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FDA approves first-in-class drug for follicular lymphoma
This product is a first-in-class bispecific antibody that is designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells, according to the manufacturer, Genentech.
Mosunetuzumab-axgb is administered as an intravenous infusion for a fixed duration, which allows for time off therapy, and can be infused in an outpatient setting, the company noted.
The drug was granted an accelerated approval on the basis of response rate data from the phase 2 GO29781 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial, the company noted.
The GO29781 study was carried out in individuals with pretreated follicular lymphoma, including those who were at high risk for disease progression or whose disease was refractory to prior therapies.
A complete response was achieved in 60% of patients (54 of 90).
An objective response rate (a combination of complete and partial responses) was seen in 80% of patients who received the drug, with a majority maintaining responses for at least 18 months.
The median duration of response among those who responded was 22.8 months.
Safety data come from 218 patients with hematologic cancers who received mosunetuzumab-axgb at the recommended dose. The most common adverse event was cytokine release syndrome (39%), which can be severe and life-threatening. The median duration of cytokine release syndrome events was 3 days (range, 1-29 days). Other common adverse events (≥ 20%) included fatigue, rash, pyrexia, and headache.
“This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” said Elizabeth Budde, MD, PhD, from the City of Hope, Los Angeles, division of lymphoma, and clinical trial investigator.
Dr. Budde presented data on mosunetuzumab-axgb at the 2021 annual meeting of the American Society of Hematology, as reported by this news organization.
She noted that the 60% complete response rate seen with this new drug contrasts with the 14% that has been seen for historical controls.
“We have seen deep and durable responses in heavily pretreated, high-risk relapsed/refractory follicular lymphoma patients with fixed-duration treatment. We also observed a very favorable tolerability profile, with most cytokine release syndrome confined to cycle 1 and low grade, and treatment administration is without mandatory hospitalization,” she commented at the time.
A lymphoma specialist who was not involved in the study told this news organization at the time that he was favorably impressed by the findings.
“To me, the single-agent data looks really outstanding, with a response rate of 80%, a complete response rate of 60%, and a median duration of response of 23 months, and really very acceptable rates of cytokine release syndrome,” commented Brad S. Kahl, MD, from the Siteman Cancer Center and Washington University in St. Louis.
“I think as a single agent – if it does get approval – it will be a really valuable addition to the armamentarium in follicular lymphoma,” he added.
A version of this article first appeared on Medscape.com.
This product is a first-in-class bispecific antibody that is designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells, according to the manufacturer, Genentech.
Mosunetuzumab-axgb is administered as an intravenous infusion for a fixed duration, which allows for time off therapy, and can be infused in an outpatient setting, the company noted.
The drug was granted an accelerated approval on the basis of response rate data from the phase 2 GO29781 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial, the company noted.
The GO29781 study was carried out in individuals with pretreated follicular lymphoma, including those who were at high risk for disease progression or whose disease was refractory to prior therapies.
A complete response was achieved in 60% of patients (54 of 90).
An objective response rate (a combination of complete and partial responses) was seen in 80% of patients who received the drug, with a majority maintaining responses for at least 18 months.
The median duration of response among those who responded was 22.8 months.
Safety data come from 218 patients with hematologic cancers who received mosunetuzumab-axgb at the recommended dose. The most common adverse event was cytokine release syndrome (39%), which can be severe and life-threatening. The median duration of cytokine release syndrome events was 3 days (range, 1-29 days). Other common adverse events (≥ 20%) included fatigue, rash, pyrexia, and headache.
“This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” said Elizabeth Budde, MD, PhD, from the City of Hope, Los Angeles, division of lymphoma, and clinical trial investigator.
Dr. Budde presented data on mosunetuzumab-axgb at the 2021 annual meeting of the American Society of Hematology, as reported by this news organization.
She noted that the 60% complete response rate seen with this new drug contrasts with the 14% that has been seen for historical controls.
“We have seen deep and durable responses in heavily pretreated, high-risk relapsed/refractory follicular lymphoma patients with fixed-duration treatment. We also observed a very favorable tolerability profile, with most cytokine release syndrome confined to cycle 1 and low grade, and treatment administration is without mandatory hospitalization,” she commented at the time.
A lymphoma specialist who was not involved in the study told this news organization at the time that he was favorably impressed by the findings.
“To me, the single-agent data looks really outstanding, with a response rate of 80%, a complete response rate of 60%, and a median duration of response of 23 months, and really very acceptable rates of cytokine release syndrome,” commented Brad S. Kahl, MD, from the Siteman Cancer Center and Washington University in St. Louis.
“I think as a single agent – if it does get approval – it will be a really valuable addition to the armamentarium in follicular lymphoma,” he added.
A version of this article first appeared on Medscape.com.
This product is a first-in-class bispecific antibody that is designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells, according to the manufacturer, Genentech.
Mosunetuzumab-axgb is administered as an intravenous infusion for a fixed duration, which allows for time off therapy, and can be infused in an outpatient setting, the company noted.
The drug was granted an accelerated approval on the basis of response rate data from the phase 2 GO29781 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial, the company noted.
The GO29781 study was carried out in individuals with pretreated follicular lymphoma, including those who were at high risk for disease progression or whose disease was refractory to prior therapies.
A complete response was achieved in 60% of patients (54 of 90).
An objective response rate (a combination of complete and partial responses) was seen in 80% of patients who received the drug, with a majority maintaining responses for at least 18 months.
The median duration of response among those who responded was 22.8 months.
Safety data come from 218 patients with hematologic cancers who received mosunetuzumab-axgb at the recommended dose. The most common adverse event was cytokine release syndrome (39%), which can be severe and life-threatening. The median duration of cytokine release syndrome events was 3 days (range, 1-29 days). Other common adverse events (≥ 20%) included fatigue, rash, pyrexia, and headache.
“This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” said Elizabeth Budde, MD, PhD, from the City of Hope, Los Angeles, division of lymphoma, and clinical trial investigator.
Dr. Budde presented data on mosunetuzumab-axgb at the 2021 annual meeting of the American Society of Hematology, as reported by this news organization.
She noted that the 60% complete response rate seen with this new drug contrasts with the 14% that has been seen for historical controls.
“We have seen deep and durable responses in heavily pretreated, high-risk relapsed/refractory follicular lymphoma patients with fixed-duration treatment. We also observed a very favorable tolerability profile, with most cytokine release syndrome confined to cycle 1 and low grade, and treatment administration is without mandatory hospitalization,” she commented at the time.
A lymphoma specialist who was not involved in the study told this news organization at the time that he was favorably impressed by the findings.
“To me, the single-agent data looks really outstanding, with a response rate of 80%, a complete response rate of 60%, and a median duration of response of 23 months, and really very acceptable rates of cytokine release syndrome,” commented Brad S. Kahl, MD, from the Siteman Cancer Center and Washington University in St. Louis.
“I think as a single agent – if it does get approval – it will be a really valuable addition to the armamentarium in follicular lymphoma,” he added.
A version of this article first appeared on Medscape.com.
MCL: Event-free survival at 2 years bodes well
In this era of efficacious treatments for mantle cell lymphoma (MCL), patients who survive 2 years sans disease recurrence or progression live nearly as long as age- and sex-matched individuals in the general population, a recent study showed.
Patients with MCL who achieved this endpoint – event-free survival at 24 months (EFS24) – also had a low risk of lymphoma-related death, and most often died from unrelated causes, according to results of the prospective cohort study.
Although longer follow-up and confirmation from other study groups are needed, these findings demonstrated a prognostic role for EFS24 in patients with mantle cell lymphoma, according to the lead author, Yucai Wang, MD, PhD, a hematologist/oncologist with Mayo Clinic in Rochester, Minn.
As more effective therapies emerge, overall survival (OS) will likely continue to improve, such that EFS24 will may become an important clinical endpoint in MCL frontline therapy, according to Dr. Wang.
“When we counseled patients with newly diagnosed MCL, we used to tell them that this is an aggressive and incurable disease, and patients would feel bad about it, “ Dr. Wang said in an interview.
“Now that we have better therapy, and outcomes are improving,” he continued, “I think it’s important to tell our patients now that we have improved outcomes for patients with this disease, and things are probably going to get better in the future, to always remain hopeful. That’s powerful for our patients to know.”
Two eras of treatment
The current analysis by Dr. Wang and colleagues was based on patients identified in the Lymphoma Specialized Program of Research Excellence Molecular Epidemiology Resource Cohort Study, a prospective observational study of lymphoma patients evaluated at the Mayo Clinic and the University of Iowa.
The patients were divided into two “eras” of treatment, based on the date of enrollment. Era 1 of enrollment was 2002 to 2009, and Era 2 was 2010 to 2015.
Patients in Era 2 had a substantially improved EFS and OS compared with those in Era 1, according to a previous report from Dr. Wang and coauthors.
Those improved treatment outcomes were likely due to advances in frontline immunochemotherapy, the authors said in that report. In particular, they pointed to the use of highly effective induction regimens containing high-dose cytarabine in patients who were eligible for autologous stem cell transplantation, and the combined use of rituximab-bendamustine in patients who were not eligible for transplant.
In addition, the increased use of salvage treatments such as lenalidomide and Bruton’s tyrosine kinase inhibitors has likely contributed to improvements in outcomes across eras, Dr. Wang and coauthors said in the present report, which looks more closely at the prognostic role of the EFS24 endpoint in Era 1 and Era 2 patients.
The five-year OS for patients diagnosed in Era 2 was 68.4%, compared with 59.2% in Era 1, the authors reported.
Achieving 2 years of EFS had no impact on OS in the earlier era, their findings further show.
In Era 1, the 98 patients who achieved EFS24 went on to have inferior OS compared with the general population, while in Era 2, the 99 patients achieving EFS24 had similar OS compared with the general population.
This was reported as a standardized mortality ratio (SMR) in Era 1 of 2.23 (95% confidence interval, 1.67-2.92; P < .001). By contrast, the SMR in Era 2 was just 1.31 (95% CI, 0.78-2.07; P = .31).
The risk of dying from lymphoma was lower among patients achieving EFS24 in the more recent Era 2, the results showed.
Among patients in Era 1 achieving EFS24, the primary cause of death was lymphoma-related, and the 5-year rate of lymphoma-related death was 19.8%, versus 6.2% for causes of death unrelated to lymphoma.
By contrast, among patients in Era 2 achieving EFS24, the 5-year rate of lymphoma-related death was 2.1% and 5.5% for other causes.
Favorable prognosis
These findings clearly showed that in one cohort of patients with MCL treated in the recent past, those patients going 2 years without evidence of disease progression or events “have a great prognosis,” said Matthew Matasar, MD, MS, chief of blood disorders, Rutgers Cancer Institute of New Jersey and RWJBarnabas Health.
However, there are limitations to describing the role of EFS24 in MCL based solely on this single-cohort study, Dr. Matasar said in an interview.
“There’s a lot of heterogeneity in how we treat mantle cell lymphoma,” he said, “so I would just caution generalizing out of a patient population treated one way to populations that may receive quite different therapeutic approaches.”
Dr. Wang said he and his coinvestigators have several confirmatory studies in the works that are focused on other groups of patients both inside and outside the United States, to validate of EFS24 as an endpoint.
“We have at least four cohorts to look into this and see whether we can see the same or similar results,” he said in the interview.
Dr. Wang disclosed ties with Incyte, InnoCare, LOXO Oncology, Novartis, Genentech, Eli Lilly, TG Therapeutics, MorphoSys, Genmab, and Kite.
In this era of efficacious treatments for mantle cell lymphoma (MCL), patients who survive 2 years sans disease recurrence or progression live nearly as long as age- and sex-matched individuals in the general population, a recent study showed.
Patients with MCL who achieved this endpoint – event-free survival at 24 months (EFS24) – also had a low risk of lymphoma-related death, and most often died from unrelated causes, according to results of the prospective cohort study.
Although longer follow-up and confirmation from other study groups are needed, these findings demonstrated a prognostic role for EFS24 in patients with mantle cell lymphoma, according to the lead author, Yucai Wang, MD, PhD, a hematologist/oncologist with Mayo Clinic in Rochester, Minn.
As more effective therapies emerge, overall survival (OS) will likely continue to improve, such that EFS24 will may become an important clinical endpoint in MCL frontline therapy, according to Dr. Wang.
“When we counseled patients with newly diagnosed MCL, we used to tell them that this is an aggressive and incurable disease, and patients would feel bad about it, “ Dr. Wang said in an interview.
