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Long-term advantages may not endure after early tight control in psoriatic arthritis
, based on data from 110 patients in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) study.
In the original study, significantly more adults with psoriatic arthritis (PsA) who were randomized to a tight control, treat-to-target group achieved minimal disease activity criteria after 48 weeks, compared with a standard care group (40% vs. 25%).
“Following exit from this study, we hypothesized that this advantage would translate to a clinical advantage in the medium term,” wrote Laura C. Coates, MBChB, PhD, of the University of Oxford (England) and colleagues.
In a study published in Rheumatology, the researchers examined data from 54 patients in the tight control arm of TICOPA and 56 patients in the standard care arm.
At 5 years after the completion of the TICOPA study, 69% of patients in the tight control group and 76% of patients in the standard care group were considered to be in low disease activity. In addition, methotrexate use after 5 years was similar between the tight control and standard care groups (44% and 54%, respectively) and both groups had reduced methotrexate use since the study’s end.
Overall use of biologic drugs was similar between the tight control and standard care groups after 5 years (54% and 52%, respectively), although overall use of biologics was higher in the tight control group at the end of the original study, compared with the standard care group (33% vs. 9%).
The findings were limited by several factors, notably the lack of intention to continue treatment or observations beyond the end of the original TICOPA study, and the patients’ status at 5 years was based on routine clinician notes with no formal assessment of minimal disease activity or objective measure of disease status, the researchers noted.
However, “this result reflects clinical practice in routine rheumatology care,” and any benefit of early tight control on later disease activity could not be determined, they added.
The current study was funded by the National Institute for Health Research infrastructure at Leeds and Oxford (England). The original TICOPA study was funded by Arthritis Research UK (now called Versus Arthritis) and Pfizer. Some of the investigators disclosed financial relationships with companies that market drugs for PsA.
SOURCE: Coates LC et al. Rheumatology. 2019 Aug 31. doi: 10.1093/rheumatology/kez369.
, based on data from 110 patients in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) study.
In the original study, significantly more adults with psoriatic arthritis (PsA) who were randomized to a tight control, treat-to-target group achieved minimal disease activity criteria after 48 weeks, compared with a standard care group (40% vs. 25%).
“Following exit from this study, we hypothesized that this advantage would translate to a clinical advantage in the medium term,” wrote Laura C. Coates, MBChB, PhD, of the University of Oxford (England) and colleagues.
In a study published in Rheumatology, the researchers examined data from 54 patients in the tight control arm of TICOPA and 56 patients in the standard care arm.
At 5 years after the completion of the TICOPA study, 69% of patients in the tight control group and 76% of patients in the standard care group were considered to be in low disease activity. In addition, methotrexate use after 5 years was similar between the tight control and standard care groups (44% and 54%, respectively) and both groups had reduced methotrexate use since the study’s end.
Overall use of biologic drugs was similar between the tight control and standard care groups after 5 years (54% and 52%, respectively), although overall use of biologics was higher in the tight control group at the end of the original study, compared with the standard care group (33% vs. 9%).
The findings were limited by several factors, notably the lack of intention to continue treatment or observations beyond the end of the original TICOPA study, and the patients’ status at 5 years was based on routine clinician notes with no formal assessment of minimal disease activity or objective measure of disease status, the researchers noted.
However, “this result reflects clinical practice in routine rheumatology care,” and any benefit of early tight control on later disease activity could not be determined, they added.
The current study was funded by the National Institute for Health Research infrastructure at Leeds and Oxford (England). The original TICOPA study was funded by Arthritis Research UK (now called Versus Arthritis) and Pfizer. Some of the investigators disclosed financial relationships with companies that market drugs for PsA.
SOURCE: Coates LC et al. Rheumatology. 2019 Aug 31. doi: 10.1093/rheumatology/kez369.
, based on data from 110 patients in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) study.
In the original study, significantly more adults with psoriatic arthritis (PsA) who were randomized to a tight control, treat-to-target group achieved minimal disease activity criteria after 48 weeks, compared with a standard care group (40% vs. 25%).
“Following exit from this study, we hypothesized that this advantage would translate to a clinical advantage in the medium term,” wrote Laura C. Coates, MBChB, PhD, of the University of Oxford (England) and colleagues.
In a study published in Rheumatology, the researchers examined data from 54 patients in the tight control arm of TICOPA and 56 patients in the standard care arm.
At 5 years after the completion of the TICOPA study, 69% of patients in the tight control group and 76% of patients in the standard care group were considered to be in low disease activity. In addition, methotrexate use after 5 years was similar between the tight control and standard care groups (44% and 54%, respectively) and both groups had reduced methotrexate use since the study’s end.
Overall use of biologic drugs was similar between the tight control and standard care groups after 5 years (54% and 52%, respectively), although overall use of biologics was higher in the tight control group at the end of the original study, compared with the standard care group (33% vs. 9%).
The findings were limited by several factors, notably the lack of intention to continue treatment or observations beyond the end of the original TICOPA study, and the patients’ status at 5 years was based on routine clinician notes with no formal assessment of minimal disease activity or objective measure of disease status, the researchers noted.
However, “this result reflects clinical practice in routine rheumatology care,” and any benefit of early tight control on later disease activity could not be determined, they added.
The current study was funded by the National Institute for Health Research infrastructure at Leeds and Oxford (England). The original TICOPA study was funded by Arthritis Research UK (now called Versus Arthritis) and Pfizer. Some of the investigators disclosed financial relationships with companies that market drugs for PsA.
SOURCE: Coates LC et al. Rheumatology. 2019 Aug 31. doi: 10.1093/rheumatology/kez369.
FROM RHEUMATOLOGY
Key clinical point: Patients in a psoriatic arthritis study comparing tight control and standard care showed no significant difference in disease activity 5 years later.
Major finding: At 5 years after the end of the TICOPA trial, 69% in the tight control group vs. 76% in the standard care group were considered to be in low disease activity.
Study details: The data come from a follow-up of 110 patients from the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) study.
Disclosures: The current study was funded by the National Institute for Health Research infrastructure at Leeds and Oxford (England). The original TICOPA study was funded by Arthritis Research UK (now called Versus Arthritis) and Pfizer. Some of the investigators disclosed financial relationships with companies that market drugs for PsA.
Source: Coates LC et al. Rheumatology. 2019 Aug 31. doi: 10.1093/rheumatology/kez369.
Two uveitis treatment options yield similar success
in an international, multicenter, open-label, randomized trial.
“The findings of this trial have implications for clinical practice because they provide scientific justification that mycophenolate mofetil is not more effective than methotrexate as a corticosteroid-sparing immunosuppressive therapy for uveitis,” wrote S.R. Rathinam, MD, PhD, of Aravind Eye Hospital and Postgraduate Institute of Ophthalmology, Madurai, India, and colleagues.
Although corticosteroid therapy is the first-line treatment for uveitis, adverse effects limit long-term use. Mycophenolate mofetil and methotrexate are options for corticosteroid-sparing immunosuppressive therapy for uveitis, but their effectiveness has not been compared until the current study, they said.
In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) trial published Sept. 10 in JAMA, the researchers randomized 216 adults with uveitis (a total of 407 eyes with uveitis) to 25 mg of weekly oral methotrexate or 1.5 g of twice-daily oral mycophenolate mofetil at nine referral eye care centers in India, the United States, Australia, Saudi Arabia, and Mexico; the investigators were masked to the treatment assignment.
Patients with treatment success continued taking their randomized medication for another 6 months. If treatment failed, patients switched to the other antimetabolite with another 6-month follow-up. Overall, 84%-93% in each group had bilateral uveitis. Forty-six patients (21%) had intermediate uveitis only or anterior uveitis and intermediate uveitis, and 170 patients (79%) had posterior uveitis or panuveitis. The median age of the patients was 36 years in the methotrexate group and 41 years in the mycophenolate group; other demographic characteristics were similar between the groups.
Overall, 64 patients given methotrexate (67%) and 56 of those given mycophenolate (57%) achieved treatment success at 6 months. Treatment success included inflammation control defined as “less than or equal to 0.5+ anterior chamber cells by Standardization of Uveitis Nomenclature criteria, less than or equal to 0.5+ vitreous haze clinical grading using the National Eye Institute scale, and no active retinal or choroidal lesions,” as well as needing no more than 7.5 mg of prednisone daily and two drops or less of prednisolone acetate 1% per day, and reporting no intolerability or safety concerns requiring study discontinuation.
Adverse events were similar between the groups. The most common nonserious adverse events were fatigue and headaches, and the most common nonserious laboratory adverse event was elevated liver enzymes. Fourteen serious adverse events occurred during the study period; three in the methotrexate group and two in the mycophenolate group were deemed drug related and all were elevated liver function tests.
The study findings had several limitations, including lack of masking of the patients to the medication and an inability to compare between types of uveitis, the researchers noted. Avenues for further research include whether one of the drugs is more effective based on the uveitis subtype, they added.
The study was supported in part by the National Eye Institute and study drugs were provided by the University of California San Francisco Pharmacy. Dr. Rathinam disclosed grants from Aravind Eye Hospital, and several coauthors disclosed relationships with AbbVie, Allergan, Novartis, Novotech, and Bayer.
SOURCE: Rathinam SR et al. JAMA. 2019;322(10):936-45. doi: 10.1001/jama.2019.12618.
in an international, multicenter, open-label, randomized trial.
“The findings of this trial have implications for clinical practice because they provide scientific justification that mycophenolate mofetil is not more effective than methotrexate as a corticosteroid-sparing immunosuppressive therapy for uveitis,” wrote S.R. Rathinam, MD, PhD, of Aravind Eye Hospital and Postgraduate Institute of Ophthalmology, Madurai, India, and colleagues.
Although corticosteroid therapy is the first-line treatment for uveitis, adverse effects limit long-term use. Mycophenolate mofetil and methotrexate are options for corticosteroid-sparing immunosuppressive therapy for uveitis, but their effectiveness has not been compared until the current study, they said.
In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) trial published Sept. 10 in JAMA, the researchers randomized 216 adults with uveitis (a total of 407 eyes with uveitis) to 25 mg of weekly oral methotrexate or 1.5 g of twice-daily oral mycophenolate mofetil at nine referral eye care centers in India, the United States, Australia, Saudi Arabia, and Mexico; the investigators were masked to the treatment assignment.
Patients with treatment success continued taking their randomized medication for another 6 months. If treatment failed, patients switched to the other antimetabolite with another 6-month follow-up. Overall, 84%-93% in each group had bilateral uveitis. Forty-six patients (21%) had intermediate uveitis only or anterior uveitis and intermediate uveitis, and 170 patients (79%) had posterior uveitis or panuveitis. The median age of the patients was 36 years in the methotrexate group and 41 years in the mycophenolate group; other demographic characteristics were similar between the groups.
Overall, 64 patients given methotrexate (67%) and 56 of those given mycophenolate (57%) achieved treatment success at 6 months. Treatment success included inflammation control defined as “less than or equal to 0.5+ anterior chamber cells by Standardization of Uveitis Nomenclature criteria, less than or equal to 0.5+ vitreous haze clinical grading using the National Eye Institute scale, and no active retinal or choroidal lesions,” as well as needing no more than 7.5 mg of prednisone daily and two drops or less of prednisolone acetate 1% per day, and reporting no intolerability or safety concerns requiring study discontinuation.
Adverse events were similar between the groups. The most common nonserious adverse events were fatigue and headaches, and the most common nonserious laboratory adverse event was elevated liver enzymes. Fourteen serious adverse events occurred during the study period; three in the methotrexate group and two in the mycophenolate group were deemed drug related and all were elevated liver function tests.
The study findings had several limitations, including lack of masking of the patients to the medication and an inability to compare between types of uveitis, the researchers noted. Avenues for further research include whether one of the drugs is more effective based on the uveitis subtype, they added.
