Key clinical point: Idelalisib demonstrated long-term efficacy in heavily pretreated patients with relapsed or refractory chronic lymphocytic leukemia (CLL), and despite having a relatively higher toxicity profile than other targeted therapeutics, can be used in such patients in the absence of alternative therapies.

Major finding: The overall response rate was 65%, with 1 patient achieving complete remission. At a median follow-up of 33.6 months, the median progression-free survival was 16.4 months (95% CI 10.4-26.3), whereas the median overall survival was not reached. Grade ≥ 3 adverse events occurred in 10 patients. The most common serious adverse event was grade ≥ 3 infection (65%).

Study details: This real-world observational retrospective study included 37 patients with CLL (for up to 2.5 years after idelalisib approval in 2014) who had relapsed after or were refractory to ≥ 1 prior lines of therapy and received idelalisib with or without concomitant rituximab.

Disclosures: This study was supported by grants from AFA Insurance (Australia), the Swedish Cancer Society, and others. Three authors declared receiving research grants or honoraria from various sources. The other authors did not have any conflicts of interest to disclose.

Source: Mattsson A et al. Idelalisib (PI3Kδ inhibitor) therapy for patients with relapsed/refractory chronic lymphocytic leukemia: A Swedish nation-wide real-world report on consecutively identified patients. Eur J Haematol. 2023 (Jul 27). doi: 10.1111/ejh.14065

Key clinical point: Idelalisib demonstrated long-term efficacy in heavily pretreated patients with relapsed or refractory chronic lymphocytic leukemia (CLL), and despite having a relatively higher toxicity profile than other targeted therapeutics, can be used in such patients in the absence of alternative therapies.

Major finding: The overall response rate was 65%, with 1 patient achieving complete remission. At a median follow-up of 33.6 months, the median progression-free survival was 16.4 months (95% CI 10.4-26.3), whereas the median overall survival was not reached. Grade ≥ 3 adverse events occurred in 10 patients. The most common serious adverse event was grade ≥ 3 infection (65%).

Study details: This real-world observational retrospective study included 37 patients with CLL (for up to 2.5 years after idelalisib approval in 2014) who had relapsed after or were refractory to ≥ 1 prior lines of therapy and received idelalisib with or without concomitant rituximab.

Disclosures: This study was supported by grants from AFA Insurance (Australia), the Swedish Cancer Society, and others. Three authors declared receiving research grants or honoraria from various sources. The other authors did not have any conflicts of interest to disclose.

Source: Mattsson A et al. Idelalisib (PI3Kδ inhibitor) therapy for patients with relapsed/refractory chronic lymphocytic leukemia: A Swedish nation-wide real-world report on consecutively identified patients. Eur J Haematol. 2023 (Jul 27). doi: 10.1111/ejh.14065

Key clinical point: Idelalisib demonstrated long-term efficacy in heavily pretreated patients with relapsed or refractory chronic lymphocytic leukemia (CLL), and despite having a relatively higher toxicity profile than other targeted therapeutics, can be used in such patients in the absence of alternative therapies.

Major finding: The overall response rate was 65%, with 1 patient achieving complete remission. At a median follow-up of 33.6 months, the median progression-free survival was 16.4 months (95% CI 10.4-26.3), whereas the median overall survival was not reached. Grade ≥ 3 adverse events occurred in 10 patients. The most common serious adverse event was grade ≥ 3 infection (65%).

Study details: This real-world observational retrospective study included 37 patients with CLL (for up to 2.5 years after idelalisib approval in 2014) who had relapsed after or were refractory to ≥ 1 prior lines of therapy and received idelalisib with or without concomitant rituximab.

Disclosures: This study was supported by grants from AFA Insurance (Australia), the Swedish Cancer Society, and others. Three authors declared receiving research grants or honoraria from various sources. The other authors did not have any conflicts of interest to disclose.

Source: Mattsson A et al. Idelalisib (PI3Kδ inhibitor) therapy for patients with relapsed/refractory chronic lymphocytic leukemia: A Swedish nation-wide real-world report on consecutively identified patients. Eur J Haematol. 2023 (Jul 27). doi: 10.1111/ejh.14065

Key clinical point: Compared with obinutuzumab alone, obinutuzumab combined with zanubrutinib significantly improved outcomes in patients with relapsed or refractory follicular lymphoma (FL) without causing safety concerns.

Major finding: At a median follow-up of 20.2 months, patients receiving zanubrutinib + obinutuzumab vs single-agent obinutuzumab had a significantly higher overall response rate (69% vs 46%; P = .001) and longer median progression-free survival (28.0 vs 10.4 months; hazard ratio 0.50; P < .001). The safety profile of zanubrutinib + obinutuzumab was consistent with the known safety profile of the individual drugs.

Study details: Findings are from the phase 2 ROSEWOOD study including 217 patients with FL who were refractory to or had relapsed after ≥ 2 prior systemic treatments, including an anti-CD20 antibody and alkylating agent, and were randomly assigned to receive zanubrutinib + obinutuzumab (n = 145) or Obinutuzumab alone (n = 72).

Disclosures: This study was sponsored by BeiGene. No information on conflicts of interest was provided.

Source: Zinzani PL et al. ROSEWOOD: A phase II randomized study of zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma. J Clin Oncol. 2023 (Jul 28). doi: 10.1200/JCO.23.00775

Key clinical point: Compared with obinutuzumab alone, obinutuzumab combined with zanubrutinib significantly improved outcomes in patients with relapsed or refractory follicular lymphoma (FL) without causing safety concerns.

Major finding: At a median follow-up of 20.2 months, patients receiving zanubrutinib + obinutuzumab vs single-agent obinutuzumab had a significantly higher overall response rate (69% vs 46%; P = .001) and longer median progression-free survival (28.0 vs 10.4 months; hazard ratio 0.50; P < .001). The safety profile of zanubrutinib + obinutuzumab was consistent with the known safety profile of the individual drugs.

Study details: Findings are from the phase 2 ROSEWOOD study including 217 patients with FL who were refractory to or had relapsed after ≥ 2 prior systemic treatments, including an anti-CD20 antibody and alkylating agent, and were randomly assigned to receive zanubrutinib + obinutuzumab (n = 145) or Obinutuzumab alone (n = 72).

Disclosures: This study was sponsored by BeiGene. No information on conflicts of interest was provided.

Source: Zinzani PL et al. ROSEWOOD: A phase II randomized study of zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma. J Clin Oncol. 2023 (Jul 28). doi: 10.1200/JCO.23.00775

Key clinical point: Compared with obinutuzumab alone, obinutuzumab combined with zanubrutinib significantly improved outcomes in patients with relapsed or refractory follicular lymphoma (FL) without causing safety concerns.

Major finding: At a median follow-up of 20.2 months, patients receiving zanubrutinib + obinutuzumab vs single-agent obinutuzumab had a significantly higher overall response rate (69% vs 46%; P = .001) and longer median progression-free survival (28.0 vs 10.4 months; hazard ratio 0.50; P < .001). The safety profile of zanubrutinib + obinutuzumab was consistent with the known safety profile of the individual drugs.

Study details: Findings are from the phase 2 ROSEWOOD study including 217 patients with FL who were refractory to or had relapsed after ≥ 2 prior systemic treatments, including an anti-CD20 antibody and alkylating agent, and were randomly assigned to receive zanubrutinib + obinutuzumab (n = 145) or Obinutuzumab alone (n = 72).

Disclosures: This study was sponsored by BeiGene. No information on conflicts of interest was provided.

Source: Zinzani PL et al. ROSEWOOD: A phase II randomized study of zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma. J Clin Oncol. 2023 (Jul 28). doi: 10.1200/JCO.23.00775

Key clinical point: The addition of rituximab (R) to standard cyclophosphamide, doxorubicine, vincristine, and prednisone (CHOP) first-line therapy significantly prolongs failure-free survival (FFS), overall survival (OS), and the duration of response (DOR) in patients with previously untreated, advanced-stage mantle cell lymphoma (MCL).

Major finding: At a median follow-up of 13.4 years, the R-CHOP vs CHOP group had significantly longer median FFS (2.07 vs 1.36 years; adjusted hazard ratio [aHR] 0.62; P < .0001), OS (5.81 vs 4.84 years; aHR 0.78; P = .039), and DOR (2.08 vs 1.48 years; aHR 0.67; P = .0012). No clinically meaningful differences in late toxicities were observed between the groups.

Study details: This long-term pooled trials analysis of two prospective randomized trials included 385 adult patients with untreated advanced-stage MCL who were randomly assigned to receive CHOP (n = 201) or R-CHOP (n = 184).

Disclosures: This study did not receive any specific funding. Some authors declared serving as advisors, consultants, or board members for or receiving research funding, travel support, or honoraria from various sources.

Source: Fischer L et al on behalf of the German Lymphoma Alliance (GLA) and the German Low-Grade Lymphoma Study Group (GLSG). The addition of rituximab to chemotherapy improves overall survival in mantle cell lymphoma-A pooled trials analysis. Ann Hematol. 2023 (Aug 8). doi: 10.1007/s00277-023-05385-1

Key clinical point: The addition of rituximab (R) to standard cyclophosphamide, doxorubicine, vincristine, and prednisone (CHOP) first-line therapy significantly prolongs failure-free survival (FFS), overall survival (OS), and the duration of response (DOR) in patients with previously untreated, advanced-stage mantle cell lymphoma (MCL).