“Now that we have better therapy, and outcomes are improving,” he continued, “I think it’s important to tell our patients now that we have improved outcomes for patients with this disease, and things are probably going to get better in the future, to always remain hopeful. That’s powerful for our patients to know.”
Two eras of treatment
The current analysis by Dr. Wang and colleagues was based on patients identified in the Lymphoma Specialized Program of Research Excellence Molecular Epidemiology Resource Cohort Study, a prospective observational study of lymphoma patients evaluated at the Mayo Clinic and the University of Iowa.
The patients were divided into two “eras” of treatment, based on the date of enrollment. Era 1 of enrollment was 2002 to 2009, and Era 2 was 2010 to 2015.
Patients in Era 2 had a substantially improved EFS and OS compared with those in Era 1, according to a previous report from Dr. Wang and coauthors.
Those improved treatment outcomes were likely due to advances in frontline immunochemotherapy, the authors said in that report. In particular, they pointed to the use of highly effective induction regimens containing high-dose cytarabine in patients who were eligible for autologous stem cell transplantation, and the combined use of rituximab-bendamustine in patients who were not eligible for transplant.
In addition, the increased use of salvage treatments such as lenalidomide and Bruton’s tyrosine kinase inhibitors has likely contributed to improvements in outcomes across eras, Dr. Wang and coauthors said in the present report, which looks more closely at the prognostic role of the EFS24 endpoint in Era 1 and Era 2 patients.
The five-year OS for patients diagnosed in Era 2 was 68.4%, compared with 59.2% in Era 1, the authors reported.
Achieving 2 years of EFS had no impact on OS in the earlier era, their findings further show.
In Era 1, the 98 patients who achieved EFS24 went on to have inferior OS compared with the general population, while in Era 2, the 99 patients achieving EFS24 had similar OS compared with the general population.
This was reported as a standardized mortality ratio (SMR) in Era 1 of 2.23 (95% confidence interval, 1.67-2.92; P < .001). By contrast, the SMR in Era 2 was just 1.31 (95% CI, 0.78-2.07; P = .31).
The risk of dying from lymphoma was lower among patients achieving EFS24 in the more recent Era 2, the results showed.
Among patients in Era 1 achieving EFS24, the primary cause of death was lymphoma-related, and the 5-year rate of lymphoma-related death was 19.8%, versus 6.2% for causes of death unrelated to lymphoma.
By contrast, among patients in Era 2 achieving EFS24, the 5-year rate of lymphoma-related death was 2.1% and 5.5% for other causes.
Favorable prognosis
These findings clearly showed that in one cohort of patients with MCL treated in the recent past, those patients going 2 years without evidence of disease progression or events “have a great prognosis,” said Matthew Matasar, MD, MS, chief of blood disorders, Rutgers Cancer Institute of New Jersey and RWJBarnabas Health.
However, there are limitations to describing the role of EFS24 in MCL based solely on this single-cohort study, Dr. Matasar said in an interview.
“There’s a lot of heterogeneity in how we treat mantle cell lymphoma,” he said, “so I would just caution generalizing out of a patient population treated one way to populations that may receive quite different therapeutic approaches.”
Dr. Wang said he and his coinvestigators have several confirmatory studies in the works that are focused on other groups of patients both inside and outside the United States, to validate of EFS24 as an endpoint.
“We have at least four cohorts to look into this and see whether we can see the same or similar results,” he said in the interview.
Dr. Wang disclosed ties with Incyte, InnoCare, LOXO Oncology, Novartis, Genentech, Eli Lilly, TG Therapeutics, MorphoSys, Genmab, and Kite.
In this era of efficacious treatments for mantle cell lymphoma (MCL), patients who survive 2 years sans disease recurrence or progression live nearly as long as age- and sex-matched individuals in the general population, a recent study showed.
Patients with MCL who achieved this endpoint – event-free survival at 24 months (EFS24) – also had a low risk of lymphoma-related death, and most often died from unrelated causes, according to results of the prospective cohort study.
Although longer follow-up and confirmation from other study groups are needed, these findings demonstrated a prognostic role for EFS24 in patients with mantle cell lymphoma, according to the lead author, Yucai Wang, MD, PhD, a hematologist/oncologist with Mayo Clinic in Rochester, Minn.
As more effective therapies emerge, overall survival (OS) will likely continue to improve, such that EFS24 will may become an important clinical endpoint in MCL frontline therapy, according to Dr. Wang.
“When we counseled patients with newly diagnosed MCL, we used to tell them that this is an aggressive and incurable disease, and patients would feel bad about it, “ Dr. Wang said in an interview.
“Now that we have better therapy, and outcomes are improving,” he continued, “I think it’s important to tell our patients now that we have improved outcomes for patients with this disease, and things are probably going to get better in the future, to always remain hopeful. That’s powerful for our patients to know.”
Two eras of treatment
The current analysis by Dr. Wang and colleagues was based on patients identified in the Lymphoma Specialized Program of Research Excellence Molecular Epidemiology Resource Cohort Study, a prospective observational study of lymphoma patients evaluated at the Mayo Clinic and the University of Iowa.
The patients were divided into two “eras” of treatment, based on the date of enrollment. Era 1 of enrollment was 2002 to 2009, and Era 2 was 2010 to 2015.
Patients in Era 2 had a substantially improved EFS and OS compared with those in Era 1, according to a previous report from Dr. Wang and coauthors.
Those improved treatment outcomes were likely due to advances in frontline immunochemotherapy, the authors said in that report. In particular, they pointed to the use of highly effective induction regimens containing high-dose cytarabine in patients who were eligible for autologous stem cell transplantation, and the combined use of rituximab-bendamustine in patients who were not eligible for transplant.
In addition, the increased use of salvage treatments such as lenalidomide and Bruton’s tyrosine kinase inhibitors has likely contributed to improvements in outcomes across eras, Dr. Wang and coauthors said in the present report, which looks more closely at the prognostic role of the EFS24 endpoint in Era 1 and Era 2 patients.
The five-year OS for patients diagnosed in Era 2 was 68.4%, compared with 59.2% in Era 1, the authors reported.
Achieving 2 years of EFS had no impact on OS in the earlier era, their findings further show.
In Era 1, the 98 patients who achieved EFS24 went on to have inferior OS compared with the general population, while in Era 2, the 99 patients achieving EFS24 had similar OS compared with the general population.
This was reported as a standardized mortality ratio (SMR) in Era 1 of 2.23 (95% confidence interval, 1.67-2.92; P < .001). By contrast, the SMR in Era 2 was just 1.31 (95% CI, 0.78-2.07; P = .31).
The risk of dying from lymphoma was lower among patients achieving EFS24 in the more recent Era 2, the results showed.
Among patients in Era 1 achieving EFS24, the primary cause of death was lymphoma-related, and the 5-year rate of lymphoma-related death was 19.8%, versus 6.2% for causes of death unrelated to lymphoma.
By contrast, among patients in Era 2 achieving EFS24, the 5-year rate of lymphoma-related death was 2.1% and 5.5% for other causes.
Favorable prognosis
These findings clearly showed that in one cohort of patients with MCL treated in the recent past, those patients going 2 years without evidence of disease progression or events “have a great prognosis,” said Matthew Matasar, MD, MS, chief of blood disorders, Rutgers Cancer Institute of New Jersey and RWJBarnabas Health.
However, there are limitations to describing the role of EFS24 in MCL based solely on this single-cohort study, Dr. Matasar said in an interview.
“There’s a lot of heterogeneity in how we treat mantle cell lymphoma,” he said, “so I would just caution generalizing out of a patient population treated one way to populations that may receive quite different therapeutic approaches.”
Dr. Wang said he and his coinvestigators have several confirmatory studies in the works that are focused on other groups of patients both inside and outside the United States, to validate of EFS24 as an endpoint.
“We have at least four cohorts to look into this and see whether we can see the same or similar results,” he said in the interview.
Dr. Wang disclosed ties with Incyte, InnoCare, LOXO Oncology, Novartis, Genentech, Eli Lilly, TG Therapeutics, MorphoSys, Genmab, and Kite.
FROM CLINICAL LYMPHOMA, MYELOMA AND LEUKEMIA
CLL phase 3 study: Zanubrutinib bests ibrutinib
Progression-free survival (PFS) was significantly higher for zanubrutinib versus ibrutinib, according to investigator Jennifer R. Brown, MD, PhD, director of the Center for Chronic Lymphocytic Leukemia at Dana-Farber Cancer Institute, Boston.
Cardiac safety was also better with zanubrutinib, the second-generation Bruton’s tyrosine kinase inhibitor, compared to ibrutinib, the first-in-class Bruton’s tyrosine kinase inhibitor. Dr. Brown noted that ibrutinib has “transformed CLL therapy,” despite toxicity and pharmacokinetics issues which limit its use.
Even in patients with high-risk CLL, there was a clear benefit of zanubrutinib over ibrutinib, according to Dr. Brown, who presented final results of ALPINE in a late-breaking clinical trials session at the annual meeting of the American Society of Hematology.
“I am not aware of a patient population in which I would select ibrutinib as compared to zanubrutinib,” Dr. Brown said in a press briefing on the study at the meeting.
Although not currently indicated in CLL, zanubrutinib received Food and Drug Administration approval for treatment of relapsed/refractory mantle cell lymphoma in late 2019, followed by indications in Waldenström’s macroglobulinemia and relapsed/refractory marginal zone lymphoma in 2021.
But the choice of zanubrutinib over ibrutinib in relapsed/refractory CLL is already supported in current clinical practice guidelines, Dr. Brown said.
The most recent CLL guidelines from the National Comprehensive Cancer Network (NCCN), updated Aug 30, describe zanubrutinib as a “preferred” regimen, while ibrutinib falls into the category of an “other recommended regimen.”
The zanubrutinib recommendation is category 1, meaning that it is based on high-level evidence, with uniform consensus that the intervention in appropriate, according to NCCN.
Improved safety, efficacy
Side effects have proved to be an Achilles heel for ibrutinib, which first received an FDA approval in CLL in 2014.
Across CLL studies, between 16% and 23% of CLL patients have discontinued ibrutinib treatment because of toxicities, Dr. Brown, the ALPINE investigator, said at the ASH meeting.
In addition, pharmacokinetic data suggest that at certain times between doses, the amount of ibrutinib in a patient’s system may drop below the level needed to effectively inhibit the target protein, Bruton’s tyrosine kinase.
By contrast, zanubrutinib is designed to have greater specificity for that target protein, Dr. Brown said. Furthermore, the pharmacokinetic studies have demonstrated concentrations of drug consistently above the level needed for effective inhibition – an effect that suggests potential for greater efficacy.
In the ALPINE study, 652 patients with relapsed/refractory CLL/small lymphocytic lymphoma (SLL) were randomized to zanubrutinib 160 mg twice daily or ibrutinib once daily.
With a mean follow-up of 29.6 months, zanubrutinib PFS was significantly superior to ibrutinib, according to Dr. Brown, with a hazard ratio (HR) of 0.65 and 95% confidence interval (CI) between 0.49 and 0.86.
Estimated PFS at 2 years was 79.5% in the zanubrutinib arm and 67.3% for ibrutinib, according to the ALPINE data presented.
However, the difference in PFS in favor of zanubrutinib was even more pronounced in high-risk patients, according to Dr. Brown. Among patients with chromosome 17 deletion or TP53 mutation, the PFS at 2 years was 77.6% for zanubrutinib and just 55.7% for ibrutinib, with an HR of 0.52 and 95% CI of 0.30 to 0.88.
Zanubrutinib’s safety profile was superior to ibrutinib, with serious adverse rates of 42.0% and 50.0%, respectively, and significantly lower cardiac toxicity for zanubrutinib, according to the investigators’ presentation.
Only 5.2% of patients on zanubrutinib had atrial fibrillation/flutter on study, compared to 13.3% for ibrutinib (P = .0004), while rates of serious cardiac adverse events were 1.9% and 7.7% , respectively.
Impressive benefit
The PFS benefit of zanubrutinib over ibrutinib was “quite impressive” in ALPINE, and in line with pharmacokinetic differences observed between Bruton’s tyrosine kinase inhibitors, said Stefan K. Barta, MD, associate professor of medicine at the University of Pennsylvania in Philadelphia.
