Doug Brunk

SAN DIEGO — Breast cancer survivors take an average of eight medications or supplements, results from a survey of nearly 400 women showed.

“This study shows that there is a need to evaluate medications women are taking prior to the start of cancer treatment to promote discussion and education about drug-drug interactions that can impact treatment,” Julie L. Otte, Ph.D., said in an interview after her poster presentation at the annual meeting of the North American Menopause Society.

“There is little research in the field of pharmacogenetics regarding drug-drug interactions and cancer treatment and survivorship,” said Dr. Otte, a nurse who is a postdoctoral fellow focusing on behavioral oncology at Indiana University School of Nursing, Indianapolis.

She and her colleagues reviewed prescription, herbal, and over-the-counter medications reported in baseline questionnaire data from the Consortium on Breast Cancer Pharmacogenomics randomized clinical trial that evaluated the pharmacogenetics and toxicities of exemestane and letrozole. The sample included 389 breast cancer survivors with a mean age of 59 years.

The women reported taking an average of eight medications or supplements per day. The five most common categories were vitamins and herbal supplements (39%), cardiac drugs (16%), medications for pain and inflammation (13%), other (9%), and drugs for psychological conditions (6%).

Disclosures: Dr. Otte had no conflicts of interest related to the study, which was funded by the National Cancer Institute.

SAN DIEGO — Breast cancer survivors take an average of eight medications or supplements, results from a survey of nearly 400 women showed.

“This study shows that there is a need to evaluate medications women are taking prior to the start of cancer treatment to promote discussion and education about drug-drug interactions that can impact treatment,” Julie L. Otte, Ph.D., said in an interview after her poster presentation at the annual meeting of the North American Menopause Society.

“There is little research in the field of pharmacogenetics regarding drug-drug interactions and cancer treatment and survivorship,” said Dr. Otte, a nurse who is a postdoctoral fellow focusing on behavioral oncology at Indiana University School of Nursing, Indianapolis.

She and her colleagues reviewed prescription, herbal, and over-the-counter medications reported in baseline questionnaire data from the Consortium on Breast Cancer Pharmacogenomics randomized clinical trial that evaluated the pharmacogenetics and toxicities of exemestane and letrozole. The sample included 389 breast cancer survivors with a mean age of 59 years.

The women reported taking an average of eight medications or supplements per day. The five most common categories were vitamins and herbal supplements (39%), cardiac drugs (16%), medications for pain and inflammation (13%), other (9%), and drugs for psychological conditions (6%).

Disclosures: Dr. Otte had no conflicts of interest related to the study, which was funded by the National Cancer Institute.

SAN DIEGO — Breast cancer survivors take an average of eight medications or supplements, results from a survey of nearly 400 women showed.

“This study shows that there is a need to evaluate medications women are taking prior to the start of cancer treatment to promote discussion and education about drug-drug interactions that can impact treatment,” Julie L. Otte, Ph.D., said in an interview after her poster presentation at the annual meeting of the North American Menopause Society.

“There is little research in the field of pharmacogenetics regarding drug-drug interactions and cancer treatment and survivorship,” said Dr. Otte, a nurse who is a postdoctoral fellow focusing on behavioral oncology at Indiana University School of Nursing, Indianapolis.

She and her colleagues reviewed prescription, herbal, and over-the-counter medications reported in baseline questionnaire data from the Consortium on Breast Cancer Pharmacogenomics randomized clinical trial that evaluated the pharmacogenetics and toxicities of exemestane and letrozole. The sample included 389 breast cancer survivors with a mean age of 59 years.

The women reported taking an average of eight medications or supplements per day. The five most common categories were vitamins and herbal supplements (39%), cardiac drugs (16%), medications for pain and inflammation (13%), other (9%), and drugs for psychological conditions (6%).

Disclosures: Dr. Otte had no conflicts of interest related to the study, which was funded by the National Cancer Institute.

LAS VEGAS – Many patients taking adalimumab for psoriasis over the long term can expect a high rate of response that persists, but there is some real but small loss of effect, Dr. Kenneth B. Gordon said at a dermatology seminar sponsored by Skin Disease Education Foundation.

Adalimumab (Humira) is approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylosis, and Crohn's disease. The best published long-term data for adalimumab in psoriasis is from the double-blind, placebo-controlled REVEAL trial, which evaluated the PASI 75 response rates between weeks 4 and 24 of treatment in 1,212 patients (J. Am. Acad. Dermatol. 2008;58:106-15). Data from the trial showed that the PASI 75 response rates among patients on adalimumab were 19% at week 4, 54% at week 8, 68% at week 12, 71% at week 16, and 70% at week 24.

A second component of the trial evaluated the sustained responsiveness from weeks 16-33 in adalimumab-treated patients. The researchers found that the mean percentage of PASI improvement in this cohort was 92% at week 16, 92% at week 24, and 89% at week 33.

The great majority, but not all, of patients on adalimumab maintain responses, said Dr. Gordon, who heads the division of dermatology at NorthShore University HealthSystem, Evanston, Ill. "We do lose patients with treatment over time."

A cohort of 233 patients from the trial who received continuous adalimumab therapy up to 100 weeks showed that 100% of patients achieved a PASI 75 at week 33. But the percentage who sustained a PASI 75 dropped over time, from 85% at week 52 to 87% at week 76, and 83% at week 100.

"This tells me that of the patients who are doing well after about 8 months, the great majority are going to maintain response, but there are going to be a few that lose," he said. "It's the patients that are having marginal responses that you lose."

As for safety, the side effect profile seems to be relatively consistent with adalimumab. "It does not seem to increase over time," he emphasized. Data from the REVEAL trial found that the rate of serious adverse events was similar to the placebo group, about 1.8%.

According to pooled data from integrated studies, the top five most common adverse reactions are nasopharyngitis, followed by upper respiratory infection, headache, arthralgia, and injection site reaction.

If loss of efficacy with long-term use of adalimumab occurs in patients with psoriasis, it tends to happen in the first year.

"We think about treatment for psoriasis in 12- or 16-week blocks because that's what the primary end points of the clinical trials are," he said. "But psoriasis is a long-term disease. People have it for 20, 30, or 40 years, so we need to think beyond the realm of short-term."

Dr. Gordon disclosed that he has received research support or honoraria from Abbott, which manufactures adalimumab as Humira, as well as Amgen, Astellas, Centocor, and Genentech.

LAS VEGAS – Many patients taking adalimumab for psoriasis over the long term can expect a high rate of response that persists, but there is some real but small loss of effect, Dr. Kenneth B. Gordon said at a dermatology seminar sponsored by Skin Disease Education Foundation.

Adalimumab (Humira) is approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylosis, and Crohn's disease. The best published long-term data for adalimumab in psoriasis is from the double-blind, placebo-controlled REVEAL trial, which evaluated the PASI 75 response rates between weeks 4 and 24 of treatment in 1,212 patients (J. Am. Acad. Dermatol. 2008;58:106-15). Data from the trial showed that the PASI 75 response rates among patients on adalimumab were 19% at week 4, 54% at week 8, 68% at week 12, 71% at week 16, and 70% at week 24.

A second component of the trial evaluated the sustained responsiveness from weeks 16-33 in adalimumab-treated patients. The researchers found that the mean percentage of PASI improvement in this cohort was 92% at week 16, 92% at week 24, and 89% at week 33.

The great majority, but not all, of patients on adalimumab maintain responses, said Dr. Gordon, who heads the division of dermatology at NorthShore University HealthSystem, Evanston, Ill. "We do lose patients with treatment over time."

A cohort of 233 patients from the trial who received continuous adalimumab therapy up to 100 weeks showed that 100% of patients achieved a PASI 75 at week 33. But the percentage who sustained a PASI 75 dropped over time, from 85% at week 52 to 87% at week 76, and 83% at week 100.

"This tells me that of the patients who are doing well after about 8 months, the great majority are going to maintain response, but there are going to be a few that lose," he said. "It's the patients that are having marginal responses that you lose."

As for safety, the side effect profile seems to be relatively consistent with adalimumab. "It does not seem to increase over time," he emphasized. Data from the REVEAL trial found that the rate of serious adverse events was similar to the placebo group, about 1.8%.

According to pooled data from integrated studies, the top five most common adverse reactions are nasopharyngitis, followed by upper respiratory infection, headache, arthralgia, and injection site reaction.

If loss of efficacy with long-term use of adalimumab occurs in patients with psoriasis, it tends to happen in the first year.

"We think about treatment for psoriasis in 12- or 16-week blocks because that's what the primary end points of the clinical trials are," he said. "But psoriasis is a long-term disease. People have it for 20, 30, or 40 years, so we need to think beyond the realm of short-term."

Dr. Gordon disclosed that he has received research support or honoraria from Abbott, which manufactures adalimumab as Humira, as well as Amgen, Astellas, Centocor, and Genentech.

LAS VEGAS – Many patients taking adalimumab for psoriasis over the long term can expect a high rate of response that persists, but there is some real but small loss of effect, Dr. Kenneth B. Gordon said at a dermatology seminar sponsored by Skin Disease Education Foundation.

Adalimumab (Humira) is approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylosis, and Crohn's disease. The best published long-term data for adalimumab in psoriasis is from the double-blind, placebo-controlled REVEAL trial, which evaluated the PASI 75 response rates between weeks 4 and 24 of treatment in 1,212 patients (J. Am. Acad. Dermatol. 2008;58:106-15). Data from the trial showed that the PASI 75 response rates among patients on adalimumab were 19% at week 4, 54% at week 8, 68% at week 12, 71% at week 16, and 70% at week 24.

A second component of the trial evaluated the sustained responsiveness from weeks 16-33 in adalimumab-treated patients. The researchers found that the mean percentage of PASI improvement in this cohort was 92% at week 16, 92% at week 24, and 89% at week 33.

The great majority, but not all, of patients on adalimumab maintain responses, said Dr. Gordon, who heads the division of dermatology at NorthShore University HealthSystem, Evanston, Ill. "We do lose patients with treatment over time."