Major finding: At a median follow-up of 13.4 years, the R-CHOP vs CHOP group had significantly longer median FFS (2.07 vs 1.36 years; adjusted hazard ratio [aHR] 0.62; P < .0001), OS (5.81 vs 4.84 years; aHR 0.78; P = .039), and DOR (2.08 vs 1.48 years; aHR 0.67; P = .0012). No clinically meaningful differences in late toxicities were observed between the groups.

Study details: This long-term pooled trials analysis of two prospective randomized trials included 385 adult patients with untreated advanced-stage MCL who were randomly assigned to receive CHOP (n = 201) or R-CHOP (n = 184).

Disclosures: This study did not receive any specific funding. Some authors declared serving as advisors, consultants, or board members for or receiving research funding, travel support, or honoraria from various sources.

Source: Fischer L et al on behalf of the German Lymphoma Alliance (GLA) and the German Low-Grade Lymphoma Study Group (GLSG). The addition of rituximab to chemotherapy improves overall survival in mantle cell lymphoma-A pooled trials analysis. Ann Hematol. 2023 (Aug 8). doi: 10.1007/s00277-023-05385-1

Key clinical point: The addition of rituximab (R) to standard cyclophosphamide, doxorubicine, vincristine, and prednisone (CHOP) first-line therapy significantly prolongs failure-free survival (FFS), overall survival (OS), and the duration of response (DOR) in patients with previously untreated, advanced-stage mantle cell lymphoma (MCL).

Major finding: At a median follow-up of 13.4 years, the R-CHOP vs CHOP group had significantly longer median FFS (2.07 vs 1.36 years; adjusted hazard ratio [aHR] 0.62; P < .0001), OS (5.81 vs 4.84 years; aHR 0.78; P = .039), and DOR (2.08 vs 1.48 years; aHR 0.67; P = .0012). No clinically meaningful differences in late toxicities were observed between the groups.

Study details: This long-term pooled trials analysis of two prospective randomized trials included 385 adult patients with untreated advanced-stage MCL who were randomly assigned to receive CHOP (n = 201) or R-CHOP (n = 184).

Disclosures: This study did not receive any specific funding. Some authors declared serving as advisors, consultants, or board members for or receiving research funding, travel support, or honoraria from various sources.

Source: Fischer L et al on behalf of the German Lymphoma Alliance (GLA) and the German Low-Grade Lymphoma Study Group (GLSG). The addition of rituximab to chemotherapy improves overall survival in mantle cell lymphoma-A pooled trials analysis. Ann Hematol. 2023 (Aug 8). doi: 10.1007/s00277-023-05385-1

Key clinical point: Allogeneic stem cell transplantation (alloSCT) results in long-term disease control in patients with mantle cell lymphoma (MCL), including those with TP53-mutated disease, and should be considered for earlier use in these high-risk patients who are unresponsive to conventional chemoimmunotherapy.

Major finding: The estimated overall survival rates were 56% (95% CI 36%-72%) at 10 years for the overall cohort and 59% (95% CI 21%-75%) at 4 years for patients with TP53-mutated disease at median follow-ups of 10.8 and 4.2 years, respectively. No relapses were observed in the TP53-mutated subset beyond 6 months after transplantation.

Study details: This retrospective study included 36 patients who underwent alloSCT for MCL, including 13 patients with TP53-mutated disease.

Disclosures: This study did not receive any funding. Some authors declared serving as advisory board members for or receiving honoraria, research funding, or speaker fees from various sources.

Source: Lew TE et al. Allogeneic stem cell transplantation achieves long-term remissions in mantle cell lymphoma, including in TP53-mutated disease. Leuk Lymphoma. 2023 (Aug 2). doi: 10.1080/10428194.2023.2241095

Key clinical point: Allogeneic stem cell transplantation (alloSCT) results in long-term disease control in patients with mantle cell lymphoma (MCL), including those with TP53-mutated disease, and should be considered for earlier use in these high-risk patients who are unresponsive to conventional chemoimmunotherapy.

Major finding: The estimated overall survival rates were 56% (95% CI 36%-72%) at 10 years for the overall cohort and 59% (95% CI 21%-75%) at 4 years for patients with TP53-mutated disease at median follow-ups of 10.8 and 4.2 years, respectively. No relapses were observed in the TP53-mutated subset beyond 6 months after transplantation.

Study details: This retrospective study included 36 patients who underwent alloSCT for MCL, including 13 patients with TP53-mutated disease.

Disclosures: This study did not receive any funding. Some authors declared serving as advisory board members for or receiving honoraria, research funding, or speaker fees from various sources.

Source: Lew TE et al. Allogeneic stem cell transplantation achieves long-term remissions in mantle cell lymphoma, including in TP53-mutated disease. Leuk Lymphoma. 2023 (Aug 2). doi: 10.1080/10428194.2023.2241095

Key clinical point: Allogeneic stem cell transplantation (alloSCT) results in long-term disease control in patients with mantle cell lymphoma (MCL), including those with TP53-mutated disease, and should be considered for earlier use in these high-risk patients who are unresponsive to conventional chemoimmunotherapy.

Major finding: The estimated overall survival rates were 56% (95% CI 36%-72%) at 10 years for the overall cohort and 59% (95% CI 21%-75%) at 4 years for patients with TP53-mutated disease at median follow-ups of 10.8 and 4.2 years, respectively. No relapses were observed in the TP53-mutated subset beyond 6 months after transplantation.

Study details: This retrospective study included 36 patients who underwent alloSCT for MCL, including 13 patients with TP53-mutated disease.

Disclosures: This study did not receive any funding. Some authors declared serving as advisory board members for or receiving honoraria, research funding, or speaker fees from various sources.

Source: Lew TE et al. Allogeneic stem cell transplantation achieves long-term remissions in mantle cell lymphoma, including in TP53-mutated disease. Leuk Lymphoma. 2023 (Aug 2). doi: 10.1080/10428194.2023.2241095

Key clinical point: The combination of the prognostic mantle cell lymphoma (MCL) International Prognostic Index (MIPI) with biological risk factors Ki-67 and p53 expression identifies a subset of patients with MCL having poor prognosis.

Major finding: Patients with high combined MIPI (MIPI-c) or p53 expression > 50% (high-risk disease) vs low, low-intermediate, or high-intermediate MIPI-c and p53 expression ≤ 50% (low-risk disease) had significantly shorter median failure-free survival (hazard ratio [HR] 2.97) and overall survival (HR 3.69) at median follow-ups of 9.6 and 9.4 years, respectively (both P < .0001). The results were confirmed in validation cohorts.

Study details: The training cohort included 684 patients with MCL from the MCL-Younger and MCL-Elderly trials with evaluable data for Ki-67 or p53; patients were classified as having high-risk or low-risk disease. The validation cohorts included 230 and 44 patients from the MCL0208 and Nordic-MCL4 trials, respectively.

Disclosures: This study did not receive any funding. Some authors declared serving on advisory boards or speakers’ bureaus of or receiving research funding, consultancy fees, or honoraria from various sources.

Source: Scheubeck G et al. Clinical outcome of mantle cell lymphoma patients with high-risk disease (high-risk MIPI-c or high p53 expression). Leukemia. 2023;37(9):1887-1894 (Jul 26). doi: 10.1038/s41375-023-01977-y

Key clinical point: The combination of the prognostic mantle cell lymphoma (MCL) International Prognostic Index (MIPI) with biological risk factors Ki-67 and p53 expression identifies a subset of patients with MCL having poor prognosis.

Major finding: Patients with high combined MIPI (MIPI-c) or p53 expression > 50% (high-risk disease) vs low, low-intermediate, or high-intermediate MIPI-c and p53 expression ≤ 50% (low-risk disease) had significantly shorter median failure-free survival (hazard ratio [HR] 2.97) and overall survival (HR 3.69) at median follow-ups of 9.6 and 9.4 years, respectively (both P < .0001). The results were confirmed in validation cohorts.

Study details: The training cohort included 684 patients with MCL from the MCL-Younger and MCL-Elderly trials with evaluable data for Ki-67 or p53; patients were classified as having high-risk or low-risk disease. The validation cohorts included 230 and 44 patients from the MCL0208 and Nordic-MCL4 trials, respectively.

Disclosures: This study did not receive any funding. Some authors declared serving on advisory boards or speakers’ bureaus of or receiving research funding, consultancy fees, or honoraria from various sources.

Source: Scheubeck G et al. Clinical outcome of mantle cell lymphoma patients with high-risk disease (high-risk MIPI-c or high p53 expression). Leukemia. 2023;37(9):1887-1894 (Jul 26). doi: 10.1038/s41375-023-01977-y

Key clinical point: The combination of the prognostic mantle cell lymphoma (MCL) International Prognostic Index (MIPI) with biological risk factors Ki-67 and p53 expression identifies a subset of patients with MCL having poor prognosis.

Major finding: Patients with high combined MIPI (MIPI-c) or p53 expression > 50% (high-risk disease) vs low, low-intermediate, or high-intermediate MIPI-c and p53 expression ≤ 50% (low-risk disease) had significantly shorter median failure-free survival (hazard ratio [HR] 2.97) and overall survival (HR 3.69) at median follow-ups of 9.6 and 9.4 years, respectively (both P < .0001). The results were confirmed in validation cohorts.

Study details: The training cohort included 684 patients with MCL from the MCL-Younger and MCL-Elderly trials with evaluable data for Ki-67 or p53; patients were classified as having high-risk or low-risk disease. The validation cohorts included 230 and 44 patients from the MCL0208 and Nordic-MCL4 trials, respectively.

