Psoriasis

SAN DIEGO – The novel oral phosphodiesterase-4 inhibitor apremilast cut an impressively wide swath through the annual meeting of the American College of Rheumatology on the strength of positive results in three separate pivotal phase III trials for psoriatic arthritis and a favorable phase II study in Behçet’s syndrome.

Dr. Alvin F. Wells reported that apremilast resulted in clinically meaningful improvement in psoriatic arthritis symptoms, physical function, and associated skin psoriasis at 16 weeks in the PALACE 4 trial. Moreover, the improvement remained durable through 52 weeks in the phase III clinical trial.

PALACE 4 compared apremilast against placebo as a first-line treatment in 527 patients with psoriatic arthritis not previously treated with a disease-modifying antirheumatic drug. This was a population with active disease: a mean baseline 11 swollen and 20 tender joints; a Health Assessment Questionnaire Disability Index score averaging 1.07; and a 50% prevalence of dactylitis, with a mean severity score of 2.0. Sixty-five percent of patients had enthesitis, with a median Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) of 3.0. Participants had a mean 16-year history of psoriasis and a 3.4-year duration of psoriatic arthritis.

The primary study endpoint was attainment of an American College of Rheumatology 20% improvement (ACR20) response at 16 weeks. This was achieved in 29.2% of patients randomized to apremilast at 20 mg twice daily, 32.3% on 30 mg twice daily, and 16.9% on placebo. At week 16, patients on placebo were re-randomized to apremilast at 20 mg or 30 mg twice weekly. By week 52, an ACR20 response was achieved by 53% of patients in the apremilast 20 mg twice-daily group and 59% of those on the higher dose, according to Dr. Wells, director of the Rheumatology and Immunotherapy Center in Franklin, Wisc.

Apremilast also scored well on numerous secondary endpoints (see chart). For example, the swollen joint count decreased by a median of 89% over the course of 52 weeks in patients on apremilast at 20 mg twice daily.

"The way I like to think of that result is at least 50% of patients had an 89% improvement in their swollen joint count," he explained.

During the first 16 weeks of PALACE 4, there were fewer serious adverse events in apremilast-treated patients than with placebo-treated patients. The most frequent side effects of apremilast were nausea, diarrhea, and headache, affecting 16%, 12%, and 8%, respectively, of patients in the higher-dose arm. These adverse events were almost exclusively mild or moderate, they began within the first 2 weeks of treatment, and they resolved in 4 weeks despite continued treatment. Less than 2% of apremilast-treated patients dropped out of the study due to nausea or diarrhea through week 52.

PALACE 4 differed from the PALACE 2 and 3 trials, also presented at the ACR meeting, in that PALACE 2 and 3 involved only patients with psoriatic arthritis previously treated with biologic agents or other disease-modifying antirheumatic drugs. All three studies had the same design, and the results in terms of both efficacy and safety were consistent across the full clinical trial program. No clinically meaningful changes in laboratory values were seen in any of the PALACE trials, suggesting ongoing lab monitoring may not be necessary.

Also at the ACR annual meeting, Dr. Gülen Hatemi of Istanbul University, Turkey, in a reprise of her report several weeks earlier at the annual congress of the European Academy of Dermatology and Venereology, presented a phase II study showing apremilast to be highly effective in treating the oral ulcers that are the cardinal feature of Behçet’s syndrome.

Celgene filed for approval of apremilast for psoriatic arthritis with the Food and Drug Administration earlier this year and anticipates a decision in March 2014. The company also plans to apply to the European regulatory agency for the same indication before year’s end, and to petition the FDA for approval in psoriasis within the same time frame. A 500-patient phase III study of apremilast in ankylosing spondylitis, known as POSTURE, is well underway.

PALACE 4 was sponsored by Celgene. Dr. Wells reported receiving a research grant from the company.

[email protected]

SAN DIEGO – The novel oral phosphodiesterase-4 inhibitor apremilast cut an impressively wide swath through the annual meeting of the American College of Rheumatology on the strength of positive results in three separate pivotal phase III trials for psoriatic arthritis and a favorable phase II study in Behçet’s syndrome.

Dr. Alvin F. Wells reported that apremilast resulted in clinically meaningful improvement in psoriatic arthritis symptoms, physical function, and associated skin psoriasis at 16 weeks in the PALACE 4 trial. Moreover, the improvement remained durable through 52 weeks in the phase III clinical trial.

PALACE 4 compared apremilast against placebo as a first-line treatment in 527 patients with psoriatic arthritis not previously treated with a disease-modifying antirheumatic drug. This was a population with active disease: a mean baseline 11 swollen and 20 tender joints; a Health Assessment Questionnaire Disability Index score averaging 1.07; and a 50% prevalence of dactylitis, with a mean severity score of 2.0. Sixty-five percent of patients had enthesitis, with a median Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) of 3.0. Participants had a mean 16-year history of psoriasis and a 3.4-year duration of psoriatic arthritis.

The primary study endpoint was attainment of an American College of Rheumatology 20% improvement (ACR20) response at 16 weeks. This was achieved in 29.2% of patients randomized to apremilast at 20 mg twice daily, 32.3% on 30 mg twice daily, and 16.9% on placebo. At week 16, patients on placebo were re-randomized to apremilast at 20 mg or 30 mg twice weekly. By week 52, an ACR20 response was achieved by 53% of patients in the apremilast 20 mg twice-daily group and 59% of those on the higher dose, according to Dr. Wells, director of the Rheumatology and Immunotherapy Center in Franklin, Wisc.

Apremilast also scored well on numerous secondary endpoints (see chart). For example, the swollen joint count decreased by a median of 89% over the course of 52 weeks in patients on apremilast at 20 mg twice daily.

"The way I like to think of that result is at least 50% of patients had an 89% improvement in their swollen joint count," he explained.

During the first 16 weeks of PALACE 4, there were fewer serious adverse events in apremilast-treated patients than with placebo-treated patients. The most frequent side effects of apremilast were nausea, diarrhea, and headache, affecting 16%, 12%, and 8%, respectively, of patients in the higher-dose arm. These adverse events were almost exclusively mild or moderate, they began within the first 2 weeks of treatment, and they resolved in 4 weeks despite continued treatment. Less than 2% of apremilast-treated patients dropped out of the study due to nausea or diarrhea through week 52.

PALACE 4 differed from the PALACE 2 and 3 trials, also presented at the ACR meeting, in that PALACE 2 and 3 involved only patients with psoriatic arthritis previously treated with biologic agents or other disease-modifying antirheumatic drugs. All three studies had the same design, and the results in terms of both efficacy and safety were consistent across the full clinical trial program. No clinically meaningful changes in laboratory values were seen in any of the PALACE trials, suggesting ongoing lab monitoring may not be necessary.

Also at the ACR annual meeting, Dr. Gülen Hatemi of Istanbul University, Turkey, in a reprise of her report several weeks earlier at the annual congress of the European Academy of Dermatology and Venereology, presented a phase II study showing apremilast to be highly effective in treating the oral ulcers that are the cardinal feature of Behçet’s syndrome.

Celgene filed for approval of apremilast for psoriatic arthritis with the Food and Drug Administration earlier this year and anticipates a decision in March 2014. The company also plans to apply to the European regulatory agency for the same indication before year’s end, and to petition the FDA for approval in psoriasis within the same time frame. A 500-patient phase III study of apremilast in ankylosing spondylitis, known as POSTURE, is well underway.

PALACE 4 was sponsored by Celgene. Dr. Wells reported receiving a research grant from the company.

[email protected]

SAN DIEGO – The novel oral phosphodiesterase-4 inhibitor apremilast cut an impressively wide swath through the annual meeting of the American College of Rheumatology on the strength of positive results in three separate pivotal phase III trials for psoriatic arthritis and a favorable phase II study in Behçet’s syndrome.

Dr. Alvin F. Wells reported that apremilast resulted in clinically meaningful improvement in psoriatic arthritis symptoms, physical function, and associated skin psoriasis at 16 weeks in the PALACE 4 trial. Moreover, the improvement remained durable through 52 weeks in the phase III clinical trial.

PALACE 4 compared apremilast against placebo as a first-line treatment in 527 patients with psoriatic arthritis not previously treated with a disease-modifying antirheumatic drug. This was a population with active disease: a mean baseline 11 swollen and 20 tender joints; a Health Assessment Questionnaire Disability Index score averaging 1.07; and a 50% prevalence of dactylitis, with a mean severity score of 2.0. Sixty-five percent of patients had enthesitis, with a median Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) of 3.0. Participants had a mean 16-year history of psoriasis and a 3.4-year duration of psoriatic arthritis.

The primary study endpoint was attainment of an American College of Rheumatology 20% improvement (ACR20) response at 16 weeks. This was achieved in 29.2% of patients randomized to apremilast at 20 mg twice daily, 32.3% on 30 mg twice daily, and 16.9% on placebo. At week 16, patients on placebo were re-randomized to apremilast at 20 mg or 30 mg twice weekly. By week 52, an ACR20 response was achieved by 53% of patients in the apremilast 20 mg twice-daily group and 59% of those on the higher dose, according to Dr. Wells, director of the Rheumatology and Immunotherapy Center in Franklin, Wisc.

Apremilast also scored well on numerous secondary endpoints (see chart). For example, the swollen joint count decreased by a median of 89% over the course of 52 weeks in patients on apremilast at 20 mg twice daily.

"The way I like to think of that result is at least 50% of patients had an 89% improvement in their swollen joint count," he explained.

During the first 16 weeks of PALACE 4, there were fewer serious adverse events in apremilast-treated patients than with placebo-treated patients. The most frequent side effects of apremilast were nausea, diarrhea, and headache, affecting 16%, 12%, and 8%, respectively, of patients in the higher-dose arm. These adverse events were almost exclusively mild or moderate, they began within the first 2 weeks of treatment, and they resolved in 4 weeks despite continued treatment. Less than 2% of apremilast-treated patients dropped out of the study due to nausea or diarrhea through week 52.