A cohort of 233 patients from the trial who received continuous adalimumab therapy up to 100 weeks showed that 100% of patients achieved a PASI 75 at week 33. But the percentage who sustained a PASI 75 dropped over time, from 85% at week 52 to 87% at week 76, and 83% at week 100.

"This tells me that of the patients who are doing well after about 8 months, the great majority are going to maintain response, but there are going to be a few that lose," he said. "It's the patients that are having marginal responses that you lose."

As for safety, the side effect profile seems to be relatively consistent with adalimumab. "It does not seem to increase over time," he emphasized. Data from the REVEAL trial found that the rate of serious adverse events was similar to the placebo group, about 1.8%.

According to pooled data from integrated studies, the top five most common adverse reactions are nasopharyngitis, followed by upper respiratory infection, headache, arthralgia, and injection site reaction.

If loss of efficacy with long-term use of adalimumab occurs in patients with psoriasis, it tends to happen in the first year.

"We think about treatment for psoriasis in 12- or 16-week blocks because that's what the primary end points of the clinical trials are," he said. "But psoriasis is a long-term disease. People have it for 20, 30, or 40 years, so we need to think beyond the realm of short-term."

Dr. Gordon disclosed that he has received research support or honoraria from Abbott, which manufactures adalimumab as Humira, as well as Amgen, Astellas, Centocor, and Genentech.

SAN DIEGO – Mohs surgery has a place in the treatment of melanoma in situ and invasive melanoma, “but in my practice it doesn’t have a place every day,” Dr. Michael H. Swann said at a melanoma update sponsored by the Scripps Clinic.

Dr. Swann, who performs Mohs surgery in a Springfield, Missouri–based dermatology practice 4-5 days per week, said that one of the main benefits of the technique for melanoma is that the recurrence rates are favorable to matched paraffin controls, a finding reported in a 1997 study of 533 patients. That study found that to achieve clear margins in 83% of patients, a 6-mm margin was required, 95% of tumors cleared with a 9-mm margin, and 99% of tumors cleared with a 16-mm margin (J. Am. Acad. Dermatol. 1997;37:236-45).

“So when we think about things that are left behind with local disease, these numbers stick in my head when I treat patients and I think about how I’m going to treat these tumors,” Dr. Swann said. “The way to treat melanoma is to detect it early and to get all the cells out surgically if you can.”

Other benefits of using Mohs surgery for melanoma are that the margin evaluation is superior to other techniques, it spares normal tissue, and immunostains are readily available for difficult cases. “You can turn around the tissue in about 40 minutes now, but immunostains by themselves are not the answer,” Dr. Swann commented. “There are plenty of Mohs surgeons like myself who don’t use immunostains, because for the most part, immunostains are used by labs to make the diagnosis of melanoma. The margins of these melanomas are seldom immunostained because the diagnosis is not in question.”

The convenience of a single-day procedure is another benefit of using Mohs surgery for melanoma, especially in geographic locations such as Missouri, where many patients live in rural areas. “It takes some patients 3 or 4 hours to drive to our practice,” Dr. Swann explained. “For them to come back 3-4 weeks in a row every 3 or 4 days to have a little more melanoma in situ taken off the edge would be inconvenient. It may make the patient decide not to treat the tumor at all. Mohs is convenient.”

Mohs surgery also has its share of drawbacks, Dr. Swann said. One is the fact that frozen sections can be difficult to interpret. “You have to have an excellent histotechnician and a surgeon who has experience with the slides,” he said. “The melanocytes are sometimes too subtle to distinguish from keratinocytes. This is particularly evident if you have freeze artifact.”

Other limitations of Mohs, he said, include the fact that the cytology is not always readable and that melanocytic hyperplasia in sun-damaged skin “is very difficult to pick out from melanoma in situ, particularly lentigo maligna.”

Another shortcoming is that immunostains are not available from all histopathology labs. “Occasionally we’ll get missing epidermis, especially if the technician is not excellent,” he said.

Dr. Swann instructs his patients to avoid sun exposure several weeks before surgery or biopsies, and emphasized that having a good supportive relationship with a pathologist “is always in the patient’s best interest.”

One alternative to Mohs micrographic surgery is slow Mohs, whereby paraffin-embedded tangential sections of tissue are submitted for 100% margin evaluation. Dr. Swann described this technique as “a coordination of a laboratory and the Mohs surgeon working as seamlessly as possible to treat these patients.” These fast-turnaround paraffin-embedded pathology specimens, known as “rushed perms,” take 24 hours in the best situation, “usually 2-3 days,” Dr. Swann added. “It’s not the easiest process. That’s why we use the same histopathology lab over and over to do our work.”

Turnaround time for hematoxylin and eosin stain is 24-72 hours and immunostains usually add 24 hours.

Other alternatives to Mohs surgery include wide local excision and en face sections via geometric serial excisions.

Dr. Swann had no conflicts to disclose.

SAN DIEGO – Mohs surgery has a place in the treatment of melanoma in situ and invasive melanoma, “but in my practice it doesn’t have a place every day,” Dr. Michael H. Swann said at a melanoma update sponsored by the Scripps Clinic.

Dr. Swann, who performs Mohs surgery in a Springfield, Missouri–based dermatology practice 4-5 days per week, said that one of the main benefits of the technique for melanoma is that the recurrence rates are favorable to matched paraffin controls, a finding reported in a 1997 study of 533 patients. That study found that to achieve clear margins in 83% of patients, a 6-mm margin was required, 95% of tumors cleared with a 9-mm margin, and 99% of tumors cleared with a 16-mm margin (J. Am. Acad. Dermatol. 1997;37:236-45).

“So when we think about things that are left behind with local disease, these numbers stick in my head when I treat patients and I think about how I’m going to treat these tumors,” Dr. Swann said. “The way to treat melanoma is to detect it early and to get all the cells out surgically if you can.”

Other benefits of using Mohs surgery for melanoma are that the margin evaluation is superior to other techniques, it spares normal tissue, and immunostains are readily available for difficult cases. “You can turn around the tissue in about 40 minutes now, but immunostains by themselves are not the answer,” Dr. Swann commented. “There are plenty of Mohs surgeons like myself who don’t use immunostains, because for the most part, immunostains are used by labs to make the diagnosis of melanoma. The margins of these melanomas are seldom immunostained because the diagnosis is not in question.”

The convenience of a single-day procedure is another benefit of using Mohs surgery for melanoma, especially in geographic locations such as Missouri, where many patients live in rural areas. “It takes some patients 3 or 4 hours to drive to our practice,” Dr. Swann explained. “For them to come back 3-4 weeks in a row every 3 or 4 days to have a little more melanoma in situ taken off the edge would be inconvenient. It may make the patient decide not to treat the tumor at all. Mohs is convenient.”

Mohs surgery also has its share of drawbacks, Dr. Swann said. One is the fact that frozen sections can be difficult to interpret. “You have to have an excellent histotechnician and a surgeon who has experience with the slides,” he said. “The melanocytes are sometimes too subtle to distinguish from keratinocytes. This is particularly evident if you have freeze artifact.”

Other limitations of Mohs, he said, include the fact that the cytology is not always readable and that melanocytic hyperplasia in sun-damaged skin “is very difficult to pick out from melanoma in situ, particularly lentigo maligna.”

Another shortcoming is that immunostains are not available from all histopathology labs. “Occasionally we’ll get missing epidermis, especially if the technician is not excellent,” he said.

Dr. Swann instructs his patients to avoid sun exposure several weeks before surgery or biopsies, and emphasized that having a good supportive relationship with a pathologist “is always in the patient’s best interest.”

One alternative to Mohs micrographic surgery is slow Mohs, whereby paraffin-embedded tangential sections of tissue are submitted for 100% margin evaluation. Dr. Swann described this technique as “a coordination of a laboratory and the Mohs surgeon working as seamlessly as possible to treat these patients.” These fast-turnaround paraffin-embedded pathology specimens, known as “rushed perms,” take 24 hours in the best situation, “usually 2-3 days,” Dr. Swann added. “It’s not the easiest process. That’s why we use the same histopathology lab over and over to do our work.”

Turnaround time for hematoxylin and eosin stain is 24-72 hours and immunostains usually add 24 hours.

Other alternatives to Mohs surgery include wide local excision and en face sections via geometric serial excisions.

Dr. Swann had no conflicts to disclose.

SAN DIEGO – Mohs surgery has a place in the treatment of melanoma in situ and invasive melanoma, “but in my practice it doesn’t have a place every day,” Dr. Michael H. Swann said at a melanoma update sponsored by the Scripps Clinic.

Dr. Swann, who performs Mohs surgery in a Springfield, Missouri–based dermatology practice 4-5 days per week, said that one of the main benefits of the technique for melanoma is that the recurrence rates are favorable to matched paraffin controls, a finding reported in a 1997 study of 533 patients. That study found that to achieve clear margins in 83% of patients, a 6-mm margin was required, 95% of tumors cleared with a 9-mm margin, and 99% of tumors cleared with a 16-mm margin (J. Am. Acad. Dermatol. 1997;37:236-45).

“So when we think about things that are left behind with local disease, these numbers stick in my head when I treat patients and I think about how I’m going to treat these tumors,” Dr. Swann said. “The way to treat melanoma is to detect it early and to get all the cells out surgically if you can.”

Other benefits of using Mohs surgery for melanoma are that the margin evaluation is superior to other techniques, it spares normal tissue, and immunostains are readily available for difficult cases. “You can turn around the tissue in about 40 minutes now, but immunostains by themselves are not the answer,” Dr. Swann commented. “There are plenty of Mohs surgeons like myself who don’t use immunostains, because for the most part, immunostains are used by labs to make the diagnosis of melanoma. The margins of these melanomas are seldom immunostained because the diagnosis is not in question.”

The convenience of a single-day procedure is another benefit of using Mohs surgery for melanoma, especially in geographic locations such as Missouri, where many patients live in rural areas. “It takes some patients 3 or 4 hours to drive to our practice,” Dr. Swann explained. “For them to come back 3-4 weeks in a row every 3 or 4 days to have a little more melanoma in situ taken off the edge would be inconvenient. It may make the patient decide not to treat the tumor at all. Mohs is convenient.”