Disclosures: This study did not receive any funding. Some authors declared serving on advisory boards or speakers’ bureaus of or receiving research funding, consultancy fees, or honoraria from various sources.

Source: Scheubeck G et al. Clinical outcome of mantle cell lymphoma patients with high-risk disease (high-risk MIPI-c or high p53 expression). Leukemia. 2023;37(9):1887-1894 (Jul 26). doi: 10.1038/s41375-023-01977-y

Key clinical point: Acalabrutinib demonstrates favorable long-term efficacy and safety in patients with relapsed or refractory mantle cell lymphoma (MCL), including those with poor prognostic factors.

Major finding: The overall and complete response rates were 81.5% (95% CI 73.5%-87.9%) and 47.6% (95% CI 38.5%-56.7%), respectively. After a 38.1-month median follow-up, median duration of response and progression-free survival were 28.6 (95% CI 17.5-39.1) and 22.0 (95% CI 16.6-33.3) months, respectively. No new safety signals were observed.

Study details: The data represent the final results of the phase 2 ACE-LY-004 study of 124 adult patients with MCL, including those with poor prognostic factors, such as blastoid or pleomorphic morphology and Ki-67 index of >30%, who relapsed after or were refractory to ≤ 5 previous therapies and received acalabrutinib twice daily.

Disclosures: This study was funded by AstraZeneca. Some authors declared serving as consultants, advisors, or speakers for and receiving research funds or travel or accommodation expenses from various sources, including AstraZeneca. Two authors declared being employees or equity holders of AstraZeneca.

Source: Le Gouill S et al. Final results and overall survival data from a phase II study of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma, including those with poor prognostic factors. Haematologica. 2023 (Jul 20). doi: 10.3324/haematol.2022.282469

Key clinical point: Acalabrutinib demonstrates favorable long-term efficacy and safety in patients with relapsed or refractory mantle cell lymphoma (MCL), including those with poor prognostic factors.

Major finding: The overall and complete response rates were 81.5% (95% CI 73.5%-87.9%) and 47.6% (95% CI 38.5%-56.7%), respectively. After a 38.1-month median follow-up, median duration of response and progression-free survival were 28.6 (95% CI 17.5-39.1) and 22.0 (95% CI 16.6-33.3) months, respectively. No new safety signals were observed.

Study details: The data represent the final results of the phase 2 ACE-LY-004 study of 124 adult patients with MCL, including those with poor prognostic factors, such as blastoid or pleomorphic morphology and Ki-67 index of >30%, who relapsed after or were refractory to ≤ 5 previous therapies and received acalabrutinib twice daily.

Disclosures: This study was funded by AstraZeneca. Some authors declared serving as consultants, advisors, or speakers for and receiving research funds or travel or accommodation expenses from various sources, including AstraZeneca. Two authors declared being employees or equity holders of AstraZeneca.

Source: Le Gouill S et al. Final results and overall survival data from a phase II study of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma, including those with poor prognostic factors. Haematologica. 2023 (Jul 20). doi: 10.3324/haematol.2022.282469

Key clinical point: Acalabrutinib demonstrates favorable long-term efficacy and safety in patients with relapsed or refractory mantle cell lymphoma (MCL), including those with poor prognostic factors.

Major finding: The overall and complete response rates were 81.5% (95% CI 73.5%-87.9%) and 47.6% (95% CI 38.5%-56.7%), respectively. After a 38.1-month median follow-up, median duration of response and progression-free survival were 28.6 (95% CI 17.5-39.1) and 22.0 (95% CI 16.6-33.3) months, respectively. No new safety signals were observed.

Study details: The data represent the final results of the phase 2 ACE-LY-004 study of 124 adult patients with MCL, including those with poor prognostic factors, such as blastoid or pleomorphic morphology and Ki-67 index of >30%, who relapsed after or were refractory to ≤ 5 previous therapies and received acalabrutinib twice daily.

Disclosures: This study was funded by AstraZeneca. Some authors declared serving as consultants, advisors, or speakers for and receiving research funds or travel or accommodation expenses from various sources, including AstraZeneca. Two authors declared being employees or equity holders of AstraZeneca.

Source: Le Gouill S et al. Final results and overall survival data from a phase II study of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma, including those with poor prognostic factors. Haematologica. 2023 (Jul 20). doi: 10.3324/haematol.2022.282469

The Centers for Disease Control and Prevention is tracking a newly discovered strain of COVID-19 called BA.2.86.

On Aug. 17, the agency posted on X, formerly known as Twitter, that the lineage has been detected in the United States, Denmark, and Israel. 

“As we learn more about BA.2.86, CDC’s advice on protecting yourself from COVID-19 remains the same,” the CDC said on X. 

A case of BA.2.86 was detected at a laboratory at the University of Michigan, CBS News reported. It’s not clear how the university obtained the sample that was sequenced. A case was also detected in the United Kingdom, the news outlet said. 

The World Health Organization is also tracking BA.2.86 and has classified it as a “variant under monitoring.” 

“More data are needed to understand this COVID-19 variant and the extent of its spread, but the number of mutations warrants attention. WHO will update countries and the public as we learn more,” the WHO said on X.

The strain is so new that scientists don’t know if BA.2.86 is more easily spread, causes more severe symptoms than existing strains, or will be more resistant to vaccines and natural immunity developed over the last few years. 

Early research indicates BA.2.86 “will have equal or greater escape than XBB.1.5 from antibodies elicited by pre-Omicron and first-generation Omicron variants,” Jesse Bloom, PhD, a virologist at the Fred Hutchinson Cancer Center, said in a slide deck published Aug. 17. (XBB.1.5 is the Omicron subvariant that is targeted in the updated COVID booster shot to be released soon.)

Still, Dr. Bloom noted that “even if a highly mutated new variant like BA.2.86 starts to spread, we will be in a far better place than we were in 2020 and 2021, since most people have some immunity to SARS-CoV-2 now.”

A version of this article first appeared on WebMD.com.

The Centers for Disease Control and Prevention is tracking a newly discovered strain of COVID-19 called BA.2.86.

On Aug. 17, the agency posted on X, formerly known as Twitter, that the lineage has been detected in the United States, Denmark, and Israel. 

“As we learn more about BA.2.86, CDC’s advice on protecting yourself from COVID-19 remains the same,” the CDC said on X. 

A case of BA.2.86 was detected at a laboratory at the University of Michigan, CBS News reported. It’s not clear how the university obtained the sample that was sequenced. A case was also detected in the United Kingdom, the news outlet said. 

The World Health Organization is also tracking BA.2.86 and has classified it as a “variant under monitoring.” 

“More data are needed to understand this COVID-19 variant and the extent of its spread, but the number of mutations warrants attention. WHO will update countries and the public as we learn more,” the WHO said on X.

The strain is so new that scientists don’t know if BA.2.86 is more easily spread, causes more severe symptoms than existing strains, or will be more resistant to vaccines and natural immunity developed over the last few years. 

Early research indicates BA.2.86 “will have equal or greater escape than XBB.1.5 from antibodies elicited by pre-Omicron and first-generation Omicron variants,” Jesse Bloom, PhD, a virologist at the Fred Hutchinson Cancer Center, said in a slide deck published Aug. 17. (XBB.1.5 is the Omicron subvariant that is targeted in the updated COVID booster shot to be released soon.)

Still, Dr. Bloom noted that “even if a highly mutated new variant like BA.2.86 starts to spread, we will be in a far better place than we were in 2020 and 2021, since most people have some immunity to SARS-CoV-2 now.”

A version of this article first appeared on WebMD.com.

The Centers for Disease Control and Prevention is tracking a newly discovered strain of COVID-19 called BA.2.86.

On Aug. 17, the agency posted on X, formerly known as Twitter, that the lineage has been detected in the United States, Denmark, and Israel. 

“As we learn more about BA.2.86, CDC’s advice on protecting yourself from COVID-19 remains the same,” the CDC said on X. 

A case of BA.2.86 was detected at a laboratory at the University of Michigan, CBS News reported. It’s not clear how the university obtained the sample that was sequenced. A case was also detected in the United Kingdom, the news outlet said. 

The World Health Organization is also tracking BA.2.86 and has classified it as a “variant under monitoring.” 

“More data are needed to understand this COVID-19 variant and the extent of its spread, but the number of mutations warrants attention. WHO will update countries and the public as we learn more,” the WHO said on X.

The strain is so new that scientists don’t know if BA.2.86 is more easily spread, causes more severe symptoms than existing strains, or will be more resistant to vaccines and natural immunity developed over the last few years. 

Early research indicates BA.2.86 “will have equal or greater escape than XBB.1.5 from antibodies elicited by pre-Omicron and first-generation Omicron variants,” Jesse Bloom, PhD, a virologist at the Fred Hutchinson Cancer Center, said in a slide deck published Aug. 17. (XBB.1.5 is the Omicron subvariant that is targeted in the updated COVID booster shot to be released soon.)

Still, Dr. Bloom noted that “even if a highly mutated new variant like BA.2.86 starts to spread, we will be in a far better place than we were in 2020 and 2021, since most people have some immunity to SARS-CoV-2 now.”

A version of this article first appeared on WebMD.com.

Men and women with prediabetes, undiagnosed diabetes, and, notably, diagnosed diabetes were at higher risk of incident cardiovascular disease (CVD), whereas those with low-normal A1c were at lower risk of this in a large, 12-year observational study of UK Biobank data.

