximab and never experienced a relapse in the intervening years, he said.

Based upon these encouraging results, a new randomized trial is underway to evaluate an expanded use of rituximab in treating pemphigus.

Instead of reserving the biologic therapy for patients with severe pemphigus who are corticosteroid refractory or have contraindications to high-dose steroids, as was the case in the original 5-year French study, the new multicenter study is testing rituximab as first-line treatment. The investigators also are enrolling patients with moderate as well as severe pemphigus vulgaris or foliaceous, he added.

Fourteen patients in the 5-year trial had pemphigus vulgaris, seven had pemphigus foliaceous, and one had paraneoplastic pemphigus.

Thirteen of the 22 patients experienced relapse after a mean delay of 28.2 months. The 2-, 3-, and 5-year relapse rates were 33%, 43%, and 59%, respectively.

Relapse in six patients was treated with a second cycle of rituximab; five of the six achieved complete remission once again. The other seven patients had their relapse treated with stepped-up doses of corticosteroids.

The mean dose of prednisone used by participants dropped from 55 mg/day at baseline to 6 mg/day after 5 years. The decrease was even more impressive in the five patients who entered the trial with steroid-refractory disease; their corticosteroid use went from a mean of 94 mg/day at baseline to 6 mg/day 5 years later, Dr. Joly continued.

The rituximab regimen consisted of four weekly infusions at 375 mg/m

Rituximab is a monoclonal antibody directed against the CD20 antigen of B lymphocytes. Beginning 3 weeks after rituximab administration, peripheral B cells became undetectable. B cells remained suppressed for 6 months to 2 years. When they reappeared they displayed a naive phenotype similar to that found in neonatal cord blood.

No changes were detected in levels of T cells, total IgG, or titers of antibodies against tetanus toxoid or pneumococcal capsule polysaccharide in response to rituximab. The pathogenic autoantibodies anti-desmoglein-1 and −3, which are produced by activated B cells, responded to rituximab differentially. Anti-desmoglein-1 titers dropped steeply in all patients with a complete response and increased when patients experienced relapse. In contrast, five patients in prolonged remission maintained high titers of anti-desmoglein-3 throughout and four other patients relapsed despite persistently low anti-desmoglein-3.

In the new randomized trial of rituximab as first-line therapy in moderate to severe pemphigus, the rituximab group receives low-dose prednisone at 0.5-0.75 mg/kg per day for the first 2-3 months of the study.

“Of course, the absence of corticosteroids would make for more spectacular results. However, rituximab typically has a 2- to 3-month delay in action, and it's difficult not to treat patients during this delay. This is why we're using low-dose corticosteroids, especially to treat the pain in our patients with mucosal lesions. A dose of 0.5 mg/kg per day of prednisone is not sufficient to lead to clearance in these patients, but it's a dose that has an anti-inflammatory effect and will decrease their pain,” Dr. Joly explained.

In light of the timing of relapses in the original 5-year study, the new trial incorporates maintenance rituximab at 500 mg given at 12 months and again at 18 months in an effort to avoid relapses in the second and third year. The dose and timing of the maintenance therapy were chosen in consultation with rheumatologists, who have the most experience with rituximab. The biologic agent's approved indications are for treatment of rheumatoid arthritis unresponsive to anti–tumor necrosis factor therapy and in B-cell lymphomas.

The study was supported by the French Society of Dermatology and Roche.

BUDAPEST — The last word on the relationship between psoriasis and cardiovascular disease may not be in, according to the results of a new study.

Contrary to earlier studies, psoriasis was found to not be an independent risk factor for hospitalization for ischemic heart disease in a large Dutch study, Dr. Marlies Wakkee reported at the annual congress of the European Society for Dermatological Research.

Even after subdividing the 15,820 Dutch psoriasis patients in the study into those who used only topical therapy versus patients with more severe disease—as defined by use of systemic therapies or hospitalization for psoriasis—the more severely affected patients did not have a higher rate of ischemic heart disease (IHD) hospitalization, said Dr. Wakkee of Erasmus University Medical Center, Rotterdam.

The same held true when the analysis was narrowed to hospitalization for acute myocardial infarction (MI). The psoriasis patients, even those with more severe skin disease, did not have a greater rate of MI than controls, she added.

The study relied upon hospital and pharmacy linked databases covering 2.5 million Dutch patients. The 15,820 psoriasis patients and 27,577 non-psoriatic controls (mean age 48 years) were followed for a mean of 6 years.

The IHD hospitalization rate was 611 cases per 100,000 person-years in psoriasis patients and 599 in controls. MI hospitalization rates were also similar: 234 per 100,000 person-years in psoriasis patients and 235 in controls.

At study entry, the psoriasis patients had slightly, but statistically significantly, higher rates of antihypertensive drug therapy, compared with controls (19.4% vs. 16.4%, respectively), lipid-lowering drugs (7.0% vs. 6.2%, respectively), and antidiabetic medications (4.4% vs. 3.6%, respectively). This wasn't surprising, said Dr. Wakkee, given that prior studies have shown the prevalence of metabolic syndrome to be elevated in psoriasis patients. Psoriasis patients also had more hospitalizations for reasons other than psoriasis in the prior 6 months.

In a multivariate analysis adjusted for age, gender, medications, and hospitalizations in the prior 6 months, the relative risk of IHD hospitalization during 6 years of follow-up was 5% higher in psoriasis patients, and the MI hospitalization risk was 6% lower than in controls. These differences were far from statistical significance, she said.

Dr. Wakkee noted that her study findings are at odds with those of a much-publicized analysis of the U.K. General Practice Research Database (JAMA 2006;296:1735-41), which concluded that psoriasis patients had a small but significantly increased risk of MI.

It is possible, she said, that the earlier finding was due to detection bias. This potential confounder could occur because psoriasis patients have greater consumption of health care.

Further muddying the waters, investigators at the University of Basel in Switzerland recently analyzed the U.K. General Practice Research Database and found no overall increased risk of MI, stroke, or transient ischemic attack (TIA) in patients with recently diagnosed psoriasis, although there was a suggestion of a possible small absolute increase in MI risk in patients younger than age 60 with severe psoriasis (Br. J. Dermatol. 2009;160:1048-56).

So the question remains: Is psoriasis as a systemic inflammatory state an independent risk factor for cardiovascular events, or does the increased risk, if present, result from psoriasis patients' increased prevalence of obesity, smoking, metabolic syndrome, and other cardiovascular risk factors?

Dr. Wakkee said the only way to resolve the controversy is to conduct a large, detailed, long-term prospective study. Whether that is realistic is unclear, she said. In the absence of definitive data, physicians will have to help their psoriasis patients work hard to optimize their cardiovascular risk factor profile.

The only way to resolve the controversy is to conduct a large, detailed, long-term prospective study.

Source Dr. Wakkee

BUDAPEST — The last word on the relationship between psoriasis and cardiovascular disease may not be in, according to the results of a new study.

Contrary to earlier studies, psoriasis was found to not be an independent risk factor for hospitalization for ischemic heart disease in a large Dutch study, Dr. Marlies Wakkee reported at the annual congress of the European Society for Dermatological Research.

Even after subdividing the 15,820 Dutch psoriasis patients in the study into those who used only topical therapy versus patients with more severe disease—as defined by use of systemic therapies or hospitalization for psoriasis—the more severely affected patients did not have a higher rate of ischemic heart disease (IHD) hospitalization, said Dr. Wakkee of Erasmus University Medical Center, Rotterdam.

The same held true when the analysis was narrowed to hospitalization for acute myocardial infarction (MI). The psoriasis patients, even those with more severe skin disease, did not have a greater rate of MI than controls, she added.

The study relied upon hospital and pharmacy linked databases covering 2.5 million Dutch patients. The 15,820 psoriasis patients and 27,577 non-psoriatic controls (mean age 48 years) were followed for a mean of 6 years.

The IHD hospitalization rate was 611 cases per 100,000 person-years in psoriasis patients and 599 in controls. MI hospitalization rates were also similar: 234 per 100,000 person-years in psoriasis patients and 235 in controls.

At study entry, the psoriasis patients had slightly, but statistically significantly, higher rates of antihypertensive drug therapy, compared with controls (19.4% vs. 16.4%, respectively), lipid-lowering drugs (7.0% vs. 6.2%, respectively), and antidiabetic medications (4.4% vs. 3.6%, respectively). This wasn't surprising, said Dr. Wakkee, given that prior studies have shown the prevalence of metabolic syndrome to be elevated in psoriasis patients. Psoriasis patients also had more hospitalizations for reasons other than psoriasis in the prior 6 months.

In a multivariate analysis adjusted for age, gender, medications, and hospitalizations in the prior 6 months, the relative risk of IHD hospitalization during 6 years of follow-up was 5% higher in psoriasis patients, and the MI hospitalization risk was 6% lower than in controls. These differences were far from statistical significance, she said.

Dr. Wakkee noted that her study findings are at odds with those of a much-publicized analysis of the U.K. General Practice Research Database (JAMA 2006;296:1735-41), which concluded that psoriasis patients had a small but significantly increased risk of MI.

It is possible, she said, that the earlier finding was due to detection bias. This potential confounder could occur because psoriasis patients have greater consumption of health care.

Further muddying the waters, investigators at the University of Basel in Switzerland recently analyzed the U.K. General Practice Research Database and found no overall increased risk of MI, stroke, or transient ischemic attack (TIA) in patients with recently diagnosed psoriasis, although there was a suggestion of a possible small absolute increase in MI risk in patients younger than age 60 with severe psoriasis (Br. J. Dermatol. 2009;160:1048-56).

So the question remains: Is psoriasis as a systemic inflammatory state an independent risk factor for cardiovascular events, or does the increased risk, if present, result from psoriasis patients' increased prevalence of obesity, smoking, metabolic syndrome, and other cardiovascular risk factors?

Dr. Wakkee said the only way to resolve the controversy is to conduct a large, detailed, long-term prospective study. Whether that is realistic is unclear, she said. In the absence of definitive data, physicians will have to help their psoriasis patients work hard to optimize their cardiovascular risk factor profile.

The only way to resolve the controversy is to conduct a large, detailed, long-term prospective study.

Source Dr. Wakkee

BUDAPEST — The last word on the relationship between psoriasis and cardiovascular disease may not be in, according to the results of a new study.

Contrary to earlier studies, psoriasis was found to not be an independent risk factor for hospitalization for ischemic heart disease in a large Dutch study, Dr. Marlies Wakkee reported at the annual congress of the European Society for Dermatological Research.

Even after subdividing the 15,820 Dutch psoriasis patients in the study into those who used only topical therapy versus patients with more severe disease—as defined by use of systemic therapies or hospitalization for psoriasis—the more severely affected patients did not have a higher rate of ischemic heart disease (IHD) hospitalization, said Dr. Wakkee of Erasmus University Medical Center, Rotterdam.

The same held true when the analysis was narrowed to hospitalization for acute myocardial infarction (MI). The psoriasis patients, even those with more severe skin disease, did not have a greater rate of MI than controls, she added.

The study relied upon hospital and pharmacy linked databases covering 2.5 million Dutch patients. The 15,820 psoriasis patients and 27,577 non-psoriatic controls (mean age 48 years) were followed for a mean of 6 years.

The IHD hospitalization rate was 611 cases per 100,000 person-years in psoriasis patients and 599 in controls. MI hospitalization rates were also similar: 234 per 100,000 person-years in psoriasis patients and 235 in controls.