The study was supported in part by the National Eye Institute and study drugs were provided by the University of California San Francisco Pharmacy. Dr. Rathinam disclosed grants from Aravind Eye Hospital, and several coauthors disclosed relationships with AbbVie, Allergan, Novartis, Novotech, and Bayer.
SOURCE: Rathinam SR et al. JAMA. 2019;322(10):936-45. doi: 10.1001/jama.2019.12618.
in an international, multicenter, open-label, randomized trial.
“The findings of this trial have implications for clinical practice because they provide scientific justification that mycophenolate mofetil is not more effective than methotrexate as a corticosteroid-sparing immunosuppressive therapy for uveitis,” wrote S.R. Rathinam, MD, PhD, of Aravind Eye Hospital and Postgraduate Institute of Ophthalmology, Madurai, India, and colleagues.
Although corticosteroid therapy is the first-line treatment for uveitis, adverse effects limit long-term use. Mycophenolate mofetil and methotrexate are options for corticosteroid-sparing immunosuppressive therapy for uveitis, but their effectiveness has not been compared until the current study, they said.
In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) trial published Sept. 10 in JAMA, the researchers randomized 216 adults with uveitis (a total of 407 eyes with uveitis) to 25 mg of weekly oral methotrexate or 1.5 g of twice-daily oral mycophenolate mofetil at nine referral eye care centers in India, the United States, Australia, Saudi Arabia, and Mexico; the investigators were masked to the treatment assignment.
Patients with treatment success continued taking their randomized medication for another 6 months. If treatment failed, patients switched to the other antimetabolite with another 6-month follow-up. Overall, 84%-93% in each group had bilateral uveitis. Forty-six patients (21%) had intermediate uveitis only or anterior uveitis and intermediate uveitis, and 170 patients (79%) had posterior uveitis or panuveitis. The median age of the patients was 36 years in the methotrexate group and 41 years in the mycophenolate group; other demographic characteristics were similar between the groups.
Overall, 64 patients given methotrexate (67%) and 56 of those given mycophenolate (57%) achieved treatment success at 6 months. Treatment success included inflammation control defined as “less than or equal to 0.5+ anterior chamber cells by Standardization of Uveitis Nomenclature criteria, less than or equal to 0.5+ vitreous haze clinical grading using the National Eye Institute scale, and no active retinal or choroidal lesions,” as well as needing no more than 7.5 mg of prednisone daily and two drops or less of prednisolone acetate 1% per day, and reporting no intolerability or safety concerns requiring study discontinuation.
Adverse events were similar between the groups. The most common nonserious adverse events were fatigue and headaches, and the most common nonserious laboratory adverse event was elevated liver enzymes. Fourteen serious adverse events occurred during the study period; three in the methotrexate group and two in the mycophenolate group were deemed drug related and all were elevated liver function tests.
The study findings had several limitations, including lack of masking of the patients to the medication and an inability to compare between types of uveitis, the researchers noted. Avenues for further research include whether one of the drugs is more effective based on the uveitis subtype, they added.
The study was supported in part by the National Eye Institute and study drugs were provided by the University of California San Francisco Pharmacy. Dr. Rathinam disclosed grants from Aravind Eye Hospital, and several coauthors disclosed relationships with AbbVie, Allergan, Novartis, Novotech, and Bayer.
SOURCE: Rathinam SR et al. JAMA. 2019;322(10):936-45. doi: 10.1001/jama.2019.12618.
FROM JAMA
Key clinical point: Mycophenolate mofetil and methotrexate were similar as corticosteroid-sparing treatment in patients with uveitis.
Major finding: Among uveitis patients, 67% of those given methotrexate and 57% of those given mycophenolate achieved corticosteroid-sparing control of inflammation.
Study details: The data come from a randomized trial of 216 adults with noninfectious uveitis at nine referral eye care centers in India, the United States, Australia, Saudi Arabia, and Mexico.
Disclosures: The study was supported in part by the National Eye Institute and study drugs were provided by the University of California San Francisco Pharmacy. Dr. Rathinam disclosed grants from Aravind Eye Hospital, and several coauthors disclosed relationships with AbbVie, Allergan, Novartis, Novotech, and Bayer.
Source: Rathinam SR et al. JAMA. 2019;322(10):936-45. doi: 10.1001/jama.2019.12618.
New evidence supports immune system involvement in hidradenitis suppurativa
Immune dysregulation is a substantial feature of hidradenitis suppurativa in African American patients, according to data from 16 adults.
The etiology of hidradenitis suppurativa (HS) remains unknown, but neutrophils are prominent in affected areas of skin, wrote Angel S. Byrd, MD, PhD, of Johns Hopkins University, Baltimore, and colleagues.
“Among the several functions of neutrophils, these cells have the ability to form neutrophil extracellular traps (NETs) after exposure to certain microbes or sterile stimuli,” the researchers noted. These NETs are weblike structures that have been shown to activate several types of immune responses and promote inflammation.
In a study published in Science Translational Medicine, the researchers analyzed biospecimens from African American HS patients. They determined that NET structures were present in the lesional skin of HS patients, but not in control skin. Additionally, serum from HS patients did not properly degrade healthy control NETs in an in vitro examination.
A significant correlation (P less than .0001) occurred between the amount of NETs released in hidradenitis suppurativa lesions and hidradenitis suppurativa severity.
“Together, these results indicate that NET formation is enhanced in HS, both systemically and in lesional skin, in association with disease severity and that NET degradation mechanisms may be impaired in this disease,” the researchers wrote.
The researchers also found that total immunoglobulin G was significantly increased in the sera of HS patients, compared with that of healthy volunteers (P = .0011), and that enzymes involved in skin citrullination were elevated in the skin of HS patients, compared with controls’ skin.
Previous studies have shown that NETs can promote type I interferon (IFN) signatures in the blood of patients with autoimmune and chronic inflammatory conditions, and in this study, several type I IFN–regulated genes had increased expression in HS skin, including IFI44L, MX1, CXCL10, RSAD2, and IFI27.
The study findings were limited by the small sample size and homogenous population, the researchers noted. Future research should include “the role that neutrophil/type I IFN dysregulation plays in the clinical manifestations of the disease, and how these abnormalities in immune responses regulate other innate and adaptive immune cell types in HS,” which could affect the development of new treatments, they wrote.
The study was supported in part by the National Institutes of Health, the Johns Hopkins School of Medicine Physician Scientist Training Program, and the Danby Hidradenitis Suppurativa Foundation. Dr. Byrd disclosed participating in the Johns Hopkins Ethnic Skin Fellowship, which was supported in part by Valeant. Dr. Byrd also disclosed serving as a former investigator for Eli Lilly.
SOURCE: Byrd AS et al. Sci Transl Med. 2019 Sep 4. doi: 10.1126/scitranslmed.aav5908.
Immune dysregulation is a substantial feature of hidradenitis suppurativa in African American patients, according to data from 16 adults.
The etiology of hidradenitis suppurativa (HS) remains unknown, but neutrophils are prominent in affected areas of skin, wrote Angel S. Byrd, MD, PhD, of Johns Hopkins University, Baltimore, and colleagues.
“Among the several functions of neutrophils, these cells have the ability to form neutrophil extracellular traps (NETs) after exposure to certain microbes or sterile stimuli,” the researchers noted. These NETs are weblike structures that have been shown to activate several types of immune responses and promote inflammation.
In a study published in Science Translational Medicine, the researchers analyzed biospecimens from African American HS patients. They determined that NET structures were present in the lesional skin of HS patients, but not in control skin. Additionally, serum from HS patients did not properly degrade healthy control NETs in an in vitro examination.
A significant correlation (P less than .0001) occurred between the amount of NETs released in hidradenitis suppurativa lesions and hidradenitis suppurativa severity.
“Together, these results indicate that NET formation is enhanced in HS, both systemically and in lesional skin, in association with disease severity and that NET degradation mechanisms may be impaired in this disease,” the researchers wrote.
The researchers also found that total immunoglobulin G was significantly increased in the sera of HS patients, compared with that of healthy volunteers (P = .0011), and that enzymes involved in skin citrullination were elevated in the skin of HS patients, compared with controls’ skin.
Previous studies have shown that NETs can promote type I interferon (IFN) signatures in the blood of patients with autoimmune and chronic inflammatory conditions, and in this study, several type I IFN–regulated genes had increased expression in HS skin, including IFI44L, MX1, CXCL10, RSAD2, and IFI27.
The study findings were limited by the small sample size and homogenous population, the researchers noted. Future research should include “the role that neutrophil/type I IFN dysregulation plays in the clinical manifestations of the disease, and how these abnormalities in immune responses regulate other innate and adaptive immune cell types in HS,” which could affect the development of new treatments, they wrote.
The study was supported in part by the National Institutes of Health, the Johns Hopkins School of Medicine Physician Scientist Training Program, and the Danby Hidradenitis Suppurativa Foundation. Dr. Byrd disclosed participating in the Johns Hopkins Ethnic Skin Fellowship, which was supported in part by Valeant. Dr. Byrd also disclosed serving as a former investigator for Eli Lilly.
SOURCE: Byrd AS et al. Sci Transl Med. 2019 Sep 4. doi: 10.1126/scitranslmed.aav5908.
Immune dysregulation is a substantial feature of hidradenitis suppurativa in African American patients, according to data from 16 adults.
The etiology of hidradenitis suppurativa (HS) remains unknown, but neutrophils are prominent in affected areas of skin, wrote Angel S. Byrd, MD, PhD, of Johns Hopkins University, Baltimore, and colleagues.
“Among the several functions of neutrophils, these cells have the ability to form neutrophil extracellular traps (NETs) after exposure to certain microbes or sterile stimuli,” the researchers noted. These NETs are weblike structures that have been shown to activate several types of immune responses and promote inflammation.
In a study published in Science Translational Medicine, the researchers analyzed biospecimens from African American HS patients. They determined that NET structures were present in the lesional skin of HS patients, but not in control skin. Additionally, serum from HS patients did not properly degrade healthy control NETs in an in vitro examination.
A significant correlation (P less than .0001) occurred between the amount of NETs released in hidradenitis suppurativa lesions and hidradenitis suppurativa severity.
“Together, these results indicate that NET formation is enhanced in HS, both systemically and in lesional skin, in association with disease severity and that NET degradation mechanisms may be impaired in this disease,” the researchers wrote.
The researchers also found that total immunoglobulin G was significantly increased in the sera of HS patients, compared with that of healthy volunteers (P = .0011), and that enzymes involved in skin citrullination were elevated in the skin of HS patients, compared with controls’ skin.
Previous studies have shown that NETs can promote type I interferon (IFN) signatures in the blood of patients with autoimmune and chronic inflammatory conditions, and in this study, several type I IFN–regulated genes had increased expression in HS skin, including IFI44L, MX1, CXCL10, RSAD2, and IFI27.
The study findings were limited by the small sample size and homogenous population, the researchers noted. Future research should include “the role that neutrophil/type I IFN dysregulation plays in the clinical manifestations of the disease, and how these abnormalities in immune responses regulate other innate and adaptive immune cell types in HS,” which could affect the development of new treatments, they wrote.
The study was supported in part by the National Institutes of Health, the Johns Hopkins School of Medicine Physician Scientist Training Program, and the Danby Hidradenitis Suppurativa Foundation. Dr. Byrd disclosed participating in the Johns Hopkins Ethnic Skin Fellowship, which was supported in part by Valeant. Dr. Byrd also disclosed serving as a former investigator for Eli Lilly.
SOURCE: Byrd AS et al. Sci Transl Med. 2019 Sep 4. doi: 10.1126/scitranslmed.aav5908.
