Diagnostic Conflicts Test Pathological Persistence

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SAN FRANCISCO — When a dermatopathologist butts heads with a pathologist over a diagnosis, it helps to keep the patient in mind.

"What do you do when your opinion differs radically from that of the contributing pathologist?" asked Dr. Dirk M. Elston, director of dermatology at Geisinger Medical Center, Danville, Pa. "You're getting cases … from all over the country. What you get to look at is sometimes not what the contributor thought. Sometimes it's a sticky situation."

Persistence in the face of diagnostic conflicts—especially when a malignancy is at issue—may be needed to achieve the appropriate treatment. "As long as we keep the patient in mind, we're doing the right thing," said Dr. Elston, who moderated a session at the annual meeting of the American Society of Dermatopathology in which speakers gave examples of cases in which their diagnostic opinions differed from others.

Dr. Ronald P. Rapini described an elderly male patient who had a spindle cell neoplasm on his face in the background of solar elastosis. The biopsy showed relatively bland spindle cells going through the fibrotic sun-damaged dermis. Some areas showed cells that were a little bit atypical, but not strikingly so.

When he looked around the sample more, however, he saw progressively more atypical cells and eventually diagnosed an atypical fibroxanthoma, using the appropriate diagnostic stains, recalled Dr. Rapini, professor and chair of dermatology at the University of Texas M.D. Anderson Cancer Center, Houston.

The patient decided to see a head and neck surgeon at another institution, which requested the biopsy slides for review by their own pathologist. "I'll call him Dr. B, because he diagnosed it as benign," Dr. Rapini said. Dr. B told the head and neck surgeon that the patient had a benign lesion that didn't need excision.

"What would you do?" Dr. Rapini asked. He called a dermatopathologist at the other institution—"I'll call him Dr. C"—and asked him to talk with Dr. B, the pathologist, to request that he at least put an addendum on his report to acknowledge that there was an alternative opinion saying this might be an atypical fibroxanthoma and that it was not a clear-cut case. "So maybe the head and neck surgeon might actually remove the lesion," Dr. Rapini said.

Dr. C reviewed the case and agreed that the lesion looked like an atypical fibroxanthoma. He did speak with Dr. B, but Dr. B refused to modify his pathology report in any way, insisting that this was a benign lesion. Although both Dr. B and Dr. C worked at the same institution, Dr. C felt it would be inappropriate for Dr. C to make an addendum himself on a colleague's case.

"Now what would you do?" Dr. Rapini asked. He asked Dr. C to talk to the head of his institution's pathology department to see what the chair would say. "The actions of the head of the department are not known to me," Dr. Rapini said. The pathology report basically stayed the same.

"Now what would you do?" he repeated. Dr. Rapini called the head and neck surgeon directly to inform him of the alternative opinion, and that Dr. Rapini had diagnosed the lesion as an atypical fibroxanthoma that should be removed.

The surgeon reexcised the area and sent the surgical specimen to the institution's dermatopathologist, who declared it an atypical fibroxanthoma with clear surgical margins. "So it had a happy ending," Dr. Rapini said.

Dr. Elston praised him for sticking with the case: "You were willing to persist, and kept in mind that there was a patient at the other end who had a malignancy that was not being treated appropriately."

Persistence in the face of diagnostic conflicts may be needed to achieve the appropriate treatment. DR. ELSTON

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SAN FRANCISCO — When a dermatopathologist butts heads with a pathologist over a diagnosis, it helps to keep the patient in mind.

"What do you do when your opinion differs radically from that of the contributing pathologist?" asked Dr. Dirk M. Elston, director of dermatology at Geisinger Medical Center, Danville, Pa. "You're getting cases … from all over the country. What you get to look at is sometimes not what the contributor thought. Sometimes it's a sticky situation."

Persistence in the face of diagnostic conflicts—especially when a malignancy is at issue—may be needed to achieve the appropriate treatment. "As long as we keep the patient in mind, we're doing the right thing," said Dr. Elston, who moderated a session at the annual meeting of the American Society of Dermatopathology in which speakers gave examples of cases in which their diagnostic opinions differed from others.

Dr. Ronald P. Rapini described an elderly male patient who had a spindle cell neoplasm on his face in the background of solar elastosis. The biopsy showed relatively bland spindle cells going through the fibrotic sun-damaged dermis. Some areas showed cells that were a little bit atypical, but not strikingly so.

When he looked around the sample more, however, he saw progressively more atypical cells and eventually diagnosed an atypical fibroxanthoma, using the appropriate diagnostic stains, recalled Dr. Rapini, professor and chair of dermatology at the University of Texas M.D. Anderson Cancer Center, Houston.

The patient decided to see a head and neck surgeon at another institution, which requested the biopsy slides for review by their own pathologist. "I'll call him Dr. B, because he diagnosed it as benign," Dr. Rapini said. Dr. B told the head and neck surgeon that the patient had a benign lesion that didn't need excision.

"What would you do?" Dr. Rapini asked. He called a dermatopathologist at the other institution—"I'll call him Dr. C"—and asked him to talk with Dr. B, the pathologist, to request that he at least put an addendum on his report to acknowledge that there was an alternative opinion saying this might be an atypical fibroxanthoma and that it was not a clear-cut case. "So maybe the head and neck surgeon might actually remove the lesion," Dr. Rapini said.

Dr. C reviewed the case and agreed that the lesion looked like an atypical fibroxanthoma. He did speak with Dr. B, but Dr. B refused to modify his pathology report in any way, insisting that this was a benign lesion. Although both Dr. B and Dr. C worked at the same institution, Dr. C felt it would be inappropriate for Dr. C to make an addendum himself on a colleague's case.

"Now what would you do?" Dr. Rapini asked. He asked Dr. C to talk to the head of his institution's pathology department to see what the chair would say. "The actions of the head of the department are not known to me," Dr. Rapini said. The pathology report basically stayed the same.

"Now what would you do?" he repeated. Dr. Rapini called the head and neck surgeon directly to inform him of the alternative opinion, and that Dr. Rapini had diagnosed the lesion as an atypical fibroxanthoma that should be removed.

The surgeon reexcised the area and sent the surgical specimen to the institution's dermatopathologist, who declared it an atypical fibroxanthoma with clear surgical margins. "So it had a happy ending," Dr. Rapini said.

Dr. Elston praised him for sticking with the case: "You were willing to persist, and kept in mind that there was a patient at the other end who had a malignancy that was not being treated appropriately."

Persistence in the face of diagnostic conflicts may be needed to achieve the appropriate treatment. DR. ELSTON

SAN FRANCISCO — When a dermatopathologist butts heads with a pathologist over a diagnosis, it helps to keep the patient in mind.

"What do you do when your opinion differs radically from that of the contributing pathologist?" asked Dr. Dirk M. Elston, director of dermatology at Geisinger Medical Center, Danville, Pa. "You're getting cases … from all over the country. What you get to look at is sometimes not what the contributor thought. Sometimes it's a sticky situation."

Persistence in the face of diagnostic conflicts—especially when a malignancy is at issue—may be needed to achieve the appropriate treatment. "As long as we keep the patient in mind, we're doing the right thing," said Dr. Elston, who moderated a session at the annual meeting of the American Society of Dermatopathology in which speakers gave examples of cases in which their diagnostic opinions differed from others.

Dr. Ronald P. Rapini described an elderly male patient who had a spindle cell neoplasm on his face in the background of solar elastosis. The biopsy showed relatively bland spindle cells going through the fibrotic sun-damaged dermis. Some areas showed cells that were a little bit atypical, but not strikingly so.

When he looked around the sample more, however, he saw progressively more atypical cells and eventually diagnosed an atypical fibroxanthoma, using the appropriate diagnostic stains, recalled Dr. Rapini, professor and chair of dermatology at the University of Texas M.D. Anderson Cancer Center, Houston.

The patient decided to see a head and neck surgeon at another institution, which requested the biopsy slides for review by their own pathologist. "I'll call him Dr. B, because he diagnosed it as benign," Dr. Rapini said. Dr. B told the head and neck surgeon that the patient had a benign lesion that didn't need excision.

"What would you do?" Dr. Rapini asked. He called a dermatopathologist at the other institution—"I'll call him Dr. C"—and asked him to talk with Dr. B, the pathologist, to request that he at least put an addendum on his report to acknowledge that there was an alternative opinion saying this might be an atypical fibroxanthoma and that it was not a clear-cut case. "So maybe the head and neck surgeon might actually remove the lesion," Dr. Rapini said.

Dr. C reviewed the case and agreed that the lesion looked like an atypical fibroxanthoma. He did speak with Dr. B, but Dr. B refused to modify his pathology report in any way, insisting that this was a benign lesion. Although both Dr. B and Dr. C worked at the same institution, Dr. C felt it would be inappropriate for Dr. C to make an addendum himself on a colleague's case.

"Now what would you do?" Dr. Rapini asked. He asked Dr. C to talk to the head of his institution's pathology department to see what the chair would say. "The actions of the head of the department are not known to me," Dr. Rapini said. The pathology report basically stayed the same.

"Now what would you do?" he repeated. Dr. Rapini called the head and neck surgeon directly to inform him of the alternative opinion, and that Dr. Rapini had diagnosed the lesion as an atypical fibroxanthoma that should be removed.

The surgeon reexcised the area and sent the surgical specimen to the institution's dermatopathologist, who declared it an atypical fibroxanthoma with clear surgical margins. "So it had a happy ending," Dr. Rapini said.

Dr. Elston praised him for sticking with the case: "You were willing to persist, and kept in mind that there was a patient at the other end who had a malignancy that was not being treated appropriately."

Persistence in the face of diagnostic conflicts may be needed to achieve the appropriate treatment. DR. ELSTON

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Negative Stain Still Positive for Rare Malignancy

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SAN FRANCISCO — The diagnosis of blastic natural killer-cell lymphoma requires a dermatopathologist who knows the typical immunohistochemical patterns of the disease and is aware of exceptions to rules.

Also called CD4-positive, CD56-positive (CD4+/CD56+) hematodermic neoplasm, the disease is a rare, aggressive malignancy that frequently presents with skin lesions. Immunohistochemical staining typically produces immunopositivity for CD4, CD56, and CD123, but rare cases have been reported of patients who tested negative in one or more of these immunohistochemical studies.

At the annual meeting of the American Society of Dermatopathology, Dr. Rajwant Malhotra and Dr. Alison L. Uzieblo reported on two cases of CD4+/CD56+ hematodermic neoplasm presenting as skin nodules and plaques. One of the cases in their poster was CD123-negative.

"Loss of CD123 expression is a distinctly unusual event" in CD4+/CD56+ hematodermic neoplasm, wrote the authors, both from the anatomic pathology department at Beaumont Hospital, Royal Oak, Mich. Given the poor prognosis associated with this disease, "it is important to be aware of this potential phenomenon when evaluating cutaneous hematolymphoid malignancies."

One patient was a 77-year-old man who presented with skin lesions on his back and trunk. Flow cytometric analysis subsequently showed bone marrow involvement. The second patient, a 70-year-old man, had a 3-cm nodular plaque on his scalp. Further clinical evaluation found no evidence of bone marrow involvement.

Histological examination of biopsies from both patients revealed dense dermal infiltrates composed of sheets of medium-sized cells with angulated to round nuclear contours in the dermis. The lesional cells were positive for CD4, CD43, and CD56, but only one patient's biopsy demonstrated CD123 positivity. Both showed a high proliferation rate with Ki-67 staining noted in approximately 50% of cells in one patient and 70% of cells in the other.

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SAN FRANCISCO — The diagnosis of blastic natural killer-cell lymphoma requires a dermatopathologist who knows the typical immunohistochemical patterns of the disease and is aware of exceptions to rules.

Also called CD4-positive, CD56-positive (CD4+/CD56+) hematodermic neoplasm, the disease is a rare, aggressive malignancy that frequently presents with skin lesions. Immunohistochemical staining typically produces immunopositivity for CD4, CD56, and CD123, but rare cases have been reported of patients who tested negative in one or more of these immunohistochemical studies.

