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E-order sets for Vitamin D testing cut deficiency among elderly
Making physicians aware of their track record assessing vitamin D deficiency and adding computerized order sets to check vitamin D levels and initiate vitamin D supplementation led to "significant improvement" in assessment and treatment of vitamin D deficiency in elderly patients with hip fracture at a North Carolina hospital, according to a study published online in the Journal of Hospital Medicine.
After these interventions, the percentage of patients screened for vitamin D deficiency improved from 37.2% to 93.5% (P less than .001), and the percentage of deficient or insufficient patients discharged on the recommended vitamin D dose improved from 40.9% to 68% (P = .008), Dr. John R. Stephens of the University of North Carolina Hospitals and his colleagues reported (J. Hosp. Med. 2014 Sept. 5 [doi:10.1002/jhm.2255]).
The study authors reviewed the literature on the prevalence of vitamin D deficiency in elderly patients and used Endocrine Society guidelines "to define vitamin D deficiency, insufficiency, and recommended treatment dosing for each condition." They presented this information along with a review of data from their hospitalist group practice at a staff meeting.
They also revised the computerized physician order entry (CPOE) set for patients with hip fractures to include two new orders: an automatic order for 25-OH vitamin D level to be drawn the morning after admission and an order for initiation of 1,000 IU daily of vitamin D at admission.
They compared records of 196 patients (mean age 80), with hip fracture treated in the 28 months before these interventions and 107 similar patients treated in the 12 months following the interventions.
Three-quarters of the patients were female and at least 81% of the patients in both the intervention and preintervention groups were white in the single-center study.
"Our study demonstrates a systematic method groups may use to adopt and reliably implement practice guidelines," the authors wrote.
"With safeguards in the electronic system to flag duplicate medications, low toxicity of standard doses of vitamin D, and minimal economic harm with duplicate laboratory therapy in the context of a hospitalization for hip fracture," the researchers wrote, any possible risks "are outweighed by the benefits of screening."
They reported no conflicts of interest.
Making physicians aware of their track record assessing vitamin D deficiency and adding computerized order sets to check vitamin D levels and initiate vitamin D supplementation led to "significant improvement" in assessment and treatment of vitamin D deficiency in elderly patients with hip fracture at a North Carolina hospital, according to a study published online in the Journal of Hospital Medicine.
After these interventions, the percentage of patients screened for vitamin D deficiency improved from 37.2% to 93.5% (P less than .001), and the percentage of deficient or insufficient patients discharged on the recommended vitamin D dose improved from 40.9% to 68% (P = .008), Dr. John R. Stephens of the University of North Carolina Hospitals and his colleagues reported (J. Hosp. Med. 2014 Sept. 5 [doi:10.1002/jhm.2255]).
The study authors reviewed the literature on the prevalence of vitamin D deficiency in elderly patients and used Endocrine Society guidelines "to define vitamin D deficiency, insufficiency, and recommended treatment dosing for each condition." They presented this information along with a review of data from their hospitalist group practice at a staff meeting.
They also revised the computerized physician order entry (CPOE) set for patients with hip fractures to include two new orders: an automatic order for 25-OH vitamin D level to be drawn the morning after admission and an order for initiation of 1,000 IU daily of vitamin D at admission.
They compared records of 196 patients (mean age 80), with hip fracture treated in the 28 months before these interventions and 107 similar patients treated in the 12 months following the interventions.
Three-quarters of the patients were female and at least 81% of the patients in both the intervention and preintervention groups were white in the single-center study.
"Our study demonstrates a systematic method groups may use to adopt and reliably implement practice guidelines," the authors wrote.
"With safeguards in the electronic system to flag duplicate medications, low toxicity of standard doses of vitamin D, and minimal economic harm with duplicate laboratory therapy in the context of a hospitalization for hip fracture," the researchers wrote, any possible risks "are outweighed by the benefits of screening."
They reported no conflicts of interest.
Making physicians aware of their track record assessing vitamin D deficiency and adding computerized order sets to check vitamin D levels and initiate vitamin D supplementation led to "significant improvement" in assessment and treatment of vitamin D deficiency in elderly patients with hip fracture at a North Carolina hospital, according to a study published online in the Journal of Hospital Medicine.
After these interventions, the percentage of patients screened for vitamin D deficiency improved from 37.2% to 93.5% (P less than .001), and the percentage of deficient or insufficient patients discharged on the recommended vitamin D dose improved from 40.9% to 68% (P = .008), Dr. John R. Stephens of the University of North Carolina Hospitals and his colleagues reported (J. Hosp. Med. 2014 Sept. 5 [doi:10.1002/jhm.2255]).
The study authors reviewed the literature on the prevalence of vitamin D deficiency in elderly patients and used Endocrine Society guidelines "to define vitamin D deficiency, insufficiency, and recommended treatment dosing for each condition." They presented this information along with a review of data from their hospitalist group practice at a staff meeting.
They also revised the computerized physician order entry (CPOE) set for patients with hip fractures to include two new orders: an automatic order for 25-OH vitamin D level to be drawn the morning after admission and an order for initiation of 1,000 IU daily of vitamin D at admission.
They compared records of 196 patients (mean age 80), with hip fracture treated in the 28 months before these interventions and 107 similar patients treated in the 12 months following the interventions.
Three-quarters of the patients were female and at least 81% of the patients in both the intervention and preintervention groups were white in the single-center study.
"Our study demonstrates a systematic method groups may use to adopt and reliably implement practice guidelines," the authors wrote.
"With safeguards in the electronic system to flag duplicate medications, low toxicity of standard doses of vitamin D, and minimal economic harm with duplicate laboratory therapy in the context of a hospitalization for hip fracture," the researchers wrote, any possible risks "are outweighed by the benefits of screening."
They reported no conflicts of interest.
FROM THE JOURNAL OF HOSPITAL MEDICINE
Key clinical point: Having CPOE prompt screening can help reduce vitamin D deficiency in elderly inpatients.
Major finding: The percentage of patients screened for vitamin D deficiency improved from 37.2% to 93.5%, and the percentage of deficient or insufficient patients discharged on the recommended vitamin D dose improved from 40.9% to 68%.
Data source: An internal review of hospital records for 196 patients treated before CPOE set interventions and 107 patients treated after interventions.
Disclosures: The authors reported no conflicts of interest.
Psoriasis risk rises in women with history of hypertension and beta-blocker use
Women with a 6-year or longer history of hypertension, and women with a 6-year or longer use of beta-blocker medications to treat hypertension, may be at increased risk of developing psoriasis, compared with women who have normal blood pressure, according to data from more than 77,000 women.
"Women with hypertension tended to be older; had higher [body mass indexes]; had proportionately higher prevalence rates of cardiovascular disease, type 2 diabetes, and hypercholesterolemia; and were less physically active than those without hypertension," the researchers wrote.
The report was published online July 2 in JAMA Dermatology [doi:10.1001/jamadermatol.2013.9957].
Dr. Shaowei Wu of Brown University, Providence, R.I., and colleagues performed a prospective cohort study of 77,728 women participating in the Nurses’ Health Study between June 1996 and June 2008. The women provided biennially updated data on hypertension and antihypertensive medications. The researchers identified 843 psoriasis cases during more than 1 million person-years of follow-up.
Women with hypertension lasting 6 years or more were at higher risk of developing psoriasis than were normotensive women [HR 1.27]. In further analysis, researchers found "a higher risk of psoriasis among hypertensive women without medication use [HR 1.49] and among hypertensive women with current medication use [HR 1.31] when compared with normotensive women without medication use." In an analysis of individual antihypertensive medications, beta-blockers were the only drugs associated with psoriasis development. Although this association disappeared in a fully-adjusted model, it "persisted in a duration-dependent manner" [HR 1.39] among women taking the medications for 6 years or more, and this trend was statistically significant.
"Special attention on psoriasis screening may be needed for patients with long-term duration of hypertension and related antihypertensive medication use in clinical practices," the authors wrote. The findings "provide novel insights into the association among hypertension, antihypertensive medications, and psoriasis," they said. "However, further work is necessary to confirm our findings and clarify the biological mechanisms that underlie these associations."
The study was supported in part by the National Institutes of Health. Senior author Dr. Abrar Qureshi has served as a consultant for Abbott, Centocor, Novartis, and the Centers for Disease Control and Prevention.
"A critical practice gap exists in identifying the causes of psoriasis flares, especially medication-related causes," said Dr. April Armstrong. "Some physicians may not consistently examine medications for their contribution to psoriasis flares. However, a careful consideration of the role of medications in psoriasis exacerbation may improve long-term psoriasis control."
Solutions to narrow these gaps "include a careful review of a patient’s medication list with special attention to medications with strong evidence of contributing to psoriasis exacerbation," including beta-blockers, lithium, antimalarials, and interferons, she said. It also is important for dermatologists "to recognize medications with latency periods beyond the typical 2-4 weeks and to inquire about historical use of these medications with known long latency periods." If dermatologists recommend discontinued use of a medication, "they need to coordinate care with other health care professionals to ensure that the patient is offered appropriate alternative treatments."
Dr. Armstrong is in the department of dermatology at the University of Colorado, Denver. She had no related financial disclosures. These remarks were taken from her editorial accompanying the report by Dr. Wu (JAMA Dermatology 2014 [doi: 10.1001/jamadermatol.2014.1019]).
"A critical practice gap exists in identifying the causes of psoriasis flares, especially medication-related causes," said Dr. April Armstrong. "Some physicians may not consistently examine medications for their contribution to psoriasis flares. However, a careful consideration of the role of medications in psoriasis exacerbation may improve long-term psoriasis control."
Solutions to narrow these gaps "include a careful review of a patient’s medication list with special attention to medications with strong evidence of contributing to psoriasis exacerbation," including beta-blockers, lithium, antimalarials, and interferons, she said. It also is important for dermatologists "to recognize medications with latency periods beyond the typical 2-4 weeks and to inquire about historical use of these medications with known long latency periods." If dermatologists recommend discontinued use of a medication, "they need to coordinate care with other health care professionals to ensure that the patient is offered appropriate alternative treatments."
Dr. Armstrong is in the department of dermatology at the University of Colorado, Denver. She had no related financial disclosures. These remarks were taken from her editorial accompanying the report by Dr. Wu (JAMA Dermatology 2014 [doi: 10.1001/jamadermatol.2014.1019]).
"A critical practice gap exists in identifying the causes of psoriasis flares, especially medication-related causes," said Dr. April Armstrong. "Some physicians may not consistently examine medications for their contribution to psoriasis flares. However, a careful consideration of the role of medications in psoriasis exacerbation may improve long-term psoriasis control."
Solutions to narrow these gaps "include a careful review of a patient’s medication list with special attention to medications with strong evidence of contributing to psoriasis exacerbation," including beta-blockers, lithium, antimalarials, and interferons, she said. It also is important for dermatologists "to recognize medications with latency periods beyond the typical 2-4 weeks and to inquire about historical use of these medications with known long latency periods." If dermatologists recommend discontinued use of a medication, "they need to coordinate care with other health care professionals to ensure that the patient is offered appropriate alternative treatments."
Dr. Armstrong is in the department of dermatology at the University of Colorado, Denver. She had no related financial disclosures. These remarks were taken from her editorial accompanying the report by Dr. Wu (JAMA Dermatology 2014 [doi: 10.1001/jamadermatol.2014.1019]).
Women with a 6-year or longer history of hypertension, and women with a 6-year or longer use of beta-blocker medications to treat hypertension, may be at increased risk of developing psoriasis, compared with women who have normal blood pressure, according to data from more than 77,000 women.
"Women with hypertension tended to be older; had higher [body mass indexes]; had proportionately higher prevalence rates of cardiovascular disease, type 2 diabetes, and hypercholesterolemia; and were less physically active than those without hypertension," the researchers wrote.
The report was published online July 2 in JAMA Dermatology [doi:10.1001/jamadermatol.2013.9957].
Dr. Shaowei Wu of Brown University, Providence, R.I., and colleagues performed a prospective cohort study of 77,728 women participating in the Nurses’ Health Study between June 1996 and June 2008. The women provided biennially updated data on hypertension and antihypertensive medications. The researchers identified 843 psoriasis cases during more than 1 million person-years of follow-up.
Women with hypertension lasting 6 years or more were at higher risk of developing psoriasis than were normotensive women [HR 1.27]. In further analysis, researchers found "a higher risk of psoriasis among hypertensive women without medication use [HR 1.49] and among hypertensive women with current medication use [HR 1.31] when compared with normotensive women without medication use." In an analysis of individual antihypertensive medications, beta-blockers were the only drugs associated with psoriasis development. Although this association disappeared in a fully-adjusted model, it "persisted in a duration-dependent manner" [HR 1.39] among women taking the medications for 6 years or more, and this trend was statistically significant.