At study entry, the psoriasis patients had slightly, but statistically significantly, higher rates of antihypertensive drug therapy, compared with controls (19.4% vs. 16.4%, respectively), lipid-lowering drugs (7.0% vs. 6.2%, respectively), and antidiabetic medications (4.4% vs. 3.6%, respectively). This wasn't surprising, said Dr. Wakkee, given that prior studies have shown the prevalence of metabolic syndrome to be elevated in psoriasis patients. Psoriasis patients also had more hospitalizations for reasons other than psoriasis in the prior 6 months.

In a multivariate analysis adjusted for age, gender, medications, and hospitalizations in the prior 6 months, the relative risk of IHD hospitalization during 6 years of follow-up was 5% higher in psoriasis patients, and the MI hospitalization risk was 6% lower than in controls. These differences were far from statistical significance, she said.

Dr. Wakkee noted that her study findings are at odds with those of a much-publicized analysis of the U.K. General Practice Research Database (JAMA 2006;296:1735-41), which concluded that psoriasis patients had a small but significantly increased risk of MI.

It is possible, she said, that the earlier finding was due to detection bias. This potential confounder could occur because psoriasis patients have greater consumption of health care.

Further muddying the waters, investigators at the University of Basel in Switzerland recently analyzed the U.K. General Practice Research Database and found no overall increased risk of MI, stroke, or transient ischemic attack (TIA) in patients with recently diagnosed psoriasis, although there was a suggestion of a possible small absolute increase in MI risk in patients younger than age 60 with severe psoriasis (Br. J. Dermatol. 2009;160:1048-56).

So the question remains: Is psoriasis as a systemic inflammatory state an independent risk factor for cardiovascular events, or does the increased risk, if present, result from psoriasis patients' increased prevalence of obesity, smoking, metabolic syndrome, and other cardiovascular risk factors?

Dr. Wakkee said the only way to resolve the controversy is to conduct a large, detailed, long-term prospective study. Whether that is realistic is unclear, she said. In the absence of definitive data, physicians will have to help their psoriasis patients work hard to optimize their cardiovascular risk factor profile.

The only way to resolve the controversy is to conduct a large, detailed, long-term prospective study.

Source Dr. Wakkee

The monoclonal antibody belimumab appears to be effective for the treatment of systemic lupus erythematosus, according to the results of a randomized, placebo-controlled trial involving 865 patients.

Human Genome Sciences and Glaxo SmithKline, which codeveloped the biologic, announced the results during a conference call for security analysts. The results have not yet undergone peer review. The trial, BLISS-52, was conducted at 90 clinical sites in 13 countries, primarily in Asia, South America, and Eastern Europe. A second phase III trial, BLISS-76, is in its final stages with 826 patients at 133 clinical sites in 19 countries, primarily in North America and Europe. Patients in BLISS-52 were followed for 52 weeks, while patients in BLISS-76 will be followed for 76 weeks.

H. Thomas Watkins, president and chief executive officer of Human Genome Sciences, said that results from BLISS-76 will be announced in November. If the results are positive, the companies will submit marketing applications in the United States, Europe, and other regions during the first half of 2010, he said.

The two trials have similar designs. Patients were randomized to receive either standard of care plus placebo or standard of care plus 1 mg/kg or 10 mg/kg of belimumab. The drug (or placebo) was delivered intravenously on days 0, 14, 28, and every 28 days thereafter.

The primary end point of BLISS-52 was “patient response,” defined as an improvement in SELENA-SLEDAI instrument scores of 4 or more at week 52 with no clinically significant flare in the BILAG index or worsening of the Physician's Global Assessment score. SELENA SLEDAI refers to the Safety of Estrogen in Lupus Erythematosus National Assessment trial version of the Systemic Lupus Erythematosus Disease Activity Index. BILAG is an index developed by the British Isles Lupus Assessment Group.

Dr. Joan T. Merrill, head of clinical pharmacology at the Oklahoma Medical Research Foundation, Oklahoma City, said in an interview: “The use of these two instruments in the trial design was very clever. The two major weaknesses of the SLEDAI have been overcome in this trial. It is not as sensitive to change as the BILAG, so if you do see a 4-point drop you are impressed. However, the 4-point drop in the overall score could happen while there is significant worsening in some organs, and this was addressed using the BILAG and the Physician's Global Assessment to eliminate such patients from the responder group.”

At week 52, 44% of the patients taking placebo met the primary efficacy end point, compared with 52% of the patients taking 1 mg/kg belimumab, and 58% of the patients taking 10 mg/kg belimumab. Both doses of belimumab proved superior to placebo with a high degree of statistical significance.

There were also significant improvements in several secondary end points. For example, investigators observed improvement in Physician's Global Assessment scores in 4-8 weeks. A significantly higher proportion of patients in both belimumab groups were able to reduce their average prednisone dose by at least 25% from baseline to 7.5 mg/day or less during the final 12 weeks of the study. Health-related quality of life at week 52, as measured by the SF-36 Physical Component Summary score, was significantly better in both belimumab treatment groups.

“This is an outstanding result,” according to Dr. Merrill, who is also the medical director of the Lupus Foundation of America. “By showing an effect on both the efficacy end point and the steroid taper, the treatment impact is more robust than it might seem just looking at the primary outcome.”

Rates of adverse events, serious adverse events, infections, and fatalities were similar in the belimu-mab and placebo groups. The most common adverse events were headache, arthralgia, upper respiratory tract infection, urinary tract infection, and influenza.

Dr. Merrill is a consultant for Genentech Inc., Bristol-Myers Squibb Co., MedImmune Inc., and other companies that develop products for lupus. She was not an investigator in the study being discussed but is involved in the ongoing phase III trial that includes sites in the United States and Western Europe. The companies plan to market belimumab under the trade name Benlysta.

The monoclonal antibody belimumab appears to be effective for the treatment of systemic lupus erythematosus, according to the results of a randomized, placebo-controlled trial involving 865 patients.

Human Genome Sciences and Glaxo SmithKline, which codeveloped the biologic, announced the results during a conference call for security analysts. The results have not yet undergone peer review. The trial, BLISS-52, was conducted at 90 clinical sites in 13 countries, primarily in Asia, South America, and Eastern Europe. A second phase III trial, BLISS-76, is in its final stages with 826 patients at 133 clinical sites in 19 countries, primarily in North America and Europe. Patients in BLISS-52 were followed for 52 weeks, while patients in BLISS-76 will be followed for 76 weeks.

H. Thomas Watkins, president and chief executive officer of Human Genome Sciences, said that results from BLISS-76 will be announced in November. If the results are positive, the companies will submit marketing applications in the United States, Europe, and other regions during the first half of 2010, he said.

The two trials have similar designs. Patients were randomized to receive either standard of care plus placebo or standard of care plus 1 mg/kg or 10 mg/kg of belimumab. The drug (or placebo) was delivered intravenously on days 0, 14, 28, and every 28 days thereafter.

The primary end point of BLISS-52 was “patient response,” defined as an improvement in SELENA-SLEDAI instrument scores of 4 or more at week 52 with no clinically significant flare in the BILAG index or worsening of the Physician's Global Assessment score. SELENA SLEDAI refers to the Safety of Estrogen in Lupus Erythematosus National Assessment trial version of the Systemic Lupus Erythematosus Disease Activity Index. BILAG is an index developed by the British Isles Lupus Assessment Group.

Dr. Joan T. Merrill, head of clinical pharmacology at the Oklahoma Medical Research Foundation, Oklahoma City, said in an interview: “The use of these two instruments in the trial design was very clever. The two major weaknesses of the SLEDAI have been overcome in this trial. It is not as sensitive to change as the BILAG, so if you do see a 4-point drop you are impressed. However, the 4-point drop in the overall score could happen while there is significant worsening in some organs, and this was addressed using the BILAG and the Physician's Global Assessment to eliminate such patients from the responder group.”

At week 52, 44% of the patients taking placebo met the primary efficacy end point, compared with 52% of the patients taking 1 mg/kg belimumab, and 58% of the patients taking 10 mg/kg belimumab. Both doses of belimumab proved superior to placebo with a high degree of statistical significance.

There were also significant improvements in several secondary end points. For example, investigators observed improvement in Physician's Global Assessment scores in 4-8 weeks. A significantly higher proportion of patients in both belimumab groups were able to reduce their average prednisone dose by at least 25% from baseline to 7.5 mg/day or less during the final 12 weeks of the study. Health-related quality of life at week 52, as measured by the SF-36 Physical Component Summary score, was significantly better in both belimumab treatment groups.

“This is an outstanding result,” according to Dr. Merrill, who is also the medical director of the Lupus Foundation of America. “By showing an effect on both the efficacy end point and the steroid taper, the treatment impact is more robust than it might seem just looking at the primary outcome.”

Rates of adverse events, serious adverse events, infections, and fatalities were similar in the belimu-mab and placebo groups. The most common adverse events were headache, arthralgia, upper respiratory tract infection, urinary tract infection, and influenza.

Dr. Merrill is a consultant for Genentech Inc., Bristol-Myers Squibb Co., MedImmune Inc., and other companies that develop products for lupus. She was not an investigator in the study being discussed but is involved in the ongoing phase III trial that includes sites in the United States and Western Europe. The companies plan to market belimumab under the trade name Benlysta.

The monoclonal antibody belimumab appears to be effective for the treatment of systemic lupus erythematosus, according to the results of a randomized, placebo-controlled trial involving 865 patients.

Human Genome Sciences and Glaxo SmithKline, which codeveloped the biologic, announced the results during a conference call for security analysts. The results have not yet undergone peer review. The trial, BLISS-52, was conducted at 90 clinical sites in 13 countries, primarily in Asia, South America, and Eastern Europe. A second phase III trial, BLISS-76, is in its final stages with 826 patients at 133 clinical sites in 19 countries, primarily in North America and Europe. Patients in BLISS-52 were followed for 52 weeks, while patients in BLISS-76 will be followed for 76 weeks.

H. Thomas Watkins, president and chief executive officer of Human Genome Sciences, said that results from BLISS-76 will be announced in November. If the results are positive, the companies will submit marketing applications in the United States, Europe, and other regions during the first half of 2010, he said.

The two trials have similar designs. Patients were randomized to receive either standard of care plus placebo or standard of care plus 1 mg/kg or 10 mg/kg of belimumab. The drug (or placebo) was delivered intravenously on days 0, 14, 28, and every 28 days thereafter.

The primary end point of BLISS-52 was “patient response,” defined as an improvement in SELENA-SLEDAI instrument scores of 4 or more at week 52 with no clinically significant flare in the BILAG index or worsening of the Physician's Global Assessment score. SELENA SLEDAI refers to the Safety of Estrogen in Lupus Erythematosus National Assessment trial version of the Systemic Lupus Erythematosus Disease Activity Index. BILAG is an index developed by the British Isles Lupus Assessment Group.

Dr. Joan T. Merrill, head of clinical pharmacology at the Oklahoma Medical Research Foundation, Oklahoma City, said in an interview: “The use of these two instruments in the trial design was very clever. The two major weaknesses of the SLEDAI have been overcome in this trial. It is not as sensitive to change as the BILAG, so if you do see a 4-point drop you are impressed. However, the 4-point drop in the overall score could happen while there is significant worsening in some organs, and this was addressed using the BILAG and the Physician's Global Assessment to eliminate such patients from the responder group.”

At week 52, 44% of the patients taking placebo met the primary efficacy end point, compared with 52% of the patients taking 1 mg/kg belimumab, and 58% of the patients taking 10 mg/kg belimumab. Both doses of belimumab proved superior to placebo with a high degree of statistical significance.

