Andrew D. Bowser

Men and women with cancer may derive a similar survival benefit from immune checkpoint inhibitor therapy, results of a recent meta-analysis suggest.

Both men and women had an overall survival benefit from immunotherapy versus standard of care therapy, with no significant difference between the sexes, according to authors of this meta-analysis, which included 23 randomized clinical trials comprising nearly 14,000 patients.

The findings, reported in JAMA Oncology, contrast with those of another recent analysis, which suggested that men had a greater advantage of receiving immunotherapy versus standard of care than women did.

“We found no evidence that sex should be considered when deciding whether to offer immunotherapy to patients with advanced cancers,” said Christopher J.D. Wallis, MD, PhD, of the University of Toronto, and his coauthors said in their report.

The present meta-analysis was based on a “more contemporary and comprehensive” literature search strategy than the earlier one, according to Dr. Wallis and his coinvestigators.

Specifically, they considered immunotherapy agents not included in the previous analysis, added seven new studies published since the previous analysis, and excluded three trials that compared immunotherapy agents, rather than comparing immunotherapy with standard of care, they explained in their report.

Their resulting meta-analysis included a total of 9,322 men and 4,399 women, most of whom were in their 70s. Overall, they found that immune checkpoint inhibitor therapy offered a statistically significant overall survival advantage versus standard systemic therapy, with a hazard ratio of 0.75 (95% confidence interval, 0.70-0.81; P less than .001).

That overall survival advantage was found for both men, with a hazard ratio of 0.75 (95% CI, 0.69-0.81; P less than .001) and women, at 0.77 (95% CI, 0.67-0.88; P = .002), investigators further reported. There was no statistically significant difference in overall survival advantage between men and women, both overall (P = 0.60) and in subgroup analyses that accounted for tumor type, line of treatment, and prevalence of women in the study.

The previous meta-analysis, published in the Lancet, found an overall survival hazard ratio of 0.72 for men receiving checkpoint inhibitors and 0.86 for women receiving checkpoint inhibitors (P = .0019), prompting those investigators to conclude that the magnitude of benefit was sex-dependent and that different immunotherapeutic approaches may be needed for men versus women.

“The present meta-analysis provides a more specific assessment of the research question while including a greater number of immunotherapy agents and an updated search,” Dr. Wallis and his coauthors said in a discussion of their more recent findings.

Dr. Wallis reported no disclosures related to the study. Study coauthors provided disclosures related to Merck, AstraZeneca, Bristol-Myers Squibb, Illumina, Tempus, Novartis, Eli Lilly, Fate, Incyte, MedImmune, Pfizer, Roche/Genentech, Xcovery, Fate Therapeutics, Genocea, and Iovance.
 

SOURCE: Wallis CJD et al. JAMA Oncol. 2019 Jan 3. doi:10.1001/jamaoncol.2018.5904.

Men and women with cancer may derive a similar survival benefit from immune checkpoint inhibitor therapy, results of a recent meta-analysis suggest.

Both men and women had an overall survival benefit from immunotherapy versus standard of care therapy, with no significant difference between the sexes, according to authors of this meta-analysis, which included 23 randomized clinical trials comprising nearly 14,000 patients.

The findings, reported in JAMA Oncology, contrast with those of another recent analysis, which suggested that men had a greater advantage of receiving immunotherapy versus standard of care than women did.

“We found no evidence that sex should be considered when deciding whether to offer immunotherapy to patients with advanced cancers,” said Christopher J.D. Wallis, MD, PhD, of the University of Toronto, and his coauthors said in their report.

The present meta-analysis was based on a “more contemporary and comprehensive” literature search strategy than the earlier one, according to Dr. Wallis and his coinvestigators.

Specifically, they considered immunotherapy agents not included in the previous analysis, added seven new studies published since the previous analysis, and excluded three trials that compared immunotherapy agents, rather than comparing immunotherapy with standard of care, they explained in their report.

Their resulting meta-analysis included a total of 9,322 men and 4,399 women, most of whom were in their 70s. Overall, they found that immune checkpoint inhibitor therapy offered a statistically significant overall survival advantage versus standard systemic therapy, with a hazard ratio of 0.75 (95% confidence interval, 0.70-0.81; P less than .001).

That overall survival advantage was found for both men, with a hazard ratio of 0.75 (95% CI, 0.69-0.81; P less than .001) and women, at 0.77 (95% CI, 0.67-0.88; P = .002), investigators further reported. There was no statistically significant difference in overall survival advantage between men and women, both overall (P = 0.60) and in subgroup analyses that accounted for tumor type, line of treatment, and prevalence of women in the study.

The previous meta-analysis, published in the Lancet, found an overall survival hazard ratio of 0.72 for men receiving checkpoint inhibitors and 0.86 for women receiving checkpoint inhibitors (P = .0019), prompting those investigators to conclude that the magnitude of benefit was sex-dependent and that different immunotherapeutic approaches may be needed for men versus women.

“The present meta-analysis provides a more specific assessment of the research question while including a greater number of immunotherapy agents and an updated search,” Dr. Wallis and his coauthors said in a discussion of their more recent findings.

Dr. Wallis reported no disclosures related to the study. Study coauthors provided disclosures related to Merck, AstraZeneca, Bristol-Myers Squibb, Illumina, Tempus, Novartis, Eli Lilly, Fate, Incyte, MedImmune, Pfizer, Roche/Genentech, Xcovery, Fate Therapeutics, Genocea, and Iovance.
 

SOURCE: Wallis CJD et al. JAMA Oncol. 2019 Jan 3. doi:10.1001/jamaoncol.2018.5904.

Men and women with cancer may derive a similar survival benefit from immune checkpoint inhibitor therapy, results of a recent meta-analysis suggest.

Both men and women had an overall survival benefit from immunotherapy versus standard of care therapy, with no significant difference between the sexes, according to authors of this meta-analysis, which included 23 randomized clinical trials comprising nearly 14,000 patients.

The findings, reported in JAMA Oncology, contrast with those of another recent analysis, which suggested that men had a greater advantage of receiving immunotherapy versus standard of care than women did.

“We found no evidence that sex should be considered when deciding whether to offer immunotherapy to patients with advanced cancers,” said Christopher J.D. Wallis, MD, PhD, of the University of Toronto, and his coauthors said in their report.

The present meta-analysis was based on a “more contemporary and comprehensive” literature search strategy than the earlier one, according to Dr. Wallis and his coinvestigators.

Specifically, they considered immunotherapy agents not included in the previous analysis, added seven new studies published since the previous analysis, and excluded three trials that compared immunotherapy agents, rather than comparing immunotherapy with standard of care, they explained in their report.

Their resulting meta-analysis included a total of 9,322 men and 4,399 women, most of whom were in their 70s. Overall, they found that immune checkpoint inhibitor therapy offered a statistically significant overall survival advantage versus standard systemic therapy, with a hazard ratio of 0.75 (95% confidence interval, 0.70-0.81; P less than .001).

That overall survival advantage was found for both men, with a hazard ratio of 0.75 (95% CI, 0.69-0.81; P less than .001) and women, at 0.77 (95% CI, 0.67-0.88; P = .002), investigators further reported. There was no statistically significant difference in overall survival advantage between men and women, both overall (P = 0.60) and in subgroup analyses that accounted for tumor type, line of treatment, and prevalence of women in the study.

The previous meta-analysis, published in the Lancet, found an overall survival hazard ratio of 0.72 for men receiving checkpoint inhibitors and 0.86 for women receiving checkpoint inhibitors (P = .0019), prompting those investigators to conclude that the magnitude of benefit was sex-dependent and that different immunotherapeutic approaches may be needed for men versus women.

“The present meta-analysis provides a more specific assessment of the research question while including a greater number of immunotherapy agents and an updated search,” Dr. Wallis and his coauthors said in a discussion of their more recent findings.

Dr. Wallis reported no disclosures related to the study. Study coauthors provided disclosures related to Merck, AstraZeneca, Bristol-Myers Squibb, Illumina, Tempus, Novartis, Eli Lilly, Fate, Incyte, MedImmune, Pfizer, Roche/Genentech, Xcovery, Fate Therapeutics, Genocea, and Iovance.
 

SOURCE: Wallis CJD et al. JAMA Oncol. 2019 Jan 3. doi:10.1001/jamaoncol.2018.5904.

A small but substantial proportion of patients with hemophilia A develop immediate acting factor VIII inhibitors, the diversity and complexity of which create a diagnostic challenge in the laboratory, according to authors of a recent observational study.

©designer491/Thinkstock

The great majority of the inhibitor-positive patients in the 4,900-patient study had classical FVIII inhibitors, which are typically time- and temperature-dependent and react more slowly in mixing studies, the researchers reported.

By contrast, about 1 in 10 patients demonstrated immediate acting inhibitors, and of those, some had lupus anticoagulants, some had factor VIII inhibitors, and some had both, according to Shrimati Shetty, PhD, of the National Institute of Immunohaematology in Mumbai, India, and her colleagues.

“There is a possibility of misdiagnosis of the patient when they present for the first time,” the researchers wrote. The report is in Thrombosis Research.

In the case of immediate-acting inhibitors, use of ELISA or chromogenic assays alongside lupus anticoagulant testing may help clarify the diagnosis; however, those tests are costly and may not be routinely available.

In the study by Dr. Shetty and her colleagues, patients in India with congenital hemophilia were initially screened for inhibitors. A total of 451 were found to be positive, and of those, 398 were observed to have classical factor VIII inhibitors, while the remaining 53 had immediate-acting inhibitors.

Looking specifically at hemophilia A patients with immediate-acting inhibitors, which comprised 48 of those 53 patients, the majority, or 42 patients, were positive for lupus anticoagulants, and of those, 38 were positive for both lupus anticoagulants and factor VIII inhibitors, while 4 patients were positive for lupus anticoagulants only.

“These are a heterogeneous group of antibodies interfering with all phospholipid dependent reactions,” the researchers wrote.

Properly interpreting factor inhibitor assays is an important step that helps guide later management of inhibitor-positive patients, according to Dr. Shetty and her coauthors.

“Once the patients become positive for inhibitors, they have to opt for alternate modalities of treatment, i.e. bypassing agents like activated prothrombin complex concentrate and activated recombinant factor VII, which are much more expensive,” they wrote.

In light of the diagnostic difficulties they highlighted, Dr. Shetty and her coauthors recommended a “systematic approach” to testing. Both factor VIII and factor IX assays need to be conducted, along with a lupus anticoagulant test. For inhibitor titer, either chromogenic assays or ELISA tests are recommended, they wrote.

Dr. Shetty and her coauthors reported that they had no conflicts of interest.

SOURCE: Patil R et al. Thromb Res. 2018 Dec;172:29-35.

A small but substantial proportion of patients with hemophilia A develop immediate acting factor VIII inhibitors, the diversity and complexity of which create a diagnostic challenge in the laboratory, according to authors of a recent observational study.