PALACE 4 differed from the PALACE 2 and 3 trials, also presented at the ACR meeting, in that PALACE 2 and 3 involved only patients with psoriatic arthritis previously treated with biologic agents or other disease-modifying antirheumatic drugs. All three studies had the same design, and the results in terms of both efficacy and safety were consistent across the full clinical trial program. No clinically meaningful changes in laboratory values were seen in any of the PALACE trials, suggesting ongoing lab monitoring may not be necessary.

Also at the ACR annual meeting, Dr. Gülen Hatemi of Istanbul University, Turkey, in a reprise of her report several weeks earlier at the annual congress of the European Academy of Dermatology and Venereology, presented a phase II study showing apremilast to be highly effective in treating the oral ulcers that are the cardinal feature of Behçet’s syndrome.

Celgene filed for approval of apremilast for psoriatic arthritis with the Food and Drug Administration earlier this year and anticipates a decision in March 2014. The company also plans to apply to the European regulatory agency for the same indication before year’s end, and to petition the FDA for approval in psoriasis within the same time frame. A 500-patient phase III study of apremilast in ankylosing spondylitis, known as POSTURE, is well underway.

PALACE 4 was sponsored by Celgene. Dr. Wells reported receiving a research grant from the company.

[email protected]

SAN DIEGO – The combination of intravenous cyclophosphamide and rituximab shows promise for the reduction of lupus flares, both renal and nonrenal, in patients with severe systemic lupus erythematosus, according to Dr. Ali Shahzad.

Moreover, this benefit did not come at the cost of a significant increase in infections, as compared with intravenous cyclophosphamide monotherapy, Dr. Shahzad reported at the annual meeting of the American College of Rheumatology.

He reported on 43 patients with severe, recurrent SLE. Thirty-one were placed on intravenous cyclophosphamide monotherapy administered according to the National Institutes of Health standard protocol for the treatment of lupus nephritis. The other 12 got cyclophosphamide plus two 1,000-mg doses of rituximab (Rituxan) given 15 days apart. The combination regimen was given at the physician’s discretion for recalcitrant or recurrent flares of lupus nephritis in 10 of 12 cases, and for treatment-resistant CNS lupus or other extrarenal lupus in the other 2. Eight of the 12 recipients of combination therapy had previously been treated with intravenous cyclophosphamide, in most cases for lupus nephritis.

In the combination therapy group, the median duration of follow-up prior to dual therapy was 36 months, with an additional 21 months of follow-up after receiving the combination. Prior to combination therapy, these 12 patients collectively had 38 lupus flares, 26 of which featured renal involvement. In contrast, post treatment they developed just 13 flares, only 3 of which were renal, according to Dr. Shahzad of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Md.

The 43 SLE patients had a total of 15 bacterial, 6 fungal, and 18 viral infections. And although there was a consistent trend toward higher rates in the combination therapy group, the differences fell far short of statistical significance.

Dr. Shahzad acknowledged the small sample size and retrospective design as important study limitations. However, based upon these encouraging, albeit preliminary, study findings, he and his NIH colleagues said they are planning a prospective clinical trial examining the efficacy and tolerability of the intravenous cyclophosphamide/rituximab combination in patients with severe, recurrent SLE.

Dr. Shahzad reported having no financial conflicts regarding this NIH-sponsored study.

[email protected]

SAN DIEGO – The combination of intravenous cyclophosphamide and rituximab shows promise for the reduction of lupus flares, both renal and nonrenal, in patients with severe systemic lupus erythematosus, according to Dr. Ali Shahzad.

Moreover, this benefit did not come at the cost of a significant increase in infections, as compared with intravenous cyclophosphamide monotherapy, Dr. Shahzad reported at the annual meeting of the American College of Rheumatology.

He reported on 43 patients with severe, recurrent SLE. Thirty-one were placed on intravenous cyclophosphamide monotherapy administered according to the National Institutes of Health standard protocol for the treatment of lupus nephritis. The other 12 got cyclophosphamide plus two 1,000-mg doses of rituximab (Rituxan) given 15 days apart. The combination regimen was given at the physician’s discretion for recalcitrant or recurrent flares of lupus nephritis in 10 of 12 cases, and for treatment-resistant CNS lupus or other extrarenal lupus in the other 2. Eight of the 12 recipients of combination therapy had previously been treated with intravenous cyclophosphamide, in most cases for lupus nephritis.

In the combination therapy group, the median duration of follow-up prior to dual therapy was 36 months, with an additional 21 months of follow-up after receiving the combination. Prior to combination therapy, these 12 patients collectively had 38 lupus flares, 26 of which featured renal involvement. In contrast, post treatment they developed just 13 flares, only 3 of which were renal, according to Dr. Shahzad of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Md.

The 43 SLE patients had a total of 15 bacterial, 6 fungal, and 18 viral infections. And although there was a consistent trend toward higher rates in the combination therapy group, the differences fell far short of statistical significance.

Dr. Shahzad acknowledged the small sample size and retrospective design as important study limitations. However, based upon these encouraging, albeit preliminary, study findings, he and his NIH colleagues said they are planning a prospective clinical trial examining the efficacy and tolerability of the intravenous cyclophosphamide/rituximab combination in patients with severe, recurrent SLE.

Dr. Shahzad reported having no financial conflicts regarding this NIH-sponsored study.

[email protected]

SAN DIEGO – The combination of intravenous cyclophosphamide and rituximab shows promise for the reduction of lupus flares, both renal and nonrenal, in patients with severe systemic lupus erythematosus, according to Dr. Ali Shahzad.

Moreover, this benefit did not come at the cost of a significant increase in infections, as compared with intravenous cyclophosphamide monotherapy, Dr. Shahzad reported at the annual meeting of the American College of Rheumatology.

He reported on 43 patients with severe, recurrent SLE. Thirty-one were placed on intravenous cyclophosphamide monotherapy administered according to the National Institutes of Health standard protocol for the treatment of lupus nephritis. The other 12 got cyclophosphamide plus two 1,000-mg doses of rituximab (Rituxan) given 15 days apart. The combination regimen was given at the physician’s discretion for recalcitrant or recurrent flares of lupus nephritis in 10 of 12 cases, and for treatment-resistant CNS lupus or other extrarenal lupus in the other 2. Eight of the 12 recipients of combination therapy had previously been treated with intravenous cyclophosphamide, in most cases for lupus nephritis.

In the combination therapy group, the median duration of follow-up prior to dual therapy was 36 months, with an additional 21 months of follow-up after receiving the combination. Prior to combination therapy, these 12 patients collectively had 38 lupus flares, 26 of which featured renal involvement. In contrast, post treatment they developed just 13 flares, only 3 of which were renal, according to Dr. Shahzad of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Md.

The 43 SLE patients had a total of 15 bacterial, 6 fungal, and 18 viral infections. And although there was a consistent trend toward higher rates in the combination therapy group, the differences fell far short of statistical significance.

Dr. Shahzad acknowledged the small sample size and retrospective design as important study limitations. However, based upon these encouraging, albeit preliminary, study findings, he and his NIH colleagues said they are planning a prospective clinical trial examining the efficacy and tolerability of the intravenous cyclophosphamide/rituximab combination in patients with severe, recurrent SLE.

Dr. Shahzad reported having no financial conflicts regarding this NIH-sponsored study.

[email protected]

ISTANBUL, TURKEY – The current intensive period of new drug development in psoriasis is cause for enthusiastic celebration by patients and physicians alike. That is, except for one glaring research gap.

Almost all of the promising drugs now in phase-II or -III clinical trials are systemic agents aimed at the minority of psoriasis patients with more severe disease. There’s not nearly as much in the pipeline for the many patients with mild psoriasis who are most appropriately treated with topical therapy, Dr. Hervé Bachelez observed at the annual congress of the European Academy of Dermatology and Venereology.

Indeed, he identified only two promising topical agents advancing through the developmental pipeline: Pfizer’s tofacitinib, a small-molecule Janus kinase inhibitor under study in both topical and oral formulations, and Anacor’s AN2728, a boron-containing molecule that inhibits phosphodiesterase-4 (PDE-4).

Industry’s lack of enthusiasm for developing new topical agents is difficult to understand, given that 84% of all U.S. prescriptions written for psoriasis in 2009 were for topical agents, according to IMS. Moreover, patients clearly believe there is a major unmet need for new and better topicals: a recent survey of 2,151 European psoriasis patients and their dermatologists found that only 45% of patients on topical therapy were satisfied with their treatment. And a mere 35% of dermatologists rated current topical treatments as satisfactory (J. Dermatolog. Treat. 2013;24:193-8).

The great bulk of the action in psoriasis drug development now is focused on injectable biologics and oral small molecules. Among them are three interleukin-17 inhibitors: Novartis’ secukinumab, Amgen’s brodalumab, and Eli Lilly’s ixekizumab. Celgene is developing apremilast as an oral PDE-4 inhibitor. Merck and Janssen Biotech are developing MK-3222 and CNTO 1959, respectively, as interleukin-23 inhibitors.

Dr. Bachelez, professor of dermatology and head of the inflammatory skin diseases unit at Saint Louis University Hospital, Paris, reported serving on the advisory boards of 10 pharmaceutical companies.

[email protected]

ISTANBUL, TURKEY – The current intensive period of new drug development in psoriasis is cause for enthusiastic celebration by patients and physicians alike. That is, except for one glaring research gap.

Almost all of the promising drugs now in phase-II or -III clinical trials are systemic agents aimed at the minority of psoriasis patients with more severe disease. There’s not nearly as much in the pipeline for the many patients with mild psoriasis who are most appropriately treated with topical therapy, Dr. Hervé Bachelez observed at the annual congress of the European Academy of Dermatology and Venereology.

Indeed, he identified only two promising topical agents advancing through the developmental pipeline: Pfizer’s tofacitinib, a small-molecule Janus kinase inhibitor under study in both topical and oral formulations, and Anacor’s AN2728, a boron-containing molecule that inhibits phosphodiesterase-4 (PDE-4).