The results highlight “the need for strategies to reduce risk of CVD across the [glycemic] spectrum,” Christopher T. Rentsch, MPH, PhD, and colleagues wrote in their study, which was published in the The Lancet Regional Health – Europe.

The findings suggest “that excess [CVD] risks in both men and women were largely explained by modifiable factors and could be ameliorated by attention to weight reduction strategies and greater use of antihypertensive and statin medications.

“Addressing these risk factors could reduce sex disparities in [glycemia]-related risks of CVD,” according to the researchers.

After the researchers accounted for age, the absolute rate of CVD events was higher among men than women (16.9 vs. 9.1 events per 1,000 person-years); however, the relative risk was higher among women than men.

Compared with men, women were more likely to have obesity (63% vs. 53%) and were less likely to be using antihypertensive medications (64% vs. 69%) or a statin (71% vs. 75%).

“This is the largest study to date to investigate sex differences in the risk of CVD across the glycemic spectrum,” the researchers noted.
 

“The lower the better”

“We uncovered compelling evidence that for blood sugar levels within the ‘normal’ range, it was a case of ‘the lower the better’ in protecting against heart disease,” Dr. Rentsch, assistant professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, told this news organization.

Compared with people with normal blood glucose levels, those with lower than normal levels were at 10% lower risk of developing any form of heart disease, he noted.

The study findings “support women being proactive in asking about medications like statins and antihypertensives as an option to help lower their [CVD] risk, if clinically appropriate,” Dr. Rentsch added.

“We found that men and women with diagnosed diabetes remained at elevated risk for three types of heart disease – coronary artery disease, stroke, and heart failure – even after accounting for a large number of sociodemographic, lifestyle, and clinical characteristics,” he pointed out.

However, “total cholesterol, family history of CVD, estimated glomerular filtration rate, and C-reactive protein had relatively little impact on explaining the risk of heart disease associated with blood sugar.”

“It is well established that being overweight can lead to higher blood sugar levels as well as higher blood pressure, these being factors that contribute to higher risk of heart attack and stroke,” Robert Storey, DM, professor of cardiology, University of Sheffield (England), told the UK Science Media Centre.

“This very large UK Biobank study,” he said, “shows that the higher heart risk associated with blood sugar can be detected at a very early stage along the path towards the abnormally high blood sugar levels associated with diabetes.

“The study provides support for a strategy of assessing cardiovascular risk in people who are overweight, including assessment of blood sugar, cholesterol, and blood pressure levels, all of which can be effectively managed to markedly reduce the risk of future heart attack and stroke,” according to Dr. Storey.
 

More than 400,000 men, women

The researchers enrolled men and women aged 40-69 between 2006 to 2010 who were living in England, Scotland, and Wales. After excluding people with type 1 diabetes or those whose A1c data were missing, the current study included 427,435 people (46% of whom were men).

The participants were classified as having low-normal A1c (< 35 mmol/mol or < 5.5%), normal A1c (35-41 mmol/mol or 5.5%-5.9%), prediabetes (42-47 mmol/mol or 6.0%-6.4%), undiagnosed diabetes (≥ 48 mmol/mol or ≥ 6.5%), or diagnosed type 2 diabetes (medical history and in receipt of glucose-lowering medication).

The researchers determined the incidence of six CVD outcomes during a median 11.8-year follow-up: coronary artery disease, atrial fibrillation, deep vein thrombosis, pulmonary embolism, stroke, and heart failure.

Few participants (5%) had any of these outcomes prior to study enrollment.

During the follow-up, there were 51,288 incident CVD events.

After adjustment for age, compared to having normal A1c, having prediabetes or undiagnosed diabetes was associated with an increased risk of CVD for women and men (hazard ratio [HR], 1.30-1.47).

Among individuals with diagnosed type 2 diabetes, the age-adjusted risk of CVD was greater for women (HR, 2.00) than for men (HR, 1.55).

After further adjustment for clinical and lifestyle factors, especially obesity and antihypertensive or statin use, the risk of CVD decreased and became similar among men and women. The fully adjusted HR for CVD was 1.17 for women and 1.06 for men with diagnosed diabetes.

Compared with having normal A1c, women and men with low-normal A1c were at decreased risk of CVD (HR, 0.86 for both).

The study was funded by Diabetes UK and the British Heart Foundation. Dr. Rentsch and Dr. Storey have disclosed no relevant financial relationships. The disclosures of the other study authors are listed in the original article.
 

A version of this article appeared on Medscape.com.

Men and women with prediabetes, undiagnosed diabetes, and, notably, diagnosed diabetes were at higher risk of incident cardiovascular disease (CVD), whereas those with low-normal A1c were at lower risk of this in a large, 12-year observational study of UK Biobank data.

The results highlight “the need for strategies to reduce risk of CVD across the [glycemic] spectrum,” Christopher T. Rentsch, MPH, PhD, and colleagues wrote in their study, which was published in the The Lancet Regional Health – Europe.

The findings suggest “that excess [CVD] risks in both men and women were largely explained by modifiable factors and could be ameliorated by attention to weight reduction strategies and greater use of antihypertensive and statin medications.

“Addressing these risk factors could reduce sex disparities in [glycemia]-related risks of CVD,” according to the researchers.

After the researchers accounted for age, the absolute rate of CVD events was higher among men than women (16.9 vs. 9.1 events per 1,000 person-years); however, the relative risk was higher among women than men.

Compared with men, women were more likely to have obesity (63% vs. 53%) and were less likely to be using antihypertensive medications (64% vs. 69%) or a statin (71% vs. 75%).

“This is the largest study to date to investigate sex differences in the risk of CVD across the glycemic spectrum,” the researchers noted.
 

“The lower the better”

“We uncovered compelling evidence that for blood sugar levels within the ‘normal’ range, it was a case of ‘the lower the better’ in protecting against heart disease,” Dr. Rentsch, assistant professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, told this news organization.

Compared with people with normal blood glucose levels, those with lower than normal levels were at 10% lower risk of developing any form of heart disease, he noted.

The study findings “support women being proactive in asking about medications like statins and antihypertensives as an option to help lower their [CVD] risk, if clinically appropriate,” Dr. Rentsch added.

“We found that men and women with diagnosed diabetes remained at elevated risk for three types of heart disease – coronary artery disease, stroke, and heart failure – even after accounting for a large number of sociodemographic, lifestyle, and clinical characteristics,” he pointed out.

However, “total cholesterol, family history of CVD, estimated glomerular filtration rate, and C-reactive protein had relatively little impact on explaining the risk of heart disease associated with blood sugar.”

“It is well established that being overweight can lead to higher blood sugar levels as well as higher blood pressure, these being factors that contribute to higher risk of heart attack and stroke,” Robert Storey, DM, professor of cardiology, University of Sheffield (England), told the UK Science Media Centre.

“This very large UK Biobank study,” he said, “shows that the higher heart risk associated with blood sugar can be detected at a very early stage along the path towards the abnormally high blood sugar levels associated with diabetes.

“The study provides support for a strategy of assessing cardiovascular risk in people who are overweight, including assessment of blood sugar, cholesterol, and blood pressure levels, all of which can be effectively managed to markedly reduce the risk of future heart attack and stroke,” according to Dr. Storey.
 

More than 400,000 men, women

The researchers enrolled men and women aged 40-69 between 2006 to 2010 who were living in England, Scotland, and Wales. After excluding people with type 1 diabetes or those whose A1c data were missing, the current study included 427,435 people (46% of whom were men).

The participants were classified as having low-normal A1c (< 35 mmol/mol or < 5.5%), normal A1c (35-41 mmol/mol or 5.5%-5.9%), prediabetes (42-47 mmol/mol or 6.0%-6.4%), undiagnosed diabetes (≥ 48 mmol/mol or ≥ 6.5%), or diagnosed type 2 diabetes (medical history and in receipt of glucose-lowering medication).

The researchers determined the incidence of six CVD outcomes during a median 11.8-year follow-up: coronary artery disease, atrial fibrillation, deep vein thrombosis, pulmonary embolism, stroke, and heart failure.

Few participants (5%) had any of these outcomes prior to study enrollment.

During the follow-up, there were 51,288 incident CVD events.

After adjustment for age, compared to having normal A1c, having prediabetes or undiagnosed diabetes was associated with an increased risk of CVD for women and men (hazard ratio [HR], 1.30-1.47).

Among individuals with diagnosed type 2 diabetes, the age-adjusted risk of CVD was greater for women (HR, 2.00) than for men (HR, 1.55).

After further adjustment for clinical and lifestyle factors, especially obesity and antihypertensive or statin use, the risk of CVD decreased and became similar among men and women. The fully adjusted HR for CVD was 1.17 for women and 1.06 for men with diagnosed diabetes.

Compared with having normal A1c, women and men with low-normal A1c were at decreased risk of CVD (HR, 0.86 for both).

The study was funded by Diabetes UK and the British Heart Foundation. Dr. Rentsch and Dr. Storey have disclosed no relevant financial relationships. The disclosures of the other study authors are listed in the original article.
 

A version of this article appeared on Medscape.com.

Men and women with prediabetes, undiagnosed diabetes, and, notably, diagnosed diabetes were at higher risk of incident cardiovascular disease (CVD), whereas those with low-normal A1c were at lower risk of this in a large, 12-year observational study of UK Biobank data.

The results highlight “the need for strategies to reduce risk of CVD across the [glycemic] spectrum,” Christopher T. Rentsch, MPH, PhD, and colleagues wrote in their study, which was published in the The Lancet Regional Health – Europe.

