News

Using data from the Million Veteran Program (MVP), researchers found people with mutations for PDE3B, PCSK9, and ANGPTL4 had better cholesterol and triglyceride levels than did those without the mutations.

The PDE3B mutation seems to protect against heart disease. A PCSK9 mutation may reduce the risk not only of heart disease, but also abdominal aortic aneurysm. The ANGPTL4 mutation was linked to lower risk of type 2 DM.

MVP, 1 of the world’s largest databases of health and genomic information, partners with veterans receiving care in the VHA to study how genes affect health. It has enrolled > 700,000 veterans to date.

Using data from the Million Veteran Program (MVP), researchers found people with mutations for PDE3B, PCSK9, and ANGPTL4 had better cholesterol and triglyceride levels than did those without the mutations.

The PDE3B mutation seems to protect against heart disease. A PCSK9 mutation may reduce the risk not only of heart disease, but also abdominal aortic aneurysm. The ANGPTL4 mutation was linked to lower risk of type 2 DM.

MVP, 1 of the world’s largest databases of health and genomic information, partners with veterans receiving care in the VHA to study how genes affect health. It has enrolled > 700,000 veterans to date.

Using data from the Million Veteran Program (MVP), researchers found people with mutations for PDE3B, PCSK9, and ANGPTL4 had better cholesterol and triglyceride levels than did those without the mutations.

The PDE3B mutation seems to protect against heart disease. A PCSK9 mutation may reduce the risk not only of heart disease, but also abdominal aortic aneurysm. The ANGPTL4 mutation was linked to lower risk of type 2 DM.

MVP, 1 of the world’s largest databases of health and genomic information, partners with veterans receiving care in the VHA to study how genes affect health. It has enrolled > 700,000 veterans to date.

The Food and Drug Administration has approved a biosimilar rituximab product for the treatment of non-Hodgkin lymphoma (NHL).

Celltrion’s Truxima (rituximab-abbs) is a biosimilar of Genentech’s Rituxan (rituximab) and the first biosimilar approved in the United States to treat NHL.

Truxima (formerly CT-P10) is approved to treat adults with CD20-positive, B-cell NHL, either as a single agent or in combination with chemotherapy. Truxima is approved as a single agent to treat relapsed or refractory, low grade or follicular, CD20-positive, B-cell NHL. Truxima is approved in combination with first-line chemotherapy to treat previously untreated follicular, CD20-positive, B-cell NHL.

Truxima is approved as single-agent maintenance therapy in patients with follicular, CD20-positive, B-cell NHL who achieve a complete or partial response to a rituximab product in combination with chemotherapy. Truxima also is approved as a single agent to treat nonprogressing, low-grade, CD20-positive, B-cell NHL after first-line treatment with cyclophosphamide, vincristine, and prednisone.The label for Truxima contains a boxed warning detailing the risk of fatal infusion reactions, severe skin and mouth reactions (some with fatal outcomes), hepatitis B virus reactivation that may cause serious liver problems (including liver failure and death), and progressive multifocal leukoencephalopathy.

The FDA said its approval of Truxima is “based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data that demonstrates Truxima is biosimilar to Rituxan.”

Findings from a phase 3 trial suggested that Truxima is equivalent to the reference product in patients with low-tumor-burden follicular lymphoma (Lancet Haematol. 2018 Nov;5[11]:e543-53).

jensmith@mdedge.com

The Food and Drug Administration has approved a biosimilar rituximab product for the treatment of non-Hodgkin lymphoma (NHL).

Celltrion’s Truxima (rituximab-abbs) is a biosimilar of Genentech’s Rituxan (rituximab) and the first biosimilar approved in the United States to treat NHL.

Truxima (formerly CT-P10) is approved to treat adults with CD20-positive, B-cell NHL, either as a single agent or in combination with chemotherapy. Truxima is approved as a single agent to treat relapsed or refractory, low grade or follicular, CD20-positive, B-cell NHL. Truxima is approved in combination with first-line chemotherapy to treat previously untreated follicular, CD20-positive, B-cell NHL.

Truxima is approved as single-agent maintenance therapy in patients with follicular, CD20-positive, B-cell NHL who achieve a complete or partial response to a rituximab product in combination with chemotherapy. Truxima also is approved as a single agent to treat nonprogressing, low-grade, CD20-positive, B-cell NHL after first-line treatment with cyclophosphamide, vincristine, and prednisone.The label for Truxima contains a boxed warning detailing the risk of fatal infusion reactions, severe skin and mouth reactions (some with fatal outcomes), hepatitis B virus reactivation that may cause serious liver problems (including liver failure and death), and progressive multifocal leukoencephalopathy.

The FDA said its approval of Truxima is “based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data that demonstrates Truxima is biosimilar to Rituxan.”

Findings from a phase 3 trial suggested that Truxima is equivalent to the reference product in patients with low-tumor-burden follicular lymphoma (Lancet Haematol. 2018 Nov;5[11]:e543-53).

jensmith@mdedge.com

The Food and Drug Administration has approved a biosimilar rituximab product for the treatment of non-Hodgkin lymphoma (NHL).

Celltrion’s Truxima (rituximab-abbs) is a biosimilar of Genentech’s Rituxan (rituximab) and the first biosimilar approved in the United States to treat NHL.

Truxima (formerly CT-P10) is approved to treat adults with CD20-positive, B-cell NHL, either as a single agent or in combination with chemotherapy. Truxima is approved as a single agent to treat relapsed or refractory, low grade or follicular, CD20-positive, B-cell NHL. Truxima is approved in combination with first-line chemotherapy to treat previously untreated follicular, CD20-positive, B-cell NHL.

Truxima is approved as single-agent maintenance therapy in patients with follicular, CD20-positive, B-cell NHL who achieve a complete or partial response to a rituximab product in combination with chemotherapy. Truxima also is approved as a single agent to treat nonprogressing, low-grade, CD20-positive, B-cell NHL after first-line treatment with cyclophosphamide, vincristine, and prednisone.The label for Truxima contains a boxed warning detailing the risk of fatal infusion reactions, severe skin and mouth reactions (some with fatal outcomes), hepatitis B virus reactivation that may cause serious liver problems (including liver failure and death), and progressive multifocal leukoencephalopathy.

The FDA said its approval of Truxima is “based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data that demonstrates Truxima is biosimilar to Rituxan.”

Findings from a phase 3 trial suggested that Truxima is equivalent to the reference product in patients with low-tumor-burden follicular lymphoma (Lancet Haematol. 2018 Nov;5[11]:e543-53).

jensmith@mdedge.com

The presence or absence in tumor cells of cortactin, a cytoskeleton-remodeling adapter protein, may be a marker to help pathologists distinguish between chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), investigators suggest.