Industry’s lack of enthusiasm for developing new topical agents is difficult to understand, given that 84% of all U.S. prescriptions written for psoriasis in 2009 were for topical agents, according to IMS. Moreover, patients clearly believe there is a major unmet need for new and better topicals: a recent survey of 2,151 European psoriasis patients and their dermatologists found that only 45% of patients on topical therapy were satisfied with their treatment. And a mere 35% of dermatologists rated current topical treatments as satisfactory (J. Dermatolog. Treat. 2013;24:193-8).

The great bulk of the action in psoriasis drug development now is focused on injectable biologics and oral small molecules. Among them are three interleukin-17 inhibitors: Novartis’ secukinumab, Amgen’s brodalumab, and Eli Lilly’s ixekizumab. Celgene is developing apremilast as an oral PDE-4 inhibitor. Merck and Janssen Biotech are developing MK-3222 and CNTO 1959, respectively, as interleukin-23 inhibitors.

Dr. Bachelez, professor of dermatology and head of the inflammatory skin diseases unit at Saint Louis University Hospital, Paris, reported serving on the advisory boards of 10 pharmaceutical companies.

[email protected]

ISTANBUL, TURKEY – The current intensive period of new drug development in psoriasis is cause for enthusiastic celebration by patients and physicians alike. That is, except for one glaring research gap.

Almost all of the promising drugs now in phase-II or -III clinical trials are systemic agents aimed at the minority of psoriasis patients with more severe disease. There’s not nearly as much in the pipeline for the many patients with mild psoriasis who are most appropriately treated with topical therapy, Dr. Hervé Bachelez observed at the annual congress of the European Academy of Dermatology and Venereology.

Indeed, he identified only two promising topical agents advancing through the developmental pipeline: Pfizer’s tofacitinib, a small-molecule Janus kinase inhibitor under study in both topical and oral formulations, and Anacor’s AN2728, a boron-containing molecule that inhibits phosphodiesterase-4 (PDE-4).

Industry’s lack of enthusiasm for developing new topical agents is difficult to understand, given that 84% of all U.S. prescriptions written for psoriasis in 2009 were for topical agents, according to IMS. Moreover, patients clearly believe there is a major unmet need for new and better topicals: a recent survey of 2,151 European psoriasis patients and their dermatologists found that only 45% of patients on topical therapy were satisfied with their treatment. And a mere 35% of dermatologists rated current topical treatments as satisfactory (J. Dermatolog. Treat. 2013;24:193-8).

The great bulk of the action in psoriasis drug development now is focused on injectable biologics and oral small molecules. Among them are three interleukin-17 inhibitors: Novartis’ secukinumab, Amgen’s brodalumab, and Eli Lilly’s ixekizumab. Celgene is developing apremilast as an oral PDE-4 inhibitor. Merck and Janssen Biotech are developing MK-3222 and CNTO 1959, respectively, as interleukin-23 inhibitors.

Dr. Bachelez, professor of dermatology and head of the inflammatory skin diseases unit at Saint Louis University Hospital, Paris, reported serving on the advisory boards of 10 pharmaceutical companies.

[email protected]

ATLANTA – Adding abatacept to low-dose intravenous cyclophosphamide did not improve the rate of complete renal response at 1 year, compared with IV cyclophosphamide alone, in patients with class III or IV lupus nephritis in the randomized, controlled ACCESS Trial.

The phase II findings suggested, however, that abatacept reduced the need for maintenance immunosuppression, and they also demonstrated for the first time that low-dose IV cyclophosphamide may have applicability in racially and ethnically diverse patients with lupus nephritis, Dr. Brad H. Rovin reported at Kidney Week 2013.

The overall complete renal response rates were similar at 33% and 31%, respectively, in 134 patients with class III or IV lupus nephritis who were enrolled in the trial, treated with a steroid taper and 500 mg of IV cyclophosphamide every 2 weeks for 6 weeks followed by 2 mg/kg of azathioprine daily. Patients then were randomized to receive abatacept or placebo at week 0, 2, and 4 and then monthly.

Complete plus partial responses occurred in 59% of patients in each arm, Dr. Rovin said at the conference, which was sponsored by the American Society of Nephrology.

Patients in the study had a urine protein-to-creatinine ratio (UPCR) greater than 1. Complete renal response was defined as a UPCR of less than 0.5, serum creatinine at normal or within 25% of baseline, and prednisone dose tapered to 10 mg daily or less. African Americans comprised 39% of the cohort, and Hispanic/Mestizo patients comprised 40%.

Among the African American patients, 33% in the treatment group, compared with 16% in the placebo group, achieved complete renal response. This difference was not statistically significant.

This finding is important, because while low-dose cyclophosphamide – the "Euro-Lupus regimen" – has been shown to be as effective as standard and more toxic higher dosing, studies had primarily included a European Caucasian population. It was unclear whether the low-dose regimen would be as effective in a multiracial and multiethnic population, said Dr. Rovin of Ohio State University Medical Center.

No differences were seen between the treatment and control groups with respect to anti-dsDNA or complement levels and/or the frequency of serious or infectious adverse events or study withdrawals.

Of note, azathioprine was stopped in treatment group patients who achieved complete renal response – but not control group patients who achieved complete renal response. These patients were followed to 52 weeks. At that time, 50% and 62% of the treatment group and control group patients, respectively, who were complete responders at 24 weeks still met the criteria for complete response, Dr. Rovin said.

While abatacept did not increase complete response rates, the treatment was associated with maintenance of complete renal response to 1 year despite discontinuation of maintenance immunosuppression in the treated patients and continued azathioprine treatment in the control group. This suggests that abatacept may reduce the need for maintenance immunosuppression, he said.

While it was disappointing that the addition of abatacept to background induction therapy with low-dose IV cyclophosphamide and corticosteroids did not improve the complete renal response rate in this study – despite murine models suggesting that the use of abatacept and IV cyclophosphamide act synergistically to arrest lupus nephritis progression – the findings offer two very important lessons for clinical practice, he said.

"We can take the low-dose cyclophosphamide regimen and potentially use that with good results in our [multiethnic, multiracial] patient population that we see here in this country, and I think that’s a huge step forward. It gives us another option to use besides mycophenolate mofetil and high-dose cyclophosphamide," he said, adding that the low-dose IV cyclophosphamide regimen is well tolerated and delivers a total dose of only 3 g of the drug – a dose that generally does not predispose to premature ovarian failure.

This is particularly important, because women of childbearing years comprise a majority of the patient population with lupus nephritis, he explained.

"We know from the Euro-Lupus trial that the low-dose regimen, over 10 years, provided the same maintenance of renal function as the high-dose regimen, so we have very good long-term follow-up. We don’t quite have that yet with mycophenolate mofetil, so I think that for those of us who are very frequent users of cyclophosphamide, this is a very good alternative to the high-dose, highly toxic regimen that has for so long been the standard of care," he said.

This study was funded by the National Institute of Allergy and Infectious Diseases via the Immune Tolerance Network. Bristol Myers Squibb provided the study drug. Dr. Rovin reported ties to Genentech, Questcor, TEVA, Biogen-IDEC, HGS, Johnson & Johnson, Roche, BMS, and TG Therapeutics.

ATLANTA – Adding abatacept to low-dose intravenous cyclophosphamide did not improve the rate of complete renal response at 1 year, compared with IV cyclophosphamide alone, in patients with class III or IV lupus nephritis in the randomized, controlled ACCESS Trial.

The phase II findings suggested, however, that abatacept reduced the need for maintenance immunosuppression, and they also demonstrated for the first time that low-dose IV cyclophosphamide may have applicability in racially and ethnically diverse patients with lupus nephritis, Dr. Brad H. Rovin reported at Kidney Week 2013.

The overall complete renal response rates were similar at 33% and 31%, respectively, in 134 patients with class III or IV lupus nephritis who were enrolled in the trial, treated with a steroid taper and 500 mg of IV cyclophosphamide every 2 weeks for 6 weeks followed by 2 mg/kg of azathioprine daily. Patients then were randomized to receive abatacept or placebo at week 0, 2, and 4 and then monthly.

Complete plus partial responses occurred in 59% of patients in each arm, Dr. Rovin said at the conference, which was sponsored by the American Society of Nephrology.

Patients in the study had a urine protein-to-creatinine ratio (UPCR) greater than 1. Complete renal response was defined as a UPCR of less than 0.5, serum creatinine at normal or within 25% of baseline, and prednisone dose tapered to 10 mg daily or less. African Americans comprised 39% of the cohort, and Hispanic/Mestizo patients comprised 40%.

Among the African American patients, 33% in the treatment group, compared with 16% in the placebo group, achieved complete renal response. This difference was not statistically significant.

This finding is important, because while low-dose cyclophosphamide – the "Euro-Lupus regimen" – has been shown to be as effective as standard and more toxic higher dosing, studies had primarily included a European Caucasian population. It was unclear whether the low-dose regimen would be as effective in a multiracial and multiethnic population, said Dr. Rovin of Ohio State University Medical Center.

No differences were seen between the treatment and control groups with respect to anti-dsDNA or complement levels and/or the frequency of serious or infectious adverse events or study withdrawals.

Of note, azathioprine was stopped in treatment group patients who achieved complete renal response – but not control group patients who achieved complete renal response. These patients were followed to 52 weeks. At that time, 50% and 62% of the treatment group and control group patients, respectively, who were complete responders at 24 weeks still met the criteria for complete response, Dr. Rovin said.

While abatacept did not increase complete response rates, the treatment was associated with maintenance of complete renal response to 1 year despite discontinuation of maintenance immunosuppression in the treated patients and continued azathioprine treatment in the control group. This suggests that abatacept may reduce the need for maintenance immunosuppression, he said.

While it was disappointing that the addition of abatacept to background induction therapy with low-dose IV cyclophosphamide and corticosteroids did not improve the complete renal response rate in this study – despite murine models suggesting that the use of abatacept and IV cyclophosphamide act synergistically to arrest lupus nephritis progression – the findings offer two very important lessons for clinical practice, he said.