©designer491/Thinkstock

The great majority of the inhibitor-positive patients in the 4,900-patient study had classical FVIII inhibitors, which are typically time- and temperature-dependent and react more slowly in mixing studies, the researchers reported.

By contrast, about 1 in 10 patients demonstrated immediate acting inhibitors, and of those, some had lupus anticoagulants, some had factor VIII inhibitors, and some had both, according to Shrimati Shetty, PhD, of the National Institute of Immunohaematology in Mumbai, India, and her colleagues.

“There is a possibility of misdiagnosis of the patient when they present for the first time,” the researchers wrote. The report is in Thrombosis Research.

In the case of immediate-acting inhibitors, use of ELISA or chromogenic assays alongside lupus anticoagulant testing may help clarify the diagnosis; however, those tests are costly and may not be routinely available.

In the study by Dr. Shetty and her colleagues, patients in India with congenital hemophilia were initially screened for inhibitors. A total of 451 were found to be positive, and of those, 398 were observed to have classical factor VIII inhibitors, while the remaining 53 had immediate-acting inhibitors.

Looking specifically at hemophilia A patients with immediate-acting inhibitors, which comprised 48 of those 53 patients, the majority, or 42 patients, were positive for lupus anticoagulants, and of those, 38 were positive for both lupus anticoagulants and factor VIII inhibitors, while 4 patients were positive for lupus anticoagulants only.

“These are a heterogeneous group of antibodies interfering with all phospholipid dependent reactions,” the researchers wrote.

Properly interpreting factor inhibitor assays is an important step that helps guide later management of inhibitor-positive patients, according to Dr. Shetty and her coauthors.

“Once the patients become positive for inhibitors, they have to opt for alternate modalities of treatment, i.e. bypassing agents like activated prothrombin complex concentrate and activated recombinant factor VII, which are much more expensive,” they wrote.

In light of the diagnostic difficulties they highlighted, Dr. Shetty and her coauthors recommended a “systematic approach” to testing. Both factor VIII and factor IX assays need to be conducted, along with a lupus anticoagulant test. For inhibitor titer, either chromogenic assays or ELISA tests are recommended, they wrote.

Dr. Shetty and her coauthors reported that they had no conflicts of interest.

SOURCE: Patil R et al. Thromb Res. 2018 Dec;172:29-35.

A small but substantial proportion of patients with hemophilia A develop immediate acting factor VIII inhibitors, the diversity and complexity of which create a diagnostic challenge in the laboratory, according to authors of a recent observational study.

©designer491/Thinkstock

The great majority of the inhibitor-positive patients in the 4,900-patient study had classical FVIII inhibitors, which are typically time- and temperature-dependent and react more slowly in mixing studies, the researchers reported.

By contrast, about 1 in 10 patients demonstrated immediate acting inhibitors, and of those, some had lupus anticoagulants, some had factor VIII inhibitors, and some had both, according to Shrimati Shetty, PhD, of the National Institute of Immunohaematology in Mumbai, India, and her colleagues.

“There is a possibility of misdiagnosis of the patient when they present for the first time,” the researchers wrote. The report is in Thrombosis Research.

In the case of immediate-acting inhibitors, use of ELISA or chromogenic assays alongside lupus anticoagulant testing may help clarify the diagnosis; however, those tests are costly and may not be routinely available.

In the study by Dr. Shetty and her colleagues, patients in India with congenital hemophilia were initially screened for inhibitors. A total of 451 were found to be positive, and of those, 398 were observed to have classical factor VIII inhibitors, while the remaining 53 had immediate-acting inhibitors.

Looking specifically at hemophilia A patients with immediate-acting inhibitors, which comprised 48 of those 53 patients, the majority, or 42 patients, were positive for lupus anticoagulants, and of those, 38 were positive for both lupus anticoagulants and factor VIII inhibitors, while 4 patients were positive for lupus anticoagulants only.

“These are a heterogeneous group of antibodies interfering with all phospholipid dependent reactions,” the researchers wrote.

Properly interpreting factor inhibitor assays is an important step that helps guide later management of inhibitor-positive patients, according to Dr. Shetty and her coauthors.

“Once the patients become positive for inhibitors, they have to opt for alternate modalities of treatment, i.e. bypassing agents like activated prothrombin complex concentrate and activated recombinant factor VII, which are much more expensive,” they wrote.

In light of the diagnostic difficulties they highlighted, Dr. Shetty and her coauthors recommended a “systematic approach” to testing. Both factor VIII and factor IX assays need to be conducted, along with a lupus anticoagulant test. For inhibitor titer, either chromogenic assays or ELISA tests are recommended, they wrote.

Dr. Shetty and her coauthors reported that they had no conflicts of interest.

SOURCE: Patil R et al. Thromb Res. 2018 Dec;172:29-35.

Taking aspirin or an omega-3 polyunsaturated fatty acid daily did not reduce the colorectal adenoma detection rate among high-risk patients in a randomized, placebo-controlled trial, though both drugs showed potential chemopreventive effects.

There was no evidence that aspirin, eicosapentaenoic acid (EPA), or the two agents combined had any effect on the adenoma detection rate, reported Mark A. Hull, PhD, of the Institute of Biomedical and Clinical Sciences at the University of Leeds (England), and his coinvestigators.

However, both agents decreased the mean number of adenomas per participants, and showed subtype- and location-specific reductions in adenomas that were consistent with previous studies, according to the investigators.

“Existing data on colorectal cancer risk reduction by aspirin suggest that the decrease in colorectal adenoma recurrence that we report for both agents is likely to translate into a clinically meaningful decrease in long-term colorectal cancer risk,” Dr. Hull and his coauthors said in the report, which appears in the Lancet.

Their randomized, double-blind, multicenter trial, known as the seAFOod Polyp Prevention trial, included participants aged 55-73 years with high-risk adenoma features at screening colonoscopy. A total of 709 participants were enrolled between November 2011 and June 2016.

Adenoma detection rate, the primary endpoint, was 62% overall, and similarly, 63% in the EPA group, 61% in the aspirin group, 61% in the EPA plus aspirin group, and 61% for placebo. There was no evidence that either drug had any effect on this endpoint, according to investigators, who reported risk ratios of 0.98 (95% confidence interval, 0.87-1.12) for EPA and 0.99 (95% CI, 0.87-1.12) for aspirin.

However, aspirin reduced the mean total number of adenomas per participant versus placebo (incidence rate ratio, 0.78; 95% CI, 0.68-0.90), as well as the number of adenomas in the right colon (IRR, 0.73; 95% CI, 0.61-0.88).

While EPA by contrast did not conclusively reduce the mean total number of adenomas per participant, it did reduce the number of adenomas in the left colon, with an IRR of 0.75 (95% CI, 0.60-0.94).

Both aspirin and EPA were generally well tolerated, according to Dr. Hall and his colleagues, though the number of gastrointestinal adverse events was higher in the EPA-alone group, at 146 events, versus 85, 86, and 68 events in the placebo, aspirin, and EPA plus aspirin groups, respectively.

To optimize use of aspirin and EPA for prevention of colorectal adenomas, the approach might need to be tailored to the individual patient, Dr. Hall and his coauthors wrote.

“A key objective of future work will be to apply precision medicine principles to establish which individuals might gain most from chemoprevention with one or both agents, based on baseline colorectal adenoma characteristics alone or together with other mucosal biomarkers,” they added.

Trial funding came from the U.K. Medical Research Council and the National Institute for Health Research. Medicine and placebo were provided without charge by SLA Pharma and Bayer. Dr. Hull provided disclosures related to SLA Pharma, Bayer, and Thetis Pharmaceuticals.

SOURCE: Hull MA et al. Lancet. 2018 Nov 19. doi: 10.1016/S0140-6736(18)31775-6.

Taking aspirin or an omega-3 polyunsaturated fatty acid daily did not reduce the colorectal adenoma detection rate among high-risk patients in a randomized, placebo-controlled trial, though both drugs showed potential chemopreventive effects.

There was no evidence that aspirin, eicosapentaenoic acid (EPA), or the two agents combined had any effect on the adenoma detection rate, reported Mark A. Hull, PhD, of the Institute of Biomedical and Clinical Sciences at the University of Leeds (England), and his coinvestigators.

However, both agents decreased the mean number of adenomas per participants, and showed subtype- and location-specific reductions in adenomas that were consistent with previous studies, according to the investigators.

“Existing data on colorectal cancer risk reduction by aspirin suggest that the decrease in colorectal adenoma recurrence that we report for both agents is likely to translate into a clinically meaningful decrease in long-term colorectal cancer risk,” Dr. Hull and his coauthors said in the report, which appears in the Lancet.

Their randomized, double-blind, multicenter trial, known as the seAFOod Polyp Prevention trial, included participants aged 55-73 years with high-risk adenoma features at screening colonoscopy. A total of 709 participants were enrolled between November 2011 and June 2016.

Adenoma detection rate, the primary endpoint, was 62% overall, and similarly, 63% in the EPA group, 61% in the aspirin group, 61% in the EPA plus aspirin group, and 61% for placebo. There was no evidence that either drug had any effect on this endpoint, according to investigators, who reported risk ratios of 0.98 (95% confidence interval, 0.87-1.12) for EPA and 0.99 (95% CI, 0.87-1.12) for aspirin.

However, aspirin reduced the mean total number of adenomas per participant versus placebo (incidence rate ratio, 0.78; 95% CI, 0.68-0.90), as well as the number of adenomas in the right colon (IRR, 0.73; 95% CI, 0.61-0.88).

While EPA by contrast did not conclusively reduce the mean total number of adenomas per participant, it did reduce the number of adenomas in the left colon, with an IRR of 0.75 (95% CI, 0.60-0.94).

Both aspirin and EPA were generally well tolerated, according to Dr. Hall and his colleagues, though the number of gastrointestinal adverse events was higher in the EPA-alone group, at 146 events, versus 85, 86, and 68 events in the placebo, aspirin, and EPA plus aspirin groups, respectively.

To optimize use of aspirin and EPA for prevention of colorectal adenomas, the approach might need to be tailored to the individual patient, Dr. Hall and his coauthors wrote.

“A key objective of future work will be to apply precision medicine principles to establish which individuals might gain most from chemoprevention with one or both agents, based on baseline colorectal adenoma characteristics alone or together with other mucosal biomarkers,” they added.

Trial funding came from the U.K. Medical Research Council and the National Institute for Health Research. Medicine and placebo were provided without charge by SLA Pharma and Bayer. Dr. Hull provided disclosures related to SLA Pharma, Bayer, and Thetis Pharmaceuticals.

SOURCE: Hull MA et al. Lancet. 2018 Nov 19. doi: 10.1016/S0140-6736(18)31775-6.

Taking aspirin or an omega-3 polyunsaturated fatty acid daily did not reduce the colorectal adenoma detection rate among high-risk patients in a randomized, placebo-controlled trial, though both drugs showed potential chemopreventive effects.