A study of cortactin expression in tumor samples from patients with B-cell CLL, MCL, and other hematologic malignancies showed that while cortactin was present in 14 of 17 CLL samples, it was not expressed on any of 16 MCL samples, reported Marco Pizzi, MD, PhD, from the University of Padova (Italy) and his colleagues.

“In particular, cortactin may contribute to the differential diagnosis between CLL and MCL, two neoplasms with similar histological features but very different clinical outcome. Further studies are needed to clarify the molecular mechanisms of deranged cortactin expression in MCL and CLL and to investigate any possible relationship between cortactin status and the biological features of these lymphomas,” they wrote in Human Pathology.

Overexpression of cortactin has been reported in several solid tumors, and increased expression of CTTN, the gene encoding for cortactin, has been associated with aggressive, poor prognosis disease, the investigators noted.

To characterize cortactin expression in lymphoid and hematopoietic cells and detect potential associations between cortactin and virulence of hematologic malignancies, the investigators performed immunohistochemical analysis on samples from 131 patients treated at their center. The samples included 17 cases of CLL, 16 of MCL, 25 of follicular lymphoma (FL), 30 of marginal zone lymphoma (MZL), 10 of hairy cell leukemia, three of splenic diffuse red pulp small B-cell lymphomas (SDRPBL), and 30 of diffuse large B-cell lymphoma (DLBCL).

They found that cortactin was expressed in 14 of the 17 CLL samples, all 10 of the HCL samples, and 22 of the 30 DLBCL samples. In contrast, there was no cortactin expression detected in any of either 16 MCL or three SDRPBL samples. The researchers found that 13 of 30 MZL samples had low-level staining. In FL, cortactin was expressed in 2 of the samples but in the remaining 23 cases the researchers found only scattered cortactin-positive lymphoid elements of non–B-cell lineage.

The investigators also found that cortactin expression in CLL correlated with other CLL-specific markers, and found that expression of two or more of the markers had 89.1% sensitivity, 100% specificity, a 100% positive predictive value, and 90.5% negative predictive value for a diagnosis of CLL.

In addition, they saw that the immunohistochemical results were similar to those for CTTN gene expression assessed by in silico analysis.

The investigators noted that CLL and MCL are challenging to differentiate from one another because of morphologic similarities and partially overlapping immunophenotypes.

“In this context, cortactin expression would strongly sustain a diagnosis of CLL over MCL, particularly in association with other CLL markers (i.e., LEF1 and CD200),” they wrote.

The study was internally supported. The authors declared no conflicts of interest.

SOURCE: Pizzi M et al. Hum Pathol. 2018 Nov 17. doi: 10.1016/j.humpath.2018.10.038.
 

The presence or absence in tumor cells of cortactin, a cytoskeleton-remodeling adapter protein, may be a marker to help pathologists distinguish between chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), investigators suggest.

A study of cortactin expression in tumor samples from patients with B-cell CLL, MCL, and other hematologic malignancies showed that while cortactin was present in 14 of 17 CLL samples, it was not expressed on any of 16 MCL samples, reported Marco Pizzi, MD, PhD, from the University of Padova (Italy) and his colleagues.

“In particular, cortactin may contribute to the differential diagnosis between CLL and MCL, two neoplasms with similar histological features but very different clinical outcome. Further studies are needed to clarify the molecular mechanisms of deranged cortactin expression in MCL and CLL and to investigate any possible relationship between cortactin status and the biological features of these lymphomas,” they wrote in Human Pathology.

Overexpression of cortactin has been reported in several solid tumors, and increased expression of CTTN, the gene encoding for cortactin, has been associated with aggressive, poor prognosis disease, the investigators noted.

To characterize cortactin expression in lymphoid and hematopoietic cells and detect potential associations between cortactin and virulence of hematologic malignancies, the investigators performed immunohistochemical analysis on samples from 131 patients treated at their center. The samples included 17 cases of CLL, 16 of MCL, 25 of follicular lymphoma (FL), 30 of marginal zone lymphoma (MZL), 10 of hairy cell leukemia, three of splenic diffuse red pulp small B-cell lymphomas (SDRPBL), and 30 of diffuse large B-cell lymphoma (DLBCL).

They found that cortactin was expressed in 14 of the 17 CLL samples, all 10 of the HCL samples, and 22 of the 30 DLBCL samples. In contrast, there was no cortactin expression detected in any of either 16 MCL or three SDRPBL samples. The researchers found that 13 of 30 MZL samples had low-level staining. In FL, cortactin was expressed in 2 of the samples but in the remaining 23 cases the researchers found only scattered cortactin-positive lymphoid elements of non–B-cell lineage.

The investigators also found that cortactin expression in CLL correlated with other CLL-specific markers, and found that expression of two or more of the markers had 89.1% sensitivity, 100% specificity, a 100% positive predictive value, and 90.5% negative predictive value for a diagnosis of CLL.

In addition, they saw that the immunohistochemical results were similar to those for CTTN gene expression assessed by in silico analysis.

The investigators noted that CLL and MCL are challenging to differentiate from one another because of morphologic similarities and partially overlapping immunophenotypes.

“In this context, cortactin expression would strongly sustain a diagnosis of CLL over MCL, particularly in association with other CLL markers (i.e., LEF1 and CD200),” they wrote.

The study was internally supported. The authors declared no conflicts of interest.

SOURCE: Pizzi M et al. Hum Pathol. 2018 Nov 17. doi: 10.1016/j.humpath.2018.10.038.
 

The presence or absence in tumor cells of cortactin, a cytoskeleton-remodeling adapter protein, may be a marker to help pathologists distinguish between chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), investigators suggest.

A study of cortactin expression in tumor samples from patients with B-cell CLL, MCL, and other hematologic malignancies showed that while cortactin was present in 14 of 17 CLL samples, it was not expressed on any of 16 MCL samples, reported Marco Pizzi, MD, PhD, from the University of Padova (Italy) and his colleagues.

“In particular, cortactin may contribute to the differential diagnosis between CLL and MCL, two neoplasms with similar histological features but very different clinical outcome. Further studies are needed to clarify the molecular mechanisms of deranged cortactin expression in MCL and CLL and to investigate any possible relationship between cortactin status and the biological features of these lymphomas,” they wrote in Human Pathology.

Overexpression of cortactin has been reported in several solid tumors, and increased expression of CTTN, the gene encoding for cortactin, has been associated with aggressive, poor prognosis disease, the investigators noted.