"Special attention on psoriasis screening may be needed for patients with long-term duration of hypertension and related antihypertensive medication use in clinical practices," the authors wrote. The findings "provide novel insights into the association among hypertension, antihypertensive medications, and psoriasis," they said. "However, further work is necessary to confirm our findings and clarify the biological mechanisms that underlie these associations."
The study was supported in part by the National Institutes of Health. Senior author Dr. Abrar Qureshi has served as a consultant for Abbott, Centocor, Novartis, and the Centers for Disease Control and Prevention.
Women with a 6-year or longer history of hypertension, and women with a 6-year or longer use of beta-blocker medications to treat hypertension, may be at increased risk of developing psoriasis, compared with women who have normal blood pressure, according to data from more than 77,000 women.
"Women with hypertension tended to be older; had higher [body mass indexes]; had proportionately higher prevalence rates of cardiovascular disease, type 2 diabetes, and hypercholesterolemia; and were less physically active than those without hypertension," the researchers wrote.
The report was published online July 2 in JAMA Dermatology [doi:10.1001/jamadermatol.2013.9957].
Dr. Shaowei Wu of Brown University, Providence, R.I., and colleagues performed a prospective cohort study of 77,728 women participating in the Nurses’ Health Study between June 1996 and June 2008. The women provided biennially updated data on hypertension and antihypertensive medications. The researchers identified 843 psoriasis cases during more than 1 million person-years of follow-up.
Women with hypertension lasting 6 years or more were at higher risk of developing psoriasis than were normotensive women [HR 1.27]. In further analysis, researchers found "a higher risk of psoriasis among hypertensive women without medication use [HR 1.49] and among hypertensive women with current medication use [HR 1.31] when compared with normotensive women without medication use." In an analysis of individual antihypertensive medications, beta-blockers were the only drugs associated with psoriasis development. Although this association disappeared in a fully-adjusted model, it "persisted in a duration-dependent manner" [HR 1.39] among women taking the medications for 6 years or more, and this trend was statistically significant.
"Special attention on psoriasis screening may be needed for patients with long-term duration of hypertension and related antihypertensive medication use in clinical practices," the authors wrote. The findings "provide novel insights into the association among hypertension, antihypertensive medications, and psoriasis," they said. "However, further work is necessary to confirm our findings and clarify the biological mechanisms that underlie these associations."
The study was supported in part by the National Institutes of Health. Senior author Dr. Abrar Qureshi has served as a consultant for Abbott, Centocor, Novartis, and the Centers for Disease Control and Prevention.
FROM JAMA DERMATOLOGY
Key clinical point: Women with a long history of hypertension, or a long history of beta-blocker use to treat hypertension, may be at increased risk of developing psoriasis.
Major finding: Women with hypertension for 6 years or more were at higher risk of developing psoriasis (HR 1.27) than were normotensive women. The risk of psoriasis was higher among hypertensive women not taking medication (HR 1.49) and among hypertensive women taking medication (HR 1.31) compared with that of normotensive women not taking medication.
Data source: A group of 77,728 women who participated in the Nurses’ Health Study from 1996 to 2008.
Disclosures: The study was supported in part by the National Institutes of Health. The senior study author has served as a consultant for Abbott, Centocor, Novartis, and the Centers for Disease Control and Prevention.
Tool predicts lymphoma, death in primary Sjögren’s syndrome patients
The European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index measured at the time of diagnosis predicted the development of lymphoma and death in Spanish patients with severe primary Sjögren’s syndrome in a large, multicenter registry.
"We identified a specific hematological and immunological profile (cytopenias, hypocomplementemia, monoclonal band, and cryoglobulinemia) as laboratory predictors of hematological neoplasia in these patients," said lead study author Dr. Pilar Brito Zerón. "If you have an SS [Sjögren’s syndrome] patient with these features, you have to be very careful because this patient has a higher probability of developing a lymphoma."
"Physicians have had an activity index tool for other diseases for a long time, but there was nothing for SS until recently," when the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) was published in 2010, Dr. Brito Zerón said. "In Spain, we have one of the largest cohorts of SS patients in the world," so it was a good opportunity to test the ESSDAI.
Dr. Brito Zerón of Hospital Clinic in Barcelona and her colleagues studied patient records from the GEAS-SS multicenter registry, a cohort of 921 patients with SS from 20 medical centers in Spain, and retrospectively calculated their 2010 ESSDAI. During a mean follow-up period of 75 months, 25 (3%) of 904 patients developed lymphoproliferative disease; 17 were excluded because they had lymphoma before their primary SS diagnosis. Two-thirds were MALT (mucosa-associated lymphoid tissue) lymphomas, 80% of which were located in the parotid glands.
The investigators found that the following baseline features at diagnosis were most associated with lymphoma development: male gender (hazard ratio [HR], 5.78; 95% confidence interval [CI], 2.14-15.63); cryoglobulins (HR, 4.44; 95% CI, 1.86-10.58); monoclonal serum band (HR, 4.23; 95% CI, 1.38-13.02); C3 values less than 0.82 g/L (HR, 3.75; 95% CI, 1.38-10.19); C4 values less than 0.07 g/L (HR, 3.22, 95% CI, 1.08-9.61); and older age (HR, 1.04; 95% CI, 1.00-1.07). Gender, low C3, monoclonal band, and cryoglobulins were significant independent variables related to lymphoma, Dr. Brito Zerón reported at the annual European Congress of Rheumatology.
An ESSDAI score of one or greater in the constitutional (HR, 4.06; 95% CI, 1.54-10.70) and hematologic (HR, 2.59; 95% CI 1.16-5.78) domains was associated with the development of lymphoma, with hematologic activity being independently associated. In the constitutional domain, patients with the highest degree of activity – including fever greater than 38.5° C, night sweats, and/or involuntary weight loss of at least 10% – showed the highest risk of developing lymphoma (HR, 9.11; 95% CI, 2.51-33.12).
At the time of diagnosis with the 2002 primary SS classification criteria, patients had a mean baseline ESSDAI of 5.81. During follow-up, the patients accumulated another mean 3.34 points for a cumulative ESSADI of 9.15. A large majority of patients were women (94%) and had a mean age of nearly 54 years at the time of diagnosis. Most of the 921 patients in the registry had xerostomia (96%), xerophthalmia (95%), positive ocular tests (93%; 805 of 863), grade 3-4 parotid scintigraphy (88%; 598 of 676), and positive salivary gland biopsy (88%; 424 of 482). Cytopenias occurred in 34% overall, including anemia (17%), leucopenia (20%), and thrombocytopenia (9%). Immunologic disease characteristics of the patients included positive autoantibody tests for antinuclear antibodies (90%), anti-Ro (73%), rheumatoid factor (57%), and anti-La (46%). Others had low C4 (12%) or C3 (9%) levels and low cryoglobulins (12%) or monoclonal gammopathy (9%).
The investigators also correlated the baseline ESSDAI score with mortality. After an average follow-up of 75 months, 83 (9%) patients died. Deaths were attributed to causes related to SS (27 patients), cardiovascular disease (20 patients), infections (17 patients), and other causes (11 patients). The cause of death was unknown in eight patients.
The active ESSDAI domains that were associated with death were the constitutional (HR, 2.66; 95% CI, 1.38-5.11), pulmonary (HR, 2.13; 95% CI, 1.09-4.16), and biologic (HR, 3.01; 95% CI, 1.91-4.76), with the pulmonary and biologic domains being independently associated with death.
Further analysis revealed that a score of one or greater in the constitutional, lymphadenopathy, hematologic, and biologic domains was predictive of death related to SS (HRs ranging from 2.59 to 7.88), while activity at the constitutional, cutaneous, pulmonary, renal, neurologic, and hematologic domains predicted mortality related to infection (HRs ranging from 3.7 to 9.29). The investigators found no associations between activity in specific ESSDAI domains and death from cardiovascular disease or other causes.
"Activity of constitutional and lymphadenopathy domains, closely related to lymphoma, correlated with death caused by SS itself, while activity in the main extraglandular sites of involvement (in which high doses of corticosteroids and immunosuppressive agents are used) correlated principally with death caused by infection," Dr. Brito Zerón said. "ESSDAI is a useful tool to score systemic activity in patients with primary SS not only in prospective studies, but also in clinical trials that evaluate the efficacy of a specific drug."
Since the analysis of these 921 patients was completed in January 2013, an additional 124 patients with primary SS have joined the cohort. In this larger cohort, baseline ESDAI score of 14 or higher and presence of more than one laboratory marker (lymphopenia, low cryoglobulins, hypocomplementemia, and monoclonal band) both were significantly associated with SS-related death.
Dr. Brito Zerón noted that the investigators have not analyzed whether treatment influenced outcomes in the cohort, but they plan to.
The investigators had no financial disclosures.
The European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index measured at the time of diagnosis predicted the development of lymphoma and death in Spanish patients with severe primary Sjögren’s syndrome in a large, multicenter registry.
"We identified a specific hematological and immunological profile (cytopenias, hypocomplementemia, monoclonal band, and cryoglobulinemia) as laboratory predictors of hematological neoplasia in these patients," said lead study author Dr. Pilar Brito Zerón. "If you have an SS [Sjögren’s syndrome] patient with these features, you have to be very careful because this patient has a higher probability of developing a lymphoma."
"Physicians have had an activity index tool for other diseases for a long time, but there was nothing for SS until recently," when the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) was published in 2010, Dr. Brito Zerón said. "In Spain, we have one of the largest cohorts of SS patients in the world," so it was a good opportunity to test the ESSDAI.
Dr. Brito Zerón of Hospital Clinic in Barcelona and her colleagues studied patient records from the GEAS-SS multicenter registry, a cohort of 921 patients with SS from 20 medical centers in Spain, and retrospectively calculated their 2010 ESSDAI. During a mean follow-up period of 75 months, 25 (3%) of 904 patients developed lymphoproliferative disease; 17 were excluded because they had lymphoma before their primary SS diagnosis. Two-thirds were MALT (mucosa-associated lymphoid tissue) lymphomas, 80% of which were located in the parotid glands.
The investigators found that the following baseline features at diagnosis were most associated with lymphoma development: male gender (hazard ratio [HR], 5.78; 95% confidence interval [CI], 2.14-15.63); cryoglobulins (HR, 4.44; 95% CI, 1.86-10.58); monoclonal serum band (HR, 4.23; 95% CI, 1.38-13.02); C3 values less than 0.82 g/L (HR, 3.75; 95% CI, 1.38-10.19); C4 values less than 0.07 g/L (HR, 3.22, 95% CI, 1.08-9.61); and older age (HR, 1.04; 95% CI, 1.00-1.07). Gender, low C3, monoclonal band, and cryoglobulins were significant independent variables related to lymphoma, Dr. Brito Zerón reported at the annual European Congress of Rheumatology.
An ESSDAI score of one or greater in the constitutional (HR, 4.06; 95% CI, 1.54-10.70) and hematologic (HR, 2.59; 95% CI 1.16-5.78) domains was associated with the development of lymphoma, with hematologic activity being independently associated. In the constitutional domain, patients with the highest degree of activity – including fever greater than 38.5° C, night sweats, and/or involuntary weight loss of at least 10% – showed the highest risk of developing lymphoma (HR, 9.11; 95% CI, 2.51-33.12).
At the time of diagnosis with the 2002 primary SS classification criteria, patients had a mean baseline ESSDAI of 5.81. During follow-up, the patients accumulated another mean 3.34 points for a cumulative ESSADI of 9.15. A large majority of patients were women (94%) and had a mean age of nearly 54 years at the time of diagnosis. Most of the 921 patients in the registry had xerostomia (96%), xerophthalmia (95%), positive ocular tests (93%; 805 of 863), grade 3-4 parotid scintigraphy (88%; 598 of 676), and positive salivary gland biopsy (88%; 424 of 482). Cytopenias occurred in 34% overall, including anemia (17%), leucopenia (20%), and thrombocytopenia (9%). Immunologic disease characteristics of the patients included positive autoantibody tests for antinuclear antibodies (90%), anti-Ro (73%), rheumatoid factor (57%), and anti-La (46%). Others had low C4 (12%) or C3 (9%) levels and low cryoglobulins (12%) or monoclonal gammopathy (9%).
The investigators also correlated the baseline ESSDAI score with mortality. After an average follow-up of 75 months, 83 (9%) patients died. Deaths were attributed to causes related to SS (27 patients), cardiovascular disease (20 patients), infections (17 patients), and other causes (11 patients). The cause of death was unknown in eight patients.