Mohs surgery also has its share of drawbacks, Dr. Swann said. One is the fact that frozen sections can be difficult to interpret. “You have to have an excellent histotechnician and a surgeon who has experience with the slides,” he said. “The melanocytes are sometimes too subtle to distinguish from keratinocytes. This is particularly evident if you have freeze artifact.”

Other limitations of Mohs, he said, include the fact that the cytology is not always readable and that melanocytic hyperplasia in sun-damaged skin “is very difficult to pick out from melanoma in situ, particularly lentigo maligna.”

Another shortcoming is that immunostains are not available from all histopathology labs. “Occasionally we’ll get missing epidermis, especially if the technician is not excellent,” he said.

Dr. Swann instructs his patients to avoid sun exposure several weeks before surgery or biopsies, and emphasized that having a good supportive relationship with a pathologist “is always in the patient’s best interest.”

One alternative to Mohs micrographic surgery is slow Mohs, whereby paraffin-embedded tangential sections of tissue are submitted for 100% margin evaluation. Dr. Swann described this technique as “a coordination of a laboratory and the Mohs surgeon working as seamlessly as possible to treat these patients.” These fast-turnaround paraffin-embedded pathology specimens, known as “rushed perms,” take 24 hours in the best situation, “usually 2-3 days,” Dr. Swann added. “It’s not the easiest process. That’s why we use the same histopathology lab over and over to do our work.”

Turnaround time for hematoxylin and eosin stain is 24-72 hours and immunostains usually add 24 hours.

Other alternatives to Mohs surgery include wide local excision and en face sections via geometric serial excisions.

Dr. Swann had no conflicts to disclose.

SAN DIEGO - The chances of a patient developing multiple primary melanomas over a lifetime is a real phenomenon, with an incidence ranging from 2% to 8% among patients who have had a first melanoma, or an average of about 5%.

"That's significantly higher than if we apply the risk of melanoma to all fair-skinned people in the country," Dr. William M. Burrows said at a melanoma update sponsored by the Scripps Clinic.

Of patients who develop additional melanomas, about 80% develop one in addition to the original, 15% develop two, and the remainder develop three or more. "In my practice I have about four people I follow who have had five or six primary melanomas," said Dr. Burrows, who has practiced dermatology for nearly 40 years and is currently with the division of dermatology at Scripps Clinic Rancho Bernardo in San Diego. "We've become the primary care physicians for patients with melanoma."

He went on to note that the risk of multiple primary melanomas is twofold higher among men, and that the majority of subsequent primary melanomas (70%) occur on a different anatomical site, while 30% occur on the same site.

"They have the same distribution as melanomas in general," he said.

The majority of subsequent primary melanomas occur after 2 months, while 30% occur within 2 months or less.

Depth of invasion is similar to national statistics for all primary melanomas. "But the second primary melanoma tends to be thinner than the first one, which makes sense," Dr. Burrows commented. "After the first primary melanoma we raise our index of suspicion on lesions that are irregular. In addition, the patient has a significant level of worry."

Recognized risk factors for multiple melanomas include presence of atypical/dysplastic nevi, family history, and early age of onset.

According to a retrospective review of 1,258 melanoma patients treated at the Scripps Clinic between 1990 and 2000, 149 (12%) developed multiple primary lesions, which is more than double the national incidence. "This could be due to one of two things," Dr. Burrows said. "One is the criteria that are used in making the diagnosis of melanoma in situ. I wonder if we [at Scripps] diagnose melanoma in situ more often, as opposed to others who might sign it out as atypical melanocytic hyperplasia or another worrisome diagnosis."

The other possibility is that incidence of melanoma is rising. "We know that we are making the diagnosis of primary melanomas at a younger age than we did 20 years ago," Dr. Burrows said.

In the Scripps series, 75% of patients had two primary melanomas, 15% had three, and the remainder had four or more. The average age at initial primary melanoma diagnosis was 64 among men and 56 among women.

Nearly half of the patients (49%) developed subsequent melanomas less than 3 years after their initial primary melanoma diagnoses.

At this point, Dr. Burrows does not recommend testing for the CDKN2A and CDK4 gene mutations in most patients. "It's not a good screening tool for the general population or fair-skinned population with multiple nevi, but it has potential use in screening patients with a family history of melanoma," he said.

"You want to know if they have a 75%-100% risk of developing melanoma. But in my opinion, this test is not helpful in people who have had one primary melanoma. It doesn't pick out the people at risk of getting a second primary melanoma."

As for managing patients with multiple melanomas, a full skin exam during initial workup and follow-up intervals is essential, he said. "Follow-up should be lifelong."

Dr. Burrows had no conflicts to disclose.

_{(Image above is of Dr. William M. Burrows/Photo credit: Doug Brunk)}

SAN DIEGO - The chances of a patient developing multiple primary melanomas over a lifetime is a real phenomenon, with an incidence ranging from 2% to 8% among patients who have had a first melanoma, or an average of about 5%.

"That's significantly higher than if we apply the risk of melanoma to all fair-skinned people in the country," Dr. William M. Burrows said at a melanoma update sponsored by the Scripps Clinic.

Of patients who develop additional melanomas, about 80% develop one in addition to the original, 15% develop two, and the remainder develop three or more. "In my practice I have about four people I follow who have had five or six primary melanomas," said Dr. Burrows, who has practiced dermatology for nearly 40 years and is currently with the division of dermatology at Scripps Clinic Rancho Bernardo in San Diego. "We've become the primary care physicians for patients with melanoma."

He went on to note that the risk of multiple primary melanomas is twofold higher among men, and that the majority of subsequent primary melanomas (70%) occur on a different anatomical site, while 30% occur on the same site.

"They have the same distribution as melanomas in general," he said.

The majority of subsequent primary melanomas occur after 2 months, while 30% occur within 2 months or less.

Depth of invasion is similar to national statistics for all primary melanomas. "But the second primary melanoma tends to be thinner than the first one, which makes sense," Dr. Burrows commented. "After the first primary melanoma we raise our index of suspicion on lesions that are irregular. In addition, the patient has a significant level of worry."

Recognized risk factors for multiple melanomas include presence of atypical/dysplastic nevi, family history, and early age of onset.

According to a retrospective review of 1,258 melanoma patients treated at the Scripps Clinic between 1990 and 2000, 149 (12%) developed multiple primary lesions, which is more than double the national incidence. "This could be due to one of two things," Dr. Burrows said. "One is the criteria that are used in making the diagnosis of melanoma in situ. I wonder if we [at Scripps] diagnose melanoma in situ more often, as opposed to others who might sign it out as atypical melanocytic hyperplasia or another worrisome diagnosis."

The other possibility is that incidence of melanoma is rising. "We know that we are making the diagnosis of primary melanomas at a younger age than we did 20 years ago," Dr. Burrows said.

In the Scripps series, 75% of patients had two primary melanomas, 15% had three, and the remainder had four or more. The average age at initial primary melanoma diagnosis was 64 among men and 56 among women.

Nearly half of the patients (49%) developed subsequent melanomas less than 3 years after their initial primary melanoma diagnoses.

At this point, Dr. Burrows does not recommend testing for the CDKN2A and CDK4 gene mutations in most patients. "It's not a good screening tool for the general population or fair-skinned population with multiple nevi, but it has potential use in screening patients with a family history of melanoma," he said.

"You want to know if they have a 75%-100% risk of developing melanoma. But in my opinion, this test is not helpful in people who have had one primary melanoma. It doesn't pick out the people at risk of getting a second primary melanoma."

As for managing patients with multiple melanomas, a full skin exam during initial workup and follow-up intervals is essential, he said. "Follow-up should be lifelong."

Dr. Burrows had no conflicts to disclose.

_{(Image above is of Dr. William M. Burrows/Photo credit: Doug Brunk)}

SAN DIEGO - The chances of a patient developing multiple primary melanomas over a lifetime is a real phenomenon, with an incidence ranging from 2% to 8% among patients who have had a first melanoma, or an average of about 5%.

"That's significantly higher than if we apply the risk of melanoma to all fair-skinned people in the country," Dr. William M. Burrows said at a melanoma update sponsored by the Scripps Clinic.

Of patients who develop additional melanomas, about 80% develop one in addition to the original, 15% develop two, and the remainder develop three or more. "In my practice I have about four people I follow who have had five or six primary melanomas," said Dr. Burrows, who has practiced dermatology for nearly 40 years and is currently with the division of dermatology at Scripps Clinic Rancho Bernardo in San Diego. "We've become the primary care physicians for patients with melanoma."

He went on to note that the risk of multiple primary melanomas is twofold higher among men, and that the majority of subsequent primary melanomas (70%) occur on a different anatomical site, while 30% occur on the same site.

"They have the same distribution as melanomas in general," he said.

The majority of subsequent primary melanomas occur after 2 months, while 30% occur within 2 months or less.

Depth of invasion is similar to national statistics for all primary melanomas. "But the second primary melanoma tends to be thinner than the first one, which makes sense," Dr. Burrows commented. "After the first primary melanoma we raise our index of suspicion on lesions that are irregular. In addition, the patient has a significant level of worry."

Recognized risk factors for multiple melanomas include presence of atypical/dysplastic nevi, family history, and early age of onset.

According to a retrospective review of 1,258 melanoma patients treated at the Scripps Clinic between 1990 and 2000, 149 (12%) developed multiple primary lesions, which is more than double the national incidence. "This could be due to one of two things," Dr. Burrows said. "One is the criteria that are used in making the diagnosis of melanoma in situ. I wonder if we [at Scripps] diagnose melanoma in situ more often, as opposed to others who might sign it out as atypical melanocytic hyperplasia or another worrisome diagnosis."

The other possibility is that incidence of melanoma is rising. "We know that we are making the diagnosis of primary melanomas at a younger age than we did 20 years ago," Dr. Burrows said.

In the Scripps series, 75% of patients had two primary melanomas, 15% had three, and the remainder had four or more. The average age at initial primary melanoma diagnosis was 64 among men and 56 among women.