To characterize cortactin expression in lymphoid and hematopoietic cells and detect potential associations between cortactin and virulence of hematologic malignancies, the investigators performed immunohistochemical analysis on samples from 131 patients treated at their center. The samples included 17 cases of CLL, 16 of MCL, 25 of follicular lymphoma (FL), 30 of marginal zone lymphoma (MZL), 10 of hairy cell leukemia, three of splenic diffuse red pulp small B-cell lymphomas (SDRPBL), and 30 of diffuse large B-cell lymphoma (DLBCL).

They found that cortactin was expressed in 14 of the 17 CLL samples, all 10 of the HCL samples, and 22 of the 30 DLBCL samples. In contrast, there was no cortactin expression detected in any of either 16 MCL or three SDRPBL samples. The researchers found that 13 of 30 MZL samples had low-level staining. In FL, cortactin was expressed in 2 of the samples but in the remaining 23 cases the researchers found only scattered cortactin-positive lymphoid elements of non–B-cell lineage.

The investigators also found that cortactin expression in CLL correlated with other CLL-specific markers, and found that expression of two or more of the markers had 89.1% sensitivity, 100% specificity, a 100% positive predictive value, and 90.5% negative predictive value for a diagnosis of CLL.

In addition, they saw that the immunohistochemical results were similar to those for CTTN gene expression assessed by in silico analysis.

The investigators noted that CLL and MCL are challenging to differentiate from one another because of morphologic similarities and partially overlapping immunophenotypes.

“In this context, cortactin expression would strongly sustain a diagnosis of CLL over MCL, particularly in association with other CLL markers (i.e., LEF1 and CD200),” they wrote.

The study was internally supported. The authors declared no conflicts of interest.

SOURCE: Pizzi M et al. Hum Pathol. 2018 Nov 17. doi: 10.1016/j.humpath.2018.10.038.
 

Interstitial lung disease (ILD) is becoming more prevalent in patients with RA while shortening survival and leading to substantial health care costs, according to a retrospective study of RA-ILD prevalence, incidence, costs, and mortality.

“To our knowledge, this is the first study to describe the incidence and prevalence of RA-ILD among the general population and to estimate costs among U.S. patients with RA-ILD,” wrote lead author Karina Raimundo, principal health economist at Genentech, and her coauthors in the Journal of Rheumatology.

The study reviewed data from the Truven Health MarketScan Commercial and Medicare Supplemental health insurance databases, along with linking a subset of patients to the Social Security Administration Death Index to determine mortality. From 2004 to 2013, with the number of patients ranging from 892 to 3,232 per year, yearly prevalence estimates ranged from 3.2 (95% confidence interval, 3.0-3.4) to 6.0 (95% CI, 5.7-6.2) RA-ILD cases per 100,000 people. Yearly incidence ranged from 2.7 (95% CI, 2.5-2.9) to 3.8 (95% CI, 3.5-4.0) cases per 100,000 people.

While incidence was relatively stable, prevalence increased over the 10-year period. The authors noted that increased prevalence suggests improved survival of RA-ILD patients but were unable to definitively state why, with explanations ranging from more effective therapies to earlier diagnosis of the disease. “Our data do not allow more in-depth evaluation of this issue, and it merits further analysis.”

In addition, they found that average yearly costs across all study years ranged from $40,941 (standard deviation, $55,682) to $51,849 (SD, $77,125), with the main cost drivers being inpatient admissions, outpatient services, and outpatient pharmacy. By the 5-year mark of first diagnosis, 35.9% of RA-ILD patients who could be linked to the SSDI had died; those patients – with a mean age of 65 years – also had a median survival of 7.8 years (95% CI, 7.1-8.3). Generally, a 65-year-old person in the United States would be expected to live for 19 more years.

The authors acknowledged the study’s limitations, including reliance on administrative claims data, subsequent misclassification of RA-ILD status, a lack of information on cause of death, and an underestimation of mortality caused by the inability to link all patients to the Social Security Administration Death Index.

The study was funded by Genentech and F. Hoffmann–La Roche. No other conflicts of interest were reported.

SOURCE: Raimundo K et al. J Rheumatol. 2018 Nov 15. doi: 10.3899/jrheum.171315.

Interstitial lung disease (ILD) is becoming more prevalent in patients with RA while shortening survival and leading to substantial health care costs, according to a retrospective study of RA-ILD prevalence, incidence, costs, and mortality.

“To our knowledge, this is the first study to describe the incidence and prevalence of RA-ILD among the general population and to estimate costs among U.S. patients with RA-ILD,” wrote lead author Karina Raimundo, principal health economist at Genentech, and her coauthors in the Journal of Rheumatology.

The study reviewed data from the Truven Health MarketScan Commercial and Medicare Supplemental health insurance databases, along with linking a subset of patients to the Social Security Administration Death Index to determine mortality. From 2004 to 2013, with the number of patients ranging from 892 to 3,232 per year, yearly prevalence estimates ranged from 3.2 (95% confidence interval, 3.0-3.4) to 6.0 (95% CI, 5.7-6.2) RA-ILD cases per 100,000 people. Yearly incidence ranged from 2.7 (95% CI, 2.5-2.9) to 3.8 (95% CI, 3.5-4.0) cases per 100,000 people.

While incidence was relatively stable, prevalence increased over the 10-year period. The authors noted that increased prevalence suggests improved survival of RA-ILD patients but were unable to definitively state why, with explanations ranging from more effective therapies to earlier diagnosis of the disease. “Our data do not allow more in-depth evaluation of this issue, and it merits further analysis.”

In addition, they found that average yearly costs across all study years ranged from $40,941 (standard deviation, $55,682) to $51,849 (SD, $77,125), with the main cost drivers being inpatient admissions, outpatient services, and outpatient pharmacy. By the 5-year mark of first diagnosis, 35.9% of RA-ILD patients who could be linked to the SSDI had died; those patients – with a mean age of 65 years – also had a median survival of 7.8 years (95% CI, 7.1-8.3). Generally, a 65-year-old person in the United States would be expected to live for 19 more years.

The authors acknowledged the study’s limitations, including reliance on administrative claims data, subsequent misclassification of RA-ILD status, a lack of information on cause of death, and an underestimation of mortality caused by the inability to link all patients to the Social Security Administration Death Index.

The study was funded by Genentech and F. Hoffmann–La Roche. No other conflicts of interest were reported.

SOURCE: Raimundo K et al. J Rheumatol. 2018 Nov 15. doi: 10.3899/jrheum.171315.