There was no evidence that aspirin, eicosapentaenoic acid (EPA), or the two agents combined had any effect on the adenoma detection rate, reported Mark A. Hull, PhD, of the Institute of Biomedical and Clinical Sciences at the University of Leeds (England), and his coinvestigators.

However, both agents decreased the mean number of adenomas per participants, and showed subtype- and location-specific reductions in adenomas that were consistent with previous studies, according to the investigators.

“Existing data on colorectal cancer risk reduction by aspirin suggest that the decrease in colorectal adenoma recurrence that we report for both agents is likely to translate into a clinically meaningful decrease in long-term colorectal cancer risk,” Dr. Hull and his coauthors said in the report, which appears in the Lancet.

Their randomized, double-blind, multicenter trial, known as the seAFOod Polyp Prevention trial, included participants aged 55-73 years with high-risk adenoma features at screening colonoscopy. A total of 709 participants were enrolled between November 2011 and June 2016.

Adenoma detection rate, the primary endpoint, was 62% overall, and similarly, 63% in the EPA group, 61% in the aspirin group, 61% in the EPA plus aspirin group, and 61% for placebo. There was no evidence that either drug had any effect on this endpoint, according to investigators, who reported risk ratios of 0.98 (95% confidence interval, 0.87-1.12) for EPA and 0.99 (95% CI, 0.87-1.12) for aspirin.

However, aspirin reduced the mean total number of adenomas per participant versus placebo (incidence rate ratio, 0.78; 95% CI, 0.68-0.90), as well as the number of adenomas in the right colon (IRR, 0.73; 95% CI, 0.61-0.88).

While EPA by contrast did not conclusively reduce the mean total number of adenomas per participant, it did reduce the number of adenomas in the left colon, with an IRR of 0.75 (95% CI, 0.60-0.94).

Both aspirin and EPA were generally well tolerated, according to Dr. Hall and his colleagues, though the number of gastrointestinal adverse events was higher in the EPA-alone group, at 146 events, versus 85, 86, and 68 events in the placebo, aspirin, and EPA plus aspirin groups, respectively.

To optimize use of aspirin and EPA for prevention of colorectal adenomas, the approach might need to be tailored to the individual patient, Dr. Hall and his coauthors wrote.

“A key objective of future work will be to apply precision medicine principles to establish which individuals might gain most from chemoprevention with one or both agents, based on baseline colorectal adenoma characteristics alone or together with other mucosal biomarkers,” they added.

Trial funding came from the U.K. Medical Research Council and the National Institute for Health Research. Medicine and placebo were provided without charge by SLA Pharma and Bayer. Dr. Hull provided disclosures related to SLA Pharma, Bayer, and Thetis Pharmaceuticals.

SOURCE: Hull MA et al. Lancet. 2018 Nov 19. doi: 10.1016/S0140-6736(18)31775-6.

Photo by Elise Amendola

An initiative that reduced red blood cell (RBC) transfusions and increased moderate anemia in hospital did not adversely impact patients long-term, according to an analysis.

Researchers found that an increase in moderate in-hospital anemia did not increase subsequent RBC use, readmission, or mortality over the next 6 months.

However, authors of a related editorial argued that additional factors must be assessed to truly determine the effects of moderate anemia on patient outcomes.

The study and the editorial were published in the Annals of Internal Medicine.

Study: Long-term outcomes

Nareg H. Roubinian, MD, of Kaiser Permanente Northern California in Oakland, and colleagues sought to evaluate the impact of blood management programs—starting in 2010—that included blood-sparing surgical and medical techniques, increased use of hemostatic and cell salvage agents, and treatment of suboptimal iron stores before surgery.

In previous retrospective cohort studies, the researchers had found that blood conservation strategies did not impact in-hospital or 30-day mortality rates, which was consistent with short-term safety data from clinical trials and other observational studies.

Their new report on longer-term outcomes was based on data from Kaiser Permanente Northern California for 445,371 adults who had 801,261 hospitalizations with discharges between 2010 and 2014.

In this cohort, moderate anemia (hemoglobin between 7 g/dL and 10 g/dL) at discharge occurred in 119,489 patients (27%) and 187,440 hospitalizations overall (23%).

Over the 2010-2014 period, RBC transfusions decreased by more than 25% in the inpatient and outpatient settings. In parallel, the prevalence of moderate anemia at hospital discharge increased from 20% to 25%.

However, the risks of subsequent RBC transfusions and rehospitalization after discharge with anemia decreased during the study period, and mortality rates stayed steady or decreased slightly.

Among patients with moderate anemia, the proportion with subsequent RBC transfusions within 6 months decreased from 18.9% in 2010 to 16.8% in 2014 (P<0.001), while the rate of rehospitalization within 6 months decreased from 36.5% to 32.8% over that same time period (P<0.001).

The adjusted 6-month mortality rate likewise decreased from 16.1% to 15.6% (P=0.004) over that time period among patients with moderate anemia.

“These data support the efficacy and safety of practice recommendations to limit red blood cell transfusion in patients with anemia during and after hospitalization,” the researchers wrote.

However, they also said additional studies are needed to guide anemia management, particularly since persistent anemia has impacts on quality of life that are “likely to be substantial” and linked to the severity of that anemia.

This study was supported by a grant from the National Heart, Lung, and Blood Institute. Dr. Roubinian and several coauthors reported grants from the National Institutes of Health.

Editorial: Aim to treat anemia, not tolerate it

Dr. Roubinian and his colleagues’ findings warrant some scrutiny, according to Aryeh Shander, MD, of Englewood Hospital and Medical Center in New Jersey, and Lawrence Tim Goodnough, MD, of Stanford University in California.

“Missing here is a wide spectrum of morbidity outcomes and issues related to diminished quality of life that do not reach the level of severity that would necessitate admission but nonetheless detract from patients’ health and well-being,” Drs. Shander and Goodnough wrote in a related editorial.

They also noted that transfusion rate is not a clinical outcome, adding that readmission and mortality are important outcomes, but they do not accurately or fully reflect patient well-being.

While blood management initiatives may be a safe practice, as the study suggests, proper management of anemia after discharge may actually improve outcomes, given the many consequences of anemia, Drs. Shander and Goodnough wrote.

The pair suggested that, instead of again testing whether restricting transfusions is acceptable because of lack of impact on outcomes, future studies could evaluate a “more sensible” hypothesis that proper anemia management, especially post-discharge, could improve outcomes.

“Let’s increase efforts to prevent and treat anemia properly, rather than requiring patients to tolerate it,” Drs. Shander and Goodnough wrote.

Dr. Shander reported consulting fees from Vifor and AMAG. Dr. Goodnough reported having no relevant financial disclosures.

Photo by Elise Amendola

An initiative that reduced red blood cell (RBC) transfusions and increased moderate anemia in hospital did not adversely impact patients long-term, according to an analysis.

Researchers found that an increase in moderate in-hospital anemia did not increase subsequent RBC use, readmission, or mortality over the next 6 months.

However, authors of a related editorial argued that additional factors must be assessed to truly determine the effects of moderate anemia on patient outcomes.

The study and the editorial were published in the Annals of Internal Medicine.

Study: Long-term outcomes

Nareg H. Roubinian, MD, of Kaiser Permanente Northern California in Oakland, and colleagues sought to evaluate the impact of blood management programs—starting in 2010—that included blood-sparing surgical and medical techniques, increased use of hemostatic and cell salvage agents, and treatment of suboptimal iron stores before surgery.

In previous retrospective cohort studies, the researchers had found that blood conservation strategies did not impact in-hospital or 30-day mortality rates, which was consistent with short-term safety data from clinical trials and other observational studies.

Their new report on longer-term outcomes was based on data from Kaiser Permanente Northern California for 445,371 adults who had 801,261 hospitalizations with discharges between 2010 and 2014.

In this cohort, moderate anemia (hemoglobin between 7 g/dL and 10 g/dL) at discharge occurred in 119,489 patients (27%) and 187,440 hospitalizations overall (23%).

Over the 2010-2014 period, RBC transfusions decreased by more than 25% in the inpatient and outpatient settings. In parallel, the prevalence of moderate anemia at hospital discharge increased from 20% to 25%.

However, the risks of subsequent RBC transfusions and rehospitalization after discharge with anemia decreased during the study period, and mortality rates stayed steady or decreased slightly.

Among patients with moderate anemia, the proportion with subsequent RBC transfusions within 6 months decreased from 18.9% in 2010 to 16.8% in 2014 (P<0.001), while the rate of rehospitalization within 6 months decreased from 36.5% to 32.8% over that same time period (P<0.001).

The adjusted 6-month mortality rate likewise decreased from 16.1% to 15.6% (P=0.004) over that time period among patients with moderate anemia.

“These data support the efficacy and safety of practice recommendations to limit red blood cell transfusion in patients with anemia during and after hospitalization,” the researchers wrote.

However, they also said additional studies are needed to guide anemia management, particularly since persistent anemia has impacts on quality of life that are “likely to be substantial” and linked to the severity of that anemia.

This study was supported by a grant from the National Heart, Lung, and Blood Institute. Dr. Roubinian and several coauthors reported grants from the National Institutes of Health.

Editorial: Aim to treat anemia, not tolerate it

Dr. Roubinian and his colleagues’ findings warrant some scrutiny, according to Aryeh Shander, MD, of Englewood Hospital and Medical Center in New Jersey, and Lawrence Tim Goodnough, MD, of Stanford University in California.

“Missing here is a wide spectrum of morbidity outcomes and issues related to diminished quality of life that do not reach the level of severity that would necessitate admission but nonetheless detract from patients’ health and well-being,” Drs. Shander and Goodnough wrote in a related editorial.

They also noted that transfusion rate is not a clinical outcome, adding that readmission and mortality are important outcomes, but they do not accurately or fully reflect patient well-being.

While blood management initiatives may be a safe practice, as the study suggests, proper management of anemia after discharge may actually improve outcomes, given the many consequences of anemia, Drs. Shander and Goodnough wrote.

The pair suggested that, instead of again testing whether restricting transfusions is acceptable because of lack of impact on outcomes, future studies could evaluate a “more sensible” hypothesis that proper anemia management, especially post-discharge, could improve outcomes.

“Let’s increase efforts to prevent and treat anemia properly, rather than requiring patients to tolerate it,” Drs. Shander and Goodnough wrote.

Dr. Shander reported consulting fees from Vifor and AMAG. Dr. Goodnough reported having no relevant financial disclosures.

Photo by Elise Amendola

An initiative that reduced red blood cell (RBC) transfusions and increased moderate anemia in hospital did not adversely impact patients long-term, according to an analysis.

Researchers found that an increase in moderate in-hospital anemia did not increase subsequent RBC use, readmission, or mortality over the next 6 months.

However, authors of a related editorial argued that additional factors must be assessed to truly determine the effects of moderate anemia on patient outcomes.