At the annual meeting of the American Society of Dermatopathology, Dr. Rajwant Malhotra and Dr. Alison L. Uzieblo reported on two cases of CD4+/CD56+ hematodermic neoplasm presenting as skin nodules and plaques. One of the cases in their poster was CD123-negative.

"Loss of CD123 expression is a distinctly unusual event" in CD4+/CD56+ hematodermic neoplasm, wrote the authors, both from the anatomic pathology department at Beaumont Hospital, Royal Oak, Mich. Given the poor prognosis associated with this disease, "it is important to be aware of this potential phenomenon when evaluating cutaneous hematolymphoid malignancies."

One patient was a 77-year-old man who presented with skin lesions on his back and trunk. Flow cytometric analysis subsequently showed bone marrow involvement. The second patient, a 70-year-old man, had a 3-cm nodular plaque on his scalp. Further clinical evaluation found no evidence of bone marrow involvement.

Histological examination of biopsies from both patients revealed dense dermal infiltrates composed of sheets of medium-sized cells with angulated to round nuclear contours in the dermis. The lesional cells were positive for CD4, CD43, and CD56, but only one patient's biopsy demonstrated CD123 positivity. Both showed a high proliferation rate with Ki-67 staining noted in approximately 50% of cells in one patient and 70% of cells in the other.

SAN FRANCISCO — The diagnosis of blastic natural killer-cell lymphoma requires a dermatopathologist who knows the typical immunohistochemical patterns of the disease and is aware of exceptions to rules.

Also called CD4-positive, CD56-positive (CD4+/CD56+) hematodermic neoplasm, the disease is a rare, aggressive malignancy that frequently presents with skin lesions. Immunohistochemical staining typically produces immunopositivity for CD4, CD56, and CD123, but rare cases have been reported of patients who tested negative in one or more of these immunohistochemical studies.

At the annual meeting of the American Society of Dermatopathology, Dr. Rajwant Malhotra and Dr. Alison L. Uzieblo reported on two cases of CD4+/CD56+ hematodermic neoplasm presenting as skin nodules and plaques. One of the cases in their poster was CD123-negative.

"Loss of CD123 expression is a distinctly unusual event" in CD4+/CD56+ hematodermic neoplasm, wrote the authors, both from the anatomic pathology department at Beaumont Hospital, Royal Oak, Mich. Given the poor prognosis associated with this disease, "it is important to be aware of this potential phenomenon when evaluating cutaneous hematolymphoid malignancies."

One patient was a 77-year-old man who presented with skin lesions on his back and trunk. Flow cytometric analysis subsequently showed bone marrow involvement. The second patient, a 70-year-old man, had a 3-cm nodular plaque on his scalp. Further clinical evaluation found no evidence of bone marrow involvement.

Histological examination of biopsies from both patients revealed dense dermal infiltrates composed of sheets of medium-sized cells with angulated to round nuclear contours in the dermis. The lesional cells were positive for CD4, CD43, and CD56, but only one patient's biopsy demonstrated CD123 positivity. Both showed a high proliferation rate with Ki-67 staining noted in approximately 50% of cells in one patient and 70% of cells in the other.

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Vulvar Granular Cell Tumors Rarely Recur

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SAN FRANCISCO — Vulvar granular cell tumors are biologically indolent lesions that may progress clinically over a decade or longer and most often occur in black patients, according to a recent review.

Of 16 granular cell tumors of the vulva that were surgically removed, 7 had positive margins, and only 1 progressed to a size requiring reexcision after 14 years, Dr. John A. Papalas and his associates reported at the annual meeting of the American Society of Dermatopathology. None of the tumors at the time of initial excision met histological criteria for malignancy.

The 16 lesions occurred on 12 patients (including 10 black patients) who were seen at Duke University, Durham, N.C. The patients' average age was 46 years.

The question of whether to reexcise a vulvar granular cell tumor with positive margins should be considered carefully because of the greater morbidity, compared with excisions in other areas of the body, noted Dr. Papalas of Duke University.

In a previous report on 20 patients with vulvar granular cell tumors, investigators suggested obtaining wide negative surgical margins (up to 2 cm), but the study provided follow-up data on only 1 patient and did not report the surgical margin resection status, he pointed out (Am. J. Obstet. Gynecol. 1995;173:1710-3).

Given the findings of the current study, which show that these tumors rarely recurred regardless of surgical margin status, "a 2-cm margin of a benign tumor on the vulva seems a bit excessive," one physician in the audience commented.

Patients with multiple vulvar granular cell tumors rarely have been reported in the literature. Three patients in the current series had multiple vulvar granular cell tumors and additional granular cell tumors in another body area. Another patient had a single vulvar tumor and an isolated lesion in another body area. Eight patients had a single granular cell tumor on the vulva alone. Extravulvar sites included the groin, perirectal area, buttock, esophagus, neck, buccal mucosa, and scalp.

Of the three patients with multiple vulvar granular cell tumors, only one presented with multiple vulvar lesions—a 50-year-old woman (just 2 years older than the average age), Dr. Papalas noted. Two other patients with an average age of 30 years presented with a single vulvar granular cell tumor and later progressed to multiple vulvar lesions over a 14-year period after the initial excision.

The surgical note or pathology report should precisely document the tumor location in order to accurately track recurrence or progression, he advised. Simply saying the tumor is on the "vulva" is not good enough, because the vulva is an anatomically complex region. The most common location of lesions in the current series was the labia majora, for 7 of 16 tumors.

Grossly, the tumors in this series either were well-circumscribed tan/white nodules or infiltrative masses, with an average tumor size of 2 cm.

A granular cell tumor is a Schwann cell-derived neoplasm that can occur throughout the body. Most involve the skin and soft tissue. Biopsies classically show tumor cells with abundant, pink granular cytoplasm and monomorphic, bland nuclei, though they can be mistaken for other lesions. "They're not always a slam-dunk diagnosis," Dr. Papalas said.

Granular cell tumors appear to be the most common peripheral nerve sheath-derived neoplasm in the vulva, he added.

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SAN FRANCISCO — Vulvar granular cell tumors are biologically indolent lesions that may progress clinically over a decade or longer and most often occur in black patients, according to a recent review.

Of 16 granular cell tumors of the vulva that were surgically removed, 7 had positive margins, and only 1 progressed to a size requiring reexcision after 14 years, Dr. John A. Papalas and his associates reported at the annual meeting of the American Society of Dermatopathology. None of the tumors at the time of initial excision met histological criteria for malignancy.

The 16 lesions occurred on 12 patients (including 10 black patients) who were seen at Duke University, Durham, N.C. The patients' average age was 46 years.

The question of whether to reexcise a vulvar granular cell tumor with positive margins should be considered carefully because of the greater morbidity, compared with excisions in other areas of the body, noted Dr. Papalas of Duke University.

In a previous report on 20 patients with vulvar granular cell tumors, investigators suggested obtaining wide negative surgical margins (up to 2 cm), but the study provided follow-up data on only 1 patient and did not report the surgical margin resection status, he pointed out (Am. J. Obstet. Gynecol. 1995;173:1710-3).

Given the findings of the current study, which show that these tumors rarely recurred regardless of surgical margin status, "a 2-cm margin of a benign tumor on the vulva seems a bit excessive," one physician in the audience commented.

Patients with multiple vulvar granular cell tumors rarely have been reported in the literature. Three patients in the current series had multiple vulvar granular cell tumors and additional granular cell tumors in another body area. Another patient had a single vulvar tumor and an isolated lesion in another body area. Eight patients had a single granular cell tumor on the vulva alone. Extravulvar sites included the groin, perirectal area, buttock, esophagus, neck, buccal mucosa, and scalp.

Of the three patients with multiple vulvar granular cell tumors, only one presented with multiple vulvar lesions—a 50-year-old woman (just 2 years older than the average age), Dr. Papalas noted. Two other patients with an average age of 30 years presented with a single vulvar granular cell tumor and later progressed to multiple vulvar lesions over a 14-year period after the initial excision.

The surgical note or pathology report should precisely document the tumor location in order to accurately track recurrence or progression, he advised. Simply saying the tumor is on the "vulva" is not good enough, because the vulva is an anatomically complex region. The most common location of lesions in the current series was the labia majora, for 7 of 16 tumors.

Grossly, the tumors in this series either were well-circumscribed tan/white nodules or infiltrative masses, with an average tumor size of 2 cm.

A granular cell tumor is a Schwann cell-derived neoplasm that can occur throughout the body. Most involve the skin and soft tissue. Biopsies classically show tumor cells with abundant, pink granular cytoplasm and monomorphic, bland nuclei, though they can be mistaken for other lesions. "They're not always a slam-dunk diagnosis," Dr. Papalas said.

Granular cell tumors appear to be the most common peripheral nerve sheath-derived neoplasm in the vulva, he added.

SAN FRANCISCO — Vulvar granular cell tumors are biologically indolent lesions that may progress clinically over a decade or longer and most often occur in black patients, according to a recent review.

Of 16 granular cell tumors of the vulva that were surgically removed, 7 had positive margins, and only 1 progressed to a size requiring reexcision after 14 years, Dr. John A. Papalas and his associates reported at the annual meeting of the American Society of Dermatopathology. None of the tumors at the time of initial excision met histological criteria for malignancy.

The 16 lesions occurred on 12 patients (including 10 black patients) who were seen at Duke University, Durham, N.C. The patients' average age was 46 years.

The question of whether to reexcise a vulvar granular cell tumor with positive margins should be considered carefully because of the greater morbidity, compared with excisions in other areas of the body, noted Dr. Papalas of Duke University.

In a previous report on 20 patients with vulvar granular cell tumors, investigators suggested obtaining wide negative surgical margins (up to 2 cm), but the study provided follow-up data on only 1 patient and did not report the surgical margin resection status, he pointed out (Am. J. Obstet. Gynecol. 1995;173:1710-3).

Given the findings of the current study, which show that these tumors rarely recurred regardless of surgical margin status, "a 2-cm margin of a benign tumor on the vulva seems a bit excessive," one physician in the audience commented.

Patients with multiple vulvar granular cell tumors rarely have been reported in the literature. Three patients in the current series had multiple vulvar granular cell tumors and additional granular cell tumors in another body area. Another patient had a single vulvar tumor and an isolated lesion in another body area. Eight patients had a single granular cell tumor on the vulva alone. Extravulvar sites included the groin, perirectal area, buttock, esophagus, neck, buccal mucosa, and scalp.

Of the three patients with multiple vulvar granular cell tumors, only one presented with multiple vulvar lesions—a 50-year-old woman (just 2 years older than the average age), Dr. Papalas noted. Two other patients with an average age of 30 years presented with a single vulvar granular cell tumor and later progressed to multiple vulvar lesions over a 14-year period after the initial excision.

The surgical note or pathology report should precisely document the tumor location in order to accurately track recurrence or progression, he advised. Simply saying the tumor is on the "vulva" is not good enough, because the vulva is an anatomically complex region. The most common location of lesions in the current series was the labia majora, for 7 of 16 tumors.

Grossly, the tumors in this series either were well-circumscribed tan/white nodules or infiltrative masses, with an average tumor size of 2 cm.

A granular cell tumor is a Schwann cell-derived neoplasm that can occur throughout the body. Most involve the skin and soft tissue. Biopsies classically show tumor cells with abundant, pink granular cytoplasm and monomorphic, bland nuclei, though they can be mistaken for other lesions. "They're not always a slam-dunk diagnosis," Dr. Papalas said.

Granular cell tumors appear to be the most common peripheral nerve sheath-derived neoplasm in the vulva, he added.

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Miscarriages, Terminations Rise After RA Onset

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SAN FRANCISCO — Women who got pregnant after the onset of rheumatoid arthritis had a slightly higher risk of miscarriage, compared with pregnant women as a whole, according to a study of 1,461 pregnancies in 636 women with rheumatoid arthritis.

Many more pregnancies in the retrospective study occurred before rheumatoid arthritis symptoms appeared than occurred after disease onset.