FROM SCIENCE TRANSLATIONAL MEDICINE
USPSTF recommends preventive breast cancer medications only for women at risk
Medication to help prevent breast cancer is not recommended for women without increased risk, but could benefit women at increased risk for the disease, according to an update from the U.S. Preventive Services Task Force.
“Although evidence on the best interval at which to reassess risk and indications for risk-reducing medications is not available, a pragmatic approach would be to repeat risk assessment when there is a significant change in breast cancer risk factors; for instance, when a family member is diagnosed with breast cancer or when there is a new diagnosis of atypical hyperplasia or lobular carcinoma in situ on breast biopsy,” wrote Douglas K. Owens, MD, of Stanford (Calif.) University and members of the task force.
The recommendation applies to asymptomatic women aged 35 years and older, including women with a history of benign breast lesions, but does not apply to women with current or previous breast cancer or ductal carcinoma in situ. The recommendation remains essentially unchanged from the 2013 version, with the addition of aromatase inhibitors (AIs) in the list of options for risk-reducing medications.
In an evidence report accompanying the recommendation, researchers reviewed data from 46 studies including 82 articles and more than 5 million individuals. Overall, among 10 placebo-controlled trials, tamoxifen, raloxifene, and AIs were associated with lower incidence of invasive breast cancer, with risk ratios of 0.69, 0.44, and 0.45, respectively.
However, based on the risk of adverse effects including thromboembolic events, endometrial cancer, and cataracts, the task force determined that the benefits of these medications were no greater than small in women with no risk factors. In addition, 18 risk assessments in 25 studies showed low levels of accuracy in predicting breast cancer risk.
Data from the studies reviewed by the USPSTF showed that the harms of AIs included vasomotor symptoms, GI symptoms, musculoskeletal pain, and potential increased risk of cardiovascular events and fractures. Potential harms of other medications to help prevent breast cancer (tamoxifen and raloxifene) included increased risk for venous thromboembolic events, endometrial cancer, cataracts, and hot flashes.
The findings were limited by several factors including possible publication bias, variation in risk assessment studies, and inability to conduct subgroup analysis, wrote Heidi D. Nelson, MD, of Oregon Health & Sciences University, Portland, and colleagues in the evidence report.
“Although most results are consistent with the 2013 USPSTF review, this update provides additional evidence of the inaccuracy of risk assessment methods,” they noted.
“The USPSTF recommendations, and the accompanying systematic evidence review by Nelson and colleagues rightfully focus on the need to identify women for whom the benefits are likely to outweigh harms, but they also underscore persistent uncertainties about how to accomplish that goal,” wrote Lydia E. Pace, MD, and Nancy L. Keating, MD, both of Brigham and Women’s Hospital in Boston, in an accompanying editorial (JAMA. 2019 Sept 3;322:821-23).
“Identifying safer and more effective preventive medications would help mitigate the low discriminatory accuracy of existing breast cancer risk models,” the editorialists wrote. “Meanwhile, considering risk-reducing medications for women with 5-year risk greater than 3% seems reasonable, as well as for women with atypical hyperplasia and [lobular carcinoma in situ].”
The research was funded by the Agency for Healthcare Research and Quality. Neither the task force researchers nor the editorialists reported relevant financial conflicts.
SOURCEs: Owens DK et al. JAMA. 2019 Sept 3. doi: 10.1001/jama.2019.11885; Nelson HD et al. JAMA. 2019 Sept 3. doi: 10.1001/jama.2019.5780.
Medication to help prevent breast cancer is not recommended for women without increased risk, but could benefit women at increased risk for the disease, according to an update from the U.S. Preventive Services Task Force.
“Although evidence on the best interval at which to reassess risk and indications for risk-reducing medications is not available, a pragmatic approach would be to repeat risk assessment when there is a significant change in breast cancer risk factors; for instance, when a family member is diagnosed with breast cancer or when there is a new diagnosis of atypical hyperplasia or lobular carcinoma in situ on breast biopsy,” wrote Douglas K. Owens, MD, of Stanford (Calif.) University and members of the task force.
The recommendation applies to asymptomatic women aged 35 years and older, including women with a history of benign breast lesions, but does not apply to women with current or previous breast cancer or ductal carcinoma in situ. The recommendation remains essentially unchanged from the 2013 version, with the addition of aromatase inhibitors (AIs) in the list of options for risk-reducing medications.
In an evidence report accompanying the recommendation, researchers reviewed data from 46 studies including 82 articles and more than 5 million individuals. Overall, among 10 placebo-controlled trials, tamoxifen, raloxifene, and AIs were associated with lower incidence of invasive breast cancer, with risk ratios of 0.69, 0.44, and 0.45, respectively.
However, based on the risk of adverse effects including thromboembolic events, endometrial cancer, and cataracts, the task force determined that the benefits of these medications were no greater than small in women with no risk factors. In addition, 18 risk assessments in 25 studies showed low levels of accuracy in predicting breast cancer risk.
Data from the studies reviewed by the USPSTF showed that the harms of AIs included vasomotor symptoms, GI symptoms, musculoskeletal pain, and potential increased risk of cardiovascular events and fractures. Potential harms of other medications to help prevent breast cancer (tamoxifen and raloxifene) included increased risk for venous thromboembolic events, endometrial cancer, cataracts, and hot flashes.
The findings were limited by several factors including possible publication bias, variation in risk assessment studies, and inability to conduct subgroup analysis, wrote Heidi D. Nelson, MD, of Oregon Health & Sciences University, Portland, and colleagues in the evidence report.
“Although most results are consistent with the 2013 USPSTF review, this update provides additional evidence of the inaccuracy of risk assessment methods,” they noted.
“The USPSTF recommendations, and the accompanying systematic evidence review by Nelson and colleagues rightfully focus on the need to identify women for whom the benefits are likely to outweigh harms, but they also underscore persistent uncertainties about how to accomplish that goal,” wrote Lydia E. Pace, MD, and Nancy L. Keating, MD, both of Brigham and Women’s Hospital in Boston, in an accompanying editorial (JAMA. 2019 Sept 3;322:821-23).
“Identifying safer and more effective preventive medications would help mitigate the low discriminatory accuracy of existing breast cancer risk models,” the editorialists wrote. “Meanwhile, considering risk-reducing medications for women with 5-year risk greater than 3% seems reasonable, as well as for women with atypical hyperplasia and [lobular carcinoma in situ].”
The research was funded by the Agency for Healthcare Research and Quality. Neither the task force researchers nor the editorialists reported relevant financial conflicts.
SOURCEs: Owens DK et al. JAMA. 2019 Sept 3. doi: 10.1001/jama.2019.11885; Nelson HD et al. JAMA. 2019 Sept 3. doi: 10.1001/jama.2019.5780.
Medication to help prevent breast cancer is not recommended for women without increased risk, but could benefit women at increased risk for the disease, according to an update from the U.S. Preventive Services Task Force.
“Although evidence on the best interval at which to reassess risk and indications for risk-reducing medications is not available, a pragmatic approach would be to repeat risk assessment when there is a significant change in breast cancer risk factors; for instance, when a family member is diagnosed with breast cancer or when there is a new diagnosis of atypical hyperplasia or lobular carcinoma in situ on breast biopsy,” wrote Douglas K. Owens, MD, of Stanford (Calif.) University and members of the task force.
The recommendation applies to asymptomatic women aged 35 years and older, including women with a history of benign breast lesions, but does not apply to women with current or previous breast cancer or ductal carcinoma in situ. The recommendation remains essentially unchanged from the 2013 version, with the addition of aromatase inhibitors (AIs) in the list of options for risk-reducing medications.
In an evidence report accompanying the recommendation, researchers reviewed data from 46 studies including 82 articles and more than 5 million individuals. Overall, among 10 placebo-controlled trials, tamoxifen, raloxifene, and AIs were associated with lower incidence of invasive breast cancer, with risk ratios of 0.69, 0.44, and 0.45, respectively.
However, based on the risk of adverse effects including thromboembolic events, endometrial cancer, and cataracts, the task force determined that the benefits of these medications were no greater than small in women with no risk factors. In addition, 18 risk assessments in 25 studies showed low levels of accuracy in predicting breast cancer risk.
Data from the studies reviewed by the USPSTF showed that the harms of AIs included vasomotor symptoms, GI symptoms, musculoskeletal pain, and potential increased risk of cardiovascular events and fractures. Potential harms of other medications to help prevent breast cancer (tamoxifen and raloxifene) included increased risk for venous thromboembolic events, endometrial cancer, cataracts, and hot flashes.
The findings were limited by several factors including possible publication bias, variation in risk assessment studies, and inability to conduct subgroup analysis, wrote Heidi D. Nelson, MD, of Oregon Health & Sciences University, Portland, and colleagues in the evidence report.
“Although most results are consistent with the 2013 USPSTF review, this update provides additional evidence of the inaccuracy of risk assessment methods,” they noted.
“The USPSTF recommendations, and the accompanying systematic evidence review by Nelson and colleagues rightfully focus on the need to identify women for whom the benefits are likely to outweigh harms, but they also underscore persistent uncertainties about how to accomplish that goal,” wrote Lydia E. Pace, MD, and Nancy L. Keating, MD, both of Brigham and Women’s Hospital in Boston, in an accompanying editorial (JAMA. 2019 Sept 3;322:821-23).
“Identifying safer and more effective preventive medications would help mitigate the low discriminatory accuracy of existing breast cancer risk models,” the editorialists wrote. “Meanwhile, considering risk-reducing medications for women with 5-year risk greater than 3% seems reasonable, as well as for women with atypical hyperplasia and [lobular carcinoma in situ].”
The research was funded by the Agency for Healthcare Research and Quality. Neither the task force researchers nor the editorialists reported relevant financial conflicts.
SOURCEs: Owens DK et al. JAMA. 2019 Sept 3. doi: 10.1001/jama.2019.11885; Nelson HD et al. JAMA. 2019 Sept 3. doi: 10.1001/jama.2019.5780.
FROM JAMA
Community intervention curbs CV disease in hypertensive adults
A community-based care model to control hypertension led by nonphysician health care workers significantly reduced cardiovascular disease risk over 12 months, data from a cluster-controlled randomized study has shown.
Hypertension remains the most common risk factor for cardiovascular disease, but fewer than 20% of individuals with hypertension have their blood pressure controlled, wrote Jon-David Schwalm, MD, of McMaster University in Hamilton, Ont., and colleagues. To help control hypertension in underserved populations, the researchers tested a care model involving nonphysician health workers (NPHWs), primary care physicians, and family members.
The HOPE4 study, presented at the annual congress of the European Society of Cardiology and published simultaneously in the Lancet, included 1,371 adults aged 50 years and older with new or poorly controlled hypertension from 30 communities in Colombia and Malaysia. Sixteen communities were randomized to usual care and 14 to an intervention. The intervention included community screening and treatment of cardiovascular disease risk factors by NPHWs, free medications recommended by NPHWs under physician supervision, and family support for treatment adherence.
After 12 months, the Framingham Risk Scores for 10-year cardiovascular disease risk were significantly lower in the intervention group, compared with the control group (–11.17% vs. –6.40%). In addition, the intervention group showed a significant 11.45 mm Hg greater reduction in systolic blood pressure and a significant 0.41 mmol/L reduction in LDL cholesterol, compared with controls (P less than .0001 for both measures).
Baseline characteristics were similar between the two groups. Approximately 74% of the participants had a history of poorly controlled hypertension, while the remaining patients had new hypertension diagnoses.
“NPHWs were found to be consistently accurate in their ability to identify cardiovascular risk (patient identified by NPHWs as having poorly controlled blood pressure and medication was indicated) and recommend appropriate therapies (antihypertensives and statin as per the study algorithm) when compared with the assessment by local primary care physicians,” the researchers wrote. The study shows how effectively NPHWs can help reduce cardiovascular disease risk at the community level with proper training, effective community outreach, and task sharing with physicians and family members, they noted.