“In the lab, [second-generation Bruton’s tyrosine kinase inhibitors] do hit the target better, but better doesn’t necessarily translate into good outcomes for patients – that’s a different question,” Dr. Barta said in an interview
However, the safety findings of ALPINE are particularly relevant, according to Dr. Barta, since today, many patients with CLL will receive treatment with Bruton’s tyrosine kinase inhibitors indefinitely.
In ALPINE results presented at ASH, zanubrutinib-treated patients had lower rates of atrial fibrillation and serious cardiac events, as well as zero deaths due to cardiac events, compared to six deaths in the ibrutinib group.
“Side effects make a big difference if you are on something for a long time,” Dr. Barta said. “It’s certainly a huge difference already, but then if you get the added bonus of also having an improvement in PFS, that’s a win-win.”
Dr. Brown reported disclosures related to Abbvie, Acerta/AstraZeneca, Beigene, Bristol-Myers Squibb/Juno/Celgene, Catapult, Genentech/Roche, Janssen, MEI Pharma, Morphosys AG, Novartis, Pfizer, Rigel, Gilead, Loxo/Lilly, Verastem/Secura Bio, Sun, TG Therapeutics, Invectys, Grifols Worldwide Operations, Hutchmed, iOnctura, and Pharmacyclics.
Progression-free survival (PFS) was significantly higher for zanubrutinib versus ibrutinib, according to investigator Jennifer R. Brown, MD, PhD, director of the Center for Chronic Lymphocytic Leukemia at Dana-Farber Cancer Institute, Boston.
Cardiac safety was also better with zanubrutinib, the second-generation Bruton’s tyrosine kinase inhibitor, compared to ibrutinib, the first-in-class Bruton’s tyrosine kinase inhibitor. Dr. Brown noted that ibrutinib has “transformed CLL therapy,” despite toxicity and pharmacokinetics issues which limit its use.
Even in patients with high-risk CLL, there was a clear benefit of zanubrutinib over ibrutinib, according to Dr. Brown, who presented final results of ALPINE in a late-breaking clinical trials session at the annual meeting of the American Society of Hematology.
“I am not aware of a patient population in which I would select ibrutinib as compared to zanubrutinib,” Dr. Brown said in a press briefing on the study at the meeting.
Although not currently indicated in CLL, zanubrutinib received Food and Drug Administration approval for treatment of relapsed/refractory mantle cell lymphoma in late 2019, followed by indications in Waldenström’s macroglobulinemia and relapsed/refractory marginal zone lymphoma in 2021.
But the choice of zanubrutinib over ibrutinib in relapsed/refractory CLL is already supported in current clinical practice guidelines, Dr. Brown said.
The most recent CLL guidelines from the National Comprehensive Cancer Network (NCCN), updated Aug 30, describe zanubrutinib as a “preferred” regimen, while ibrutinib falls into the category of an “other recommended regimen.”
The zanubrutinib recommendation is category 1, meaning that it is based on high-level evidence, with uniform consensus that the intervention in appropriate, according to NCCN.
Improved safety, efficacy
Side effects have proved to be an Achilles heel for ibrutinib, which first received an FDA approval in CLL in 2014.
Across CLL studies, between 16% and 23% of CLL patients have discontinued ibrutinib treatment because of toxicities, Dr. Brown, the ALPINE investigator, said at the ASH meeting.
In addition, pharmacokinetic data suggest that at certain times between doses, the amount of ibrutinib in a patient’s system may drop below the level needed to effectively inhibit the target protein, Bruton’s tyrosine kinase.
By contrast, zanubrutinib is designed to have greater specificity for that target protein, Dr. Brown said. Furthermore, the pharmacokinetic studies have demonstrated concentrations of drug consistently above the level needed for effective inhibition – an effect that suggests potential for greater efficacy.
In the ALPINE study, 652 patients with relapsed/refractory CLL/small lymphocytic lymphoma (SLL) were randomized to zanubrutinib 160 mg twice daily or ibrutinib once daily.
With a mean follow-up of 29.6 months, zanubrutinib PFS was significantly superior to ibrutinib, according to Dr. Brown, with a hazard ratio (HR) of 0.65 and 95% confidence interval (CI) between 0.49 and 0.86.
Estimated PFS at 2 years was 79.5% in the zanubrutinib arm and 67.3% for ibrutinib, according to the ALPINE data presented.
However, the difference in PFS in favor of zanubrutinib was even more pronounced in high-risk patients, according to Dr. Brown. Among patients with chromosome 17 deletion or TP53 mutation, the PFS at 2 years was 77.6% for zanubrutinib and just 55.7% for ibrutinib, with an HR of 0.52 and 95% CI of 0.30 to 0.88.
Zanubrutinib’s safety profile was superior to ibrutinib, with serious adverse rates of 42.0% and 50.0%, respectively, and significantly lower cardiac toxicity for zanubrutinib, according to the investigators’ presentation.
Only 5.2% of patients on zanubrutinib had atrial fibrillation/flutter on study, compared to 13.3% for ibrutinib (P = .0004), while rates of serious cardiac adverse events were 1.9% and 7.7% , respectively.
Impressive benefit
The PFS benefit of zanubrutinib over ibrutinib was “quite impressive” in ALPINE, and in line with pharmacokinetic differences observed between Bruton’s tyrosine kinase inhibitors, said Stefan K. Barta, MD, associate professor of medicine at the University of Pennsylvania in Philadelphia.
“In the lab, [second-generation Bruton’s tyrosine kinase inhibitors] do hit the target better, but better doesn’t necessarily translate into good outcomes for patients – that’s a different question,” Dr. Barta said in an interview
However, the safety findings of ALPINE are particularly relevant, according to Dr. Barta, since today, many patients with CLL will receive treatment with Bruton’s tyrosine kinase inhibitors indefinitely.
In ALPINE results presented at ASH, zanubrutinib-treated patients had lower rates of atrial fibrillation and serious cardiac events, as well as zero deaths due to cardiac events, compared to six deaths in the ibrutinib group.
“Side effects make a big difference if you are on something for a long time,” Dr. Barta said. “It’s certainly a huge difference already, but then if you get the added bonus of also having an improvement in PFS, that’s a win-win.”
Dr. Brown reported disclosures related to Abbvie, Acerta/AstraZeneca, Beigene, Bristol-Myers Squibb/Juno/Celgene, Catapult, Genentech/Roche, Janssen, MEI Pharma, Morphosys AG, Novartis, Pfizer, Rigel, Gilead, Loxo/Lilly, Verastem/Secura Bio, Sun, TG Therapeutics, Invectys, Grifols Worldwide Operations, Hutchmed, iOnctura, and Pharmacyclics.
Progression-free survival (PFS) was significantly higher for zanubrutinib versus ibrutinib, according to investigator Jennifer R. Brown, MD, PhD, director of the Center for Chronic Lymphocytic Leukemia at Dana-Farber Cancer Institute, Boston.
Cardiac safety was also better with zanubrutinib, the second-generation Bruton’s tyrosine kinase inhibitor, compared to ibrutinib, the first-in-class Bruton’s tyrosine kinase inhibitor. Dr. Brown noted that ibrutinib has “transformed CLL therapy,” despite toxicity and pharmacokinetics issues which limit its use.
Even in patients with high-risk CLL, there was a clear benefit of zanubrutinib over ibrutinib, according to Dr. Brown, who presented final results of ALPINE in a late-breaking clinical trials session at the annual meeting of the American Society of Hematology.
“I am not aware of a patient population in which I would select ibrutinib as compared to zanubrutinib,” Dr. Brown said in a press briefing on the study at the meeting.
Although not currently indicated in CLL, zanubrutinib received Food and Drug Administration approval for treatment of relapsed/refractory mantle cell lymphoma in late 2019, followed by indications in Waldenström’s macroglobulinemia and relapsed/refractory marginal zone lymphoma in 2021.
But the choice of zanubrutinib over ibrutinib in relapsed/refractory CLL is already supported in current clinical practice guidelines, Dr. Brown said.
The most recent CLL guidelines from the National Comprehensive Cancer Network (NCCN), updated Aug 30, describe zanubrutinib as a “preferred” regimen, while ibrutinib falls into the category of an “other recommended regimen.”
The zanubrutinib recommendation is category 1, meaning that it is based on high-level evidence, with uniform consensus that the intervention in appropriate, according to NCCN.
Improved safety, efficacy
Side effects have proved to be an Achilles heel for ibrutinib, which first received an FDA approval in CLL in 2014.
Across CLL studies, between 16% and 23% of CLL patients have discontinued ibrutinib treatment because of toxicities, Dr. Brown, the ALPINE investigator, said at the ASH meeting.
In addition, pharmacokinetic data suggest that at certain times between doses, the amount of ibrutinib in a patient’s system may drop below the level needed to effectively inhibit the target protein, Bruton’s tyrosine kinase.
By contrast, zanubrutinib is designed to have greater specificity for that target protein, Dr. Brown said. Furthermore, the pharmacokinetic studies have demonstrated concentrations of drug consistently above the level needed for effective inhibition – an effect that suggests potential for greater efficacy.
In the ALPINE study, 652 patients with relapsed/refractory CLL/small lymphocytic lymphoma (SLL) were randomized to zanubrutinib 160 mg twice daily or ibrutinib once daily.
With a mean follow-up of 29.6 months, zanubrutinib PFS was significantly superior to ibrutinib, according to Dr. Brown, with a hazard ratio (HR) of 0.65 and 95% confidence interval (CI) between 0.49 and 0.86.
Estimated PFS at 2 years was 79.5% in the zanubrutinib arm and 67.3% for ibrutinib, according to the ALPINE data presented.
However, the difference in PFS in favor of zanubrutinib was even more pronounced in high-risk patients, according to Dr. Brown. Among patients with chromosome 17 deletion or TP53 mutation, the PFS at 2 years was 77.6% for zanubrutinib and just 55.7% for ibrutinib, with an HR of 0.52 and 95% CI of 0.30 to 0.88.
Zanubrutinib’s safety profile was superior to ibrutinib, with serious adverse rates of 42.0% and 50.0%, respectively, and significantly lower cardiac toxicity for zanubrutinib, according to the investigators’ presentation.
Only 5.2% of patients on zanubrutinib had atrial fibrillation/flutter on study, compared to 13.3% for ibrutinib (P = .0004), while rates of serious cardiac adverse events were 1.9% and 7.7% , respectively.
Impressive benefit
The PFS benefit of zanubrutinib over ibrutinib was “quite impressive” in ALPINE, and in line with pharmacokinetic differences observed between Bruton’s tyrosine kinase inhibitors, said Stefan K. Barta, MD, associate professor of medicine at the University of Pennsylvania in Philadelphia.
“In the lab, [second-generation Bruton’s tyrosine kinase inhibitors] do hit the target better, but better doesn’t necessarily translate into good outcomes for patients – that’s a different question,” Dr. Barta said in an interview
However, the safety findings of ALPINE are particularly relevant, according to Dr. Barta, since today, many patients with CLL will receive treatment with Bruton’s tyrosine kinase inhibitors indefinitely.
In ALPINE results presented at ASH, zanubrutinib-treated patients had lower rates of atrial fibrillation and serious cardiac events, as well as zero deaths due to cardiac events, compared to six deaths in the ibrutinib group.
“Side effects make a big difference if you are on something for a long time,” Dr. Barta said. “It’s certainly a huge difference already, but then if you get the added bonus of also having an improvement in PFS, that’s a win-win.”
Dr. Brown reported disclosures related to Abbvie, Acerta/AstraZeneca, Beigene, Bristol-Myers Squibb/Juno/Celgene, Catapult, Genentech/Roche, Janssen, MEI Pharma, Morphosys AG, Novartis, Pfizer, Rigel, Gilead, Loxo/Lilly, Verastem/Secura Bio, Sun, TG Therapeutics, Invectys, Grifols Worldwide Operations, Hutchmed, iOnctura, and Pharmacyclics.
FROM ASH 2022
Intermittent fasting can lead to type 2 diabetes remission
In a small randomized controlled trial of patients with type 2 diabetes in China, close to half of those who followed a novel intermittent fasting program for 3 months had diabetes remission (A1c less than 6.5% without taking antidiabetic drugs) that persisted for 1 year.
Importantly, “this study was performed under real-life conditions, and the intervention was delivered by trained nurses in primary care rather than by specialized staff at a research institute, making it a more practical and achievable way to manage” type 2 diabetes, the authors report.