"We can take the low-dose cyclophosphamide regimen and potentially use that with good results in our [multiethnic, multiracial] patient population that we see here in this country, and I think that’s a huge step forward. It gives us another option to use besides mycophenolate mofetil and high-dose cyclophosphamide," he said, adding that the low-dose IV cyclophosphamide regimen is well tolerated and delivers a total dose of only 3 g of the drug – a dose that generally does not predispose to premature ovarian failure.

This is particularly important, because women of childbearing years comprise a majority of the patient population with lupus nephritis, he explained.

"We know from the Euro-Lupus trial that the low-dose regimen, over 10 years, provided the same maintenance of renal function as the high-dose regimen, so we have very good long-term follow-up. We don’t quite have that yet with mycophenolate mofetil, so I think that for those of us who are very frequent users of cyclophosphamide, this is a very good alternative to the high-dose, highly toxic regimen that has for so long been the standard of care," he said.

This study was funded by the National Institute of Allergy and Infectious Diseases via the Immune Tolerance Network. Bristol Myers Squibb provided the study drug. Dr. Rovin reported ties to Genentech, Questcor, TEVA, Biogen-IDEC, HGS, Johnson & Johnson, Roche, BMS, and TG Therapeutics.

ATLANTA – Adding abatacept to low-dose intravenous cyclophosphamide did not improve the rate of complete renal response at 1 year, compared with IV cyclophosphamide alone, in patients with class III or IV lupus nephritis in the randomized, controlled ACCESS Trial.

The phase II findings suggested, however, that abatacept reduced the need for maintenance immunosuppression, and they also demonstrated for the first time that low-dose IV cyclophosphamide may have applicability in racially and ethnically diverse patients with lupus nephritis, Dr. Brad H. Rovin reported at Kidney Week 2013.

The overall complete renal response rates were similar at 33% and 31%, respectively, in 134 patients with class III or IV lupus nephritis who were enrolled in the trial, treated with a steroid taper and 500 mg of IV cyclophosphamide every 2 weeks for 6 weeks followed by 2 mg/kg of azathioprine daily. Patients then were randomized to receive abatacept or placebo at week 0, 2, and 4 and then monthly.

Complete plus partial responses occurred in 59% of patients in each arm, Dr. Rovin said at the conference, which was sponsored by the American Society of Nephrology.

Patients in the study had a urine protein-to-creatinine ratio (UPCR) greater than 1. Complete renal response was defined as a UPCR of less than 0.5, serum creatinine at normal or within 25% of baseline, and prednisone dose tapered to 10 mg daily or less. African Americans comprised 39% of the cohort, and Hispanic/Mestizo patients comprised 40%.

Among the African American patients, 33% in the treatment group, compared with 16% in the placebo group, achieved complete renal response. This difference was not statistically significant.

This finding is important, because while low-dose cyclophosphamide – the "Euro-Lupus regimen" – has been shown to be as effective as standard and more toxic higher dosing, studies had primarily included a European Caucasian population. It was unclear whether the low-dose regimen would be as effective in a multiracial and multiethnic population, said Dr. Rovin of Ohio State University Medical Center.

No differences were seen between the treatment and control groups with respect to anti-dsDNA or complement levels and/or the frequency of serious or infectious adverse events or study withdrawals.

Of note, azathioprine was stopped in treatment group patients who achieved complete renal response – but not control group patients who achieved complete renal response. These patients were followed to 52 weeks. At that time, 50% and 62% of the treatment group and control group patients, respectively, who were complete responders at 24 weeks still met the criteria for complete response, Dr. Rovin said.

While abatacept did not increase complete response rates, the treatment was associated with maintenance of complete renal response to 1 year despite discontinuation of maintenance immunosuppression in the treated patients and continued azathioprine treatment in the control group. This suggests that abatacept may reduce the need for maintenance immunosuppression, he said.

While it was disappointing that the addition of abatacept to background induction therapy with low-dose IV cyclophosphamide and corticosteroids did not improve the complete renal response rate in this study – despite murine models suggesting that the use of abatacept and IV cyclophosphamide act synergistically to arrest lupus nephritis progression – the findings offer two very important lessons for clinical practice, he said.

"We can take the low-dose cyclophosphamide regimen and potentially use that with good results in our [multiethnic, multiracial] patient population that we see here in this country, and I think that’s a huge step forward. It gives us another option to use besides mycophenolate mofetil and high-dose cyclophosphamide," he said, adding that the low-dose IV cyclophosphamide regimen is well tolerated and delivers a total dose of only 3 g of the drug – a dose that generally does not predispose to premature ovarian failure.

This is particularly important, because women of childbearing years comprise a majority of the patient population with lupus nephritis, he explained.

"We know from the Euro-Lupus trial that the low-dose regimen, over 10 years, provided the same maintenance of renal function as the high-dose regimen, so we have very good long-term follow-up. We don’t quite have that yet with mycophenolate mofetil, so I think that for those of us who are very frequent users of cyclophosphamide, this is a very good alternative to the high-dose, highly toxic regimen that has for so long been the standard of care," he said.

This study was funded by the National Institute of Allergy and Infectious Diseases via the Immune Tolerance Network. Bristol Myers Squibb provided the study drug. Dr. Rovin reported ties to Genentech, Questcor, TEVA, Biogen-IDEC, HGS, Johnson & Johnson, Roche, BMS, and TG Therapeutics.

SAN DIEGO – Alteration in the balance of placentally secreted angiogenic factors early in pregnancy provides a potent new predictor of subsequent preeclampsia and other poor outcomes in pregnant women with systemic lupus erythematosus and/or antiphospholipid antibody syndrome.

Patients with systemic lupus erythematosus (SLE) and/or antiphospholipid antibody syndrome (APS) who had an elevated ratio of a splice variant of vascular endothelial growth factor R1 called sFLT1 to placental growth factor (PlGF) when measured at 16-19 weeks’ gestation were at 13.8-fold increased relative risk of preeclampsia before 34 weeks, compared with patients with an sFLT1/PlGF ratio below that cut-point in the large, multicenter, observational PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and SLE) study, Dr. Jane E. Salmon reported at the annual meeting of the American College of Rheumatology.

"Nearly half of the patients with an SFLT1/PlGF ratio greater than 3.45 when measured at 16-19 weeks’ gestation will develop early preeclampsia. On the other hand, a low ratio, as well as low levels of sFLT1 or high levels of PlGF, can reassure physicians and patients that preterm preeclampsia is unlikely: a 3% chance," said Dr. Salmon, professor of medicine and of ob.gyn. at Cornell University and a rheumatologist at the Hospital for Special Surgery, both in New York.

Pregnancy in patients with lupus is associated with obstetric complications placing both mother and fetus at great risk. Yet, until now it hasn’t been possible to predict which patients will have poor outcomes.

The key to identifying those at high risk lies in a recognition that preeclampsia and other poor outcomes are dramatic manifestations of placental insufficiency, which actually begins, initially silently, early in pregnancy. The maternal hypertension, proteinuria, thrombocytopenia, and other end-organ manifestations of preeclampsia are caused by maternal endothelial dysfunction mediated by placental secretion of antiangiogenic factors. Angiogenic growth factors, such as PIGF and vascular endothelial growth factor (VEGF), are essential to a healthy endothelium. But placentally secreted sFLT1 binds to these two angiogenic growth factors, rendering them unavailable to the endothelium, she explained.

Overexpression of sFLT1 in multiple animal models results in hypertension and proteinuria, the hallmarks of preeclampsia. Moreover, cancer patients treated with VEGF inhibitors often develop these two conditions. Based in part on these observations, Dr. Salmon and her coinvestigators turned to the PROMISSE study to test their hypothesis that elevated levels of antiangiogenic factors early in pregnancy predict poor outcomes in patients with SLE and/or APS. The prospective study involved 503 pregnant women with SLE and/or APS and 204 healthy controls, all with monthly blood draws starting before 12 weeks’ gestation.

The composite outcome of preeclampsia, small for gestational age, indicated preterm delivery, and other adverse events occurred in 37% of SLE patients who also had APS. The rate was 16% in patients with SLE alone, 26% in those with APS alone, and 3% in controls.

Subjects with SLE and/or APS who developed preeclampsia and other pregnancy complications displayed significantly higher levels of sFLT1 beginning at 12 weeks and sustained through 31 weeks’ gestation, compared with those with normal pregnancies. Moreover, PlGF levels were significantly lower during weeks 16-31 in the patients with pregnancy complications. The investigators determined that the best predictor of pregnancy complications was the ratio of antiangiogenic sFLT1 to angiogenic PlGF. And the optimal cut-point was 3.45.

Audience members said that while a predictive test for preeclampsia is most welcome, the fact remains that physicians don’t have a lot to offer in terms of prevention or treatment of this feared pregnancy complication. Dr. Salmon responded that the SFLT1/PlGF ratio can be used to risk-stratify pregnant lupus patients for future interventional trials with new drugs looking at new pathways. Already, for example, other investigators have reported some success using a strategy targeting sFLT1 itself. In a small study, they found that women with severe preeclampsia who had their blood run through a heparin column that binds and removes sFLT1 were able to maintain their pregnancies for up to 2 weeks.

"It’s a tiny, open-label trial involving a device, but I think that will move forward," she predicted.

The PROMISSE study was funded by the National Institutes of Health, the Alliance for Lupus Research, and the Mary Kirkland Center for Lupus Research at the Hospital for Special Surgery. Dr. Salmon reported having received research grants from and/or serving as a consultant to Alexion, Novartis, and Roche.

[email protected]

SAN DIEGO – Alteration in the balance of placentally secreted angiogenic factors early in pregnancy provides a potent new predictor of subsequent preeclampsia and other poor outcomes in pregnant women with systemic lupus erythematosus and/or antiphospholipid antibody syndrome.