The study and the editorial were published in the Annals of Internal Medicine.

Study: Long-term outcomes

Nareg H. Roubinian, MD, of Kaiser Permanente Northern California in Oakland, and colleagues sought to evaluate the impact of blood management programs—starting in 2010—that included blood-sparing surgical and medical techniques, increased use of hemostatic and cell salvage agents, and treatment of suboptimal iron stores before surgery.

In previous retrospective cohort studies, the researchers had found that blood conservation strategies did not impact in-hospital or 30-day mortality rates, which was consistent with short-term safety data from clinical trials and other observational studies.

Their new report on longer-term outcomes was based on data from Kaiser Permanente Northern California for 445,371 adults who had 801,261 hospitalizations with discharges between 2010 and 2014.

In this cohort, moderate anemia (hemoglobin between 7 g/dL and 10 g/dL) at discharge occurred in 119,489 patients (27%) and 187,440 hospitalizations overall (23%).

Over the 2010-2014 period, RBC transfusions decreased by more than 25% in the inpatient and outpatient settings. In parallel, the prevalence of moderate anemia at hospital discharge increased from 20% to 25%.

However, the risks of subsequent RBC transfusions and rehospitalization after discharge with anemia decreased during the study period, and mortality rates stayed steady or decreased slightly.

Among patients with moderate anemia, the proportion with subsequent RBC transfusions within 6 months decreased from 18.9% in 2010 to 16.8% in 2014 (P<0.001), while the rate of rehospitalization within 6 months decreased from 36.5% to 32.8% over that same time period (P<0.001).

The adjusted 6-month mortality rate likewise decreased from 16.1% to 15.6% (P=0.004) over that time period among patients with moderate anemia.

“These data support the efficacy and safety of practice recommendations to limit red blood cell transfusion in patients with anemia during and after hospitalization,” the researchers wrote.

However, they also said additional studies are needed to guide anemia management, particularly since persistent anemia has impacts on quality of life that are “likely to be substantial” and linked to the severity of that anemia.

This study was supported by a grant from the National Heart, Lung, and Blood Institute. Dr. Roubinian and several coauthors reported grants from the National Institutes of Health.

Editorial: Aim to treat anemia, not tolerate it

Dr. Roubinian and his colleagues’ findings warrant some scrutiny, according to Aryeh Shander, MD, of Englewood Hospital and Medical Center in New Jersey, and Lawrence Tim Goodnough, MD, of Stanford University in California.

“Missing here is a wide spectrum of morbidity outcomes and issues related to diminished quality of life that do not reach the level of severity that would necessitate admission but nonetheless detract from patients’ health and well-being,” Drs. Shander and Goodnough wrote in a related editorial.

They also noted that transfusion rate is not a clinical outcome, adding that readmission and mortality are important outcomes, but they do not accurately or fully reflect patient well-being.

While blood management initiatives may be a safe practice, as the study suggests, proper management of anemia after discharge may actually improve outcomes, given the many consequences of anemia, Drs. Shander and Goodnough wrote.

The pair suggested that, instead of again testing whether restricting transfusions is acceptable because of lack of impact on outcomes, future studies could evaluate a “more sensible” hypothesis that proper anemia management, especially post-discharge, could improve outcomes.

“Let’s increase efforts to prevent and treat anemia properly, rather than requiring patients to tolerate it,” Drs. Shander and Goodnough wrote.

Dr. Shander reported consulting fees from Vifor and AMAG. Dr. Goodnough reported having no relevant financial disclosures.

A back pain screening questionnaire developed for ankylosing spondylitis performs well for identifying the subset of axial psoriatic arthritis patients who have active symptoms, according to researchers.

The inflammatory back pain criteria didn’t perform as well when patients with established disease but no symptoms were included, though using a lower cutoff point for the questionnaire improved its sensitivity, the researchers reported in the Annals of the Rheumatic Diseases.

Previous investigations showed that the inflammatory back pain criteria, as defined by the Assessment of Spondyloarthritis International Society (ASAS), had low sensitivity and high specificity for axial involvement in psoriatic arthritis.

Those earlier studies may have registered suboptimal performance of the inflammatory back pain criteria by not distinguishing between patients with axial disease in remission and those with active symptoms, according to Muhammad Haroon, PhD, of the division of rheumatology at University Hospital Kerry in Tralee, Ireland, and his coinvestigators.

The present study, which they said represents a much larger cohort than earlier investigations, included 406 patients with psoriatic arthritis, about one-quarter of whom had rheumatologist-diagnosed axial psoriatic arthritis. The mean age of the axial psoriatic arthritis patients was 51 years and 53% were male.

The researchers found that the inflammatory back pain criteria had poor sensitivity but good specificity at 59% and 84%, respectively, in patients with established axial psoriatic arthritis, defined as axial disease regardless of whether it was active or in remission.

By contrast, the criteria had good sensitivity and good specificity at 82% and 88%, respectively, in patients who had active axial psoriatic arthritis, according to the investigators.

The standard cutoff points used by the ASAS inflammatory back pain criteria may be too high for screening for early disease or for evaluating patients already receiving systemic therapies for psoriatic disease, the investigators said.

Looking at a lower cutoff point of three of five ASAS criteria, sensitivity was “quite high” for detecting established axial psoriatic arthritis, they said, increasing from 59% to 84%, while specificity remained relatively high, decreasing from 84% to 80%.

“We suggest that the standard cutoffs for this questionnaire be used for patients with active axial psoriatic arthritis, and the lower cutoffs should be used among patients with established axial psoriatic arthritis, where patients can potentially be in remission or partial remission,” they wrote in their report.

These findings could have important implications for the use of this screening tool in patients with psoriatic arthritis; however, more research is needed to validate the observations, the researchers cautioned.

Dr. Haroon reported competing interests related to AbbVie, Pfizer, and Celgene.

SOURCE: Haroon M et al. Ann Rheum Dis. 2018 Dec 14. doi: 10.1136/annrheumdis-2018-214583.

A back pain screening questionnaire developed for ankylosing spondylitis performs well for identifying the subset of axial psoriatic arthritis patients who have active symptoms, according to researchers.

The inflammatory back pain criteria didn’t perform as well when patients with established disease but no symptoms were included, though using a lower cutoff point for the questionnaire improved its sensitivity, the researchers reported in the Annals of the Rheumatic Diseases.

Previous investigations showed that the inflammatory back pain criteria, as defined by the Assessment of Spondyloarthritis International Society (ASAS), had low sensitivity and high specificity for axial involvement in psoriatic arthritis.

Those earlier studies may have registered suboptimal performance of the inflammatory back pain criteria by not distinguishing between patients with axial disease in remission and those with active symptoms, according to Muhammad Haroon, PhD, of the division of rheumatology at University Hospital Kerry in Tralee, Ireland, and his coinvestigators.

The present study, which they said represents a much larger cohort than earlier investigations, included 406 patients with psoriatic arthritis, about one-quarter of whom had rheumatologist-diagnosed axial psoriatic arthritis. The mean age of the axial psoriatic arthritis patients was 51 years and 53% were male.

The researchers found that the inflammatory back pain criteria had poor sensitivity but good specificity at 59% and 84%, respectively, in patients with established axial psoriatic arthritis, defined as axial disease regardless of whether it was active or in remission.

By contrast, the criteria had good sensitivity and good specificity at 82% and 88%, respectively, in patients who had active axial psoriatic arthritis, according to the investigators.

The standard cutoff points used by the ASAS inflammatory back pain criteria may be too high for screening for early disease or for evaluating patients already receiving systemic therapies for psoriatic disease, the investigators said.

Looking at a lower cutoff point of three of five ASAS criteria, sensitivity was “quite high” for detecting established axial psoriatic arthritis, they said, increasing from 59% to 84%, while specificity remained relatively high, decreasing from 84% to 80%.

“We suggest that the standard cutoffs for this questionnaire be used for patients with active axial psoriatic arthritis, and the lower cutoffs should be used among patients with established axial psoriatic arthritis, where patients can potentially be in remission or partial remission,” they wrote in their report.

These findings could have important implications for the use of this screening tool in patients with psoriatic arthritis; however, more research is needed to validate the observations, the researchers cautioned.

Dr. Haroon reported competing interests related to AbbVie, Pfizer, and Celgene.

SOURCE: Haroon M et al. Ann Rheum Dis. 2018 Dec 14. doi: 10.1136/annrheumdis-2018-214583.

A back pain screening questionnaire developed for ankylosing spondylitis performs well for identifying the subset of axial psoriatic arthritis patients who have active symptoms, according to researchers.

The inflammatory back pain criteria didn’t perform as well when patients with established disease but no symptoms were included, though using a lower cutoff point for the questionnaire improved its sensitivity, the researchers reported in the Annals of the Rheumatic Diseases.

Previous investigations showed that the inflammatory back pain criteria, as defined by the Assessment of Spondyloarthritis International Society (ASAS), had low sensitivity and high specificity for axial involvement in psoriatic arthritis.

Those earlier studies may have registered suboptimal performance of the inflammatory back pain criteria by not distinguishing between patients with axial disease in remission and those with active symptoms, according to Muhammad Haroon, PhD, of the division of rheumatology at University Hospital Kerry in Tralee, Ireland, and his coinvestigators.

The present study, which they said represents a much larger cohort than earlier investigations, included 406 patients with psoriatic arthritis, about one-quarter of whom had rheumatologist-diagnosed axial psoriatic arthritis. The mean age of the axial psoriatic arthritis patients was 51 years and 53% were male.

The researchers found that the inflammatory back pain criteria had poor sensitivity but good specificity at 59% and 84%, respectively, in patients with established axial psoriatic arthritis, defined as axial disease regardless of whether it was active or in remission.

By contrast, the criteria had good sensitivity and good specificity at 82% and 88%, respectively, in patients who had active axial psoriatic arthritis, according to the investigators.

The standard cutoff points used by the ASAS inflammatory back pain criteria may be too high for screening for early disease or for evaluating patients already receiving systemic therapies for psoriatic disease, the investigators said.

Looking at a lower cutoff point of three of five ASAS criteria, sensitivity was “quite high” for detecting established axial psoriatic arthritis, they said, increasing from 59% to 84%, while specificity remained relatively high, decreasing from 84% to 80%.

“We suggest that the standard cutoffs for this questionnaire be used for patients with active axial psoriatic arthritis, and the lower cutoffs should be used among patients with established axial psoriatic arthritis, where patients can potentially be in remission or partial remission,” they wrote in their report.

These findings could have important implications for the use of this screening tool in patients with psoriatic arthritis; however, more research is needed to validate the observations, the researchers cautioned.

Dr. Haroon reported competing interests related to AbbVie, Pfizer, and Celgene.

SOURCE: Haroon M et al. Ann Rheum Dis. 2018 Dec 14. doi: 10.1136/annrheumdis-2018-214583.