Moreover, 65% of the patients in the intervention group who achieved diabetes remission had had diabetes for more than 6 years, which “suggests the possibility of remission for patients with longer duration” of diabetes, they note.
In addition, antidiabetic medication costs decreased by 77%, compared with baseline, in patients in the intermittent-fasting intervention group.
Although intermittent fasting has been studied for weight loss, it had not been investigated for effectiveness for diabetes remission.
These findings suggest that intermittent fasting “could be a paradigm shift in the management goals in diabetes care,” Xiao Yang and colleagues conclude in their study, published online in The Journal of Clinical Endocrinology & Metabolism.
“Type 2 diabetes is not necessarily a permanent, lifelong disease,” senior author Dongbo Liu, PhD, from the Hunan Agricultural University, Changsha, China, added in a press release from The Endocrine Society.
“Diabetes remission is possible if patients lose weight by changing their diet and exercise habits,” Dr. Liu said.
‘Excellent outcome’
Invited to comment, Amy E. Rothberg, MD, PhD, who was not involved with the research, agreed that the study indicates that intermittent fasting works for diabetes remission.
“We know that diabetes remission is possible with calorie restriction and subsequent weight loss, and intermittent fasting is just one of the many [dietary] approaches that may be suitable, appealing, and sustainable to some individuals, and usually results in calorie restriction and therefore weight loss,” she said.
The most studied types of intermittent fasting diets are alternate-day fasting, the 5:2 diet, and time-restricted consumption, Dr. Rothberg told this news organization.
This study presented a novel type of intermittent fasting, she noted. The intervention consisted of 6 cycles (3 months) of 5 fasting days followed by 10 ad libitum days, and then 3 months of follow-up (with no fasting days).
After 3 months of the intervention plus 3 months of follow-up, 47% of the 36 patients in the intervention group achieved diabetes remission (with a mean A1c of 5.66%), compared with only 2.8% of the 36 patients in the control group.
At 12 months, 44% of patients in the intervention group had sustained diabetes remission (with a mean A1c of 6.33%).
This was “an excellent outcome,” said Dr. Rothberg, professor of nutritional sciences, School of Public Health, University of Michigan, Ann Arbor, and a co-author of an international consensus statement that defined diabetes remission.
On average, patients in the intermittent fasting group lost 5.93 kg (13.0 lb) in 3 months, which was sustained over 12 months. “The large amount of weight reduction is key to continuing to achieve diabetes remission,” she noted.
This contrasted with an average weight loss of just 0.27 kg (0.6 lb) in the control group.
Participants who were prescribed fewer antidiabetic medications were more likely to achieve diabetes remission. The researchers acknowledge that the study was not blinded, and they did not record physical activity (although participants were encouraged to maintain their usual physical activity).
This was a small study, Dr. Rothberg acknowledged. The researchers did not specify which specific antidiabetic drugs patients were taking, and they did not determine waist or hip circumference or assess lipids.
The diet was culturally sensitive, appropriate, and feasible in this Chinese population and would not be generalizable to non-Asians.
Nevertheless, a similar approach could be used in any population if the diet is tailored to the individual, according to Dr. Rothberg. Importantly, patients would need to receive guidance from a dietician to make sure their diet comprises all the necessary micronutrients, vitamins, and minerals on fasting days, and they would need to maintain a relatively balanced diet and not gorge themselves on feast days.
“I think we should campaign widely about lifestyle approaches to achieve diabetes remission,” she urged.
72 patients with diabetes for an average of 6.6 years
“Despite a widespread public consensus that [type 2 diabetes] is irreversible and requires drug treatment escalation, there is some evidence of the possibility of remission,” Dr. Yang and colleagues write in their article.
They aimed to evaluate the effectiveness of intermittent fasting for diabetes remission and the durability of diabetes remission at 1 year.
Diabetes remission was defined having a stable A1c less than 6.5% for at least 3 months after discontinuing all antidiabetic medications, confirmed in at least annual A1c measurements (according to a 2021 consensus statement initiated by the American Diabetes Association).
Between 2019 and 2020, the researchers enrolled 72 participants aged 38-72 years who had had type 2 diabetes (duration 1 to 11 years) and a body mass index (BMI) of 19.1-30.4 kg/m2. Patients were randomized 1:1 to the intermittent fasting group or control group.
Baseline characteristics were similar in both groups. Patients were a mean age of 53 years and roughly 60% were men. They had a mean BMI of 24 kg/m2, a mean duration of diabetes of 6.6 years, and a mean A1c of 7.6%, and they were taking an average of 1.8 glucose-lowering medications.
On fasting days, patients in the intervention group received a Chinese Medical Nutrition Therapy kit that provided approximately 840 kcal/day (46% carbohydrates, 46% fat, 8% protein). The kit included a breakfast of a fruit and vegetable gruel, lunch of a solid beverage plus a nutritional rice composite, and dinner of a solid beverage and a meal replacement biscuit, which participants reconstituted by mixing with boiling water. They were allowed to consume noncaloric beverages.
On nonfasting days, patients chose foods ad libitum based on the 2017 Dietary Guidelines for Diabetes in China, which recommend approximately 50%-65% of total energy intake from carbohydrates, 15%-20% from protein, and 20%-30% from fat, and had greater than or equal to 5 g fiber per serving.
Patients in the control group chose foods ad libitum from the dietary guidelines during the entire study.
The study received funding from the National Natural Science Foundation of China. The authors have reported no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
In a small randomized controlled trial of patients with type 2 diabetes in China, close to half of those who followed a novel intermittent fasting program for 3 months had diabetes remission (A1c less than 6.5% without taking antidiabetic drugs) that persisted for 1 year.
Importantly, “this study was performed under real-life conditions, and the intervention was delivered by trained nurses in primary care rather than by specialized staff at a research institute, making it a more practical and achievable way to manage” type 2 diabetes, the authors report.
Moreover, 65% of the patients in the intervention group who achieved diabetes remission had had diabetes for more than 6 years, which “suggests the possibility of remission for patients with longer duration” of diabetes, they note.
In addition, antidiabetic medication costs decreased by 77%, compared with baseline, in patients in the intermittent-fasting intervention group.
Although intermittent fasting has been studied for weight loss, it had not been investigated for effectiveness for diabetes remission.
These findings suggest that intermittent fasting “could be a paradigm shift in the management goals in diabetes care,” Xiao Yang and colleagues conclude in their study, published online in The Journal of Clinical Endocrinology & Metabolism.
“Type 2 diabetes is not necessarily a permanent, lifelong disease,” senior author Dongbo Liu, PhD, from the Hunan Agricultural University, Changsha, China, added in a press release from The Endocrine Society.
“Diabetes remission is possible if patients lose weight by changing their diet and exercise habits,” Dr. Liu said.
‘Excellent outcome’
Invited to comment, Amy E. Rothberg, MD, PhD, who was not involved with the research, agreed that the study indicates that intermittent fasting works for diabetes remission.
“We know that diabetes remission is possible with calorie restriction and subsequent weight loss, and intermittent fasting is just one of the many [dietary] approaches that may be suitable, appealing, and sustainable to some individuals, and usually results in calorie restriction and therefore weight loss,” she said.
The most studied types of intermittent fasting diets are alternate-day fasting, the 5:2 diet, and time-restricted consumption, Dr. Rothberg told this news organization.
This study presented a novel type of intermittent fasting, she noted. The intervention consisted of 6 cycles (3 months) of 5 fasting days followed by 10 ad libitum days, and then 3 months of follow-up (with no fasting days).
After 3 months of the intervention plus 3 months of follow-up, 47% of the 36 patients in the intervention group achieved diabetes remission (with a mean A1c of 5.66%), compared with only 2.8% of the 36 patients in the control group.
At 12 months, 44% of patients in the intervention group had sustained diabetes remission (with a mean A1c of 6.33%).
This was “an excellent outcome,” said Dr. Rothberg, professor of nutritional sciences, School of Public Health, University of Michigan, Ann Arbor, and a co-author of an international consensus statement that defined diabetes remission.
On average, patients in the intermittent fasting group lost 5.93 kg (13.0 lb) in 3 months, which was sustained over 12 months. “The large amount of weight reduction is key to continuing to achieve diabetes remission,” she noted.
This contrasted with an average weight loss of just 0.27 kg (0.6 lb) in the control group.
Participants who were prescribed fewer antidiabetic medications were more likely to achieve diabetes remission. The researchers acknowledge that the study was not blinded, and they did not record physical activity (although participants were encouraged to maintain their usual physical activity).
This was a small study, Dr. Rothberg acknowledged. The researchers did not specify which specific antidiabetic drugs patients were taking, and they did not determine waist or hip circumference or assess lipids.
The diet was culturally sensitive, appropriate, and feasible in this Chinese population and would not be generalizable to non-Asians.
Nevertheless, a similar approach could be used in any population if the diet is tailored to the individual, according to Dr. Rothberg. Importantly, patients would need to receive guidance from a dietician to make sure their diet comprises all the necessary micronutrients, vitamins, and minerals on fasting days, and they would need to maintain a relatively balanced diet and not gorge themselves on feast days.
“I think we should campaign widely about lifestyle approaches to achieve diabetes remission,” she urged.
72 patients with diabetes for an average of 6.6 years
“Despite a widespread public consensus that [type 2 diabetes] is irreversible and requires drug treatment escalation, there is some evidence of the possibility of remission,” Dr. Yang and colleagues write in their article.
They aimed to evaluate the effectiveness of intermittent fasting for diabetes remission and the durability of diabetes remission at 1 year.
Diabetes remission was defined having a stable A1c less than 6.5% for at least 3 months after discontinuing all antidiabetic medications, confirmed in at least annual A1c measurements (according to a 2021 consensus statement initiated by the American Diabetes Association).
Between 2019 and 2020, the researchers enrolled 72 participants aged 38-72 years who had had type 2 diabetes (duration 1 to 11 years) and a body mass index (BMI) of 19.1-30.4 kg/m2. Patients were randomized 1:1 to the intermittent fasting group or control group.
Baseline characteristics were similar in both groups. Patients were a mean age of 53 years and roughly 60% were men. They had a mean BMI of 24 kg/m2, a mean duration of diabetes of 6.6 years, and a mean A1c of 7.6%, and they were taking an average of 1.8 glucose-lowering medications.
On fasting days, patients in the intervention group received a Chinese Medical Nutrition Therapy kit that provided approximately 840 kcal/day (46% carbohydrates, 46% fat, 8% protein). The kit included a breakfast of a fruit and vegetable gruel, lunch of a solid beverage plus a nutritional rice composite, and dinner of a solid beverage and a meal replacement biscuit, which participants reconstituted by mixing with boiling water. They were allowed to consume noncaloric beverages.
On nonfasting days, patients chose foods ad libitum based on the 2017 Dietary Guidelines for Diabetes in China, which recommend approximately 50%-65% of total energy intake from carbohydrates, 15%-20% from protein, and 20%-30% from fat, and had greater than or equal to 5 g fiber per serving.
Patients in the control group chose foods ad libitum from the dietary guidelines during the entire study.
The study received funding from the National Natural Science Foundation of China. The authors have reported no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
In a small randomized controlled trial of patients with type 2 diabetes in China, close to half of those who followed a novel intermittent fasting program for 3 months had diabetes remission (A1c less than 6.5% without taking antidiabetic drugs) that persisted for 1 year.
Importantly, “this study was performed under real-life conditions, and the intervention was delivered by trained nurses in primary care rather than by specialized staff at a research institute, making it a more practical and achievable way to manage” type 2 diabetes, the authors report.
Moreover, 65% of the patients in the intervention group who achieved diabetes remission had had diabetes for more than 6 years, which “suggests the possibility of remission for patients with longer duration” of diabetes, they note.
In addition, antidiabetic medication costs decreased by 77%, compared with baseline, in patients in the intermittent-fasting intervention group.
Although intermittent fasting has been studied for weight loss, it had not been investigated for effectiveness for diabetes remission.
These findings suggest that intermittent fasting “could be a paradigm shift in the management goals in diabetes care,” Xiao Yang and colleagues conclude in their study, published online in The Journal of Clinical Endocrinology & Metabolism.
“Type 2 diabetes is not necessarily a permanent, lifelong disease,” senior author Dongbo Liu, PhD, from the Hunan Agricultural University, Changsha, China, added in a press release from The Endocrine Society.
“Diabetes remission is possible if patients lose weight by changing their diet and exercise habits,” Dr. Liu said.