Patients with systemic lupus erythematosus (SLE) and/or antiphospholipid antibody syndrome (APS) who had an elevated ratio of a splice variant of vascular endothelial growth factor R1 called sFLT1 to placental growth factor (PlGF) when measured at 16-19 weeks’ gestation were at 13.8-fold increased relative risk of preeclampsia before 34 weeks, compared with patients with an sFLT1/PlGF ratio below that cut-point in the large, multicenter, observational PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and SLE) study, Dr. Jane E. Salmon reported at the annual meeting of the American College of Rheumatology.

"Nearly half of the patients with an SFLT1/PlGF ratio greater than 3.45 when measured at 16-19 weeks’ gestation will develop early preeclampsia. On the other hand, a low ratio, as well as low levels of sFLT1 or high levels of PlGF, can reassure physicians and patients that preterm preeclampsia is unlikely: a 3% chance," said Dr. Salmon, professor of medicine and of ob.gyn. at Cornell University and a rheumatologist at the Hospital for Special Surgery, both in New York.

Pregnancy in patients with lupus is associated with obstetric complications placing both mother and fetus at great risk. Yet, until now it hasn’t been possible to predict which patients will have poor outcomes.

The key to identifying those at high risk lies in a recognition that preeclampsia and other poor outcomes are dramatic manifestations of placental insufficiency, which actually begins, initially silently, early in pregnancy. The maternal hypertension, proteinuria, thrombocytopenia, and other end-organ manifestations of preeclampsia are caused by maternal endothelial dysfunction mediated by placental secretion of antiangiogenic factors. Angiogenic growth factors, such as PIGF and vascular endothelial growth factor (VEGF), are essential to a healthy endothelium. But placentally secreted sFLT1 binds to these two angiogenic growth factors, rendering them unavailable to the endothelium, she explained.

Overexpression of sFLT1 in multiple animal models results in hypertension and proteinuria, the hallmarks of preeclampsia. Moreover, cancer patients treated with VEGF inhibitors often develop these two conditions. Based in part on these observations, Dr. Salmon and her coinvestigators turned to the PROMISSE study to test their hypothesis that elevated levels of antiangiogenic factors early in pregnancy predict poor outcomes in patients with SLE and/or APS. The prospective study involved 503 pregnant women with SLE and/or APS and 204 healthy controls, all with monthly blood draws starting before 12 weeks’ gestation.

The composite outcome of preeclampsia, small for gestational age, indicated preterm delivery, and other adverse events occurred in 37% of SLE patients who also had APS. The rate was 16% in patients with SLE alone, 26% in those with APS alone, and 3% in controls.

Subjects with SLE and/or APS who developed preeclampsia and other pregnancy complications displayed significantly higher levels of sFLT1 beginning at 12 weeks and sustained through 31 weeks’ gestation, compared with those with normal pregnancies. Moreover, PlGF levels were significantly lower during weeks 16-31 in the patients with pregnancy complications. The investigators determined that the best predictor of pregnancy complications was the ratio of antiangiogenic sFLT1 to angiogenic PlGF. And the optimal cut-point was 3.45.

Audience members said that while a predictive test for preeclampsia is most welcome, the fact remains that physicians don’t have a lot to offer in terms of prevention or treatment of this feared pregnancy complication. Dr. Salmon responded that the SFLT1/PlGF ratio can be used to risk-stratify pregnant lupus patients for future interventional trials with new drugs looking at new pathways. Already, for example, other investigators have reported some success using a strategy targeting sFLT1 itself. In a small study, they found that women with severe preeclampsia who had their blood run through a heparin column that binds and removes sFLT1 were able to maintain their pregnancies for up to 2 weeks.

"It’s a tiny, open-label trial involving a device, but I think that will move forward," she predicted.

The PROMISSE study was funded by the National Institutes of Health, the Alliance for Lupus Research, and the Mary Kirkland Center for Lupus Research at the Hospital for Special Surgery. Dr. Salmon reported having received research grants from and/or serving as a consultant to Alexion, Novartis, and Roche.

[email protected]

SAN DIEGO – Alteration in the balance of placentally secreted angiogenic factors early in pregnancy provides a potent new predictor of subsequent preeclampsia and other poor outcomes in pregnant women with systemic lupus erythematosus and/or antiphospholipid antibody syndrome.

Patients with systemic lupus erythematosus (SLE) and/or antiphospholipid antibody syndrome (APS) who had an elevated ratio of a splice variant of vascular endothelial growth factor R1 called sFLT1 to placental growth factor (PlGF) when measured at 16-19 weeks’ gestation were at 13.8-fold increased relative risk of preeclampsia before 34 weeks, compared with patients with an sFLT1/PlGF ratio below that cut-point in the large, multicenter, observational PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and SLE) study, Dr. Jane E. Salmon reported at the annual meeting of the American College of Rheumatology.

"Nearly half of the patients with an SFLT1/PlGF ratio greater than 3.45 when measured at 16-19 weeks’ gestation will develop early preeclampsia. On the other hand, a low ratio, as well as low levels of sFLT1 or high levels of PlGF, can reassure physicians and patients that preterm preeclampsia is unlikely: a 3% chance," said Dr. Salmon, professor of medicine and of ob.gyn. at Cornell University and a rheumatologist at the Hospital for Special Surgery, both in New York.

Pregnancy in patients with lupus is associated with obstetric complications placing both mother and fetus at great risk. Yet, until now it hasn’t been possible to predict which patients will have poor outcomes.

The key to identifying those at high risk lies in a recognition that preeclampsia and other poor outcomes are dramatic manifestations of placental insufficiency, which actually begins, initially silently, early in pregnancy. The maternal hypertension, proteinuria, thrombocytopenia, and other end-organ manifestations of preeclampsia are caused by maternal endothelial dysfunction mediated by placental secretion of antiangiogenic factors. Angiogenic growth factors, such as PIGF and vascular endothelial growth factor (VEGF), are essential to a healthy endothelium. But placentally secreted sFLT1 binds to these two angiogenic growth factors, rendering them unavailable to the endothelium, she explained.

Overexpression of sFLT1 in multiple animal models results in hypertension and proteinuria, the hallmarks of preeclampsia. Moreover, cancer patients treated with VEGF inhibitors often develop these two conditions. Based in part on these observations, Dr. Salmon and her coinvestigators turned to the PROMISSE study to test their hypothesis that elevated levels of antiangiogenic factors early in pregnancy predict poor outcomes in patients with SLE and/or APS. The prospective study involved 503 pregnant women with SLE and/or APS and 204 healthy controls, all with monthly blood draws starting before 12 weeks’ gestation.

The composite outcome of preeclampsia, small for gestational age, indicated preterm delivery, and other adverse events occurred in 37% of SLE patients who also had APS. The rate was 16% in patients with SLE alone, 26% in those with APS alone, and 3% in controls.

Subjects with SLE and/or APS who developed preeclampsia and other pregnancy complications displayed significantly higher levels of sFLT1 beginning at 12 weeks and sustained through 31 weeks’ gestation, compared with those with normal pregnancies. Moreover, PlGF levels were significantly lower during weeks 16-31 in the patients with pregnancy complications. The investigators determined that the best predictor of pregnancy complications was the ratio of antiangiogenic sFLT1 to angiogenic PlGF. And the optimal cut-point was 3.45.

Audience members said that while a predictive test for preeclampsia is most welcome, the fact remains that physicians don’t have a lot to offer in terms of prevention or treatment of this feared pregnancy complication. Dr. Salmon responded that the SFLT1/PlGF ratio can be used to risk-stratify pregnant lupus patients for future interventional trials with new drugs looking at new pathways. Already, for example, other investigators have reported some success using a strategy targeting sFLT1 itself. In a small study, they found that women with severe preeclampsia who had their blood run through a heparin column that binds and removes sFLT1 were able to maintain their pregnancies for up to 2 weeks.

"It’s a tiny, open-label trial involving a device, but I think that will move forward," she predicted.

The PROMISSE study was funded by the National Institutes of Health, the Alliance for Lupus Research, and the Mary Kirkland Center for Lupus Research at the Hospital for Special Surgery. Dr. Salmon reported having received research grants from and/or serving as a consultant to Alexion, Novartis, and Roche.

[email protected]

SAN DIEGO – Compared with standard care, intensive management of psoriatic arthritis using a treat-to-target approach significantly improved joint and skin outcomes for patients newly diagnosed with the disease, results from a multicenter, randomized controlled trial showed.

"Treating to target works in this disease, and it’s going to result in better long-term outcomes," lead investigator Dr. Philip Helliwell said during a press briefing at the annual meeting of the American College of Rheumatology.

Dr. Helliwell and his associates at eight centers in the United Kingdom randomized 206 patients with early psoriatic arthritis to standard care or intensive management, and followed them for 48 weeks. Patients in the standard care group were treated by a rheumatologist with no set protocol and no limitations, while those in the intensive management group followed a strict treatment protocol with escalation of therapy if minimal disease activity criteria were not met.

Patients in the intensive management group were started on methotrexate with rapid escalation to a dose of *25 mg/week after 6 weeks if they tolerated the drug. If they did not meet minimal disease criteria after 12 weeks, they received a more powerful combination of disease-modifying antirheumatic drugs (DMARDs).

After another 12 weeks, patients in the intensive management group were given anti–tumor necrosis factor therapy if they had three or more tender joints. If they had fewer than three tender or swollen joints but did not meet the minimal disease activity criteria, they were given methotrexate and an alternative DMARD. Patients in the standard care group were treated with DMARDs, but with no set time limits for drug therapy escalation or measurements to reach.

The primary outcome measures were the proportion of patients in both groups who achieved ACR20, ACR50, and ACR70 criteria for disease activity, which represent disease improvement of 20%, 50%, and 70%, respectively. Dr. Helliwell reported that compared with the standard care group, a higher proportion of patients in the intensive management group achieved ACR20 (62% vs. 45%, respectively), ACR50 (51% vs. 25%), and ACR70 (38% vs. 17%). A higher proportion of patients in the intensive management group also achieved a Psoriasis Area and Severity Index 75 compared with their counterparts in the standard care group (59% vs. 33%).