Interstitial lung disease (ILD) is becoming more prevalent in patients with RA while shortening survival and leading to substantial health care costs, according to a retrospective study of RA-ILD prevalence, incidence, costs, and mortality.

“To our knowledge, this is the first study to describe the incidence and prevalence of RA-ILD among the general population and to estimate costs among U.S. patients with RA-ILD,” wrote lead author Karina Raimundo, principal health economist at Genentech, and her coauthors in the Journal of Rheumatology.

The study reviewed data from the Truven Health MarketScan Commercial and Medicare Supplemental health insurance databases, along with linking a subset of patients to the Social Security Administration Death Index to determine mortality. From 2004 to 2013, with the number of patients ranging from 892 to 3,232 per year, yearly prevalence estimates ranged from 3.2 (95% confidence interval, 3.0-3.4) to 6.0 (95% CI, 5.7-6.2) RA-ILD cases per 100,000 people. Yearly incidence ranged from 2.7 (95% CI, 2.5-2.9) to 3.8 (95% CI, 3.5-4.0) cases per 100,000 people.

While incidence was relatively stable, prevalence increased over the 10-year period. The authors noted that increased prevalence suggests improved survival of RA-ILD patients but were unable to definitively state why, with explanations ranging from more effective therapies to earlier diagnosis of the disease. “Our data do not allow more in-depth evaluation of this issue, and it merits further analysis.”

In addition, they found that average yearly costs across all study years ranged from $40,941 (standard deviation, $55,682) to $51,849 (SD, $77,125), with the main cost drivers being inpatient admissions, outpatient services, and outpatient pharmacy. By the 5-year mark of first diagnosis, 35.9% of RA-ILD patients who could be linked to the SSDI had died; those patients – with a mean age of 65 years – also had a median survival of 7.8 years (95% CI, 7.1-8.3). Generally, a 65-year-old person in the United States would be expected to live for 19 more years.

The authors acknowledged the study’s limitations, including reliance on administrative claims data, subsequent misclassification of RA-ILD status, a lack of information on cause of death, and an underestimation of mortality caused by the inability to link all patients to the Social Security Administration Death Index.

The study was funded by Genentech and F. Hoffmann–La Roche. No other conflicts of interest were reported.

SOURCE: Raimundo K et al. J Rheumatol. 2018 Nov 15. doi: 10.3899/jrheum.171315.

Health care is more effective when patients understand what they can do to be healthier. But many patients cannot read routine preventive information. To help busy clinicians learn more about what they can do to support patient wellness, the Indian Health Service (IHs) Health Literacy workgroup has developed a 20-minute health literacy and plain-language training module.

The IHS also is:

• Pretesting printed educational materials through focus groups and in-depth interviews to ensure messages are clear;
• Revising the IHS website;
• Hosting webinars on health literacy; and
•  Planning to refresh and promote “As Me 3” campaign, which encourages patients to ask 3 specific questions of their providers to better understand their conditions.

In addition to taking the training module, available at the Learning Management System, the IHS suggests clinicians participate in ongoing training in health literacy, plain language and culturally and linguistically appropriate services; use the “health factor” tab in the electronic health record to assess and document the patient’s level of understanding; and learn about the teach-back technique to enhance patients’ understanding.

Health care is more effective when patients understand what they can do to be healthier. But many patients cannot read routine preventive information. To help busy clinicians learn more about what they can do to support patient wellness, the Indian Health Service (IHs) Health Literacy workgroup has developed a 20-minute health literacy and plain-language training module.

The IHS also is:

• Pretesting printed educational materials through focus groups and in-depth interviews to ensure messages are clear;
• Revising the IHS website;
• Hosting webinars on health literacy; and
•  Planning to refresh and promote “As Me 3” campaign, which encourages patients to ask 3 specific questions of their providers to better understand their conditions.

In addition to taking the training module, available at the Learning Management System, the IHS suggests clinicians participate in ongoing training in health literacy, plain language and culturally and linguistically appropriate services; use the “health factor” tab in the electronic health record to assess and document the patient’s level of understanding; and learn about the teach-back technique to enhance patients’ understanding.

Health care is more effective when patients understand what they can do to be healthier. But many patients cannot read routine preventive information. To help busy clinicians learn more about what they can do to support patient wellness, the Indian Health Service (IHs) Health Literacy workgroup has developed a 20-minute health literacy and plain-language training module.

The IHS also is:

• Pretesting printed educational materials through focus groups and in-depth interviews to ensure messages are clear;
• Revising the IHS website;
• Hosting webinars on health literacy; and
•  Planning to refresh and promote “As Me 3” campaign, which encourages patients to ask 3 specific questions of their providers to better understand their conditions.

In addition to taking the training module, available at the Learning Management System, the IHS suggests clinicians participate in ongoing training in health literacy, plain language and culturally and linguistically appropriate services; use the “health factor” tab in the electronic health record to assess and document the patient’s level of understanding; and learn about the teach-back technique to enhance patients’ understanding.

Cancer survivors have a higher risk of depression within 2 years after the diagnosis, according to a meta-analysis. But is that true of survivors of all types of cancer? In fact, risk is multifactorial because patients, cancers, comorbidities, and impacts of treatments are all different, say researchers who conducted a study to compare the risk of mood disorders longitudinally.

They matched 190,748 survivors with controls from the Taiwan National Health Insurance Research Database. The median follow-up times were 8.13 and 8.49 years, respectively. The 3 most common cancers were breast, colorectal, and head and neck. Surgery alone was the main treatment, followed by combinations of surgery, chemotherapy, and radiation.

Survivors had a significantly higher risk of mood disorders: 8.38 per 1,000 person-years, compared with 7.21 in the control patients. Major depression and depression disorder were the most common subtypes.

However, the risk of mood disorders (1.13-fold) peaked during the year after the index date and declined thereafter. Moreover, 2 and 5 years later, the risk was similar between the 2 groups. And after 5 years, the risk was even lower in the survivor group than in the control group.

The researchers found patients fell into 3 main categories: persistently increasing risk, higher risk in the first few years and after 5 years of follow-up, and higher risk in the first few years but no difference thereafter. Patients with head and neck cancer, nasopharyngeal cancer, and esophageal cancer were in the first group, with distinct longitudinal patterns. Their risk at 5 years was greater than that of the general population.

Being female, aged 40-59 years, having > 2 primary cancers, having ≥ 2 treatment modalities, Charlson comorbidity index scores > 3, higher urbanization level, and lower income levels were independent risk factors for mood disorders.

The researchers say their findings highlight the importance of taking follow-up time, cancer types, and cancer-related treatment into consideration when evaluating mood disorders in cancer survivors. They also emphasize the need for better psychological management not only in the early postdiagnosis years, but in late follow-up for patients with a “persistent” risk.