The active ESSDAI domains that were associated with death were the constitutional (HR, 2.66; 95% CI, 1.38-5.11), pulmonary (HR, 2.13; 95% CI, 1.09-4.16), and biologic (HR, 3.01; 95% CI, 1.91-4.76), with the pulmonary and biologic domains being independently associated with death.
Further analysis revealed that a score of one or greater in the constitutional, lymphadenopathy, hematologic, and biologic domains was predictive of death related to SS (HRs ranging from 2.59 to 7.88), while activity at the constitutional, cutaneous, pulmonary, renal, neurologic, and hematologic domains predicted mortality related to infection (HRs ranging from 3.7 to 9.29). The investigators found no associations between activity in specific ESSDAI domains and death from cardiovascular disease or other causes.
"Activity of constitutional and lymphadenopathy domains, closely related to lymphoma, correlated with death caused by SS itself, while activity in the main extraglandular sites of involvement (in which high doses of corticosteroids and immunosuppressive agents are used) correlated principally with death caused by infection," Dr. Brito Zerón said. "ESSDAI is a useful tool to score systemic activity in patients with primary SS not only in prospective studies, but also in clinical trials that evaluate the efficacy of a specific drug."
Since the analysis of these 921 patients was completed in January 2013, an additional 124 patients with primary SS have joined the cohort. In this larger cohort, baseline ESDAI score of 14 or higher and presence of more than one laboratory marker (lymphopenia, low cryoglobulins, hypocomplementemia, and monoclonal band) both were significantly associated with SS-related death.
Dr. Brito Zerón noted that the investigators have not analyzed whether treatment influenced outcomes in the cohort, but they plan to.
The investigators had no financial disclosures.
The European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index measured at the time of diagnosis predicted the development of lymphoma and death in Spanish patients with severe primary Sjögren’s syndrome in a large, multicenter registry.
"We identified a specific hematological and immunological profile (cytopenias, hypocomplementemia, monoclonal band, and cryoglobulinemia) as laboratory predictors of hematological neoplasia in these patients," said lead study author Dr. Pilar Brito Zerón. "If you have an SS [Sjögren’s syndrome] patient with these features, you have to be very careful because this patient has a higher probability of developing a lymphoma."
"Physicians have had an activity index tool for other diseases for a long time, but there was nothing for SS until recently," when the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) was published in 2010, Dr. Brito Zerón said. "In Spain, we have one of the largest cohorts of SS patients in the world," so it was a good opportunity to test the ESSDAI.
Dr. Brito Zerón of Hospital Clinic in Barcelona and her colleagues studied patient records from the GEAS-SS multicenter registry, a cohort of 921 patients with SS from 20 medical centers in Spain, and retrospectively calculated their 2010 ESSDAI. During a mean follow-up period of 75 months, 25 (3%) of 904 patients developed lymphoproliferative disease; 17 were excluded because they had lymphoma before their primary SS diagnosis. Two-thirds were MALT (mucosa-associated lymphoid tissue) lymphomas, 80% of which were located in the parotid glands.
The investigators found that the following baseline features at diagnosis were most associated with lymphoma development: male gender (hazard ratio [HR], 5.78; 95% confidence interval [CI], 2.14-15.63); cryoglobulins (HR, 4.44; 95% CI, 1.86-10.58); monoclonal serum band (HR, 4.23; 95% CI, 1.38-13.02); C3 values less than 0.82 g/L (HR, 3.75; 95% CI, 1.38-10.19); C4 values less than 0.07 g/L (HR, 3.22, 95% CI, 1.08-9.61); and older age (HR, 1.04; 95% CI, 1.00-1.07). Gender, low C3, monoclonal band, and cryoglobulins were significant independent variables related to lymphoma, Dr. Brito Zerón reported at the annual European Congress of Rheumatology.
An ESSDAI score of one or greater in the constitutional (HR, 4.06; 95% CI, 1.54-10.70) and hematologic (HR, 2.59; 95% CI 1.16-5.78) domains was associated with the development of lymphoma, with hematologic activity being independently associated. In the constitutional domain, patients with the highest degree of activity – including fever greater than 38.5° C, night sweats, and/or involuntary weight loss of at least 10% – showed the highest risk of developing lymphoma (HR, 9.11; 95% CI, 2.51-33.12).
At the time of diagnosis with the 2002 primary SS classification criteria, patients had a mean baseline ESSDAI of 5.81. During follow-up, the patients accumulated another mean 3.34 points for a cumulative ESSADI of 9.15. A large majority of patients were women (94%) and had a mean age of nearly 54 years at the time of diagnosis. Most of the 921 patients in the registry had xerostomia (96%), xerophthalmia (95%), positive ocular tests (93%; 805 of 863), grade 3-4 parotid scintigraphy (88%; 598 of 676), and positive salivary gland biopsy (88%; 424 of 482). Cytopenias occurred in 34% overall, including anemia (17%), leucopenia (20%), and thrombocytopenia (9%). Immunologic disease characteristics of the patients included positive autoantibody tests for antinuclear antibodies (90%), anti-Ro (73%), rheumatoid factor (57%), and anti-La (46%). Others had low C4 (12%) or C3 (9%) levels and low cryoglobulins (12%) or monoclonal gammopathy (9%).
The investigators also correlated the baseline ESSDAI score with mortality. After an average follow-up of 75 months, 83 (9%) patients died. Deaths were attributed to causes related to SS (27 patients), cardiovascular disease (20 patients), infections (17 patients), and other causes (11 patients). The cause of death was unknown in eight patients.
The active ESSDAI domains that were associated with death were the constitutional (HR, 2.66; 95% CI, 1.38-5.11), pulmonary (HR, 2.13; 95% CI, 1.09-4.16), and biologic (HR, 3.01; 95% CI, 1.91-4.76), with the pulmonary and biologic domains being independently associated with death.
Further analysis revealed that a score of one or greater in the constitutional, lymphadenopathy, hematologic, and biologic domains was predictive of death related to SS (HRs ranging from 2.59 to 7.88), while activity at the constitutional, cutaneous, pulmonary, renal, neurologic, and hematologic domains predicted mortality related to infection (HRs ranging from 3.7 to 9.29). The investigators found no associations between activity in specific ESSDAI domains and death from cardiovascular disease or other causes.
"Activity of constitutional and lymphadenopathy domains, closely related to lymphoma, correlated with death caused by SS itself, while activity in the main extraglandular sites of involvement (in which high doses of corticosteroids and immunosuppressive agents are used) correlated principally with death caused by infection," Dr. Brito Zerón said. "ESSDAI is a useful tool to score systemic activity in patients with primary SS not only in prospective studies, but also in clinical trials that evaluate the efficacy of a specific drug."
Since the analysis of these 921 patients was completed in January 2013, an additional 124 patients with primary SS have joined the cohort. In this larger cohort, baseline ESDAI score of 14 or higher and presence of more than one laboratory marker (lymphopenia, low cryoglobulins, hypocomplementemia, and monoclonal band) both were significantly associated with SS-related death.
Dr. Brito Zerón noted that the investigators have not analyzed whether treatment influenced outcomes in the cohort, but they plan to.
The investigators had no financial disclosures.
FROM THE EULAR CONGRESS 2014
Key clinical point: Patients with specific hematologic and immunologic laboratory markers, as well as high degrees of activity in the constitutional domain of the ESSDAI, should be monitored closely for the development of lymphoma.
Major finding: Male gender (HR, 5.78; 95% CI, 2.14-15.63); low C3 (HR, 3.75; 95% CI, 1.38-10.19); monoclonal band (HR, 4.23; 95% CI, 1.38-13.02); and cryoglobulins (HR, 4.44; 95% CI, 1.86-10.58) were significant independent variables related to lymphoma.
Data source: A retrospective analysis of 921 Spanish patients with primary Sjögren’s syndrome in the GEAS-SS multicenter registry.
Disclosures: The investigators had no financial disclosures.
Different triggers found for knee and hand OA
Mechanical stress is the most important underlying mechanism in osteoarthritis of the knees, while systemic processes may contribute most to hand osteoarthritis, Dutch researchers have found.
"How obesity results in osteoarthritis [OA] is not quite clear, but several mechanisms are thought to play a role, such as increased mechanical stress and systemic processes that are associated with adipose tissue," said senior study author Dr. Margreet Kloppenburg, professor of rheumatology at Leiden (the Netherlands) University Medical Center.
"Adipose tissue is known to be a source of active mediators, proinflammatory proteins and hormones, influencing inflammation, lipids, glucose metabolism, and insulin resistance," she said. "These systemic processes also could result in the development of OA. Our aim was to understand more about the link between obesity and OA because this insight could help us reach our ultimate goal: to improve treatment for OA patients."
Dr. Kloppenburg and her colleagues reviewed records from 6,628 participants in the Netherlands Epidemiology of Obesity (NEO) study, a population-based cohort of adults aged 45-65 years that is designed to investigate pathways leading to common diseases and conditions in overweight and obese individuals. Participants had a mean age of 56 years and a body mass index of 26 kg/m2; 56% were women. The estimated prevalence of OA was 10% in the knee, 8% in the hand, and 4% in both.
Researchers measured weight and fat mass and calculated fat-free mass. They also calculated odds ratios (ORs) to test for associations between surrogates for mechanical stress (weight and fat-free mass) and systemic processes (metabolic syndrome) with OA in knees alone, hands alone, or both knees and hands. Adjusted ORs were calculated for each OA type in three weight categories: less than 75 kg, 75-90 kg, and more than 90 kg.
After adjustment for metabolic factors, knee OA was significantly associated with weight (OR, 1.49) and fat-free mass (OR, 2.05). Similar results were observed for OA in both the knees and hands. In hand OA, however, investigators found the opposite: Hand OA was significantly associated with metabolic syndrome, independent of weight (OR, 1.46), and had no associations with weight and fat-free mass, Dr. Kloppenburg reported at the annual European Congress of Rheumatology.
"As we hypothesized, knee OA was predominantly associated with surrogates for mechanical stress, whereas hand OA was predominantly associated with surrogates for systemic processes," she said. "But what we had not expected was that surrogates for mechanical stress were predominantly associated with OA in both the knees and hands. This suggests that the co-occurrence of knee and hand OA may not be based on a common underlying pathogenic mechanism, but may represent the presence of two different types of OA."
Adjusted ORs for knee OA and for OA of both the knees and hands were greater in the higher weight categories, but, in hand OA, ORs did not increase with weight.
"Our study supports findings from clinical trials in obese patients with knee OA demonstrating that weight loss, together with exercise, which can potentially modify mechanical stress, is beneficial," she said. "It would be worthwhile to investigate whether weight loss also is beneficial in hand OA."
The NEO study is supported by the Dutch Arthritis Association, Leiden University Medical Center, and Leiden University. The investigators had no conflicts of interest to declare.
Mechanical stress is the most important underlying mechanism in osteoarthritis of the knees, while systemic processes may contribute most to hand osteoarthritis, Dutch researchers have found.
"How obesity results in osteoarthritis [OA] is not quite clear, but several mechanisms are thought to play a role, such as increased mechanical stress and systemic processes that are associated with adipose tissue," said senior study author Dr. Margreet Kloppenburg, professor of rheumatology at Leiden (the Netherlands) University Medical Center.
"Adipose tissue is known to be a source of active mediators, proinflammatory proteins and hormones, influencing inflammation, lipids, glucose metabolism, and insulin resistance," she said. "These systemic processes also could result in the development of OA. Our aim was to understand more about the link between obesity and OA because this insight could help us reach our ultimate goal: to improve treatment for OA patients."
Dr. Kloppenburg and her colleagues reviewed records from 6,628 participants in the Netherlands Epidemiology of Obesity (NEO) study, a population-based cohort of adults aged 45-65 years that is designed to investigate pathways leading to common diseases and conditions in overweight and obese individuals. Participants had a mean age of 56 years and a body mass index of 26 kg/m2; 56% were women. The estimated prevalence of OA was 10% in the knee, 8% in the hand, and 4% in both.
Researchers measured weight and fat mass and calculated fat-free mass. They also calculated odds ratios (ORs) to test for associations between surrogates for mechanical stress (weight and fat-free mass) and systemic processes (metabolic syndrome) with OA in knees alone, hands alone, or both knees and hands. Adjusted ORs were calculated for each OA type in three weight categories: less than 75 kg, 75-90 kg, and more than 90 kg.