Research in psoriatic arthritis has "lagged behind that of rheumatoid arthritis for years in terms of pathogenesis and treatment paradigms," noted Dr. Helliwell, a senior lecturer in rheumatology at the Institute of Rheumatic and Musculoskeletal Medicine at the University of Leeds (England). "I think the study we’ve reported brings psoriatic arthritis right up to date alongside RA."

He said that up to one-third of people with psoriasis will develop psoriatic arthritis, "so it’s not an insignificant arthritis. It’s often not recognized. One survey we did of people with psoriasis in the community in the U.K. found that up to half of the people with psoriatic arthritis didn’t know they had it. They’d seen their doctor for various reasons and had been told they’d had another form of arthritis, or they were fobbed off with other diagnoses."

The researchers have yet to perform a cost analysis comparing the two treatment groups.

The study was funded by Arthritis Research UK and Pfizer. Dr. Helliwell disclosed that he has received consulting fees from Pfizer.

[email protected]

*Correction 11/11/13: A previous version of this story misstated the methotrexate dosage used in the study. This version has been updated to reflect the correct dosage. 

SAN DIEGO – Compared with standard care, intensive management of psoriatic arthritis using a treat-to-target approach significantly improved joint and skin outcomes for patients newly diagnosed with the disease, results from a multicenter, randomized controlled trial showed.

"Treating to target works in this disease, and it’s going to result in better long-term outcomes," lead investigator Dr. Philip Helliwell said during a press briefing at the annual meeting of the American College of Rheumatology.

Dr. Helliwell and his associates at eight centers in the United Kingdom randomized 206 patients with early psoriatic arthritis to standard care or intensive management, and followed them for 48 weeks. Patients in the standard care group were treated by a rheumatologist with no set protocol and no limitations, while those in the intensive management group followed a strict treatment protocol with escalation of therapy if minimal disease activity criteria were not met.

Patients in the intensive management group were started on methotrexate with rapid escalation to a dose of *25 mg/week after 6 weeks if they tolerated the drug. If they did not meet minimal disease criteria after 12 weeks, they received a more powerful combination of disease-modifying antirheumatic drugs (DMARDs).

After another 12 weeks, patients in the intensive management group were given anti–tumor necrosis factor therapy if they had three or more tender joints. If they had fewer than three tender or swollen joints but did not meet the minimal disease activity criteria, they were given methotrexate and an alternative DMARD. Patients in the standard care group were treated with DMARDs, but with no set time limits for drug therapy escalation or measurements to reach.

The primary outcome measures were the proportion of patients in both groups who achieved ACR20, ACR50, and ACR70 criteria for disease activity, which represent disease improvement of 20%, 50%, and 70%, respectively. Dr. Helliwell reported that compared with the standard care group, a higher proportion of patients in the intensive management group achieved ACR20 (62% vs. 45%, respectively), ACR50 (51% vs. 25%), and ACR70 (38% vs. 17%). A higher proportion of patients in the intensive management group also achieved a Psoriasis Area and Severity Index 75 compared with their counterparts in the standard care group (59% vs. 33%).

Research in psoriatic arthritis has "lagged behind that of rheumatoid arthritis for years in terms of pathogenesis and treatment paradigms," noted Dr. Helliwell, a senior lecturer in rheumatology at the Institute of Rheumatic and Musculoskeletal Medicine at the University of Leeds (England). "I think the study we’ve reported brings psoriatic arthritis right up to date alongside RA."

He said that up to one-third of people with psoriasis will develop psoriatic arthritis, "so it’s not an insignificant arthritis. It’s often not recognized. One survey we did of people with psoriasis in the community in the U.K. found that up to half of the people with psoriatic arthritis didn’t know they had it. They’d seen their doctor for various reasons and had been told they’d had another form of arthritis, or they were fobbed off with other diagnoses."

The researchers have yet to perform a cost analysis comparing the two treatment groups.

The study was funded by Arthritis Research UK and Pfizer. Dr. Helliwell disclosed that he has received consulting fees from Pfizer.

[email protected]

*Correction 11/11/13: A previous version of this story misstated the methotrexate dosage used in the study. This version has been updated to reflect the correct dosage. 

SAN DIEGO – Compared with standard care, intensive management of psoriatic arthritis using a treat-to-target approach significantly improved joint and skin outcomes for patients newly diagnosed with the disease, results from a multicenter, randomized controlled trial showed.

"Treating to target works in this disease, and it’s going to result in better long-term outcomes," lead investigator Dr. Philip Helliwell said during a press briefing at the annual meeting of the American College of Rheumatology.

Dr. Helliwell and his associates at eight centers in the United Kingdom randomized 206 patients with early psoriatic arthritis to standard care or intensive management, and followed them for 48 weeks. Patients in the standard care group were treated by a rheumatologist with no set protocol and no limitations, while those in the intensive management group followed a strict treatment protocol with escalation of therapy if minimal disease activity criteria were not met.

Patients in the intensive management group were started on methotrexate with rapid escalation to a dose of *25 mg/week after 6 weeks if they tolerated the drug. If they did not meet minimal disease criteria after 12 weeks, they received a more powerful combination of disease-modifying antirheumatic drugs (DMARDs).

After another 12 weeks, patients in the intensive management group were given anti–tumor necrosis factor therapy if they had three or more tender joints. If they had fewer than three tender or swollen joints but did not meet the minimal disease activity criteria, they were given methotrexate and an alternative DMARD. Patients in the standard care group were treated with DMARDs, but with no set time limits for drug therapy escalation or measurements to reach.

The primary outcome measures were the proportion of patients in both groups who achieved ACR20, ACR50, and ACR70 criteria for disease activity, which represent disease improvement of 20%, 50%, and 70%, respectively. Dr. Helliwell reported that compared with the standard care group, a higher proportion of patients in the intensive management group achieved ACR20 (62% vs. 45%, respectively), ACR50 (51% vs. 25%), and ACR70 (38% vs. 17%). A higher proportion of patients in the intensive management group also achieved a Psoriasis Area and Severity Index 75 compared with their counterparts in the standard care group (59% vs. 33%).

Research in psoriatic arthritis has "lagged behind that of rheumatoid arthritis for years in terms of pathogenesis and treatment paradigms," noted Dr. Helliwell, a senior lecturer in rheumatology at the Institute of Rheumatic and Musculoskeletal Medicine at the University of Leeds (England). "I think the study we’ve reported brings psoriatic arthritis right up to date alongside RA."

He said that up to one-third of people with psoriasis will develop psoriatic arthritis, "so it’s not an insignificant arthritis. It’s often not recognized. One survey we did of people with psoriasis in the community in the U.K. found that up to half of the people with psoriatic arthritis didn’t know they had it. They’d seen their doctor for various reasons and had been told they’d had another form of arthritis, or they were fobbed off with other diagnoses."

The researchers have yet to perform a cost analysis comparing the two treatment groups.

The study was funded by Arthritis Research UK and Pfizer. Dr. Helliwell disclosed that he has received consulting fees from Pfizer.

[email protected]

*Correction 11/11/13: A previous version of this story misstated the methotrexate dosage used in the study. This version has been updated to reflect the correct dosage. 

LAS VEGAS – Psoriasis has a negative impact on women’s sexual desire, sexual ability, and sexual relationships, according to Dr. Jennifer Cather of the Modern Dermatology-Aesthetics Center in Dallas.

Dr. Cather and her colleagues are developing a clinical tool to assess the disease’s sexual impact; as part of those efforts, they conducted 60 interviews with moderately to severely psoriatic women with a mean age of 41 years.

The survey results showed that sexuality was clearly another reason why it’s important to keep psoriasis in check. Pain and itchiness during sex, self-consciousness and embarrassment, and avoidance of dating and intimate relationships were among the most common problems the women reported.

"We really didn’t appreciate the impact psoriasis had on relationships" before the survey, Dr. Cather said at the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar. "The sexual impact has been underappreciated," she said.

Those problems might help explain why women with psoriasis, especially those aged younger than 35 years, tend to have fewer babies, she added. Psoriatic women also have higher rates of induced and spontaneous abortions and are more likely to have preterm and underweight births.

Some of the women surveyed said that they worried about passing psoriasis to their children. "Maybe there’s voluntary childlessness," Dr. Cather said. But when women in her practice mention they don’t want kids for fear of passing on the disease, "I answer right back, ‘You don’t have to have what you have. I can help you with it,’ " she said.

Methotrexate, acitretin, and psoralen photochemotherapy (PUVA) are contraindicated during pregnancy, but ultraviolet B (UVB) treatments are safe, said Dr. Cather. She also uses tumor necrosis factor inhibitors, which are FDA pregnancy category B agents; she prefers etanercept for its short half-life (just over 4 days) and because ob.gyns. are usually familiar with it. The Organization of Teratology Information Specialists (OTIS) keeps the etanercept and adalimumab pregnancy registries, and "there’s [been] no signal to date" for those drugs, she said.

Psoriatic women should know that the odds are with them for having a normal pregnancy, and that pregnancy is likely to help clear their skin, Dr. Cather said.

But because half of the pregnancies in the United States are unplanned, it’s important to discuss pregnancy – and psoriasis treatment during pregnancy – as part of routine care. "It’s difficult if a psoriasis patient calls you in a panic because they’re not sure their drug is safe, and not sure their doctor will let them continue it,’ she said. Some ob.gyns. are comfortable with letting women stay on their psoriasis therapy, while others want them to quit everything, even topical steroids.

"In my clinic, when a psoriasis patient gets pregnant, usually we’ve planned for it and are excited about it, and we’ve had some dialogue with the ob.gyn.," she explained.

SDEF and this news organization are owned by Frontline Medical Communications. Dr. Cather is a consultant, speaker, or researcher for AbbVie, Novartis, Leo, Janssen, Amgen, Celgene, Merck, and Pfizer.