There were also significant improvements in several secondary end points. For example, investigators observed improvement in Physician's Global Assessment scores in 4-8 weeks. A significantly higher proportion of patients in both belimumab groups were able to reduce their average prednisone dose by at least 25% from baseline to 7.5 mg/day or less during the final 12 weeks of the study. Health-related quality of life at week 52, as measured by the SF-36 Physical Component Summary score, was significantly better in both belimumab treatment groups.

“This is an outstanding result,” according to Dr. Merrill, who is also the medical director of the Lupus Foundation of America. “By showing an effect on both the efficacy end point and the steroid taper, the treatment impact is more robust than it might seem just looking at the primary outcome.”

Rates of adverse events, serious adverse events, infections, and fatalities were similar in the belimu-mab and placebo groups. The most common adverse events were headache, arthralgia, upper respiratory tract infection, urinary tract infection, and influenza.

Dr. Merrill is a consultant for Genentech Inc., Bristol-Myers Squibb Co., MedImmune Inc., and other companies that develop products for lupus. She was not an investigator in the study being discussed but is involved in the ongoing phase III trial that includes sites in the United States and Western Europe. The companies plan to market belimumab under the trade name Benlysta.

COPENHAGEN — Psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis are as strong as diabetes as risk factors for cardiovascular disease, prompting a European League Against Rheumatism task force to issue the group's first consensus recommendations for managing cardiovascular risk in these patients.

“In our view, rheumatoid arthritis [RA], ankylosing spondylitis [AS], and psoriatic arthritis [PsA] should be seen as new, independent cardiovascular risk factors,” Dr. Michael T. Nurmohamed said at the annual European Congress of Rheumatology. “The risk is comparable to type 2 diabetes,” added Dr. Nurmohamed, of Free University Medical Center in Amsterdam.

“Cardiovascular risk management is absolutely necessary” in patients with RA, AS, or PsA, and should involve assessing and treating conventional cardiovascular disease (CVD) risk factors as well as suppressing the underlying inflammatory process by treatment with disease-modifying antirheumatic drugs (DMARDs). “Most important is to decrease the inflammatory burden as much as possible,” through the use of biologic and/or synthetic DMARDs, he said in an interview. “The extent to which antirheumatic treatment decreases the risk is not known.”

Just as cardiovascular disease is now the most feared outcome of diabetes, it may be time to expand the definition of the clinical impact of RA, AS, and PsA to include the extra CVD burden they trigger, Dr. Nurmohamed said.

Designation of RA, AS, and PsA as CVD risk factors by a task force of the European League Against Rheumatism (EULAR) is the first time a major medical group has singled out these conditions in this way.

The extra risk from these disorders is substantial.

When a clinician uses the European SCORE (Systemic Coronary Risk Evaluation) formula to calculate an RA patient's 10-year risk for cardiovascular disease death, the number should be increased by 50% to get the patient's actual risk when at least two of three criteria are present: disease duration more than 10 years, positivity for rheumatoid factor or anti-cyclic citrullinated peptide antibody, or extra-articular manifestations.

Dr. Nurmohamed based his recommendation on findings from an analysis done with his associates that found a greater than twofold increased risk for CVD in patients with RA, compared with people without RA. The higher level of conventional risk factors among the RA patients in the study explained roughly half of the doubled risk. The other half of the increased risk was directly attributable to RA, he said.

Similarly, a person's Framingham risk score for having a cardiovascular event should also be boosted by about 50% if RA, AS, or PsA is present, he said.

Major evidence for the impact of rheumatoid diseases on cardiovascular risk came in data on findings—from 294 patients with RA, 194 patients with type 2 diabetes, and 258 controls, all aged 50-75 years—that Dr. Nurmohamed and his associates first reported last year.

In an analysis that controlled for age, sex, and cardiovascular risk factors, patients with RA had a 2.7-fold increased risk for cardiovascular disease events, compared with controls, and patients with type 2 diabetes had a twofold increased risk (Ann. Rheum. Dis. 2008 Aug. 12 [doi:10.1136/ard.2008.094151]).

These and other findings prompted Dr. Nurmohamed to convene an 18-member task force for EULAR that included rheumatologists, cardiologists, internists, and epidemiologists from nine European countries. The panel wrote nine evidence- and expert-opinion-based recommendations for the management of cardiovascular risk in these patients.

The key recommendation is that patients with RA, AS, or PsA should be considered at high risk for developing CVD because of both an increased prevalence of traditional CVD risk factors and their inflammatory burden.

“The increased CVD risk in patients with inflammatory arthritis is now well recognized. Everyone is aware that something should be done,” he said in the interview. But the extent to which the new guidelines are already routinely followed in Europe by physicians who manage these patients is variable. In some countries, CVD risk management in patients with rheumatoid diseases is uncommon.

He acknowledged that the evidence supporting a CVD effect is stronger for RA than for AS and PsA, but added that adequate evidence exists to support including AS and PsA in the recommendations.

Dr. Nurmohamed itemized the other eight task force recommendations:

▸ Adequate control of rheumatoid disease activity is necessary to lower a patient's CVD risk.

▸ A CVD risk assessment following evidence-based EULAR guidelines is recommended annually for all RA patients, and should be considered for all patients with AS and PsA.

▸ CVD risk score models should be multiplied by 1.5 when an RA patient has at least two of the following three criteria: disease duration of more than 10 years, positivity for rheumatoid factor or anti-cyclic citrullinated peptide antibody, and extra-articular manifestations.

▸ The total cholesterol: HDL cholesterol ratio should be used in the formula for estimating CVD risk.

▸ Interventions with lipid-lowering drugs and with antihypertensive medications should follow national guidelines.

▸ Statins, ACE inhibitors, and angiotensin receptor blockers are the preferred treatment agents because of their pleiotropic effects. Therapy with 40 mg atorvastatin daily in patients with RA was shown to produce a modest but significant improvement in RA disease activity (Lancet 2004;363:2015-21).

▸ The role of cyclooxygenase-2 selective inhibitors (coxibs) and most NSAIDs in most CVD is not well established and needs further investigation; therefore, these agents should be prescribed with caution.

▸ When corticosteroids are prescribed, they should be at the lowest dose possible.

Dr. Nurmohamed reported having no financial conflicts.

COPENHAGEN — Psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis are as strong as diabetes as risk factors for cardiovascular disease, prompting a European League Against Rheumatism task force to issue the group's first consensus recommendations for managing cardiovascular risk in these patients.

“In our view, rheumatoid arthritis [RA], ankylosing spondylitis [AS], and psoriatic arthritis [PsA] should be seen as new, independent cardiovascular risk factors,” Dr. Michael T. Nurmohamed said at the annual European Congress of Rheumatology. “The risk is comparable to type 2 diabetes,” added Dr. Nurmohamed, of Free University Medical Center in Amsterdam.

“Cardiovascular risk management is absolutely necessary” in patients with RA, AS, or PsA, and should involve assessing and treating conventional cardiovascular disease (CVD) risk factors as well as suppressing the underlying inflammatory process by treatment with disease-modifying antirheumatic drugs (DMARDs). “Most important is to decrease the inflammatory burden as much as possible,” through the use of biologic and/or synthetic DMARDs, he said in an interview. “The extent to which antirheumatic treatment decreases the risk is not known.”

Just as cardiovascular disease is now the most feared outcome of diabetes, it may be time to expand the definition of the clinical impact of RA, AS, and PsA to include the extra CVD burden they trigger, Dr. Nurmohamed said.

Designation of RA, AS, and PsA as CVD risk factors by a task force of the European League Against Rheumatism (EULAR) is the first time a major medical group has singled out these conditions in this way.

The extra risk from these disorders is substantial.

When a clinician uses the European SCORE (Systemic Coronary Risk Evaluation) formula to calculate an RA patient's 10-year risk for cardiovascular disease death, the number should be increased by 50% to get the patient's actual risk when at least two of three criteria are present: disease duration more than 10 years, positivity for rheumatoid factor or anti-cyclic citrullinated peptide antibody, or extra-articular manifestations.

Dr. Nurmohamed based his recommendation on findings from an analysis done with his associates that found a greater than twofold increased risk for CVD in patients with RA, compared with people without RA. The higher level of conventional risk factors among the RA patients in the study explained roughly half of the doubled risk. The other half of the increased risk was directly attributable to RA, he said.

Similarly, a person's Framingham risk score for having a cardiovascular event should also be boosted by about 50% if RA, AS, or PsA is present, he said.

Major evidence for the impact of rheumatoid diseases on cardiovascular risk came in data on findings—from 294 patients with RA, 194 patients with type 2 diabetes, and 258 controls, all aged 50-75 years—that Dr. Nurmohamed and his associates first reported last year.

In an analysis that controlled for age, sex, and cardiovascular risk factors, patients with RA had a 2.7-fold increased risk for cardiovascular disease events, compared with controls, and patients with type 2 diabetes had a twofold increased risk (Ann. Rheum. Dis. 2008 Aug. 12 [doi:10.1136/ard.2008.094151]).

These and other findings prompted Dr. Nurmohamed to convene an 18-member task force for EULAR that included rheumatologists, cardiologists, internists, and epidemiologists from nine European countries. The panel wrote nine evidence- and expert-opinion-based recommendations for the management of cardiovascular risk in these patients.

The key recommendation is that patients with RA, AS, or PsA should be considered at high risk for developing CVD because of both an increased prevalence of traditional CVD risk factors and their inflammatory burden.

“The increased CVD risk in patients with inflammatory arthritis is now well recognized. Everyone is aware that something should be done,” he said in the interview. But the extent to which the new guidelines are already routinely followed in Europe by physicians who manage these patients is variable. In some countries, CVD risk management in patients with rheumatoid diseases is uncommon.

He acknowledged that the evidence supporting a CVD effect is stronger for RA than for AS and PsA, but added that adequate evidence exists to support including AS and PsA in the recommendations.

Dr. Nurmohamed itemized the other eight task force recommendations:

▸ Adequate control of rheumatoid disease activity is necessary to lower a patient's CVD risk.

▸ A CVD risk assessment following evidence-based EULAR guidelines is recommended annually for all RA patients, and should be considered for all patients with AS and PsA.

▸ CVD risk score models should be multiplied by 1.5 when an RA patient has at least two of the following three criteria: disease duration of more than 10 years, positivity for rheumatoid factor or anti-cyclic citrullinated peptide antibody, and extra-articular manifestations.

▸ The total cholesterol: HDL cholesterol ratio should be used in the formula for estimating CVD risk.

▸ Interventions with lipid-lowering drugs and with antihypertensive medications should follow national guidelines.

▸ Statins, ACE inhibitors, and angiotensin receptor blockers are the preferred treatment agents because of their pleiotropic effects. Therapy with 40 mg atorvastatin daily in patients with RA was shown to produce a modest but significant improvement in RA disease activity (Lancet 2004;363:2015-21).

▸ The role of cyclooxygenase-2 selective inhibitors (coxibs) and most NSAIDs in most CVD is not well established and needs further investigation; therefore, these agents should be prescribed with caution.

▸ When corticosteroids are prescribed, they should be at the lowest dose possible.

Dr. Nurmohamed reported having no financial conflicts.

COPENHAGEN — Psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis are as strong as diabetes as risk factors for cardiovascular disease, prompting a European League Against Rheumatism task force to issue the group's first consensus recommendations for managing cardiovascular risk in these patients.

“In our view, rheumatoid arthritis [RA], ankylosing spondylitis [AS], and psoriatic arthritis [PsA] should be seen as new, independent cardiovascular risk factors,” Dr. Michael T. Nurmohamed said at the annual European Congress of Rheumatology. “The risk is comparable to type 2 diabetes,” added Dr. Nurmohamed, of Free University Medical Center in Amsterdam.