Nearly half of the patients (49%) developed subsequent melanomas less than 3 years after their initial primary melanoma diagnoses.

At this point, Dr. Burrows does not recommend testing for the CDKN2A and CDK4 gene mutations in most patients. "It's not a good screening tool for the general population or fair-skinned population with multiple nevi, but it has potential use in screening patients with a family history of melanoma," he said.

"You want to know if they have a 75%-100% risk of developing melanoma. But in my opinion, this test is not helpful in people who have had one primary melanoma. It doesn't pick out the people at risk of getting a second primary melanoma."

As for managing patients with multiple melanomas, a full skin exam during initial workup and follow-up intervals is essential, he said. "Follow-up should be lifelong."

Dr. Burrows had no conflicts to disclose.

_{(Image above is of Dr. William M. Burrows/Photo credit: Doug Brunk)}

SAN DIEGO — The way Dr. Charles H. Miller sees it, dermatologists should have a digital camera at the ready to take photos of every lesion they biopsy.

"You should jump in and start doing this as part of your daily practice, because the future of dermatology is going to be significantly impacted by how we use digital images," Dr. Miller, chief of dermatology at Kaiser Permanente, San Diego, said at a melanoma update sponsored by the Scripps Clinic.

He and his associates routinely send along digital images of relevant lesions when they refer their patients to other specialists. "Anytime we send a patient for Mohs surgery, head and neck surgery, general surgery, or plastic surgery, we'll upload photos," he explained. "The surgeons love it because they can get an idea of what to expect before they see the patient. They're well prepared for what's to come, oftentimes saving a preop appointment."

He emphasized the importance of choosing a digital camera that fits you and your style of practice. Some can be had for less than $200, but the most important characteristic of a camera is not price. It's "that it's one you'll use often," Dr. Miller said.

"Some people wear white coats; others don't. Some people see 60-80 patients a day; other people see 20 a day. If you're seeing a lot more than 30 patients a day, make sure you have the camera with you at all times or else you're just not going to take the time to snap a picture."

In general, digital cameras with a resolution of at least 11 megapixels (MP) take pictures that are just as clear as those taken with the old 35-mm Kodachrome film technology. And when viewed on computer monitors, photos of much lower resolutions are acceptable. He divided his favorite cameras currently on the market into one of three groups based on size: "shirt pocket," "pants pocket," and "white-coat pocket" cameras "The actual measurements won't vary much," just an inch or so, "but it's enough" to make a difference, Dr. Miller said. Prices are approximate.

His recommended shirt-pocket cameras, which are "usually no bigger than a deck of cards," include the Canon SD790 (8 MP, $225), the Nikon S210 (8 MP, $150), the Sony T700 (10 MP, $350), and the Panasonic FX37 (10 MP, $270).
His recommended pants-pocket cameras include the Fujifilm 200EXR (12 MP, $360), the Canon A470 (8 MP, $145), the Canon S90 (10 MP, $399), the Canon SD780 IS (12 MP, $250), the Panasonic FX150 (15 MP, $300), and the Sony W300 (14 MP, $300).

Dr. Miller's recommended white coat-pocket cameras include the Panasonic LX3 (10 MP, $425), the Nikon P6000 (14 MP, $450), and the Canon G11 (10 MP, $459).

For even higher resolution, consider digital single lens reflex (DSLR) cameras, which accept macro lenses that are more optically correct and have less distortion than lenses in the smaller cameras listed above. Dr. Miller's suggested cameras in this category include the Nikon D40x (10 MP, $499), the Canon EOS Rebel T1i (15 MP, $720), the Nikon D90 (12 MP, $900), and the Nikon D700 (12 MP, $2,450).

"A lot of these cameras now include video capability as well," he noted. "That's something that dermatologists will start to consider in the future. It may be easier to take a quick video of a patient if it's at high-enough resolution, as opposed to taking single pictures. But that's something that needs to be more thoroughly evaluated."

Dr. Miller also advises dermatologists to think of digital cameras as disposable items that they'll want to replace every 3-5 years. "Once you get into that mind-set, it's not nearly as hard to jump in, because you realize that every few years you're going to grant yourself the benefit of upgrading," he said. He is on his sixth digital camera in 13 years.

Disclosures: Dr. Miller had no relevant conflicts to disclose.

SAN DIEGO — The way Dr. Charles H. Miller sees it, dermatologists should have a digital camera at the ready to take photos of every lesion they biopsy.

"You should jump in and start doing this as part of your daily practice, because the future of dermatology is going to be significantly impacted by how we use digital images," Dr. Miller, chief of dermatology at Kaiser Permanente, San Diego, said at a melanoma update sponsored by the Scripps Clinic.

He and his associates routinely send along digital images of relevant lesions when they refer their patients to other specialists. "Anytime we send a patient for Mohs surgery, head and neck surgery, general surgery, or plastic surgery, we'll upload photos," he explained. "The surgeons love it because they can get an idea of what to expect before they see the patient. They're well prepared for what's to come, oftentimes saving a preop appointment."

He emphasized the importance of choosing a digital camera that fits you and your style of practice. Some can be had for less than $200, but the most important characteristic of a camera is not price. It's "that it's one you'll use often," Dr. Miller said.

"Some people wear white coats; others don't. Some people see 60-80 patients a day; other people see 20 a day. If you're seeing a lot more than 30 patients a day, make sure you have the camera with you at all times or else you're just not going to take the time to snap a picture."

In general, digital cameras with a resolution of at least 11 megapixels (MP) take pictures that are just as clear as those taken with the old 35-mm Kodachrome film technology. And when viewed on computer monitors, photos of much lower resolutions are acceptable. He divided his favorite cameras currently on the market into one of three groups based on size: "shirt pocket," "pants pocket," and "white-coat pocket" cameras "The actual measurements won't vary much," just an inch or so, "but it's enough" to make a difference, Dr. Miller said. Prices are approximate.

His recommended shirt-pocket cameras, which are "usually no bigger than a deck of cards," include the Canon SD790 (8 MP, $225), the Nikon S210 (8 MP, $150), the Sony T700 (10 MP, $350), and the Panasonic FX37 (10 MP, $270).
His recommended pants-pocket cameras include the Fujifilm 200EXR (12 MP, $360), the Canon A470 (8 MP, $145), the Canon S90 (10 MP, $399), the Canon SD780 IS (12 MP, $250), the Panasonic FX150 (15 MP, $300), and the Sony W300 (14 MP, $300).

Dr. Miller's recommended white coat-pocket cameras include the Panasonic LX3 (10 MP, $425), the Nikon P6000 (14 MP, $450), and the Canon G11 (10 MP, $459).

For even higher resolution, consider digital single lens reflex (DSLR) cameras, which accept macro lenses that are more optically correct and have less distortion than lenses in the smaller cameras listed above. Dr. Miller's suggested cameras in this category include the Nikon D40x (10 MP, $499), the Canon EOS Rebel T1i (15 MP, $720), the Nikon D90 (12 MP, $900), and the Nikon D700 (12 MP, $2,450).

"A lot of these cameras now include video capability as well," he noted. "That's something that dermatologists will start to consider in the future. It may be easier to take a quick video of a patient if it's at high-enough resolution, as opposed to taking single pictures. But that's something that needs to be more thoroughly evaluated."

Dr. Miller also advises dermatologists to think of digital cameras as disposable items that they'll want to replace every 3-5 years. "Once you get into that mind-set, it's not nearly as hard to jump in, because you realize that every few years you're going to grant yourself the benefit of upgrading," he said. He is on his sixth digital camera in 13 years.

Disclosures: Dr. Miller had no relevant conflicts to disclose.

SAN DIEGO — The way Dr. Charles H. Miller sees it, dermatologists should have a digital camera at the ready to take photos of every lesion they biopsy.

"You should jump in and start doing this as part of your daily practice, because the future of dermatology is going to be significantly impacted by how we use digital images," Dr. Miller, chief of dermatology at Kaiser Permanente, San Diego, said at a melanoma update sponsored by the Scripps Clinic.

He and his associates routinely send along digital images of relevant lesions when they refer their patients to other specialists. "Anytime we send a patient for Mohs surgery, head and neck surgery, general surgery, or plastic surgery, we'll upload photos," he explained. "The surgeons love it because they can get an idea of what to expect before they see the patient. They're well prepared for what's to come, oftentimes saving a preop appointment."

He emphasized the importance of choosing a digital camera that fits you and your style of practice. Some can be had for less than $200, but the most important characteristic of a camera is not price. It's "that it's one you'll use often," Dr. Miller said.

"Some people wear white coats; others don't. Some people see 60-80 patients a day; other people see 20 a day. If you're seeing a lot more than 30 patients a day, make sure you have the camera with you at all times or else you're just not going to take the time to snap a picture."

In general, digital cameras with a resolution of at least 11 megapixels (MP) take pictures that are just as clear as those taken with the old 35-mm Kodachrome film technology. And when viewed on computer monitors, photos of much lower resolutions are acceptable. He divided his favorite cameras currently on the market into one of three groups based on size: "shirt pocket," "pants pocket," and "white-coat pocket" cameras "The actual measurements won't vary much," just an inch or so, "but it's enough" to make a difference, Dr. Miller said. Prices are approximate.

His recommended shirt-pocket cameras, which are "usually no bigger than a deck of cards," include the Canon SD790 (8 MP, $225), the Nikon S210 (8 MP, $150), the Sony T700 (10 MP, $350), and the Panasonic FX37 (10 MP, $270).
His recommended pants-pocket cameras include the Fujifilm 200EXR (12 MP, $360), the Canon A470 (8 MP, $145), the Canon S90 (10 MP, $399), the Canon SD780 IS (12 MP, $250), the Panasonic FX150 (15 MP, $300), and the Sony W300 (14 MP, $300).

Dr. Miller's recommended white coat-pocket cameras include the Panasonic LX3 (10 MP, $425), the Nikon P6000 (14 MP, $450), and the Canon G11 (10 MP, $459).