‘Excellent outcome’
Invited to comment, Amy E. Rothberg, MD, PhD, who was not involved with the research, agreed that the study indicates that intermittent fasting works for diabetes remission.
“We know that diabetes remission is possible with calorie restriction and subsequent weight loss, and intermittent fasting is just one of the many [dietary] approaches that may be suitable, appealing, and sustainable to some individuals, and usually results in calorie restriction and therefore weight loss,” she said.
The most studied types of intermittent fasting diets are alternate-day fasting, the 5:2 diet, and time-restricted consumption, Dr. Rothberg told this news organization.
This study presented a novel type of intermittent fasting, she noted. The intervention consisted of 6 cycles (3 months) of 5 fasting days followed by 10 ad libitum days, and then 3 months of follow-up (with no fasting days).
After 3 months of the intervention plus 3 months of follow-up, 47% of the 36 patients in the intervention group achieved diabetes remission (with a mean A1c of 5.66%), compared with only 2.8% of the 36 patients in the control group.
At 12 months, 44% of patients in the intervention group had sustained diabetes remission (with a mean A1c of 6.33%).
This was “an excellent outcome,” said Dr. Rothberg, professor of nutritional sciences, School of Public Health, University of Michigan, Ann Arbor, and a co-author of an international consensus statement that defined diabetes remission.
On average, patients in the intermittent fasting group lost 5.93 kg (13.0 lb) in 3 months, which was sustained over 12 months. “The large amount of weight reduction is key to continuing to achieve diabetes remission,” she noted.
This contrasted with an average weight loss of just 0.27 kg (0.6 lb) in the control group.
Participants who were prescribed fewer antidiabetic medications were more likely to achieve diabetes remission. The researchers acknowledge that the study was not blinded, and they did not record physical activity (although participants were encouraged to maintain their usual physical activity).
This was a small study, Dr. Rothberg acknowledged. The researchers did not specify which specific antidiabetic drugs patients were taking, and they did not determine waist or hip circumference or assess lipids.
The diet was culturally sensitive, appropriate, and feasible in this Chinese population and would not be generalizable to non-Asians.
Nevertheless, a similar approach could be used in any population if the diet is tailored to the individual, according to Dr. Rothberg. Importantly, patients would need to receive guidance from a dietician to make sure their diet comprises all the necessary micronutrients, vitamins, and minerals on fasting days, and they would need to maintain a relatively balanced diet and not gorge themselves on feast days.
“I think we should campaign widely about lifestyle approaches to achieve diabetes remission,” she urged.
72 patients with diabetes for an average of 6.6 years
“Despite a widespread public consensus that [type 2 diabetes] is irreversible and requires drug treatment escalation, there is some evidence of the possibility of remission,” Dr. Yang and colleagues write in their article.
They aimed to evaluate the effectiveness of intermittent fasting for diabetes remission and the durability of diabetes remission at 1 year.
Diabetes remission was defined having a stable A1c less than 6.5% for at least 3 months after discontinuing all antidiabetic medications, confirmed in at least annual A1c measurements (according to a 2021 consensus statement initiated by the American Diabetes Association).
Between 2019 and 2020, the researchers enrolled 72 participants aged 38-72 years who had had type 2 diabetes (duration 1 to 11 years) and a body mass index (BMI) of 19.1-30.4 kg/m2. Patients were randomized 1:1 to the intermittent fasting group or control group.
Baseline characteristics were similar in both groups. Patients were a mean age of 53 years and roughly 60% were men. They had a mean BMI of 24 kg/m2, a mean duration of diabetes of 6.6 years, and a mean A1c of 7.6%, and they were taking an average of 1.8 glucose-lowering medications.
On fasting days, patients in the intervention group received a Chinese Medical Nutrition Therapy kit that provided approximately 840 kcal/day (46% carbohydrates, 46% fat, 8% protein). The kit included a breakfast of a fruit and vegetable gruel, lunch of a solid beverage plus a nutritional rice composite, and dinner of a solid beverage and a meal replacement biscuit, which participants reconstituted by mixing with boiling water. They were allowed to consume noncaloric beverages.
On nonfasting days, patients chose foods ad libitum based on the 2017 Dietary Guidelines for Diabetes in China, which recommend approximately 50%-65% of total energy intake from carbohydrates, 15%-20% from protein, and 20%-30% from fat, and had greater than or equal to 5 g fiber per serving.
Patients in the control group chose foods ad libitum from the dietary guidelines during the entire study.
The study received funding from the National Natural Science Foundation of China. The authors have reported no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
Updated materials and mentoring can boost diversity in dermatology
LAS VEGAS – in the specialty.
The growing ethnic minority population in the United States “underscores the need for medical education to ensure dermatologists are prepared to provide quality care for patients of diverse racial and ethnic backgrounds,” said Dr. Taylor, the Bernett L. Johnson Jr., MD, Professor, and vice chair for diversity, equity, and inclusion in the department of dermatology at the University of Pennsylvania.
Improving education includes diversifying resource material, she said. A recent study in the Journal of the American Academy of Dermatology showed the representation of skin tones on Google searches for skin conditions was mostly light skin (91.7%), although non-Hispanic Whites account for less than two-thirds (approximately 60%) of the U.S. population, she said. Many people with darker skin tones “are not finding people who look like themselves” when they search skin conditions online, she noted.
The lack of diversity in images occurs not only on Google, “but in our textbooks, which are the foundational resources for our students,” said Nada M. Elbuluk, MD, founder and director of the Skin of Color and Pigmentary Disorders Program at the University of Southern California, Los Angeles. She also established the Dermatology Diversity and Inclusion Program at USC.
The underrepresentation of teaching images, combined with the lack of data on epidemiology and treatment, can translate to poorer quality of care for skin of color patients and contribute to more misdiagnoses in these populations, Dr. Elbuluk emphasized.
Cultural competency and workforce diversity are ongoing issues in dermatology, added Valerie D. Callender, MD, professor of dermatology at Howard University, Washington, and medical director of the Callender Dermatology & Cosmetic Center in Glenn Dale, Md.
“We know that patients of color seek physicians of color,” she said. “We need to target our residents’ interest in dermatology,” and all physicians need to be comfortable with treating patients of all races, she added.
Although more than 13% of Americans are Black, only 3% of dermatologists in the United States are Black, Dr. Callender noted. Similarly, 4.2% of dermatologists in the United States are Hispanic or Latino, but these groups make up more than 18% of the general U.S. population, according to a recent study, she said.
Cheryl M. Burgess, MD, founder and medical director of the Center for Dermatology and Dermatologic Surgery in Washington, presented a roadmap of strategies for improving diversity in dermatology, starting with increasing STEM education at the high school and college levels among all populations and increasing the pipeline of underrepresented students to medical schools.
Then, faculty should work to increase interest in dermatology among underrepresented medical students and increase the numbers of underrepresented medical students in dermatology residency programs, said Dr. Burgess, assistant clinical professor of dermatology at Georgetown University and George Washington University, Washington.
“The more diversity we have in our specialty, the more we learn from each other,” and increased diversity can promote new research questions, said Andrew F. Alexis, MD, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, New York.
Increasing the diversity of populations in clinical trials is another important strategy to improve diversity in dermatology, he emphasized.
Mentoring is an excellent way to help underrepresented students develop and pursue a career in dermatology, the panelists agreed. Time is precious for everyone, so don’t hesitate to use Zoom and other technology to help connect with mentees, Dr. Burgess advised.
Dr. Taylor added that mentoring doesn’t have to be a huge time commitment, it can be as simple as volunteering once a year at a school career forum. “It is so gratifying to have these young people looking up to you,” she said.
The panelists disclosed relationships with multiple companies, but none were relevant to this panel discussion. MedscapeLive and this news organization are owned by the same parent company.
LAS VEGAS – in the specialty.
The growing ethnic minority population in the United States “underscores the need for medical education to ensure dermatologists are prepared to provide quality care for patients of diverse racial and ethnic backgrounds,” said Dr. Taylor, the Bernett L. Johnson Jr., MD, Professor, and vice chair for diversity, equity, and inclusion in the department of dermatology at the University of Pennsylvania.
Improving education includes diversifying resource material, she said. A recent study in the Journal of the American Academy of Dermatology showed the representation of skin tones on Google searches for skin conditions was mostly light skin (91.7%), although non-Hispanic Whites account for less than two-thirds (approximately 60%) of the U.S. population, she said. Many people with darker skin tones “are not finding people who look like themselves” when they search skin conditions online, she noted.
The lack of diversity in images occurs not only on Google, “but in our textbooks, which are the foundational resources for our students,” said Nada M. Elbuluk, MD, founder and director of the Skin of Color and Pigmentary Disorders Program at the University of Southern California, Los Angeles. She also established the Dermatology Diversity and Inclusion Program at USC.
The underrepresentation of teaching images, combined with the lack of data on epidemiology and treatment, can translate to poorer quality of care for skin of color patients and contribute to more misdiagnoses in these populations, Dr. Elbuluk emphasized.
Cultural competency and workforce diversity are ongoing issues in dermatology, added Valerie D. Callender, MD, professor of dermatology at Howard University, Washington, and medical director of the Callender Dermatology & Cosmetic Center in Glenn Dale, Md.
“We know that patients of color seek physicians of color,” she said. “We need to target our residents’ interest in dermatology,” and all physicians need to be comfortable with treating patients of all races, she added.
Although more than 13% of Americans are Black, only 3% of dermatologists in the United States are Black, Dr. Callender noted. Similarly, 4.2% of dermatologists in the United States are Hispanic or Latino, but these groups make up more than 18% of the general U.S. population, according to a recent study, she said.
Cheryl M. Burgess, MD, founder and medical director of the Center for Dermatology and Dermatologic Surgery in Washington, presented a roadmap of strategies for improving diversity in dermatology, starting with increasing STEM education at the high school and college levels among all populations and increasing the pipeline of underrepresented students to medical schools.
Then, faculty should work to increase interest in dermatology among underrepresented medical students and increase the numbers of underrepresented medical students in dermatology residency programs, said Dr. Burgess, assistant clinical professor of dermatology at Georgetown University and George Washington University, Washington.
“The more diversity we have in our specialty, the more we learn from each other,” and increased diversity can promote new research questions, said Andrew F. Alexis, MD, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, New York.
Increasing the diversity of populations in clinical trials is another important strategy to improve diversity in dermatology, he emphasized.
Mentoring is an excellent way to help underrepresented students develop and pursue a career in dermatology, the panelists agreed. Time is precious for everyone, so don’t hesitate to use Zoom and other technology to help connect with mentees, Dr. Burgess advised.
Dr. Taylor added that mentoring doesn’t have to be a huge time commitment, it can be as simple as volunteering once a year at a school career forum. “It is so gratifying to have these young people looking up to you,” she said.
The panelists disclosed relationships with multiple companies, but none were relevant to this panel discussion. MedscapeLive and this news organization are owned by the same parent company.
LAS VEGAS – in the specialty.
The growing ethnic minority population in the United States “underscores the need for medical education to ensure dermatologists are prepared to provide quality care for patients of diverse racial and ethnic backgrounds,” said Dr. Taylor, the Bernett L. Johnson Jr., MD, Professor, and vice chair for diversity, equity, and inclusion in the department of dermatology at the University of Pennsylvania.
Improving education includes diversifying resource material, she said. A recent study in the Journal of the American Academy of Dermatology showed the representation of skin tones on Google searches for skin conditions was mostly light skin (91.7%), although non-Hispanic Whites account for less than two-thirds (approximately 60%) of the U.S. population, she said. Many people with darker skin tones “are not finding people who look like themselves” when they search skin conditions online, she noted.
The lack of diversity in images occurs not only on Google, “but in our textbooks, which are the foundational resources for our students,” said Nada M. Elbuluk, MD, founder and director of the Skin of Color and Pigmentary Disorders Program at the University of Southern California, Los Angeles. She also established the Dermatology Diversity and Inclusion Program at USC.
The underrepresentation of teaching images, combined with the lack of data on epidemiology and treatment, can translate to poorer quality of care for skin of color patients and contribute to more misdiagnoses in these populations, Dr. Elbuluk emphasized.
Cultural competency and workforce diversity are ongoing issues in dermatology, added Valerie D. Callender, MD, professor of dermatology at Howard University, Washington, and medical director of the Callender Dermatology & Cosmetic Center in Glenn Dale, Md.