The findings were limited by the inability to assess the safety of specific medications, but no differences in adverse events were reported between the intervention and control groups. Other limitations included the screening of controls for cardiovascular disease risk at baseline, which meant that controls may have modified their behavior as a result, the researchers noted. In addition, the study was not blinded and surrogate outcomes were used because of the short study duration and relatively small sample size, they said.
However, the results support the use of a comprehensive, NPHW-led model, and “the HOPE 4 strategy could help to attain the UN General Assembly Action Plan for a one-third reduction in premature mortality from cardiovascular disease” by 2030, the researchers concluded.
The study was supported by the Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, World Health Organization; and the Population Health Research Institute. Lead author Dr. Schwalm and several coauthors disclosed grants to their institutions for this study from the Canadian Institutes of Health Research, Ontario Ministry of Health and Long-Term Care, Boehringer Ingelheim, and the Department of Management of Non-Communicable Diseases, WHO.
SOURCE: Schwalm J-D et al. Lancet. 2019 Sept 2. doi: http://dx.doi.org/10.1016/ S0140-6736(19)31949-X.
A community-based care model to control hypertension led by nonphysician health care workers significantly reduced cardiovascular disease risk over 12 months, data from a cluster-controlled randomized study has shown.
Hypertension remains the most common risk factor for cardiovascular disease, but fewer than 20% of individuals with hypertension have their blood pressure controlled, wrote Jon-David Schwalm, MD, of McMaster University in Hamilton, Ont., and colleagues. To help control hypertension in underserved populations, the researchers tested a care model involving nonphysician health workers (NPHWs), primary care physicians, and family members.
The HOPE4 study, presented at the annual congress of the European Society of Cardiology and published simultaneously in the Lancet, included 1,371 adults aged 50 years and older with new or poorly controlled hypertension from 30 communities in Colombia and Malaysia. Sixteen communities were randomized to usual care and 14 to an intervention. The intervention included community screening and treatment of cardiovascular disease risk factors by NPHWs, free medications recommended by NPHWs under physician supervision, and family support for treatment adherence.
After 12 months, the Framingham Risk Scores for 10-year cardiovascular disease risk were significantly lower in the intervention group, compared with the control group (–11.17% vs. –6.40%). In addition, the intervention group showed a significant 11.45 mm Hg greater reduction in systolic blood pressure and a significant 0.41 mmol/L reduction in LDL cholesterol, compared with controls (P less than .0001 for both measures).
Baseline characteristics were similar between the two groups. Approximately 74% of the participants had a history of poorly controlled hypertension, while the remaining patients had new hypertension diagnoses.
“NPHWs were found to be consistently accurate in their ability to identify cardiovascular risk (patient identified by NPHWs as having poorly controlled blood pressure and medication was indicated) and recommend appropriate therapies (antihypertensives and statin as per the study algorithm) when compared with the assessment by local primary care physicians,” the researchers wrote. The study shows how effectively NPHWs can help reduce cardiovascular disease risk at the community level with proper training, effective community outreach, and task sharing with physicians and family members, they noted.
The findings were limited by the inability to assess the safety of specific medications, but no differences in adverse events were reported between the intervention and control groups. Other limitations included the screening of controls for cardiovascular disease risk at baseline, which meant that controls may have modified their behavior as a result, the researchers noted. In addition, the study was not blinded and surrogate outcomes were used because of the short study duration and relatively small sample size, they said.
However, the results support the use of a comprehensive, NPHW-led model, and “the HOPE 4 strategy could help to attain the UN General Assembly Action Plan for a one-third reduction in premature mortality from cardiovascular disease” by 2030, the researchers concluded.
The study was supported by the Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, World Health Organization; and the Population Health Research Institute. Lead author Dr. Schwalm and several coauthors disclosed grants to their institutions for this study from the Canadian Institutes of Health Research, Ontario Ministry of Health and Long-Term Care, Boehringer Ingelheim, and the Department of Management of Non-Communicable Diseases, WHO.
SOURCE: Schwalm J-D et al. Lancet. 2019 Sept 2. doi: http://dx.doi.org/10.1016/ S0140-6736(19)31949-X.
A community-based care model to control hypertension led by nonphysician health care workers significantly reduced cardiovascular disease risk over 12 months, data from a cluster-controlled randomized study has shown.
Hypertension remains the most common risk factor for cardiovascular disease, but fewer than 20% of individuals with hypertension have their blood pressure controlled, wrote Jon-David Schwalm, MD, of McMaster University in Hamilton, Ont., and colleagues. To help control hypertension in underserved populations, the researchers tested a care model involving nonphysician health workers (NPHWs), primary care physicians, and family members.
The HOPE4 study, presented at the annual congress of the European Society of Cardiology and published simultaneously in the Lancet, included 1,371 adults aged 50 years and older with new or poorly controlled hypertension from 30 communities in Colombia and Malaysia. Sixteen communities were randomized to usual care and 14 to an intervention. The intervention included community screening and treatment of cardiovascular disease risk factors by NPHWs, free medications recommended by NPHWs under physician supervision, and family support for treatment adherence.
After 12 months, the Framingham Risk Scores for 10-year cardiovascular disease risk were significantly lower in the intervention group, compared with the control group (–11.17% vs. –6.40%). In addition, the intervention group showed a significant 11.45 mm Hg greater reduction in systolic blood pressure and a significant 0.41 mmol/L reduction in LDL cholesterol, compared with controls (P less than .0001 for both measures).
Baseline characteristics were similar between the two groups. Approximately 74% of the participants had a history of poorly controlled hypertension, while the remaining patients had new hypertension diagnoses.
“NPHWs were found to be consistently accurate in their ability to identify cardiovascular risk (patient identified by NPHWs as having poorly controlled blood pressure and medication was indicated) and recommend appropriate therapies (antihypertensives and statin as per the study algorithm) when compared with the assessment by local primary care physicians,” the researchers wrote. The study shows how effectively NPHWs can help reduce cardiovascular disease risk at the community level with proper training, effective community outreach, and task sharing with physicians and family members, they noted.
The findings were limited by the inability to assess the safety of specific medications, but no differences in adverse events were reported between the intervention and control groups. Other limitations included the screening of controls for cardiovascular disease risk at baseline, which meant that controls may have modified their behavior as a result, the researchers noted. In addition, the study was not blinded and surrogate outcomes were used because of the short study duration and relatively small sample size, they said.
However, the results support the use of a comprehensive, NPHW-led model, and “the HOPE 4 strategy could help to attain the UN General Assembly Action Plan for a one-third reduction in premature mortality from cardiovascular disease” by 2030, the researchers concluded.
The study was supported by the Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, World Health Organization; and the Population Health Research Institute. Lead author Dr. Schwalm and several coauthors disclosed grants to their institutions for this study from the Canadian Institutes of Health Research, Ontario Ministry of Health and Long-Term Care, Boehringer Ingelheim, and the Department of Management of Non-Communicable Diseases, WHO.
SOURCE: Schwalm J-D et al. Lancet. 2019 Sept 2. doi: http://dx.doi.org/10.1016/ S0140-6736(19)31949-X.
AT THE ESC CONGRESS 2019
Key clinical point: A community-based model for managing hypertension significantly improved blood pressure and reduced cardiovascular disease risk in adults with hypertension.
Major finding: Framingham Risk Scores decreased by –11.17% in the intervention group vs. –6.40% in the control group (P less than ·0001).
Study details: The data come from a community-based, randomized, controlled trial of 1,371 adults with new or poorly controlled hypertension.
Disclosures: The study was supported by the Canadian Institutes of Health Research: Grand Challenges Canada: Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, WHO; and Population Health Research Institute. Lead author Dr. Schwalm and several coauthors disclosed grants to their institutions for this study from the Canadian Institutes of Health Research, Ontario Ministry of Health and Long-Term Care, Boehringer Ingelheim, and the Department of Management of Non-Communicable Diseases, WHO.
Source: Schwalm J-D et al. Lancet. 2019 Sept 2. doi: http://dx.doi.org/10.1016/ S0140-6736(19)31949-X.
Prior DMARD use in RA may limit adalimumab treatment response
A history of using multiple conventional synthetic disease-modifying antirheumatic drugs (DMARDs) is a key predictor for poorer response to adalimumab therapy in rheumatoid arthritis patients, according to data from a pair of studies with a total of 274 patients.
Although patients with RA who have failed methotrexate or tumor necrosis factor inhibitor therapy respond less than methotrexate-naive patients, “it remains unknown if response to the first biologic DMARD, in particular a [tumor necrosis factor inhibitor], depends on disease duration or prior numbers of failed [conventional synthetic] DMARDs,” wrote Daniel Aletaha, MD, of the Medical University of Vienna and colleagues.
In a study published in Annals of the Rheumatic Diseases, the researchers reviewed data from two randomized, controlled trials of patients with RA. In the larger trial of 207 adults (known as DE019), past use of two or more conventional synthetic DMARDs was associated with less improvement in 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP) after 24 weeks of adalimumab (Humira), compared with use of one or no DMARDs (–1.8 vs. –2.2, respectively). Similarly, disease activity and disability scores improved significantly less in patients who had used two or more DMARDs, compared with those who used one or no DMARDs, according to the Simplified Disease Activity Index (SDAI; –22.1 vs. –26.9) and the Health Assessment Questionnaire Disability Index (HAQ-DI; –0.43 vs. –0.64).
The researchers also examined the role of disease duration on treatment response. Overall, patients with disease duration greater than 10 years showed more improvement at 24 weeks than did those with disease duration less than 1 year, based on HAQ-DI scores (1.1 vs. 0.7), but final scores on the SDAI and DAS28-CRP were not significantly different between those with disease duration greater than 10 years and those with duration of less than 1 year. These results suggest that the impact of DMARDs holds true regardless of disease duration, the researchers noted.
The findings were similar with regard to number of prior conventional synthetic DMARDs and the effects of disease duration in the second trial of 67 patients, known as the ARMADA study.
The study findings were limited by several factors, including the post hoc analysis design, use of only adalimumab data, and the small number of patients in several subgroups, the researchers noted. However, the results support the need for more standardized treatment guidelines and suggest that RA patients who fail to respond to methotrexate soon after RA diagnosis may benefit most from adding adalimumab, they said.
“Furthermore, these findings should be considered in future trials when defining inclusion criteria not only by duration of disease but also by number of prior DMARDs,” they concluded.
The study was sponsored by AbbVie, which markets adalimumab. Dr. Aletaha disclosed grants and consulting fees from AbbVie, as well as other pharmaceutical companies. Four of the authors were current or former employees of AbbVie, and some other authors also reported financial relationships with the company.
SOURCE: Aletaha D et al. Ann Rheum Dis. 2019 Aug 21. doi: 10.1136/annrheumdis-2018-214918.
A history of using multiple conventional synthetic disease-modifying antirheumatic drugs (DMARDs) is a key predictor for poorer response to adalimumab therapy in rheumatoid arthritis patients, according to data from a pair of studies with a total of 274 patients.
Although patients with RA who have failed methotrexate or tumor necrosis factor inhibitor therapy respond less than methotrexate-naive patients, “it remains unknown if response to the first biologic DMARD, in particular a [tumor necrosis factor inhibitor], depends on disease duration or prior numbers of failed [conventional synthetic] DMARDs,” wrote Daniel Aletaha, MD, of the Medical University of Vienna and colleagues.
In a study published in Annals of the Rheumatic Diseases, the researchers reviewed data from two randomized, controlled trials of patients with RA. In the larger trial of 207 adults (known as DE019), past use of two or more conventional synthetic DMARDs was associated with less improvement in 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP) after 24 weeks of adalimumab (Humira), compared with use of one or no DMARDs (–1.8 vs. –2.2, respectively). Similarly, disease activity and disability scores improved significantly less in patients who had used two or more DMARDs, compared with those who used one or no DMARDs, according to the Simplified Disease Activity Index (SDAI; –22.1 vs. –26.9) and the Health Assessment Questionnaire Disability Index (HAQ-DI; –0.43 vs. –0.64).