The findings suggest “that excess [CVD] risks in both men and women were largely explained by modifiable factors and could be ameliorated by attention to weight reduction strategies and greater use of antihypertensive and statin medications.

“Addressing these risk factors could reduce sex disparities in [glycemia]-related risks of CVD,” according to the researchers.

After the researchers accounted for age, the absolute rate of CVD events was higher among men than women (16.9 vs. 9.1 events per 1,000 person-years); however, the relative risk was higher among women than men.

Compared with men, women were more likely to have obesity (63% vs. 53%) and were less likely to be using antihypertensive medications (64% vs. 69%) or a statin (71% vs. 75%).

“This is the largest study to date to investigate sex differences in the risk of CVD across the glycemic spectrum,” the researchers noted.
 

“The lower the better”

“We uncovered compelling evidence that for blood sugar levels within the ‘normal’ range, it was a case of ‘the lower the better’ in protecting against heart disease,” Dr. Rentsch, assistant professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, told this news organization.

Compared with people with normal blood glucose levels, those with lower than normal levels were at 10% lower risk of developing any form of heart disease, he noted.

The study findings “support women being proactive in asking about medications like statins and antihypertensives as an option to help lower their [CVD] risk, if clinically appropriate,” Dr. Rentsch added.

“We found that men and women with diagnosed diabetes remained at elevated risk for three types of heart disease – coronary artery disease, stroke, and heart failure – even after accounting for a large number of sociodemographic, lifestyle, and clinical characteristics,” he pointed out.

However, “total cholesterol, family history of CVD, estimated glomerular filtration rate, and C-reactive protein had relatively little impact on explaining the risk of heart disease associated with blood sugar.”

“It is well established that being overweight can lead to higher blood sugar levels as well as higher blood pressure, these being factors that contribute to higher risk of heart attack and stroke,” Robert Storey, DM, professor of cardiology, University of Sheffield (England), told the UK Science Media Centre.

“This very large UK Biobank study,” he said, “shows that the higher heart risk associated with blood sugar can be detected at a very early stage along the path towards the abnormally high blood sugar levels associated with diabetes.

“The study provides support for a strategy of assessing cardiovascular risk in people who are overweight, including assessment of blood sugar, cholesterol, and blood pressure levels, all of which can be effectively managed to markedly reduce the risk of future heart attack and stroke,” according to Dr. Storey.
 

More than 400,000 men, women

The researchers enrolled men and women aged 40-69 between 2006 to 2010 who were living in England, Scotland, and Wales. After excluding people with type 1 diabetes or those whose A1c data were missing, the current study included 427,435 people (46% of whom were men).

The participants were classified as having low-normal A1c (< 35 mmol/mol or < 5.5%), normal A1c (35-41 mmol/mol or 5.5%-5.9%), prediabetes (42-47 mmol/mol or 6.0%-6.4%), undiagnosed diabetes (≥ 48 mmol/mol or ≥ 6.5%), or diagnosed type 2 diabetes (medical history and in receipt of glucose-lowering medication).

The researchers determined the incidence of six CVD outcomes during a median 11.8-year follow-up: coronary artery disease, atrial fibrillation, deep vein thrombosis, pulmonary embolism, stroke, and heart failure.

Few participants (5%) had any of these outcomes prior to study enrollment.

During the follow-up, there were 51,288 incident CVD events.

After adjustment for age, compared to having normal A1c, having prediabetes or undiagnosed diabetes was associated with an increased risk of CVD for women and men (hazard ratio [HR], 1.30-1.47).

Among individuals with diagnosed type 2 diabetes, the age-adjusted risk of CVD was greater for women (HR, 2.00) than for men (HR, 1.55).

After further adjustment for clinical and lifestyle factors, especially obesity and antihypertensive or statin use, the risk of CVD decreased and became similar among men and women. The fully adjusted HR for CVD was 1.17 for women and 1.06 for men with diagnosed diabetes.

Compared with having normal A1c, women and men with low-normal A1c were at decreased risk of CVD (HR, 0.86 for both).

The study was funded by Diabetes UK and the British Heart Foundation. Dr. Rentsch and Dr. Storey have disclosed no relevant financial relationships. The disclosures of the other study authors are listed in the original article.
 

A version of this article appeared on Medscape.com.

Only a small fraction of older adults in the early stages of Alzheimer’s disease (AD) meet eligibility criteria to receive treatment with newly approved antiamyloid drugs, largely because of the presence of medical conditions or neuroimaging findings, new research shows. 

Applying the clinical trial criteria, only about 8%-17% of amyloid-positive individuals with early AD would be eligible for lecanemab (Leqembi), and even fewer, 5%-9%, would be eligible for aducanumab (Aduhelm), the researchers found.

This study highlights the “limited suitability” of most adults with mild cognitive impairment (MCI) or mild dementia with elevated brain amyloid for treatment with these anti–beta amyloid monoclonal antibodies, write Maria Vassilaki, MD, PhD, and colleagues with Mayo Clinic, Rochester, Minn.

The study was published online in Neurology 

The authors of an accompanying editorial write that this study “provides an important estimate of treatment eligibility for amyloid-lowering monoclonal antibodies for early AD to help health systems make realistic plans for providing these treatments.”
 

More real-world data needed

Dr. Vassilaki and colleagues applied eligibility criteria for lecanemab and aducanumab to 237 older adults with MCI or mild dementia and increased brain amyloid burden from the Mayo Clinic Study of Aging (MCSA). Their mean age was 80.9 years, 55% were men, and most were White. 

After applying lecanemab’s inclusion criteria, less than half of the study population was eligible to receive treatment (112 of 237, or 47%). 

A total of 21 people were excluded because of a body mass index less than 17 or greater than or equal to 35; 48 due to a Clinical Dementia Rating (CDR) global score other than 0.5 or 1.0; 46 because they did not meet WMS-R Logical Memory II scores for age; 8 because of a Mini Mental State Examination (MMSE) score outside the bounds of 22-30; and two because of a CDR memory score less than 0.5. 

Applying lecanemab’s exclusion criteria further narrowed the number of eligible participants from 112 to 19 (8% of 237). 

Notable exclusions included cardiopulmonary contraindications, central nervous system–related exclusions such as brain cancer, Parkinson’s disease, epilepsy or brain injury, imaging findings, and history of cancer. 

The results were similar for aducanumab, with 104 of the 237 participants (44%) meeting the trial’s inclusion criteria. Applying aducanumab’s exclusion criteria further reduced the number of eligible participants to 12 (5% of 237).

A sensitivity analysis including participants with MCI, without CDR global, MMSE, or WMS-R Logical Memory II score restrictions, resulted in a somewhat higher percentage of eligible participants (17.4% for lecanemab and 8.9% for aducanumab). 
 

Shared decision-making

“Clinicians and health systems should be aware that by applying the clinical trial criteria, a smaller percentage might be eligible for these treatments than originally anticipated,” Dr. Vassilaki told this news organization. To help clinicians, there are published recommendations for the appropriate use of these treatments, she noted. 

Given that clinical trial participants are typically healthier than the general population, Dr. Vassilaki said that research is needed to examine the safety and efficacy of antiamyloid therapies in larger, more diverse populations as well as in less healthy populations, before these therapies may be more widely available to people with AD. 

“We can take advantage of the postmarketing surveillance of side effects, and also enrollment of patients receiving these treatments to registries could provide us with data useful for any necessary adjustment to drug use,” Dr. Vassilaki told this news organization. 
 

‘Sharp focus’

This study “brings the issue of eligibility for amyloid-lowering antibody treatment into sharp focus,” Matthew Howe, MD, PhD, with Butler Hospital Memory & Aging Program, Providence, R.I., and colleagues note in their editorial. 

“The results underscore the importance of careful patient selection to help identify patients most likely to benefit from treatment and exclude those at risk for serious outcomes,” they write. 

They also write that appropriate use recommendations for lecanemab and aducanumab “will be revisited as more real-world data emerge, especially about safety.”

For now, clinicians “must exercise clinical judgment in selecting patients for treatment with shared decision-making with patients and families,” they add. 

The study was supported by the National Institutes of Health, the National Institute on Aging, the Alexander Family Alzheimer’s Disease Research Professorship of the Mayo Clinic, the Mayo Foundation for Medical Education and Research, the Liston Award, the GHR Foundation and the Schuler Foundation. Dr. Vassilaki has consulted for F. Hoffmann-La Roche and has equity ownership in Abbott Laboratories, Johnson & Johnson, Medtronic, Merck, and Amgen. Dr. Howe has no conflicts of interest. 

A version of this article first appeared on Medscape.com.

Only a small fraction of older adults in the early stages of Alzheimer’s disease (AD) meet eligibility criteria to receive treatment with newly approved antiamyloid drugs, largely because of the presence of medical conditions or neuroimaging findings, new research shows. 

Applying the clinical trial criteria, only about 8%-17% of amyloid-positive individuals with early AD would be eligible for lecanemab (Leqembi), and even fewer, 5%-9%, would be eligible for aducanumab (Aduhelm), the researchers found.

This study highlights the “limited suitability” of most adults with mild cognitive impairment (MCI) or mild dementia with elevated brain amyloid for treatment with these anti–beta amyloid monoclonal antibodies, write Maria Vassilaki, MD, PhD, and colleagues with Mayo Clinic, Rochester, Minn.