“We know that patients of color seek physicians of color,” she said. “We need to target our residents’ interest in dermatology,” and all physicians need to be comfortable with treating patients of all races, she added.
Although more than 13% of Americans are Black, only 3% of dermatologists in the United States are Black, Dr. Callender noted. Similarly, 4.2% of dermatologists in the United States are Hispanic or Latino, but these groups make up more than 18% of the general U.S. population, according to a recent study, she said.
Cheryl M. Burgess, MD, founder and medical director of the Center for Dermatology and Dermatologic Surgery in Washington, presented a roadmap of strategies for improving diversity in dermatology, starting with increasing STEM education at the high school and college levels among all populations and increasing the pipeline of underrepresented students to medical schools.
Then, faculty should work to increase interest in dermatology among underrepresented medical students and increase the numbers of underrepresented medical students in dermatology residency programs, said Dr. Burgess, assistant clinical professor of dermatology at Georgetown University and George Washington University, Washington.
“The more diversity we have in our specialty, the more we learn from each other,” and increased diversity can promote new research questions, said Andrew F. Alexis, MD, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, New York.
Increasing the diversity of populations in clinical trials is another important strategy to improve diversity in dermatology, he emphasized.
Mentoring is an excellent way to help underrepresented students develop and pursue a career in dermatology, the panelists agreed. Time is precious for everyone, so don’t hesitate to use Zoom and other technology to help connect with mentees, Dr. Burgess advised.
Dr. Taylor added that mentoring doesn’t have to be a huge time commitment, it can be as simple as volunteering once a year at a school career forum. “It is so gratifying to have these young people looking up to you,” she said.
The panelists disclosed relationships with multiple companies, but none were relevant to this panel discussion. MedscapeLive and this news organization are owned by the same parent company.
AT INNOVATIONS IN DERMATOLOGY
Experts dispel incorrect dogmas in aesthetic medicine
At least once a week,
Those images may help Dr. Stankiewicz understand patient preferences in terms of lip size and proportion, but she points out that shape is unique to each person. “I tell them: ‘All we can do is enhance that lip shape with filler. We can’t give you somebody else’s lip shape with an injection of filler.’ ”
During a virtual course on laser and aesthetic skin therapy, she and Omar A. Ibrahimi, MD, PhD, dispelled this and other false dogmas that they hear from some clinicians who practice aesthetic medicine and the patients who see them.
Wait 1 year before treating traumatic and surgical scars with vascular and fractional CO2 lasers. “I don’t think this is controversial anymore, because there is a boatload of data, which has shown that early treatment can prevent hypertrophic scarring and promote scar maturation,” said Dr. Stankiewicz, who practices dermatology in Park City, Utah. “Histology has also shown more organized dermal collagen from early treatment. Of course, there will be situations where you may want to hold off, like doing an ablative fractional [laser treatment] over the scar of a joint replacement ... where you may risk infection.” In her clinic, she routinely treats scars on the same day as suture removal, “as long as the healing looks appropriate.”
Dr. Ibrahimi, a dermatologist and medical director of the Connecticut Skin Institute, Stamford, also jumps on treating scars early. For a patient with postacne erythema, for example, he will use a pulsed-dye laser, which he believes will prevent scars from becoming atrophic.
Used equipment is a better investment than new equipment. While purchasing used laser and light devices can save money, especially when starting out, be wary of potential pitfalls, including the fact that many devices have disposable tips. “If your laser isn’t certified or you’re not the authorized owner of the device, you won’t be able to buy the disposables,” Dr. Stankiewicz noted. “So, before you buy a used device, ensure that you can buy them.”
Also, consider the cost of service if the device breaks down, she advised. Some lasers are complicated to service and others have codes set by the manufacturer so that only contracted engineers can work on them. “Otherwise, third-party engineers and service providers have to figure out how to crack the code to get into the machine,” she said. “If you’re in the situation where you have to ask the manufacturer to service your device, you have to pay a lot of money to recertify your device. Then you’ve lost all the savings you thought you made by buying a used machine.” She prefers to negotiate a good deal on a new device. “Often, a very good deal on a new device can rival the offer of a used one.”
Dr. Ibrahimi recalled buying a used fractional laser that came with a 30-day guarantee, but it stopped working around day 45. “I didn’t have much recourse there,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “You can’t go back to the company [for repair] unless you pay a recertification fee.”
Avoid exercise after Botox treatment. Although inverted yoga poses and lying down should be avoided for several hours after receiving Botox, there are no other limits to other forms of exercise post treatment, Dr. Stankiewicz said. If she suspects that a patient will develop bruising on one or more injection sites, she treats the areas with a laser. “Doing this on the same day as Botox treatment doesn’t always stop or treat bruising, many times it does.”
Another myth she hears is that it is not safe to fly in an airplane after Botox treatment. “That recommendation comes from the fact that the atmospheric pressure is lower in an airplane, so we worry about the risk of Botox spread,” Dr. Stankiewicz said. “But I practice at 7,000 feet above sea level, which is the same atmospheric pressure as that in an airplane,” she added, noting Botox is administered throughout the day in her practice and she does not see increased complications or worry about spread.
Clinician self-treatment is okay. In the opinion of Dr. Stankiewicz, aesthetic clinicians who treat themselves “have a fool for a patient.” She added: “Although no one is going to blame you and may not even know if you give yourself a little Botox touch-up at home, glorifying self-treatment on social media must stop. It’s dangerous and it can be ineffective.”
Self-treatment can also impair judgment and the objectivity of cosmetic therapies. “Also, when you’re pointing a laser at your own face and posting it on social media, it gives viewers the impression that this is not a serious medical treatment when it really is,” she emphasized. In addition, “when you treat yourself, you lose the ability to see the proper clinical endpoint. You also lose the ability to see the angle and the appropriate position for injection to avoid intervascular occlusion.”
Neither Dr. Stankiewicz nor Dr. Ibrahimi reported having relevant financial disclosures.
At least once a week,
Those images may help Dr. Stankiewicz understand patient preferences in terms of lip size and proportion, but she points out that shape is unique to each person. “I tell them: ‘All we can do is enhance that lip shape with filler. We can’t give you somebody else’s lip shape with an injection of filler.’ ”
During a virtual course on laser and aesthetic skin therapy, she and Omar A. Ibrahimi, MD, PhD, dispelled this and other false dogmas that they hear from some clinicians who practice aesthetic medicine and the patients who see them.
Wait 1 year before treating traumatic and surgical scars with vascular and fractional CO2 lasers. “I don’t think this is controversial anymore, because there is a boatload of data, which has shown that early treatment can prevent hypertrophic scarring and promote scar maturation,” said Dr. Stankiewicz, who practices dermatology in Park City, Utah. “Histology has also shown more organized dermal collagen from early treatment. Of course, there will be situations where you may want to hold off, like doing an ablative fractional [laser treatment] over the scar of a joint replacement ... where you may risk infection.” In her clinic, she routinely treats scars on the same day as suture removal, “as long as the healing looks appropriate.”
Dr. Ibrahimi, a dermatologist and medical director of the Connecticut Skin Institute, Stamford, also jumps on treating scars early. For a patient with postacne erythema, for example, he will use a pulsed-dye laser, which he believes will prevent scars from becoming atrophic.
Used equipment is a better investment than new equipment. While purchasing used laser and light devices can save money, especially when starting out, be wary of potential pitfalls, including the fact that many devices have disposable tips. “If your laser isn’t certified or you’re not the authorized owner of the device, you won’t be able to buy the disposables,” Dr. Stankiewicz noted. “So, before you buy a used device, ensure that you can buy them.”
Also, consider the cost of service if the device breaks down, she advised. Some lasers are complicated to service and others have codes set by the manufacturer so that only contracted engineers can work on them. “Otherwise, third-party engineers and service providers have to figure out how to crack the code to get into the machine,” she said. “If you’re in the situation where you have to ask the manufacturer to service your device, you have to pay a lot of money to recertify your device. Then you’ve lost all the savings you thought you made by buying a used machine.” She prefers to negotiate a good deal on a new device. “Often, a very good deal on a new device can rival the offer of a used one.”
Dr. Ibrahimi recalled buying a used fractional laser that came with a 30-day guarantee, but it stopped working around day 45. “I didn’t have much recourse there,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “You can’t go back to the company [for repair] unless you pay a recertification fee.”
Avoid exercise after Botox treatment. Although inverted yoga poses and lying down should be avoided for several hours after receiving Botox, there are no other limits to other forms of exercise post treatment, Dr. Stankiewicz said. If she suspects that a patient will develop bruising on one or more injection sites, she treats the areas with a laser. “Doing this on the same day as Botox treatment doesn’t always stop or treat bruising, many times it does.”
Another myth she hears is that it is not safe to fly in an airplane after Botox treatment. “That recommendation comes from the fact that the atmospheric pressure is lower in an airplane, so we worry about the risk of Botox spread,” Dr. Stankiewicz said. “But I practice at 7,000 feet above sea level, which is the same atmospheric pressure as that in an airplane,” she added, noting Botox is administered throughout the day in her practice and she does not see increased complications or worry about spread.
Clinician self-treatment is okay. In the opinion of Dr. Stankiewicz, aesthetic clinicians who treat themselves “have a fool for a patient.” She added: “Although no one is going to blame you and may not even know if you give yourself a little Botox touch-up at home, glorifying self-treatment on social media must stop. It’s dangerous and it can be ineffective.”
Self-treatment can also impair judgment and the objectivity of cosmetic therapies. “Also, when you’re pointing a laser at your own face and posting it on social media, it gives viewers the impression that this is not a serious medical treatment when it really is,” she emphasized. In addition, “when you treat yourself, you lose the ability to see the proper clinical endpoint. You also lose the ability to see the angle and the appropriate position for injection to avoid intervascular occlusion.”
Neither Dr. Stankiewicz nor Dr. Ibrahimi reported having relevant financial disclosures.
At least once a week,
Those images may help Dr. Stankiewicz understand patient preferences in terms of lip size and proportion, but she points out that shape is unique to each person. “I tell them: ‘All we can do is enhance that lip shape with filler. We can’t give you somebody else’s lip shape with an injection of filler.’ ”
During a virtual course on laser and aesthetic skin therapy, she and Omar A. Ibrahimi, MD, PhD, dispelled this and other false dogmas that they hear from some clinicians who practice aesthetic medicine and the patients who see them.
Wait 1 year before treating traumatic and surgical scars with vascular and fractional CO2 lasers. “I don’t think this is controversial anymore, because there is a boatload of data, which has shown that early treatment can prevent hypertrophic scarring and promote scar maturation,” said Dr. Stankiewicz, who practices dermatology in Park City, Utah. “Histology has also shown more organized dermal collagen from early treatment. Of course, there will be situations where you may want to hold off, like doing an ablative fractional [laser treatment] over the scar of a joint replacement ... where you may risk infection.” In her clinic, she routinely treats scars on the same day as suture removal, “as long as the healing looks appropriate.”
Dr. Ibrahimi, a dermatologist and medical director of the Connecticut Skin Institute, Stamford, also jumps on treating scars early. For a patient with postacne erythema, for example, he will use a pulsed-dye laser, which he believes will prevent scars from becoming atrophic.
Used equipment is a better investment than new equipment. While purchasing used laser and light devices can save money, especially when starting out, be wary of potential pitfalls, including the fact that many devices have disposable tips. “If your laser isn’t certified or you’re not the authorized owner of the device, you won’t be able to buy the disposables,” Dr. Stankiewicz noted. “So, before you buy a used device, ensure that you can buy them.”
Also, consider the cost of service if the device breaks down, she advised. Some lasers are complicated to service and others have codes set by the manufacturer so that only contracted engineers can work on them. “Otherwise, third-party engineers and service providers have to figure out how to crack the code to get into the machine,” she said. “If you’re in the situation where you have to ask the manufacturer to service your device, you have to pay a lot of money to recertify your device. Then you’ve lost all the savings you thought you made by buying a used machine.” She prefers to negotiate a good deal on a new device. “Often, a very good deal on a new device can rival the offer of a used one.”
Dr. Ibrahimi recalled buying a used fractional laser that came with a 30-day guarantee, but it stopped working around day 45. “I didn’t have much recourse there,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “You can’t go back to the company [for repair] unless you pay a recertification fee.”