The researchers also examined the role of disease duration on treatment response. Overall, patients with disease duration greater than 10 years showed more improvement at 24 weeks than did those with disease duration less than 1 year, based on HAQ-DI scores (1.1 vs. 0.7), but final scores on the SDAI and DAS28-CRP were not significantly different between those with disease duration greater than 10 years and those with duration of less than 1 year. These results suggest that the impact of DMARDs holds true regardless of disease duration, the researchers noted.
The findings were similar with regard to number of prior conventional synthetic DMARDs and the effects of disease duration in the second trial of 67 patients, known as the ARMADA study.
The study findings were limited by several factors, including the post hoc analysis design, use of only adalimumab data, and the small number of patients in several subgroups, the researchers noted. However, the results support the need for more standardized treatment guidelines and suggest that RA patients who fail to respond to methotrexate soon after RA diagnosis may benefit most from adding adalimumab, they said.
“Furthermore, these findings should be considered in future trials when defining inclusion criteria not only by duration of disease but also by number of prior DMARDs,” they concluded.
The study was sponsored by AbbVie, which markets adalimumab. Dr. Aletaha disclosed grants and consulting fees from AbbVie, as well as other pharmaceutical companies. Four of the authors were current or former employees of AbbVie, and some other authors also reported financial relationships with the company.
SOURCE: Aletaha D et al. Ann Rheum Dis. 2019 Aug 21. doi: 10.1136/annrheumdis-2018-214918.
A history of using multiple conventional synthetic disease-modifying antirheumatic drugs (DMARDs) is a key predictor for poorer response to adalimumab therapy in rheumatoid arthritis patients, according to data from a pair of studies with a total of 274 patients.
Although patients with RA who have failed methotrexate or tumor necrosis factor inhibitor therapy respond less than methotrexate-naive patients, “it remains unknown if response to the first biologic DMARD, in particular a [tumor necrosis factor inhibitor], depends on disease duration or prior numbers of failed [conventional synthetic] DMARDs,” wrote Daniel Aletaha, MD, of the Medical University of Vienna and colleagues.
In a study published in Annals of the Rheumatic Diseases, the researchers reviewed data from two randomized, controlled trials of patients with RA. In the larger trial of 207 adults (known as DE019), past use of two or more conventional synthetic DMARDs was associated with less improvement in 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP) after 24 weeks of adalimumab (Humira), compared with use of one or no DMARDs (–1.8 vs. –2.2, respectively). Similarly, disease activity and disability scores improved significantly less in patients who had used two or more DMARDs, compared with those who used one or no DMARDs, according to the Simplified Disease Activity Index (SDAI; –22.1 vs. –26.9) and the Health Assessment Questionnaire Disability Index (HAQ-DI; –0.43 vs. –0.64).
The researchers also examined the role of disease duration on treatment response. Overall, patients with disease duration greater than 10 years showed more improvement at 24 weeks than did those with disease duration less than 1 year, based on HAQ-DI scores (1.1 vs. 0.7), but final scores on the SDAI and DAS28-CRP were not significantly different between those with disease duration greater than 10 years and those with duration of less than 1 year. These results suggest that the impact of DMARDs holds true regardless of disease duration, the researchers noted.
The findings were similar with regard to number of prior conventional synthetic DMARDs and the effects of disease duration in the second trial of 67 patients, known as the ARMADA study.
The study findings were limited by several factors, including the post hoc analysis design, use of only adalimumab data, and the small number of patients in several subgroups, the researchers noted. However, the results support the need for more standardized treatment guidelines and suggest that RA patients who fail to respond to methotrexate soon after RA diagnosis may benefit most from adding adalimumab, they said.
“Furthermore, these findings should be considered in future trials when defining inclusion criteria not only by duration of disease but also by number of prior DMARDs,” they concluded.
The study was sponsored by AbbVie, which markets adalimumab. Dr. Aletaha disclosed grants and consulting fees from AbbVie, as well as other pharmaceutical companies. Four of the authors were current or former employees of AbbVie, and some other authors also reported financial relationships with the company.
SOURCE: Aletaha D et al. Ann Rheum Dis. 2019 Aug 21. doi: 10.1136/annrheumdis-2018-214918.
FROM ANNALS OF THE RHEUMATIC DISEASES
ACOG advises bleeding disorder screening for teens with heavy menstruation
Adolescent girls with heavy menstrual bleeding should be assessed for bleeding disorders, according to a Committee Opinion issued by the American College of Obstetricians and Gynecologists.
A bleeding disorder is secondary only to anovulation as a cause of heavy menstrual bleeding in adolescents.
Bleeding disorders affect 1%-2% of the general population, but are “found in approximately 20% of adolescent girls who present for evaluation of heavy menstrual bleeding and in 33% of adolescent girls hospitalized for heavy menstrual bleeding,” wrote Oluyemisi Adeyemi-Fowode, MD, and Judith Simms-Cendan, MD, and members of the ACOG Committee on Adolescent Health Care in the opinion, published in Obstetrics & Gynecology.
The committee advised that physical examination of teens with acute heavy menstrual bleeding should include assessment of hemodynamic stability with orthostatic blood pressure and pulse measurements. A speculum exam is not usually needed in teen girls with heavy menstrual bleeding. Evaluation should include screening for anemia attributable to blood loss with serum ferritin, endocrine disorders, and bleeding disorders. In suspected cases of bleeding disorders, laboratory evaluation and medical management should be done in consultation with a hematologist.
Those who are actively bleeding or hemodynamically unstable should be hospitalized for medical management, they said.
Ultrasonography is not necessary for an initial work-up of teens with heavy menstrual bleeding, but could be useful in patients who fail to respond to medical management.
Adolescent girls without contraindications to estrogen can be treated with hormone therapy in various forms including intravenous conjugated estrogen every 4-6 hours or oral 30-50 mg ethinyl estradiol every 6-8 hours until cessation of bleeding. Antifibrinolytics also can be used to stop bleeding.
Maintenance therapy after correction of acute heavy bleeding can include a combination of treatments such as hormonal contraceptives, oral and injectable progestins, and levonorgestrel-releasing intrauterine devices, the committee wrote. They also recommended oral iron replacement therapy for all women of reproductive age with anemia caused by menstrual bleeding.
If a patient fails to respond to medical therapy, nonmedical options or surgery may be considered, according to the committee. In addition, all teen girls with bleeding disorders should be advised about safe medication use, including the use of aspirin or NSAIDs only on the recommendation of a hematologist.
Patients and their families need education on menstrual issues including possible options for surgery in the future if heavy menstruation does not resolve. If a patient has a known bleeding disorder and is considering surgery, preoperative evaluation should include a consultation with a hematologist and an anesthesiologist, the committee noted.
Melissa Kottke, MD, MPH, said in an interview, “Every ob.gyn. will see a young patient with ‘heavy menstrual bleeding.’ And it becomes part of the art and challenge to work with the patient and family to collectively explore if this is, indeed, ‘heavy’ and of concern … or is it is a ‘normal’ menstrual period and simply reflects a newer life experience that would benefit from some education? And the stakes are high. Young people who have heavy menstrual cycles are much more likely to have an underlying bleeding disorder than the general population (20% vs. 1%-2%), and 75%-80% of adolescents with bleeding disorders report heavy menses as the most common clinical manifestation of their disorder.
“Fortunately, Committee Opinion 785, ‘Screening and Management of Bleeding Disorders in Adolescents with Heavy Menstrual Bleeding’ from the ACOG Committee on Adolescent Health Care is detailed and pragmatic. It outlines how to translate everyday conversations with young people about their menses into a quantifiable estimate of bleeding, including a very teen-friendly Pictorial Blood Loss Assessment Chart. It also gives ob.gyns. ever-important guidance about what to do next for evaluation and diagnosis. This committee opinion nicely outlines how to help manage heavy bleeding in an adolescent with a detailed algorithm. And very importantly, it gives clear management guidance and encourages ob.gyns. to avoid frequently unnecessary (speculum exams and ultrasounds) and excessive (early transfusion or surgical interventions) approaches to management for the young patient. I think it will be a great resource for any provider who is taking care of heavy menstrual bleeding for a young person,” said Dr. Kottke, who is director of the Jane Fonda Center for Adolescent Reproductive Health and associate professor of gynecology and obstetrics, both at Emory University, Atlanta. Dr. Kottke is not a member of the ACOG Committee on Adolescent Health and was asked to comment on the opinion.*
The complete opinion, ACOG Committee Opinion number 785, includes recommended laboratory tests, an eight-question screening tool, and a management algorithm.
The committee members had no financial conflicts to disclose. Dr. Kottke said she had no relevant financial disclosures.
SOURCE: Adeyemi-Fowode O and Simms-Cendan J. Obstet Gynecol. 2019 Sep. 134:e71-83.
*This article was updated on 9/9/2019.
Adolescent girls with heavy menstrual bleeding should be assessed for bleeding disorders, according to a Committee Opinion issued by the American College of Obstetricians and Gynecologists.
A bleeding disorder is secondary only to anovulation as a cause of heavy menstrual bleeding in adolescents.
Bleeding disorders affect 1%-2% of the general population, but are “found in approximately 20% of adolescent girls who present for evaluation of heavy menstrual bleeding and in 33% of adolescent girls hospitalized for heavy menstrual bleeding,” wrote Oluyemisi Adeyemi-Fowode, MD, and Judith Simms-Cendan, MD, and members of the ACOG Committee on Adolescent Health Care in the opinion, published in Obstetrics & Gynecology.
The committee advised that physical examination of teens with acute heavy menstrual bleeding should include assessment of hemodynamic stability with orthostatic blood pressure and pulse measurements. A speculum exam is not usually needed in teen girls with heavy menstrual bleeding. Evaluation should include screening for anemia attributable to blood loss with serum ferritin, endocrine disorders, and bleeding disorders. In suspected cases of bleeding disorders, laboratory evaluation and medical management should be done in consultation with a hematologist.
Those who are actively bleeding or hemodynamically unstable should be hospitalized for medical management, they said.
Ultrasonography is not necessary for an initial work-up of teens with heavy menstrual bleeding, but could be useful in patients who fail to respond to medical management.
Adolescent girls without contraindications to estrogen can be treated with hormone therapy in various forms including intravenous conjugated estrogen every 4-6 hours or oral 30-50 mg ethinyl estradiol every 6-8 hours until cessation of bleeding. Antifibrinolytics also can be used to stop bleeding.
Maintenance therapy after correction of acute heavy bleeding can include a combination of treatments such as hormonal contraceptives, oral and injectable progestins, and levonorgestrel-releasing intrauterine devices, the committee wrote. They also recommended oral iron replacement therapy for all women of reproductive age with anemia caused by menstrual bleeding.
If a patient fails to respond to medical therapy, nonmedical options or surgery may be considered, according to the committee. In addition, all teen girls with bleeding disorders should be advised about safe medication use, including the use of aspirin or NSAIDs only on the recommendation of a hematologist.
Patients and their families need education on menstrual issues including possible options for surgery in the future if heavy menstruation does not resolve. If a patient has a known bleeding disorder and is considering surgery, preoperative evaluation should include a consultation with a hematologist and an anesthesiologist, the committee noted.
Melissa Kottke, MD, MPH, said in an interview, “Every ob.gyn. will see a young patient with ‘heavy menstrual bleeding.’ And it becomes part of the art and challenge to work with the patient and family to collectively explore if this is, indeed, ‘heavy’ and of concern … or is it is a ‘normal’ menstrual period and simply reflects a newer life experience that would benefit from some education? And the stakes are high. Young people who have heavy menstrual cycles are much more likely to have an underlying bleeding disorder than the general population (20% vs. 1%-2%), and 75%-80% of adolescents with bleeding disorders report heavy menses as the most common clinical manifestation of their disorder.