For even higher resolution, consider digital single lens reflex (DSLR) cameras, which accept macro lenses that are more optically correct and have less distortion than lenses in the smaller cameras listed above. Dr. Miller's suggested cameras in this category include the Nikon D40x (10 MP, $499), the Canon EOS Rebel T1i (15 MP, $720), the Nikon D90 (12 MP, $900), and the Nikon D700 (12 MP, $2,450).

"A lot of these cameras now include video capability as well," he noted. "That's something that dermatologists will start to consider in the future. It may be easier to take a quick video of a patient if it's at high-enough resolution, as opposed to taking single pictures. But that's something that needs to be more thoroughly evaluated."

Dr. Miller also advises dermatologists to think of digital cameras as disposable items that they'll want to replace every 3-5 years. "Once you get into that mind-set, it's not nearly as hard to jump in, because you realize that every few years you're going to grant yourself the benefit of upgrading," he said. He is on his sixth digital camera in 13 years.

Disclosures: Dr. Miller had no relevant conflicts to disclose.

Every Friday, Dr. Shariar Cohen-Gadol drives 71 miles from his home in West Los Angeles to California State Prison, Los Angeles County, a 262-acre facility in Lancaster that houses more than 5,000 convicted felons, some of whom have rheumatoid arthritis, osteoarthritis, or other rheumatologic disorders. To the California prison system, these inmates need medical care despite their being held in minimum, high-medium, and maximum custody, and Dr. Cohen-Gadol is the physician who provides that care.

Dr. Cohen-Gadol described the overall rheumatologic care provided to California inmates as being better than what some managed care organizations offer. If an inmate with moderate to severe arthritis fails to respond to methotrexate, “I have no problem getting him adalimumab or etanercept,” he said.

“My recommendation may have to be reviewed by the chief medical officer at the institution. But so far, I have been impressed by how prisons have been able to provide [anti-tumor necrosis factor] agents so fast.”

The care he gives the California inmates with rheumatologic disorders is not limited to infusions of biologic agents. Dr. Cohen-Gadol does everything from giving general physical exams to administering intra-articular injections and conducting follow-up visits with those who've started therapy with anti-TNF agents or other medications.

Telemedicine also plays a roll in this care. Dr. Cohen-Gadol uses a telemedicine setup that is located in a dedicated office at the prison and provides him with access via two-way video feed to about 30 other sites in the state operated by the California Department of Corrections and Rehabilitation, a program that he helped launch nearly 2 years ago.

“We may consult with four or five institutions by telemedicine in one day,” said Dr. Cohen-Gadol, a rheumatologist who practices in Thousand Oaks. “I call in and the other health care providers appear on the TV screen. We may evaluate two inmates from one institution, or five follow-ups. I take the history and the nurse at the other end of the connection does the exam.”

He said he was drawn to the work because it broadens his clinical experience without the burden of administrative overhead. His interest in the health issues of prison populations was born during his residency at the University of California, Los Angeles, when he conducted grand rounds on the manifestations of hepatitis C. At the Lancaster facility, at least one-third of inmates are infected with the disease.

“That means that more than 1,200 have chronic hepatitis C,” he said, noting that most of the inmates he treats are in their 30s and 40s. The chronic infection seems to increase the inmates' risk for some markers of rheumatologic disorders. With hepatitis C, many patients “have antibodies for markers of lupus, like [antinuclear antibody], or markers of rheumatoid arthritis, like rheumatoid factor. It creates an enigma for the primary care doctors, so I get the referrals.”

He's seen cases of cryoglobulinemia, Raynaud's disease, exotic rashes, kidney involvement, hives, urticaria, joint pain, myalgia, and polyarthralgia associated with hepatitis C.

“One thing that increases the difficulty of providing rheumatologic care to inmates is the limitation of using certain drugs in patients with hepatitis C infection,” Dr. Cohen-Gadol commented. “A lot of drugs are immunosuppressive and are processed through the liver, like methotrexate. That makes it difficult for a patient with chronic RA. Sometimes we have to use drugs like etanercept or adalimumab because they have worse disease.

“It creates a challenge.”

If an inmate needs an intramuscular injection, the nursing staff can administer it locally. However, for intra-articular or bursa/tendon injections, an on-site physician needs to give it. “This is obviously one of the many shortcomings of telemedicine,” he said.

However, many glitches in his efforts to provide care have nothing to do with flaws of technology. “We are sometimes limited when inmates refuse care, or there are lockdowns, or they are getting paroled, or there are family visits,” Dr. Cohen-Gadol explained. “Let's say you're scheduled to see 20 patients one day. Maybe you'll see 13 or 15 patients instead. It's not perfect.”

As the only rheumatologist consultant for the California's prison system, Dr. Cohen-Gadol endures long waits, sometimes up to 4 months, for certain tests, imaging, and follow-up visits. “Patients may have to be transferred to an academic center for a biopsy.”

He went on to note that the physician-patient relationship in the prison setting is different because “you're dealing with a population you can't fully trust. Many of the patients have a history of polysubstance abuse. A large number have used cocaine, heroin, and crystal methamphetamine. Some of the patients with whom you deal are very manipulative and drug seeking. Others are rude and abusive. Some are brought in wearing shackles because of their past histories. But most of them behave pretty well because they know they need your help.”

 

Telemedicine works for the prison system “because it saves the taxpayers a lot of mone,” he said.

Every Friday, Dr. Shariar Cohen-Gadol drives 71 miles from his home in West Los Angeles to California State Prison, Los Angeles County, a 262-acre facility in Lancaster that houses more than 5,000 convicted felons, some of whom have rheumatoid arthritis, osteoarthritis, or other rheumatologic disorders. To the California prison system, these inmates need medical care despite their being held in minimum, high-medium, and maximum custody, and Dr. Cohen-Gadol is the physician who provides that care.

Dr. Cohen-Gadol described the overall rheumatologic care provided to California inmates as being better than what some managed care organizations offer. If an inmate with moderate to severe arthritis fails to respond to methotrexate, “I have no problem getting him adalimumab or etanercept,” he said.

“My recommendation may have to be reviewed by the chief medical officer at the institution. But so far, I have been impressed by how prisons have been able to provide [anti-tumor necrosis factor] agents so fast.”

The care he gives the California inmates with rheumatologic disorders is not limited to infusions of biologic agents. Dr. Cohen-Gadol does everything from giving general physical exams to administering intra-articular injections and conducting follow-up visits with those who've started therapy with anti-TNF agents or other medications.

Telemedicine also plays a roll in this care. Dr. Cohen-Gadol uses a telemedicine setup that is located in a dedicated office at the prison and provides him with access via two-way video feed to about 30 other sites in the state operated by the California Department of Corrections and Rehabilitation, a program that he helped launch nearly 2 years ago.

“We may consult with four or five institutions by telemedicine in one day,” said Dr. Cohen-Gadol, a rheumatologist who practices in Thousand Oaks. “I call in and the other health care providers appear on the TV screen. We may evaluate two inmates from one institution, or five follow-ups. I take the history and the nurse at the other end of the connection does the exam.”

He said he was drawn to the work because it broadens his clinical experience without the burden of administrative overhead. His interest in the health issues of prison populations was born during his residency at the University of California, Los Angeles, when he conducted grand rounds on the manifestations of hepatitis C. At the Lancaster facility, at least one-third of inmates are infected with the disease.

“That means that more than 1,200 have chronic hepatitis C,” he said, noting that most of the inmates he treats are in their 30s and 40s. The chronic infection seems to increase the inmates' risk for some markers of rheumatologic disorders. With hepatitis C, many patients “have antibodies for markers of lupus, like [antinuclear antibody], or markers of rheumatoid arthritis, like rheumatoid factor. It creates an enigma for the primary care doctors, so I get the referrals.”

He's seen cases of cryoglobulinemia, Raynaud's disease, exotic rashes, kidney involvement, hives, urticaria, joint pain, myalgia, and polyarthralgia associated with hepatitis C.

“One thing that increases the difficulty of providing rheumatologic care to inmates is the limitation of using certain drugs in patients with hepatitis C infection,” Dr. Cohen-Gadol commented. “A lot of drugs are immunosuppressive and are processed through the liver, like methotrexate. That makes it difficult for a patient with chronic RA. Sometimes we have to use drugs like etanercept or adalimumab because they have worse disease.

“It creates a challenge.”

If an inmate needs an intramuscular injection, the nursing staff can administer it locally. However, for intra-articular or bursa/tendon injections, an on-site physician needs to give it. “This is obviously one of the many shortcomings of telemedicine,” he said.

However, many glitches in his efforts to provide care have nothing to do with flaws of technology. “We are sometimes limited when inmates refuse care, or there are lockdowns, or they are getting paroled, or there are family visits,” Dr. Cohen-Gadol explained. “Let's say you're scheduled to see 20 patients one day. Maybe you'll see 13 or 15 patients instead. It's not perfect.”

As the only rheumatologist consultant for the California's prison system, Dr. Cohen-Gadol endures long waits, sometimes up to 4 months, for certain tests, imaging, and follow-up visits. “Patients may have to be transferred to an academic center for a biopsy.”

He went on to note that the physician-patient relationship in the prison setting is different because “you're dealing with a population you can't fully trust. Many of the patients have a history of polysubstance abuse. A large number have used cocaine, heroin, and crystal methamphetamine. Some of the patients with whom you deal are very manipulative and drug seeking. Others are rude and abusive. Some are brought in wearing shackles because of their past histories. But most of them behave pretty well because they know they need your help.”

 

Telemedicine works for the prison system “because it saves the taxpayers a lot of mone,” he said.

Every Friday, Dr. Shariar Cohen-Gadol drives 71 miles from his home in West Los Angeles to California State Prison, Los Angeles County, a 262-acre facility in Lancaster that houses more than 5,000 convicted felons, some of whom have rheumatoid arthritis, osteoarthritis, or other rheumatologic disorders. To the California prison system, these inmates need medical care despite their being held in minimum, high-medium, and maximum custody, and Dr. Cohen-Gadol is the physician who provides that care.

Dr. Cohen-Gadol described the overall rheumatologic care provided to California inmates as being better than what some managed care organizations offer. If an inmate with moderate to severe arthritis fails to respond to methotrexate, “I have no problem getting him adalimumab or etanercept,” he said.