Avoid exercise after Botox treatment. Although inverted yoga poses and lying down should be avoided for several hours after receiving Botox, there are no other limits to other forms of exercise post treatment, Dr. Stankiewicz said. If she suspects that a patient will develop bruising on one or more injection sites, she treats the areas with a laser. “Doing this on the same day as Botox treatment doesn’t always stop or treat bruising, many times it does.”
Another myth she hears is that it is not safe to fly in an airplane after Botox treatment. “That recommendation comes from the fact that the atmospheric pressure is lower in an airplane, so we worry about the risk of Botox spread,” Dr. Stankiewicz said. “But I practice at 7,000 feet above sea level, which is the same atmospheric pressure as that in an airplane,” she added, noting Botox is administered throughout the day in her practice and she does not see increased complications or worry about spread.
Clinician self-treatment is okay. In the opinion of Dr. Stankiewicz, aesthetic clinicians who treat themselves “have a fool for a patient.” She added: “Although no one is going to blame you and may not even know if you give yourself a little Botox touch-up at home, glorifying self-treatment on social media must stop. It’s dangerous and it can be ineffective.”
Self-treatment can also impair judgment and the objectivity of cosmetic therapies. “Also, when you’re pointing a laser at your own face and posting it on social media, it gives viewers the impression that this is not a serious medical treatment when it really is,” she emphasized. In addition, “when you treat yourself, you lose the ability to see the proper clinical endpoint. You also lose the ability to see the angle and the appropriate position for injection to avoid intervascular occlusion.”
Neither Dr. Stankiewicz nor Dr. Ibrahimi reported having relevant financial disclosures.
FROM A LASER & AESTHETIC SKIN THERAPY COURSE
ITP: Biologic beat placebo, but few patients improved
NEW ORLEANS –
Nevertheless, “efgartigimod demonstrated a strong clinical benefit,” said hematologist/oncologist and study lead author Catherine M. Broome, MD, of Georgetown University, Washington, in an interview about the findings presented at the annual meeting of the American Society of Hematology.
“The data showed statistically significant and clinically meaningful improvement in platelet counts over placebo, a fast and robust platelet count improvement over placebo, and the confirmed ability for every-other-week dosing, as well as a favorable safety and tolerability profile, consistent with previous clinical trials,” she said.
In ITP, according to the National Organization for Rare Disorders, “the patient’s immune system tags their own platelets as ‘foreign,’ leading their B lymphocytes and plasma cells to produce self-reactive antiplatelet antibodies that attach to platelet surface.”
The prevalence of ITP among adults in the United States is 9.5 per 100,000, NORD says. Children are also affected, but they usually recover. An estimated 60% of adults recover within 3 years.
Treatment options include corticosteroids and intravenous immunoglobulin.
“There are a relatively large number of current treatments, and they tend to work well for most patients. However, there are a minority of patients who do not respond to or tolerate current therapies and would benefit from new treatment options,” said hematologist Adam C. Cuker, MD, MS, of Penn Medicine, Philadelphia, in an interview. He is chair of ASH’s Committee on Quality.
For the new industry-funded ADVANCE study, researchers recruited patients with long-standing, persistent/chronic ITP (an average of two platelet counts of < 30×109/L).
Subjects were randomized 2:1 to receive 10 mg/kg of efgartigimod weekly – or response-dependent doses after the first 4 weeks – or placebo for 24 weeks. There were 86 patients in the intervention group and 45 in the placebo group. Overall, 60 were male and 71 were female; 107 were under 65; 121 were White and 8 were Asian. Details about the others were not provided.
Subjects were allowed to take several other drugs such as oral corticosteroids, and oral thrombopoietin receptor agonists other than romiplostim.
Per the primary endpoint, 17/78 (21.8%) reached a sustained response, defined as platelet counts ≥ 50×109/L in ≥ four of six visits between weeks 19 and 24 without intercurrent events, such as rescue therapy at week 12 or later. In the placebo group, 2/40 reached this response (5.0%; P = .0316).
“The primary endpoint was a high bar to achieve,” Dr. Broome said. “This was a difficult-to-treat patient population heavily pretreated and refractory to other treatments: 68.6% of patients in the efgartigimod arm had received three or more prior ITP treatments.”
She added that “subgroup analyses – including prior ITP therapy, time since diagnosis, baseline platelet count and age/region demographics – of patients who achieved the primary endpoint all favored efgartigimod over placebo.”
Side effects were extremely common among both the drug and placebo groups, and serious adverse events were common in the placebo group. No deaths were reported.
Efgartigimod, a neonatal Fc receptor blocker, is an extremely expensive drug that is Food and Drug Administration approved for some cases of generalized myasthenia gravis. According to a report in Neurology earlier this year, company statements listed its price as $855,400 a year; the report questioned its cost-effectiveness.
In response to a query about price, Luc Truyen, MD, PhD, chief medical officer of drug manufacturer Argenx, declined to talk about cost – a sensitive topic for pharmaceutical companies. “It is too early to discuss pricing and access as no regulatory submission or discussion has occurred,” Dr. Truyen said.
Penn Medicine’s Dr. Cuker, who is familiar with the study findings, said the primary endpoint results are not very impressive. “That said, it should be borne in mind that the patients enrolled in the trial tended to be heavily pretreated and refractory patients,” he said.
As for adverse effects, he said the drug “appears to be safe and well tolerated. The biggest theoretical concern with this class of drugs is an increased risk of infection due to lowering of IgG levels.”
It would be helpful to have trials that directly compare second-line therapies in ITP, he added. “Unfortunately, no such trials exist, and pharmaceutical companies would not be motivated to conduct them.”
For now, he said, off-label use of efgartigimod “may be reasonable, but only in rare situations where other approved and better established ITP treatments have been exhausted.”
What’s next? According to Dr. Broome, another trial is currently evaluating efgartigimod for the treatment of primary ITP, with top-line data expected in the second half of 2023.
The study was funded by Argenx. Dr. Broome discloses honoraria from Alexion, Argenx, Apellis, and Sano. Dr. Truyen’s disclosures weren’t available. Dr. Cuker has no disclosures.
NEW ORLEANS –
Nevertheless, “efgartigimod demonstrated a strong clinical benefit,” said hematologist/oncologist and study lead author Catherine M. Broome, MD, of Georgetown University, Washington, in an interview about the findings presented at the annual meeting of the American Society of Hematology.
“The data showed statistically significant and clinically meaningful improvement in platelet counts over placebo, a fast and robust platelet count improvement over placebo, and the confirmed ability for every-other-week dosing, as well as a favorable safety and tolerability profile, consistent with previous clinical trials,” she said.
In ITP, according to the National Organization for Rare Disorders, “the patient’s immune system tags their own platelets as ‘foreign,’ leading their B lymphocytes and plasma cells to produce self-reactive antiplatelet antibodies that attach to platelet surface.”
The prevalence of ITP among adults in the United States is 9.5 per 100,000, NORD says. Children are also affected, but they usually recover. An estimated 60% of adults recover within 3 years.
Treatment options include corticosteroids and intravenous immunoglobulin.
“There are a relatively large number of current treatments, and they tend to work well for most patients. However, there are a minority of patients who do not respond to or tolerate current therapies and would benefit from new treatment options,” said hematologist Adam C. Cuker, MD, MS, of Penn Medicine, Philadelphia, in an interview. He is chair of ASH’s Committee on Quality.
For the new industry-funded ADVANCE study, researchers recruited patients with long-standing, persistent/chronic ITP (an average of two platelet counts of < 30×109/L).
Subjects were randomized 2:1 to receive 10 mg/kg of efgartigimod weekly – or response-dependent doses after the first 4 weeks – or placebo for 24 weeks. There were 86 patients in the intervention group and 45 in the placebo group. Overall, 60 were male and 71 were female; 107 were under 65; 121 were White and 8 were Asian. Details about the others were not provided.
Subjects were allowed to take several other drugs such as oral corticosteroids, and oral thrombopoietin receptor agonists other than romiplostim.
Per the primary endpoint, 17/78 (21.8%) reached a sustained response, defined as platelet counts ≥ 50×109/L in ≥ four of six visits between weeks 19 and 24 without intercurrent events, such as rescue therapy at week 12 or later. In the placebo group, 2/40 reached this response (5.0%; P = .0316).
“The primary endpoint was a high bar to achieve,” Dr. Broome said. “This was a difficult-to-treat patient population heavily pretreated and refractory to other treatments: 68.6% of patients in the efgartigimod arm had received three or more prior ITP treatments.”
She added that “subgroup analyses – including prior ITP therapy, time since diagnosis, baseline platelet count and age/region demographics – of patients who achieved the primary endpoint all favored efgartigimod over placebo.”
Side effects were extremely common among both the drug and placebo groups, and serious adverse events were common in the placebo group. No deaths were reported.
Efgartigimod, a neonatal Fc receptor blocker, is an extremely expensive drug that is Food and Drug Administration approved for some cases of generalized myasthenia gravis. According to a report in Neurology earlier this year, company statements listed its price as $855,400 a year; the report questioned its cost-effectiveness.
In response to a query about price, Luc Truyen, MD, PhD, chief medical officer of drug manufacturer Argenx, declined to talk about cost – a sensitive topic for pharmaceutical companies. “It is too early to discuss pricing and access as no regulatory submission or discussion has occurred,” Dr. Truyen said.
Penn Medicine’s Dr. Cuker, who is familiar with the study findings, said the primary endpoint results are not very impressive. “That said, it should be borne in mind that the patients enrolled in the trial tended to be heavily pretreated and refractory patients,” he said.
As for adverse effects, he said the drug “appears to be safe and well tolerated. The biggest theoretical concern with this class of drugs is an increased risk of infection due to lowering of IgG levels.”
It would be helpful to have trials that directly compare second-line therapies in ITP, he added. “Unfortunately, no such trials exist, and pharmaceutical companies would not be motivated to conduct them.”
For now, he said, off-label use of efgartigimod “may be reasonable, but only in rare situations where other approved and better established ITP treatments have been exhausted.”
What’s next? According to Dr. Broome, another trial is currently evaluating efgartigimod for the treatment of primary ITP, with top-line data expected in the second half of 2023.
The study was funded by Argenx. Dr. Broome discloses honoraria from Alexion, Argenx, Apellis, and Sano. Dr. Truyen’s disclosures weren’t available. Dr. Cuker has no disclosures.
NEW ORLEANS –
Nevertheless, “efgartigimod demonstrated a strong clinical benefit,” said hematologist/oncologist and study lead author Catherine M. Broome, MD, of Georgetown University, Washington, in an interview about the findings presented at the annual meeting of the American Society of Hematology.
“The data showed statistically significant and clinically meaningful improvement in platelet counts over placebo, a fast and robust platelet count improvement over placebo, and the confirmed ability for every-other-week dosing, as well as a favorable safety and tolerability profile, consistent with previous clinical trials,” she said.
In ITP, according to the National Organization for Rare Disorders, “the patient’s immune system tags their own platelets as ‘foreign,’ leading their B lymphocytes and plasma cells to produce self-reactive antiplatelet antibodies that attach to platelet surface.”
The prevalence of ITP among adults in the United States is 9.5 per 100,000, NORD says. Children are also affected, but they usually recover. An estimated 60% of adults recover within 3 years.
Treatment options include corticosteroids and intravenous immunoglobulin.
“There are a relatively large number of current treatments, and they tend to work well for most patients. However, there are a minority of patients who do not respond to or tolerate current therapies and would benefit from new treatment options,” said hematologist Adam C. Cuker, MD, MS, of Penn Medicine, Philadelphia, in an interview. He is chair of ASH’s Committee on Quality.
For the new industry-funded ADVANCE study, researchers recruited patients with long-standing, persistent/chronic ITP (an average of two platelet counts of < 30×109/L).
Subjects were randomized 2:1 to receive 10 mg/kg of efgartigimod weekly – or response-dependent doses after the first 4 weeks – or placebo for 24 weeks. There were 86 patients in the intervention group and 45 in the placebo group. Overall, 60 were male and 71 were female; 107 were under 65; 121 were White and 8 were Asian. Details about the others were not provided.
Subjects were allowed to take several other drugs such as oral corticosteroids, and oral thrombopoietin receptor agonists other than romiplostim.
Per the primary endpoint, 17/78 (21.8%) reached a sustained response, defined as platelet counts ≥ 50×109/L in ≥ four of six visits between weeks 19 and 24 without intercurrent events, such as rescue therapy at week 12 or later. In the placebo group, 2/40 reached this response (5.0%; P = .0316).