“Cardiovascular risk management is absolutely necessary” in patients with RA, AS, or PsA, and should involve assessing and treating conventional cardiovascular disease (CVD) risk factors as well as suppressing the underlying inflammatory process by treatment with disease-modifying antirheumatic drugs (DMARDs). “Most important is to decrease the inflammatory burden as much as possible,” through the use of biologic and/or synthetic DMARDs, he said in an interview. “The extent to which antirheumatic treatment decreases the risk is not known.”

Just as cardiovascular disease is now the most feared outcome of diabetes, it may be time to expand the definition of the clinical impact of RA, AS, and PsA to include the extra CVD burden they trigger, Dr. Nurmohamed said.

Designation of RA, AS, and PsA as CVD risk factors by a task force of the European League Against Rheumatism (EULAR) is the first time a major medical group has singled out these conditions in this way.

The extra risk from these disorders is substantial.

When a clinician uses the European SCORE (Systemic Coronary Risk Evaluation) formula to calculate an RA patient's 10-year risk for cardiovascular disease death, the number should be increased by 50% to get the patient's actual risk when at least two of three criteria are present: disease duration more than 10 years, positivity for rheumatoid factor or anti-cyclic citrullinated peptide antibody, or extra-articular manifestations.

Dr. Nurmohamed based his recommendation on findings from an analysis done with his associates that found a greater than twofold increased risk for CVD in patients with RA, compared with people without RA. The higher level of conventional risk factors among the RA patients in the study explained roughly half of the doubled risk. The other half of the increased risk was directly attributable to RA, he said.

Similarly, a person's Framingham risk score for having a cardiovascular event should also be boosted by about 50% if RA, AS, or PsA is present, he said.

Major evidence for the impact of rheumatoid diseases on cardiovascular risk came in data on findings—from 294 patients with RA, 194 patients with type 2 diabetes, and 258 controls, all aged 50-75 years—that Dr. Nurmohamed and his associates first reported last year.

In an analysis that controlled for age, sex, and cardiovascular risk factors, patients with RA had a 2.7-fold increased risk for cardiovascular disease events, compared with controls, and patients with type 2 diabetes had a twofold increased risk (Ann. Rheum. Dis. 2008 Aug. 12 [doi:10.1136/ard.2008.094151]).

These and other findings prompted Dr. Nurmohamed to convene an 18-member task force for EULAR that included rheumatologists, cardiologists, internists, and epidemiologists from nine European countries. The panel wrote nine evidence- and expert-opinion-based recommendations for the management of cardiovascular risk in these patients.

The key recommendation is that patients with RA, AS, or PsA should be considered at high risk for developing CVD because of both an increased prevalence of traditional CVD risk factors and their inflammatory burden.

“The increased CVD risk in patients with inflammatory arthritis is now well recognized. Everyone is aware that something should be done,” he said in the interview. But the extent to which the new guidelines are already routinely followed in Europe by physicians who manage these patients is variable. In some countries, CVD risk management in patients with rheumatoid diseases is uncommon.

He acknowledged that the evidence supporting a CVD effect is stronger for RA than for AS and PsA, but added that adequate evidence exists to support including AS and PsA in the recommendations.

Dr. Nurmohamed itemized the other eight task force recommendations:

▸ Adequate control of rheumatoid disease activity is necessary to lower a patient's CVD risk.

▸ A CVD risk assessment following evidence-based EULAR guidelines is recommended annually for all RA patients, and should be considered for all patients with AS and PsA.

▸ CVD risk score models should be multiplied by 1.5 when an RA patient has at least two of the following three criteria: disease duration of more than 10 years, positivity for rheumatoid factor or anti-cyclic citrullinated peptide antibody, and extra-articular manifestations.

▸ The total cholesterol: HDL cholesterol ratio should be used in the formula for estimating CVD risk.

▸ Interventions with lipid-lowering drugs and with antihypertensive medications should follow national guidelines.

▸ Statins, ACE inhibitors, and angiotensin receptor blockers are the preferred treatment agents because of their pleiotropic effects. Therapy with 40 mg atorvastatin daily in patients with RA was shown to produce a modest but significant improvement in RA disease activity (Lancet 2004;363:2015-21).

▸ The role of cyclooxygenase-2 selective inhibitors (coxibs) and most NSAIDs in most CVD is not well established and needs further investigation; therefore, these agents should be prescribed with caution.

▸ When corticosteroids are prescribed, they should be at the lowest dose possible.

Dr. Nurmohamed reported having no financial conflicts.

COPENHAGEN — New European League Against Rheumatism recommendations for monitoring systemic lupus erythematosus offer a road map for careful assessment of the multiple organ systems that the disease can attack.

The guidelines also distinguish among potentially reversible disease activity, disease-related organ damage, and health problems that are unrelated to the disease, Dr. Marta Mosca reported at the annual European Congress of Rheumatology.

The evidence-based recommendations “are designed specifically for use in clinical practice by rheumatologists and other clinicians caring for lupus patients,” said Dr. Mosca, a rheumatologist at the University of Pisa, Italy, and lead author of the recommendation paper.

The 10 recommendations include:

▸ Patient assessment. In addition to routine clinical practice, “the assessment of SLE patients must include an evaluation of disease activity with a validated index at each visit and an annual evaluation of organ damage,” said Dr. Mosca.

Additionally, general quality of life, as ascertained by patient history and by a 0-10 visual analog scale, comorbidities, and drug toxicity should be assessed at each visit.

▸ Cardiovascular risk factors. At the baseline visit, and at least once annually during follow-up, “ask patients about smoking, vascular events, physical activity, their use of oral contraceptives and/or hormonal therapies, and family history,” Dr. Mosca said.

Lipid profile and serum glucose measurement should be done at baseline and annually thereafter, as should examination of blood pressure and body mass index or waist circumference. “Dependent on the findings, a patient may require more regular follow-up for specific conditions,” she said.

▸ Other comorbidities. Individuals with lupus are at increased risk for certain comorbidities, in particular osteoporosis, said Dr. Mosca. “Corticosteroid medications can trigger bone loss; disease-associated pain and fatigue can lead to inactivity, further increasing the osteoporosis risk; and bone loss may occur as a direct result of the disease.”

The guidelines recommend assessing all SLE patients for adequate calcium and vitamin D intake, regular exercise, and smoking status.

SLE patients should be screened and followed for osteoporosis according to the guidelines for postmenopausal women, for patients on steroids, or for patients on any other drug that may interfere with bone mineral density, she said at the meeting.

Studies have also shown that SLE patients are at an increased risk for certain cancers, “yet lupus patients tend to undergo screening less often than do individuals in the general population,” possibly because lupus-related concerns may take precedence, said Dr. Mosca. The guidelines recommend cancer screening according to the guidelines for the general population.

“It's up to the clinicians who care for these patients to encourage appropriate screening,” she said.

▸ Infection risk. Lupus patients should be screened for HIV based on individual risk factors, and they should be screened for the hepatitis C and the hepatitis B viruses and for tuberculosis according to local guidelines before beginning immunosuppressive therapy, according to the recommendations.

During immunosuppressive therapy, selected SLE patients should be tested for cytomegalovirus infection, because it increases the degree of immunosuppression of cell-mediated immunity, Dr. Mosca said.

Because of the increased risk of infection in SLE, patients should receive only inactivated pneumococcal and influenzae vaccines, according to CDC guidelines for immunosuppressed patients, “preferably during periods of inactive disease,” she said.

▸ Frequency of assessment. The recommendations suggest patient assessments every 6-12 months for individuals with inactive disease, no organ damage, and no comorbidities. The treating clinician should emphasize prevention at the time of these assessments, Dr. Mosca said.

▸ Laboratory assessment. According to the guidelines, baseline laboratory assessment should include testing for anti-nuclear antibodies (ANA), anti-phospholipid (aPL) antibodies, Complement 3 (C3) and Complement 4 (C4), as well as the following autoantibodies: anti-double stranded DNA (anti-dsDNA), anti-Ro, anti-La, and anti-ribonuclear protein (RNP).

Prior to pregnancy, previously negative patients should be re-evaluated for aPL, anti-Ro, and anti-La antibodies. Prior to surgery, transplant, or the initiation of estrogen-containing treatments, or in the presence of a new neurologic or vascular event, previously negative patients should be tested for aPL, according to Dr. Mosca.

At 6- to 12-month intervals in patients with inactive disease, “we recommend performing a complete blood cell count, erythrocyte sedimentation rate, C-reactive protein, serum albumin, serum creatinine, and urinalysis,” she said. “Monitoring should be tailored to specific treatment drugs, when necessary.”

▸ Mucocutaneous involvement. “Mucocutaneous lesions should be characterized, according to existing classification systems, as to whether they may be lupus-specific, lupus nonspecific, lupus mimickers, or drug related,” Dr. Mosca reported. “All lesions should be assessed for activity and damage using validated indexes.”

▸ Kidney involvement. Monitoring recommendations in this domain depend on kidney status.

“Patients with persistently abnormal urinalysis or creatinine should have a urine protein/creatinine ratio or 24-hour proteinuria [test], urine microscopy, renal ultrasound, and be considered for biopsy referral,” Dr. Mosca said. “Patients with established nephropathy should have urine protein/creatinine ratio or 24-hour proteinuria [test], immunological studies [C3, C4, anti-dsDNA], and urine microscopy at least every 3 months for the first 2-3 years; and patients with established chronic kidney disease should be followed according to the National Kidney Foundation guidelines for chronic kidney disease.”

▸ Neuropsychological manifestations. Although the rate of neurocognitive impairment in SLE is high, “monitoring neurocognitive status is difficult because there are no standardized assessment tools for this population,” Dr. Mosca stated.

All SLE patients should be monitored for neuropsychological symptoms using a focused history. Additionally, “cognitive impairment may be assessed by evaluating memory, attention, concentration, and word finding difficulties; and if there is suspicion of cognitive impairment, the patient should be referred to a specialist for a more detailed assessment,” she said.

▸ Eye assessment. Eye damage in patients with lupus varies from minor problems to severe retinopathy. A small percentage of lupus patients develop scleritis, retinal vasculitis, cotton wool spots at the back of the eyeball, or retinal bleeding and swelling of the optic disc.

According to the guidelines, patients on steroids or antimalarial drugs should undergo a baseline eye examination according to standard recommendations.

Annual follow-up eye exams are recommended in selected patients taking steroids and those at high risk for eye problems.

“In patients taking antimalarial drugs who are low risk for eye problems, no further testing is required until after 5 years from baseline, at which point yearly examinations are recommended,” Dr. Mosca said.

In addition to facilitating good clinical practice, the recommendations for monitoring SLE are expected to “improve the quality control of care for lupus patients and to standardize the collection and comparison of data in observational studies,” Dr. Mosca concluded.

The recommendations, which are expected to be published in the Annals of Rheumatic Disease later this year, were developed by an expert panel using a three-staged consensus approach comprising a discussion of relevant categories, a comprehensive literature review and level of evidence assessment, and the integration of the evidence with expert opinion, said Dr. Mosca.

She reported having no financial conflicts of interest to disclose.

COPENHAGEN — New European League Against Rheumatism recommendations for monitoring systemic lupus erythematosus offer a road map for careful assessment of the multiple organ systems that the disease can attack.

The guidelines also distinguish among potentially reversible disease activity, disease-related organ damage, and health problems that are unrelated to the disease, Dr. Marta Mosca reported at the annual European Congress of Rheumatology.

The evidence-based recommendations “are designed specifically for use in clinical practice by rheumatologists and other clinicians caring for lupus patients,” said Dr. Mosca, a rheumatologist at the University of Pisa, Italy, and lead author of the recommendation paper.