The 2% rate of pregnancy termination in the 86% of women who got pregnant before the onset of rheumatoid arthritis symptoms was significantly lower than a 6% termination rate among the 14% of women who got pregnant after developing arthritis, Dr. Cecilia Friden and her associates reported at the annual meeting of the American College of Rheumatology.

The investigators compared data on pregnancy histories in women who were enrolled in a hospital-based rheumatoid arthritis registry in Boston with U.S. data on pregnant women of comparable ages (20–44 years), and compared outcomes between women who became pregnant before or after developing arthritis.

The cohort's history of 1,461 pregnancies included 1,146 live births, with birth defects in 2% of neonates.

There was no association between the risk of birth defects and the timing of the onset of rheumatoid arthritis, said Dr. Friden of the Karolinska Institute, Stockholm.

The study did not collect information on the use of disease-modifying anti-rheumatic drugs.

Although the effects of pregnancy on rheumatoid arthritis (disease activity decreases during pregnancy and increases during the postpartum period and with breast-feeding) are well known, little has been known about the effects of rheumatoid arthritis on pregnancy outcomes, she noted.

More research will be needed to be able to correctly inform women with rheumatoid arthritis about the potential risks of pregnancy with the disease, Dr. Friden added.

Compared with the nationwide data on pregnant women, the investigators found that the women who had rheumatoid arthritis had slightly higher rates of miscarriage but slightly lower rates of stillbirths.

Pregnancy outcomes did not differ significantly between the pre- and post-arthritis pregnancy groups except for the termination rate.

The rate of miscarriages, stillbirths, multiple births, low-birth-weight babies, and infants born before or after 32 weeks did not differ significantly between the two arthritis groups.

Dr. Friden stated that she had no relevant conflicts of interest to report.

Her associates in the study have received research funds from pharmaceutical companies (some of which make arthritis medications) including Amgen Inc., Biogen Idec Inc., Bristol-Myers Squibb Co., and Millennium Pharmaceuticals Inc.

One associate has been a consultant for GlaxoSmithKline.

ELSEVIER GLOBAL MEDICAL NEWS

Reports on Birth Outcomes in Autoimmune Diseases From the ACR Meeting

Several posters at the annual meeting of the American College of Rheumatology reported on the following pregnancy outcomes for women who had autoimmune diseases or were taking drugs for autoimmune diseases:

Lupus. A study of 198 women with clinically stable or mildly active systemic lupus erythematosus (SLE) at the time of conception found that they rarely developed severe SLE flares and generally had good pregnancy outcomes, Dr. Jane E. Salmon of the Hospital for Special Surgery, New York, and her associates reported.

Mild or moderate disease flares occurred in 6% of women within 20 weeks of gestation, in 5% at 32 weeks, and in 8% during the postpartum period, according to data from the PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus) study.

No severe flares occurred by 20 weeks. Severe flares were seen in fewer than 1% of women by 32 weeks and in 1.5% during the postpartum period in the ongoing prospective, multicenter, observational study.

Of the four severe SLE flares, two involved the central nervous system, one involved kidney disease, and the other was an arthritis flare.

Pregnancy complications occurred in 15% of women, and included fetal death (in 8%), neonatal death (3%), preeclampsia (15%), and fetal growth restriction (10%), with some women having more than one complication.

Although 28% of women had a past history of renal disease and 39% had blood abnormalities associated with active lupus, these were not associated with flares or poor pregnancy outcomes, Dr. Salmon reported. The investigators reported no relevant conflicts of interest.

Etanercept. Babies born to 139 women who took etanercept for autoimmune diseases during the first trimester of pregnancy had more than twice the rate of congenital anomalies, compared with the newborns of 67 women with the same diseases who were not on etanercept. The data came from the ongoing Autoimmune Diseases in Pregnancy Project run by OTIS (Organization of Teratology Information Specialists), a network of telephone-based teratogen counseling services in North American universities and hospitals. The project recruits women in a prospective cohort; the women are interviewed three times during pregnancy and their medical records studied. Pediatric specialists examine all live-born infants and follow them for up to a year.

 

 

In the etanercept group, major defects were seen in 9.4% of all pregnancies in the etanercept group and in 4.5% of the control group. Pregnancies resulted in live births in 94% of the etanercept group and 88% of the control group (due to a higher rate of spontaneous abortion in the control group).

Among live births, 8.5% in the etanercept group had major defects, compared with 1.7% of the control group, reported Dr. Diana L. Johnson of the University of California, San Diego, and her associates.

The two groups did not differ significantly in mean birth weight of full-term infants, mean gestational age at delivery of live births, or pregnancy terminations.

The women took etanercept to treat rheumatoid arthritis; psoriasis or psoriatic arthritis; ankylosing spondylitis; or multiple diseases.

The project is sponsored in part by grants from 10 pharmaceutical companies including Amgen Inc., which markets etanercept with Wyeth Pharmaceuticals.

Adalimumab. The OTIS Autoimmune Diseases in Pregnancy Project also followed 33 women who took adalimumab for rheumatoid arthritis during the first trimester of pregnancy and followed them in the same manner as the etanercept cohort. Their birth outcomes were compared with birth outcomes of 52 pregnant women with the same disease but no adalimumab treatment and 45 pregnant women without rheumatoid arthritis.

Preliminary data from the ongoing study suggest that rates of spontaneous abortion, stillbirth, congenital defects, and preterm deliveries are similar between groups and within the expected range in the general population, Dr. Johnson and her associates reported in a separate poster. A larger sample size is needed, however, to draw firm conclusions, she added.

The companies that fund the project include Abbott Laboratories, which markets adalimumab.

Systemic sclerosis. Worsening of systemic sclerosis and progression to organ problems in three out of five Hungarian women after pregnancy surprised investigators in a separate study. Previous reports identified a higher risk for maternal scleroderma renal crisis in the third trimester, but other than that have suggested that disease symptoms generally do not change or may improve during pregnancy.

The five pregnancies among 400 women with systemic sclerosis who were seen at two medical centers from 1995 to 2007 resulted in five infants with no severe organ complications, reported Dr. G. Szucs of the University of Debrecen (Hungary), and associates.

One mother with limited cutaneous disease had a normal, full-term delivery. One with diffuse cutaneous disease had a spontaneous preterm birth. Three women (one with limited cutaneous disease and two with diffuse systemic sclerosis) were delivered by C-section because of maternal hypertension and proteinuria with a high risk for renal crisis.

The hypertension and proteinuria disappeared after C-section delivery in one woman with diffuse disease, who was treated with an ACE inhibitor to avert renal crisis.

Three other women (one with limited disease and two with diffuse disease) developed severe manifestations of systemic sclerosis after delivery—fibrosing alveolitis; cardiomyopathy with arrhythmias or cardiac failure; renal failure; and/or rapidly progressing skin symptoms.

Pregnant women with systemic sclerosis “should be monitored often and carefully after delivery for not only renal but other life-threatening complications,” Dr. Szucs suggested.

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SAN FRANCISCO — Women who got pregnant after the onset of rheumatoid arthritis had a slightly higher risk of miscarriage, compared with pregnant women as a whole, according to a study of 1,461 pregnancies in 636 women with rheumatoid arthritis.

Many more pregnancies in the retrospective study occurred before rheumatoid arthritis symptoms appeared than occurred after disease onset.

The 2% rate of pregnancy termination in the 86% of women who got pregnant before the onset of rheumatoid arthritis symptoms was significantly lower than a 6% termination rate among the 14% of women who got pregnant after developing arthritis, Dr. Cecilia Friden and her associates reported at the annual meeting of the American College of Rheumatology.

The investigators compared data on pregnancy histories in women who were enrolled in a hospital-based rheumatoid arthritis registry in Boston with U.S. data on pregnant women of comparable ages (20–44 years), and compared outcomes between women who became pregnant before or after developing arthritis.

The cohort's history of 1,461 pregnancies included 1,146 live births, with birth defects in 2% of neonates.

There was no association between the risk of birth defects and the timing of the onset of rheumatoid arthritis, said Dr. Friden of the Karolinska Institute, Stockholm.

The study did not collect information on the use of disease-modifying anti-rheumatic drugs.

Although the effects of pregnancy on rheumatoid arthritis (disease activity decreases during pregnancy and increases during the postpartum period and with breast-feeding) are well known, little has been known about the effects of rheumatoid arthritis on pregnancy outcomes, she noted.

More research will be needed to be able to correctly inform women with rheumatoid arthritis about the potential risks of pregnancy with the disease, Dr. Friden added.

Compared with the nationwide data on pregnant women, the investigators found that the women who had rheumatoid arthritis had slightly higher rates of miscarriage but slightly lower rates of stillbirths.

Pregnancy outcomes did not differ significantly between the pre- and post-arthritis pregnancy groups except for the termination rate.

The rate of miscarriages, stillbirths, multiple births, low-birth-weight babies, and infants born before or after 32 weeks did not differ significantly between the two arthritis groups.

Dr. Friden stated that she had no relevant conflicts of interest to report.

Her associates in the study have received research funds from pharmaceutical companies (some of which make arthritis medications) including Amgen Inc., Biogen Idec Inc., Bristol-Myers Squibb Co., and Millennium Pharmaceuticals Inc.

One associate has been a consultant for GlaxoSmithKline.

ELSEVIER GLOBAL MEDICAL NEWS

Reports on Birth Outcomes in Autoimmune Diseases From the ACR Meeting

Several posters at the annual meeting of the American College of Rheumatology reported on the following pregnancy outcomes for women who had autoimmune diseases or were taking drugs for autoimmune diseases:

Lupus. A study of 198 women with clinically stable or mildly active systemic lupus erythematosus (SLE) at the time of conception found that they rarely developed severe SLE flares and generally had good pregnancy outcomes, Dr. Jane E. Salmon of the Hospital for Special Surgery, New York, and her associates reported.

Mild or moderate disease flares occurred in 6% of women within 20 weeks of gestation, in 5% at 32 weeks, and in 8% during the postpartum period, according to data from the PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus) study.

No severe flares occurred by 20 weeks. Severe flares were seen in fewer than 1% of women by 32 weeks and in 1.5% during the postpartum period in the ongoing prospective, multicenter, observational study.

Of the four severe SLE flares, two involved the central nervous system, one involved kidney disease, and the other was an arthritis flare.

Pregnancy complications occurred in 15% of women, and included fetal death (in 8%), neonatal death (3%), preeclampsia (15%), and fetal growth restriction (10%), with some women having more than one complication.

Although 28% of women had a past history of renal disease and 39% had blood abnormalities associated with active lupus, these were not associated with flares or poor pregnancy outcomes, Dr. Salmon reported. The investigators reported no relevant conflicts of interest.

Etanercept. Babies born to 139 women who took etanercept for autoimmune diseases during the first trimester of pregnancy had more than twice the rate of congenital anomalies, compared with the newborns of 67 women with the same diseases who were not on etanercept. The data came from the ongoing Autoimmune Diseases in Pregnancy Project run by OTIS (Organization of Teratology Information Specialists), a network of telephone-based teratogen counseling services in North American universities and hospitals. The project recruits women in a prospective cohort; the women are interviewed three times during pregnancy and their medical records studied. Pediatric specialists examine all live-born infants and follow them for up to a year.

 

 

In the etanercept group, major defects were seen in 9.4% of all pregnancies in the etanercept group and in 4.5% of the control group. Pregnancies resulted in live births in 94% of the etanercept group and 88% of the control group (due to a higher rate of spontaneous abortion in the control group).

Among live births, 8.5% in the etanercept group had major defects, compared with 1.7% of the control group, reported Dr. Diana L. Johnson of the University of California, San Diego, and her associates.

The two groups did not differ significantly in mean birth weight of full-term infants, mean gestational age at delivery of live births, or pregnancy terminations.

The women took etanercept to treat rheumatoid arthritis; psoriasis or psoriatic arthritis; ankylosing spondylitis; or multiple diseases.

The project is sponsored in part by grants from 10 pharmaceutical companies including Amgen Inc., which markets etanercept with Wyeth Pharmaceuticals.