Source:
Huang WK, Juang YY, Chung CC, et al. J Affect Disord. 2018;236:80-87.

Cancer survivors have a higher risk of depression within 2 years after the diagnosis, according to a meta-analysis. But is that true of survivors of all types of cancer? In fact, risk is multifactorial because patients, cancers, comorbidities, and impacts of treatments are all different, say researchers who conducted a study to compare the risk of mood disorders longitudinally.

They matched 190,748 survivors with controls from the Taiwan National Health Insurance Research Database. The median follow-up times were 8.13 and 8.49 years, respectively. The 3 most common cancers were breast, colorectal, and head and neck. Surgery alone was the main treatment, followed by combinations of surgery, chemotherapy, and radiation.

Survivors had a significantly higher risk of mood disorders: 8.38 per 1,000 person-years, compared with 7.21 in the control patients. Major depression and depression disorder were the most common subtypes.

However, the risk of mood disorders (1.13-fold) peaked during the year after the index date and declined thereafter. Moreover, 2 and 5 years later, the risk was similar between the 2 groups. And after 5 years, the risk was even lower in the survivor group than in the control group.

The researchers found patients fell into 3 main categories: persistently increasing risk, higher risk in the first few years and after 5 years of follow-up, and higher risk in the first few years but no difference thereafter. Patients with head and neck cancer, nasopharyngeal cancer, and esophageal cancer were in the first group, with distinct longitudinal patterns. Their risk at 5 years was greater than that of the general population.

Being female, aged 40-59 years, having > 2 primary cancers, having ≥ 2 treatment modalities, Charlson comorbidity index scores > 3, higher urbanization level, and lower income levels were independent risk factors for mood disorders.

The researchers say their findings highlight the importance of taking follow-up time, cancer types, and cancer-related treatment into consideration when evaluating mood disorders in cancer survivors. They also emphasize the need for better psychological management not only in the early postdiagnosis years, but in late follow-up for patients with a “persistent” risk.

Source:
Huang WK, Juang YY, Chung CC, et al. J Affect Disord. 2018;236:80-87.

Cancer survivors have a higher risk of depression within 2 years after the diagnosis, according to a meta-analysis. But is that true of survivors of all types of cancer? In fact, risk is multifactorial because patients, cancers, comorbidities, and impacts of treatments are all different, say researchers who conducted a study to compare the risk of mood disorders longitudinally.

They matched 190,748 survivors with controls from the Taiwan National Health Insurance Research Database. The median follow-up times were 8.13 and 8.49 years, respectively. The 3 most common cancers were breast, colorectal, and head and neck. Surgery alone was the main treatment, followed by combinations of surgery, chemotherapy, and radiation.

Survivors had a significantly higher risk of mood disorders: 8.38 per 1,000 person-years, compared with 7.21 in the control patients. Major depression and depression disorder were the most common subtypes.

However, the risk of mood disorders (1.13-fold) peaked during the year after the index date and declined thereafter. Moreover, 2 and 5 years later, the risk was similar between the 2 groups. And after 5 years, the risk was even lower in the survivor group than in the control group.

The researchers found patients fell into 3 main categories: persistently increasing risk, higher risk in the first few years and after 5 years of follow-up, and higher risk in the first few years but no difference thereafter. Patients with head and neck cancer, nasopharyngeal cancer, and esophageal cancer were in the first group, with distinct longitudinal patterns. Their risk at 5 years was greater than that of the general population.

Being female, aged 40-59 years, having > 2 primary cancers, having ≥ 2 treatment modalities, Charlson comorbidity index scores > 3, higher urbanization level, and lower income levels were independent risk factors for mood disorders.

The researchers say their findings highlight the importance of taking follow-up time, cancer types, and cancer-related treatment into consideration when evaluating mood disorders in cancer survivors. They also emphasize the need for better psychological management not only in the early postdiagnosis years, but in late follow-up for patients with a “persistent” risk.

Source:
Huang WK, Juang YY, Chung CC, et al. J Affect Disord. 2018;236:80-87.

Researchers from Harvard and Brigham and Women’s Hospital say their study is the first to fully evaluate the link between mutations in sodium glucose co-transporter-1 (SGLT-1)—the gene responsible for absorbing glucose in the gut—and cardiometabolic disease.

The researchers used genetic data from 8,478 participants in the 25-year Atherosclerosis Risk In Communities (ARIC) study. The participants who carried the mutation (6%) had a lower risk of type 2 diabetes, were less obese, had a lower incidence of heart failure, and a lower mortality rate than did those without the mutation, regardless of dietary intake.

The researchers suggest that their findings “open the door to improved therapies” for cardiometabolic diseases.

Researchers from Harvard and Brigham and Women’s Hospital say their study is the first to fully evaluate the link between mutations in sodium glucose co-transporter-1 (SGLT-1)—the gene responsible for absorbing glucose in the gut—and cardiometabolic disease.

The researchers used genetic data from 8,478 participants in the 25-year Atherosclerosis Risk In Communities (ARIC) study. The participants who carried the mutation (6%) had a lower risk of type 2 diabetes, were less obese, had a lower incidence of heart failure, and a lower mortality rate than did those without the mutation, regardless of dietary intake.

The researchers suggest that their findings “open the door to improved therapies” for cardiometabolic diseases.

Researchers from Harvard and Brigham and Women’s Hospital say their study is the first to fully evaluate the link between mutations in sodium glucose co-transporter-1 (SGLT-1)—the gene responsible for absorbing glucose in the gut—and cardiometabolic disease.

The researchers used genetic data from 8,478 participants in the 25-year Atherosclerosis Risk In Communities (ARIC) study. The participants who carried the mutation (6%) had a lower risk of type 2 diabetes, were less obese, had a lower incidence of heart failure, and a lower mortality rate than did those without the mutation, regardless of dietary intake.

The researchers suggest that their findings “open the door to improved therapies” for cardiometabolic diseases.

Reliable treatment with broadly neutralizing antibodies—bNAbs—could change the future for people living with HIV. But studies have found that infusions of a single bNAb did not suppress HIV because some patients developed resistance.

Rockefeller University researchers, however, theorized that combining multiple antibodies that target distinct regions of HIV would both suppress the virus and prevent resistance. So in an NIH-supported pilot study, researhcers recruited 15 volunteers whose HIV was suppressed with antiretroviral treatment (ART) and who were sensitive to 3BNC117 and 10-1074, both potent bNAbs.