SAN DIEGO – Switching to lenalidomide maintenance after nine cycles of lenalidomide/dexamethasone (Rd) may avoid toxicity without sacrificing survival benefit in elderly multiple myeloma patients of intermediate fitness, results from a randomized trial showed.

Andrew D. Bowser/MDedge News

The Rd-R strategy yielded a “slight improvement” in event-free survival due largely to fewer adverse events, and no significant differences in progression-free or overall survival versus continuous Rd, reported Alessandra Larocca, MD, of GIMEMA/European Myeloma Network in Italy.

That finding suggests the promise of adapting myeloma treatment to a patient’s level of frailty or fitness, as determined by a myeloma frailty score, Dr. Larocca said at the annual meeting of the American Society of Hematology.

“A frailty-adjusted treatment approach is important in intermediate-fit patients to balance efficacy and safety,” she said.

The frailty score, developed by the International Myeloma Working Group (IMWG), classifies individuals as fit, intermediate, or frail based on age, comorbidities, cognitive status, and functional status. In a 2015 report in Blood, the IMWG frailty score was shown to predict mortality and treatment-related toxicity in elderly myeloma patients.

Dr. Larocca described results of the RV-MM-PI-0752 phase 3 study, which enrolled 199 newly diagnosed myeloma patients of intermediate fitness and randomized them to continuous Rd or nine cycles of Rd induction followed by lenalidomide maintenance (Rd-R).

The goal was to see if Rd could be “further optimized” for elderly, intermediate-fit patients, Dr. Larocca said.

The primary endpoint of RV-MM-PI-0752 was event-free survival, which included grade 4 hematologic and grade 3-4 nonhematologic adverse events, lenalidomide discontinuation, disease progression, or death.

Median event-free survival was 9.3 months for the Rd-R strategy, compared with 6.6 months for continuous Rd (hazard ratio, 0.72; 95% confidence interval, 0.52-0.99; P = .044), Dr. Larocca reported.

No difference was seen in survival outcomes, she added. The 20-month progression-free survival was 43% and 42% for Rd-R and continuous Rd, respectively. The 20-month overall survival was 84% vs. 79%, with P values that were not significant for either comparison.

Patients in the Rd-R group had a somewhat higher incidence of grade 3 or greater neutropenia, but the continuous Rd group had a somewhat higher rate of nonhematologic adverse events, leading to slightly higher rates of lenalidomide discontinuation and dose reduction, Dr. Larocca said.

Overall, 9% of patients dropped out of the RV-MM-PI-0752 trial within the first 60 days, due mainly to toxicity, she added.

“We have to evaluate how to better prevent toxicity, potentially enabling patients to stay on therapy longer,” Dr. Larocca said. “Probably we have to evaluate, in prospective clinical trials, the role of up-front dose adjustment or dose reduction, and subsequent dose increase in a subgroup of patients.”

Dr. Larocca reported disclosures related to Celgene, Bristol-Myers Squibb, Janssen-Cilag, Takeda, and Amgen.

SOURCE: Larocca A, et al. ASH 2018, Abstract 305.

SAN DIEGO – Switching to lenalidomide maintenance after nine cycles of lenalidomide/dexamethasone (Rd) may avoid toxicity without sacrificing survival benefit in elderly multiple myeloma patients of intermediate fitness, results from a randomized trial showed.

Andrew D. Bowser/MDedge News

The Rd-R strategy yielded a “slight improvement” in event-free survival due largely to fewer adverse events, and no significant differences in progression-free or overall survival versus continuous Rd, reported Alessandra Larocca, MD, of GIMEMA/European Myeloma Network in Italy.

That finding suggests the promise of adapting myeloma treatment to a patient’s level of frailty or fitness, as determined by a myeloma frailty score, Dr. Larocca said at the annual meeting of the American Society of Hematology.

“A frailty-adjusted treatment approach is important in intermediate-fit patients to balance efficacy and safety,” she said.

The frailty score, developed by the International Myeloma Working Group (IMWG), classifies individuals as fit, intermediate, or frail based on age, comorbidities, cognitive status, and functional status. In a 2015 report in Blood, the IMWG frailty score was shown to predict mortality and treatment-related toxicity in elderly myeloma patients.

Dr. Larocca described results of the RV-MM-PI-0752 phase 3 study, which enrolled 199 newly diagnosed myeloma patients of intermediate fitness and randomized them to continuous Rd or nine cycles of Rd induction followed by lenalidomide maintenance (Rd-R).

The goal was to see if Rd could be “further optimized” for elderly, intermediate-fit patients, Dr. Larocca said.

The primary endpoint of RV-MM-PI-0752 was event-free survival, which included grade 4 hematologic and grade 3-4 nonhematologic adverse events, lenalidomide discontinuation, disease progression, or death.

Median event-free survival was 9.3 months for the Rd-R strategy, compared with 6.6 months for continuous Rd (hazard ratio, 0.72; 95% confidence interval, 0.52-0.99; P = .044), Dr. Larocca reported.

No difference was seen in survival outcomes, she added. The 20-month progression-free survival was 43% and 42% for Rd-R and continuous Rd, respectively. The 20-month overall survival was 84% vs. 79%, with P values that were not significant for either comparison.

Patients in the Rd-R group had a somewhat higher incidence of grade 3 or greater neutropenia, but the continuous Rd group had a somewhat higher rate of nonhematologic adverse events, leading to slightly higher rates of lenalidomide discontinuation and dose reduction, Dr. Larocca said.

Overall, 9% of patients dropped out of the RV-MM-PI-0752 trial within the first 60 days, due mainly to toxicity, she added.

“We have to evaluate how to better prevent toxicity, potentially enabling patients to stay on therapy longer,” Dr. Larocca said. “Probably we have to evaluate, in prospective clinical trials, the role of up-front dose adjustment or dose reduction, and subsequent dose increase in a subgroup of patients.”

Dr. Larocca reported disclosures related to Celgene, Bristol-Myers Squibb, Janssen-Cilag, Takeda, and Amgen.

SOURCE: Larocca A, et al. ASH 2018, Abstract 305.

SAN DIEGO – Switching to lenalidomide maintenance after nine cycles of lenalidomide/dexamethasone (Rd) may avoid toxicity without sacrificing survival benefit in elderly multiple myeloma patients of intermediate fitness, results from a randomized trial showed.

Andrew D. Bowser/MDedge News

The Rd-R strategy yielded a “slight improvement” in event-free survival due largely to fewer adverse events, and no significant differences in progression-free or overall survival versus continuous Rd, reported Alessandra Larocca, MD, of GIMEMA/European Myeloma Network in Italy.

That finding suggests the promise of adapting myeloma treatment to a patient’s level of frailty or fitness, as determined by a myeloma frailty score, Dr. Larocca said at the annual meeting of the American Society of Hematology.

“A frailty-adjusted treatment approach is important in intermediate-fit patients to balance efficacy and safety,” she said.

The frailty score, developed by the International Myeloma Working Group (IMWG), classifies individuals as fit, intermediate, or frail based on age, comorbidities, cognitive status, and functional status. In a 2015 report in Blood, the IMWG frailty score was shown to predict mortality and treatment-related toxicity in elderly myeloma patients.

Dr. Larocca described results of the RV-MM-PI-0752 phase 3 study, which enrolled 199 newly diagnosed myeloma patients of intermediate fitness and randomized them to continuous Rd or nine cycles of Rd induction followed by lenalidomide maintenance (Rd-R).

The goal was to see if Rd could be “further optimized” for elderly, intermediate-fit patients, Dr. Larocca said.

The primary endpoint of RV-MM-PI-0752 was event-free survival, which included grade 4 hematologic and grade 3-4 nonhematologic adverse events, lenalidomide discontinuation, disease progression, or death.

Median event-free survival was 9.3 months for the Rd-R strategy, compared with 6.6 months for continuous Rd (hazard ratio, 0.72; 95% confidence interval, 0.52-0.99; P = .044), Dr. Larocca reported.

No difference was seen in survival outcomes, she added. The 20-month progression-free survival was 43% and 42% for Rd-R and continuous Rd, respectively. The 20-month overall survival was 84% vs. 79%, with P values that were not significant for either comparison.

Patients in the Rd-R group had a somewhat higher incidence of grade 3 or greater neutropenia, but the continuous Rd group had a somewhat higher rate of nonhematologic adverse events, leading to slightly higher rates of lenalidomide discontinuation and dose reduction, Dr. Larocca said.

Overall, 9% of patients dropped out of the RV-MM-PI-0752 trial within the first 60 days, due mainly to toxicity, she added.

“We have to evaluate how to better prevent toxicity, potentially enabling patients to stay on therapy longer,” Dr. Larocca said. “Probably we have to evaluate, in prospective clinical trials, the role of up-front dose adjustment or dose reduction, and subsequent dose increase in a subgroup of patients.”

Dr. Larocca reported disclosures related to Celgene, Bristol-Myers Squibb, Janssen-Cilag, Takeda, and Amgen.

SOURCE: Larocca A, et al. ASH 2018, Abstract 305.

Marburg virus has been found in fruit bats in Sierra Leone, marking the first appearance of the deadly, Ebola-like virus in West Africa, the Centers for Disease Control and Prevention (CDC) is reporting.

Wikimedia Commons/Mickey Samuni-Blank

Five Egyptian rousette fruit bats found in three different districts tested positive for infection with Marburg virus, a cousin to Ebola that can cause a hemorrhagic fever with case fatality rates up to 90%, according to CDC.

While no confirmed cases of Marburg infection have been reported in Sierra Leone, the presence of virus in these bats indicates that people nearby may be at risk, according to scientists.

“We have known for a long time that rousette bats, which carry Marburg virus in other parts of Africa, also live in West Africa, so it’s not surprising that we’d find the virus in bats there,” CDC ecologist Jonathan S. Towner, PhD, said in a news release.

The Egyptian rousette bat (Rousettus aegyptiacus) is the natural reservoir for Marburg, shedding the virus in saliva, urine, and feces while feeding on fruit. People and are exposed to the virus when they eat contaminated fruit or capture bats for food, according to the CDC.

The most recent Marburg virus outbreak, which occurred in Uganda in 2017, was the 12th reported outbreak linked to Africa, according to the agency. The largest and deadliest outbreak occurred in 2005 in Angola, infecting 252 people, of whom 90% died.

Testing of the Marburg-positive bats revealed genetically diverse strains, suggesting the virus has been present in Sierra Leone bat colonies for many years, the agency said. Two of the four Marburg virus strains identified in the Sierra Leone bats were genetically similar to the strain implicated in the Angola outbreak.

Egyptian fruit bats are in fact common throughout Africa, living in caves or underground mines. Marburg-positive bats have been found in sub-Saharan Africa, according to researchers, mainly in Uganda and the Democratic Republic of Congo.

Colonies of Egyptian fruit bats can number more than 100,000 animals in eastern and central Africa, while in Sierra Leone, colonies are much smaller, which may explain the lack of Marburg virus disease outbreaks in that country, CDC said.