After adjustment for metabolic factors, knee OA was significantly associated with weight (OR, 1.49) and fat-free mass (OR, 2.05). Similar results were observed for OA in both the knees and hands. In hand OA, however, investigators found the opposite: Hand OA was significantly associated with metabolic syndrome, independent of weight (OR, 1.46), and had no associations with weight and fat-free mass, Dr. Kloppenburg reported at the annual European Congress of Rheumatology.
"As we hypothesized, knee OA was predominantly associated with surrogates for mechanical stress, whereas hand OA was predominantly associated with surrogates for systemic processes," she said. "But what we had not expected was that surrogates for mechanical stress were predominantly associated with OA in both the knees and hands. This suggests that the co-occurrence of knee and hand OA may not be based on a common underlying pathogenic mechanism, but may represent the presence of two different types of OA."
Adjusted ORs for knee OA and for OA of both the knees and hands were greater in the higher weight categories, but, in hand OA, ORs did not increase with weight.
"Our study supports findings from clinical trials in obese patients with knee OA demonstrating that weight loss, together with exercise, which can potentially modify mechanical stress, is beneficial," she said. "It would be worthwhile to investigate whether weight loss also is beneficial in hand OA."
The NEO study is supported by the Dutch Arthritis Association, Leiden University Medical Center, and Leiden University. The investigators had no conflicts of interest to declare.
Mechanical stress is the most important underlying mechanism in osteoarthritis of the knees, while systemic processes may contribute most to hand osteoarthritis, Dutch researchers have found.
"How obesity results in osteoarthritis [OA] is not quite clear, but several mechanisms are thought to play a role, such as increased mechanical stress and systemic processes that are associated with adipose tissue," said senior study author Dr. Margreet Kloppenburg, professor of rheumatology at Leiden (the Netherlands) University Medical Center.
"Adipose tissue is known to be a source of active mediators, proinflammatory proteins and hormones, influencing inflammation, lipids, glucose metabolism, and insulin resistance," she said. "These systemic processes also could result in the development of OA. Our aim was to understand more about the link between obesity and OA because this insight could help us reach our ultimate goal: to improve treatment for OA patients."
Dr. Kloppenburg and her colleagues reviewed records from 6,628 participants in the Netherlands Epidemiology of Obesity (NEO) study, a population-based cohort of adults aged 45-65 years that is designed to investigate pathways leading to common diseases and conditions in overweight and obese individuals. Participants had a mean age of 56 years and a body mass index of 26 kg/m2; 56% were women. The estimated prevalence of OA was 10% in the knee, 8% in the hand, and 4% in both.
Researchers measured weight and fat mass and calculated fat-free mass. They also calculated odds ratios (ORs) to test for associations between surrogates for mechanical stress (weight and fat-free mass) and systemic processes (metabolic syndrome) with OA in knees alone, hands alone, or both knees and hands. Adjusted ORs were calculated for each OA type in three weight categories: less than 75 kg, 75-90 kg, and more than 90 kg.
After adjustment for metabolic factors, knee OA was significantly associated with weight (OR, 1.49) and fat-free mass (OR, 2.05). Similar results were observed for OA in both the knees and hands. In hand OA, however, investigators found the opposite: Hand OA was significantly associated with metabolic syndrome, independent of weight (OR, 1.46), and had no associations with weight and fat-free mass, Dr. Kloppenburg reported at the annual European Congress of Rheumatology.
"As we hypothesized, knee OA was predominantly associated with surrogates for mechanical stress, whereas hand OA was predominantly associated with surrogates for systemic processes," she said. "But what we had not expected was that surrogates for mechanical stress were predominantly associated with OA in both the knees and hands. This suggests that the co-occurrence of knee and hand OA may not be based on a common underlying pathogenic mechanism, but may represent the presence of two different types of OA."
Adjusted ORs for knee OA and for OA of both the knees and hands were greater in the higher weight categories, but, in hand OA, ORs did not increase with weight.
"Our study supports findings from clinical trials in obese patients with knee OA demonstrating that weight loss, together with exercise, which can potentially modify mechanical stress, is beneficial," she said. "It would be worthwhile to investigate whether weight loss also is beneficial in hand OA."
The NEO study is supported by the Dutch Arthritis Association, Leiden University Medical Center, and Leiden University. The investigators had no conflicts of interest to declare.
FROM THE EULAR CONGRESS 2014
Key clinical point: Weight loss may be a primary target for improving knee OA, but improvements in metabolic factors may most benefit hand OA.
Major finding: Hand OA was significantly associated with metabolic syndrome, independent of weight (OR, 1.46), and knee OA was significantly associated with weight (OR, 1.49) and fat-free mass (OR, 2.05), after adjustment for metabolic factors.
Data source: A population-based study of 6,628 individuals who were monitored for the development of hand or knee OA.
Disclosures: The NEO study is supported by the Dutch Arthritis Association, Leiden University Medical Center, and Leiden University. The investigators had no conflicts of interest to declare.
Sirukumab improves rheumatoid arthritis symptoms in phase II trial
The investigational drug sirukumab significantly improved signs and symptoms of rheumatoid arthritis in a phase II trial of patients who had active disease despite receiving methotrexate.
The multicenter, randomized, placebo-controlled, double-blind study found that the drug, a human anti–interleukin (IL)-6 monoclonal antibody, led to significant improvements in American College of Rheumatology (ACR) criteria 50 and 20 responses, 28-joint count Disease Activity Score using C-reactive protein (DAS28-CRP), and scores on the Health Assessment Questionnaire-disability index (HAQ-DI) and Clinical Disease Activity Index (CDAI), compared with placebo. Of five sirukumab treatment arms in the trial, the most effective dose was 100 mg every 2 weeks.
Differences in ACR20 and ACR50 response rates between the sirukumab groups versus placebo at week 12 in the study "were generally broadly consistent with those achieved with the anti-IL-6 receptor antibodies tocilizumab and sarilumab, and the anti-IL-6 antibody clazakizumab in patients with an inadequate response to prior [methotrexate] therapy," wrote lead investigator Dr. Josef S. Smolen of the Medical University of Vienna and Hietzing Hospital, Vienna, and his colleagues.
In the two-part study, the investigators recruited adults from sites across Europe, North America, and Asia who had active RA despite methotrexate therapy. For the first part, 36 patients were randomized to receive either an injection of 100 mg of sirukumab or placebo every 2 weeks for 10 weeks and then switch to the other regimen for the next 12 weeks. For the second part, 151 patients were randomly assigned to one of five groups: injections of sirukumab at a dose of 100 mg every 2 weeks, 100 mg every 4 weeks, 50 mg every 4 weeks, 25 mg every 4 weeks for 24 weeks, and placebo every 2 weeks for 12 weeks (followed by 100 mg sirukumab every 2 weeks for 12 weeks).
In part 1, patients who received sirukumab at 100 mg every 2 weeks had a "significantly greater mean improvement from baseline to week 12 in DAS28-CRP (2.1 vs. 0.6)" than did those receiving placebo, the investigators said. Patients receiving sirukumab also had significantly greater ACR20 response rates (71% vs. 18%) and greater improvements in HAQ-DI (0.74 vs. 0.17) and CDAI (16.7 vs. 7.2) scores. At 12 weeks, 29% of patients treated with sirukumab achieved ACR50 responses, compared with 6% of patients who received placebo. Clinical responses to the 100-mg dose of sirukumab occurred as early as the second week of the study.
Patients who originally received placebo and were switched to sirukumab quickly achieved a clinical response similar to the patients who originally received the drug. Among patients switched from active drug to placebo, the clinical response lasted through the study’s end.
In part 2 of the study, only the group receiving 100 mg of sirukumab every 2 weeks achieved a statistically significant difference from placebo in ACR50 response rates at 12 weeks (the primary endpoint), occurring in 27% of the drug group versus 3% of the placebo group. ACR20 responses also were significantly higher in the 100-mg sirukumab groups versus placebo.
The authors noted that all four sirukumab groups had "a significantly greater mean improvement in DAS28-CRP at week 12 versus placebo." Six patients receiving 100 mg sirukumab every 2 weeks achieved DAS28-CRP remission versus none on placebo; patients receiving that sirukumab dose also had a greater improvement in CDAI scores (20.7 vs. 13.3).
"This study demonstrates proof-of-concept that IL-6 blockade by sirukumab provides a biologic therapy for RA," the authors wrote (Ann. Rheum. Dis. 2014 April 3 [doi:10.1136/annrheumdis-2013-205137).
Researchers observed decreases in white blood cells, neutrophils, and platelets in all sirukumab groups, generally within 2 weeks of starting treatment.
In part 1, 24 patients before crossover reported at least one adverse effect and 25 reported at least one after crossover. In part 2, 119 patients reported at least one adverse effect. Adverse effects were most often infections such as nasopharyngitis and upper respiratory tract infections. Serious adverse effects, including pneumonia, were reported by 1 patient in part 1 and 17 patients in part 2.
Phase III trials of the drug are ongoing.
This study was supported by Janssen Research & Development (a division of Johnson & Johnson). Three of the five study authors are employees of the study sponsor and own stock in Johnson & Johnson. Dr. Smolen and a coauthor have received grants and/or fees from multiple pharmaceutical companies, including Janssen.
The investigational drug sirukumab significantly improved signs and symptoms of rheumatoid arthritis in a phase II trial of patients who had active disease despite receiving methotrexate.
The multicenter, randomized, placebo-controlled, double-blind study found that the drug, a human anti–interleukin (IL)-6 monoclonal antibody, led to significant improvements in American College of Rheumatology (ACR) criteria 50 and 20 responses, 28-joint count Disease Activity Score using C-reactive protein (DAS28-CRP), and scores on the Health Assessment Questionnaire-disability index (HAQ-DI) and Clinical Disease Activity Index (CDAI), compared with placebo. Of five sirukumab treatment arms in the trial, the most effective dose was 100 mg every 2 weeks.
Differences in ACR20 and ACR50 response rates between the sirukumab groups versus placebo at week 12 in the study "were generally broadly consistent with those achieved with the anti-IL-6 receptor antibodies tocilizumab and sarilumab, and the anti-IL-6 antibody clazakizumab in patients with an inadequate response to prior [methotrexate] therapy," wrote lead investigator Dr. Josef S. Smolen of the Medical University of Vienna and Hietzing Hospital, Vienna, and his colleagues.
In the two-part study, the investigators recruited adults from sites across Europe, North America, and Asia who had active RA despite methotrexate therapy. For the first part, 36 patients were randomized to receive either an injection of 100 mg of sirukumab or placebo every 2 weeks for 10 weeks and then switch to the other regimen for the next 12 weeks. For the second part, 151 patients were randomly assigned to one of five groups: injections of sirukumab at a dose of 100 mg every 2 weeks, 100 mg every 4 weeks, 50 mg every 4 weeks, 25 mg every 4 weeks for 24 weeks, and placebo every 2 weeks for 12 weeks (followed by 100 mg sirukumab every 2 weeks for 12 weeks).
In part 1, patients who received sirukumab at 100 mg every 2 weeks had a "significantly greater mean improvement from baseline to week 12 in DAS28-CRP (2.1 vs. 0.6)" than did those receiving placebo, the investigators said. Patients receiving sirukumab also had significantly greater ACR20 response rates (71% vs. 18%) and greater improvements in HAQ-DI (0.74 vs. 0.17) and CDAI (16.7 vs. 7.2) scores. At 12 weeks, 29% of patients treated with sirukumab achieved ACR50 responses, compared with 6% of patients who received placebo. Clinical responses to the 100-mg dose of sirukumab occurred as early as the second week of the study.
Patients who originally received placebo and were switched to sirukumab quickly achieved a clinical response similar to the patients who originally received the drug. Among patients switched from active drug to placebo, the clinical response lasted through the study’s end.
In part 2 of the study, only the group receiving 100 mg of sirukumab every 2 weeks achieved a statistically significant difference from placebo in ACR50 response rates at 12 weeks (the primary endpoint), occurring in 27% of the drug group versus 3% of the placebo group. ACR20 responses also were significantly higher in the 100-mg sirukumab groups versus placebo.
The authors noted that all four sirukumab groups had "a significantly greater mean improvement in DAS28-CRP at week 12 versus placebo." Six patients receiving 100 mg sirukumab every 2 weeks achieved DAS28-CRP remission versus none on placebo; patients receiving that sirukumab dose also had a greater improvement in CDAI scores (20.7 vs. 13.3).
"This study demonstrates proof-of-concept that IL-6 blockade by sirukumab provides a biologic therapy for RA," the authors wrote (Ann. Rheum. Dis. 2014 April 3 [doi:10.1136/annrheumdis-2013-205137).
Researchers observed decreases in white blood cells, neutrophils, and platelets in all sirukumab groups, generally within 2 weeks of starting treatment.