“My recommendation may have to be reviewed by the chief medical officer at the institution. But so far, I have been impressed by how prisons have been able to provide [anti-tumor necrosis factor] agents so fast.”

The care he gives the California inmates with rheumatologic disorders is not limited to infusions of biologic agents. Dr. Cohen-Gadol does everything from giving general physical exams to administering intra-articular injections and conducting follow-up visits with those who've started therapy with anti-TNF agents or other medications.

Telemedicine also plays a roll in this care. Dr. Cohen-Gadol uses a telemedicine setup that is located in a dedicated office at the prison and provides him with access via two-way video feed to about 30 other sites in the state operated by the California Department of Corrections and Rehabilitation, a program that he helped launch nearly 2 years ago.

“We may consult with four or five institutions by telemedicine in one day,” said Dr. Cohen-Gadol, a rheumatologist who practices in Thousand Oaks. “I call in and the other health care providers appear on the TV screen. We may evaluate two inmates from one institution, or five follow-ups. I take the history and the nurse at the other end of the connection does the exam.”

He said he was drawn to the work because it broadens his clinical experience without the burden of administrative overhead. His interest in the health issues of prison populations was born during his residency at the University of California, Los Angeles, when he conducted grand rounds on the manifestations of hepatitis C. At the Lancaster facility, at least one-third of inmates are infected with the disease.

“That means that more than 1,200 have chronic hepatitis C,” he said, noting that most of the inmates he treats are in their 30s and 40s. The chronic infection seems to increase the inmates' risk for some markers of rheumatologic disorders. With hepatitis C, many patients “have antibodies for markers of lupus, like [antinuclear antibody], or markers of rheumatoid arthritis, like rheumatoid factor. It creates an enigma for the primary care doctors, so I get the referrals.”

He's seen cases of cryoglobulinemia, Raynaud's disease, exotic rashes, kidney involvement, hives, urticaria, joint pain, myalgia, and polyarthralgia associated with hepatitis C.

“One thing that increases the difficulty of providing rheumatologic care to inmates is the limitation of using certain drugs in patients with hepatitis C infection,” Dr. Cohen-Gadol commented. “A lot of drugs are immunosuppressive and are processed through the liver, like methotrexate. That makes it difficult for a patient with chronic RA. Sometimes we have to use drugs like etanercept or adalimumab because they have worse disease.

“It creates a challenge.”

If an inmate needs an intramuscular injection, the nursing staff can administer it locally. However, for intra-articular or bursa/tendon injections, an on-site physician needs to give it. “This is obviously one of the many shortcomings of telemedicine,” he said.

However, many glitches in his efforts to provide care have nothing to do with flaws of technology. “We are sometimes limited when inmates refuse care, or there are lockdowns, or they are getting paroled, or there are family visits,” Dr. Cohen-Gadol explained. “Let's say you're scheduled to see 20 patients one day. Maybe you'll see 13 or 15 patients instead. It's not perfect.”

As the only rheumatologist consultant for the California's prison system, Dr. Cohen-Gadol endures long waits, sometimes up to 4 months, for certain tests, imaging, and follow-up visits. “Patients may have to be transferred to an academic center for a biopsy.”

He went on to note that the physician-patient relationship in the prison setting is different because “you're dealing with a population you can't fully trust. Many of the patients have a history of polysubstance abuse. A large number have used cocaine, heroin, and crystal methamphetamine. Some of the patients with whom you deal are very manipulative and drug seeking. Others are rude and abusive. Some are brought in wearing shackles because of their past histories. But most of them behave pretty well because they know they need your help.”

 

Telemedicine works for the prison system “because it saves the taxpayers a lot of mone,” he said.

Major Finding: More than half of patients with JIA who were transferred to an adult rheumatologist received inadequate follow-up at 2 years.

Data Source: Chart review of 100 patients with JIA.

Disclosures: The researchers disclosed having no relevant financial conflicts.

More than half of patients with juvenile idiopathic arthritis who transferred to an adult rheumatologist had inadequate follow-up for their disease 2 years after being transferred, judging from results of a Canadian study.

“Every effort should be made to ensure that young adults with JIA have timely access to a rheumatologist in the event of a disease flare, in order to minimize their disease burden,” researchers led by Dr. Elizabeth M. Hazel, an adult rheumatologist at McGill University Health Centre in Montreal, wrote in a study published online in Pediatric Rheumatology.

In the first published analysis of its kind, the researchers conducted a systematic chart review of 100 patients with JIA who attended their final JIA clinic appointment at Montreal Children's Hospital between 1992 and 2005 when they were aged 17 years or older. More than two-thirds of the patients (68%) were female, and the mean age of disease onset was 9.84 years (Pediatr. Rheumatol. 2010 Jan. 11 [doi:10.1186/1546-0096-8-2]).

“Once the name of the adult rheumatologist was identified in the transfer letter, or the last clinic note, his/her office was contacted for permission for a chart review to be conducted,” the researchers explained. The chart was then reviewed for 2 years after transfer.

A patient was deemed to have had an unsuccessful transfer if he or she “never made contact with the identified adult rheumatologist or was lost to follow-up at 2 years following transfer.”

Dr. Hazel and her associates also compared a number of factors among patients who did and did not have successful transfers, including sex, category of JIA, age at diagnosis, use of disease-modifying antirheumatic agents, active joint count, and level of educational attainment.

Of the 100 patients, 52 (52%) met the criteria for unsuccessful transfer from pediatric to adult care. Of these, 17 (33%) did not make initial contact with the appointed adult rheumatologist and 35 (67%) were lost to follow-up at 2 years.

“I was very surprised that more than half of the patients were lost to follow-up,” Dr. Hazel commented in an interview.

Of the patient factors tested, only one was significantly associated with unsuccessful patient transfer: an active joint count of zero at the last visit (odds ratio, 2.67). “This group of young adults with relatively inactive disease should be educated about the importance of ongoing follow-up in the adult milieu given the high possibility of active disease into adulthood,” the researchers advised.

Male sex trended toward a higher risk for unsuccessful transfer (OR, 2.15).

In her interview, Dr. Hazel acknowledged certain limitations of the study, including its retrospective cohort design. “This was a chart review, so we were limited by the information recorded in the charts,” she said.

“We could not track patients who sought out other rheumatologists on their own if they did not request a transfer letter from the pediatric group. While this may have improved the rate of transfer, these cases would still represent a suboptimal situation, with the adult rheumatologist not having information about the pediatric course of illness.”

Major Finding: More than half of patients with JIA who were transferred to an adult rheumatologist received inadequate follow-up at 2 years.

Data Source: Chart review of 100 patients with JIA.

Disclosures: The researchers disclosed having no relevant financial conflicts.

More than half of patients with juvenile idiopathic arthritis who transferred to an adult rheumatologist had inadequate follow-up for their disease 2 years after being transferred, judging from results of a Canadian study.

“Every effort should be made to ensure that young adults with JIA have timely access to a rheumatologist in the event of a disease flare, in order to minimize their disease burden,” researchers led by Dr. Elizabeth M. Hazel, an adult rheumatologist at McGill University Health Centre in Montreal, wrote in a study published online in Pediatric Rheumatology.

In the first published analysis of its kind, the researchers conducted a systematic chart review of 100 patients with JIA who attended their final JIA clinic appointment at Montreal Children's Hospital between 1992 and 2005 when they were aged 17 years or older. More than two-thirds of the patients (68%) were female, and the mean age of disease onset was 9.84 years (Pediatr. Rheumatol. 2010 Jan. 11 [doi:10.1186/1546-0096-8-2]).

“Once the name of the adult rheumatologist was identified in the transfer letter, or the last clinic note, his/her office was contacted for permission for a chart review to be conducted,” the researchers explained. The chart was then reviewed for 2 years after transfer.

A patient was deemed to have had an unsuccessful transfer if he or she “never made contact with the identified adult rheumatologist or was lost to follow-up at 2 years following transfer.”

Dr. Hazel and her associates also compared a number of factors among patients who did and did not have successful transfers, including sex, category of JIA, age at diagnosis, use of disease-modifying antirheumatic agents, active joint count, and level of educational attainment.

Of the 100 patients, 52 (52%) met the criteria for unsuccessful transfer from pediatric to adult care. Of these, 17 (33%) did not make initial contact with the appointed adult rheumatologist and 35 (67%) were lost to follow-up at 2 years.

“I was very surprised that more than half of the patients were lost to follow-up,” Dr. Hazel commented in an interview.

Of the patient factors tested, only one was significantly associated with unsuccessful patient transfer: an active joint count of zero at the last visit (odds ratio, 2.67). “This group of young adults with relatively inactive disease should be educated about the importance of ongoing follow-up in the adult milieu given the high possibility of active disease into adulthood,” the researchers advised.

Male sex trended toward a higher risk for unsuccessful transfer (OR, 2.15).

In her interview, Dr. Hazel acknowledged certain limitations of the study, including its retrospective cohort design. “This was a chart review, so we were limited by the information recorded in the charts,” she said.

“We could not track patients who sought out other rheumatologists on their own if they did not request a transfer letter from the pediatric group. While this may have improved the rate of transfer, these cases would still represent a suboptimal situation, with the adult rheumatologist not having information about the pediatric course of illness.”

Major Finding: More than half of patients with JIA who were transferred to an adult rheumatologist received inadequate follow-up at 2 years.

Data Source: Chart review of 100 patients with JIA.

Disclosures: The researchers disclosed having no relevant financial conflicts.

More than half of patients with juvenile idiopathic arthritis who transferred to an adult rheumatologist had inadequate follow-up for their disease 2 years after being transferred, judging from results of a Canadian study.

“Every effort should be made to ensure that young adults with JIA have timely access to a rheumatologist in the event of a disease flare, in order to minimize their disease burden,” researchers led by Dr. Elizabeth M. Hazel, an adult rheumatologist at McGill University Health Centre in Montreal, wrote in a study published online in Pediatric Rheumatology.