[email protected]

LAS VEGAS – Psoriasis has a negative impact on women’s sexual desire, sexual ability, and sexual relationships, according to Dr. Jennifer Cather of the Modern Dermatology-Aesthetics Center in Dallas.

Dr. Cather and her colleagues are developing a clinical tool to assess the disease’s sexual impact; as part of those efforts, they conducted 60 interviews with moderately to severely psoriatic women with a mean age of 41 years.

The survey results showed that sexuality was clearly another reason why it’s important to keep psoriasis in check. Pain and itchiness during sex, self-consciousness and embarrassment, and avoidance of dating and intimate relationships were among the most common problems the women reported.

"We really didn’t appreciate the impact psoriasis had on relationships" before the survey, Dr. Cather said at the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar. "The sexual impact has been underappreciated," she said.

Those problems might help explain why women with psoriasis, especially those aged younger than 35 years, tend to have fewer babies, she added. Psoriatic women also have higher rates of induced and spontaneous abortions and are more likely to have preterm and underweight births.

Some of the women surveyed said that they worried about passing psoriasis to their children. "Maybe there’s voluntary childlessness," Dr. Cather said. But when women in her practice mention they don’t want kids for fear of passing on the disease, "I answer right back, ‘You don’t have to have what you have. I can help you with it,’ " she said.

Methotrexate, acitretin, and psoralen photochemotherapy (PUVA) are contraindicated during pregnancy, but ultraviolet B (UVB) treatments are safe, said Dr. Cather. She also uses tumor necrosis factor inhibitors, which are FDA pregnancy category B agents; she prefers etanercept for its short half-life (just over 4 days) and because ob.gyns. are usually familiar with it. The Organization of Teratology Information Specialists (OTIS) keeps the etanercept and adalimumab pregnancy registries, and "there’s [been] no signal to date" for those drugs, she said.

Psoriatic women should know that the odds are with them for having a normal pregnancy, and that pregnancy is likely to help clear their skin, Dr. Cather said.

But because half of the pregnancies in the United States are unplanned, it’s important to discuss pregnancy – and psoriasis treatment during pregnancy – as part of routine care. "It’s difficult if a psoriasis patient calls you in a panic because they’re not sure their drug is safe, and not sure their doctor will let them continue it,’ she said. Some ob.gyns. are comfortable with letting women stay on their psoriasis therapy, while others want them to quit everything, even topical steroids.

"In my clinic, when a psoriasis patient gets pregnant, usually we’ve planned for it and are excited about it, and we’ve had some dialogue with the ob.gyn.," she explained.

SDEF and this news organization are owned by Frontline Medical Communications. Dr. Cather is a consultant, speaker, or researcher for AbbVie, Novartis, Leo, Janssen, Amgen, Celgene, Merck, and Pfizer.

[email protected]

LAS VEGAS – Psoriasis has a negative impact on women’s sexual desire, sexual ability, and sexual relationships, according to Dr. Jennifer Cather of the Modern Dermatology-Aesthetics Center in Dallas.

Dr. Cather and her colleagues are developing a clinical tool to assess the disease’s sexual impact; as part of those efforts, they conducted 60 interviews with moderately to severely psoriatic women with a mean age of 41 years.

The survey results showed that sexuality was clearly another reason why it’s important to keep psoriasis in check. Pain and itchiness during sex, self-consciousness and embarrassment, and avoidance of dating and intimate relationships were among the most common problems the women reported.

"We really didn’t appreciate the impact psoriasis had on relationships" before the survey, Dr. Cather said at the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar. "The sexual impact has been underappreciated," she said.

Those problems might help explain why women with psoriasis, especially those aged younger than 35 years, tend to have fewer babies, she added. Psoriatic women also have higher rates of induced and spontaneous abortions and are more likely to have preterm and underweight births.

Some of the women surveyed said that they worried about passing psoriasis to their children. "Maybe there’s voluntary childlessness," Dr. Cather said. But when women in her practice mention they don’t want kids for fear of passing on the disease, "I answer right back, ‘You don’t have to have what you have. I can help you with it,’ " she said.

Methotrexate, acitretin, and psoralen photochemotherapy (PUVA) are contraindicated during pregnancy, but ultraviolet B (UVB) treatments are safe, said Dr. Cather. She also uses tumor necrosis factor inhibitors, which are FDA pregnancy category B agents; she prefers etanercept for its short half-life (just over 4 days) and because ob.gyns. are usually familiar with it. The Organization of Teratology Information Specialists (OTIS) keeps the etanercept and adalimumab pregnancy registries, and "there’s [been] no signal to date" for those drugs, she said.

Psoriatic women should know that the odds are with them for having a normal pregnancy, and that pregnancy is likely to help clear their skin, Dr. Cather said.

But because half of the pregnancies in the United States are unplanned, it’s important to discuss pregnancy – and psoriasis treatment during pregnancy – as part of routine care. "It’s difficult if a psoriasis patient calls you in a panic because they’re not sure their drug is safe, and not sure their doctor will let them continue it,’ she said. Some ob.gyns. are comfortable with letting women stay on their psoriasis therapy, while others want them to quit everything, even topical steroids.

"In my clinic, when a psoriasis patient gets pregnant, usually we’ve planned for it and are excited about it, and we’ve had some dialogue with the ob.gyn.," she explained.

SDEF and this news organization are owned by Frontline Medical Communications. Dr. Cather is a consultant, speaker, or researcher for AbbVie, Novartis, Leo, Janssen, Amgen, Celgene, Merck, and Pfizer.

[email protected]

LAS VEGAS – Wet dressing, a technique forgotten in most places but in continual use at the Mayo Clinic for more than 80 years, knocks out intractable pruritus – whatever its cause – in children and adults, according to Dr. Mark Davis, chair of the division of clinical dermatology at the clinic in Rochester, Minn.

"It’s a simple technique that works extraordinarily well for any itchy condition from head to toe, and has virtually no side effects. It stops itching reliably, when nothing else has worked," including prednisone, methotrexate, phototherapy, and elimination diets, among other strategies, he said at Skin Disease Education Foundation’s annual Las Vegas dermatology seminar.

M. Alexander Otto/IMNG Medical Media

Even so, "there’s remarkably little on this in the literature, and what’s published is mostly just in kids, but in adults it works brilliantly, too, particularly for atopic dermatitis. We use it when people come in itching from anything, like psoriasis," he said (J. Am. Acad. Dermatol. 2009;60:792-800).

"The commonest question [we hear from people] is ‘I’ve been going to doctors for years. Why didn’t anybody tell me about this?’ " said Dr. Davis.

If their pruritus is severe enough, patients will be admitted to the Mayo Clinic and have wet cloths applied to wherever the itch happens to be – above the waist, below the waist, the feet, or even the entire body, including the face – with a dry blanket on top if needed to ward of the chill. Patients can get up from bed for a bathroom break when the dressings are changed every 3 hours.

Topical steroids are used with the dressings up to three times a day; 1% percent hydrocortisone for the face or genitals, 0.1% or 0.05% triamcinolone elsewhere. The Mayo Clinic has never had a case of hypothalamic-pituitary-adrenal axis suppression with the technique, and insurance usually covers the cost for 3 days, Dr. Davis said.

When outpatient treatment is sufficient, pruritic patients are instructed to put on wet pajamas or long johns, or hop into the shower in dry ones, and then leave them on for 30 minutes to an hour, 3-4 times a day. Nurses, with the help of handouts and videos, teach patients how to do this, and call them every 24 hours to see how they are getting along.

Hospital patients get the same instructions at discharge. "Initially, they have to do [it] at least once a day for a number of weeks, and then they can use [the technique] on an as-needed basis, maybe once or twice a week," Dr. Davis said.

"Wet dressings went out of favor" in most places because "they are just so much trouble," he said. At present, the technique is "largely unknown," as is the reason why it works, he added.

Dr. Davis has no relevant disclosures. SDEF and this news organization are owned by Frontline Medical Communications.

[email protected]

LAS VEGAS – Wet dressing, a technique forgotten in most places but in continual use at the Mayo Clinic for more than 80 years, knocks out intractable pruritus – whatever its cause – in children and adults, according to Dr. Mark Davis, chair of the division of clinical dermatology at the clinic in Rochester, Minn.

"It’s a simple technique that works extraordinarily well for any itchy condition from head to toe, and has virtually no side effects. It stops itching reliably, when nothing else has worked," including prednisone, methotrexate, phototherapy, and elimination diets, among other strategies, he said at Skin Disease Education Foundation’s annual Las Vegas dermatology seminar.

M. Alexander Otto/IMNG Medical Media

Even so, "there’s remarkably little on this in the literature, and what’s published is mostly just in kids, but in adults it works brilliantly, too, particularly for atopic dermatitis. We use it when people come in itching from anything, like psoriasis," he said (J. Am. Acad. Dermatol. 2009;60:792-800).

"The commonest question [we hear from people] is ‘I’ve been going to doctors for years. Why didn’t anybody tell me about this?’ " said Dr. Davis.

If their pruritus is severe enough, patients will be admitted to the Mayo Clinic and have wet cloths applied to wherever the itch happens to be – above the waist, below the waist, the feet, or even the entire body, including the face – with a dry blanket on top if needed to ward of the chill. Patients can get up from bed for a bathroom break when the dressings are changed every 3 hours.

Topical steroids are used with the dressings up to three times a day; 1% percent hydrocortisone for the face or genitals, 0.1% or 0.05% triamcinolone elsewhere. The Mayo Clinic has never had a case of hypothalamic-pituitary-adrenal axis suppression with the technique, and insurance usually covers the cost for 3 days, Dr. Davis said.

When outpatient treatment is sufficient, pruritic patients are instructed to put on wet pajamas or long johns, or hop into the shower in dry ones, and then leave them on for 30 minutes to an hour, 3-4 times a day. Nurses, with the help of handouts and videos, teach patients how to do this, and call them every 24 hours to see how they are getting along.