Adalimumab. The OTIS Autoimmune Diseases in Pregnancy Project also followed 33 women who took adalimumab for rheumatoid arthritis during the first trimester of pregnancy and followed them in the same manner as the etanercept cohort. Their birth outcomes were compared with birth outcomes of 52 pregnant women with the same disease but no adalimumab treatment and 45 pregnant women without rheumatoid arthritis.

Preliminary data from the ongoing study suggest that rates of spontaneous abortion, stillbirth, congenital defects, and preterm deliveries are similar between groups and within the expected range in the general population, Dr. Johnson and her associates reported in a separate poster. A larger sample size is needed, however, to draw firm conclusions, she added.

The companies that fund the project include Abbott Laboratories, which markets adalimumab.

Systemic sclerosis. Worsening of systemic sclerosis and progression to organ problems in three out of five Hungarian women after pregnancy surprised investigators in a separate study. Previous reports identified a higher risk for maternal scleroderma renal crisis in the third trimester, but other than that have suggested that disease symptoms generally do not change or may improve during pregnancy.

The five pregnancies among 400 women with systemic sclerosis who were seen at two medical centers from 1995 to 2007 resulted in five infants with no severe organ complications, reported Dr. G. Szucs of the University of Debrecen (Hungary), and associates.

One mother with limited cutaneous disease had a normal, full-term delivery. One with diffuse cutaneous disease had a spontaneous preterm birth. Three women (one with limited cutaneous disease and two with diffuse systemic sclerosis) were delivered by C-section because of maternal hypertension and proteinuria with a high risk for renal crisis.

The hypertension and proteinuria disappeared after C-section delivery in one woman with diffuse disease, who was treated with an ACE inhibitor to avert renal crisis.

Three other women (one with limited disease and two with diffuse disease) developed severe manifestations of systemic sclerosis after delivery—fibrosing alveolitis; cardiomyopathy with arrhythmias or cardiac failure; renal failure; and/or rapidly progressing skin symptoms.

Pregnant women with systemic sclerosis “should be monitored often and carefully after delivery for not only renal but other life-threatening complications,” Dr. Szucs suggested.

SAN FRANCISCO — Women who got pregnant after the onset of rheumatoid arthritis had a slightly higher risk of miscarriage, compared with pregnant women as a whole, according to a study of 1,461 pregnancies in 636 women with rheumatoid arthritis.

Many more pregnancies in the retrospective study occurred before rheumatoid arthritis symptoms appeared than occurred after disease onset.

The 2% rate of pregnancy termination in the 86% of women who got pregnant before the onset of rheumatoid arthritis symptoms was significantly lower than a 6% termination rate among the 14% of women who got pregnant after developing arthritis, Dr. Cecilia Friden and her associates reported at the annual meeting of the American College of Rheumatology.

The investigators compared data on pregnancy histories in women who were enrolled in a hospital-based rheumatoid arthritis registry in Boston with U.S. data on pregnant women of comparable ages (20–44 years), and compared outcomes between women who became pregnant before or after developing arthritis.

The cohort's history of 1,461 pregnancies included 1,146 live births, with birth defects in 2% of neonates.

There was no association between the risk of birth defects and the timing of the onset of rheumatoid arthritis, said Dr. Friden of the Karolinska Institute, Stockholm.

The study did not collect information on the use of disease-modifying anti-rheumatic drugs.

Although the effects of pregnancy on rheumatoid arthritis (disease activity decreases during pregnancy and increases during the postpartum period and with breast-feeding) are well known, little has been known about the effects of rheumatoid arthritis on pregnancy outcomes, she noted.

More research will be needed to be able to correctly inform women with rheumatoid arthritis about the potential risks of pregnancy with the disease, Dr. Friden added.

Compared with the nationwide data on pregnant women, the investigators found that the women who had rheumatoid arthritis had slightly higher rates of miscarriage but slightly lower rates of stillbirths.

Pregnancy outcomes did not differ significantly between the pre- and post-arthritis pregnancy groups except for the termination rate.

The rate of miscarriages, stillbirths, multiple births, low-birth-weight babies, and infants born before or after 32 weeks did not differ significantly between the two arthritis groups.

Dr. Friden stated that she had no relevant conflicts of interest to report.

Her associates in the study have received research funds from pharmaceutical companies (some of which make arthritis medications) including Amgen Inc., Biogen Idec Inc., Bristol-Myers Squibb Co., and Millennium Pharmaceuticals Inc.

One associate has been a consultant for GlaxoSmithKline.

ELSEVIER GLOBAL MEDICAL NEWS

Reports on Birth Outcomes in Autoimmune Diseases From the ACR Meeting

Several posters at the annual meeting of the American College of Rheumatology reported on the following pregnancy outcomes for women who had autoimmune diseases or were taking drugs for autoimmune diseases:

Lupus. A study of 198 women with clinically stable or mildly active systemic lupus erythematosus (SLE) at the time of conception found that they rarely developed severe SLE flares and generally had good pregnancy outcomes, Dr. Jane E. Salmon of the Hospital for Special Surgery, New York, and her associates reported.

Mild or moderate disease flares occurred in 6% of women within 20 weeks of gestation, in 5% at 32 weeks, and in 8% during the postpartum period, according to data from the PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus) study.

No severe flares occurred by 20 weeks. Severe flares were seen in fewer than 1% of women by 32 weeks and in 1.5% during the postpartum period in the ongoing prospective, multicenter, observational study.

Of the four severe SLE flares, two involved the central nervous system, one involved kidney disease, and the other was an arthritis flare.

Pregnancy complications occurred in 15% of women, and included fetal death (in 8%), neonatal death (3%), preeclampsia (15%), and fetal growth restriction (10%), with some women having more than one complication.

Although 28% of women had a past history of renal disease and 39% had blood abnormalities associated with active lupus, these were not associated with flares or poor pregnancy outcomes, Dr. Salmon reported. The investigators reported no relevant conflicts of interest.

Etanercept. Babies born to 139 women who took etanercept for autoimmune diseases during the first trimester of pregnancy had more than twice the rate of congenital anomalies, compared with the newborns of 67 women with the same diseases who were not on etanercept. The data came from the ongoing Autoimmune Diseases in Pregnancy Project run by OTIS (Organization of Teratology Information Specialists), a network of telephone-based teratogen counseling services in North American universities and hospitals. The project recruits women in a prospective cohort; the women are interviewed three times during pregnancy and their medical records studied. Pediatric specialists examine all live-born infants and follow them for up to a year.

 

 

In the etanercept group, major defects were seen in 9.4% of all pregnancies in the etanercept group and in 4.5% of the control group. Pregnancies resulted in live births in 94% of the etanercept group and 88% of the control group (due to a higher rate of spontaneous abortion in the control group).

Among live births, 8.5% in the etanercept group had major defects, compared with 1.7% of the control group, reported Dr. Diana L. Johnson of the University of California, San Diego, and her associates.

The two groups did not differ significantly in mean birth weight of full-term infants, mean gestational age at delivery of live births, or pregnancy terminations.

The women took etanercept to treat rheumatoid arthritis; psoriasis or psoriatic arthritis; ankylosing spondylitis; or multiple diseases.

The project is sponsored in part by grants from 10 pharmaceutical companies including Amgen Inc., which markets etanercept with Wyeth Pharmaceuticals.

Adalimumab. The OTIS Autoimmune Diseases in Pregnancy Project also followed 33 women who took adalimumab for rheumatoid arthritis during the first trimester of pregnancy and followed them in the same manner as the etanercept cohort. Their birth outcomes were compared with birth outcomes of 52 pregnant women with the same disease but no adalimumab treatment and 45 pregnant women without rheumatoid arthritis.

Preliminary data from the ongoing study suggest that rates of spontaneous abortion, stillbirth, congenital defects, and preterm deliveries are similar between groups and within the expected range in the general population, Dr. Johnson and her associates reported in a separate poster. A larger sample size is needed, however, to draw firm conclusions, she added.

The companies that fund the project include Abbott Laboratories, which markets adalimumab.

Systemic sclerosis. Worsening of systemic sclerosis and progression to organ problems in three out of five Hungarian women after pregnancy surprised investigators in a separate study. Previous reports identified a higher risk for maternal scleroderma renal crisis in the third trimester, but other than that have suggested that disease symptoms generally do not change or may improve during pregnancy.

The five pregnancies among 400 women with systemic sclerosis who were seen at two medical centers from 1995 to 2007 resulted in five infants with no severe organ complications, reported Dr. G. Szucs of the University of Debrecen (Hungary), and associates.

One mother with limited cutaneous disease had a normal, full-term delivery. One with diffuse cutaneous disease had a spontaneous preterm birth. Three women (one with limited cutaneous disease and two with diffuse systemic sclerosis) were delivered by C-section because of maternal hypertension and proteinuria with a high risk for renal crisis.

The hypertension and proteinuria disappeared after C-section delivery in one woman with diffuse disease, who was treated with an ACE inhibitor to avert renal crisis.

Three other women (one with limited disease and two with diffuse disease) developed severe manifestations of systemic sclerosis after delivery—fibrosing alveolitis; cardiomyopathy with arrhythmias or cardiac failure; renal failure; and/or rapidly progressing skin symptoms.

Pregnant women with systemic sclerosis “should be monitored often and carefully after delivery for not only renal but other life-threatening complications,” Dr. Szucs suggested.

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Dual-Energy CT Imaging May Play Role in Gout Diagnosis

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SAN FRANCISCO — Dual-energy computed tomography scans showed red-colored uric acid deposits in 20 consecutive patients with clinically obvious tophaceous gout but not in 10 control subjects with other nongout joint conditions.

The 100% sensitivity and specificity of dual-energy computed tomography (DECT) scans to identify uric acid deposits could provide a sorely needed accurate imaging tool to aid in the diagnosis of gout and its response to treatment, Dr. Abdullatif M. Alarfaj said at the annual meeting of the American College of Rheumatology.

DECT assesses chemical composition and provides specific color-coded displays to differentiate between uric acid (which shows up as red), calcium (blue), and other renal calculi, previous investigators have shown.

The current proof-of-concept study, in addition to assessing the accuracy of DECT in gout patients, also measured the uric acid burden in peripheral joints and performed a computerized quantification of tophus volume. The volume of uric acid deposits in each anatomic area was measured by automated volume estimation software. The sum of tophus volume in the hands, wrists, elbows, feet, ankles, and knees comprised the total uric acid volume of peripheral joints.

DECT scans identified 440 areas of urate deposition, compared with 111 areas identified on clinical examination, reported Dr. Alarfaj of the University of British Columbia, Vancouver, and his associates. The investigators have no conflicts of interest related to this study.

DECT could be useful in detecting subclinical tophus deposits and the extent of intra- and extra-articular gout, Dr. Alarfaj suggested. Treatment response might be monitored by using DECT to measure both individual tophus volume and total tophus burden.

DECT differentiates uric acid deposits (red) and calcium in bone (blue).

The 3-D DECT image shows numerous tophi in the same patient. Images courtesy Dr. Hyon Choi

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SAN FRANCISCO — Dual-energy computed tomography scans showed red-colored uric acid deposits in 20 consecutive patients with clinically obvious tophaceous gout but not in 10 control subjects with other nongout joint conditions.

The 100% sensitivity and specificity of dual-energy computed tomography (DECT) scans to identify uric acid deposits could provide a sorely needed accurate imaging tool to aid in the diagnosis of gout and its response to treatment, Dr. Abdullatif M. Alarfaj said at the annual meeting of the American College of Rheumatology.

DECT assesses chemical composition and provides specific color-coded displays to differentiate between uric acid (which shows up as red), calcium (blue), and other renal calculi, previous investigators have shown.

The current proof-of-concept study, in addition to assessing the accuracy of DECT in gout patients, also measured the uric acid burden in peripheral joints and performed a computerized quantification of tophus volume. The volume of uric acid deposits in each anatomic area was measured by automated volume estimation software. The sum of tophus volume in the hands, wrists, elbows, feet, ankles, and knees comprised the total uric acid volume of peripheral joints.