In the first published analysis of its kind, the researchers conducted a systematic chart review of 100 patients with JIA who attended their final JIA clinic appointment at Montreal Children's Hospital between 1992 and 2005 when they were aged 17 years or older. More than two-thirds of the patients (68%) were female, and the mean age of disease onset was 9.84 years (Pediatr. Rheumatol. 2010 Jan. 11 [doi:10.1186/1546-0096-8-2]).

“Once the name of the adult rheumatologist was identified in the transfer letter, or the last clinic note, his/her office was contacted for permission for a chart review to be conducted,” the researchers explained. The chart was then reviewed for 2 years after transfer.

A patient was deemed to have had an unsuccessful transfer if he or she “never made contact with the identified adult rheumatologist or was lost to follow-up at 2 years following transfer.”

Dr. Hazel and her associates also compared a number of factors among patients who did and did not have successful transfers, including sex, category of JIA, age at diagnosis, use of disease-modifying antirheumatic agents, active joint count, and level of educational attainment.

Of the 100 patients, 52 (52%) met the criteria for unsuccessful transfer from pediatric to adult care. Of these, 17 (33%) did not make initial contact with the appointed adult rheumatologist and 35 (67%) were lost to follow-up at 2 years.

“I was very surprised that more than half of the patients were lost to follow-up,” Dr. Hazel commented in an interview.

Of the patient factors tested, only one was significantly associated with unsuccessful patient transfer: an active joint count of zero at the last visit (odds ratio, 2.67). “This group of young adults with relatively inactive disease should be educated about the importance of ongoing follow-up in the adult milieu given the high possibility of active disease into adulthood,” the researchers advised.

Male sex trended toward a higher risk for unsuccessful transfer (OR, 2.15).

In her interview, Dr. Hazel acknowledged certain limitations of the study, including its retrospective cohort design. “This was a chart review, so we were limited by the information recorded in the charts,” she said.

“We could not track patients who sought out other rheumatologists on their own if they did not request a transfer letter from the pediatric group. While this may have improved the rate of transfer, these cases would still represent a suboptimal situation, with the adult rheumatologist not having information about the pediatric course of illness.”

Major Finding: Post-CABG acute kidney injury was significantly linked with long-term mortality.

Data Source: Swedish study of 6,447 patients.

Disclosures: None reported.

SAN DIEGO — Acute kidney injury after coronary artery bypass grafting is significantly associated with long-term mortality, even after adjustment for potential confounders, results from a large Swedish study showed.

“At follow-up of CABG, whether it's by the cardiologist or the family practitioner, we should be aware of acute kidney injury,” Dr. Martin J. Holzmann said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

The cause of the association is unclear, “but it means something in the long run for these patients. It may have to do with their coexisting medical conditions. I think we should treat them more aggressively when it comes to lipids and blood pressure,” said Dr. Holzmann of Karolinska University Hospital, Stockholm.

He and his associates evaluated the impact of acute kidney injury in 6,447 patients who underwent a first isolated CABG procedure between 2005 and 2008, had preoperative and postoperative serum creatinine levels drawn, and were alive 60 days after the procedure.

The patients' mean age was 65 years. The researchers used postoperative increases in serum creatinine levels measured 48 hours after surgery to categorize the patients according to the RIFLE criteria, which classifies renal disease as risk, injury, failure, loss, or end-stage renal disease. A total of 290 patients (4.5%) were in the risk category for acute renal failure, 103 (1.6%) were in the injury category, and 22 (0.3%) were in the failure category.

During a median follow-up of 7.3 years, 1,297 patients died (20%).

After adjustment for age, gender, preoperative estimated glomerular filtration rate, left ventricular function, diabetes mellitus, extr a corporeal circulation, body mass index, and unstable angina, the hazard ratio for mortality increased with each progressive RIFLE category: 1.34 (risk category), 1.63 (injury category), and 1.70 (failure category).

At hospital discharge, more patients who did not have acute kidney injury were treated with beta-blockers and statins (87% and 67%, respectively), compared with their counterparts who had acute kidney injury (79% and 61%, respectively).

However, ACE inhibitors were more frequently prescribed among those who had acute kidney injury (38%), compared with those who did not (32%).

This is “a surprising finding,” Dr. Holzmann said, adding that it is “difficult to draw conclusions from it.”

Major Finding: Post-CABG acute kidney injury was significantly linked with long-term mortality.

Data Source: Swedish study of 6,447 patients.

Disclosures: None reported.

SAN DIEGO — Acute kidney injury after coronary artery bypass grafting is significantly associated with long-term mortality, even after adjustment for potential confounders, results from a large Swedish study showed.

“At follow-up of CABG, whether it's by the cardiologist or the family practitioner, we should be aware of acute kidney injury,” Dr. Martin J. Holzmann said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

The cause of the association is unclear, “but it means something in the long run for these patients. It may have to do with their coexisting medical conditions. I think we should treat them more aggressively when it comes to lipids and blood pressure,” said Dr. Holzmann of Karolinska University Hospital, Stockholm.

He and his associates evaluated the impact of acute kidney injury in 6,447 patients who underwent a first isolated CABG procedure between 2005 and 2008, had preoperative and postoperative serum creatinine levels drawn, and were alive 60 days after the procedure.

The patients' mean age was 65 years. The researchers used postoperative increases in serum creatinine levels measured 48 hours after surgery to categorize the patients according to the RIFLE criteria, which classifies renal disease as risk, injury, failure, loss, or end-stage renal disease. A total of 290 patients (4.5%) were in the risk category for acute renal failure, 103 (1.6%) were in the injury category, and 22 (0.3%) were in the failure category.

During a median follow-up of 7.3 years, 1,297 patients died (20%).

After adjustment for age, gender, preoperative estimated glomerular filtration rate, left ventricular function, diabetes mellitus, extr a corporeal circulation, body mass index, and unstable angina, the hazard ratio for mortality increased with each progressive RIFLE category: 1.34 (risk category), 1.63 (injury category), and 1.70 (failure category).

At hospital discharge, more patients who did not have acute kidney injury were treated with beta-blockers and statins (87% and 67%, respectively), compared with their counterparts who had acute kidney injury (79% and 61%, respectively).

However, ACE inhibitors were more frequently prescribed among those who had acute kidney injury (38%), compared with those who did not (32%).

This is “a surprising finding,” Dr. Holzmann said, adding that it is “difficult to draw conclusions from it.”

Major Finding: Post-CABG acute kidney injury was significantly linked with long-term mortality.

Data Source: Swedish study of 6,447 patients.

Disclosures: None reported.

SAN DIEGO — Acute kidney injury after coronary artery bypass grafting is significantly associated with long-term mortality, even after adjustment for potential confounders, results from a large Swedish study showed.

“At follow-up of CABG, whether it's by the cardiologist or the family practitioner, we should be aware of acute kidney injury,” Dr. Martin J. Holzmann said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

The cause of the association is unclear, “but it means something in the long run for these patients. It may have to do with their coexisting medical conditions. I think we should treat them more aggressively when it comes to lipids and blood pressure,” said Dr. Holzmann of Karolinska University Hospital, Stockholm.

He and his associates evaluated the impact of acute kidney injury in 6,447 patients who underwent a first isolated CABG procedure between 2005 and 2008, had preoperative and postoperative serum creatinine levels drawn, and were alive 60 days after the procedure.

The patients' mean age was 65 years. The researchers used postoperative increases in serum creatinine levels measured 48 hours after surgery to categorize the patients according to the RIFLE criteria, which classifies renal disease as risk, injury, failure, loss, or end-stage renal disease. A total of 290 patients (4.5%) were in the risk category for acute renal failure, 103 (1.6%) were in the injury category, and 22 (0.3%) were in the failure category.

During a median follow-up of 7.3 years, 1,297 patients died (20%).

After adjustment for age, gender, preoperative estimated glomerular filtration rate, left ventricular function, diabetes mellitus, extr a corporeal circulation, body mass index, and unstable angina, the hazard ratio for mortality increased with each progressive RIFLE category: 1.34 (risk category), 1.63 (injury category), and 1.70 (failure category).

At hospital discharge, more patients who did not have acute kidney injury were treated with beta-blockers and statins (87% and 67%, respectively), compared with their counterparts who had acute kidney injury (79% and 61%, respectively).

However, ACE inhibitors were more frequently prescribed among those who had acute kidney injury (38%), compared with those who did not (32%).

This is “a surprising finding,” Dr. Holzmann said, adding that it is “difficult to draw conclusions from it.”

The Centers for Disease Control and Prevention has announced a voluntary recall of certain lots of the Sanofi Pasteur H1N1 pediatric vaccine in prefilled syringes shipped in November 2009. Approximately 800,000 vaccine doses in these lots are affected.

According to a statement issued by the CDC, Sanofi Pasteur Inc. distributed certain lots that contain antigen content below the specified limit for the product. The statement emphasized “that the small decrease in antigen content is unlikely to result in a clinically significant reduction in immune response among persons who have received the vaccine. For this reason there is no need to revaccinate persons who have received vaccine from these lots.”

The lots of concern, intended for children aged 6-35 months, are 0.25-mL prefilled syringes, 10-packs (NDC #49281-650-25, sometimes coded as 49281-0650-25): UT023DA, UT028DA, and UT028CB, as well as 0.25-mL prefilled syringes, 25-packs (NDC #49281-650-70, sometimes coded as 49281-0650-70): UT030CA.

Clinicians will receive instructions from Sanofi Pasteur regarding how to return unused vaccine from these lots, the statement said.

For more information about the recall, visit: www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm

The Centers for Disease Control and Prevention has announced a voluntary recall of certain lots of the Sanofi Pasteur H1N1 pediatric vaccine in prefilled syringes shipped in November 2009. Approximately 800,000 vaccine doses in these lots are affected.

According to a statement issued by the CDC, Sanofi Pasteur Inc. distributed certain lots that contain antigen content below the specified limit for the product. The statement emphasized “that the small decrease in antigen content is unlikely to result in a clinically significant reduction in immune response among persons who have received the vaccine. For this reason there is no need to revaccinate persons who have received vaccine from these lots.”