Discovery of Marburg virus in Sierra Leone was the result of two projects, one led by the CDC and Njala University in Freetown, Sierra Leone, and the other by the University of California, Davis, and the University of Makeni, Sierra Leone, which was funded by the United States Agency for International Development (USAID).

“This discovery is an excellent example of how our work can identify a threat and help us warn people of the risk before they get sick.” Dr. Towner said in the news release.

The two projects began in 2016 after the large Ebola outbreak in West Africa with the aim of identifying the reservoir of Ebola, according to CDC.

SOURCES: U.S. Department of Health and Human Services CDC Newsroom and Centers for Disease Control and Prevention (Marburg Virus).

Marburg virus has been found in fruit bats in Sierra Leone, marking the first appearance of the deadly, Ebola-like virus in West Africa, the Centers for Disease Control and Prevention (CDC) is reporting.

Wikimedia Commons/Mickey Samuni-Blank

Five Egyptian rousette fruit bats found in three different districts tested positive for infection with Marburg virus, a cousin to Ebola that can cause a hemorrhagic fever with case fatality rates up to 90%, according to CDC.

While no confirmed cases of Marburg infection have been reported in Sierra Leone, the presence of virus in these bats indicates that people nearby may be at risk, according to scientists.

“We have known for a long time that rousette bats, which carry Marburg virus in other parts of Africa, also live in West Africa, so it’s not surprising that we’d find the virus in bats there,” CDC ecologist Jonathan S. Towner, PhD, said in a news release.

The Egyptian rousette bat (Rousettus aegyptiacus) is the natural reservoir for Marburg, shedding the virus in saliva, urine, and feces while feeding on fruit. People and are exposed to the virus when they eat contaminated fruit or capture bats for food, according to the CDC.

The most recent Marburg virus outbreak, which occurred in Uganda in 2017, was the 12th reported outbreak linked to Africa, according to the agency. The largest and deadliest outbreak occurred in 2005 in Angola, infecting 252 people, of whom 90% died.

Testing of the Marburg-positive bats revealed genetically diverse strains, suggesting the virus has been present in Sierra Leone bat colonies for many years, the agency said. Two of the four Marburg virus strains identified in the Sierra Leone bats were genetically similar to the strain implicated in the Angola outbreak.

Egyptian fruit bats are in fact common throughout Africa, living in caves or underground mines. Marburg-positive bats have been found in sub-Saharan Africa, according to researchers, mainly in Uganda and the Democratic Republic of Congo.

Colonies of Egyptian fruit bats can number more than 100,000 animals in eastern and central Africa, while in Sierra Leone, colonies are much smaller, which may explain the lack of Marburg virus disease outbreaks in that country, CDC said.

Discovery of Marburg virus in Sierra Leone was the result of two projects, one led by the CDC and Njala University in Freetown, Sierra Leone, and the other by the University of California, Davis, and the University of Makeni, Sierra Leone, which was funded by the United States Agency for International Development (USAID).

“This discovery is an excellent example of how our work can identify a threat and help us warn people of the risk before they get sick.” Dr. Towner said in the news release.

The two projects began in 2016 after the large Ebola outbreak in West Africa with the aim of identifying the reservoir of Ebola, according to CDC.

SOURCES: U.S. Department of Health and Human Services CDC Newsroom and Centers for Disease Control and Prevention (Marburg Virus).

Marburg virus has been found in fruit bats in Sierra Leone, marking the first appearance of the deadly, Ebola-like virus in West Africa, the Centers for Disease Control and Prevention (CDC) is reporting.

Wikimedia Commons/Mickey Samuni-Blank

Five Egyptian rousette fruit bats found in three different districts tested positive for infection with Marburg virus, a cousin to Ebola that can cause a hemorrhagic fever with case fatality rates up to 90%, according to CDC.

While no confirmed cases of Marburg infection have been reported in Sierra Leone, the presence of virus in these bats indicates that people nearby may be at risk, according to scientists.

“We have known for a long time that rousette bats, which carry Marburg virus in other parts of Africa, also live in West Africa, so it’s not surprising that we’d find the virus in bats there,” CDC ecologist Jonathan S. Towner, PhD, said in a news release.

The Egyptian rousette bat (Rousettus aegyptiacus) is the natural reservoir for Marburg, shedding the virus in saliva, urine, and feces while feeding on fruit. People and are exposed to the virus when they eat contaminated fruit or capture bats for food, according to the CDC.

The most recent Marburg virus outbreak, which occurred in Uganda in 2017, was the 12th reported outbreak linked to Africa, according to the agency. The largest and deadliest outbreak occurred in 2005 in Angola, infecting 252 people, of whom 90% died.

Testing of the Marburg-positive bats revealed genetically diverse strains, suggesting the virus has been present in Sierra Leone bat colonies for many years, the agency said. Two of the four Marburg virus strains identified in the Sierra Leone bats were genetically similar to the strain implicated in the Angola outbreak.

Egyptian fruit bats are in fact common throughout Africa, living in caves or underground mines. Marburg-positive bats have been found in sub-Saharan Africa, according to researchers, mainly in Uganda and the Democratic Republic of Congo.

Colonies of Egyptian fruit bats can number more than 100,000 animals in eastern and central Africa, while in Sierra Leone, colonies are much smaller, which may explain the lack of Marburg virus disease outbreaks in that country, CDC said.

Discovery of Marburg virus in Sierra Leone was the result of two projects, one led by the CDC and Njala University in Freetown, Sierra Leone, and the other by the University of California, Davis, and the University of Makeni, Sierra Leone, which was funded by the United States Agency for International Development (USAID).

“This discovery is an excellent example of how our work can identify a threat and help us warn people of the risk before they get sick.” Dr. Towner said in the news release.

The two projects began in 2016 after the large Ebola outbreak in West Africa with the aim of identifying the reservoir of Ebola, according to CDC.

SOURCES: U.S. Department of Health and Human Services CDC Newsroom and Centers for Disease Control and Prevention (Marburg Virus).

An mRNA-based assay for surveillance of patients with bladder cancer outperformed standard urine tests on certain measures in a validation study, investigators report.

The mRNA-based urine test (Xpert, Cepheid) had better sensitivity and negative predictive value compared to urine cytology and to UroVysion fluorescence in situ hybridization (FISH) testing, according to F. Johannes P. van Valenberg, of Radboud University Medical Center, Nijmegen, the Netherlands, and his colleagues.

The reported results suggest this mRNA test could partially replace white-light cystoscopy, helping urologists maintain the recommended follow-up schedules for patients with a history of bladder cancer, Dr. van Valenberg and his coauthors wrote. The report is in European Urology.

“If used in the follow-up of non–muscle invasive bladder cancer, a cystoscopy might be waived if the Xpert result is negative,” they wrote.

The negative predictive value for high-grade disease was 98%, suggesting the mRNA-based test could help urologists avoid invasive cystoscopies for intermediate- to high-risk patients, which could reduce costs and patient discomfort, they added.

The prospective, 19-center validation study enrolled 363 individuals with a history of non–muscle invasive bladder cancer who were scheduled for a standard cystoscopy. Voided urine specimens from a total of 259 patients were evaluated with all three methods: the mRNA test, FISH testing, and cytology.

In a comparison of the tests, the mRNA test identified more recurrent cancers correctly, and was more sensitive in detecting low-grade tumors than was FISH (P less than .001) or cytology (P = .021), they reported.

The mRNA test was more sensitive for detection of the most common recurrent tumors, independent of grade.

The sensitivity, specificity, and negative predictive values for mRNA testing were 74%, 80%, and 93%, respectively. By comparison the sensitivity, specificity, and negative predictive values were 51%, 80%, and 88% for FISH and 30%, 90%, and 86% for cytology.

Looking at high-grade disease only, the sensitivity, specificity, and negative predictive values were 83.3%, 75.8%, and 97.6% for mRNA testing, 75.0%, 79.5%, and 96.6% for FISH testing, and 50.0%, 90.7%, and 94.2% for cytology.

Bacillus Calmette-Guérin treatment in the past 90 days did not influence results of the mRNA test, one additional analysis showed.

The Xpert mRNA assay evaluates five mRNA targets: ABL1, ANXA10, UPK1B, CRH, and IGF2, results of which are combined to classify samples as either negative or positive. The test has a “hands-on time” of less than 2 minutes and provides results in 90 minutes, according to Dr. van Valenberg and his coinvestigators.

“Cytology requires a review by a pathologist, is not performed on the same day as a clinic visit, and has associated inter- and intraobserver variability,” the researchers wrote.

Dr. van Valenberg reported no financial disclosures related to the study. Several study coauthors reported employment or financial disclosures related to Cepheid, which provided funding and support for the conduct of the study. Study coauthors provided additional disclosures related to MDxHealth, PHotocure, Bristol-Myers Squibb, Johnson & Johnson, Roche, Bayer, and Astellas, among others.
 

SOURCE: van Valenberg FJP et al. Eur Urol. 2018 Dec 12. doi: 10.1016/j.eururo.2018.11.055.

An mRNA-based assay for surveillance of patients with bladder cancer outperformed standard urine tests on certain measures in a validation study, investigators report.

The mRNA-based urine test (Xpert, Cepheid) had better sensitivity and negative predictive value compared to urine cytology and to UroVysion fluorescence in situ hybridization (FISH) testing, according to F. Johannes P. van Valenberg, of Radboud University Medical Center, Nijmegen, the Netherlands, and his colleagues.

The reported results suggest this mRNA test could partially replace white-light cystoscopy, helping urologists maintain the recommended follow-up schedules for patients with a history of bladder cancer, Dr. van Valenberg and his coauthors wrote. The report is in European Urology.

“If used in the follow-up of non–muscle invasive bladder cancer, a cystoscopy might be waived if the Xpert result is negative,” they wrote.

The negative predictive value for high-grade disease was 98%, suggesting the mRNA-based test could help urologists avoid invasive cystoscopies for intermediate- to high-risk patients, which could reduce costs and patient discomfort, they added.

The prospective, 19-center validation study enrolled 363 individuals with a history of non–muscle invasive bladder cancer who were scheduled for a standard cystoscopy. Voided urine specimens from a total of 259 patients were evaluated with all three methods: the mRNA test, FISH testing, and cytology.

In a comparison of the tests, the mRNA test identified more recurrent cancers correctly, and was more sensitive in detecting low-grade tumors than was FISH (P less than .001) or cytology (P = .021), they reported.

The mRNA test was more sensitive for detection of the most common recurrent tumors, independent of grade.

The sensitivity, specificity, and negative predictive values for mRNA testing were 74%, 80%, and 93%, respectively. By comparison the sensitivity, specificity, and negative predictive values were 51%, 80%, and 88% for FISH and 30%, 90%, and 86% for cytology.