DECT scans identified 440 areas of urate deposition, compared with 111 areas identified on clinical examination, reported Dr. Alarfaj of the University of British Columbia, Vancouver, and his associates. The investigators have no conflicts of interest related to this study.

DECT could be useful in detecting subclinical tophus deposits and the extent of intra- and extra-articular gout, Dr. Alarfaj suggested. Treatment response might be monitored by using DECT to measure both individual tophus volume and total tophus burden.

DECT differentiates uric acid deposits (red) and calcium in bone (blue).

The 3-D DECT image shows numerous tophi in the same patient. Images courtesy Dr. Hyon Choi

SAN FRANCISCO — Dual-energy computed tomography scans showed red-colored uric acid deposits in 20 consecutive patients with clinically obvious tophaceous gout but not in 10 control subjects with other nongout joint conditions.

The 100% sensitivity and specificity of dual-energy computed tomography (DECT) scans to identify uric acid deposits could provide a sorely needed accurate imaging tool to aid in the diagnosis of gout and its response to treatment, Dr. Abdullatif M. Alarfaj said at the annual meeting of the American College of Rheumatology.

DECT assesses chemical composition and provides specific color-coded displays to differentiate between uric acid (which shows up as red), calcium (blue), and other renal calculi, previous investigators have shown.

The current proof-of-concept study, in addition to assessing the accuracy of DECT in gout patients, also measured the uric acid burden in peripheral joints and performed a computerized quantification of tophus volume. The volume of uric acid deposits in each anatomic area was measured by automated volume estimation software. The sum of tophus volume in the hands, wrists, elbows, feet, ankles, and knees comprised the total uric acid volume of peripheral joints.

DECT scans identified 440 areas of urate deposition, compared with 111 areas identified on clinical examination, reported Dr. Alarfaj of the University of British Columbia, Vancouver, and his associates. The investigators have no conflicts of interest related to this study.

DECT could be useful in detecting subclinical tophus deposits and the extent of intra- and extra-articular gout, Dr. Alarfaj suggested. Treatment response might be monitored by using DECT to measure both individual tophus volume and total tophus burden.

DECT differentiates uric acid deposits (red) and calcium in bone (blue).

The 3-D DECT image shows numerous tophi in the same patient. Images courtesy Dr. Hyon Choi

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Fibromyalgia Diagnosis, Therapy Vary by Provider

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SAN FRANCISCO — Rheumatologists and primary care physicians tend to use different diagnostic tests and prescribe different treatments for fibromyalgia syndrome, survey results indicated.

A large fraction of physicians in both groups did not follow the American College of Rheumatology (ACR) 1990 criteria for diagnosing fibromyalgia, Dr. Terence W. Starz and his associates reported in a poster presentation at the annual meeting of the American College of Rheumatology.

“I don't know what that means,” conceded Dr. Starz, a rheumatologist at the University of Pittsburgh Medical Center. “We've got to adhere to criteria” to develop standards of care, he said in an interview.

Questionnaires e-mailed to 199 rheumatologists throughout Pennsylvania and 183 primary care physicians in the Southwestern portion of the state were returned by 74 (37%) of the rheumatologists and 89 (49%) of the primary care physicians.

Rheumatologists were significantly more likely to use ACR criteria to diagnose fibromyalgia (56, or 76%) compared with primary care physicians (50, or 56%). The two groups also differed significantly in the use of tests to measure levels of vitamin D, rheumatoid factor, antinuclear antibody, and anti-cyclic citrullinated peptide (anti-CCP) antibody. They reported similar rates of testing for thyroid function, metabolic profile, and human leukocyte antigen B27.

“We need to determine which ones of those should be utilized, because they're very expensive,” Dr. Starz said.

Vitamin D levels were ordered by 36 rheumatologists (49%) and 15 primary care physicians (17%). Tests for rheumatoid factor were ordered by 43 (58%) and 68 (76%), respectively. Rheumatologists were more likely to measure anti-CCP level (24, or 32%) than were primary care physicians (5, or 6%) but less likely to test for antinuclear antibody (45, or 61%, compared with 68, or 76%, of primary care physicians).

The two groups reported similar perceptions about the pathophysiology of fibromyalgia. Approximately three-fourths said fibromyalgia is both a medical and psychological condition, less than 20% said it's solely a medical condition, and less than 10% said it's solely a psychological condition, judging from the findings in the research, which was recognized as a “notable poster” by ACR.

Nearly all physicians in both groups prescribed exercise and physical therapy to treat fibromyalgia, but their use of most other therapies differed significantly.

Cognitive therapy was prescribed by 39 rheumatologists (52%) and 26 primary care physicians (29%). Non-steroidal anti-inflammatory drugs were prescribed by 42 (57%) of the rheumatologists and favored by primary care physicians (75, or 84%). “The data on NSAIDs, though, are not very good for fibromyalgia,” Dr. Starz said.

The primary care physicians also were significantly more likely to use selective serotonin reuptake inhibitors (68, or 76%) compared with rheumatologists (42, or 57%).

The investigators reported no conflicts of interest.

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SAN FRANCISCO — Rheumatologists and primary care physicians tend to use different diagnostic tests and prescribe different treatments for fibromyalgia syndrome, survey results indicated.

A large fraction of physicians in both groups did not follow the American College of Rheumatology (ACR) 1990 criteria for diagnosing fibromyalgia, Dr. Terence W. Starz and his associates reported in a poster presentation at the annual meeting of the American College of Rheumatology.

“I don't know what that means,” conceded Dr. Starz, a rheumatologist at the University of Pittsburgh Medical Center. “We've got to adhere to criteria” to develop standards of care, he said in an interview.

Questionnaires e-mailed to 199 rheumatologists throughout Pennsylvania and 183 primary care physicians in the Southwestern portion of the state were returned by 74 (37%) of the rheumatologists and 89 (49%) of the primary care physicians.

Rheumatologists were significantly more likely to use ACR criteria to diagnose fibromyalgia (56, or 76%) compared with primary care physicians (50, or 56%). The two groups also differed significantly in the use of tests to measure levels of vitamin D, rheumatoid factor, antinuclear antibody, and anti-cyclic citrullinated peptide (anti-CCP) antibody. They reported similar rates of testing for thyroid function, metabolic profile, and human leukocyte antigen B27.

“We need to determine which ones of those should be utilized, because they're very expensive,” Dr. Starz said.

Vitamin D levels were ordered by 36 rheumatologists (49%) and 15 primary care physicians (17%). Tests for rheumatoid factor were ordered by 43 (58%) and 68 (76%), respectively. Rheumatologists were more likely to measure anti-CCP level (24, or 32%) than were primary care physicians (5, or 6%) but less likely to test for antinuclear antibody (45, or 61%, compared with 68, or 76%, of primary care physicians).

The two groups reported similar perceptions about the pathophysiology of fibromyalgia. Approximately three-fourths said fibromyalgia is both a medical and psychological condition, less than 20% said it's solely a medical condition, and less than 10% said it's solely a psychological condition, judging from the findings in the research, which was recognized as a “notable poster” by ACR.

Nearly all physicians in both groups prescribed exercise and physical therapy to treat fibromyalgia, but their use of most other therapies differed significantly.

Cognitive therapy was prescribed by 39 rheumatologists (52%) and 26 primary care physicians (29%). Non-steroidal anti-inflammatory drugs were prescribed by 42 (57%) of the rheumatologists and favored by primary care physicians (75, or 84%). “The data on NSAIDs, though, are not very good for fibromyalgia,” Dr. Starz said.

The primary care physicians also were significantly more likely to use selective serotonin reuptake inhibitors (68, or 76%) compared with rheumatologists (42, or 57%).

The investigators reported no conflicts of interest.

SAN FRANCISCO — Rheumatologists and primary care physicians tend to use different diagnostic tests and prescribe different treatments for fibromyalgia syndrome, survey results indicated.

A large fraction of physicians in both groups did not follow the American College of Rheumatology (ACR) 1990 criteria for diagnosing fibromyalgia, Dr. Terence W. Starz and his associates reported in a poster presentation at the annual meeting of the American College of Rheumatology.

“I don't know what that means,” conceded Dr. Starz, a rheumatologist at the University of Pittsburgh Medical Center. “We've got to adhere to criteria” to develop standards of care, he said in an interview.

Questionnaires e-mailed to 199 rheumatologists throughout Pennsylvania and 183 primary care physicians in the Southwestern portion of the state were returned by 74 (37%) of the rheumatologists and 89 (49%) of the primary care physicians.

Rheumatologists were significantly more likely to use ACR criteria to diagnose fibromyalgia (56, or 76%) compared with primary care physicians (50, or 56%). The two groups also differed significantly in the use of tests to measure levels of vitamin D, rheumatoid factor, antinuclear antibody, and anti-cyclic citrullinated peptide (anti-CCP) antibody. They reported similar rates of testing for thyroid function, metabolic profile, and human leukocyte antigen B27.

“We need to determine which ones of those should be utilized, because they're very expensive,” Dr. Starz said.

Vitamin D levels were ordered by 36 rheumatologists (49%) and 15 primary care physicians (17%). Tests for rheumatoid factor were ordered by 43 (58%) and 68 (76%), respectively. Rheumatologists were more likely to measure anti-CCP level (24, or 32%) than were primary care physicians (5, or 6%) but less likely to test for antinuclear antibody (45, or 61%, compared with 68, or 76%, of primary care physicians).

The two groups reported similar perceptions about the pathophysiology of fibromyalgia. Approximately three-fourths said fibromyalgia is both a medical and psychological condition, less than 20% said it's solely a medical condition, and less than 10% said it's solely a psychological condition, judging from the findings in the research, which was recognized as a “notable poster” by ACR.

Nearly all physicians in both groups prescribed exercise and physical therapy to treat fibromyalgia, but their use of most other therapies differed significantly.

Cognitive therapy was prescribed by 39 rheumatologists (52%) and 26 primary care physicians (29%). Non-steroidal anti-inflammatory drugs were prescribed by 42 (57%) of the rheumatologists and favored by primary care physicians (75, or 84%). “The data on NSAIDs, though, are not very good for fibromyalgia,” Dr. Starz said.

The primary care physicians also were significantly more likely to use selective serotonin reuptake inhibitors (68, or 76%) compared with rheumatologists (42, or 57%).

The investigators reported no conflicts of interest.

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Dual-Energy CT May Aid Diagnosis of Gout

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SAN FRANCISCO — Dual-energy CT scans showed red-colored uric acid deposits in 20 consecutive patients with clinically obvious tophaceous gout but not in 10 control subjects with other nongout joint conditions.

The 100% sensitivity and specificity of dual-energy computed tomography (DECT) scans to identify uric acid deposits could provide a sorely needed accurate imaging tool to aid in the diagnosis of gout and its response to treatment, Dr. Abdullatif M. Alarfaj said at the annual meeting of the American College of Rheumatology.

DECT assesses chemical composition and provides specific color-coded displays to differentiate between uric acid (which shows up as red), calcium (blue), and other renal calculi, previous investigators have shown.

The current proof-of-concept study, in addition to assessing the accuracy of DECT in gout patients, also measured the uric acid burden in peripheral joints and performed a computerized quantification of tophus volume. The volume of uric acid deposits in each anatomic area was measured by automated volume estimation software. The sum of tophus volume in the hands, wrists, elbows, feet, ankles, and knees comprised the total uric acid volume of peripheral joints.

DECT scans identified 440 areas of urate deposition, compared with 111 areas identified on clinical examination, reported Dr. Alarfaj of the University of British Columbia, Vancouver, and his associates. The investigators have no conflicts of interest related to this study.

DECT could be useful in detecting subclinical tophus deposits and the extent of intra- and extra-articular gout, Dr. Alarfaj suggested. Treatment response might be monitored by using DECT to measure both individual tophus volume and total tophus burden.

This relatively new technology also may prove useful in evaluating nodular lesions, diagnosing concurrent gout in patients with other arthropathies, and identifying urate deposits in body areas that are atypical for gout or challenging to assess.