The study was published online in Neurology 

The authors of an accompanying editorial write that this study “provides an important estimate of treatment eligibility for amyloid-lowering monoclonal antibodies for early AD to help health systems make realistic plans for providing these treatments.”
 

More real-world data needed

Dr. Vassilaki and colleagues applied eligibility criteria for lecanemab and aducanumab to 237 older adults with MCI or mild dementia and increased brain amyloid burden from the Mayo Clinic Study of Aging (MCSA). Their mean age was 80.9 years, 55% were men, and most were White. 

After applying lecanemab’s inclusion criteria, less than half of the study population was eligible to receive treatment (112 of 237, or 47%). 

A total of 21 people were excluded because of a body mass index less than 17 or greater than or equal to 35; 48 due to a Clinical Dementia Rating (CDR) global score other than 0.5 or 1.0; 46 because they did not meet WMS-R Logical Memory II scores for age; 8 because of a Mini Mental State Examination (MMSE) score outside the bounds of 22-30; and two because of a CDR memory score less than 0.5. 

Applying lecanemab’s exclusion criteria further narrowed the number of eligible participants from 112 to 19 (8% of 237). 

Notable exclusions included cardiopulmonary contraindications, central nervous system–related exclusions such as brain cancer, Parkinson’s disease, epilepsy or brain injury, imaging findings, and history of cancer. 

The results were similar for aducanumab, with 104 of the 237 participants (44%) meeting the trial’s inclusion criteria. Applying aducanumab’s exclusion criteria further reduced the number of eligible participants to 12 (5% of 237).

A sensitivity analysis including participants with MCI, without CDR global, MMSE, or WMS-R Logical Memory II score restrictions, resulted in a somewhat higher percentage of eligible participants (17.4% for lecanemab and 8.9% for aducanumab). 
 

Shared decision-making

“Clinicians and health systems should be aware that by applying the clinical trial criteria, a smaller percentage might be eligible for these treatments than originally anticipated,” Dr. Vassilaki told this news organization. To help clinicians, there are published recommendations for the appropriate use of these treatments, she noted. 

Given that clinical trial participants are typically healthier than the general population, Dr. Vassilaki said that research is needed to examine the safety and efficacy of antiamyloid therapies in larger, more diverse populations as well as in less healthy populations, before these therapies may be more widely available to people with AD. 

“We can take advantage of the postmarketing surveillance of side effects, and also enrollment of patients receiving these treatments to registries could provide us with data useful for any necessary adjustment to drug use,” Dr. Vassilaki told this news organization. 
 

‘Sharp focus’

This study “brings the issue of eligibility for amyloid-lowering antibody treatment into sharp focus,” Matthew Howe, MD, PhD, with Butler Hospital Memory & Aging Program, Providence, R.I., and colleagues note in their editorial. 

“The results underscore the importance of careful patient selection to help identify patients most likely to benefit from treatment and exclude those at risk for serious outcomes,” they write. 

They also write that appropriate use recommendations for lecanemab and aducanumab “will be revisited as more real-world data emerge, especially about safety.”

For now, clinicians “must exercise clinical judgment in selecting patients for treatment with shared decision-making with patients and families,” they add. 

The study was supported by the National Institutes of Health, the National Institute on Aging, the Alexander Family Alzheimer’s Disease Research Professorship of the Mayo Clinic, the Mayo Foundation for Medical Education and Research, the Liston Award, the GHR Foundation and the Schuler Foundation. Dr. Vassilaki has consulted for F. Hoffmann-La Roche and has equity ownership in Abbott Laboratories, Johnson & Johnson, Medtronic, Merck, and Amgen. Dr. Howe has no conflicts of interest. 

A version of this article first appeared on Medscape.com.

Only a small fraction of older adults in the early stages of Alzheimer’s disease (AD) meet eligibility criteria to receive treatment with newly approved antiamyloid drugs, largely because of the presence of medical conditions or neuroimaging findings, new research shows. 

Applying the clinical trial criteria, only about 8%-17% of amyloid-positive individuals with early AD would be eligible for lecanemab (Leqembi), and even fewer, 5%-9%, would be eligible for aducanumab (Aduhelm), the researchers found.

This study highlights the “limited suitability” of most adults with mild cognitive impairment (MCI) or mild dementia with elevated brain amyloid for treatment with these anti–beta amyloid monoclonal antibodies, write Maria Vassilaki, MD, PhD, and colleagues with Mayo Clinic, Rochester, Minn.

The study was published online in Neurology 

The authors of an accompanying editorial write that this study “provides an important estimate of treatment eligibility for amyloid-lowering monoclonal antibodies for early AD to help health systems make realistic plans for providing these treatments.”
 

More real-world data needed

Dr. Vassilaki and colleagues applied eligibility criteria for lecanemab and aducanumab to 237 older adults with MCI or mild dementia and increased brain amyloid burden from the Mayo Clinic Study of Aging (MCSA). Their mean age was 80.9 years, 55% were men, and most were White. 

After applying lecanemab’s inclusion criteria, less than half of the study population was eligible to receive treatment (112 of 237, or 47%). 

A total of 21 people were excluded because of a body mass index less than 17 or greater than or equal to 35; 48 due to a Clinical Dementia Rating (CDR) global score other than 0.5 or 1.0; 46 because they did not meet WMS-R Logical Memory II scores for age; 8 because of a Mini Mental State Examination (MMSE) score outside the bounds of 22-30; and two because of a CDR memory score less than 0.5. 

Applying lecanemab’s exclusion criteria further narrowed the number of eligible participants from 112 to 19 (8% of 237). 

Notable exclusions included cardiopulmonary contraindications, central nervous system–related exclusions such as brain cancer, Parkinson’s disease, epilepsy or brain injury, imaging findings, and history of cancer. 

The results were similar for aducanumab, with 104 of the 237 participants (44%) meeting the trial’s inclusion criteria. Applying aducanumab’s exclusion criteria further reduced the number of eligible participants to 12 (5% of 237).

A sensitivity analysis including participants with MCI, without CDR global, MMSE, or WMS-R Logical Memory II score restrictions, resulted in a somewhat higher percentage of eligible participants (17.4% for lecanemab and 8.9% for aducanumab). 
 

Shared decision-making

“Clinicians and health systems should be aware that by applying the clinical trial criteria, a smaller percentage might be eligible for these treatments than originally anticipated,” Dr. Vassilaki told this news organization. To help clinicians, there are published recommendations for the appropriate use of these treatments, she noted. 

Given that clinical trial participants are typically healthier than the general population, Dr. Vassilaki said that research is needed to examine the safety and efficacy of antiamyloid therapies in larger, more diverse populations as well as in less healthy populations, before these therapies may be more widely available to people with AD. 

“We can take advantage of the postmarketing surveillance of side effects, and also enrollment of patients receiving these treatments to registries could provide us with data useful for any necessary adjustment to drug use,” Dr. Vassilaki told this news organization. 
 

‘Sharp focus’

This study “brings the issue of eligibility for amyloid-lowering antibody treatment into sharp focus,” Matthew Howe, MD, PhD, with Butler Hospital Memory & Aging Program, Providence, R.I., and colleagues note in their editorial. 

“The results underscore the importance of careful patient selection to help identify patients most likely to benefit from treatment and exclude those at risk for serious outcomes,” they write. 

They also write that appropriate use recommendations for lecanemab and aducanumab “will be revisited as more real-world data emerge, especially about safety.”

For now, clinicians “must exercise clinical judgment in selecting patients for treatment with shared decision-making with patients and families,” they add. 

The study was supported by the National Institutes of Health, the National Institute on Aging, the Alexander Family Alzheimer’s Disease Research Professorship of the Mayo Clinic, the Mayo Foundation for Medical Education and Research, the Liston Award, the GHR Foundation and the Schuler Foundation. Dr. Vassilaki has consulted for F. Hoffmann-La Roche and has equity ownership in Abbott Laboratories, Johnson & Johnson, Medtronic, Merck, and Amgen. Dr. Howe has no conflicts of interest. 

A version of this article first appeared on Medscape.com.

PARIS – “We need to develop new therapies to treat addiction because of the related cost to society, which is extremely high,” said Bruno Roméo, MD, psychiatrist and addiction specialist at Paul Brousse Hospital in Villejuif, France, at the Paris-based Neuroscience, Psychiatry and Neurology Conference. Dr. Roméo spoke about the current place of psychedelics in the treatment of addiction.

“Smoking and alcohol consumption are the two main preventable causes of death in France,” he said. “Current management strategies for these addictions rarely involve pharmacological therapies, which are not very effective, in any case. We have massive relapse rates, signaling the need to develop other treatments, like psychedelic drugs.”

But what data are available on the efficacy of psychedelics in treating addiction?

Alcohol use disorder

There are few data concerning the role of psychedelics in the treatment of alcohol use disorder, but one controlled, randomized trial evaluated the efficacy of psilocybin. That trial was published in JAMA Psychiatry in 2022.

That study included 95 patients with alcohol use disorder; 49 were treated with psilocybin, and 46 were treated with diphenhydramine.

An initial medication session of psilocybin was given in week 4, then another in week 8 at a higher dose. The number of drinking days, the number of heavy drinking days, and the number of drinks consumed between weeks 32 and 36 were assessed.

The investigators showed that, after two sessions with psilocybin, there was a significant reduction in the number of heavy drinking days. In the control group, between weeks 5 and 36, 20% of days involved heavy drinking, whereas in the psilocybin group, 10% of days involved heavy drinking.