Looking at high-grade disease only, the sensitivity, specificity, and negative predictive values were 83.3%, 75.8%, and 97.6% for mRNA testing, 75.0%, 79.5%, and 96.6% for FISH testing, and 50.0%, 90.7%, and 94.2% for cytology.

Bacillus Calmette-Guérin treatment in the past 90 days did not influence results of the mRNA test, one additional analysis showed.

The Xpert mRNA assay evaluates five mRNA targets: ABL1, ANXA10, UPK1B, CRH, and IGF2, results of which are combined to classify samples as either negative or positive. The test has a “hands-on time” of less than 2 minutes and provides results in 90 minutes, according to Dr. van Valenberg and his coinvestigators.

“Cytology requires a review by a pathologist, is not performed on the same day as a clinic visit, and has associated inter- and intraobserver variability,” the researchers wrote.

Dr. van Valenberg reported no financial disclosures related to the study. Several study coauthors reported employment or financial disclosures related to Cepheid, which provided funding and support for the conduct of the study. Study coauthors provided additional disclosures related to MDxHealth, PHotocure, Bristol-Myers Squibb, Johnson & Johnson, Roche, Bayer, and Astellas, among others.
 

SOURCE: van Valenberg FJP et al. Eur Urol. 2018 Dec 12. doi: 10.1016/j.eururo.2018.11.055.

An mRNA-based assay for surveillance of patients with bladder cancer outperformed standard urine tests on certain measures in a validation study, investigators report.

The mRNA-based urine test (Xpert, Cepheid) had better sensitivity and negative predictive value compared to urine cytology and to UroVysion fluorescence in situ hybridization (FISH) testing, according to F. Johannes P. van Valenberg, of Radboud University Medical Center, Nijmegen, the Netherlands, and his colleagues.

The reported results suggest this mRNA test could partially replace white-light cystoscopy, helping urologists maintain the recommended follow-up schedules for patients with a history of bladder cancer, Dr. van Valenberg and his coauthors wrote. The report is in European Urology.

“If used in the follow-up of non–muscle invasive bladder cancer, a cystoscopy might be waived if the Xpert result is negative,” they wrote.

The negative predictive value for high-grade disease was 98%, suggesting the mRNA-based test could help urologists avoid invasive cystoscopies for intermediate- to high-risk patients, which could reduce costs and patient discomfort, they added.

The prospective, 19-center validation study enrolled 363 individuals with a history of non–muscle invasive bladder cancer who were scheduled for a standard cystoscopy. Voided urine specimens from a total of 259 patients were evaluated with all three methods: the mRNA test, FISH testing, and cytology.

In a comparison of the tests, the mRNA test identified more recurrent cancers correctly, and was more sensitive in detecting low-grade tumors than was FISH (P less than .001) or cytology (P = .021), they reported.

The mRNA test was more sensitive for detection of the most common recurrent tumors, independent of grade.

The sensitivity, specificity, and negative predictive values for mRNA testing were 74%, 80%, and 93%, respectively. By comparison the sensitivity, specificity, and negative predictive values were 51%, 80%, and 88% for FISH and 30%, 90%, and 86% for cytology.

Looking at high-grade disease only, the sensitivity, specificity, and negative predictive values were 83.3%, 75.8%, and 97.6% for mRNA testing, 75.0%, 79.5%, and 96.6% for FISH testing, and 50.0%, 90.7%, and 94.2% for cytology.

Bacillus Calmette-Guérin treatment in the past 90 days did not influence results of the mRNA test, one additional analysis showed.

The Xpert mRNA assay evaluates five mRNA targets: ABL1, ANXA10, UPK1B, CRH, and IGF2, results of which are combined to classify samples as either negative or positive. The test has a “hands-on time” of less than 2 minutes and provides results in 90 minutes, according to Dr. van Valenberg and his coinvestigators.

“Cytology requires a review by a pathologist, is not performed on the same day as a clinic visit, and has associated inter- and intraobserver variability,” the researchers wrote.

Dr. van Valenberg reported no financial disclosures related to the study. Several study coauthors reported employment or financial disclosures related to Cepheid, which provided funding and support for the conduct of the study. Study coauthors provided additional disclosures related to MDxHealth, PHotocure, Bristol-Myers Squibb, Johnson & Johnson, Roche, Bayer, and Astellas, among others.
 

SOURCE: van Valenberg FJP et al. Eur Urol. 2018 Dec 12. doi: 10.1016/j.eururo.2018.11.055.

Patients with multiple sclerosis (MS) and food allergies had more relapses and gadolinium-enhancing lesions than patients with MS but no food allergies, according to a recent analysis of a longitudinal study.

Patients with food allergies had a 1.3-times higher rate for cumulative number of attacks and a 2.5-times higher likelihood of enhancing lesions on brain MRI in the analysis of patients enrolled in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women’s Hospital (CLIMB).

By contrast, there were no significant differences in relapse or lesion rates for patients with environmental or drug allergies when compared with those without allergies, reported Tanuja Chitnis, MD, of Partners Multiple Sclerosis Center at Brigham and Women’s Hospital, Boston, and her coinvestigators.

“Our findings suggest that MS patients with allergies have more active disease than those without allergies, and that this effect is driven by food allergies,” Dr. Tanuja and her coauthors wrote in their report, which appeared in the Journal of Neurology, Neurosurgery and Psychiatry.

Previous investigations have looked at whether allergy history increases risk of developing MS, with conflicting results, they added, noting a meta-analysis of 10 observational studies suggesting no such link.

By contrast, whether allergies lead to more or less intense MS activity has not been addressed, according to investigators, who said this is the first study tying allergy history to MS disease course using clinical and MRI variables.

Their study was based on a subset of 1,349 patients with a diagnosis of MS who were enrolled in CLIMB and completed a self-administered questionnaire on food, environmental, and drug allergies. Of those patients, 922 reported allergies, while 427 reported no known allergies.

Patients with food allergies had a significantly increased rate of cumulative number of attacks, compared with those with no allergies, according to investigators, even after adjusting the analysis for gender, age at symptom onset, disease category, and time on treatment (relapse rate ratio, 1.274; 95% confidence interval, 1.023-1.587; P = .0305).

Food allergy patients were more than twice as likely as no-allergy patients were to have gadolinium-enhancing lesions on brain MRI after adjusting for other covariates (odds ratio, 2.53; 95% CI, 1.25-5.11; P = .0096), they added.

Patients with environmental and drug allergies also appeared to have more relapses, compared with patients with no allergies, in univariate analysis, but the differences were not significant in the adjusted analysis, investigators said. Likewise, there were trends toward a link between number of lesions and presence of environmental or drug allergies that did not hold up on multivariate analysis.

It is unknown what underlying biological mechanisms might potentially link food allergies to MS disease severity; however, findings of experimental studies support the hypothesis that gut microbiota might affect the risk and course of MS, Dr. Chitnis and her coauthors wrote in their report.

The CLIMB study was supported by Merck Serono and the National MS Society Nancy Davis Center Without Walls. Dr. Chitnis reported consulting fees from Biogen Idec, Novartis, Sanofi, Bayer, and Celgene outside the submitted work. Coauthors provided additional disclosures related to Merck Serono, Genentech, Verily Life Sciences, EMD Serono, Biogen, Teva, Sanofi, and Novartis, among others.

SOURCE: Fakih R et al. J Neurol Neurosurg Psychiatry. 2018 Dec 18. doi: 10.1136/jnnp-2018-319301.

Patients with multiple sclerosis (MS) and food allergies had more relapses and gadolinium-enhancing lesions than patients with MS but no food allergies, according to a recent analysis of a longitudinal study.

Patients with food allergies had a 1.3-times higher rate for cumulative number of attacks and a 2.5-times higher likelihood of enhancing lesions on brain MRI in the analysis of patients enrolled in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women’s Hospital (CLIMB).

By contrast, there were no significant differences in relapse or lesion rates for patients with environmental or drug allergies when compared with those without allergies, reported Tanuja Chitnis, MD, of Partners Multiple Sclerosis Center at Brigham and Women’s Hospital, Boston, and her coinvestigators.

“Our findings suggest that MS patients with allergies have more active disease than those without allergies, and that this effect is driven by food allergies,” Dr. Tanuja and her coauthors wrote in their report, which appeared in the Journal of Neurology, Neurosurgery and Psychiatry.

Previous investigations have looked at whether allergy history increases risk of developing MS, with conflicting results, they added, noting a meta-analysis of 10 observational studies suggesting no such link.

By contrast, whether allergies lead to more or less intense MS activity has not been addressed, according to investigators, who said this is the first study tying allergy history to MS disease course using clinical and MRI variables.

Their study was based on a subset of 1,349 patients with a diagnosis of MS who were enrolled in CLIMB and completed a self-administered questionnaire on food, environmental, and drug allergies. Of those patients, 922 reported allergies, while 427 reported no known allergies.

Patients with food allergies had a significantly increased rate of cumulative number of attacks, compared with those with no allergies, according to investigators, even after adjusting the analysis for gender, age at symptom onset, disease category, and time on treatment (relapse rate ratio, 1.274; 95% confidence interval, 1.023-1.587; P = .0305).

Food allergy patients were more than twice as likely as no-allergy patients were to have gadolinium-enhancing lesions on brain MRI after adjusting for other covariates (odds ratio, 2.53; 95% CI, 1.25-5.11; P = .0096), they added.

Patients with environmental and drug allergies also appeared to have more relapses, compared with patients with no allergies, in univariate analysis, but the differences were not significant in the adjusted analysis, investigators said. Likewise, there were trends toward a link between number of lesions and presence of environmental or drug allergies that did not hold up on multivariate analysis.

It is unknown what underlying biological mechanisms might potentially link food allergies to MS disease severity; however, findings of experimental studies support the hypothesis that gut microbiota might affect the risk and course of MS, Dr. Chitnis and her coauthors wrote in their report.

The CLIMB study was supported by Merck Serono and the National MS Society Nancy Davis Center Without Walls. Dr. Chitnis reported consulting fees from Biogen Idec, Novartis, Sanofi, Bayer, and Celgene outside the submitted work. Coauthors provided additional disclosures related to Merck Serono, Genentech, Verily Life Sciences, EMD Serono, Biogen, Teva, Sanofi, and Novartis, among others.

SOURCE: Fakih R et al. J Neurol Neurosurg Psychiatry. 2018 Dec 18. doi: 10.1136/jnnp-2018-319301.

Patients with multiple sclerosis (MS) and food allergies had more relapses and gadolinium-enhancing lesions than patients with MS but no food allergies, according to a recent analysis of a longitudinal study.

Patients with food allergies had a 1.3-times higher rate for cumulative number of attacks and a 2.5-times higher likelihood of enhancing lesions on brain MRI in the analysis of patients enrolled in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women’s Hospital (CLIMB).

By contrast, there were no significant differences in relapse or lesion rates for patients with environmental or drug allergies when compared with those without allergies, reported Tanuja Chitnis, MD, of Partners Multiple Sclerosis Center at Brigham and Women’s Hospital, Boston, and her coinvestigators.