The lots of concern, intended for children aged 6-35 months, are 0.25-mL prefilled syringes, 10-packs (NDC #49281-650-25, sometimes coded as 49281-0650-25): UT023DA, UT028DA, and UT028CB, as well as 0.25-mL prefilled syringes, 25-packs (NDC #49281-650-70, sometimes coded as 49281-0650-70): UT030CA.

Clinicians will receive instructions from Sanofi Pasteur regarding how to return unused vaccine from these lots, the statement said.

For more information about the recall, visit: www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm

The Centers for Disease Control and Prevention has announced a voluntary recall of certain lots of the Sanofi Pasteur H1N1 pediatric vaccine in prefilled syringes shipped in November 2009. Approximately 800,000 vaccine doses in these lots are affected.

According to a statement issued by the CDC, Sanofi Pasteur Inc. distributed certain lots that contain antigen content below the specified limit for the product. The statement emphasized “that the small decrease in antigen content is unlikely to result in a clinically significant reduction in immune response among persons who have received the vaccine. For this reason there is no need to revaccinate persons who have received vaccine from these lots.”

The lots of concern, intended for children aged 6-35 months, are 0.25-mL prefilled syringes, 10-packs (NDC #49281-650-25, sometimes coded as 49281-0650-25): UT023DA, UT028DA, and UT028CB, as well as 0.25-mL prefilled syringes, 25-packs (NDC #49281-650-70, sometimes coded as 49281-0650-70): UT030CA.

Clinicians will receive instructions from Sanofi Pasteur regarding how to return unused vaccine from these lots, the statement said.

For more information about the recall, visit: www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm

Ustekinumab at a dose of 45 or 90 mg at baseline and again at week 4 was more effective than a 50-mg dose of etanercept twice weekly in a 12-week randomized study of patients with moderate to severe psoriasis.

The findings “are generally consistent with those of previous studies,” researchers led by Dr. Christopher E.M. Griffiths reported. “The high level of efficacy of ustekinumab treatment that we observed was achieved with only two injections during the 12-week period, as compared with twice-weekly injections of etanercept, which may be important for improved treatment compliance.”

For this phase III study, 903 patients with moderate to severe arthritis were randomly assigned to one of three treatment groups: 45 mg ustekinumab at baseline and week 4 (209 patients), 90 mg of ustekinumab at baseline and week 4 (347 patients), or 50 mg etanercept twice weekly for 12 weeks (347 patients).

Ustekinumab (marketed as Stelara by Centocor Ortho Biotech Services) blocks interleukin-12 and interleukin-23 while etanercept (marketed as Enbrel by Amgen and Wyeth) blocks tumor necrosis factor (TNF)–alpha.

The primary end point was the proportion of patients who achieved at least 75% improvement in the Psoriasis Area and Severity Index (PASI) at week 12 (N. Engl. J. Med. 2010;362:1118–28).

A total of 68% of patients in the 45-mg ustekinumab arm and 74% in the 90-mg ustekinumab arm achieved at least a 75% in the PASI score at week 12, compared with 57% of those in the etanercept arm.

Similarly, 65% of patients in the 45-mg ustekinumab arm and 71% of those in the 90-mg ustekinumab arm had cleared or minimal disease based on the physician's global assessment score, compared with 49% in the etanercept arm.

Disclosures: The study was supported by Centocor Research and Development. The investigators disclosed conflicts with a number of pharmaceutical companies, including Centocor, Amgen, and Wyeth.

My Take

Comparison Was Long Overdue

This is the first study to directly compare two biologic agents for the treatment of moderate to severe psoriasis. We have been assuming that ustekinumab was better than etanercept for patients with moderate to severe psoriasis based upon individual clinical trials, but this study now provides proof.

For situations in which insurance companies have a tiered approval process whereby etanercept failure is a condition for ustekinumab use, this study is unlikely to change that requirement. For insurance companies that do not have a tiered approval process, this study could logically lead to treatment guidelines that support initial use of ustekinumab without prior use of etanercept.

Clinicians who provide care to patients with moderate to severe psoriasis have cautious optimism for ustekinumab in terms of its long-term safety profile. However, we really don't know for sure what that long-term safety profile is going to be. Accordingly, some of my colleagues will argue for the use of etanercept over ustekinumab from a safety point of view until more is known.

ANDREW BLAUVELT, M.D., is professor of dermatology and molecular microbiology and immunology at Oregon Health and Science University, Portland. He has been a scientific adviser for Amgen Wyeth and Centocor.

Document

70126_fx1.sml

Ustekinumab at a dose of 45 or 90 mg at baseline and again at week 4 was more effective than a 50-mg dose of etanercept twice weekly in a 12-week randomized study of patients with moderate to severe psoriasis.

The findings “are generally consistent with those of previous studies,” researchers led by Dr. Christopher E.M. Griffiths reported. “The high level of efficacy of ustekinumab treatment that we observed was achieved with only two injections during the 12-week period, as compared with twice-weekly injections of etanercept, which may be important for improved treatment compliance.”

For this phase III study, 903 patients with moderate to severe arthritis were randomly assigned to one of three treatment groups: 45 mg ustekinumab at baseline and week 4 (209 patients), 90 mg of ustekinumab at baseline and week 4 (347 patients), or 50 mg etanercept twice weekly for 12 weeks (347 patients).

Ustekinumab (marketed as Stelara by Centocor Ortho Biotech Services) blocks interleukin-12 and interleukin-23 while etanercept (marketed as Enbrel by Amgen and Wyeth) blocks tumor necrosis factor (TNF)–alpha.

The primary end point was the proportion of patients who achieved at least 75% improvement in the Psoriasis Area and Severity Index (PASI) at week 12 (N. Engl. J. Med. 2010;362:1118–28).

A total of 68% of patients in the 45-mg ustekinumab arm and 74% in the 90-mg ustekinumab arm achieved at least a 75% in the PASI score at week 12, compared with 57% of those in the etanercept arm.

Similarly, 65% of patients in the 45-mg ustekinumab arm and 71% of those in the 90-mg ustekinumab arm had cleared or minimal disease based on the physician's global assessment score, compared with 49% in the etanercept arm.

Disclosures: The study was supported by Centocor Research and Development. The investigators disclosed conflicts with a number of pharmaceutical companies, including Centocor, Amgen, and Wyeth.

My Take

Comparison Was Long Overdue

This is the first study to directly compare two biologic agents for the treatment of moderate to severe psoriasis. We have been assuming that ustekinumab was better than etanercept for patients with moderate to severe psoriasis based upon individual clinical trials, but this study now provides proof.

For situations in which insurance companies have a tiered approval process whereby etanercept failure is a condition for ustekinumab use, this study is unlikely to change that requirement. For insurance companies that do not have a tiered approval process, this study could logically lead to treatment guidelines that support initial use of ustekinumab without prior use of etanercept.

Clinicians who provide care to patients with moderate to severe psoriasis have cautious optimism for ustekinumab in terms of its long-term safety profile. However, we really don't know for sure what that long-term safety profile is going to be. Accordingly, some of my colleagues will argue for the use of etanercept over ustekinumab from a safety point of view until more is known.

ANDREW BLAUVELT, M.D., is professor of dermatology and molecular microbiology and immunology at Oregon Health and Science University, Portland. He has been a scientific adviser for Amgen Wyeth and Centocor.

Document

70126_fx1.sml

Ustekinumab at a dose of 45 or 90 mg at baseline and again at week 4 was more effective than a 50-mg dose of etanercept twice weekly in a 12-week randomized study of patients with moderate to severe psoriasis.

The findings “are generally consistent with those of previous studies,” researchers led by Dr. Christopher E.M. Griffiths reported. “The high level of efficacy of ustekinumab treatment that we observed was achieved with only two injections during the 12-week period, as compared with twice-weekly injections of etanercept, which may be important for improved treatment compliance.”

For this phase III study, 903 patients with moderate to severe arthritis were randomly assigned to one of three treatment groups: 45 mg ustekinumab at baseline and week 4 (209 patients), 90 mg of ustekinumab at baseline and week 4 (347 patients), or 50 mg etanercept twice weekly for 12 weeks (347 patients).

Ustekinumab (marketed as Stelara by Centocor Ortho Biotech Services) blocks interleukin-12 and interleukin-23 while etanercept (marketed as Enbrel by Amgen and Wyeth) blocks tumor necrosis factor (TNF)–alpha.

The primary end point was the proportion of patients who achieved at least 75% improvement in the Psoriasis Area and Severity Index (PASI) at week 12 (N. Engl. J. Med. 2010;362:1118–28).

A total of 68% of patients in the 45-mg ustekinumab arm and 74% in the 90-mg ustekinumab arm achieved at least a 75% in the PASI score at week 12, compared with 57% of those in the etanercept arm.

Similarly, 65% of patients in the 45-mg ustekinumab arm and 71% of those in the 90-mg ustekinumab arm had cleared or minimal disease based on the physician's global assessment score, compared with 49% in the etanercept arm.

Disclosures: The study was supported by Centocor Research and Development. The investigators disclosed conflicts with a number of pharmaceutical companies, including Centocor, Amgen, and Wyeth.

My Take

Comparison Was Long Overdue

This is the first study to directly compare two biologic agents for the treatment of moderate to severe psoriasis. We have been assuming that ustekinumab was better than etanercept for patients with moderate to severe psoriasis based upon individual clinical trials, but this study now provides proof.

For situations in which insurance companies have a tiered approval process whereby etanercept failure is a condition for ustekinumab use, this study is unlikely to change that requirement. For insurance companies that do not have a tiered approval process, this study could logically lead to treatment guidelines that support initial use of ustekinumab without prior use of etanercept.

Clinicians who provide care to patients with moderate to severe psoriasis have cautious optimism for ustekinumab in terms of its long-term safety profile. However, we really don't know for sure what that long-term safety profile is going to be. Accordingly, some of my colleagues will argue for the use of etanercept over ustekinumab from a safety point of view until more is known.

ANDREW BLAUVELT, M.D., is professor of dermatology and molecular microbiology and immunology at Oregon Health and Science University, Portland. He has been a scientific adviser for Amgen Wyeth and Centocor.

Document

70126_fx1.sml