An individual DECT scan can cost about one-sixth of the amount for an MRI, Dr. Alarfaj's senior investigator, Dr. Hyon Choi, said during a question-and-answer session. The DECT hardware equipment is expensive but is used for a variety of purposes, such as imaging coronary artery calcifications and renal calculi, added Dr. Choi, also of the university.

The technology provides dramatic color displays and can be used to create impressive three-dimensional images of uric acid deposits that could aid clinicians in communicating about the disease to patients with gout, he added.

The patients in the gout group of the study had an average 12-year history of the disease and nine painful joints in the previous year. The mean serum uric acid level was 492 micromol/L. The patients had a mean age of 63 years, 15 (75%) were men, and 12 (60%) were white. Comorbid conditions were present in 17 patients (85%).

DECT shows uric acid deposits in red, while calcium in bone looks blue.

A 3-D volume-rendered image of the same patient shows many tophi (red). Images courtesy Dr. Hyon Choi

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SAN FRANCISCO — Dual-energy CT scans showed red-colored uric acid deposits in 20 consecutive patients with clinically obvious tophaceous gout but not in 10 control subjects with other nongout joint conditions.

The 100% sensitivity and specificity of dual-energy computed tomography (DECT) scans to identify uric acid deposits could provide a sorely needed accurate imaging tool to aid in the diagnosis of gout and its response to treatment, Dr. Abdullatif M. Alarfaj said at the annual meeting of the American College of Rheumatology.

DECT assesses chemical composition and provides specific color-coded displays to differentiate between uric acid (which shows up as red), calcium (blue), and other renal calculi, previous investigators have shown.

The current proof-of-concept study, in addition to assessing the accuracy of DECT in gout patients, also measured the uric acid burden in peripheral joints and performed a computerized quantification of tophus volume. The volume of uric acid deposits in each anatomic area was measured by automated volume estimation software. The sum of tophus volume in the hands, wrists, elbows, feet, ankles, and knees comprised the total uric acid volume of peripheral joints.

DECT scans identified 440 areas of urate deposition, compared with 111 areas identified on clinical examination, reported Dr. Alarfaj of the University of British Columbia, Vancouver, and his associates. The investigators have no conflicts of interest related to this study.

DECT could be useful in detecting subclinical tophus deposits and the extent of intra- and extra-articular gout, Dr. Alarfaj suggested. Treatment response might be monitored by using DECT to measure both individual tophus volume and total tophus burden.

This relatively new technology also may prove useful in evaluating nodular lesions, diagnosing concurrent gout in patients with other arthropathies, and identifying urate deposits in body areas that are atypical for gout or challenging to assess.

An individual DECT scan can cost about one-sixth of the amount for an MRI, Dr. Alarfaj's senior investigator, Dr. Hyon Choi, said during a question-and-answer session. The DECT hardware equipment is expensive but is used for a variety of purposes, such as imaging coronary artery calcifications and renal calculi, added Dr. Choi, also of the university.

The technology provides dramatic color displays and can be used to create impressive three-dimensional images of uric acid deposits that could aid clinicians in communicating about the disease to patients with gout, he added.

The patients in the gout group of the study had an average 12-year history of the disease and nine painful joints in the previous year. The mean serum uric acid level was 492 micromol/L. The patients had a mean age of 63 years, 15 (75%) were men, and 12 (60%) were white. Comorbid conditions were present in 17 patients (85%).

DECT shows uric acid deposits in red, while calcium in bone looks blue.

A 3-D volume-rendered image of the same patient shows many tophi (red). Images courtesy Dr. Hyon Choi

SAN FRANCISCO — Dual-energy CT scans showed red-colored uric acid deposits in 20 consecutive patients with clinically obvious tophaceous gout but not in 10 control subjects with other nongout joint conditions.

The 100% sensitivity and specificity of dual-energy computed tomography (DECT) scans to identify uric acid deposits could provide a sorely needed accurate imaging tool to aid in the diagnosis of gout and its response to treatment, Dr. Abdullatif M. Alarfaj said at the annual meeting of the American College of Rheumatology.

DECT assesses chemical composition and provides specific color-coded displays to differentiate between uric acid (which shows up as red), calcium (blue), and other renal calculi, previous investigators have shown.

The current proof-of-concept study, in addition to assessing the accuracy of DECT in gout patients, also measured the uric acid burden in peripheral joints and performed a computerized quantification of tophus volume. The volume of uric acid deposits in each anatomic area was measured by automated volume estimation software. The sum of tophus volume in the hands, wrists, elbows, feet, ankles, and knees comprised the total uric acid volume of peripheral joints.

DECT scans identified 440 areas of urate deposition, compared with 111 areas identified on clinical examination, reported Dr. Alarfaj of the University of British Columbia, Vancouver, and his associates. The investigators have no conflicts of interest related to this study.

DECT could be useful in detecting subclinical tophus deposits and the extent of intra- and extra-articular gout, Dr. Alarfaj suggested. Treatment response might be monitored by using DECT to measure both individual tophus volume and total tophus burden.

This relatively new technology also may prove useful in evaluating nodular lesions, diagnosing concurrent gout in patients with other arthropathies, and identifying urate deposits in body areas that are atypical for gout or challenging to assess.

An individual DECT scan can cost about one-sixth of the amount for an MRI, Dr. Alarfaj's senior investigator, Dr. Hyon Choi, said during a question-and-answer session. The DECT hardware equipment is expensive but is used for a variety of purposes, such as imaging coronary artery calcifications and renal calculi, added Dr. Choi, also of the university.

The technology provides dramatic color displays and can be used to create impressive three-dimensional images of uric acid deposits that could aid clinicians in communicating about the disease to patients with gout, he added.

The patients in the gout group of the study had an average 12-year history of the disease and nine painful joints in the previous year. The mean serum uric acid level was 492 micromol/L. The patients had a mean age of 63 years, 15 (75%) were men, and 12 (60%) were white. Comorbid conditions were present in 17 patients (85%).

DECT shows uric acid deposits in red, while calcium in bone looks blue.

A 3-D volume-rendered image of the same patient shows many tophi (red). Images courtesy Dr. Hyon Choi

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Low-Dose Colchicine Effective for Acute Gout

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SAN FRANCISCO — Low-dose colchicine appeared to be as effective as a more conventional dose in treating acute gout flares, but produced far fewer side effects in a randomized, double-blind, placebo-controlled trial in 185 patients.

The results support European League Against Rheumatism 2006 consensus guidelines recommending low doses (0.5 mg t.i.d.) when using colchicine to treat gout flare, a recommendation that was made without the backing of clinical trial data, Dr. Robert A. Terkeltaub said at the annual meeting of the American College of Rheumatology.

The study prerandomized 575 patients to receive high-dose colchicine, low-dose colchicine, or placebo capsules if they called a 24-hour service within 12 hours of the onset of a gout flare. Of the 184 patients who called and received treatment, 52 received high-dose colchicine (1.2 mg, then 0.6 mg hourly for 6 hours, for a total of 4.8 mg); 74 received low-dose colchicine (1.2 mg, then 0.6 mg in 1 hour, for a total of 4.8 mg), and 58 were given placebo (two capsules, then one capsule hourly for 6 hours). One more patient in the placebo group who had no outcomes recorded was excluded from the intent-to-treat analysis of efficacy but included in the safety analysis.

In the only previous placebo-controlled study of colchicine for gout flare, patients on colchicine received a mean total dose of 6.7 mg (higher than the high dose in the current study) and all patients developed diarrhea by the time of clinical response.

In the current study, 33% of patients in the high-dose group and 38% in the low-dose group recorded at least a 50% reduction in pain scores on a seven-point Likert scale within 24 hours of taking the first dose without taking a rescue medication. These rates were significantly higher than the 16% of patients on placebo who achieved this primary outcome. The efficacy between colchicine groups did not differ significantly, said Dr. Terkeltaub, chief of rheumatology in the Veterans Affairs San Diego Healthcare System and professor of medicine at the University of California, San Diego.

The study was funded by Mutual Pharmaceutical Co., a subsidiary of URL Pharma Inc., which manufactures a colchicine tablet. Based on these results, the companies are seeking Food and Drug Administration approval of the medication to treat the pain of gout flares.

Dr. Terkeltaub has been a consultant for AR Scientific, the branded arm of URL Pharma, and for other pharmaceutical companies. One of his coinvestigators is an employee and stockholder in AR Scientific, and other associates have been consultants to that company and to others.

High-dose colchicine produced GI side effects at a significantly higher rate (94%), compared with placebo (28%)—especially diarrhea (77% vs. 14%, respectively).

In the low-dose colchicine group, 45% had GI side effects and 23% developed diarrhea. These rates were not significantly different from those with placebo.

In addition, rates of all adverse events, vomiting, severe adverse events, or severe diarrhea were significantly higher in the high-dose group, compared with the placebo group, but did not differ significantly between patients on low-dose colchicine or placebo.

Patients resorted to rescue medications within 24 hours of the first dose at statistically similar rates in the high-dose group (35%) and placebo group (48%), but the rate of rescue in the low-dose group (28%) was significantly lower than in the placebo group.

While it's good news that a lower dose of colchicine may suffice, it's possible that doses could go lower still, Dr. Terkeltaub said. “Perhaps we need another study” to find the minimum effective dose, he said.

Patients had to have a creatinine clearance rate of at least 60 mL/min to be eligible for the study, and no recent change in the use of serum urate-lowering drugs. A subanalysis found that patients with a higher degree of hyperuricemia (those with serum urate level greater than 10 mg/dL) were less likely to respond to colchicine than patients with lower serum urate levels, he said.

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SAN FRANCISCO — Low-dose colchicine appeared to be as effective as a more conventional dose in treating acute gout flares, but produced far fewer side effects in a randomized, double-blind, placebo-controlled trial in 185 patients.

The results support European League Against Rheumatism 2006 consensus guidelines recommending low doses (0.5 mg t.i.d.) when using colchicine to treat gout flare, a recommendation that was made without the backing of clinical trial data, Dr. Robert A. Terkeltaub said at the annual meeting of the American College of Rheumatology.

The study prerandomized 575 patients to receive high-dose colchicine, low-dose colchicine, or placebo capsules if they called a 24-hour service within 12 hours of the onset of a gout flare. Of the 184 patients who called and received treatment, 52 received high-dose colchicine (1.2 mg, then 0.6 mg hourly for 6 hours, for a total of 4.8 mg); 74 received low-dose colchicine (1.2 mg, then 0.6 mg in 1 hour, for a total of 4.8 mg), and 58 were given placebo (two capsules, then one capsule hourly for 6 hours). One more patient in the placebo group who had no outcomes recorded was excluded from the intent-to-treat analysis of efficacy but included in the safety analysis.

In the only previous placebo-controlled study of colchicine for gout flare, patients on colchicine received a mean total dose of 6.7 mg (higher than the high dose in the current study) and all patients developed diarrhea by the time of clinical response.

In the current study, 33% of patients in the high-dose group and 38% in the low-dose group recorded at least a 50% reduction in pain scores on a seven-point Likert scale within 24 hours of taking the first dose without taking a rescue medication. These rates were significantly higher than the 16% of patients on placebo who achieved this primary outcome. The efficacy between colchicine groups did not differ significantly, said Dr. Terkeltaub, chief of rheumatology in the Veterans Affairs San Diego Healthcare System and professor of medicine at the University of California, San Diego.

The study was funded by Mutual Pharmaceutical Co., a subsidiary of URL Pharma Inc., which manufactures a colchicine tablet. Based on these results, the companies are seeking Food and Drug Administration approval of the medication to treat the pain of gout flares.

Dr. Terkeltaub has been a consultant for AR Scientific, the branded arm of URL Pharma, and for other pharmaceutical companies. One of his coinvestigators is an employee and stockholder in AR Scientific, and other associates have been consultants to that company and to others.

High-dose colchicine produced GI side effects at a significantly higher rate (94%), compared with placebo (28%)—especially diarrhea (77% vs. 14%, respectively).