“Our findings suggest that MS patients with allergies have more active disease than those without allergies, and that this effect is driven by food allergies,” Dr. Tanuja and her coauthors wrote in their report, which appeared in the Journal of Neurology, Neurosurgery and Psychiatry.

Previous investigations have looked at whether allergy history increases risk of developing MS, with conflicting results, they added, noting a meta-analysis of 10 observational studies suggesting no such link.

By contrast, whether allergies lead to more or less intense MS activity has not been addressed, according to investigators, who said this is the first study tying allergy history to MS disease course using clinical and MRI variables.

Their study was based on a subset of 1,349 patients with a diagnosis of MS who were enrolled in CLIMB and completed a self-administered questionnaire on food, environmental, and drug allergies. Of those patients, 922 reported allergies, while 427 reported no known allergies.

Patients with food allergies had a significantly increased rate of cumulative number of attacks, compared with those with no allergies, according to investigators, even after adjusting the analysis for gender, age at symptom onset, disease category, and time on treatment (relapse rate ratio, 1.274; 95% confidence interval, 1.023-1.587; P = .0305).

Food allergy patients were more than twice as likely as no-allergy patients were to have gadolinium-enhancing lesions on brain MRI after adjusting for other covariates (odds ratio, 2.53; 95% CI, 1.25-5.11; P = .0096), they added.

Patients with environmental and drug allergies also appeared to have more relapses, compared with patients with no allergies, in univariate analysis, but the differences were not significant in the adjusted analysis, investigators said. Likewise, there were trends toward a link between number of lesions and presence of environmental or drug allergies that did not hold up on multivariate analysis.

It is unknown what underlying biological mechanisms might potentially link food allergies to MS disease severity; however, findings of experimental studies support the hypothesis that gut microbiota might affect the risk and course of MS, Dr. Chitnis and her coauthors wrote in their report.

The CLIMB study was supported by Merck Serono and the National MS Society Nancy Davis Center Without Walls. Dr. Chitnis reported consulting fees from Biogen Idec, Novartis, Sanofi, Bayer, and Celgene outside the submitted work. Coauthors provided additional disclosures related to Merck Serono, Genentech, Verily Life Sciences, EMD Serono, Biogen, Teva, Sanofi, and Novartis, among others.

SOURCE: Fakih R et al. J Neurol Neurosurg Psychiatry. 2018 Dec 18. doi: 10.1136/jnnp-2018-319301.

A blood management initiative that reduced RBC transfusions in the hospital did not adversely impact long-term outcomes after discharge, a retrospective analysis of an extensive patient database suggested.

Vlad/Fotolia

Tolerating moderate in-hospital anemia did not increase subsequent RBC use, readmission, or mortality over the next 6 months, according to results of the study, which drew on nearly half a million patient records.

In fact, modest mortality decreases were seen over time for patients with moderate anemia, perhaps because of concomitant initiatives that targeted infectious and circulatory conditions, reported Nareg H. Roubinian, MD, of Kaiser Permanente Northern California in Oakland and the University of California, San Francisco, and coinvestigators.

“These data support the efficacy and safety of practice recommendations to limit red blood cell transfusion in patients with anemia during and after hospitalization,” Dr. Roubinian and colleagues wrote in their report, which appears in the Annals of Internal Medicine.

However, additional studies are needed to guide anemia management, they wrote, particularly since persistent anemia has impacts on quality of life that are “likely substantial” and linked to the severity of that anemia.

Dr. Roubinian and colleagues sought to evaluate the impact of blood management programs – initiated starting in 2010 – that included blood-sparing surgical and medical techniques, increased use of hemostatic and cell salvage agents, and treatment of suboptimal iron stores before surgery.

In previous retrospective cohort studies, the researchers had found that the blood conservation strategies did not impact in-hospital or 30-day mortality rates, which was consistent with short-term safety data from clinical trials and other observational studies.

Their latest report on longer-term outcomes was based on data from Kaiser Permanente Northern California for 445,371 adults who had 801,261 hospitalizations with discharges between 2010 and 2014. In this cohort, moderate anemia (hemoglobin between 7 g/dL and 10 g/dL) at discharge occurred in 119,489 patients (27%) and 187,440 hospitalizations overall (23%).

Over the 2010-2014 period, RBC transfusions decreased by more than 25% in the inpatient and outpatient settings; and in parallel, the prevalence of moderate anemia at hospital discharge increased from 20% to 25%.

However, the risks of subsequent RBC transfusions and rehospitalization after discharge with anemia decreased during the study period, and mortality rates stayed steady or decreased slightly.

Among patients with moderate anemia, the proportion with subsequent RBC transfusions within 6 months decreased from 18.9% in 2010 to 16.8% in 2014 (P less than .001), while the rate of rehospitalization within 6 months decreased from 36.5% to 32.8% over that same time period (P less than .001).

The adjusted 6-month mortality rate likewise decreased from 16.1% to 15.6% (P = .004) over that time period among patients with moderate anemia.

The study was supported by a grant from the National Heart, Lung, and Blood Institute. Dr. Roubinian and several coauthors reported grants during the conduct of the study from the National Institutes of Health.

SOURCE: Roubinian NH et al. Ann Intern Med. 2018 Dec 18. doi: 10.7326/M17-3253.

A blood management initiative that reduced RBC transfusions in the hospital did not adversely impact long-term outcomes after discharge, a retrospective analysis of an extensive patient database suggested.

Vlad/Fotolia

Tolerating moderate in-hospital anemia did not increase subsequent RBC use, readmission, or mortality over the next 6 months, according to results of the study, which drew on nearly half a million patient records.

In fact, modest mortality decreases were seen over time for patients with moderate anemia, perhaps because of concomitant initiatives that targeted infectious and circulatory conditions, reported Nareg H. Roubinian, MD, of Kaiser Permanente Northern California in Oakland and the University of California, San Francisco, and coinvestigators.

“These data support the efficacy and safety of practice recommendations to limit red blood cell transfusion in patients with anemia during and after hospitalization,” Dr. Roubinian and colleagues wrote in their report, which appears in the Annals of Internal Medicine.

However, additional studies are needed to guide anemia management, they wrote, particularly since persistent anemia has impacts on quality of life that are “likely substantial” and linked to the severity of that anemia.

Dr. Roubinian and colleagues sought to evaluate the impact of blood management programs – initiated starting in 2010 – that included blood-sparing surgical and medical techniques, increased use of hemostatic and cell salvage agents, and treatment of suboptimal iron stores before surgery.

In previous retrospective cohort studies, the researchers had found that the blood conservation strategies did not impact in-hospital or 30-day mortality rates, which was consistent with short-term safety data from clinical trials and other observational studies.

Their latest report on longer-term outcomes was based on data from Kaiser Permanente Northern California for 445,371 adults who had 801,261 hospitalizations with discharges between 2010 and 2014. In this cohort, moderate anemia (hemoglobin between 7 g/dL and 10 g/dL) at discharge occurred in 119,489 patients (27%) and 187,440 hospitalizations overall (23%).

Over the 2010-2014 period, RBC transfusions decreased by more than 25% in the inpatient and outpatient settings; and in parallel, the prevalence of moderate anemia at hospital discharge increased from 20% to 25%.

However, the risks of subsequent RBC transfusions and rehospitalization after discharge with anemia decreased during the study period, and mortality rates stayed steady or decreased slightly.

Among patients with moderate anemia, the proportion with subsequent RBC transfusions within 6 months decreased from 18.9% in 2010 to 16.8% in 2014 (P less than .001), while the rate of rehospitalization within 6 months decreased from 36.5% to 32.8% over that same time period (P less than .001).

The adjusted 6-month mortality rate likewise decreased from 16.1% to 15.6% (P = .004) over that time period among patients with moderate anemia.

The study was supported by a grant from the National Heart, Lung, and Blood Institute. Dr. Roubinian and several coauthors reported grants during the conduct of the study from the National Institutes of Health.

SOURCE: Roubinian NH et al. Ann Intern Med. 2018 Dec 18. doi: 10.7326/M17-3253.

A blood management initiative that reduced RBC transfusions in the hospital did not adversely impact long-term outcomes after discharge, a retrospective analysis of an extensive patient database suggested.

Vlad/Fotolia

Tolerating moderate in-hospital anemia did not increase subsequent RBC use, readmission, or mortality over the next 6 months, according to results of the study, which drew on nearly half a million patient records.

In fact, modest mortality decreases were seen over time for patients with moderate anemia, perhaps because of concomitant initiatives that targeted infectious and circulatory conditions, reported Nareg H. Roubinian, MD, of Kaiser Permanente Northern California in Oakland and the University of California, San Francisco, and coinvestigators.

“These data support the efficacy and safety of practice recommendations to limit red blood cell transfusion in patients with anemia during and after hospitalization,” Dr. Roubinian and colleagues wrote in their report, which appears in the Annals of Internal Medicine.

However, additional studies are needed to guide anemia management, they wrote, particularly since persistent anemia has impacts on quality of life that are “likely substantial” and linked to the severity of that anemia.

Dr. Roubinian and colleagues sought to evaluate the impact of blood management programs – initiated starting in 2010 – that included blood-sparing surgical and medical techniques, increased use of hemostatic and cell salvage agents, and treatment of suboptimal iron stores before surgery.

In previous retrospective cohort studies, the researchers had found that the blood conservation strategies did not impact in-hospital or 30-day mortality rates, which was consistent with short-term safety data from clinical trials and other observational studies.

Their latest report on longer-term outcomes was based on data from Kaiser Permanente Northern California for 445,371 adults who had 801,261 hospitalizations with discharges between 2010 and 2014. In this cohort, moderate anemia (hemoglobin between 7 g/dL and 10 g/dL) at discharge occurred in 119,489 patients (27%) and 187,440 hospitalizations overall (23%).

Over the 2010-2014 period, RBC transfusions decreased by more than 25% in the inpatient and outpatient settings; and in parallel, the prevalence of moderate anemia at hospital discharge increased from 20% to 25%.

However, the risks of subsequent RBC transfusions and rehospitalization after discharge with anemia decreased during the study period, and mortality rates stayed steady or decreased slightly.

Among patients with moderate anemia, the proportion with subsequent RBC transfusions within 6 months decreased from 18.9% in 2010 to 16.8% in 2014 (P less than .001), while the rate of rehospitalization within 6 months decreased from 36.5% to 32.8% over that same time period (P less than .001).

The adjusted 6-month mortality rate likewise decreased from 16.1% to 15.6% (P = .004) over that time period among patients with moderate anemia.

The study was supported by a grant from the National Heart, Lung, and Blood Institute. Dr. Roubinian and several coauthors reported grants during the conduct of the study from the National Institutes of Health.

SOURCE: Roubinian NH et al. Ann Intern Med. 2018 Dec 18. doi: 10.7326/M17-3253.