The 10 recommendations include:

▸ Patient assessment. In addition to routine clinical practice, “the assessment of SLE patients must include an evaluation of disease activity with a validated index at each visit and an annual evaluation of organ damage,” said Dr. Mosca.

Additionally, general quality of life, as ascertained by patient history and by a 0-10 visual analog scale, comorbidities, and drug toxicity should be assessed at each visit.

▸ Cardiovascular risk factors. At the baseline visit, and at least once annually during follow-up, “ask patients about smoking, vascular events, physical activity, their use of oral contraceptives and/or hormonal therapies, and family history,” Dr. Mosca said.

Lipid profile and serum glucose measurement should be done at baseline and annually thereafter, as should examination of blood pressure and body mass index or waist circumference. “Dependent on the findings, a patient may require more regular follow-up for specific conditions,” she said.

▸ Other comorbidities. Individuals with lupus are at increased risk for certain comorbidities, in particular osteoporosis, said Dr. Mosca. “Corticosteroid medications can trigger bone loss; disease-associated pain and fatigue can lead to inactivity, further increasing the osteoporosis risk; and bone loss may occur as a direct result of the disease.”

The guidelines recommend assessing all SLE patients for adequate calcium and vitamin D intake, regular exercise, and smoking status.

SLE patients should be screened and followed for osteoporosis according to the guidelines for postmenopausal women, for patients on steroids, or for patients on any other drug that may interfere with bone mineral density, she said at the meeting.

Studies have also shown that SLE patients are at an increased risk for certain cancers, “yet lupus patients tend to undergo screening less often than do individuals in the general population,” possibly because lupus-related concerns may take precedence, said Dr. Mosca. The guidelines recommend cancer screening according to the guidelines for the general population.

“It's up to the clinicians who care for these patients to encourage appropriate screening,” she said.

▸ Infection risk. Lupus patients should be screened for HIV based on individual risk factors, and they should be screened for the hepatitis C and the hepatitis B viruses and for tuberculosis according to local guidelines before beginning immunosuppressive therapy, according to the recommendations.

During immunosuppressive therapy, selected SLE patients should be tested for cytomegalovirus infection, because it increases the degree of immunosuppression of cell-mediated immunity, Dr. Mosca said.

Because of the increased risk of infection in SLE, patients should receive only inactivated pneumococcal and influenzae vaccines, according to CDC guidelines for immunosuppressed patients, “preferably during periods of inactive disease,” she said.

▸ Frequency of assessment. The recommendations suggest patient assessments every 6-12 months for individuals with inactive disease, no organ damage, and no comorbidities. The treating clinician should emphasize prevention at the time of these assessments, Dr. Mosca said.

▸ Laboratory assessment. According to the guidelines, baseline laboratory assessment should include testing for anti-nuclear antibodies (ANA), anti-phospholipid (aPL) antibodies, Complement 3 (C3) and Complement 4 (C4), as well as the following autoantibodies: anti-double stranded DNA (anti-dsDNA), anti-Ro, anti-La, and anti-ribonuclear protein (RNP).

Prior to pregnancy, previously negative patients should be re-evaluated for aPL, anti-Ro, and anti-La antibodies. Prior to surgery, transplant, or the initiation of estrogen-containing treatments, or in the presence of a new neurologic or vascular event, previously negative patients should be tested for aPL, according to Dr. Mosca.

At 6- to 12-month intervals in patients with inactive disease, “we recommend performing a complete blood cell count, erythrocyte sedimentation rate, C-reactive protein, serum albumin, serum creatinine, and urinalysis,” she said. “Monitoring should be tailored to specific treatment drugs, when necessary.”

▸ Mucocutaneous involvement. “Mucocutaneous lesions should be characterized, according to existing classification systems, as to whether they may be lupus-specific, lupus nonspecific, lupus mimickers, or drug related,” Dr. Mosca reported. “All lesions should be assessed for activity and damage using validated indexes.”

▸ Kidney involvement. Monitoring recommendations in this domain depend on kidney status.

“Patients with persistently abnormal urinalysis or creatinine should have a urine protein/creatinine ratio or 24-hour proteinuria [test], urine microscopy, renal ultrasound, and be considered for biopsy referral,” Dr. Mosca said. “Patients with established nephropathy should have urine protein/creatinine ratio or 24-hour proteinuria [test], immunological studies [C3, C4, anti-dsDNA], and urine microscopy at least every 3 months for the first 2-3 years; and patients with established chronic kidney disease should be followed according to the National Kidney Foundation guidelines for chronic kidney disease.”

▸ Neuropsychological manifestations. Although the rate of neurocognitive impairment in SLE is high, “monitoring neurocognitive status is difficult because there are no standardized assessment tools for this population,” Dr. Mosca stated.

All SLE patients should be monitored for neuropsychological symptoms using a focused history. Additionally, “cognitive impairment may be assessed by evaluating memory, attention, concentration, and word finding difficulties; and if there is suspicion of cognitive impairment, the patient should be referred to a specialist for a more detailed assessment,” she said.

▸ Eye assessment. Eye damage in patients with lupus varies from minor problems to severe retinopathy. A small percentage of lupus patients develop scleritis, retinal vasculitis, cotton wool spots at the back of the eyeball, or retinal bleeding and swelling of the optic disc.

According to the guidelines, patients on steroids or antimalarial drugs should undergo a baseline eye examination according to standard recommendations.

Annual follow-up eye exams are recommended in selected patients taking steroids and those at high risk for eye problems.

“In patients taking antimalarial drugs who are low risk for eye problems, no further testing is required until after 5 years from baseline, at which point yearly examinations are recommended,” Dr. Mosca said.

In addition to facilitating good clinical practice, the recommendations for monitoring SLE are expected to “improve the quality control of care for lupus patients and to standardize the collection and comparison of data in observational studies,” Dr. Mosca concluded.

The recommendations, which are expected to be published in the Annals of Rheumatic Disease later this year, were developed by an expert panel using a three-staged consensus approach comprising a discussion of relevant categories, a comprehensive literature review and level of evidence assessment, and the integration of the evidence with expert opinion, said Dr. Mosca.

She reported having no financial conflicts of interest to disclose.

COPENHAGEN — New European League Against Rheumatism recommendations for monitoring systemic lupus erythematosus offer a road map for careful assessment of the multiple organ systems that the disease can attack.

The guidelines also distinguish among potentially reversible disease activity, disease-related organ damage, and health problems that are unrelated to the disease, Dr. Marta Mosca reported at the annual European Congress of Rheumatology.

The evidence-based recommendations “are designed specifically for use in clinical practice by rheumatologists and other clinicians caring for lupus patients,” said Dr. Mosca, a rheumatologist at the University of Pisa, Italy, and lead author of the recommendation paper.

The 10 recommendations include:

▸ Patient assessment. In addition to routine clinical practice, “the assessment of SLE patients must include an evaluation of disease activity with a validated index at each visit and an annual evaluation of organ damage,” said Dr. Mosca.

Additionally, general quality of life, as ascertained by patient history and by a 0-10 visual analog scale, comorbidities, and drug toxicity should be assessed at each visit.

▸ Cardiovascular risk factors. At the baseline visit, and at least once annually during follow-up, “ask patients about smoking, vascular events, physical activity, their use of oral contraceptives and/or hormonal therapies, and family history,” Dr. Mosca said.

Lipid profile and serum glucose measurement should be done at baseline and annually thereafter, as should examination of blood pressure and body mass index or waist circumference. “Dependent on the findings, a patient may require more regular follow-up for specific conditions,” she said.

▸ Other comorbidities. Individuals with lupus are at increased risk for certain comorbidities, in particular osteoporosis, said Dr. Mosca. “Corticosteroid medications can trigger bone loss; disease-associated pain and fatigue can lead to inactivity, further increasing the osteoporosis risk; and bone loss may occur as a direct result of the disease.”

The guidelines recommend assessing all SLE patients for adequate calcium and vitamin D intake, regular exercise, and smoking status.

SLE patients should be screened and followed for osteoporosis according to the guidelines for postmenopausal women, for patients on steroids, or for patients on any other drug that may interfere with bone mineral density, she said at the meeting.

Studies have also shown that SLE patients are at an increased risk for certain cancers, “yet lupus patients tend to undergo screening less often than do individuals in the general population,” possibly because lupus-related concerns may take precedence, said Dr. Mosca. The guidelines recommend cancer screening according to the guidelines for the general population.

“It's up to the clinicians who care for these patients to encourage appropriate screening,” she said.

▸ Infection risk. Lupus patients should be screened for HIV based on individual risk factors, and they should be screened for the hepatitis C and the hepatitis B viruses and for tuberculosis according to local guidelines before beginning immunosuppressive therapy, according to the recommendations.

During immunosuppressive therapy, selected SLE patients should be tested for cytomegalovirus infection, because it increases the degree of immunosuppression of cell-mediated immunity, Dr. Mosca said.

Because of the increased risk of infection in SLE, patients should receive only inactivated pneumococcal and influenzae vaccines, according to CDC guidelines for immunosuppressed patients, “preferably during periods of inactive disease,” she said.

▸ Frequency of assessment. The recommendations suggest patient assessments every 6-12 months for individuals with inactive disease, no organ damage, and no comorbidities. The treating clinician should emphasize prevention at the time of these assessments, Dr. Mosca said.

▸ Laboratory assessment. According to the guidelines, baseline laboratory assessment should include testing for anti-nuclear antibodies (ANA), anti-phospholipid (aPL) antibodies, Complement 3 (C3) and Complement 4 (C4), as well as the following autoantibodies: anti-double stranded DNA (anti-dsDNA), anti-Ro, anti-La, and anti-ribonuclear protein (RNP).

Prior to pregnancy, previously negative patients should be re-evaluated for aPL, anti-Ro, and anti-La antibodies. Prior to surgery, transplant, or the initiation of estrogen-containing treatments, or in the presence of a new neurologic or vascular event, previously negative patients should be tested for aPL, according to Dr. Mosca.

At 6- to 12-month intervals in patients with inactive disease, “we recommend performing a complete blood cell count, erythrocyte sedimentation rate, C-reactive protein, serum albumin, serum creatinine, and urinalysis,” she said. “Monitoring should be tailored to specific treatment drugs, when necessary.”

▸ Mucocutaneous involvement. “Mucocutaneous lesions should be characterized, according to existing classification systems, as to whether they may be lupus-specific, lupus nonspecific, lupus mimickers, or drug related,” Dr. Mosca reported. “All lesions should be assessed for activity and damage using validated indexes.”

▸ Kidney involvement. Monitoring recommendations in this domain depend on kidney status.

“Patients with persistently abnormal urinalysis or creatinine should have a urine protein/creatinine ratio or 24-hour proteinuria [test], urine microscopy, renal ultrasound, and be considered for biopsy referral,” Dr. Mosca said. “Patients with established nephropathy should have urine protein/creatinine ratio or 24-hour proteinuria [test], immunological studies [C3, C4, anti-dsDNA], and urine microscopy at least every 3 months for the first 2-3 years; and patients with established chronic kidney disease should be followed according to the National Kidney Foundation guidelines for chronic kidney disease.”

▸ Neuropsychological manifestations. Although the rate of neurocognitive impairment in SLE is high, “monitoring neurocognitive status is difficult because there are no standardized assessment tools for this population,” Dr. Mosca stated.

All SLE patients should be monitored for neuropsychological symptoms using a focused history. Additionally, “cognitive impairment may be assessed by evaluating memory, attention, concentration, and word finding difficulties; and if there is suspicion of cognitive impairment, the patient should be referred to a specialist for a more detailed assessment,” she said.