There was also a significant and rapid reduction in the number of drinking days, and this was maintained over time. Between weeks 5 and 36, just over 40% of days were reported as drinking days in the control group versus slightly more than 30% in the psilocybin group.

Similarly, the number of glasses per day was drastically reduced after taking psilocybin, and the effect occurred extremely quickly. Consumption went from six drinks to less than one drink between weeks 5 and 8. Overall, between weeks 5 and 36, the number of drinks consumed per day was more than two in the placebo group and more than one in the psilocybin group.

“Psilocybin was seen as having potential efficacy in treating alcohol use disorder. But we must tread carefully with these results; the profile of the patients enrolled in this study is different to that of the patients we regularly see in our addiction clinics. The patients enrolled in the study reported less than 60% of days as heavy drinking days,” said Dr. Romeo.
 

Candidates for psilocybin

According to a retrospective survey of 160 respondents that was conducted online at Paul Brousse Hospital, patients with the most severe cases of alcohol use disorder who have the most mystical psychedelic experiences seem to respond best to psilocybin and to reduce their alcohol use. It also appears that patients whose alcohol use decreased the most had lower psychological flexibility on enrollment in the study. (Psychological flexibility is the ability to adapt to change and to cope with positive and negative experiences in real time without being fazed or trying to flee from the situation.) “It’s as if they had a broader capacity for change, and psychedelics helped them more,” said Dr. Roméo.

Smoking cessation

“There are even fewer studies for smoking,” said Dr. Roméo. In a pilot study with 15 patients, the researchers gave two or three doses of psilocybin at 20-30 mg in combination with cognitive-behavioral therapy one session per week for 10 weeks. Thereafter, patients were assessed three times: after 6 months, 12 months, and 30 months.

The results showed a significant reduction in smoking. Patients went from smoking more than 15 cigarettes per day to smoking one to two cigarettes per day before going back up to six cigarettes daily.

Regarding abstinence rates, 12 of 15 patients had stopped smoking after 6 months, 8 of 15 after 1 year, and 7 of 15 after 30 months. “This study produced some interesting results, although caution must obviously be taken due to the very low number of patients enrolled,” said Dr. Roméo.

As is the case for alcohol, a retrospective survey conducted via questionnaire at Paul Brousse Hospital showed that the patients who smoked the most and who had the most mystical psychedelic experiences seemed to respond best to psilocybin and therefore to reduce their tobacco use. It also seemed to be the case that patients who reduced tobacco use the most had lower psychological flexibility on enrollment in the study.
 

Constraints on psychedelics

“Psychedelics are somewhat effective in treating addiction, but there are various limitations to their use,” said Dr. Roméo.

One of those limitations is societal. Laurence Bézo, MD, of the addiction services clinic at Paul Brousse Hospital, asked doctors to respond to a questionnaire to determine what they thought about psychedelics. To date, 407 have responded, including 280 general practitioners, 50 addiction specialists, and 50 specialist physicians. Overall, 50% think that psychedelics have no therapeutic potential. Three of five doctors also said that psychedelics are dangerous. Just over half thought that their use is associated with a severe risk of aggression aimed at oneself and toward others. Likewise, half think that the risk of dependency is very high and that there is a risk of co-occurring psychiatric disorders. “From the pool of physicians queried, the consensus is that psychedelics are pretty dangerous. People also seem to frown upon prescribing psychedelics in France,” said Dr. Roméo.

Participants went as far as to classify psychedelics as some of the most dangerous drugs out there.

Using a 7-point scale, they classified psychedelics below heroin and cocaine in terms of dangerousness. They are deemed much more harmful than alcohol, tobacco, and cannabis.

“A survey of the public carried out several years ago by leading French market research group IFOP had the exact same findings. Nevertheless, a number of studies have set out to determine how dangerous psychedelics are, and their findings point to this class of drugs as being among the least harmful for the individual patient and those around them. On the contrary, alcohol, heroin, crack cocaine (or even cocaine),methamphetamine, and tobacco were shown to be the most harmful. Additionally, psychedelics have a very low risk of dependency and the lowest risk of lethality. There is complete dissonance between what recent studies show us and what society, and some doctors, think,” said Dr. Roméo.

Besides these assumptions, another constraint to the use of psychedelics relates to methods adopted in related clinical studies. “Due to the effect psychedelics have, in the trials conducted, 9 participants and 9 doctors out of 10 are aware of what they have taken or given, respectively. This is a very important limitation. Nowadays, researchers don’t know how to conduct accurate double-blind studies,” said Dr. Roméo.

In sum, for psychiatrists, psychedelics are promising in addiction therapy, but health care professionals, public authorities, and society as a whole must be better informed about their use, and received ideas must be dispelled.

“The findings need to be replicated, but overall, psychedelics are really quite promising in treating both alcohol and tobacco use disorder. They are generally well tolerated with few serious side effects. There is no deterioration in patients with psychiatric conditions while they are taking psychedelics. And if persistent symptoms of psychosis do occur, which is extremely rare, it’s probably because there are preexisting underlying issues at play. We also don’t see increased blood pressure or any other serious physical anomalies. In a supervised setting, as is the case with studies involving psychotherapeutic support, we can no longer say, in this day and age, that psychedelics are harmful,” said Dr. Roméo.

Dr. Roméo reported no conflicts of interest regarding the content of this article.

This article was translated from the Medscape French Edition and a version appeared on Medscape.com.

PARIS – “We need to develop new therapies to treat addiction because of the related cost to society, which is extremely high,” said Bruno Roméo, MD, psychiatrist and addiction specialist at Paul Brousse Hospital in Villejuif, France, at the Paris-based Neuroscience, Psychiatry and Neurology Conference. Dr. Roméo spoke about the current place of psychedelics in the treatment of addiction.

“Smoking and alcohol consumption are the two main preventable causes of death in France,” he said. “Current management strategies for these addictions rarely involve pharmacological therapies, which are not very effective, in any case. We have massive relapse rates, signaling the need to develop other treatments, like psychedelic drugs.”

But what data are available on the efficacy of psychedelics in treating addiction?

Alcohol use disorder

There are few data concerning the role of psychedelics in the treatment of alcohol use disorder, but one controlled, randomized trial evaluated the efficacy of psilocybin. That trial was published in JAMA Psychiatry in 2022.

That study included 95 patients with alcohol use disorder; 49 were treated with psilocybin, and 46 were treated with diphenhydramine.

An initial medication session of psilocybin was given in week 4, then another in week 8 at a higher dose. The number of drinking days, the number of heavy drinking days, and the number of drinks consumed between weeks 32 and 36 were assessed.

The investigators showed that, after two sessions with psilocybin, there was a significant reduction in the number of heavy drinking days. In the control group, between weeks 5 and 36, 20% of days involved heavy drinking, whereas in the psilocybin group, 10% of days involved heavy drinking.

There was also a significant and rapid reduction in the number of drinking days, and this was maintained over time. Between weeks 5 and 36, just over 40% of days were reported as drinking days in the control group versus slightly more than 30% in the psilocybin group.

Similarly, the number of glasses per day was drastically reduced after taking psilocybin, and the effect occurred extremely quickly. Consumption went from six drinks to less than one drink between weeks 5 and 8. Overall, between weeks 5 and 36, the number of drinks consumed per day was more than two in the placebo group and more than one in the psilocybin group.

“Psilocybin was seen as having potential efficacy in treating alcohol use disorder. But we must tread carefully with these results; the profile of the patients enrolled in this study is different to that of the patients we regularly see in our addiction clinics. The patients enrolled in the study reported less than 60% of days as heavy drinking days,” said Dr. Romeo.
 

Candidates for psilocybin

According to a retrospective survey of 160 respondents that was conducted online at Paul Brousse Hospital, patients with the most severe cases of alcohol use disorder who have the most mystical psychedelic experiences seem to respond best to psilocybin and to reduce their alcohol use. It also appears that patients whose alcohol use decreased the most had lower psychological flexibility on enrollment in the study. (Psychological flexibility is the ability to adapt to change and to cope with positive and negative experiences in real time without being fazed or trying to flee from the situation.) “It’s as if they had a broader capacity for change, and psychedelics helped them more,” said Dr. Roméo.

Smoking cessation

“There are even fewer studies for smoking,” said Dr. Roméo. In a pilot study with 15 patients, the researchers gave two or three doses of psilocybin at 20-30 mg in combination with cognitive-behavioral therapy one session per week for 10 weeks. Thereafter, patients were assessed three times: after 6 months, 12 months, and 30 months.

The results showed a significant reduction in smoking. Patients went from smoking more than 15 cigarettes per day to smoking one to two cigarettes per day before going back up to six cigarettes daily.

Regarding abstinence rates, 12 of 15 patients had stopped smoking after 6 months, 8 of 15 after 1 year, and 7 of 15 after 30 months. “This study produced some interesting results, although caution must obviously be taken due to the very low number of patients enrolled,” said Dr. Roméo.

As is the case for alcohol, a retrospective survey conducted via questionnaire at Paul Brousse Hospital showed that the patients who smoked the most and who had the most mystical psychedelic experiences seemed to respond best to psilocybin and therefore to reduce their tobacco use. It also seemed to be the case that patients who reduced tobacco use the most had lower psychological flexibility on enrollment in the study.
 

Constraints on psychedelics

“Psychedelics are somewhat effective in treating addiction, but there are various limitations to their use,” said Dr. Roméo.