In part 1, 24 patients before crossover reported at least one adverse effect and 25 reported at least one after crossover. In part 2, 119 patients reported at least one adverse effect. Adverse effects were most often infections such as nasopharyngitis and upper respiratory tract infections. Serious adverse effects, including pneumonia, were reported by 1 patient in part 1 and 17 patients in part 2.
Phase III trials of the drug are ongoing.
This study was supported by Janssen Research & Development (a division of Johnson & Johnson). Three of the five study authors are employees of the study sponsor and own stock in Johnson & Johnson. Dr. Smolen and a coauthor have received grants and/or fees from multiple pharmaceutical companies, including Janssen.
The investigational drug sirukumab significantly improved signs and symptoms of rheumatoid arthritis in a phase II trial of patients who had active disease despite receiving methotrexate.
The multicenter, randomized, placebo-controlled, double-blind study found that the drug, a human anti–interleukin (IL)-6 monoclonal antibody, led to significant improvements in American College of Rheumatology (ACR) criteria 50 and 20 responses, 28-joint count Disease Activity Score using C-reactive protein (DAS28-CRP), and scores on the Health Assessment Questionnaire-disability index (HAQ-DI) and Clinical Disease Activity Index (CDAI), compared with placebo. Of five sirukumab treatment arms in the trial, the most effective dose was 100 mg every 2 weeks.
Differences in ACR20 and ACR50 response rates between the sirukumab groups versus placebo at week 12 in the study "were generally broadly consistent with those achieved with the anti-IL-6 receptor antibodies tocilizumab and sarilumab, and the anti-IL-6 antibody clazakizumab in patients with an inadequate response to prior [methotrexate] therapy," wrote lead investigator Dr. Josef S. Smolen of the Medical University of Vienna and Hietzing Hospital, Vienna, and his colleagues.
In the two-part study, the investigators recruited adults from sites across Europe, North America, and Asia who had active RA despite methotrexate therapy. For the first part, 36 patients were randomized to receive either an injection of 100 mg of sirukumab or placebo every 2 weeks for 10 weeks and then switch to the other regimen for the next 12 weeks. For the second part, 151 patients were randomly assigned to one of five groups: injections of sirukumab at a dose of 100 mg every 2 weeks, 100 mg every 4 weeks, 50 mg every 4 weeks, 25 mg every 4 weeks for 24 weeks, and placebo every 2 weeks for 12 weeks (followed by 100 mg sirukumab every 2 weeks for 12 weeks).
In part 1, patients who received sirukumab at 100 mg every 2 weeks had a "significantly greater mean improvement from baseline to week 12 in DAS28-CRP (2.1 vs. 0.6)" than did those receiving placebo, the investigators said. Patients receiving sirukumab also had significantly greater ACR20 response rates (71% vs. 18%) and greater improvements in HAQ-DI (0.74 vs. 0.17) and CDAI (16.7 vs. 7.2) scores. At 12 weeks, 29% of patients treated with sirukumab achieved ACR50 responses, compared with 6% of patients who received placebo. Clinical responses to the 100-mg dose of sirukumab occurred as early as the second week of the study.
Patients who originally received placebo and were switched to sirukumab quickly achieved a clinical response similar to the patients who originally received the drug. Among patients switched from active drug to placebo, the clinical response lasted through the study’s end.
In part 2 of the study, only the group receiving 100 mg of sirukumab every 2 weeks achieved a statistically significant difference from placebo in ACR50 response rates at 12 weeks (the primary endpoint), occurring in 27% of the drug group versus 3% of the placebo group. ACR20 responses also were significantly higher in the 100-mg sirukumab groups versus placebo.
The authors noted that all four sirukumab groups had "a significantly greater mean improvement in DAS28-CRP at week 12 versus placebo." Six patients receiving 100 mg sirukumab every 2 weeks achieved DAS28-CRP remission versus none on placebo; patients receiving that sirukumab dose also had a greater improvement in CDAI scores (20.7 vs. 13.3).
"This study demonstrates proof-of-concept that IL-6 blockade by sirukumab provides a biologic therapy for RA," the authors wrote (Ann. Rheum. Dis. 2014 April 3 [doi:10.1136/annrheumdis-2013-205137).
Researchers observed decreases in white blood cells, neutrophils, and platelets in all sirukumab groups, generally within 2 weeks of starting treatment.
In part 1, 24 patients before crossover reported at least one adverse effect and 25 reported at least one after crossover. In part 2, 119 patients reported at least one adverse effect. Adverse effects were most often infections such as nasopharyngitis and upper respiratory tract infections. Serious adverse effects, including pneumonia, were reported by 1 patient in part 1 and 17 patients in part 2.
Phase III trials of the drug are ongoing.
This study was supported by Janssen Research & Development (a division of Johnson & Johnson). Three of the five study authors are employees of the study sponsor and own stock in Johnson & Johnson. Dr. Smolen and a coauthor have received grants and/or fees from multiple pharmaceutical companies, including Janssen.
FROM ANNALS OF THE RHEUMATIC DISEASES
Major finding: Sirukumab, an anti–interleukin-6 monoclonal antibody, improves the signs and symptoms of patients with active RA who are receiving methotrexate therapy.
Data source: A multicenter, randomized, placebo-controlled, double-blind phase II trial involving 187 patients.
Disclosures: This study was supported by Janssen Research & Development (a division of Johnson & Johnson). Three of the five study authors are employees of the study sponsor and own stock in Johnson & Johnson. The two lead authors have received grants and/or fees from several pharmaceutical companies, including Janssen.
Schizophrenia patients had less prefrontal lobe gray matter
Schizophrenia patients and their unaffected relatives have smaller volumes of prefrontal lobe gray matter, a new report suggests.
In schizophrenia patients, this finding was associated with worse working memory performance, compared with their unaffected relatives and healthy controls, noted Vina M. Goghari, Ph.D., of the University of Calgary’s Hotchkiss Brain Institute and her colleagues at the University of Minnesota and the Minneapolis Veterans Affairs Health Care System.
The investigators recruited about 30 schizophrenia patients and their nonpsychotic relatives from the Minneapolis VA Medical Center. They completed the Structured Clinical Interview for DSM Disorders (SCID) and the psychosis module of the Diagnostic Interview for Genetic Studies (DIGS) for each participant. They assessed Axis II cluster A traits using the Structured Interview for Schizotypy (SIS) in relatives and a control group of healthy volunteers. The patients’ current symptoms were assessed using the Scale for the Assessment of Negative Symptoms (SANS) and the Scale for the Assessment of Positive Symptoms (SAPS).
Finally, all participants’ psychiatric functioning was assessed using the Brief Psychiatric Rating Scale (BPRS).
After noting the participants’ medication use, Dr. Goghari and her colleagues found that schizophrenia patients tended to be on more antidepressants and other psychiatric medications, compared with controls. Relatives were more likely to be on more antidepressants, compared with controls (Schizophr. Res. 2014;153:113-21).
The researchers used structural MRI (a standard MP-RAGE sequence) to study the brains of 24 schizophrenia patients, 21 nonpsychotic relatives of schizophrenia patients, and 37 control subjects. A Freesurfer image analysis suite was used to better measure volumetric segmentation, cortical reconstruction, and cortical and subcortical parcels.
Researchers also gave participants (30 schizophrenia patients, 25 nonpsychotic relatives, and 30 controls) a spatial working memory task with maintenance and maintenance/manipulation sections. For the maintenance condition, "participants were asked to remember the location of three filled circles and, after a delay, respond whether a second set of three circles was a spatial match or not." In the manipulation condition, "participants were asked to mentally mirror flip/rotate an initial image consisting of three filled circles, and after a delay respond if a second set of circles was a mirror flip or not."
Analyses revealed that "both schizophrenic patients and their nonpsychotic relatives had less bilateral superior frontal gray matter, compared to controls." However, in the working memory test, schizophrenia patients performed less accurately than did their relatives and the controls, indicating that "nonpsychotic relatives may rely on compensatory brain mechanisms that preserve working memory performance."
In developing novel pharmacological and cognitive interventions, "family members may serve as a sample to investigate neural and behavioral compensatory mechanisms that lead to intact executive control," the authors said.
The study was funded by the University of Minnesota, the Natural Sciences and Engineering Research Council of Canada, the University of Calgary, the Canadian Institutes of Health, the U.S. Department of Veterans Affairs, and the U.S. National Institutes of Health. The authors reported no relevant financial conflicts of interest.
Schizophrenia patients and their unaffected relatives have smaller volumes of prefrontal lobe gray matter, a new report suggests.
In schizophrenia patients, this finding was associated with worse working memory performance, compared with their unaffected relatives and healthy controls, noted Vina M. Goghari, Ph.D., of the University of Calgary’s Hotchkiss Brain Institute and her colleagues at the University of Minnesota and the Minneapolis Veterans Affairs Health Care System.
The investigators recruited about 30 schizophrenia patients and their nonpsychotic relatives from the Minneapolis VA Medical Center. They completed the Structured Clinical Interview for DSM Disorders (SCID) and the psychosis module of the Diagnostic Interview for Genetic Studies (DIGS) for each participant. They assessed Axis II cluster A traits using the Structured Interview for Schizotypy (SIS) in relatives and a control group of healthy volunteers. The patients’ current symptoms were assessed using the Scale for the Assessment of Negative Symptoms (SANS) and the Scale for the Assessment of Positive Symptoms (SAPS).
Finally, all participants’ psychiatric functioning was assessed using the Brief Psychiatric Rating Scale (BPRS).
After noting the participants’ medication use, Dr. Goghari and her colleagues found that schizophrenia patients tended to be on more antidepressants and other psychiatric medications, compared with controls. Relatives were more likely to be on more antidepressants, compared with controls (Schizophr. Res. 2014;153:113-21).
The researchers used structural MRI (a standard MP-RAGE sequence) to study the brains of 24 schizophrenia patients, 21 nonpsychotic relatives of schizophrenia patients, and 37 control subjects. A Freesurfer image analysis suite was used to better measure volumetric segmentation, cortical reconstruction, and cortical and subcortical parcels.
Researchers also gave participants (30 schizophrenia patients, 25 nonpsychotic relatives, and 30 controls) a spatial working memory task with maintenance and maintenance/manipulation sections. For the maintenance condition, "participants were asked to remember the location of three filled circles and, after a delay, respond whether a second set of three circles was a spatial match or not." In the manipulation condition, "participants were asked to mentally mirror flip/rotate an initial image consisting of three filled circles, and after a delay respond if a second set of circles was a mirror flip or not."
Analyses revealed that "both schizophrenic patients and their nonpsychotic relatives had less bilateral superior frontal gray matter, compared to controls." However, in the working memory test, schizophrenia patients performed less accurately than did their relatives and the controls, indicating that "nonpsychotic relatives may rely on compensatory brain mechanisms that preserve working memory performance."
In developing novel pharmacological and cognitive interventions, "family members may serve as a sample to investigate neural and behavioral compensatory mechanisms that lead to intact executive control," the authors said.
The study was funded by the University of Minnesota, the Natural Sciences and Engineering Research Council of Canada, the University of Calgary, the Canadian Institutes of Health, the U.S. Department of Veterans Affairs, and the U.S. National Institutes of Health. The authors reported no relevant financial conflicts of interest.
Schizophrenia patients and their unaffected relatives have smaller volumes of prefrontal lobe gray matter, a new report suggests.
In schizophrenia patients, this finding was associated with worse working memory performance, compared with their unaffected relatives and healthy controls, noted Vina M. Goghari, Ph.D., of the University of Calgary’s Hotchkiss Brain Institute and her colleagues at the University of Minnesota and the Minneapolis Veterans Affairs Health Care System.
The investigators recruited about 30 schizophrenia patients and their nonpsychotic relatives from the Minneapolis VA Medical Center. They completed the Structured Clinical Interview for DSM Disorders (SCID) and the psychosis module of the Diagnostic Interview for Genetic Studies (DIGS) for each participant. They assessed Axis II cluster A traits using the Structured Interview for Schizotypy (SIS) in relatives and a control group of healthy volunteers. The patients’ current symptoms were assessed using the Scale for the Assessment of Negative Symptoms (SANS) and the Scale for the Assessment of Positive Symptoms (SAPS).
Finally, all participants’ psychiatric functioning was assessed using the Brief Psychiatric Rating Scale (BPRS).
After noting the participants’ medication use, Dr. Goghari and her colleagues found that schizophrenia patients tended to be on more antidepressants and other psychiatric medications, compared with controls. Relatives were more likely to be on more antidepressants, compared with controls (Schizophr. Res. 2014;153:113-21).