In the low-dose colchicine group, 45% had GI side effects and 23% developed diarrhea. These rates were not significantly different from those with placebo.

In addition, rates of all adverse events, vomiting, severe adverse events, or severe diarrhea were significantly higher in the high-dose group, compared with the placebo group, but did not differ significantly between patients on low-dose colchicine or placebo.

Patients resorted to rescue medications within 24 hours of the first dose at statistically similar rates in the high-dose group (35%) and placebo group (48%), but the rate of rescue in the low-dose group (28%) was significantly lower than in the placebo group.

While it's good news that a lower dose of colchicine may suffice, it's possible that doses could go lower still, Dr. Terkeltaub said. “Perhaps we need another study” to find the minimum effective dose, he said.

Patients had to have a creatinine clearance rate of at least 60 mL/min to be eligible for the study, and no recent change in the use of serum urate-lowering drugs. A subanalysis found that patients with a higher degree of hyperuricemia (those with serum urate level greater than 10 mg/dL) were less likely to respond to colchicine than patients with lower serum urate levels, he said.

SAN FRANCISCO — Low-dose colchicine appeared to be as effective as a more conventional dose in treating acute gout flares, but produced far fewer side effects in a randomized, double-blind, placebo-controlled trial in 185 patients.

The results support European League Against Rheumatism 2006 consensus guidelines recommending low doses (0.5 mg t.i.d.) when using colchicine to treat gout flare, a recommendation that was made without the backing of clinical trial data, Dr. Robert A. Terkeltaub said at the annual meeting of the American College of Rheumatology.

The study prerandomized 575 patients to receive high-dose colchicine, low-dose colchicine, or placebo capsules if they called a 24-hour service within 12 hours of the onset of a gout flare. Of the 184 patients who called and received treatment, 52 received high-dose colchicine (1.2 mg, then 0.6 mg hourly for 6 hours, for a total of 4.8 mg); 74 received low-dose colchicine (1.2 mg, then 0.6 mg in 1 hour, for a total of 4.8 mg), and 58 were given placebo (two capsules, then one capsule hourly for 6 hours). One more patient in the placebo group who had no outcomes recorded was excluded from the intent-to-treat analysis of efficacy but included in the safety analysis.

In the only previous placebo-controlled study of colchicine for gout flare, patients on colchicine received a mean total dose of 6.7 mg (higher than the high dose in the current study) and all patients developed diarrhea by the time of clinical response.

In the current study, 33% of patients in the high-dose group and 38% in the low-dose group recorded at least a 50% reduction in pain scores on a seven-point Likert scale within 24 hours of taking the first dose without taking a rescue medication. These rates were significantly higher than the 16% of patients on placebo who achieved this primary outcome. The efficacy between colchicine groups did not differ significantly, said Dr. Terkeltaub, chief of rheumatology in the Veterans Affairs San Diego Healthcare System and professor of medicine at the University of California, San Diego.

The study was funded by Mutual Pharmaceutical Co., a subsidiary of URL Pharma Inc., which manufactures a colchicine tablet. Based on these results, the companies are seeking Food and Drug Administration approval of the medication to treat the pain of gout flares.

Dr. Terkeltaub has been a consultant for AR Scientific, the branded arm of URL Pharma, and for other pharmaceutical companies. One of his coinvestigators is an employee and stockholder in AR Scientific, and other associates have been consultants to that company and to others.

High-dose colchicine produced GI side effects at a significantly higher rate (94%), compared with placebo (28%)—especially diarrhea (77% vs. 14%, respectively).

In the low-dose colchicine group, 45% had GI side effects and 23% developed diarrhea. These rates were not significantly different from those with placebo.

In addition, rates of all adverse events, vomiting, severe adverse events, or severe diarrhea were significantly higher in the high-dose group, compared with the placebo group, but did not differ significantly between patients on low-dose colchicine or placebo.

Patients resorted to rescue medications within 24 hours of the first dose at statistically similar rates in the high-dose group (35%) and placebo group (48%), but the rate of rescue in the low-dose group (28%) was significantly lower than in the placebo group.

While it's good news that a lower dose of colchicine may suffice, it's possible that doses could go lower still, Dr. Terkeltaub said. “Perhaps we need another study” to find the minimum effective dose, he said.

Patients had to have a creatinine clearance rate of at least 60 mL/min to be eligible for the study, and no recent change in the use of serum urate-lowering drugs. A subanalysis found that patients with a higher degree of hyperuricemia (those with serum urate level greater than 10 mg/dL) were less likely to respond to colchicine than patients with lower serum urate levels, he said.

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Two Predictors of Early Arthritis Identified

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SAN FRANCISCO — An observational study of 395 patients with suspected early arthritis identified two factors that predicted a diagnosis of rheumatoid arthritis within a year's time.

Patients with swelling in a small joint of the hands and/or feet were six times more likely to be diagnosed with rheumatoid arthritis within a year than were patients whose swollen joints did not include those sites. A diagnosis of rheumatoid arthritis within a year was 39 times more likely in patients whose laboratory tests at baseline showed the presence of anti-cyclic citrullinated peptide (anti-CCP) antibodies, compared with anti-CCP-negative patients, Dr. Maria D. Mjaavatten reported at the annual meeting of the American College of Rheumatology.

The same factors also were predictive (though to a lesser degree) of persistent arthritis and of subsequent use of disease-modifying antirheumatic drugs within a year, added Dr. Mjaavatten of the department of rheumatology at Diakonhjemmet Hospital, Oslo.

Patients with small-joint arthritis were twice as likely to develop persistent arthritis and four times as likely to start a DMARD within a year compared with patients without small-joint involvement. Patients with anti-CCP positivity were five times more likely to develop persistent arthritis and nine times more likely to start a DMARD, compared with anti-CCP-negative patients.

The results will help inform an ongoing effort by a joint European-American task force to define new diagnostic criteria for early rheumatoid arthritis, Dr. Mjaavatten said. Classification criteria from the American College of Rheumatology (ACR) were developed in 1997 for established disease and are not as useful in early arthritis. The ACR and the European League Against Rheumatism (EULAR) convened the current task force.

“Rheumatoid arthritis is often undifferentiated. The disease course can be difficult to predict in the early stages,” but the newly identified predictors should help, she said.

The study enrolled adult patients with at least a 16-week history of one or more clinically swollen joints diagnosed as arthritis by rheumatologists at one of five Norwegian centers, and followed patients for at least a year. Although physicians were aware of the ACR diagnostic criteria for rheumatoid arthritis, diagnoses were not limited to patients who met those criteria, Dr. Mjaavatten noted.

The cohort represented approximately 70% of all patients enrolled. The other 30% were lost to follow-up before completing at least two follow-up assessments and were presumed to have nonpersistent arthritis. The study defined persistent arthritis as the presence of joint swelling on at least two out of three follow-up assessments during the first year.

The cohort was younger (mean age, 46 years) and included fewer women (57%) than might be expected in a “typical” rheumatoid arthritis cohort, she noted. The mean arthritis duration at baseline was short (30 days), with a duration of 10 days or less in a quarter of the patients.

During the year of follow-up, 18% of patients were diagnosed with rheumatoid arthritis and 26% had persistent arthritis. Among 301 patients whose charts had information on DMARDs, 36% started a DMARD during the year. Methotrexate was the dominant drug, used by 59% of patients on a DMARD. Another 9% used sulfasalazine, 28% took a combination of DMARDs or more than one DMARD during the year (including 13 patients who received biologics), and 4% used other DMARDs.

Some patients had more than one of the three main outcomes: a rheumatoid arthritis diagnosis, persistent arthritis, or DMARD use. DMARDs were not started in approximately 5% of patients diagnosed with rheumatoid arthritis and about 15% of patients with persistent arthritis, Dr. Mjaavatten said. Around 16% of DMARD users had neither a diagnosis of rheumatoid arthritis nor persistent arthritis.

Dr. Mjaavatten reported no conflicts of interest regarding this study.

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SAN FRANCISCO — An observational study of 395 patients with suspected early arthritis identified two factors that predicted a diagnosis of rheumatoid arthritis within a year's time.

Patients with swelling in a small joint of the hands and/or feet were six times more likely to be diagnosed with rheumatoid arthritis within a year than were patients whose swollen joints did not include those sites. A diagnosis of rheumatoid arthritis within a year was 39 times more likely in patients whose laboratory tests at baseline showed the presence of anti-cyclic citrullinated peptide (anti-CCP) antibodies, compared with anti-CCP-negative patients, Dr. Maria D. Mjaavatten reported at the annual meeting of the American College of Rheumatology.

The same factors also were predictive (though to a lesser degree) of persistent arthritis and of subsequent use of disease-modifying antirheumatic drugs within a year, added Dr. Mjaavatten of the department of rheumatology at Diakonhjemmet Hospital, Oslo.

Patients with small-joint arthritis were twice as likely to develop persistent arthritis and four times as likely to start a DMARD within a year compared with patients without small-joint involvement. Patients with anti-CCP positivity were five times more likely to develop persistent arthritis and nine times more likely to start a DMARD, compared with anti-CCP-negative patients.

The results will help inform an ongoing effort by a joint European-American task force to define new diagnostic criteria for early rheumatoid arthritis, Dr. Mjaavatten said. Classification criteria from the American College of Rheumatology (ACR) were developed in 1997 for established disease and are not as useful in early arthritis. The ACR and the European League Against Rheumatism (EULAR) convened the current task force.

“Rheumatoid arthritis is often undifferentiated. The disease course can be difficult to predict in the early stages,” but the newly identified predictors should help, she said.

The study enrolled adult patients with at least a 16-week history of one or more clinically swollen joints diagnosed as arthritis by rheumatologists at one of five Norwegian centers, and followed patients for at least a year. Although physicians were aware of the ACR diagnostic criteria for rheumatoid arthritis, diagnoses were not limited to patients who met those criteria, Dr. Mjaavatten noted.

The cohort represented approximately 70% of all patients enrolled. The other 30% were lost to follow-up before completing at least two follow-up assessments and were presumed to have nonpersistent arthritis. The study defined persistent arthritis as the presence of joint swelling on at least two out of three follow-up assessments during the first year.

The cohort was younger (mean age, 46 years) and included fewer women (57%) than might be expected in a “typical” rheumatoid arthritis cohort, she noted. The mean arthritis duration at baseline was short (30 days), with a duration of 10 days or less in a quarter of the patients.

During the year of follow-up, 18% of patients were diagnosed with rheumatoid arthritis and 26% had persistent arthritis. Among 301 patients whose charts had information on DMARDs, 36% started a DMARD during the year. Methotrexate was the dominant drug, used by 59% of patients on a DMARD. Another 9% used sulfasalazine, 28% took a combination of DMARDs or more than one DMARD during the year (including 13 patients who received biologics), and 4% used other DMARDs.

Some patients had more than one of the three main outcomes: a rheumatoid arthritis diagnosis, persistent arthritis, or DMARD use. DMARDs were not started in approximately 5% of patients diagnosed with rheumatoid arthritis and about 15% of patients with persistent arthritis, Dr. Mjaavatten said. Around 16% of DMARD users had neither a diagnosis of rheumatoid arthritis nor persistent arthritis.

Dr. Mjaavatten reported no conflicts of interest regarding this study.

SAN FRANCISCO — An observational study of 395 patients with suspected early arthritis identified two factors that predicted a diagnosis of rheumatoid arthritis within a year's time.

Patients with swelling in a small joint of the hands and/or feet were six times more likely to be diagnosed with rheumatoid arthritis within a year than were patients whose swollen joints did not include those sites. A diagnosis of rheumatoid arthritis within a year was 39 times more likely in patients whose laboratory tests at baseline showed the presence of anti-cyclic citrullinated peptide (anti-CCP) antibodies, compared with anti-CCP-negative patients, Dr. Maria D. Mjaavatten reported at the annual meeting of the American College of Rheumatology.