Hospital patients get the same instructions at discharge. "Initially, they have to do [it] at least once a day for a number of weeks, and then they can use [the technique] on an as-needed basis, maybe once or twice a week," Dr. Davis said.

"Wet dressings went out of favor" in most places because "they are just so much trouble," he said. At present, the technique is "largely unknown," as is the reason why it works, he added.

Dr. Davis has no relevant disclosures. SDEF and this news organization are owned by Frontline Medical Communications.

[email protected]

LAS VEGAS – Wet dressing, a technique forgotten in most places but in continual use at the Mayo Clinic for more than 80 years, knocks out intractable pruritus – whatever its cause – in children and adults, according to Dr. Mark Davis, chair of the division of clinical dermatology at the clinic in Rochester, Minn.

"It’s a simple technique that works extraordinarily well for any itchy condition from head to toe, and has virtually no side effects. It stops itching reliably, when nothing else has worked," including prednisone, methotrexate, phototherapy, and elimination diets, among other strategies, he said at Skin Disease Education Foundation’s annual Las Vegas dermatology seminar.

M. Alexander Otto/IMNG Medical Media

Even so, "there’s remarkably little on this in the literature, and what’s published is mostly just in kids, but in adults it works brilliantly, too, particularly for atopic dermatitis. We use it when people come in itching from anything, like psoriasis," he said (J. Am. Acad. Dermatol. 2009;60:792-800).

"The commonest question [we hear from people] is ‘I’ve been going to doctors for years. Why didn’t anybody tell me about this?’ " said Dr. Davis.

If their pruritus is severe enough, patients will be admitted to the Mayo Clinic and have wet cloths applied to wherever the itch happens to be – above the waist, below the waist, the feet, or even the entire body, including the face – with a dry blanket on top if needed to ward of the chill. Patients can get up from bed for a bathroom break when the dressings are changed every 3 hours.

Topical steroids are used with the dressings up to three times a day; 1% percent hydrocortisone for the face or genitals, 0.1% or 0.05% triamcinolone elsewhere. The Mayo Clinic has never had a case of hypothalamic-pituitary-adrenal axis suppression with the technique, and insurance usually covers the cost for 3 days, Dr. Davis said.

When outpatient treatment is sufficient, pruritic patients are instructed to put on wet pajamas or long johns, or hop into the shower in dry ones, and then leave them on for 30 minutes to an hour, 3-4 times a day. Nurses, with the help of handouts and videos, teach patients how to do this, and call them every 24 hours to see how they are getting along.

Hospital patients get the same instructions at discharge. "Initially, they have to do [it] at least once a day for a number of weeks, and then they can use [the technique] on an as-needed basis, maybe once or twice a week," Dr. Davis said.

"Wet dressings went out of favor" in most places because "they are just so much trouble," he said. At present, the technique is "largely unknown," as is the reason why it works, he added.

Dr. Davis has no relevant disclosures. SDEF and this news organization are owned by Frontline Medical Communications.

[email protected]

As evidence supporting an association between psoriasis and cardiovascular disease continues to mount, dermatologists may be the first line of defense in lowering heart failure risk.

"The increased risk of cardiovascular disease for patients with psoriasis may be of a similar magnitude as other well-described CV risk factors, such as uncontrolled hypertension," said Dr. Bruce E. Strober of the University of Connecticut, Farmington. "Further, epidemiological studies show that psoriasis patients have a shortened life expectancy, likely as a result of their experience with CV comorbitidies."

Patient education is essential, he noted at the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar. "At the very least, dermatologists should alert patients of the link between psoriasis and CV disease, and remind these patients of the necessity of having a primary care physician who monitors conventional risk factors of CV disease. Patients should be reminded that psoriasis is ‘systemic disease of inflammation’ that creates risks beyond the skin and may shorten life expectancy."

"Dermatologists who care for moderate to severe psoriasis patients should measure blood pressure and draw baseline blood tests assessing for abnormalities of cholesterol, triglycerides, kidney function, liver function, and blood glucose. Abnormalities should prompt an appropriate referral to a primary care physician," he noted.

In a population-based Dutch study presented at the annual congress of the European Society of Cardiology in September, adults with mild psoriasis developed 4.02 cases of new-onset heart failure per 1,000 person-years of follow-up, compared with 4.50/1,000 person-years in patients with severe psoriasis; both of which were significantly higher than the rate of 2.27/1,000 person-years in the general population.

Data from a 2006 study found that diabetes, hypertension, hyperlipidemia, and obesity were more prevalent in psoriasis patients, when compared with controls (J. Am. Acad. Dermatol. 2006;55:829-35). Diabetes and obesity were significantly more prevalent in patients with severe psoriasis, compared with patients with mild psoriasis.

Although the reasons for the increased cardiovascular risk in psoriasis patients remain unknown, possible causes include the use of dyslipidemic therapies, including corticosteroids, acitretin, and cyclosporine, as well as uncontrolled inflammation that could lead to endothelial dysfunction and dyslipidemia, said Dr. Strober. The prevalence of other associated and/or independent risk factors including obesity, hypertension, smoking, and alcohol misuse in psoriasis patients, also could play a role.

Dr. Strober disclosed relationships with multiple pharmaceutical companies including Abbott, Amgen, Janssen, Pfizer, Novartis, and Celgene. SDEF and this news organization are owned by Frontline Medical Communications.

[email protected]

As evidence supporting an association between psoriasis and cardiovascular disease continues to mount, dermatologists may be the first line of defense in lowering heart failure risk.

"The increased risk of cardiovascular disease for patients with psoriasis may be of a similar magnitude as other well-described CV risk factors, such as uncontrolled hypertension," said Dr. Bruce E. Strober of the University of Connecticut, Farmington. "Further, epidemiological studies show that psoriasis patients have a shortened life expectancy, likely as a result of their experience with CV comorbitidies."

Patient education is essential, he noted at the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar. "At the very least, dermatologists should alert patients of the link between psoriasis and CV disease, and remind these patients of the necessity of having a primary care physician who monitors conventional risk factors of CV disease. Patients should be reminded that psoriasis is ‘systemic disease of inflammation’ that creates risks beyond the skin and may shorten life expectancy."

"Dermatologists who care for moderate to severe psoriasis patients should measure blood pressure and draw baseline blood tests assessing for abnormalities of cholesterol, triglycerides, kidney function, liver function, and blood glucose. Abnormalities should prompt an appropriate referral to a primary care physician," he noted.

In a population-based Dutch study presented at the annual congress of the European Society of Cardiology in September, adults with mild psoriasis developed 4.02 cases of new-onset heart failure per 1,000 person-years of follow-up, compared with 4.50/1,000 person-years in patients with severe psoriasis; both of which were significantly higher than the rate of 2.27/1,000 person-years in the general population.

Data from a 2006 study found that diabetes, hypertension, hyperlipidemia, and obesity were more prevalent in psoriasis patients, when compared with controls (J. Am. Acad. Dermatol. 2006;55:829-35). Diabetes and obesity were significantly more prevalent in patients with severe psoriasis, compared with patients with mild psoriasis.

Although the reasons for the increased cardiovascular risk in psoriasis patients remain unknown, possible causes include the use of dyslipidemic therapies, including corticosteroids, acitretin, and cyclosporine, as well as uncontrolled inflammation that could lead to endothelial dysfunction and dyslipidemia, said Dr. Strober. The prevalence of other associated and/or independent risk factors including obesity, hypertension, smoking, and alcohol misuse in psoriasis patients, also could play a role.

Dr. Strober disclosed relationships with multiple pharmaceutical companies including Abbott, Amgen, Janssen, Pfizer, Novartis, and Celgene. SDEF and this news organization are owned by Frontline Medical Communications.

[email protected]

As evidence supporting an association between psoriasis and cardiovascular disease continues to mount, dermatologists may be the first line of defense in lowering heart failure risk.

"The increased risk of cardiovascular disease for patients with psoriasis may be of a similar magnitude as other well-described CV risk factors, such as uncontrolled hypertension," said Dr. Bruce E. Strober of the University of Connecticut, Farmington. "Further, epidemiological studies show that psoriasis patients have a shortened life expectancy, likely as a result of their experience with CV comorbitidies."

Patient education is essential, he noted at the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar. "At the very least, dermatologists should alert patients of the link between psoriasis and CV disease, and remind these patients of the necessity of having a primary care physician who monitors conventional risk factors of CV disease. Patients should be reminded that psoriasis is ‘systemic disease of inflammation’ that creates risks beyond the skin and may shorten life expectancy."

"Dermatologists who care for moderate to severe psoriasis patients should measure blood pressure and draw baseline blood tests assessing for abnormalities of cholesterol, triglycerides, kidney function, liver function, and blood glucose. Abnormalities should prompt an appropriate referral to a primary care physician," he noted.

In a population-based Dutch study presented at the annual congress of the European Society of Cardiology in September, adults with mild psoriasis developed 4.02 cases of new-onset heart failure per 1,000 person-years of follow-up, compared with 4.50/1,000 person-years in patients with severe psoriasis; both of which were significantly higher than the rate of 2.27/1,000 person-years in the general population.

Data from a 2006 study found that diabetes, hypertension, hyperlipidemia, and obesity were more prevalent in psoriasis patients, when compared with controls (J. Am. Acad. Dermatol. 2006;55:829-35). Diabetes and obesity were significantly more prevalent in patients with severe psoriasis, compared with patients with mild psoriasis.

Although the reasons for the increased cardiovascular risk in psoriasis patients remain unknown, possible causes include the use of dyslipidemic therapies, including corticosteroids, acitretin, and cyclosporine, as well as uncontrolled inflammation that could lead to endothelial dysfunction and dyslipidemia, said Dr. Strober. The prevalence of other associated and/or independent risk factors including obesity, hypertension, smoking, and alcohol misuse in psoriasis patients, also could play a role.

Dr. Strober disclosed relationships with multiple pharmaceutical companies including Abbott, Amgen, Janssen, Pfizer, Novartis, and Celgene. SDEF and this news organization are owned by Frontline Medical Communications.

[email protected]