“Fortunately, Committee Opinion 785, ‘Screening and Management of Bleeding Disorders in Adolescents with Heavy Menstrual Bleeding’ from the ACOG Committee on Adolescent Health Care is detailed and pragmatic. It outlines how to translate everyday conversations with young people about their menses into a quantifiable estimate of bleeding, including a very teen-friendly Pictorial Blood Loss Assessment Chart. It also gives ob.gyns. ever-important guidance about what to do next for evaluation and diagnosis. This committee opinion nicely outlines how to help manage heavy bleeding in an adolescent with a detailed algorithm. And very importantly, it gives clear management guidance and encourages ob.gyns. to avoid frequently unnecessary (speculum exams and ultrasounds) and excessive (early transfusion or surgical interventions) approaches to management for the young patient. I think it will be a great resource for any provider who is taking care of heavy menstrual bleeding for a young person,” said Dr. Kottke, who is director of the Jane Fonda Center for Adolescent Reproductive Health and associate professor of gynecology and obstetrics, both at Emory University, Atlanta. Dr. Kottke is not a member of the ACOG Committee on Adolescent Health and was asked to comment on the opinion.*
The complete opinion, ACOG Committee Opinion number 785, includes recommended laboratory tests, an eight-question screening tool, and a management algorithm.
The committee members had no financial conflicts to disclose. Dr. Kottke said she had no relevant financial disclosures.
SOURCE: Adeyemi-Fowode O and Simms-Cendan J. Obstet Gynecol. 2019 Sep. 134:e71-83.
*This article was updated on 9/9/2019.
Adolescent girls with heavy menstrual bleeding should be assessed for bleeding disorders, according to a Committee Opinion issued by the American College of Obstetricians and Gynecologists.
A bleeding disorder is secondary only to anovulation as a cause of heavy menstrual bleeding in adolescents.
Bleeding disorders affect 1%-2% of the general population, but are “found in approximately 20% of adolescent girls who present for evaluation of heavy menstrual bleeding and in 33% of adolescent girls hospitalized for heavy menstrual bleeding,” wrote Oluyemisi Adeyemi-Fowode, MD, and Judith Simms-Cendan, MD, and members of the ACOG Committee on Adolescent Health Care in the opinion, published in Obstetrics & Gynecology.
The committee advised that physical examination of teens with acute heavy menstrual bleeding should include assessment of hemodynamic stability with orthostatic blood pressure and pulse measurements. A speculum exam is not usually needed in teen girls with heavy menstrual bleeding. Evaluation should include screening for anemia attributable to blood loss with serum ferritin, endocrine disorders, and bleeding disorders. In suspected cases of bleeding disorders, laboratory evaluation and medical management should be done in consultation with a hematologist.
Those who are actively bleeding or hemodynamically unstable should be hospitalized for medical management, they said.
Ultrasonography is not necessary for an initial work-up of teens with heavy menstrual bleeding, but could be useful in patients who fail to respond to medical management.
Adolescent girls without contraindications to estrogen can be treated with hormone therapy in various forms including intravenous conjugated estrogen every 4-6 hours or oral 30-50 mg ethinyl estradiol every 6-8 hours until cessation of bleeding. Antifibrinolytics also can be used to stop bleeding.
Maintenance therapy after correction of acute heavy bleeding can include a combination of treatments such as hormonal contraceptives, oral and injectable progestins, and levonorgestrel-releasing intrauterine devices, the committee wrote. They also recommended oral iron replacement therapy for all women of reproductive age with anemia caused by menstrual bleeding.
If a patient fails to respond to medical therapy, nonmedical options or surgery may be considered, according to the committee. In addition, all teen girls with bleeding disorders should be advised about safe medication use, including the use of aspirin or NSAIDs only on the recommendation of a hematologist.
Patients and their families need education on menstrual issues including possible options for surgery in the future if heavy menstruation does not resolve. If a patient has a known bleeding disorder and is considering surgery, preoperative evaluation should include a consultation with a hematologist and an anesthesiologist, the committee noted.
Melissa Kottke, MD, MPH, said in an interview, “Every ob.gyn. will see a young patient with ‘heavy menstrual bleeding.’ And it becomes part of the art and challenge to work with the patient and family to collectively explore if this is, indeed, ‘heavy’ and of concern … or is it is a ‘normal’ menstrual period and simply reflects a newer life experience that would benefit from some education? And the stakes are high. Young people who have heavy menstrual cycles are much more likely to have an underlying bleeding disorder than the general population (20% vs. 1%-2%), and 75%-80% of adolescents with bleeding disorders report heavy menses as the most common clinical manifestation of their disorder.
“Fortunately, Committee Opinion 785, ‘Screening and Management of Bleeding Disorders in Adolescents with Heavy Menstrual Bleeding’ from the ACOG Committee on Adolescent Health Care is detailed and pragmatic. It outlines how to translate everyday conversations with young people about their menses into a quantifiable estimate of bleeding, including a very teen-friendly Pictorial Blood Loss Assessment Chart. It also gives ob.gyns. ever-important guidance about what to do next for evaluation and diagnosis. This committee opinion nicely outlines how to help manage heavy bleeding in an adolescent with a detailed algorithm. And very importantly, it gives clear management guidance and encourages ob.gyns. to avoid frequently unnecessary (speculum exams and ultrasounds) and excessive (early transfusion or surgical interventions) approaches to management for the young patient. I think it will be a great resource for any provider who is taking care of heavy menstrual bleeding for a young person,” said Dr. Kottke, who is director of the Jane Fonda Center for Adolescent Reproductive Health and associate professor of gynecology and obstetrics, both at Emory University, Atlanta. Dr. Kottke is not a member of the ACOG Committee on Adolescent Health and was asked to comment on the opinion.*
The complete opinion, ACOG Committee Opinion number 785, includes recommended laboratory tests, an eight-question screening tool, and a management algorithm.
The committee members had no financial conflicts to disclose. Dr. Kottke said she had no relevant financial disclosures.
SOURCE: Adeyemi-Fowode O and Simms-Cendan J. Obstet Gynecol. 2019 Sep. 134:e71-83.
*This article was updated on 9/9/2019.
FROM OBSTETRICS AND GYNECOLOGY
FRAX with BMD may not be accurate for women with diabetes
according to data from 566 women aged 40-90 years.
In a study published in Bone Reports, Lelia L.F. de Abreu, MD, of Deakin University, Geelong, Australia, and colleagues investigated the accuracy of FRAX scores and the role of impaired fasting glucose (IFG) and bone mineral density (BMD) on fracture risk by comparing FRAX scores for 252 normoglycemic women, 247 women with IFG, and 67 women with diabetes.
When BMD was not included, women with diabetes had a higher median FRAX score for major osteoporotic fractures of the hip, clinical spine, forearm, and wrist than women without diabetes or women with IFG (7.1, 4.3, and 5.1, respectively). In the diabetes group, 11 major osteoporotic fractures were observed versus 5 predicted by FRAX. In the normoglycemic group, 28 fractures were observed versus 15 predicted, and in the IFG group 31 fractures were observed versus 16 predicted.
When BMD was included, major osteoporotic fractures and hip fractures also were underestimated in the diabetes group (11 observed vs. 4 observed; 6 observed vs. 1 predicted, respectively), but the difference in observed versus predicted fractures trended toward statistical significance but was not significant (P = .055; P = .52, respectively). FRAX with BMD increased the underestimation of major osteoporotic fractures in the normoglycemic and IFG groups (28 observed vs. 13 predicted; 31 observed vs. 13 predicted).
The study findings were limited by several factors including the inability to determine the impact of specific types of diabetes on fracture risk, lack of data on the duration of diabetes in study participants, the use of self-reports, and a relatively small and homogeneous sample size, the researchers noted.
However, the results support data from previous studies showing an increased fracture risk in diabetes patients regardless of BMD, and suggest that FRAX may be unreliable as a predictor of fractures in the diabetes population, they concluded.
The study was supported in part by the Victorian Health Promotion Foundation, National Health and Medical Research Council Australia, and the Geelong Region Medical Research Foundation. Two researchers were supported by university postgraduate rewards and one researcher was supported by a university postdoctoral research fellowship. The remaining coauthors reported no relevant financial conflicts.
SOURCE: de Abreu LLF et al. Bone Reports. 2019 Aug 13. doi: 10.1016/j.bonr.2019.100223.
according to data from 566 women aged 40-90 years.
In a study published in Bone Reports, Lelia L.F. de Abreu, MD, of Deakin University, Geelong, Australia, and colleagues investigated the accuracy of FRAX scores and the role of impaired fasting glucose (IFG) and bone mineral density (BMD) on fracture risk by comparing FRAX scores for 252 normoglycemic women, 247 women with IFG, and 67 women with diabetes.
When BMD was not included, women with diabetes had a higher median FRAX score for major osteoporotic fractures of the hip, clinical spine, forearm, and wrist than women without diabetes or women with IFG (7.1, 4.3, and 5.1, respectively). In the diabetes group, 11 major osteoporotic fractures were observed versus 5 predicted by FRAX. In the normoglycemic group, 28 fractures were observed versus 15 predicted, and in the IFG group 31 fractures were observed versus 16 predicted.
When BMD was included, major osteoporotic fractures and hip fractures also were underestimated in the diabetes group (11 observed vs. 4 observed; 6 observed vs. 1 predicted, respectively), but the difference in observed versus predicted fractures trended toward statistical significance but was not significant (P = .055; P = .52, respectively). FRAX with BMD increased the underestimation of major osteoporotic fractures in the normoglycemic and IFG groups (28 observed vs. 13 predicted; 31 observed vs. 13 predicted).
The study findings were limited by several factors including the inability to determine the impact of specific types of diabetes on fracture risk, lack of data on the duration of diabetes in study participants, the use of self-reports, and a relatively small and homogeneous sample size, the researchers noted.
However, the results support data from previous studies showing an increased fracture risk in diabetes patients regardless of BMD, and suggest that FRAX may be unreliable as a predictor of fractures in the diabetes population, they concluded.
The study was supported in part by the Victorian Health Promotion Foundation, National Health and Medical Research Council Australia, and the Geelong Region Medical Research Foundation. Two researchers were supported by university postgraduate rewards and one researcher was supported by a university postdoctoral research fellowship. The remaining coauthors reported no relevant financial conflicts.
SOURCE: de Abreu LLF et al. Bone Reports. 2019 Aug 13. doi: 10.1016/j.bonr.2019.100223.
according to data from 566 women aged 40-90 years.
In a study published in Bone Reports, Lelia L.F. de Abreu, MD, of Deakin University, Geelong, Australia, and colleagues investigated the accuracy of FRAX scores and the role of impaired fasting glucose (IFG) and bone mineral density (BMD) on fracture risk by comparing FRAX scores for 252 normoglycemic women, 247 women with IFG, and 67 women with diabetes.
When BMD was not included, women with diabetes had a higher median FRAX score for major osteoporotic fractures of the hip, clinical spine, forearm, and wrist than women without diabetes or women with IFG (7.1, 4.3, and 5.1, respectively). In the diabetes group, 11 major osteoporotic fractures were observed versus 5 predicted by FRAX. In the normoglycemic group, 28 fractures were observed versus 15 predicted, and in the IFG group 31 fractures were observed versus 16 predicted.
When BMD was included, major osteoporotic fractures and hip fractures also were underestimated in the diabetes group (11 observed vs. 4 observed; 6 observed vs. 1 predicted, respectively), but the difference in observed versus predicted fractures trended toward statistical significance but was not significant (P = .055; P = .52, respectively). FRAX with BMD increased the underestimation of major osteoporotic fractures in the normoglycemic and IFG groups (28 observed vs. 13 predicted; 31 observed vs. 13 predicted).