The same factors also were predictive (though to a lesser degree) of persistent arthritis and of subsequent use of disease-modifying antirheumatic drugs within a year, added Dr. Mjaavatten of the department of rheumatology at Diakonhjemmet Hospital, Oslo.

Patients with small-joint arthritis were twice as likely to develop persistent arthritis and four times as likely to start a DMARD within a year compared with patients without small-joint involvement. Patients with anti-CCP positivity were five times more likely to develop persistent arthritis and nine times more likely to start a DMARD, compared with anti-CCP-negative patients.

The results will help inform an ongoing effort by a joint European-American task force to define new diagnostic criteria for early rheumatoid arthritis, Dr. Mjaavatten said. Classification criteria from the American College of Rheumatology (ACR) were developed in 1997 for established disease and are not as useful in early arthritis. The ACR and the European League Against Rheumatism (EULAR) convened the current task force.

“Rheumatoid arthritis is often undifferentiated. The disease course can be difficult to predict in the early stages,” but the newly identified predictors should help, she said.

The study enrolled adult patients with at least a 16-week history of one or more clinically swollen joints diagnosed as arthritis by rheumatologists at one of five Norwegian centers, and followed patients for at least a year. Although physicians were aware of the ACR diagnostic criteria for rheumatoid arthritis, diagnoses were not limited to patients who met those criteria, Dr. Mjaavatten noted.

The cohort represented approximately 70% of all patients enrolled. The other 30% were lost to follow-up before completing at least two follow-up assessments and were presumed to have nonpersistent arthritis. The study defined persistent arthritis as the presence of joint swelling on at least two out of three follow-up assessments during the first year.

The cohort was younger (mean age, 46 years) and included fewer women (57%) than might be expected in a “typical” rheumatoid arthritis cohort, she noted. The mean arthritis duration at baseline was short (30 days), with a duration of 10 days or less in a quarter of the patients.

During the year of follow-up, 18% of patients were diagnosed with rheumatoid arthritis and 26% had persistent arthritis. Among 301 patients whose charts had information on DMARDs, 36% started a DMARD during the year. Methotrexate was the dominant drug, used by 59% of patients on a DMARD. Another 9% used sulfasalazine, 28% took a combination of DMARDs or more than one DMARD during the year (including 13 patients who received biologics), and 4% used other DMARDs.

Some patients had more than one of the three main outcomes: a rheumatoid arthritis diagnosis, persistent arthritis, or DMARD use. DMARDs were not started in approximately 5% of patients diagnosed with rheumatoid arthritis and about 15% of patients with persistent arthritis, Dr. Mjaavatten said. Around 16% of DMARD users had neither a diagnosis of rheumatoid arthritis nor persistent arthritis.

Dr. Mjaavatten reported no conflicts of interest regarding this study.

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Anti-CCP Positivity, Small-Joint Swells Predict RA

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SAN FRANCISCO — An observational study of 395 patients with suspected early arthritis identified two factors that predicted a diagnosis of rheumatoid arthritis within a year's time.

Patients with swelling in a small joint of the hands and/or feet were six times more likely to be diagnosed with RA within a year than were patients whose swollen joints did not include those sites. A diagnosis was 39 times more likely in patients whose laboratory tests at baseline showed the presence of anti-cyclic citrullinated peptide antibodies, versus anti-CCP-negative patients, Dr. Maria D. Mjaavatten said at the annual meeting of the American College of Rheumatology.

The same factors also predicted (to a lesser degree) persistent arthritis and of subsequent use of disease-modifying antirheumatic drugs within a year, added Dr. Mjaavatten of the rheumatology department at Diakonhjemmet Hospital, Oslo.

Patients with small-joint arthritis were twice as likely to develop persistent arthritis and four times as likely to start a DMARD within a year compared with patients without small-joint involvement. Patients with anti-CCP positivity were five times more likely to develop persistent arthritis and nine times more likely to start a DMARD compared with anti-CCP-negative patients.

The results will help inform an ongoing effort by a joint European-American task force to define new diagnostic criteria for early rheumatoid arthritis, Dr. Mjaavatten said. Classification criteria from the ACR were developed in 1997 for established disease and are not as useful in early arthritis. The ACR and the European League Against Rheumatism convened the current task force.

The study enrolled adult patients with at least a 16-week history of one or more clinically swollen joints diagnosed as arthritis by rheumatologists at one of five Norwegian centers, and followed patients for at least a year. Although physicians were aware of the ACR diagnostic criteria for rheumatoid arthritis, diagnoses were not limited to patients who met those criteria, Dr. Mjaavatten noted.

The cohort represented approximately 70% of all patients enrolled. The other 30% were lost to follow-up before completing at least two follow-up assessments and were presumed to have nonpersistent arthritis. The study defined persistent arthritis as the presence of joint swelling on at least two out of three follow-up assessments during the first year.

The cohort was younger (mean age, 46) and included fewer women (57%) than a “typical” RA cohort, she noted. The mean arthritis duration at baseline was very short (30 days), with a duration of 10 days or less in a quarter of the patients.

During the year of follow-up, 18% of patients were diagnosed with rheumatoid arthritis and 26% had persistent arthritis. Among 301 patients whose charts had information on DMARDs, 36% started a DMARD during the year. Methotrexate was the dominant drug, used by 59% of patients on a DMARD. Another 9% used sulfasalazine, 28% took a combination of DMARDs or more than one DMARD during the year (including 13 patients who received biologics), and 4% used other DMARDs.

Some patients had more than one of the three main outcomes: an RA diagnosis, persistent arthritis, or DMARD use.

DMARDs were not started in about 5% of patients diagnosed with RA and about 15% of patients with persistent arthritis, Dr. Mjaavatten said. Around 16% of DMARD users had neither a diagnosis of RA nor persistent arthritis. At presentation, 38% of patients had single-joint arthritis, 33% had two to four swollen joints, and 29% had polyarthritis.

Dr. Mjaavatten reported no conflicts of interest relevant to this study.

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SAN FRANCISCO — An observational study of 395 patients with suspected early arthritis identified two factors that predicted a diagnosis of rheumatoid arthritis within a year's time.

Patients with swelling in a small joint of the hands and/or feet were six times more likely to be diagnosed with RA within a year than were patients whose swollen joints did not include those sites. A diagnosis was 39 times more likely in patients whose laboratory tests at baseline showed the presence of anti-cyclic citrullinated peptide antibodies, versus anti-CCP-negative patients, Dr. Maria D. Mjaavatten said at the annual meeting of the American College of Rheumatology.

The same factors also predicted (to a lesser degree) persistent arthritis and of subsequent use of disease-modifying antirheumatic drugs within a year, added Dr. Mjaavatten of the rheumatology department at Diakonhjemmet Hospital, Oslo.

Patients with small-joint arthritis were twice as likely to develop persistent arthritis and four times as likely to start a DMARD within a year compared with patients without small-joint involvement. Patients with anti-CCP positivity were five times more likely to develop persistent arthritis and nine times more likely to start a DMARD compared with anti-CCP-negative patients.

The results will help inform an ongoing effort by a joint European-American task force to define new diagnostic criteria for early rheumatoid arthritis, Dr. Mjaavatten said. Classification criteria from the ACR were developed in 1997 for established disease and are not as useful in early arthritis. The ACR and the European League Against Rheumatism convened the current task force.

The study enrolled adult patients with at least a 16-week history of one or more clinically swollen joints diagnosed as arthritis by rheumatologists at one of five Norwegian centers, and followed patients for at least a year. Although physicians were aware of the ACR diagnostic criteria for rheumatoid arthritis, diagnoses were not limited to patients who met those criteria, Dr. Mjaavatten noted.

The cohort represented approximately 70% of all patients enrolled. The other 30% were lost to follow-up before completing at least two follow-up assessments and were presumed to have nonpersistent arthritis. The study defined persistent arthritis as the presence of joint swelling on at least two out of three follow-up assessments during the first year.

The cohort was younger (mean age, 46) and included fewer women (57%) than a “typical” RA cohort, she noted. The mean arthritis duration at baseline was very short (30 days), with a duration of 10 days or less in a quarter of the patients.

During the year of follow-up, 18% of patients were diagnosed with rheumatoid arthritis and 26% had persistent arthritis. Among 301 patients whose charts had information on DMARDs, 36% started a DMARD during the year. Methotrexate was the dominant drug, used by 59% of patients on a DMARD. Another 9% used sulfasalazine, 28% took a combination of DMARDs or more than one DMARD during the year (including 13 patients who received biologics), and 4% used other DMARDs.

Some patients had more than one of the three main outcomes: an RA diagnosis, persistent arthritis, or DMARD use.

DMARDs were not started in about 5% of patients diagnosed with RA and about 15% of patients with persistent arthritis, Dr. Mjaavatten said. Around 16% of DMARD users had neither a diagnosis of RA nor persistent arthritis. At presentation, 38% of patients had single-joint arthritis, 33% had two to four swollen joints, and 29% had polyarthritis.

Dr. Mjaavatten reported no conflicts of interest relevant to this study.

SAN FRANCISCO — An observational study of 395 patients with suspected early arthritis identified two factors that predicted a diagnosis of rheumatoid arthritis within a year's time.

Patients with swelling in a small joint of the hands and/or feet were six times more likely to be diagnosed with RA within a year than were patients whose swollen joints did not include those sites. A diagnosis was 39 times more likely in patients whose laboratory tests at baseline showed the presence of anti-cyclic citrullinated peptide antibodies, versus anti-CCP-negative patients, Dr. Maria D. Mjaavatten said at the annual meeting of the American College of Rheumatology.

The same factors also predicted (to a lesser degree) persistent arthritis and of subsequent use of disease-modifying antirheumatic drugs within a year, added Dr. Mjaavatten of the rheumatology department at Diakonhjemmet Hospital, Oslo.

Patients with small-joint arthritis were twice as likely to develop persistent arthritis and four times as likely to start a DMARD within a year compared with patients without small-joint involvement. Patients with anti-CCP positivity were five times more likely to develop persistent arthritis and nine times more likely to start a DMARD compared with anti-CCP-negative patients.

The results will help inform an ongoing effort by a joint European-American task force to define new diagnostic criteria for early rheumatoid arthritis, Dr. Mjaavatten said. Classification criteria from the ACR were developed in 1997 for established disease and are not as useful in early arthritis. The ACR and the European League Against Rheumatism convened the current task force.

The study enrolled adult patients with at least a 16-week history of one or more clinically swollen joints diagnosed as arthritis by rheumatologists at one of five Norwegian centers, and followed patients for at least a year. Although physicians were aware of the ACR diagnostic criteria for rheumatoid arthritis, diagnoses were not limited to patients who met those criteria, Dr. Mjaavatten noted.

The cohort represented approximately 70% of all patients enrolled. The other 30% were lost to follow-up before completing at least two follow-up assessments and were presumed to have nonpersistent arthritis. The study defined persistent arthritis as the presence of joint swelling on at least two out of three follow-up assessments during the first year.

The cohort was younger (mean age, 46) and included fewer women (57%) than a “typical” RA cohort, she noted. The mean arthritis duration at baseline was very short (30 days), with a duration of 10 days or less in a quarter of the patients.

During the year of follow-up, 18% of patients were diagnosed with rheumatoid arthritis and 26% had persistent arthritis. Among 301 patients whose charts had information on DMARDs, 36% started a DMARD during the year. Methotrexate was the dominant drug, used by 59% of patients on a DMARD. Another 9% used sulfasalazine, 28% took a combination of DMARDs or more than one DMARD during the year (including 13 patients who received biologics), and 4% used other DMARDs.

Some patients had more than one of the three main outcomes: an RA diagnosis, persistent arthritis, or DMARD use.

DMARDs were not started in about 5% of patients diagnosed with RA and about 15% of patients with persistent arthritis, Dr. Mjaavatten said. Around 16% of DMARD users had neither a diagnosis of RA nor persistent arthritis. At presentation, 38% of patients had single-joint arthritis, 33% had two to four swollen joints, and 29% had polyarthritis.

Dr. Mjaavatten reported no conflicts of interest relevant to this study.

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