“The primary endpoint was a high bar to achieve,” Dr. Broome said. “This was a difficult-to-treat patient population heavily pretreated and refractory to other treatments: 68.6% of patients in the efgartigimod arm had received three or more prior ITP treatments.”
She added that “subgroup analyses – including prior ITP therapy, time since diagnosis, baseline platelet count and age/region demographics – of patients who achieved the primary endpoint all favored efgartigimod over placebo.”
Side effects were extremely common among both the drug and placebo groups, and serious adverse events were common in the placebo group. No deaths were reported.
Efgartigimod, a neonatal Fc receptor blocker, is an extremely expensive drug that is Food and Drug Administration approved for some cases of generalized myasthenia gravis. According to a report in Neurology earlier this year, company statements listed its price as $855,400 a year; the report questioned its cost-effectiveness.
In response to a query about price, Luc Truyen, MD, PhD, chief medical officer of drug manufacturer Argenx, declined to talk about cost – a sensitive topic for pharmaceutical companies. “It is too early to discuss pricing and access as no regulatory submission or discussion has occurred,” Dr. Truyen said.
Penn Medicine’s Dr. Cuker, who is familiar with the study findings, said the primary endpoint results are not very impressive. “That said, it should be borne in mind that the patients enrolled in the trial tended to be heavily pretreated and refractory patients,” he said.
As for adverse effects, he said the drug “appears to be safe and well tolerated. The biggest theoretical concern with this class of drugs is an increased risk of infection due to lowering of IgG levels.”
It would be helpful to have trials that directly compare second-line therapies in ITP, he added. “Unfortunately, no such trials exist, and pharmaceutical companies would not be motivated to conduct them.”
For now, he said, off-label use of efgartigimod “may be reasonable, but only in rare situations where other approved and better established ITP treatments have been exhausted.”
What’s next? According to Dr. Broome, another trial is currently evaluating efgartigimod for the treatment of primary ITP, with top-line data expected in the second half of 2023.
The study was funded by Argenx. Dr. Broome discloses honoraria from Alexion, Argenx, Apellis, and Sano. Dr. Truyen’s disclosures weren’t available. Dr. Cuker has no disclosures.
AT ASH 2022
Migraine: A significant risk factor for cardiovascular diseases
Key clinical point: Migraine or severe headache is a significant risk factor for cardiovascular diseases and significantly increases the risk for angina and stroke.
Major finding: Migraine or severe headache increased the overall risk for cardiovascular diseases (adjusted odds ratio [aOR] 2.77; P = .001), angina (aOR 2.27; P = .046), and stroke (aOR 3.80; P = .006), with the increased risk for cardiovascular diseases being the most prominent among participants with migraine who were women (aOR 6.02; P < .001), aged >60 years (aOR 2.69; P = .049), or had hypertension (aOR 3.57; P < .001) or hyperlipidemia (aOR 2.74; P = .003).
Study details: This cross-sectional study evaluated 5692 participants from the US National Health and Nutrition Examination Survey (NHANES), of which 1090 had migraine or severe headache.
Disclosures: This study was supported by grants from the National Natural Science Foundation of China and the Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.
Source: Wang K et al. Association between migraine and cardiovascular disease: A cross-sectional study. Front Cardiovasc Med. 2022;9:1044465 (Nov 24). Doi: 10.3389/fcvm.2022.1044465
Key clinical point: Migraine or severe headache is a significant risk factor for cardiovascular diseases and significantly increases the risk for angina and stroke.
Major finding: Migraine or severe headache increased the overall risk for cardiovascular diseases (adjusted odds ratio [aOR] 2.77; P = .001), angina (aOR 2.27; P = .046), and stroke (aOR 3.80; P = .006), with the increased risk for cardiovascular diseases being the most prominent among participants with migraine who were women (aOR 6.02; P < .001), aged >60 years (aOR 2.69; P = .049), or had hypertension (aOR 3.57; P < .001) or hyperlipidemia (aOR 2.74; P = .003).
Study details: This cross-sectional study evaluated 5692 participants from the US National Health and Nutrition Examination Survey (NHANES), of which 1090 had migraine or severe headache.
Disclosures: This study was supported by grants from the National Natural Science Foundation of China and the Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.
Source: Wang K et al. Association between migraine and cardiovascular disease: A cross-sectional study. Front Cardiovasc Med. 2022;9:1044465 (Nov 24). Doi: 10.3389/fcvm.2022.1044465
Key clinical point: Migraine or severe headache is a significant risk factor for cardiovascular diseases and significantly increases the risk for angina and stroke.
Major finding: Migraine or severe headache increased the overall risk for cardiovascular diseases (adjusted odds ratio [aOR] 2.77; P = .001), angina (aOR 2.27; P = .046), and stroke (aOR 3.80; P = .006), with the increased risk for cardiovascular diseases being the most prominent among participants with migraine who were women (aOR 6.02; P < .001), aged >60 years (aOR 2.69; P = .049), or had hypertension (aOR 3.57; P < .001) or hyperlipidemia (aOR 2.74; P = .003).
Study details: This cross-sectional study evaluated 5692 participants from the US National Health and Nutrition Examination Survey (NHANES), of which 1090 had migraine or severe headache.
Disclosures: This study was supported by grants from the National Natural Science Foundation of China and the Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.
Source: Wang K et al. Association between migraine and cardiovascular disease: A cross-sectional study. Front Cardiovasc Med. 2022;9:1044465 (Nov 24). Doi: 10.3389/fcvm.2022.1044465
How COVID-19 pandemic affected headache-related disability in young adults with migraine
Key clinical point: The COVID-19 pandemic adversely affected psychological functioning in young US college students with migraine and increased depression and anxiety, attenuating potential improvements achieved in headache-related disability during the pandemic.
Major finding: Levels of depression, anxiety, and stress were significantly higher during vs before the COVID-19 pandemic (all P ≤ .01), whereas headache-related disability was lower (direct effect [c′] −1.6; 95% CI −3.1 to −0.1). However, anxiety (indirect effect [b] 0.3; 95% CI 0.01-0.9) and depression (b 0.7; 95% CI 0.07-1.4) mediated an increase in headache-related disability during vs before the pandemic, thereby canceling improvements achieved during the pandemic.
Study details: This cross-sectional study included 365 undergraduate students aged ≥18 years with episodic migraine with or without aura or chronic migraine who were surveyed before (n = 223) or during (n = 142) the COVID-19 pandemic.
Disclosures: This study did not receive any specific funding. TA Smitherman reported previously serving on the advisory board for Teva Pharmaceuticals (unrelated to this study).
Source: Thaxter LY and Smitherman TA. The effect of the COVID-19 pandemic on headache-related disability among young adults with migraine. Headache. 2022;62(10):1293-1301 (Nov 23). Doi: 10.1111/head.14411
Key clinical point: The COVID-19 pandemic adversely affected psychological functioning in young US college students with migraine and increased depression and anxiety, attenuating potential improvements achieved in headache-related disability during the pandemic.
Major finding: Levels of depression, anxiety, and stress were significantly higher during vs before the COVID-19 pandemic (all P ≤ .01), whereas headache-related disability was lower (direct effect [c′] −1.6; 95% CI −3.1 to −0.1). However, anxiety (indirect effect [b] 0.3; 95% CI 0.01-0.9) and depression (b 0.7; 95% CI 0.07-1.4) mediated an increase in headache-related disability during vs before the pandemic, thereby canceling improvements achieved during the pandemic.
Study details: This cross-sectional study included 365 undergraduate students aged ≥18 years with episodic migraine with or without aura or chronic migraine who were surveyed before (n = 223) or during (n = 142) the COVID-19 pandemic.
Disclosures: This study did not receive any specific funding. TA Smitherman reported previously serving on the advisory board for Teva Pharmaceuticals (unrelated to this study).
Source: Thaxter LY and Smitherman TA. The effect of the COVID-19 pandemic on headache-related disability among young adults with migraine. Headache. 2022;62(10):1293-1301 (Nov 23). Doi: 10.1111/head.14411
Key clinical point: The COVID-19 pandemic adversely affected psychological functioning in young US college students with migraine and increased depression and anxiety, attenuating potential improvements achieved in headache-related disability during the pandemic.
Major finding: Levels of depression, anxiety, and stress were significantly higher during vs before the COVID-19 pandemic (all P ≤ .01), whereas headache-related disability was lower (direct effect [c′] −1.6; 95% CI −3.1 to −0.1). However, anxiety (indirect effect [b] 0.3; 95% CI 0.01-0.9) and depression (b 0.7; 95% CI 0.07-1.4) mediated an increase in headache-related disability during vs before the pandemic, thereby canceling improvements achieved during the pandemic.
Study details: This cross-sectional study included 365 undergraduate students aged ≥18 years with episodic migraine with or without aura or chronic migraine who were surveyed before (n = 223) or during (n = 142) the COVID-19 pandemic.
Disclosures: This study did not receive any specific funding. TA Smitherman reported previously serving on the advisory board for Teva Pharmaceuticals (unrelated to this study).
Source: Thaxter LY and Smitherman TA. The effect of the COVID-19 pandemic on headache-related disability among young adults with migraine. Headache. 2022;62(10):1293-1301 (Nov 23). Doi: 10.1111/head.14411
Erenumab serves as an effective and safe preventive treatment for migraine
Key clinical point: Erenumab may serve as an effective and well-tolerated therapeutic agent for migraine prophylaxis.
Major finding: Compared with placebo, 28 mg (mean difference [MD] −1.1; P = .02), 70 mg (MD −1.4; P < .001), and 140 mg (MD −1.8; P < .001) erenumab led to significant reductions in monthly migraine days at 12 weeks, with each erenumab dose being associated with a significantly higher proportion of patients achieving ≥50% reduction in migraine days (all P < .001) and similar risk for adverse events.
Study details: This was a systematic review and meta-analysis of eight randomized controlled trials including 4860 patients with migraine who received erenumab (7, 21, 28, 70, or 140 mg) or placebo.
Disclosures: This study was funded by the Jiangsu Province Key Research and Development Program, National Natural Science Foundation of China, and Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.
Source: Gui T, Li H et al. Different dosage regimens of erenumab for the treatment of migraine: A systematic review and meta-analysis of the efficacy and safety of randomized controlled trials. Headache. 2022;62(10):1281-1292 (Nov 14). Doi: 10.1111/head.14423
Key clinical point: Erenumab may serve as an effective and well-tolerated therapeutic agent for migraine prophylaxis.
Major finding: Compared with placebo, 28 mg (mean difference [MD] −1.1; P = .02), 70 mg (MD −1.4; P < .001), and 140 mg (MD −1.8; P < .001) erenumab led to significant reductions in monthly migraine days at 12 weeks, with each erenumab dose being associated with a significantly higher proportion of patients achieving ≥50% reduction in migraine days (all P < .001) and similar risk for adverse events.
Study details: This was a systematic review and meta-analysis of eight randomized controlled trials including 4860 patients with migraine who received erenumab (7, 21, 28, 70, or 140 mg) or placebo.
Disclosures: This study was funded by the Jiangsu Province Key Research and Development Program, National Natural Science Foundation of China, and Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.
Source: Gui T, Li H et al. Different dosage regimens of erenumab for the treatment of migraine: A systematic review and meta-analysis of the efficacy and safety of randomized controlled trials. Headache. 2022;62(10):1281-1292 (Nov 14). Doi: 10.1111/head.14423
Key clinical point: Erenumab may serve as an effective and well-tolerated therapeutic agent for migraine prophylaxis.
Major finding: Compared with placebo, 28 mg (mean difference [MD] −1.1; P = .02), 70 mg (MD −1.4; P < .001), and 140 mg (MD −1.8; P < .001) erenumab led to significant reductions in monthly migraine days at 12 weeks, with each erenumab dose being associated with a significantly higher proportion of patients achieving ≥50% reduction in migraine days (all P < .001) and similar risk for adverse events.
Study details: This was a systematic review and meta-analysis of eight randomized controlled trials including 4860 patients with migraine who received erenumab (7, 21, 28, 70, or 140 mg) or placebo.
Disclosures: This study was funded by the Jiangsu Province Key Research and Development Program, National Natural Science Foundation of China, and Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.
Source: Gui T, Li H et al. Different dosage regimens of erenumab for the treatment of migraine: A systematic review and meta-analysis of the efficacy and safety of randomized controlled trials. Headache. 2022;62(10):1281-1292 (Nov 14). Doi: 10.1111/head.14423