Participants received infusions of both bNAbs, stopped taking ART 2 days later, and received additional infusions 3 and 6 weeks later.

Of the 11 people who completed the study, 9 maintained viral suppression without ART for an average of 15 weeks, until the amount of bNAbs in their bodies fell below protective levels. In 2 of the 9, virus was controlled through the end of the 30-week follow-up period. The remaining 2 participants were found to harbor HIV resistant to at least 1 bNAb and experienced viral rebound before 12 weeks after stopping ART.

The researchers are enrolling people with HIV in a larger study to determine an optimal regimen of bNAbs.

Reliable treatment with broadly neutralizing antibodies—bNAbs—could change the future for people living with HIV. But studies have found that infusions of a single bNAb did not suppress HIV because some patients developed resistance.

Rockefeller University researchers, however, theorized that combining multiple antibodies that target distinct regions of HIV would both suppress the virus and prevent resistance. So in an NIH-supported pilot study, researhcers recruited 15 volunteers whose HIV was suppressed with antiretroviral treatment (ART) and who were sensitive to 3BNC117 and 10-1074, both potent bNAbs.

Participants received infusions of both bNAbs, stopped taking ART 2 days later, and received additional infusions 3 and 6 weeks later.

Of the 11 people who completed the study, 9 maintained viral suppression without ART for an average of 15 weeks, until the amount of bNAbs in their bodies fell below protective levels. In 2 of the 9, virus was controlled through the end of the 30-week follow-up period. The remaining 2 participants were found to harbor HIV resistant to at least 1 bNAb and experienced viral rebound before 12 weeks after stopping ART.

The researchers are enrolling people with HIV in a larger study to determine an optimal regimen of bNAbs.

Reliable treatment with broadly neutralizing antibodies—bNAbs—could change the future for people living with HIV. But studies have found that infusions of a single bNAb did not suppress HIV because some patients developed resistance.

Rockefeller University researchers, however, theorized that combining multiple antibodies that target distinct regions of HIV would both suppress the virus and prevent resistance. So in an NIH-supported pilot study, researhcers recruited 15 volunteers whose HIV was suppressed with antiretroviral treatment (ART) and who were sensitive to 3BNC117 and 10-1074, both potent bNAbs.

Participants received infusions of both bNAbs, stopped taking ART 2 days later, and received additional infusions 3 and 6 weeks later.

Of the 11 people who completed the study, 9 maintained viral suppression without ART for an average of 15 weeks, until the amount of bNAbs in their bodies fell below protective levels. In 2 of the 9, virus was controlled through the end of the 30-week follow-up period. The remaining 2 participants were found to harbor HIV resistant to at least 1 bNAb and experienced viral rebound before 12 weeks after stopping ART.

The researchers are enrolling people with HIV in a larger study to determine an optimal regimen of bNAbs.

Areas that have adopted smoke-free policies in their restaurants, bars, and workplaces have seen a corresponding drop in systolic blood pressure, according to data from the Coronary Artery Risk Development in Young Adults (CARDIA) study.

“Among a geographically diverse cohort of black and white nonsmoking adults followed for 15 years, we found that participants living in areas with smoke-free policies in restaurants, bars, and workplaces had lower systolic blood pressure at the end of follow-up, compared with participants living in areas without smoke-free policies,” wrote Stephanie L. Mayne, PhD, of the department of preventative medicine at Northwestern University, Chicago, and her coauthors in the Journal of the American Heart Association.

The study analyzed data from 2,606 CARDIA participants, all of whom enrolled in 1985-1986 and underwent follow-up exams after 2, 5, 7, 10, 15, 20, 25, and 30 years. Smoke-free policies were obtained from the American Non-Smokers’ Rights Foundation’s Local Ordinance Database and linked to participants based on their census tract and examination date. Systolic and diastolic blood pressure (SBP, DBP), along with physical activity and dietary quality, were measured at each examination.

By year 25, participants in areas with smoke-free restaurants had SBP values that were 1.14 mm Hg lower than participants who lived in areas with smoke-friendly restaurants (95% confidence interval, 2.15-0.12). Participants in areas with smoke-free bars returned similar results, with a SBP difference of 1.52 mm Hg (95% CI, 2.48-0.57). The data were less conclusive for DBP, though CARDIA indicated that SBP was more associated with cardiovascular disease risk than DBP and “even small reductions in SBP may result in meaningful reductions in CVD risk.”

The coauthors shared the study’s potential limitations, including an inability to control for antismoking campaigns and the possibility that participants did not report any infrequent smoking habits. However, they highlighted previous associations between smoke-free policies and reduced risk of hospitalization for CVD, noting the relation and suggesting “BP reduction as a potential mechanism through which smoke-free policies may reduce rates of CVD at the population level.”

This study was supported by the National Heart, Lung, and Blood Institute, in collaboration with the University of Alabama at Birmingham, Northwestern University, the University of Minnesota, Kaiser Foundation Research Institute, and Johns Hopkins University School of Medicine. It was partially supported by the Intramural Research Program of the National Institute on Aging. No conflicts of interest were reported.

SOURCE: Mayne SL et al. J Am Heart Assoc. 2018 Nov 21. doi: 10.1161/JAHA.118.009829.

Areas that have adopted smoke-free policies in their restaurants, bars, and workplaces have seen a corresponding drop in systolic blood pressure, according to data from the Coronary Artery Risk Development in Young Adults (CARDIA) study.

“Among a geographically diverse cohort of black and white nonsmoking adults followed for 15 years, we found that participants living in areas with smoke-free policies in restaurants, bars, and workplaces had lower systolic blood pressure at the end of follow-up, compared with participants living in areas without smoke-free policies,” wrote Stephanie L. Mayne, PhD, of the department of preventative medicine at Northwestern University, Chicago, and her coauthors in the Journal of the American Heart Association.

The study analyzed data from 2,606 CARDIA participants, all of whom enrolled in 1985-1986 and underwent follow-up exams after 2, 5, 7, 10, 15, 20, 25, and 30 years. Smoke-free policies were obtained from the American Non-Smokers’ Rights Foundation’s Local Ordinance Database and linked to participants based on their census tract and examination date. Systolic and diastolic blood pressure (SBP, DBP), along with physical activity and dietary quality, were measured at each examination.

By year 25, participants in areas with smoke-free restaurants had SBP values that were 1.14 mm Hg lower than participants who lived in areas with smoke-friendly restaurants (95% confidence interval, 2.15-0.12). Participants in areas with smoke-free bars returned similar results, with a SBP difference of 1.52 mm Hg (95% CI, 2.48-0.57). The data were less conclusive for DBP, though CARDIA indicated that SBP was more associated with cardiovascular disease risk than DBP and “even small reductions in SBP may result in meaningful reductions in CVD risk.”