▸ Eye assessment. Eye damage in patients with lupus varies from minor problems to severe retinopathy. A small percentage of lupus patients develop scleritis, retinal vasculitis, cotton wool spots at the back of the eyeball, or retinal bleeding and swelling of the optic disc.

According to the guidelines, patients on steroids or antimalarial drugs should undergo a baseline eye examination according to standard recommendations.

Annual follow-up eye exams are recommended in selected patients taking steroids and those at high risk for eye problems.

“In patients taking antimalarial drugs who are low risk for eye problems, no further testing is required until after 5 years from baseline, at which point yearly examinations are recommended,” Dr. Mosca said.

In addition to facilitating good clinical practice, the recommendations for monitoring SLE are expected to “improve the quality control of care for lupus patients and to standardize the collection and comparison of data in observational studies,” Dr. Mosca concluded.

The recommendations, which are expected to be published in the Annals of Rheumatic Disease later this year, were developed by an expert panel using a three-staged consensus approach comprising a discussion of relevant categories, a comprehensive literature review and level of evidence assessment, and the integration of the evidence with expert opinion, said Dr. Mosca.

She reported having no financial conflicts of interest to disclose.

SAN FRANCISCO — Nearly 8% of 152 patients with cutaneous lupus erythematosus had refractory disease, a prospective epidemiologic study found.

Skin lesions remained active in these patients despite aggressive medical treatment with conventional therapies, Dr. Siamak Moghadam-Kia and associates reported in a poster presentation at the annual meeting of the Federation of Clinical Immunology Societies.

The investigators created an online database to describe disease characteristics and to gather longitudinal information on patients with cutaneous lupus erythematosus (CLE). The information should prove useful as biotechnology companies prepare to test new therapies for the disease, noted Dr. Siamak Moghadam-Kia of the dermatology department at the University of Pennsylvania, Philadelphia.

All adult patients with CLE who were seen from January 2007 to December 2008 at the university's cutaneous autoimmunity outpatient clinic were invited to participate in the pilot study. Their cutaneous disease was evaluated using the CLE Disease Area and Severity Index (CLASI), and at each visit patients completed the CLE-Modified Skindex-29 to assess quality of life.

Subgroups included patients with acute CLE (6%), subacute CLE (25%), chronic CLE (61%), SLE plus lupus erythematous-nonspecific skin disease (8%), and one patient (less than 1%) who had only lupus erythematosus-nonspecific skin disease. (Percentages total more than 100 because of rounding.)

Among patients whose disease was refractory to therapy, 58% had generalized chronic CLE, 17% had localized chronic CLE, and 8% had subacute CLE, with the rest in other categories, Dr. Moghadam-Kia reported.

Most participants in the study were women (82%), and most cases of refractory disease were in women. In the whole cohort, the female:male sex ratio was 8:1 in subjects with acute CLE, 5:1 in subjects with subacute CLE, and nearly 4:1 in subjects with chronic CLE.

The cohort and most subgroups included a mix of races, although the subacute CLE cohort was predominantly white. The racial profile of patients with refractory disease did not differ from race distribution in the cohort as a whole.

Patients with refractory disease were significantly more likely to have a current or prior history of smoking, compared with those whose CLE responded to treatment. Smoking may be a risk factor for refractory CLE, Dr. Moghadam-Kia suggested.

The study may be the first systemic multicenter epidemiologic study of CLE in the United States, he noted.

The investigators hope to use the database prospectively to monitor response to treatment and disease severity, to assess the feasibility of measures of disease flares, and to compare measures of skin-specific and general quality of life in patients with CLE. They also hope more clinical sites will be incorporated into the database.

The poster and the meeting program did not disclose any potential conflicts of interest for the investigators.

SAN FRANCISCO — Nearly 8% of 152 patients with cutaneous lupus erythematosus had refractory disease, a prospective epidemiologic study found.

Skin lesions remained active in these patients despite aggressive medical treatment with conventional therapies, Dr. Siamak Moghadam-Kia and associates reported in a poster presentation at the annual meeting of the Federation of Clinical Immunology Societies.

The investigators created an online database to describe disease characteristics and to gather longitudinal information on patients with cutaneous lupus erythematosus (CLE). The information should prove useful as biotechnology companies prepare to test new therapies for the disease, noted Dr. Siamak Moghadam-Kia of the dermatology department at the University of Pennsylvania, Philadelphia.

All adult patients with CLE who were seen from January 2007 to December 2008 at the university's cutaneous autoimmunity outpatient clinic were invited to participate in the pilot study. Their cutaneous disease was evaluated using the CLE Disease Area and Severity Index (CLASI), and at each visit patients completed the CLE-Modified Skindex-29 to assess quality of life.

Subgroups included patients with acute CLE (6%), subacute CLE (25%), chronic CLE (61%), SLE plus lupus erythematous-nonspecific skin disease (8%), and one patient (less than 1%) who had only lupus erythematosus-nonspecific skin disease. (Percentages total more than 100 because of rounding.)

Among patients whose disease was refractory to therapy, 58% had generalized chronic CLE, 17% had localized chronic CLE, and 8% had subacute CLE, with the rest in other categories, Dr. Moghadam-Kia reported.

Most participants in the study were women (82%), and most cases of refractory disease were in women. In the whole cohort, the female:male sex ratio was 8:1 in subjects with acute CLE, 5:1 in subjects with subacute CLE, and nearly 4:1 in subjects with chronic CLE.

The cohort and most subgroups included a mix of races, although the subacute CLE cohort was predominantly white. The racial profile of patients with refractory disease did not differ from race distribution in the cohort as a whole.

Patients with refractory disease were significantly more likely to have a current or prior history of smoking, compared with those whose CLE responded to treatment. Smoking may be a risk factor for refractory CLE, Dr. Moghadam-Kia suggested.

The study may be the first systemic multicenter epidemiologic study of CLE in the United States, he noted.

The investigators hope to use the database prospectively to monitor response to treatment and disease severity, to assess the feasibility of measures of disease flares, and to compare measures of skin-specific and general quality of life in patients with CLE. They also hope more clinical sites will be incorporated into the database.

The poster and the meeting program did not disclose any potential conflicts of interest for the investigators.

SAN FRANCISCO — Nearly 8% of 152 patients with cutaneous lupus erythematosus had refractory disease, a prospective epidemiologic study found.

Skin lesions remained active in these patients despite aggressive medical treatment with conventional therapies, Dr. Siamak Moghadam-Kia and associates reported in a poster presentation at the annual meeting of the Federation of Clinical Immunology Societies.

The investigators created an online database to describe disease characteristics and to gather longitudinal information on patients with cutaneous lupus erythematosus (CLE). The information should prove useful as biotechnology companies prepare to test new therapies for the disease, noted Dr. Siamak Moghadam-Kia of the dermatology department at the University of Pennsylvania, Philadelphia.

All adult patients with CLE who were seen from January 2007 to December 2008 at the university's cutaneous autoimmunity outpatient clinic were invited to participate in the pilot study. Their cutaneous disease was evaluated using the CLE Disease Area and Severity Index (CLASI), and at each visit patients completed the CLE-Modified Skindex-29 to assess quality of life.

Subgroups included patients with acute CLE (6%), subacute CLE (25%), chronic CLE (61%), SLE plus lupus erythematous-nonspecific skin disease (8%), and one patient (less than 1%) who had only lupus erythematosus-nonspecific skin disease. (Percentages total more than 100 because of rounding.)

Among patients whose disease was refractory to therapy, 58% had generalized chronic CLE, 17% had localized chronic CLE, and 8% had subacute CLE, with the rest in other categories, Dr. Moghadam-Kia reported.

Most participants in the study were women (82%), and most cases of refractory disease were in women. In the whole cohort, the female:male sex ratio was 8:1 in subjects with acute CLE, 5:1 in subjects with subacute CLE, and nearly 4:1 in subjects with chronic CLE.

The cohort and most subgroups included a mix of races, although the subacute CLE cohort was predominantly white. The racial profile of patients with refractory disease did not differ from race distribution in the cohort as a whole.

Patients with refractory disease were significantly more likely to have a current or prior history of smoking, compared with those whose CLE responded to treatment. Smoking may be a risk factor for refractory CLE, Dr. Moghadam-Kia suggested.

The study may be the first systemic multicenter epidemiologic study of CLE in the United States, he noted.

The investigators hope to use the database prospectively to monitor response to treatment and disease severity, to assess the feasibility of measures of disease flares, and to compare measures of skin-specific and general quality of life in patients with CLE. They also hope more clinical sites will be incorporated into the database.

The poster and the meeting program did not disclose any potential conflicts of interest for the investigators.

Source ELSEVIER GLOBAL MEDICAL NEWS

Source ELSEVIER GLOBAL MEDICAL NEWS

Source ELSEVIER GLOBAL MEDICAL NEWS

The palliative effects of immersing in baths or pools of thermomineral water, known as balneotherapy, have been known for centuries, with modern practices dating back to the 1800s and natural health spas dating back more than 3,000 years (Dermatol. Ther. 2003;16:132-40; Clin. Dermatol. 1996;14:659-64).

Places such as the Kangal hot spring in Turkey, the Blue Lagoon in Iceland, and the Dead Sea between Israel and Jordan are particularly popular “hot spots” for such therapy.

The Dead Sea is the lowest saline lake—and the lowest accessible point—on earth (400 meters, or about 1,300 feet, below sea level). Its therapeutic benefits have been well known for 1,500 years, with the modern era for such treatments beginning in 1959 (Clin. Dermatol. 1998;16:695-8). Over the past half century, the Dead Sea has become well recognized for its balneologic activity, allowing climatotherapy to be used for dermatologic and rheumatologic conditions.

In particular, Dead Sea climatotherapy is considered to be very effective in the treatment of psoriasis and, to a lesser extent, atopic dermatitis (J. Am. Acad. Dermatol. 2005;52:445-50; Arch. Dermatol. 1998;134:1416-20). Other conditions successfully treated with balneotherapy include acne, alopecia areata, chronic ulcers, contact dermatitis, dyshidrotic dermatitis, granuloma annulare, ichthyosis, lichen planus, lichen sclerosus and atrophicus, mycosis fungoides, palmoplantar keratosis, pityriasis rubra pilaris, pruritus, rosacea, scleroderma, seborrheic dermatitis, urticaria pigmentosa, vitiligo, and xerosis (Dermatol. Ther. 2003;16:132-40). Products that contain Dead Sea minerals are currently used to treat several of these cutaneous conditions.

 Dissolved Minerals

The Dead Sea, which contains exceedingly high salt concentrations, acts as a reservoir of minerals with distinct evaporation properties. Dead Sea salts are the source of numerous chemical and health products. Specifically, various skin conditions and allergies, as well as arthritis and respiratory disorders, have been treated with Dead Sea-derived magnesium salts and sulfur-containing mud (Rev. Environ. Health 1999;14:257-67). Magnesium salts, which are known to have anti-inflammatory activity, are the prevailing minerals in Dead Sea water (Int. J. Dermatol. 2005;44:151-7). Compared with the world's oceans, the Dead Sea is more abundant in calcium, magnesium, potassium, and bromide, and lower in sodium, sulfate, and carbonate (Dermatol. Ther. 2003;16:132-40; Int. J. Dermatol. 1989;28:1-9).

Enzyme Stimulation

In 1985, Shani et al. found that glutathione peroxidase activity was significantly increased in 35 psoriatic Danes who received 4-week therapy at the Ein Bokek International Psoriasis Treatment Center along the Dead Sea in Israel. The drinking water at the center was found to be rich in selenium. The researchers assayed the activity of erythrocyte glutathione peroxidase, the most reliable marker for increases in selenium bioavailability, in the psoriasis patients, in 25 long-time local hotel workers, and in healthy volunteers who consumed low-selenium water. Enzymatic activity in the hotel workers was found to be 50% higher than in the low-selenium drinkers. The investigators concluded that selenium might play a beneficial role in psoriasis treatment (Pharmacol. Res. Commun. 1985;17:479-88).