The researchers used structural MRI (a standard MP-RAGE sequence) to study the brains of 24 schizophrenia patients, 21 nonpsychotic relatives of schizophrenia patients, and 37 control subjects. A Freesurfer image analysis suite was used to better measure volumetric segmentation, cortical reconstruction, and cortical and subcortical parcels.
Researchers also gave participants (30 schizophrenia patients, 25 nonpsychotic relatives, and 30 controls) a spatial working memory task with maintenance and maintenance/manipulation sections. For the maintenance condition, "participants were asked to remember the location of three filled circles and, after a delay, respond whether a second set of three circles was a spatial match or not." In the manipulation condition, "participants were asked to mentally mirror flip/rotate an initial image consisting of three filled circles, and after a delay respond if a second set of circles was a mirror flip or not."
Analyses revealed that "both schizophrenic patients and their nonpsychotic relatives had less bilateral superior frontal gray matter, compared to controls." However, in the working memory test, schizophrenia patients performed less accurately than did their relatives and the controls, indicating that "nonpsychotic relatives may rely on compensatory brain mechanisms that preserve working memory performance."
In developing novel pharmacological and cognitive interventions, "family members may serve as a sample to investigate neural and behavioral compensatory mechanisms that lead to intact executive control," the authors said.
The study was funded by the University of Minnesota, the Natural Sciences and Engineering Research Council of Canada, the University of Calgary, the Canadian Institutes of Health, the U.S. Department of Veterans Affairs, and the U.S. National Institutes of Health. The authors reported no relevant financial conflicts of interest.
FROM SCHIZOPHRENIA RESEARCH
Major finding: Schizophrenia patients had smaller volumes of prefrontal gray matter and performed poorly on tests of spatial working memory.
Data source: A study of structural MRI scans and spatial working memory tests in a sample of about 30 schizophrenia patients, their unaffected relatives, and healthy volunteers.
Disclosures: The study was funded by the University of Minnesota, the Natural Sciences and Engineering Research Council of Canada, the University of Calgary, the Canadian Institutes of Health, the U.S. Department of Veterans Affairs, and the U.S. National Institutes of Health. The authors reported no relevant financial conflicts of interest.
Treatment Decisions Complex for Pregnant, Postpartum Women With Bipolar Disorder
The clinical features of perinatal women with bipolar disorder are much more severe than those of women seeking care for other psychiatric conditions, including greater history of suicidal behavior and substance abuse, and more difficulties during childbirth and while breastfeeding, a retrospective study of 334 pregnant and postpartum women suggests.
Cynthia L. Battle, Ph.D., of Butler Hospital in Providence, R.I., and her colleagues reviewed the clinical records of the women, who sought treatment at a specialized partial hospitalization program that serves patients during pregnancy and the first postpartum year. Their ages ranged from 15 to 43 years, and they came from a range of ethnic backgrounds. Less than half of the women in the sample were either married or had partners (J. Affect. Disord. 2014;158:97-100). Two-thirds were postpartum, and one-third of them were pregnant.
The investigators asked the patients to complete the Edinburgh Postnatal Depression Scale and the facility’s Day Hospital Screener for self-reporting of psychiatric disorders, including bipolar disorder.
About 10% of women had a bipolar disorder diagnosis, including 19 with bipolar I disorder, 10 with bipolar II disorder, and 5 with bipolar not otherwise specified. Twenty-six percent reported bipolar disorder symptoms of elation, and 76% reported symptoms of irritability lasting 4 or more days within the previous month.
"Pregnant and postpartum women with [bipolar disorder] reported more extensive mental health histories, including prior use of pharmacotherapy and psychotherapy, as well as higher rates of prior substance abuse," the authors noted. Women with bipolar disorder were significantly more likely than those with other Axis I disorders to report prior suicidal behavior and attempts. A higher proportion of expectant mothers with bipolar disorder took psychotropics than did pregnant women with other disorders. Among postpartum women, mothers with bipolar disorder were more likely to report delivery complications and difficulties breastfeeding their babies.
Although analyses were limited to data recorded in the charts, the current findings "shed light on the clinical and demographic features associated with perinatal bipolar disorder," including a high level of functional impairment experienced by these women, the authors wrote. The high level of self-reported symptoms of elation and irritability "underscore the importance of consistently assessing for mania and hypomania during pregnancy and postpartum."
While bipolar disorder guidelines recommend maintenance pharmacotherapy and adjunctive psychotherapy, the authors say, "tailored psychosocial interventions have not yet been developed for this population. ... Patient-centered decision support and development of tailored adjunctive psychotherapies for perinatal [bipolar disorder] may play a key role in helping women with [bipolar disorder] remain engaged in treatment during pregnancy and postpartum."
Dr. Battle and her colleagues noted several limitations of the study. For example, because the methodology used was retrospective, their analyses were limited to data that had been recorded in the charts.
This study was unfunded; one author was supported in part through a National Institutes of Health mentored career development award. The authors reported no relevant financial conflicts of interest.
The clinical features of perinatal women with bipolar disorder are much more severe than those of women seeking care for other psychiatric conditions, including greater history of suicidal behavior and substance abuse, and more difficulties during childbirth and while breastfeeding, a retrospective study of 334 pregnant and postpartum women suggests.
Cynthia L. Battle, Ph.D., of Butler Hospital in Providence, R.I., and her colleagues reviewed the clinical records of the women, who sought treatment at a specialized partial hospitalization program that serves patients during pregnancy and the first postpartum year. Their ages ranged from 15 to 43 years, and they came from a range of ethnic backgrounds. Less than half of the women in the sample were either married or had partners (J. Affect. Disord. 2014;158:97-100). Two-thirds were postpartum, and one-third of them were pregnant.
The investigators asked the patients to complete the Edinburgh Postnatal Depression Scale and the facility’s Day Hospital Screener for self-reporting of psychiatric disorders, including bipolar disorder.
About 10% of women had a bipolar disorder diagnosis, including 19 with bipolar I disorder, 10 with bipolar II disorder, and 5 with bipolar not otherwise specified. Twenty-six percent reported bipolar disorder symptoms of elation, and 76% reported symptoms of irritability lasting 4 or more days within the previous month.
"Pregnant and postpartum women with [bipolar disorder] reported more extensive mental health histories, including prior use of pharmacotherapy and psychotherapy, as well as higher rates of prior substance abuse," the authors noted. Women with bipolar disorder were significantly more likely than those with other Axis I disorders to report prior suicidal behavior and attempts. A higher proportion of expectant mothers with bipolar disorder took psychotropics than did pregnant women with other disorders. Among postpartum women, mothers with bipolar disorder were more likely to report delivery complications and difficulties breastfeeding their babies.
Although analyses were limited to data recorded in the charts, the current findings "shed light on the clinical and demographic features associated with perinatal bipolar disorder," including a high level of functional impairment experienced by these women, the authors wrote. The high level of self-reported symptoms of elation and irritability "underscore the importance of consistently assessing for mania and hypomania during pregnancy and postpartum."
While bipolar disorder guidelines recommend maintenance pharmacotherapy and adjunctive psychotherapy, the authors say, "tailored psychosocial interventions have not yet been developed for this population. ... Patient-centered decision support and development of tailored adjunctive psychotherapies for perinatal [bipolar disorder] may play a key role in helping women with [bipolar disorder] remain engaged in treatment during pregnancy and postpartum."
Dr. Battle and her colleagues noted several limitations of the study. For example, because the methodology used was retrospective, their analyses were limited to data that had been recorded in the charts.
This study was unfunded; one author was supported in part through a National Institutes of Health mentored career development award. The authors reported no relevant financial conflicts of interest.
The clinical features of perinatal women with bipolar disorder are much more severe than those of women seeking care for other psychiatric conditions, including greater history of suicidal behavior and substance abuse, and more difficulties during childbirth and while breastfeeding, a retrospective study of 334 pregnant and postpartum women suggests.
Cynthia L. Battle, Ph.D., of Butler Hospital in Providence, R.I., and her colleagues reviewed the clinical records of the women, who sought treatment at a specialized partial hospitalization program that serves patients during pregnancy and the first postpartum year. Their ages ranged from 15 to 43 years, and they came from a range of ethnic backgrounds. Less than half of the women in the sample were either married or had partners (J. Affect. Disord. 2014;158:97-100). Two-thirds were postpartum, and one-third of them were pregnant.
The investigators asked the patients to complete the Edinburgh Postnatal Depression Scale and the facility’s Day Hospital Screener for self-reporting of psychiatric disorders, including bipolar disorder.
About 10% of women had a bipolar disorder diagnosis, including 19 with bipolar I disorder, 10 with bipolar II disorder, and 5 with bipolar not otherwise specified. Twenty-six percent reported bipolar disorder symptoms of elation, and 76% reported symptoms of irritability lasting 4 or more days within the previous month.
"Pregnant and postpartum women with [bipolar disorder] reported more extensive mental health histories, including prior use of pharmacotherapy and psychotherapy, as well as higher rates of prior substance abuse," the authors noted. Women with bipolar disorder were significantly more likely than those with other Axis I disorders to report prior suicidal behavior and attempts. A higher proportion of expectant mothers with bipolar disorder took psychotropics than did pregnant women with other disorders. Among postpartum women, mothers with bipolar disorder were more likely to report delivery complications and difficulties breastfeeding their babies.
Although analyses were limited to data recorded in the charts, the current findings "shed light on the clinical and demographic features associated with perinatal bipolar disorder," including a high level of functional impairment experienced by these women, the authors wrote. The high level of self-reported symptoms of elation and irritability "underscore the importance of consistently assessing for mania and hypomania during pregnancy and postpartum."
While bipolar disorder guidelines recommend maintenance pharmacotherapy and adjunctive psychotherapy, the authors say, "tailored psychosocial interventions have not yet been developed for this population. ... Patient-centered decision support and development of tailored adjunctive psychotherapies for perinatal [bipolar disorder] may play a key role in helping women with [bipolar disorder] remain engaged in treatment during pregnancy and postpartum."
Dr. Battle and her colleagues noted several limitations of the study. For example, because the methodology used was retrospective, their analyses were limited to data that had been recorded in the charts.
This study was unfunded; one author was supported in part through a National Institutes of Health mentored career development award. The authors reported no relevant financial conflicts of interest.
FROM JOURNAL OF AFFECTIVE DISORDERS
Treatment decisions complex for pregnant, postpartum women with bipolar disorder
The clinical features of perinatal women with bipolar disorder are much more severe than those of women seeking care for other psychiatric conditions, including greater history of suicidal behavior and substance abuse, and more difficulties during childbirth and while breastfeeding, a retrospective study of 334 pregnant and postpartum women suggests.
Cynthia L. Battle, Ph.D., of Butler Hospital in Providence, R.I., and her colleagues reviewed the clinical records of the women, who sought treatment at a specialized partial hospitalization program that serves patients during pregnancy and the first postpartum year. Their ages ranged from 15 to 43 years, and they came from a range of ethnic backgrounds. Less than half of the women in the sample were either married or had partners (J. Affect. Disord. 2014;158:97-100). Two-thirds were postpartum, and one-third of them were pregnant.
The investigators asked the patients to complete the Edinburgh Postnatal Depression Scale and the facility’s Day Hospital Screener for self-reporting of psychiatric disorders, including bipolar disorder.
About 10% of women had a bipolar disorder diagnosis, including 19 with bipolar I disorder, 10 with bipolar II disorder, and 5 with bipolar not otherwise specified. Twenty-six percent reported bipolar disorder symptoms of elation, and 76% reported symptoms of irritability lasting 4 or more days within the previous month.
"Pregnant and postpartum women with [bipolar disorder] reported more extensive mental health histories, including prior use of pharmacotherapy and psychotherapy, as well as higher rates of prior substance abuse," the authors noted. Women with bipolar disorder were significantly more likely than those with other Axis I disorders to report prior suicidal behavior and attempts. A higher proportion of expectant mothers with bipolar disorder took psychotropics than did pregnant women with other disorders. Among postpartum women, mothers with bipolar disorder were more likely to report delivery complications and difficulties breastfeeding their babies.
Although analyses were limited to data recorded in the charts, the current findings "shed light on the clinical and demographic features associated with perinatal bipolar disorder," including a high level of functional impairment experienced by these women, the authors wrote. The high level of self-reported symptoms of elation and irritability "underscore the importance of consistently assessing for mania and hypomania during pregnancy and postpartum."
While bipolar disorder guidelines recommend maintenance pharmacotherapy and adjunctive psychotherapy, the authors say, "tailored psychosocial interventions have not yet been developed for this population. ... Patient-centered decision support and development of tailored adjunctive psychotherapies for perinatal [bipolar disorder] may play a key role in helping women with [bipolar disorder] remain engaged in treatment during pregnancy and postpartum."