The coauthors shared the study’s potential limitations, including an inability to control for antismoking campaigns and the possibility that participants did not report any infrequent smoking habits. However, they highlighted previous associations between smoke-free policies and reduced risk of hospitalization for CVD, noting the relation and suggesting “BP reduction as a potential mechanism through which smoke-free policies may reduce rates of CVD at the population level.”

This study was supported by the National Heart, Lung, and Blood Institute, in collaboration with the University of Alabama at Birmingham, Northwestern University, the University of Minnesota, Kaiser Foundation Research Institute, and Johns Hopkins University School of Medicine. It was partially supported by the Intramural Research Program of the National Institute on Aging. No conflicts of interest were reported.

SOURCE: Mayne SL et al. J Am Heart Assoc. 2018 Nov 21. doi: 10.1161/JAHA.118.009829.

Areas that have adopted smoke-free policies in their restaurants, bars, and workplaces have seen a corresponding drop in systolic blood pressure, according to data from the Coronary Artery Risk Development in Young Adults (CARDIA) study.

“Among a geographically diverse cohort of black and white nonsmoking adults followed for 15 years, we found that participants living in areas with smoke-free policies in restaurants, bars, and workplaces had lower systolic blood pressure at the end of follow-up, compared with participants living in areas without smoke-free policies,” wrote Stephanie L. Mayne, PhD, of the department of preventative medicine at Northwestern University, Chicago, and her coauthors in the Journal of the American Heart Association.

The study analyzed data from 2,606 CARDIA participants, all of whom enrolled in 1985-1986 and underwent follow-up exams after 2, 5, 7, 10, 15, 20, 25, and 30 years. Smoke-free policies were obtained from the American Non-Smokers’ Rights Foundation’s Local Ordinance Database and linked to participants based on their census tract and examination date. Systolic and diastolic blood pressure (SBP, DBP), along with physical activity and dietary quality, were measured at each examination.

By year 25, participants in areas with smoke-free restaurants had SBP values that were 1.14 mm Hg lower than participants who lived in areas with smoke-friendly restaurants (95% confidence interval, 2.15-0.12). Participants in areas with smoke-free bars returned similar results, with a SBP difference of 1.52 mm Hg (95% CI, 2.48-0.57). The data were less conclusive for DBP, though CARDIA indicated that SBP was more associated with cardiovascular disease risk than DBP and “even small reductions in SBP may result in meaningful reductions in CVD risk.”

The coauthors shared the study’s potential limitations, including an inability to control for antismoking campaigns and the possibility that participants did not report any infrequent smoking habits. However, they highlighted previous associations between smoke-free policies and reduced risk of hospitalization for CVD, noting the relation and suggesting “BP reduction as a potential mechanism through which smoke-free policies may reduce rates of CVD at the population level.”

This study was supported by the National Heart, Lung, and Blood Institute, in collaboration with the University of Alabama at Birmingham, Northwestern University, the University of Minnesota, Kaiser Foundation Research Institute, and Johns Hopkins University School of Medicine. It was partially supported by the Intramural Research Program of the National Institute on Aging. No conflicts of interest were reported.

SOURCE: Mayne SL et al. J Am Heart Assoc. 2018 Nov 21. doi: 10.1161/JAHA.118.009829.

The rituximab biosimilar CT-P10 has equivalent efficacy, compared with rituximab, and is well tolerated in the treatment of low–tumor-burden follicular lymphoma, according to results from a multinational, randomized, phase 3 study.

Overall response after 7 months of treatment exceeded 80% for patients assigned to CT-P10 and for those assigned to rituximab, investigators reported in the Lancet Haematology.

Adverse event profiles were comparable for rituximab and the biosimilar over that time period, while pharmacokinetics, pharmacodynamics, and immunogenicity were likewise comparable between arms, according to investigators.

“Thus, CT-P10 monotherapy is suggested as a new therapeutic option for patients with low–tumor-burden follicular lymphoma,” wrote senior author Larry W Kwak, MD, PhD, of the Comprehensive Cancer Center, City of Hope, Duarte, Calif., and his colleagues.

CT-P10, the first rituximab biosimilar to be authorized by the European Medicines Agency, has been recommended for approval in the United States by the Food and Drug Administration’s Oncologic Drugs Advisory Committee.

If approved by the FDA, CT-P10 would be the first rituximab biosimilar available in the United States, according to the company, which noted three proposed indications in non-Hodgkin lymphoma.

In the current randomized, double-blind, parallel-group, phase 3 trial, 258 patients with stage II-IV low–tumor-burden follicular lymphoma were randomly assigned to CT-P10 (130 patients) or rituximab sourced in the United States (128 patients).

Treatment consisted of an induction period of intravenous CT-P10 or rituximab weekly for 4 weeks, while patients experiencing disease control went on to a maintenance phase with their assigned treatment given every 8 weeks for six cycles, followed by another year of maintenance therapy with CT-P10 for those still on study.

The primary endpoint of the study was overall response at 7 months, defined as a complete response, unconfirmed complete response, or partial response.

Overall response was seen in 83% of patients randomized to CT-P10 and 81% of patients randomized to rituximab at 7 months, Dr. Kwak and his colleagues reported.

The two treatments were deemed therapeutically equivalent, as illustrated by 90% confidence intervals within a prespecified equivalence margin of 17%, investigators said.

The most common treatment-emergent adverse events in either group were infusion-related reactions, which were of grade 1-2, except for one grade 3 reaction reported in the CT-P10 group, according to the report. Other common adverse events were upper respiratory tract infections and fatigue.

Serious adverse events were reported in six patients in the CT-P10 arm and three patients in the rituximab arm.

The availability of a rituximab biosimilar is anticipated to reduce the cost of treatment and improve patient access, according to investigators.

Introduction of CT-P10 in the European Union was projected to save between 90 and 150 million euros over a year, enabling more than 12,500 new patients to be treated with the biosimilar, according to results of a budget impact analysis investigators cited in their report.

“Widespread adoption of a rituximab biosimilar could have a substantial effect on health care budgets and might also have effects at a societal level,” Dr. Kwak and his coauthors said in the report.

The trial was sponsored by Celltrion and three coauthors of the study were employees of the company. Dr. Kwak and several other coinvestigators not employed by Celltrion reported disclosures related to the company. Other disclosures provided related to Novartis, Roche, AbbVie, Celgene, and Takeda, among other entities.