That same year, several of the same researchers compared the penetration of electrolytes through the skin of healthy volunteers and psoriasis patients who bathed in the Dead Sea or comparable bath-salt solutions for a 4-week period. Only the psoriasis patients had significant increases in serum levels of bromine, calcium, and zinc (Pharmacol. Res. Commun. 1985;17:501-12).

Antiproliferative Action

Two years later, Shani et al. tested diluted Dead Sea brine and salt solutions, and found that they reversibly suppressed cell proliferation in vitro. They noted that bromides were more potent inhibitors than chlorides, and that potassium salts exhibited greater effectiveness than sodium or magnesium salts. The authors speculated that the penetration of minerals through the skin, along with antiproliferative effects, may help explain the effectiveness of Dead Sea spa treatments for psoriasis (Pharmacology 1987;35:339-47).

Interestingly, in 1996, investigators sought to identify the antiproliferative effects of certain Dead Sea minerals that play a role in ameliorating psoriasis, by comparing the in vitro proliferation of fibroblasts grown from biopsy specimens of healthy and psoriatic skin. They found that magnesium bromide and magnesium chloride exhibited significantly more potent inhibitory effects on cell growth than did their corresponding potassium salts and sodium chloride, and that these effects were manifested in healthy as well as psoriatic fibroblasts (Pharmacology 1996;52:321-8).

Moisturizing Action

In 1997, Ma'or et al. compared the cutaneous smoothing effects of three different liquid gels, one of which contained Dead Sea minerals. The formulations were applied to 20 mature women twice daily over 4 weeks, with computer-aided laser profilometry used to evaluate skin roughness before and after the treatment period. At the conclusion of treatment, the gel containing 1% Dead Sea mineral solution was associated with a 41% reduction in skin roughness. A 28% reduction was achieved with the use of the gel devoid of mineral additives, and a 10% reduction was seen with a control gel absent any antiwrinkle ingredients (Int. J. Cosmet. Sci. 1997;19:105-10).

Photodamage and Skin Cancer

In 2005, in a multicenter controlled cross-sectional study, investigators determined the prevalence of photodamage and skin cancer in a cohort of psoriasis patients undergoing climatotherapy by the Dead Sea. The cohort consisted of 1,198 patients (460 psoriasis patients and 738 controls) between 20 and 70 years of age who received treatment at the Dead Sea Solarium Clinic and participating outpatient clinics.

Results indicated that psoriasis patients were much more likely to manifest elastosis, poikiloderma, solar lentigines, and facial wrinkles than controls, with a dose response associated with increased exposure time to the Dead Sea. Control patients self-reported more previous skin cancers than psoriasis patients, but examinations revealed no differences in the prevalence of nonmelanoma skin cancer. Neither group included cases of malignant melanoma. The researchers concluded that Dead Sea climatotherapy poses no increased risk for developing skin cancer among psoriasis patients, but the prolonged solar exposure inherent in this therapeutic modality may increase the risk of inducing photodamage (J. Am. Acad. Dermatol. 2005;52:445-50).

Easing Chemotherapy's Side Effects

In another recent study, researchers assessed the effectiveness of Dead Sea products in mitigating the side effects of radiochemotherapy in 24 patients suffering from head and neck cancer. The control group consisted of 30 conventionally treated patients. The radiochemotherapy patients were directed to use two products containing Dead Sea minerals—a mouthwash (Lenom, made by Clinica Lenom Ltd.) and a moisturizing cream (Solaris)—three times daily for 1 week before, during, and up to 2 weeks following the conclusion of radiotherapy.

The investigators observed grade 1-2 mucositis in 13 patients treated with Dead Sea minerals (54%), with none exhibiting grade 3-4 mucositis. In the control group, 17 subjects (57%) had grade 1-2 mucositis, while grade 3-4 mucositis was noted in 4 (13%). In addition, grade 1-2 dermatitis was seen in 13 patients treated with Dead Sea minerals (54%), with none displaying grade 3-4 dermatitis, whereas grade 1-2 dermatitis was observed in 11 control patients (37%) and grade 3-4, in 5 (17%) (Isr. Med. Assoc. J. 2007;9:439-42).

On the Market

Several companies offer product lines that feature Dead Sea minerals, including Adovia Inc., Ahava, Health & Beauty Dead Sea Minerals, Kawar, La Cure, and Obey Your Body.

The array of such products includes hand and body lotions, bath salts, body butter, eye cream, cleansing mud masks, mineral mud soaps, mineral peeling soaps, body exfoliants, collagen firming creams with SPF, acne lotions, lightening cream with SPF, firming night creams, antidandruff and numerous other shampoos, scalp masks, and sunscreens.

Conclusions

The therapeutic effects of mineral waters at various spas, and at the Dead Sea in particular, have been well established. Such results help explain the popularity of makeup and other skin products that contain mineral ingredients. Vichy Thermal Spa Water (Vichy Laboratories Inc.) and La Roche-Posay Spa Water (La Roche-Posay) contain the anti-inflammatory minerals sulfur and selenium, respectively, and mineral-laden Dead Sea water is known to exert a lenitive influence on psoriasis, eczema, and other cutaneous conditions.

It remains unclear, however, how effective several products touted for harnessing the curative powers of the Dead Sea are in conferring similar benefits. Although these products likely do no harm and, given the host of other ingredients, probably at least contribute to moisturizing the skin, more research is necessary to establish these products as adjuvants for any of various skin disorders.

The therapeutic effects of immersion in the water of the Dead Sea have been well known for 1,500 years.

Source ©Edward Shtern/Fotolia.com

The palliative effects of immersing in baths or pools of thermomineral water, known as balneotherapy, have been known for centuries, with modern practices dating back to the 1800s and natural health spas dating back more than 3,000 years (Dermatol. Ther. 2003;16:132-40; Clin. Dermatol. 1996;14:659-64).

Places such as the Kangal hot spring in Turkey, the Blue Lagoon in Iceland, and the Dead Sea between Israel and Jordan are particularly popular “hot spots” for such therapy.

The Dead Sea is the lowest saline lake—and the lowest accessible point—on earth (400 meters, or about 1,300 feet, below sea level). Its therapeutic benefits have been well known for 1,500 years, with the modern era for such treatments beginning in 1959 (Clin. Dermatol. 1998;16:695-8). Over the past half century, the Dead Sea has become well recognized for its balneologic activity, allowing climatotherapy to be used for dermatologic and rheumatologic conditions.

In particular, Dead Sea climatotherapy is considered to be very effective in the treatment of psoriasis and, to a lesser extent, atopic dermatitis (J. Am. Acad. Dermatol. 2005;52:445-50; Arch. Dermatol. 1998;134:1416-20). Other conditions successfully treated with balneotherapy include acne, alopecia areata, chronic ulcers, contact dermatitis, dyshidrotic dermatitis, granuloma annulare, ichthyosis, lichen planus, lichen sclerosus and atrophicus, mycosis fungoides, palmoplantar keratosis, pityriasis rubra pilaris, pruritus, rosacea, scleroderma, seborrheic dermatitis, urticaria pigmentosa, vitiligo, and xerosis (Dermatol. Ther. 2003;16:132-40). Products that contain Dead Sea minerals are currently used to treat several of these cutaneous conditions.

 Dissolved Minerals

The Dead Sea, which contains exceedingly high salt concentrations, acts as a reservoir of minerals with distinct evaporation properties. Dead Sea salts are the source of numerous chemical and health products. Specifically, various skin conditions and allergies, as well as arthritis and respiratory disorders, have been treated with Dead Sea-derived magnesium salts and sulfur-containing mud (Rev. Environ. Health 1999;14:257-67). Magnesium salts, which are known to have anti-inflammatory activity, are the prevailing minerals in Dead Sea water (Int. J. Dermatol. 2005;44:151-7). Compared with the world's oceans, the Dead Sea is more abundant in calcium, magnesium, potassium, and bromide, and lower in sodium, sulfate, and carbonate (Dermatol. Ther. 2003;16:132-40; Int. J. Dermatol. 1989;28:1-9).

Enzyme Stimulation

In 1985, Shani et al. found that glutathione peroxidase activity was significantly increased in 35 psoriatic Danes who received 4-week therapy at the Ein Bokek International Psoriasis Treatment Center along the Dead Sea in Israel. The drinking water at the center was found to be rich in selenium. The researchers assayed the activity of erythrocyte glutathione peroxidase, the most reliable marker for increases in selenium bioavailability, in the psoriasis patients, in 25 long-time local hotel workers, and in healthy volunteers who consumed low-selenium water. Enzymatic activity in the hotel workers was found to be 50% higher than in the low-selenium drinkers. The investigators concluded that selenium might play a beneficial role in psoriasis treatment (Pharmacol. Res. Commun. 1985;17:479-88).

That same year, several of the same researchers compared the penetration of electrolytes through the skin of healthy volunteers and psoriasis patients who bathed in the Dead Sea or comparable bath-salt solutions for a 4-week period. Only the psoriasis patients had significant increases in serum levels of bromine, calcium, and zinc (Pharmacol. Res. Commun. 1985;17:501-12).

Antiproliferative Action

Two years later, Shani et al. tested diluted Dead Sea brine and salt solutions, and found that they reversibly suppressed cell proliferation in vitro. They noted that bromides were more potent inhibitors than chlorides, and that potassium salts exhibited greater effectiveness than sodium or magnesium salts. The authors speculated that the penetration of minerals through the skin, along with antiproliferative effects, may help explain the effectiveness of Dead Sea spa treatments for psoriasis (Pharmacology 1987;35:339-47).

Interestingly, in 1996, investigators sought to identify the antiproliferative effects of certain Dead Sea minerals that play a role in ameliorating psoriasis, by comparing the in vitro proliferation of fibroblasts grown from biopsy specimens of healthy and psoriatic skin. They found that magnesium bromide and magnesium chloride exhibited significantly more potent inhibitory effects on cell growth than did their corresponding potassium salts and sodium chloride, and that these effects were manifested in healthy as well as psoriatic fibroblasts (Pharmacology 1996;52:321-8).

Moisturizing Action

In 1997, Ma'or et al. compared the cutaneous smoothing effects of three different liquid gels, one of which contained Dead Sea minerals. The formulations were applied to 20 mature women twice daily over 4 weeks, with computer-aided laser profilometry used to evaluate skin roughness before and after the treatment period. At the conclusion of treatment, the gel containing 1% Dead Sea mineral solution was associated with a 41% reduction in skin roughness. A 28% reduction was achieved with the use of the gel devoid of mineral additives, and a 10% reduction was seen with a control gel absent any antiwrinkle ingredients (Int. J. Cosmet. Sci. 1997;19:105-10).

Photodamage and Skin Cancer

In 2005, in a multicenter controlled cross-sectional study, investigators determined the prevalence of photodamage and skin cancer in a cohort of psoriasis patients undergoing climatotherapy by the Dead Sea. The cohort consisted of 1,198 patients (460 psoriasis patients and 738 controls) between 20 and 70 years of age who received treatment at the Dead Sea Solarium Clinic and participating outpatient clinics.