One of those limitations is societal. Laurence Bézo, MD, of the addiction services clinic at Paul Brousse Hospital, asked doctors to respond to a questionnaire to determine what they thought about psychedelics. To date, 407 have responded, including 280 general practitioners, 50 addiction specialists, and 50 specialist physicians. Overall, 50% think that psychedelics have no therapeutic potential. Three of five doctors also said that psychedelics are dangerous. Just over half thought that their use is associated with a severe risk of aggression aimed at oneself and toward others. Likewise, half think that the risk of dependency is very high and that there is a risk of co-occurring psychiatric disorders. “From the pool of physicians queried, the consensus is that psychedelics are pretty dangerous. People also seem to frown upon prescribing psychedelics in France,” said Dr. Roméo.

Participants went as far as to classify psychedelics as some of the most dangerous drugs out there.

Using a 7-point scale, they classified psychedelics below heroin and cocaine in terms of dangerousness. They are deemed much more harmful than alcohol, tobacco, and cannabis.

“A survey of the public carried out several years ago by leading French market research group IFOP had the exact same findings. Nevertheless, a number of studies have set out to determine how dangerous psychedelics are, and their findings point to this class of drugs as being among the least harmful for the individual patient and those around them. On the contrary, alcohol, heroin, crack cocaine (or even cocaine),methamphetamine, and tobacco were shown to be the most harmful. Additionally, psychedelics have a very low risk of dependency and the lowest risk of lethality. There is complete dissonance between what recent studies show us and what society, and some doctors, think,” said Dr. Roméo.

Besides these assumptions, another constraint to the use of psychedelics relates to methods adopted in related clinical studies. “Due to the effect psychedelics have, in the trials conducted, 9 participants and 9 doctors out of 10 are aware of what they have taken or given, respectively. This is a very important limitation. Nowadays, researchers don’t know how to conduct accurate double-blind studies,” said Dr. Roméo.

In sum, for psychiatrists, psychedelics are promising in addiction therapy, but health care professionals, public authorities, and society as a whole must be better informed about their use, and received ideas must be dispelled.

“The findings need to be replicated, but overall, psychedelics are really quite promising in treating both alcohol and tobacco use disorder. They are generally well tolerated with few serious side effects. There is no deterioration in patients with psychiatric conditions while they are taking psychedelics. And if persistent symptoms of psychosis do occur, which is extremely rare, it’s probably because there are preexisting underlying issues at play. We also don’t see increased blood pressure or any other serious physical anomalies. In a supervised setting, as is the case with studies involving psychotherapeutic support, we can no longer say, in this day and age, that psychedelics are harmful,” said Dr. Roméo.

Dr. Roméo reported no conflicts of interest regarding the content of this article.

This article was translated from the Medscape French Edition and a version appeared on Medscape.com.

PARIS – “We need to develop new therapies to treat addiction because of the related cost to society, which is extremely high,” said Bruno Roméo, MD, psychiatrist and addiction specialist at Paul Brousse Hospital in Villejuif, France, at the Paris-based Neuroscience, Psychiatry and Neurology Conference. Dr. Roméo spoke about the current place of psychedelics in the treatment of addiction.

“Smoking and alcohol consumption are the two main preventable causes of death in France,” he said. “Current management strategies for these addictions rarely involve pharmacological therapies, which are not very effective, in any case. We have massive relapse rates, signaling the need to develop other treatments, like psychedelic drugs.”

But what data are available on the efficacy of psychedelics in treating addiction?

Alcohol use disorder

There are few data concerning the role of psychedelics in the treatment of alcohol use disorder, but one controlled, randomized trial evaluated the efficacy of psilocybin. That trial was published in JAMA Psychiatry in 2022.

That study included 95 patients with alcohol use disorder; 49 were treated with psilocybin, and 46 were treated with diphenhydramine.

An initial medication session of psilocybin was given in week 4, then another in week 8 at a higher dose. The number of drinking days, the number of heavy drinking days, and the number of drinks consumed between weeks 32 and 36 were assessed.

The investigators showed that, after two sessions with psilocybin, there was a significant reduction in the number of heavy drinking days. In the control group, between weeks 5 and 36, 20% of days involved heavy drinking, whereas in the psilocybin group, 10% of days involved heavy drinking.

There was also a significant and rapid reduction in the number of drinking days, and this was maintained over time. Between weeks 5 and 36, just over 40% of days were reported as drinking days in the control group versus slightly more than 30% in the psilocybin group.

Similarly, the number of glasses per day was drastically reduced after taking psilocybin, and the effect occurred extremely quickly. Consumption went from six drinks to less than one drink between weeks 5 and 8. Overall, between weeks 5 and 36, the number of drinks consumed per day was more than two in the placebo group and more than one in the psilocybin group.

“Psilocybin was seen as having potential efficacy in treating alcohol use disorder. But we must tread carefully with these results; the profile of the patients enrolled in this study is different to that of the patients we regularly see in our addiction clinics. The patients enrolled in the study reported less than 60% of days as heavy drinking days,” said Dr. Romeo.
 

Candidates for psilocybin

According to a retrospective survey of 160 respondents that was conducted online at Paul Brousse Hospital, patients with the most severe cases of alcohol use disorder who have the most mystical psychedelic experiences seem to respond best to psilocybin and to reduce their alcohol use. It also appears that patients whose alcohol use decreased the most had lower psychological flexibility on enrollment in the study. (Psychological flexibility is the ability to adapt to change and to cope with positive and negative experiences in real time without being fazed or trying to flee from the situation.) “It’s as if they had a broader capacity for change, and psychedelics helped them more,” said Dr. Roméo.

Smoking cessation

“There are even fewer studies for smoking,” said Dr. Roméo. In a pilot study with 15 patients, the researchers gave two or three doses of psilocybin at 20-30 mg in combination with cognitive-behavioral therapy one session per week for 10 weeks. Thereafter, patients were assessed three times: after 6 months, 12 months, and 30 months.

The results showed a significant reduction in smoking. Patients went from smoking more than 15 cigarettes per day to smoking one to two cigarettes per day before going back up to six cigarettes daily.

Regarding abstinence rates, 12 of 15 patients had stopped smoking after 6 months, 8 of 15 after 1 year, and 7 of 15 after 30 months. “This study produced some interesting results, although caution must obviously be taken due to the very low number of patients enrolled,” said Dr. Roméo.

As is the case for alcohol, a retrospective survey conducted via questionnaire at Paul Brousse Hospital showed that the patients who smoked the most and who had the most mystical psychedelic experiences seemed to respond best to psilocybin and therefore to reduce their tobacco use. It also seemed to be the case that patients who reduced tobacco use the most had lower psychological flexibility on enrollment in the study.
 

Constraints on psychedelics

“Psychedelics are somewhat effective in treating addiction, but there are various limitations to their use,” said Dr. Roméo.

One of those limitations is societal. Laurence Bézo, MD, of the addiction services clinic at Paul Brousse Hospital, asked doctors to respond to a questionnaire to determine what they thought about psychedelics. To date, 407 have responded, including 280 general practitioners, 50 addiction specialists, and 50 specialist physicians. Overall, 50% think that psychedelics have no therapeutic potential. Three of five doctors also said that psychedelics are dangerous. Just over half thought that their use is associated with a severe risk of aggression aimed at oneself and toward others. Likewise, half think that the risk of dependency is very high and that there is a risk of co-occurring psychiatric disorders. “From the pool of physicians queried, the consensus is that psychedelics are pretty dangerous. People also seem to frown upon prescribing psychedelics in France,” said Dr. Roméo.

Participants went as far as to classify psychedelics as some of the most dangerous drugs out there.

Using a 7-point scale, they classified psychedelics below heroin and cocaine in terms of dangerousness. They are deemed much more harmful than alcohol, tobacco, and cannabis.

“A survey of the public carried out several years ago by leading French market research group IFOP had the exact same findings. Nevertheless, a number of studies have set out to determine how dangerous psychedelics are, and their findings point to this class of drugs as being among the least harmful for the individual patient and those around them. On the contrary, alcohol, heroin, crack cocaine (or even cocaine),methamphetamine, and tobacco were shown to be the most harmful. Additionally, psychedelics have a very low risk of dependency and the lowest risk of lethality. There is complete dissonance between what recent studies show us and what society, and some doctors, think,” said Dr. Roméo.

Besides these assumptions, another constraint to the use of psychedelics relates to methods adopted in related clinical studies. “Due to the effect psychedelics have, in the trials conducted, 9 participants and 9 doctors out of 10 are aware of what they have taken or given, respectively. This is a very important limitation. Nowadays, researchers don’t know how to conduct accurate double-blind studies,” said Dr. Roméo.

In sum, for psychiatrists, psychedelics are promising in addiction therapy, but health care professionals, public authorities, and society as a whole must be better informed about their use, and received ideas must be dispelled.

“The findings need to be replicated, but overall, psychedelics are really quite promising in treating both alcohol and tobacco use disorder. They are generally well tolerated with few serious side effects. There is no deterioration in patients with psychiatric conditions while they are taking psychedelics. And if persistent symptoms of psychosis do occur, which is extremely rare, it’s probably because there are preexisting underlying issues at play. We also don’t see increased blood pressure or any other serious physical anomalies. In a supervised setting, as is the case with studies involving psychotherapeutic support, we can no longer say, in this day and age, that psychedelics are harmful,” said Dr. Roméo.

Dr. Roméo reported no conflicts of interest regarding the content of this article.

This article was translated from the Medscape French Edition and a version appeared on Medscape.com.