The study findings were limited by several factors including the inability to determine the impact of specific types of diabetes on fracture risk, lack of data on the duration of diabetes in study participants, the use of self-reports, and a relatively small and homogeneous sample size, the researchers noted.
However, the results support data from previous studies showing an increased fracture risk in diabetes patients regardless of BMD, and suggest that FRAX may be unreliable as a predictor of fractures in the diabetes population, they concluded.
The study was supported in part by the Victorian Health Promotion Foundation, National Health and Medical Research Council Australia, and the Geelong Region Medical Research Foundation. Two researchers were supported by university postgraduate rewards and one researcher was supported by a university postdoctoral research fellowship. The remaining coauthors reported no relevant financial conflicts.
SOURCE: de Abreu LLF et al. Bone Reports. 2019 Aug 13. doi: 10.1016/j.bonr.2019.100223.
FROM BONE REPORTS
EULAR updates vaccination recommendations for autoimmune inflammatory rheumatic disease patients
Vaccination status should be reviewed annually for patients with autoimmune inflammatory rheumatic diseases, according to updated recommendations from the European League Against Rheumatism.
Patients with autoimmune inflammatory rheumatic diseases (AIIRD) are at increased risk for infections, and vaccination has been shown to reduce risk by “potentially translating into a lower rate of hospital admissions due to infections, emergency room visits, and the rate of invasive infectious diseases,” wrote Victoria Furer, MD, of Tel Aviv Sourasky Medical Center, and members of the task force that updated the recommendations, which were published in Annals of the Rheumatic Diseases.
However, AIIRD patients often go unvaccinated because of a lack of awareness or concerns about vaccine safety and efficacy, they said (Ann Rheum Dis. 2019 Aug 14. doi: 10.1136/annrheumdis-2019-215882).
The task force consisted of 21 experts, including patients, rheumatologists, immunologists, an infectious disease specialist, and health professionals in rheumatology representing eight countries. They evaluated data from four systematic literature reviews and developed nine recommendations based on six key principles.
“For each recommendation, the level of evidence for the incidence/prevalence of vaccine preventable infection in AIIRD, and efficacy/immunogenicity/safety of vaccination were stated, when available, followed by the strength of recommendation and the level of agreement,” the task force wrote.
These overarching principles start with an annual assessment of vaccination status by the AIIRD patient’s rheumatology team. Other principles include explanation of an individualized vaccination program to the patient as a foundation for joint decision-making, vaccinating patients during quiescent disease periods, vaccinating in advance of planned immunosuppression when possible, considering non-live vaccines for AIIRD patients also treated with systemic glucocorticoids and DMARDs, and considering live-attenuated vaccines with caution.
Several of the nine recommendations developed by the task force are modified from the previous recommendations issued in 2011. The task force made its recommendations with an eye toward optimizing individual risk stratification and avoiding “unnecessary” vaccination in AIIRD patients with low risk of infection as part of the update process. A notable change from the 2011 guidelines is the recommendation of both influenza and pneumococcal vaccinations for the majority of patients with AIIRD as opposed to all patients to emphasize the importance of individualized risk assessment, the task force noted.
The recommendations state that influenza vaccination and pneumococcal vaccination should be “strongly considered” for patients with AIIRD, and patients also should receive tetanus toxoid vaccination according to recommendations for the general population. However, clinicians should consider passive immunization for patients treated with B-cell depleting therapy, the task force wrote.
AIIRD patients at risk for hepatitis A and B should receive vaccinations for those diseases, with boosters or passive immunization if indicated, and high-risk patients may consider herpes zoster vaccination, according to the recommendations.
In addition, AIIRD patients – especially patients with systemic lupus erythematosus – should receive human papilloma virus vaccination according to recommendations for the general population, but AIIRD patients should avoid yellow fever vaccination, the task force stated. However, for AIIRD patients traveling to areas of yellow fever risk, “withholding immunosuppressive therapy to allow a safe vaccination or measuring serology in previously exposed patients may be considered.”
Finally, mothers treated with biologics during the second half of pregnancy should avoid live-attenuated vaccines for their newborns, and immunocompetent household members of AIIRD patients should be encouraged to follow national guidelines for routine vaccination with the exception of the oral polio vaccine, the task force concluded.
Vaccination status should be reviewed annually for patients with autoimmune inflammatory rheumatic diseases, according to updated recommendations from the European League Against Rheumatism.
Patients with autoimmune inflammatory rheumatic diseases (AIIRD) are at increased risk for infections, and vaccination has been shown to reduce risk by “potentially translating into a lower rate of hospital admissions due to infections, emergency room visits, and the rate of invasive infectious diseases,” wrote Victoria Furer, MD, of Tel Aviv Sourasky Medical Center, and members of the task force that updated the recommendations, which were published in Annals of the Rheumatic Diseases.
However, AIIRD patients often go unvaccinated because of a lack of awareness or concerns about vaccine safety and efficacy, they said (Ann Rheum Dis. 2019 Aug 14. doi: 10.1136/annrheumdis-2019-215882).
The task force consisted of 21 experts, including patients, rheumatologists, immunologists, an infectious disease specialist, and health professionals in rheumatology representing eight countries. They evaluated data from four systematic literature reviews and developed nine recommendations based on six key principles.
“For each recommendation, the level of evidence for the incidence/prevalence of vaccine preventable infection in AIIRD, and efficacy/immunogenicity/safety of vaccination were stated, when available, followed by the strength of recommendation and the level of agreement,” the task force wrote.
These overarching principles start with an annual assessment of vaccination status by the AIIRD patient’s rheumatology team. Other principles include explanation of an individualized vaccination program to the patient as a foundation for joint decision-making, vaccinating patients during quiescent disease periods, vaccinating in advance of planned immunosuppression when possible, considering non-live vaccines for AIIRD patients also treated with systemic glucocorticoids and DMARDs, and considering live-attenuated vaccines with caution.
Several of the nine recommendations developed by the task force are modified from the previous recommendations issued in 2011. The task force made its recommendations with an eye toward optimizing individual risk stratification and avoiding “unnecessary” vaccination in AIIRD patients with low risk of infection as part of the update process. A notable change from the 2011 guidelines is the recommendation of both influenza and pneumococcal vaccinations for the majority of patients with AIIRD as opposed to all patients to emphasize the importance of individualized risk assessment, the task force noted.
The recommendations state that influenza vaccination and pneumococcal vaccination should be “strongly considered” for patients with AIIRD, and patients also should receive tetanus toxoid vaccination according to recommendations for the general population. However, clinicians should consider passive immunization for patients treated with B-cell depleting therapy, the task force wrote.
AIIRD patients at risk for hepatitis A and B should receive vaccinations for those diseases, with boosters or passive immunization if indicated, and high-risk patients may consider herpes zoster vaccination, according to the recommendations.
In addition, AIIRD patients – especially patients with systemic lupus erythematosus – should receive human papilloma virus vaccination according to recommendations for the general population, but AIIRD patients should avoid yellow fever vaccination, the task force stated. However, for AIIRD patients traveling to areas of yellow fever risk, “withholding immunosuppressive therapy to allow a safe vaccination or measuring serology in previously exposed patients may be considered.”
Finally, mothers treated with biologics during the second half of pregnancy should avoid live-attenuated vaccines for their newborns, and immunocompetent household members of AIIRD patients should be encouraged to follow national guidelines for routine vaccination with the exception of the oral polio vaccine, the task force concluded.
Vaccination status should be reviewed annually for patients with autoimmune inflammatory rheumatic diseases, according to updated recommendations from the European League Against Rheumatism.
Patients with autoimmune inflammatory rheumatic diseases (AIIRD) are at increased risk for infections, and vaccination has been shown to reduce risk by “potentially translating into a lower rate of hospital admissions due to infections, emergency room visits, and the rate of invasive infectious diseases,” wrote Victoria Furer, MD, of Tel Aviv Sourasky Medical Center, and members of the task force that updated the recommendations, which were published in Annals of the Rheumatic Diseases.
However, AIIRD patients often go unvaccinated because of a lack of awareness or concerns about vaccine safety and efficacy, they said (Ann Rheum Dis. 2019 Aug 14. doi: 10.1136/annrheumdis-2019-215882).
The task force consisted of 21 experts, including patients, rheumatologists, immunologists, an infectious disease specialist, and health professionals in rheumatology representing eight countries. They evaluated data from four systematic literature reviews and developed nine recommendations based on six key principles.
“For each recommendation, the level of evidence for the incidence/prevalence of vaccine preventable infection in AIIRD, and efficacy/immunogenicity/safety of vaccination were stated, when available, followed by the strength of recommendation and the level of agreement,” the task force wrote.
These overarching principles start with an annual assessment of vaccination status by the AIIRD patient’s rheumatology team. Other principles include explanation of an individualized vaccination program to the patient as a foundation for joint decision-making, vaccinating patients during quiescent disease periods, vaccinating in advance of planned immunosuppression when possible, considering non-live vaccines for AIIRD patients also treated with systemic glucocorticoids and DMARDs, and considering live-attenuated vaccines with caution.
Several of the nine recommendations developed by the task force are modified from the previous recommendations issued in 2011. The task force made its recommendations with an eye toward optimizing individual risk stratification and avoiding “unnecessary” vaccination in AIIRD patients with low risk of infection as part of the update process. A notable change from the 2011 guidelines is the recommendation of both influenza and pneumococcal vaccinations for the majority of patients with AIIRD as opposed to all patients to emphasize the importance of individualized risk assessment, the task force noted.
The recommendations state that influenza vaccination and pneumococcal vaccination should be “strongly considered” for patients with AIIRD, and patients also should receive tetanus toxoid vaccination according to recommendations for the general population. However, clinicians should consider passive immunization for patients treated with B-cell depleting therapy, the task force wrote.
AIIRD patients at risk for hepatitis A and B should receive vaccinations for those diseases, with boosters or passive immunization if indicated, and high-risk patients may consider herpes zoster vaccination, according to the recommendations.
In addition, AIIRD patients – especially patients with systemic lupus erythematosus – should receive human papilloma virus vaccination according to recommendations for the general population, but AIIRD patients should avoid yellow fever vaccination, the task force stated. However, for AIIRD patients traveling to areas of yellow fever risk, “withholding immunosuppressive therapy to allow a safe vaccination or measuring serology in previously exposed patients may be considered.”
Finally, mothers treated with biologics during the second half of pregnancy should avoid live-attenuated vaccines for their newborns, and immunocompetent household members of AIIRD patients should be encouraged to follow national guidelines for routine vaccination with the exception of the oral polio vaccine, the task force concluded.
FROM ANNALS OF THE RHEUMATIC DISEASES
False links between violence, mental illness fast-tracked report release
Stigmatizing language in the public domain that falsely links U.S. gun violence to mental illness led the National Council for Behavioral Health to move up release of a report analyzing causes, impacts, and solutions of mass violence, according to Jack Rozel, MD.
“We were planning to release it in October but released it early to push back,” Dr. Rozel, a member of the report’s expert panel and medical director of resolve Crisis Services, said on the Aug. 21 MDedge Psychcast.
The 82-page report examines behavior-based motives and solutions related to mass violence in the United States (Parks J et al. National Council for Behavioral Health. 2019 Aug 6. “Mass Violence in America: Causes, Impacts and Solutions”). It was created by the Medical Director Institute, which advises the National Council on current issues affecting clinical practice.
Policy makers and the public often leap to conclusions about the role of mental illness in the actions of individuals responsible for mass violence, wrote the panel convened by the institute. The panel included not only clinicians such as Dr. Rozel with expertise in treating mental illness, but also researchers, educators, law enforcement personnel, FBI members, judges, policy makers, and parents.