Results indicated that psoriasis patients were much more likely to manifest elastosis, poikiloderma, solar lentigines, and facial wrinkles than controls, with a dose response associated with increased exposure time to the Dead Sea. Control patients self-reported more previous skin cancers than psoriasis patients, but examinations revealed no differences in the prevalence of nonmelanoma skin cancer. Neither group included cases of malignant melanoma. The researchers concluded that Dead Sea climatotherapy poses no increased risk for developing skin cancer among psoriasis patients, but the prolonged solar exposure inherent in this therapeutic modality may increase the risk of inducing photodamage (J. Am. Acad. Dermatol. 2005;52:445-50).

Easing Chemotherapy's Side Effects

In another recent study, researchers assessed the effectiveness of Dead Sea products in mitigating the side effects of radiochemotherapy in 24 patients suffering from head and neck cancer. The control group consisted of 30 conventionally treated patients. The radiochemotherapy patients were directed to use two products containing Dead Sea minerals—a mouthwash (Lenom, made by Clinica Lenom Ltd.) and a moisturizing cream (Solaris)—three times daily for 1 week before, during, and up to 2 weeks following the conclusion of radiotherapy.

The investigators observed grade 1-2 mucositis in 13 patients treated with Dead Sea minerals (54%), with none exhibiting grade 3-4 mucositis. In the control group, 17 subjects (57%) had grade 1-2 mucositis, while grade 3-4 mucositis was noted in 4 (13%). In addition, grade 1-2 dermatitis was seen in 13 patients treated with Dead Sea minerals (54%), with none displaying grade 3-4 dermatitis, whereas grade 1-2 dermatitis was observed in 11 control patients (37%) and grade 3-4, in 5 (17%) (Isr. Med. Assoc. J. 2007;9:439-42).

On the Market

Several companies offer product lines that feature Dead Sea minerals, including Adovia Inc., Ahava, Health & Beauty Dead Sea Minerals, Kawar, La Cure, and Obey Your Body.

The array of such products includes hand and body lotions, bath salts, body butter, eye cream, cleansing mud masks, mineral mud soaps, mineral peeling soaps, body exfoliants, collagen firming creams with SPF, acne lotions, lightening cream with SPF, firming night creams, antidandruff and numerous other shampoos, scalp masks, and sunscreens.

Conclusions

The therapeutic effects of mineral waters at various spas, and at the Dead Sea in particular, have been well established. Such results help explain the popularity of makeup and other skin products that contain mineral ingredients. Vichy Thermal Spa Water (Vichy Laboratories Inc.) and La Roche-Posay Spa Water (La Roche-Posay) contain the anti-inflammatory minerals sulfur and selenium, respectively, and mineral-laden Dead Sea water is known to exert a lenitive influence on psoriasis, eczema, and other cutaneous conditions.

It remains unclear, however, how effective several products touted for harnessing the curative powers of the Dead Sea are in conferring similar benefits. Although these products likely do no harm and, given the host of other ingredients, probably at least contribute to moisturizing the skin, more research is necessary to establish these products as adjuvants for any of various skin disorders.

The therapeutic effects of immersion in the water of the Dead Sea have been well known for 1,500 years.

Source ©Edward Shtern/Fotolia.com

The palliative effects of immersing in baths or pools of thermomineral water, known as balneotherapy, have been known for centuries, with modern practices dating back to the 1800s and natural health spas dating back more than 3,000 years (Dermatol. Ther. 2003;16:132-40; Clin. Dermatol. 1996;14:659-64).

Places such as the Kangal hot spring in Turkey, the Blue Lagoon in Iceland, and the Dead Sea between Israel and Jordan are particularly popular “hot spots” for such therapy.

The Dead Sea is the lowest saline lake—and the lowest accessible point—on earth (400 meters, or about 1,300 feet, below sea level). Its therapeutic benefits have been well known for 1,500 years, with the modern era for such treatments beginning in 1959 (Clin. Dermatol. 1998;16:695-8). Over the past half century, the Dead Sea has become well recognized for its balneologic activity, allowing climatotherapy to be used for dermatologic and rheumatologic conditions.

In particular, Dead Sea climatotherapy is considered to be very effective in the treatment of psoriasis and, to a lesser extent, atopic dermatitis (J. Am. Acad. Dermatol. 2005;52:445-50; Arch. Dermatol. 1998;134:1416-20). Other conditions successfully treated with balneotherapy include acne, alopecia areata, chronic ulcers, contact dermatitis, dyshidrotic dermatitis, granuloma annulare, ichthyosis, lichen planus, lichen sclerosus and atrophicus, mycosis fungoides, palmoplantar keratosis, pityriasis rubra pilaris, pruritus, rosacea, scleroderma, seborrheic dermatitis, urticaria pigmentosa, vitiligo, and xerosis (Dermatol. Ther. 2003;16:132-40). Products that contain Dead Sea minerals are currently used to treat several of these cutaneous conditions.

 Dissolved Minerals

The Dead Sea, which contains exceedingly high salt concentrations, acts as a reservoir of minerals with distinct evaporation properties. Dead Sea salts are the source of numerous chemical and health products. Specifically, various skin conditions and allergies, as well as arthritis and respiratory disorders, have been treated with Dead Sea-derived magnesium salts and sulfur-containing mud (Rev. Environ. Health 1999;14:257-67). Magnesium salts, which are known to have anti-inflammatory activity, are the prevailing minerals in Dead Sea water (Int. J. Dermatol. 2005;44:151-7). Compared with the world's oceans, the Dead Sea is more abundant in calcium, magnesium, potassium, and bromide, and lower in sodium, sulfate, and carbonate (Dermatol. Ther. 2003;16:132-40; Int. J. Dermatol. 1989;28:1-9).

Enzyme Stimulation

In 1985, Shani et al. found that glutathione peroxidase activity was significantly increased in 35 psoriatic Danes who received 4-week therapy at the Ein Bokek International Psoriasis Treatment Center along the Dead Sea in Israel. The drinking water at the center was found to be rich in selenium. The researchers assayed the activity of erythrocyte glutathione peroxidase, the most reliable marker for increases in selenium bioavailability, in the psoriasis patients, in 25 long-time local hotel workers, and in healthy volunteers who consumed low-selenium water. Enzymatic activity in the hotel workers was found to be 50% higher than in the low-selenium drinkers. The investigators concluded that selenium might play a beneficial role in psoriasis treatment (Pharmacol. Res. Commun. 1985;17:479-88).

That same year, several of the same researchers compared the penetration of electrolytes through the skin of healthy volunteers and psoriasis patients who bathed in the Dead Sea or comparable bath-salt solutions for a 4-week period. Only the psoriasis patients had significant increases in serum levels of bromine, calcium, and zinc (Pharmacol. Res. Commun. 1985;17:501-12).

Antiproliferative Action

Two years later, Shani et al. tested diluted Dead Sea brine and salt solutions, and found that they reversibly suppressed cell proliferation in vitro. They noted that bromides were more potent inhibitors than chlorides, and that potassium salts exhibited greater effectiveness than sodium or magnesium salts. The authors speculated that the penetration of minerals through the skin, along with antiproliferative effects, may help explain the effectiveness of Dead Sea spa treatments for psoriasis (Pharmacology 1987;35:339-47).

Interestingly, in 1996, investigators sought to identify the antiproliferative effects of certain Dead Sea minerals that play a role in ameliorating psoriasis, by comparing the in vitro proliferation of fibroblasts grown from biopsy specimens of healthy and psoriatic skin. They found that magnesium bromide and magnesium chloride exhibited significantly more potent inhibitory effects on cell growth than did their corresponding potassium salts and sodium chloride, and that these effects were manifested in healthy as well as psoriatic fibroblasts (Pharmacology 1996;52:321-8).

Moisturizing Action

In 1997, Ma'or et al. compared the cutaneous smoothing effects of three different liquid gels, one of which contained Dead Sea minerals. The formulations were applied to 20 mature women twice daily over 4 weeks, with computer-aided laser profilometry used to evaluate skin roughness before and after the treatment period. At the conclusion of treatment, the gel containing 1% Dead Sea mineral solution was associated with a 41% reduction in skin roughness. A 28% reduction was achieved with the use of the gel devoid of mineral additives, and a 10% reduction was seen with a control gel absent any antiwrinkle ingredients (Int. J. Cosmet. Sci. 1997;19:105-10).

Photodamage and Skin Cancer

In 2005, in a multicenter controlled cross-sectional study, investigators determined the prevalence of photodamage and skin cancer in a cohort of psoriasis patients undergoing climatotherapy by the Dead Sea. The cohort consisted of 1,198 patients (460 psoriasis patients and 738 controls) between 20 and 70 years of age who received treatment at the Dead Sea Solarium Clinic and participating outpatient clinics.

Results indicated that psoriasis patients were much more likely to manifest elastosis, poikiloderma, solar lentigines, and facial wrinkles than controls, with a dose response associated with increased exposure time to the Dead Sea. Control patients self-reported more previous skin cancers than psoriasis patients, but examinations revealed no differences in the prevalence of nonmelanoma skin cancer. Neither group included cases of malignant melanoma. The researchers concluded that Dead Sea climatotherapy poses no increased risk for developing skin cancer among psoriasis patients, but the prolonged solar exposure inherent in this therapeutic modality may increase the risk of inducing photodamage (J. Am. Acad. Dermatol. 2005;52:445-50).

Easing Chemotherapy's Side Effects

In another recent study, researchers assessed the effectiveness of Dead Sea products in mitigating the side effects of radiochemotherapy in 24 patients suffering from head and neck cancer. The control group consisted of 30 conventionally treated patients. The radiochemotherapy patients were directed to use two products containing Dead Sea minerals—a mouthwash (Lenom, made by Clinica Lenom Ltd.) and a moisturizing cream (Solaris)—three times daily for 1 week before, during, and up to 2 weeks following the conclusion of radiotherapy.

The investigators observed grade 1-2 mucositis in 13 patients treated with Dead Sea minerals (54%), with none exhibiting grade 3-4 mucositis. In the control group, 17 subjects (57%) had grade 1-2 mucositis, while grade 3-4 mucositis was noted in 4 (13%). In addition, grade 1-2 dermatitis was seen in 13 patients treated with Dead Sea minerals (54%), with none displaying grade 3-4 dermatitis, whereas grade 1-2 dermatitis was observed in 11 control patients (37%) and grade 3-4, in 5 (17%) (Isr. Med. Assoc. J. 2007;9:439-42).

On the Market

Several companies offer product lines that feature Dead Sea minerals, including Adovia Inc., Ahava, Health & Beauty Dead Sea Minerals, Kawar, La Cure, and Obey Your Body.

The array of such products includes hand and body lotions, bath salts, body butter, eye cream, cleansing mud masks, mineral mud soaps, mineral peeling soaps, body exfoliants, collagen firming creams with SPF, acne lotions, lightening cream with SPF, firming night creams, antidandruff and numerous other shampoos, scalp masks, and sunscreens.

Conclusions

The therapeutic effects of mineral waters at various spas, and at the Dead Sea in particular, have been well established. Such results help explain the popularity of makeup and other skin products that contain mineral ingredients. Vichy Thermal Spa Water (Vichy Laboratories Inc.) and La Roche-Posay Spa Water (La Roche-Posay) contain the anti-inflammatory minerals sulfur and selenium, respectively, and mineral-laden Dead Sea water is known to exert a lenitive influence on psoriasis, eczema, and other cutaneous conditions.

It remains unclear, however, how effective several products touted for harnessing the curative powers of the Dead Sea are in conferring similar benefits. Although these products likely do no harm and, given the host of other ingredients, probably at least contribute to moisturizing the skin, more research is necessary to establish these products as adjuvants for any of various skin disorders.

The therapeutic effects of immersion in the water of the Dead Sea have been well known for 1,500 years.

Source ©Edward Shtern/Fotolia.com