SOURCE: Ogura M et al. Lancet Haematol. 2018 Nov;5(11):e543-53.

The rituximab biosimilar CT-P10 has equivalent efficacy, compared with rituximab, and is well tolerated in the treatment of low–tumor-burden follicular lymphoma, according to results from a multinational, randomized, phase 3 study.

Overall response after 7 months of treatment exceeded 80% for patients assigned to CT-P10 and for those assigned to rituximab, investigators reported in the Lancet Haematology.

Adverse event profiles were comparable for rituximab and the biosimilar over that time period, while pharmacokinetics, pharmacodynamics, and immunogenicity were likewise comparable between arms, according to investigators.

“Thus, CT-P10 monotherapy is suggested as a new therapeutic option for patients with low–tumor-burden follicular lymphoma,” wrote senior author Larry W Kwak, MD, PhD, of the Comprehensive Cancer Center, City of Hope, Duarte, Calif., and his colleagues.

CT-P10, the first rituximab biosimilar to be authorized by the European Medicines Agency, has been recommended for approval in the United States by the Food and Drug Administration’s Oncologic Drugs Advisory Committee.

If approved by the FDA, CT-P10 would be the first rituximab biosimilar available in the United States, according to the company, which noted three proposed indications in non-Hodgkin lymphoma.

In the current randomized, double-blind, parallel-group, phase 3 trial, 258 patients with stage II-IV low–tumor-burden follicular lymphoma were randomly assigned to CT-P10 (130 patients) or rituximab sourced in the United States (128 patients).

Treatment consisted of an induction period of intravenous CT-P10 or rituximab weekly for 4 weeks, while patients experiencing disease control went on to a maintenance phase with their assigned treatment given every 8 weeks for six cycles, followed by another year of maintenance therapy with CT-P10 for those still on study.

The primary endpoint of the study was overall response at 7 months, defined as a complete response, unconfirmed complete response, or partial response.

Overall response was seen in 83% of patients randomized to CT-P10 and 81% of patients randomized to rituximab at 7 months, Dr. Kwak and his colleagues reported.

The two treatments were deemed therapeutically equivalent, as illustrated by 90% confidence intervals within a prespecified equivalence margin of 17%, investigators said.

The most common treatment-emergent adverse events in either group were infusion-related reactions, which were of grade 1-2, except for one grade 3 reaction reported in the CT-P10 group, according to the report. Other common adverse events were upper respiratory tract infections and fatigue.

Serious adverse events were reported in six patients in the CT-P10 arm and three patients in the rituximab arm.

The availability of a rituximab biosimilar is anticipated to reduce the cost of treatment and improve patient access, according to investigators.

Introduction of CT-P10 in the European Union was projected to save between 90 and 150 million euros over a year, enabling more than 12,500 new patients to be treated with the biosimilar, according to results of a budget impact analysis investigators cited in their report.

“Widespread adoption of a rituximab biosimilar could have a substantial effect on health care budgets and might also have effects at a societal level,” Dr. Kwak and his coauthors said in the report.

The trial was sponsored by Celltrion and three coauthors of the study were employees of the company. Dr. Kwak and several other coinvestigators not employed by Celltrion reported disclosures related to the company. Other disclosures provided related to Novartis, Roche, AbbVie, Celgene, and Takeda, among other entities.

SOURCE: Ogura M et al. Lancet Haematol. 2018 Nov;5(11):e543-53.

The rituximab biosimilar CT-P10 has equivalent efficacy, compared with rituximab, and is well tolerated in the treatment of low–tumor-burden follicular lymphoma, according to results from a multinational, randomized, phase 3 study.

Overall response after 7 months of treatment exceeded 80% for patients assigned to CT-P10 and for those assigned to rituximab, investigators reported in the Lancet Haematology.

Adverse event profiles were comparable for rituximab and the biosimilar over that time period, while pharmacokinetics, pharmacodynamics, and immunogenicity were likewise comparable between arms, according to investigators.

“Thus, CT-P10 monotherapy is suggested as a new therapeutic option for patients with low–tumor-burden follicular lymphoma,” wrote senior author Larry W Kwak, MD, PhD, of the Comprehensive Cancer Center, City of Hope, Duarte, Calif., and his colleagues.

CT-P10, the first rituximab biosimilar to be authorized by the European Medicines Agency, has been recommended for approval in the United States by the Food and Drug Administration’s Oncologic Drugs Advisory Committee.

If approved by the FDA, CT-P10 would be the first rituximab biosimilar available in the United States, according to the company, which noted three proposed indications in non-Hodgkin lymphoma.

In the current randomized, double-blind, parallel-group, phase 3 trial, 258 patients with stage II-IV low–tumor-burden follicular lymphoma were randomly assigned to CT-P10 (130 patients) or rituximab sourced in the United States (128 patients).

Treatment consisted of an induction period of intravenous CT-P10 or rituximab weekly for 4 weeks, while patients experiencing disease control went on to a maintenance phase with their assigned treatment given every 8 weeks for six cycles, followed by another year of maintenance therapy with CT-P10 for those still on study.

The primary endpoint of the study was overall response at 7 months, defined as a complete response, unconfirmed complete response, or partial response.

Overall response was seen in 83% of patients randomized to CT-P10 and 81% of patients randomized to rituximab at 7 months, Dr. Kwak and his colleagues reported.

The two treatments were deemed therapeutically equivalent, as illustrated by 90% confidence intervals within a prespecified equivalence margin of 17%, investigators said.

The most common treatment-emergent adverse events in either group were infusion-related reactions, which were of grade 1-2, except for one grade 3 reaction reported in the CT-P10 group, according to the report. Other common adverse events were upper respiratory tract infections and fatigue.

Serious adverse events were reported in six patients in the CT-P10 arm and three patients in the rituximab arm.

The availability of a rituximab biosimilar is anticipated to reduce the cost of treatment and improve patient access, according to investigators.

Introduction of CT-P10 in the European Union was projected to save between 90 and 150 million euros over a year, enabling more than 12,500 new patients to be treated with the biosimilar, according to results of a budget impact analysis investigators cited in their report.

“Widespread adoption of a rituximab biosimilar could have a substantial effect on health care budgets and might also have effects at a societal level,” Dr. Kwak and his coauthors said in the report.

The trial was sponsored by Celltrion and three coauthors of the study were employees of the company. Dr. Kwak and several other coinvestigators not employed by Celltrion reported disclosures related to the company. Other disclosures provided related to Novartis, Roche, AbbVie, Celgene, and Takeda, among other entities.

SOURCE: Ogura M et al. Lancet Haematol. 2018 Nov;5(11):e543-53.