Dr. Battle and her colleagues noted several limitations of the study. For example, because the methodology used was retrospective, their analyses were limited to data that had been recorded in the charts.
This study was unfunded; one author was supported in part through a National Institutes of Health mentored career development award. The authors reported no relevant financial conflicts of interest.
The clinical features of perinatal women with bipolar disorder are much more severe than those of women seeking care for other psychiatric conditions, including greater history of suicidal behavior and substance abuse, and more difficulties during childbirth and while breastfeeding, a retrospective study of 334 pregnant and postpartum women suggests.
Cynthia L. Battle, Ph.D., of Butler Hospital in Providence, R.I., and her colleagues reviewed the clinical records of the women, who sought treatment at a specialized partial hospitalization program that serves patients during pregnancy and the first postpartum year. Their ages ranged from 15 to 43 years, and they came from a range of ethnic backgrounds. Less than half of the women in the sample were either married or had partners (J. Affect. Disord. 2014;158:97-100). Two-thirds were postpartum, and one-third of them were pregnant.
The investigators asked the patients to complete the Edinburgh Postnatal Depression Scale and the facility’s Day Hospital Screener for self-reporting of psychiatric disorders, including bipolar disorder.
About 10% of women had a bipolar disorder diagnosis, including 19 with bipolar I disorder, 10 with bipolar II disorder, and 5 with bipolar not otherwise specified. Twenty-six percent reported bipolar disorder symptoms of elation, and 76% reported symptoms of irritability lasting 4 or more days within the previous month.
"Pregnant and postpartum women with [bipolar disorder] reported more extensive mental health histories, including prior use of pharmacotherapy and psychotherapy, as well as higher rates of prior substance abuse," the authors noted. Women with bipolar disorder were significantly more likely than those with other Axis I disorders to report prior suicidal behavior and attempts. A higher proportion of expectant mothers with bipolar disorder took psychotropics than did pregnant women with other disorders. Among postpartum women, mothers with bipolar disorder were more likely to report delivery complications and difficulties breastfeeding their babies.
Although analyses were limited to data recorded in the charts, the current findings "shed light on the clinical and demographic features associated with perinatal bipolar disorder," including a high level of functional impairment experienced by these women, the authors wrote. The high level of self-reported symptoms of elation and irritability "underscore the importance of consistently assessing for mania and hypomania during pregnancy and postpartum."
While bipolar disorder guidelines recommend maintenance pharmacotherapy and adjunctive psychotherapy, the authors say, "tailored psychosocial interventions have not yet been developed for this population. ... Patient-centered decision support and development of tailored adjunctive psychotherapies for perinatal [bipolar disorder] may play a key role in helping women with [bipolar disorder] remain engaged in treatment during pregnancy and postpartum."
Dr. Battle and her colleagues noted several limitations of the study. For example, because the methodology used was retrospective, their analyses were limited to data that had been recorded in the charts.
This study was unfunded; one author was supported in part through a National Institutes of Health mentored career development award. The authors reported no relevant financial conflicts of interest.
The clinical features of perinatal women with bipolar disorder are much more severe than those of women seeking care for other psychiatric conditions, including greater history of suicidal behavior and substance abuse, and more difficulties during childbirth and while breastfeeding, a retrospective study of 334 pregnant and postpartum women suggests.
Cynthia L. Battle, Ph.D., of Butler Hospital in Providence, R.I., and her colleagues reviewed the clinical records of the women, who sought treatment at a specialized partial hospitalization program that serves patients during pregnancy and the first postpartum year. Their ages ranged from 15 to 43 years, and they came from a range of ethnic backgrounds. Less than half of the women in the sample were either married or had partners (J. Affect. Disord. 2014;158:97-100). Two-thirds were postpartum, and one-third of them were pregnant.
The investigators asked the patients to complete the Edinburgh Postnatal Depression Scale and the facility’s Day Hospital Screener for self-reporting of psychiatric disorders, including bipolar disorder.
About 10% of women had a bipolar disorder diagnosis, including 19 with bipolar I disorder, 10 with bipolar II disorder, and 5 with bipolar not otherwise specified. Twenty-six percent reported bipolar disorder symptoms of elation, and 76% reported symptoms of irritability lasting 4 or more days within the previous month.
"Pregnant and postpartum women with [bipolar disorder] reported more extensive mental health histories, including prior use of pharmacotherapy and psychotherapy, as well as higher rates of prior substance abuse," the authors noted. Women with bipolar disorder were significantly more likely than those with other Axis I disorders to report prior suicidal behavior and attempts. A higher proportion of expectant mothers with bipolar disorder took psychotropics than did pregnant women with other disorders. Among postpartum women, mothers with bipolar disorder were more likely to report delivery complications and difficulties breastfeeding their babies.
Although analyses were limited to data recorded in the charts, the current findings "shed light on the clinical and demographic features associated with perinatal bipolar disorder," including a high level of functional impairment experienced by these women, the authors wrote. The high level of self-reported symptoms of elation and irritability "underscore the importance of consistently assessing for mania and hypomania during pregnancy and postpartum."
While bipolar disorder guidelines recommend maintenance pharmacotherapy and adjunctive psychotherapy, the authors say, "tailored psychosocial interventions have not yet been developed for this population. ... Patient-centered decision support and development of tailored adjunctive psychotherapies for perinatal [bipolar disorder] may play a key role in helping women with [bipolar disorder] remain engaged in treatment during pregnancy and postpartum."
Dr. Battle and her colleagues noted several limitations of the study. For example, because the methodology used was retrospective, their analyses were limited to data that had been recorded in the charts.
This study was unfunded; one author was supported in part through a National Institutes of Health mentored career development award. The authors reported no relevant financial conflicts of interest.
FROM JOURNAL OF AFFECTIVE DISORDERS
Major finding: Perinatal women with bipolar disorder have a greater history of suicidal behavior and substance abuse, and report more difficulties during delivery and while breastfeeding, than do women with other psychiatric disorders.
Data source: A chart review of 334 women who sought treatment at a specialized partial hospitalization program serving perinatal women with psychiatric conditions. A third of the women were pregnant; two-thirds were postpartum.
Disclosures: This study was unfunded; one author was supported in part through a National Institutes of Health mentored career development award. The authors reported no relevant financial conflicts of interest.
Personal health records help mentally ill patients with comorbidities access medical services
Personal health records can help people with serious mental illnesses and comorbid medical conditions improve the quality of their medical care, according to a randomized trial of 170 patients.
Patients with serious mental illnesses and at least one comorbid medical condition were recruited from a community mental health center by Dr. Benjamin G. Druss, professor and Rosalynn Carter Chair in Mental Health at Emory University in Atlanta, and his colleagues. The mean age of the patients was 49; most (83.5%) were African American and had a mean annual income of less than $7,000. Nearly half had major depression and 28% had schizophrenia. Other patients had schizoaffective disorder, bipolar disorder, or posttraumatic stress disorder. Overall, patients had an average 2.3 comorbid chronic medical diagnoses such as diabetes, hyperlipidemia, and hypertension.
The investigators assigned half of the patients to use of a personal health record (PHR) for a 1-year period and helped patients set them up; the other half did not use PHRs (Am. J. Psychiatry 2014;171:360-8).
Dr. Druss and his colleagues adapted an available PHR system for participants by rewriting elements to a sixth-grade reading level, adding a section on mental health and health goals, adding a mental health advanced directive section listing patient preferences for mental health care, and providing a list of resources such as local grocery stores and health providers in patients’ neighborhoods. They gave participants computer training and set up a computer workstation at the mental health clinic.
Overall, those in the PHR group accessed their PHRs an average of 42 times over the course of the year. The proportion of eligible preventive services received "increased in the PHR group from 24% at baseline to 40% at the 12-month follow-up, compared with a decline in the usual care group from 25% to 18% (P less than .001)." The PHR group had "significantly greater improvements in rates of physical examination (P less than .001), screening (P = .02), vaccination (P less than .001), and education (P less than .001)."
Among 118 patients with cardiometabolic conditions, the proportion of cardiometabolic services received "improved by 2 percentage points in the personal health record group but declined by 11 percentage points in the usual care group, resulting in a significant difference in change between the two groups (P = .003)."
"Having a personal health record resulted in significantly improved quality of medical care and increased use of medical services among patients," Dr. Druss and his colleagues wrote. "Personal health records could provide a relatively low-cost, scalable strategy for improving medical care for patients with comorbid medical and serious mental illnesses."
The limitations cited by Dr. Druss and his colleagues included the study’s focus on patients in one urban community health center. "Further work is needed to establish generalizability to other mental health settings," they wrote. Also, the study focused on those patients who had a regular mental health care provider, which suggests that access issues would need to be addressed for those without a regular source of care before this kind of approach could be broadly implemented.
The study was supported by the Agency for Healthcare Research and Quality. The authors reported no relevant financial conflicts of interest.
Personal health records can help people with serious mental illnesses and comorbid medical conditions improve the quality of their medical care, according to a randomized trial of 170 patients.
Patients with serious mental illnesses and at least one comorbid medical condition were recruited from a community mental health center by Dr. Benjamin G. Druss, professor and Rosalynn Carter Chair in Mental Health at Emory University in Atlanta, and his colleagues. The mean age of the patients was 49; most (83.5%) were African American and had a mean annual income of less than $7,000. Nearly half had major depression and 28% had schizophrenia. Other patients had schizoaffective disorder, bipolar disorder, or posttraumatic stress disorder. Overall, patients had an average 2.3 comorbid chronic medical diagnoses such as diabetes, hyperlipidemia, and hypertension.
The investigators assigned half of the patients to use of a personal health record (PHR) for a 1-year period and helped patients set them up; the other half did not use PHRs (Am. J. Psychiatry 2014;171:360-8).
Dr. Druss and his colleagues adapted an available PHR system for participants by rewriting elements to a sixth-grade reading level, adding a section on mental health and health goals, adding a mental health advanced directive section listing patient preferences for mental health care, and providing a list of resources such as local grocery stores and health providers in patients’ neighborhoods. They gave participants computer training and set up a computer workstation at the mental health clinic.
Overall, those in the PHR group accessed their PHRs an average of 42 times over the course of the year. The proportion of eligible preventive services received "increased in the PHR group from 24% at baseline to 40% at the 12-month follow-up, compared with a decline in the usual care group from 25% to 18% (P less than .001)." The PHR group had "significantly greater improvements in rates of physical examination (P less than .001), screening (P = .02), vaccination (P less than .001), and education (P less than .001)."
Among 118 patients with cardiometabolic conditions, the proportion of cardiometabolic services received "improved by 2 percentage points in the personal health record group but declined by 11 percentage points in the usual care group, resulting in a significant difference in change between the two groups (P = .003)."
"Having a personal health record resulted in significantly improved quality of medical care and increased use of medical services among patients," Dr. Druss and his colleagues wrote. "Personal health records could provide a relatively low-cost, scalable strategy for improving medical care for patients with comorbid medical and serious mental illnesses."
The limitations cited by Dr. Druss and his colleagues included the study’s focus on patients in one urban community health center. "Further work is needed to establish generalizability to other mental health settings," they wrote. Also, the study focused on those patients who had a regular mental health care provider, which suggests that access issues would need to be addressed for those without a regular source of care before this kind of approach could be broadly implemented.
The study was supported by the Agency for Healthcare Research and Quality. The authors reported no relevant financial conflicts of interest.
Personal health records can help people with serious mental illnesses and comorbid medical conditions improve the quality of their medical care, according to a randomized trial of 170 patients.
Patients with serious mental illnesses and at least one comorbid medical condition were recruited from a community mental health center by Dr. Benjamin G. Druss, professor and Rosalynn Carter Chair in Mental Health at Emory University in Atlanta, and his colleagues. The mean age of the patients was 49; most (83.5%) were African American and had a mean annual income of less than $7,000. Nearly half had major depression and 28% had schizophrenia. Other patients had schizoaffective disorder, bipolar disorder, or posttraumatic stress disorder. Overall, patients had an average 2.3 comorbid chronic medical diagnoses such as diabetes, hyperlipidemia, and hypertension.
The investigators assigned half of the patients to use of a personal health record (PHR) for a 1-year period and helped patients set them up; the other half did not use PHRs (Am. J. Psychiatry 2014;171:360-8).