According to the report’s executive summary, perpetrators of mass violence share certain traits independent of cultural, demographic, socioeconomic, and occupational factors. The most common perpetrators of mass violence are “males, often hopeless and harboring grievances that are frequently related to work, school, finances, or interpersonal relationships; feeling victimized and sympathizing with others whom they perceive to be similarly mistreated; indifference to life; and often subsequently dying by suicide.”
, according to the report. In fact, many perpetrators do not suffer from any major psychiatric disorder, and most individuals who do suffer from mental illness are not violent.
“Lumping all mental illness together, and then assuming that acts that seem incomprehensible to the average person are due to mental illness, results in millions of harmless, nonviolent individuals recovering from treatable mental health conditions being subjected to stigma, rejection, discrimination and even unwarranted legal restrictions and social control,” the panel wrote. Recent episodes of mass violence in the United States can contribute to a generalized fear of individuals with mental illness, they added.
More research and strategies are needed to explore and address the root causes that contribute to acts of mass violence, including social problems and insufficient mental health care, the report said.
The panelists also offered recommendations for stakeholders, including health care organizations, schools, law enforcement, and community groups.
Recommendations for health care organizations in particular include establishing multidisciplinary teams for threat assessment and management that include not only security personnel, but also human resources, legal, and law enforcement. In addition, the panel recommended that health care staff be trained in lethal means reduction. “This is a rational strategy for lethal violence reduction and very helpful in combating suicide,” they said. However, staff also should be prepared for compassion fatigue and vicarious trauma, and health care organizations should develop resources for self-care and staff support.
Other recommendations include enacting state red flag laws that would remove guns from high-risk individuals for the short term, and reassessing the value of school safety protocols, such as bulletproof glass, zero tolerance policies, and active shooter drills.
The panel also offered recommendations for additional research on mass violence, including studies on “the nature and factors that contribute to mass violence, including neurobiological, psychological and sociological factors,” as well as research on methods of intervention and prevention of mass violence and the creation of a standardized analysis for mass violence incidence led by the Department of Justice with a multidisciplinary team.
Working with the media is important for engaging and educating the public about mental illness and mass violence, the panel members wrote. They recommended that all stakeholders in mental health develop messages in advance and protocols about how to respond to media requests for information about behavioral health.
“Talk about the role of treatment in helping people at risk of violence. Highlight the fact that most people with mental illnesses will never become violent. Speak to untreated or undertreated mental illness in combination with other risk factors,” they said.
Finally, they emphasized the need to remind the public to be aware of risk factors for mass violence, and the value of the “see something, say something” message.
In the Psychcast interview, Dr. Rozel said he and several colleagues will be conducting talks and training on these issues over the next few months, including at the Institute on Psychiatric Services conference (IPS 2019) in October in New York; at the National Council’s preconference (NatCon20) in April in Austin, Tex.; and at the American College of Emergency Physicians (ACEP 2019) meeting in October in Denver.
The National Council’s expert panel was led by Joe Parks, MD, medical director of the National Council; Donald W. Bechtold, MD, of the Colorado-based Jefferson Center for Mental Health; Sara Coffey, DO, of Oklahoma State University, Tulsa; Jeffrey A. Lieberman, MD, of Columbia University, New York; and Frank Shelp, MD, MPH, of Envolve Health, Atlanta.
Stigmatizing language in the public domain that falsely links U.S. gun violence to mental illness led the National Council for Behavioral Health to move up release of a report analyzing causes, impacts, and solutions of mass violence, according to Jack Rozel, MD.
“We were planning to release it in October but released it early to push back,” Dr. Rozel, a member of the report’s expert panel and medical director of resolve Crisis Services, said on the Aug. 21 MDedge Psychcast.
The 82-page report examines behavior-based motives and solutions related to mass violence in the United States (Parks J et al. National Council for Behavioral Health. 2019 Aug 6. “Mass Violence in America: Causes, Impacts and Solutions”). It was created by the Medical Director Institute, which advises the National Council on current issues affecting clinical practice.
Policy makers and the public often leap to conclusions about the role of mental illness in the actions of individuals responsible for mass violence, wrote the panel convened by the institute. The panel included not only clinicians such as Dr. Rozel with expertise in treating mental illness, but also researchers, educators, law enforcement personnel, FBI members, judges, policy makers, and parents.
According to the report’s executive summary, perpetrators of mass violence share certain traits independent of cultural, demographic, socioeconomic, and occupational factors. The most common perpetrators of mass violence are “males, often hopeless and harboring grievances that are frequently related to work, school, finances, or interpersonal relationships; feeling victimized and sympathizing with others whom they perceive to be similarly mistreated; indifference to life; and often subsequently dying by suicide.”
, according to the report. In fact, many perpetrators do not suffer from any major psychiatric disorder, and most individuals who do suffer from mental illness are not violent.
“Lumping all mental illness together, and then assuming that acts that seem incomprehensible to the average person are due to mental illness, results in millions of harmless, nonviolent individuals recovering from treatable mental health conditions being subjected to stigma, rejection, discrimination and even unwarranted legal restrictions and social control,” the panel wrote. Recent episodes of mass violence in the United States can contribute to a generalized fear of individuals with mental illness, they added.
More research and strategies are needed to explore and address the root causes that contribute to acts of mass violence, including social problems and insufficient mental health care, the report said.
The panelists also offered recommendations for stakeholders, including health care organizations, schools, law enforcement, and community groups.
Recommendations for health care organizations in particular include establishing multidisciplinary teams for threat assessment and management that include not only security personnel, but also human resources, legal, and law enforcement. In addition, the panel recommended that health care staff be trained in lethal means reduction. “This is a rational strategy for lethal violence reduction and very helpful in combating suicide,” they said. However, staff also should be prepared for compassion fatigue and vicarious trauma, and health care organizations should develop resources for self-care and staff support.
Other recommendations include enacting state red flag laws that would remove guns from high-risk individuals for the short term, and reassessing the value of school safety protocols, such as bulletproof glass, zero tolerance policies, and active shooter drills.
The panel also offered recommendations for additional research on mass violence, including studies on “the nature and factors that contribute to mass violence, including neurobiological, psychological and sociological factors,” as well as research on methods of intervention and prevention of mass violence and the creation of a standardized analysis for mass violence incidence led by the Department of Justice with a multidisciplinary team.
Working with the media is important for engaging and educating the public about mental illness and mass violence, the panel members wrote. They recommended that all stakeholders in mental health develop messages in advance and protocols about how to respond to media requests for information about behavioral health.
“Talk about the role of treatment in helping people at risk of violence. Highlight the fact that most people with mental illnesses will never become violent. Speak to untreated or undertreated mental illness in combination with other risk factors,” they said.
Finally, they emphasized the need to remind the public to be aware of risk factors for mass violence, and the value of the “see something, say something” message.
In the Psychcast interview, Dr. Rozel said he and several colleagues will be conducting talks and training on these issues over the next few months, including at the Institute on Psychiatric Services conference (IPS 2019) in October in New York; at the National Council’s preconference (NatCon20) in April in Austin, Tex.; and at the American College of Emergency Physicians (ACEP 2019) meeting in October in Denver.
The National Council’s expert panel was led by Joe Parks, MD, medical director of the National Council; Donald W. Bechtold, MD, of the Colorado-based Jefferson Center for Mental Health; Sara Coffey, DO, of Oklahoma State University, Tulsa; Jeffrey A. Lieberman, MD, of Columbia University, New York; and Frank Shelp, MD, MPH, of Envolve Health, Atlanta.
Stigmatizing language in the public domain that falsely links U.S. gun violence to mental illness led the National Council for Behavioral Health to move up release of a report analyzing causes, impacts, and solutions of mass violence, according to Jack Rozel, MD.
“We were planning to release it in October but released it early to push back,” Dr. Rozel, a member of the report’s expert panel and medical director of resolve Crisis Services, said on the Aug. 21 MDedge Psychcast.
The 82-page report examines behavior-based motives and solutions related to mass violence in the United States (Parks J et al. National Council for Behavioral Health. 2019 Aug 6. “Mass Violence in America: Causes, Impacts and Solutions”). It was created by the Medical Director Institute, which advises the National Council on current issues affecting clinical practice.
Policy makers and the public often leap to conclusions about the role of mental illness in the actions of individuals responsible for mass violence, wrote the panel convened by the institute. The panel included not only clinicians such as Dr. Rozel with expertise in treating mental illness, but also researchers, educators, law enforcement personnel, FBI members, judges, policy makers, and parents.
According to the report’s executive summary, perpetrators of mass violence share certain traits independent of cultural, demographic, socioeconomic, and occupational factors. The most common perpetrators of mass violence are “males, often hopeless and harboring grievances that are frequently related to work, school, finances, or interpersonal relationships; feeling victimized and sympathizing with others whom they perceive to be similarly mistreated; indifference to life; and often subsequently dying by suicide.”
, according to the report. In fact, many perpetrators do not suffer from any major psychiatric disorder, and most individuals who do suffer from mental illness are not violent.
“Lumping all mental illness together, and then assuming that acts that seem incomprehensible to the average person are due to mental illness, results in millions of harmless, nonviolent individuals recovering from treatable mental health conditions being subjected to stigma, rejection, discrimination and even unwarranted legal restrictions and social control,” the panel wrote. Recent episodes of mass violence in the United States can contribute to a generalized fear of individuals with mental illness, they added.
More research and strategies are needed to explore and address the root causes that contribute to acts of mass violence, including social problems and insufficient mental health care, the report said.
The panelists also offered recommendations for stakeholders, including health care organizations, schools, law enforcement, and community groups.
Recommendations for health care organizations in particular include establishing multidisciplinary teams for threat assessment and management that include not only security personnel, but also human resources, legal, and law enforcement. In addition, the panel recommended that health care staff be trained in lethal means reduction. “This is a rational strategy for lethal violence reduction and very helpful in combating suicide,” they said. However, staff also should be prepared for compassion fatigue and vicarious trauma, and health care organizations should develop resources for self-care and staff support.
Other recommendations include enacting state red flag laws that would remove guns from high-risk individuals for the short term, and reassessing the value of school safety protocols, such as bulletproof glass, zero tolerance policies, and active shooter drills.
The panel also offered recommendations for additional research on mass violence, including studies on “the nature and factors that contribute to mass violence, including neurobiological, psychological and sociological factors,” as well as research on methods of intervention and prevention of mass violence and the creation of a standardized analysis for mass violence incidence led by the Department of Justice with a multidisciplinary team.
Working with the media is important for engaging and educating the public about mental illness and mass violence, the panel members wrote. They recommended that all stakeholders in mental health develop messages in advance and protocols about how to respond to media requests for information about behavioral health.
“Talk about the role of treatment in helping people at risk of violence. Highlight the fact that most people with mental illnesses will never become violent. Speak to untreated or undertreated mental illness in combination with other risk factors,” they said.
Finally, they emphasized the need to remind the public to be aware of risk factors for mass violence, and the value of the “see something, say something” message.
In the Psychcast interview, Dr. Rozel said he and several colleagues will be conducting talks and training on these issues over the next few months, including at the Institute on Psychiatric Services conference (IPS 2019) in October in New York; at the National Council’s preconference (NatCon20) in April in Austin, Tex.; and at the American College of Emergency Physicians (ACEP 2019) meeting in October in Denver.
The National Council’s expert panel was led by Joe Parks, MD, medical director of the National Council; Donald W. Bechtold, MD, of the Colorado-based Jefferson Center for Mental Health; Sara Coffey, DO, of Oklahoma State University, Tulsa; Jeffrey A. Lieberman, MD, of Columbia University, New York; and Frank Shelp, MD, MPH, of Envolve Health, Atlanta.