Dr. Druss and his colleagues adapted an available PHR system for participants by rewriting elements to a sixth-grade reading level, adding a section on mental health and health goals, adding a mental health advanced directive section listing patient preferences for mental health care, and providing a list of resources such as local grocery stores and health providers in patients’ neighborhoods. They gave participants computer training and set up a computer workstation at the mental health clinic.
Overall, those in the PHR group accessed their PHRs an average of 42 times over the course of the year. The proportion of eligible preventive services received "increased in the PHR group from 24% at baseline to 40% at the 12-month follow-up, compared with a decline in the usual care group from 25% to 18% (P less than .001)." The PHR group had "significantly greater improvements in rates of physical examination (P less than .001), screening (P = .02), vaccination (P less than .001), and education (P less than .001)."
Among 118 patients with cardiometabolic conditions, the proportion of cardiometabolic services received "improved by 2 percentage points in the personal health record group but declined by 11 percentage points in the usual care group, resulting in a significant difference in change between the two groups (P = .003)."
"Having a personal health record resulted in significantly improved quality of medical care and increased use of medical services among patients," Dr. Druss and his colleagues wrote. "Personal health records could provide a relatively low-cost, scalable strategy for improving medical care for patients with comorbid medical and serious mental illnesses."
The limitations cited by Dr. Druss and his colleagues included the study’s focus on patients in one urban community health center. "Further work is needed to establish generalizability to other mental health settings," they wrote. Also, the study focused on those patients who had a regular mental health care provider, which suggests that access issues would need to be addressed for those without a regular source of care before this kind of approach could be broadly implemented.
The study was supported by the Agency for Healthcare Research and Quality. The authors reported no relevant financial conflicts of interest.
FROM THE AMERICAN JOURNAL OF PSYCHIATRY
Major finding: The proportion of eligible preventive services received increased in the PHR group from 24% at baseline to 40% at the 12-month follow-up, compared with a decline in the usual care group from 25% to 18% (P less than .001). The PHR group had significantly greater improvements in rates of physical examination (P less than .001), screening (P = .02), vaccination (P less than .001), and education (P less than .001)."
Data source: A randomized trial of 170 people with a serious mental disorder and at least one comorbid condition treated at a community mental health center.
Disclosures: The study was supported by the Agency for Healthcare Research and Quality. The authors reported no conflicts of interest.
Overgeneral autobiographical memory is a trait of bipolar I
Overgeneral autobiographical memory – an alteration in the specificity of memory from an individual’s life – is a characteristic of bipolar I disorder and relates to executive function, according to a report published in Comprehensive Psychiatry.
"We found a greater prevalence of overgeneralized [autobiographical memory] in [bipolar disorder] patients compared to healthy controls," wrote lead study author Woo Jung Kim of Yonsei University in Seoul, South Korea, and his associates. "Our results suggest [autobiographical memory] may be a characteristic of [bipolar disorder] along with certain cognitive functions."
The investigators recruited 28 bipolar I disorder patients from inpatient and outpatient clinics at Severance Mental Health Hospital, and 28 healthy age- and sex-matched controls. The patients were between the ages of 20 and 50.The researchers gave all participants the autobiographical memory test (AMT), a word-cuing technique aimed at assessing the degree of specificity of autobiographical memory, and a 2-hour neuropsychological battery to assess general intelligence, attention, verbal memory, verbal fluency, visual memory, and executive functions.
The AMT was adapted to Korean culture, using five positive adjectives (happy, successful, safe, interested, and loved) and five negative adjectives (hurtful, angry, lonely, failed, and dangerous). The words were written on paper cards and shown to participants one at a time, while those administering the test encouraged participants to recall specific memories and describe them in as much detail as possible within 1 minute each.
Each patient was interviewed using the Mini-International Neuropsychiatric Interview. Their residual mania symptoms were assessed using the Young Mania Rating Scale, and their depressive symptoms were assessed by the Montgomery-Asberg Depression Rating Scale. Patients with other medical or psychiatric comorbidities were excluded, as were those with mental retardation or a history of head trauma (Compr. Psychiatry 2014;55:290-7).
The investigators found the total and negative AMT scores to be significantly lower in the patients with bipolar disorder than in healthy controls. For example, among the patients with bipolar disorder, the total autobiographical memory test scores were 3.86 plus or minus 2.85, compared with 5.32 plus or minus 2.57 among the healthy controls. Meanwhile, the negative autobiographical memory test scores were 1.86 plus or minus 1.38 among the patients with bipolar disorder and 2.75 plus or minus 1.40 among the healthy controls.
In addition, the patients with bipolar disorder "tended to report more general and fewer specific positive memories than did the healthy controls, although the difference was not statistically significant." The bipolar disorder group had significantly lower verbal memory, verbal fluency, and visual memory test scores than the healthy controls, but the results of tests for executive function were not different between the groups.
In bipolar disorder patients, the AMT scores correlated significantly with intelligence and perseverative errors. In healthy controls, they correlated with verbal memory and fluency.
The investigators cited several limitations. The sample size was fairly small, but it was similar to that of previous studies of autobiographical memory and bipolar disorder, they said. None of the patients in the study had psychotic symptoms at the time of enrollment, but the investigators did not access the patients’ prior history of such symptoms.
"Future research should investigate the specific [autobiographical memory] neural network in [bipolar disorder] individuals and examine the relationship between [autobiographical memory] and psychosocial functions and quality of life," the authors wrote. This may provide insight into the benefit of additional treatment focusing on overgeneral autobiographical memory in bipolar disorder, they said.
This study was supported by the Korea Healthcare Technology R&D Project of the Ministry of Health & Welfare of the Republic of Korea. The authors reported no relevant financial disclosures.
Overgeneral autobiographical memory – an alteration in the specificity of memory from an individual’s life – is a characteristic of bipolar I disorder and relates to executive function, according to a report published in Comprehensive Psychiatry.
"We found a greater prevalence of overgeneralized [autobiographical memory] in [bipolar disorder] patients compared to healthy controls," wrote lead study author Woo Jung Kim of Yonsei University in Seoul, South Korea, and his associates. "Our results suggest [autobiographical memory] may be a characteristic of [bipolar disorder] along with certain cognitive functions."
The investigators recruited 28 bipolar I disorder patients from inpatient and outpatient clinics at Severance Mental Health Hospital, and 28 healthy age- and sex-matched controls. The patients were between the ages of 20 and 50.The researchers gave all participants the autobiographical memory test (AMT), a word-cuing technique aimed at assessing the degree of specificity of autobiographical memory, and a 2-hour neuropsychological battery to assess general intelligence, attention, verbal memory, verbal fluency, visual memory, and executive functions.
The AMT was adapted to Korean culture, using five positive adjectives (happy, successful, safe, interested, and loved) and five negative adjectives (hurtful, angry, lonely, failed, and dangerous). The words were written on paper cards and shown to participants one at a time, while those administering the test encouraged participants to recall specific memories and describe them in as much detail as possible within 1 minute each.
Each patient was interviewed using the Mini-International Neuropsychiatric Interview. Their residual mania symptoms were assessed using the Young Mania Rating Scale, and their depressive symptoms were assessed by the Montgomery-Asberg Depression Rating Scale. Patients with other medical or psychiatric comorbidities were excluded, as were those with mental retardation or a history of head trauma (Compr. Psychiatry 2014;55:290-7).
The investigators found the total and negative AMT scores to be significantly lower in the patients with bipolar disorder than in healthy controls. For example, among the patients with bipolar disorder, the total autobiographical memory test scores were 3.86 plus or minus 2.85, compared with 5.32 plus or minus 2.57 among the healthy controls. Meanwhile, the negative autobiographical memory test scores were 1.86 plus or minus 1.38 among the patients with bipolar disorder and 2.75 plus or minus 1.40 among the healthy controls.
In addition, the patients with bipolar disorder "tended to report more general and fewer specific positive memories than did the healthy controls, although the difference was not statistically significant." The bipolar disorder group had significantly lower verbal memory, verbal fluency, and visual memory test scores than the healthy controls, but the results of tests for executive function were not different between the groups.
In bipolar disorder patients, the AMT scores correlated significantly with intelligence and perseverative errors. In healthy controls, they correlated with verbal memory and fluency.
The investigators cited several limitations. The sample size was fairly small, but it was similar to that of previous studies of autobiographical memory and bipolar disorder, they said. None of the patients in the study had psychotic symptoms at the time of enrollment, but the investigators did not access the patients’ prior history of such symptoms.
"Future research should investigate the specific [autobiographical memory] neural network in [bipolar disorder] individuals and examine the relationship between [autobiographical memory] and psychosocial functions and quality of life," the authors wrote. This may provide insight into the benefit of additional treatment focusing on overgeneral autobiographical memory in bipolar disorder, they said.
This study was supported by the Korea Healthcare Technology R&D Project of the Ministry of Health & Welfare of the Republic of Korea. The authors reported no relevant financial disclosures.
Overgeneral autobiographical memory – an alteration in the specificity of memory from an individual’s life – is a characteristic of bipolar I disorder and relates to executive function, according to a report published in Comprehensive Psychiatry.
"We found a greater prevalence of overgeneralized [autobiographical memory] in [bipolar disorder] patients compared to healthy controls," wrote lead study author Woo Jung Kim of Yonsei University in Seoul, South Korea, and his associates. "Our results suggest [autobiographical memory] may be a characteristic of [bipolar disorder] along with certain cognitive functions."
The investigators recruited 28 bipolar I disorder patients from inpatient and outpatient clinics at Severance Mental Health Hospital, and 28 healthy age- and sex-matched controls. The patients were between the ages of 20 and 50.The researchers gave all participants the autobiographical memory test (AMT), a word-cuing technique aimed at assessing the degree of specificity of autobiographical memory, and a 2-hour neuropsychological battery to assess general intelligence, attention, verbal memory, verbal fluency, visual memory, and executive functions.
The AMT was adapted to Korean culture, using five positive adjectives (happy, successful, safe, interested, and loved) and five negative adjectives (hurtful, angry, lonely, failed, and dangerous). The words were written on paper cards and shown to participants one at a time, while those administering the test encouraged participants to recall specific memories and describe them in as much detail as possible within 1 minute each.
Each patient was interviewed using the Mini-International Neuropsychiatric Interview. Their residual mania symptoms were assessed using the Young Mania Rating Scale, and their depressive symptoms were assessed by the Montgomery-Asberg Depression Rating Scale. Patients with other medical or psychiatric comorbidities were excluded, as were those with mental retardation or a history of head trauma (Compr. Psychiatry 2014;55:290-7).
The investigators found the total and negative AMT scores to be significantly lower in the patients with bipolar disorder than in healthy controls. For example, among the patients with bipolar disorder, the total autobiographical memory test scores were 3.86 plus or minus 2.85, compared with 5.32 plus or minus 2.57 among the healthy controls. Meanwhile, the negative autobiographical memory test scores were 1.86 plus or minus 1.38 among the patients with bipolar disorder and 2.75 plus or minus 1.40 among the healthy controls.
In addition, the patients with bipolar disorder "tended to report more general and fewer specific positive memories than did the healthy controls, although the difference was not statistically significant." The bipolar disorder group had significantly lower verbal memory, verbal fluency, and visual memory test scores than the healthy controls, but the results of tests for executive function were not different between the groups.
In bipolar disorder patients, the AMT scores correlated significantly with intelligence and perseverative errors. In healthy controls, they correlated with verbal memory and fluency.
The investigators cited several limitations. The sample size was fairly small, but it was similar to that of previous studies of autobiographical memory and bipolar disorder, they said. None of the patients in the study had psychotic symptoms at the time of enrollment, but the investigators did not access the patients’ prior history of such symptoms.
"Future research should investigate the specific [autobiographical memory] neural network in [bipolar disorder] individuals and examine the relationship between [autobiographical memory] and psychosocial functions and quality of life," the authors wrote. This may provide insight into the benefit of additional treatment focusing on overgeneral autobiographical memory in bipolar disorder, they said.
This study was supported by the Korea Healthcare Technology R&D Project of the Ministry of Health & Welfare of the Republic of Korea. The authors reported no relevant financial disclosures.
FROM COMPREHENSIVE PSYCHIATRY
Major finding: Patients with bipolar disorder scored significantly lower on the autobiographical memory test than did healthy controls (3.86 plus or minus 2.85, compared with 5.32 plus or minus 2.57). Overgeneral autobiographical memory is a characteristic of bipolar I disorder and relates to executive function.
Data source: A study of 28 clinically stable bipolar I patients and 28 healthy controls evaluated with an autobiographical memory test and a neuropsychological battery.
Disclosures: This study was supported by the Korea Healthcare Technology R&D Project of the Ministry of Health & Welfare of the Republic of Korea. The authors reported no relevant financial disclosures.