Key clinical point: Compared with tisagenlecleucel, axicabtagene ciloleucel (axi-cel) was associated with improved treatment outcomes but increased the risk for grade ≥ 3 neurologic events in patients with relapsed or refractory large B-cell lymphoma (LBCL) in real-world settings.

Major finding: Axi-cel vs tisagenlecleucel improved the overall survival (adjusted hazard ratio [aHR] 0.60; 95% CI 0.47-0.77), progression-free survival (aHR 0.67; 95% CI 0.57-0.78), and overall response rate (odds ratio 2.05; 95% CI 1.76-2.40). However, it was associated with a higher incidence of grade ≥ 3 immune effector cell-associated neurotoxicity syndrome (odds ratio 3.95; 95% CI 3.05-5.11).

Study details: This comparative meta-analysis of 14 real-world cohorts included patients with relapsed or refractory LBCL who received axi-cel (n = 2432) or tisagenlecleucel (n = 1514) chimeric antigen receptor T-cell therapy.

Disclosures: This study was funded by Kite, a Gilead Company. Six authors declared being employees of or holding leadership positions and stocks in Kite or Gilead. Several authors reported receiving honoraria, travel fees, research funding, etc., from various sources, including Kite.

Source: Jacobson CA et al. Real-world outcomes with CAR T-cell therapies in large B-cell lymphoma: A systematic review and meta-analysis. Transplant Cell Ther. 2023 (Oct 25). doi: 10.1016/j.jtct.2023.10.017

Key clinical point: Compared with tisagenlecleucel, axicabtagene ciloleucel (axi-cel) was associated with improved treatment outcomes but increased the risk for grade ≥ 3 neurologic events in patients with relapsed or refractory large B-cell lymphoma (LBCL) in real-world settings.

Major finding: Axi-cel vs tisagenlecleucel improved the overall survival (adjusted hazard ratio [aHR] 0.60; 95% CI 0.47-0.77), progression-free survival (aHR 0.67; 95% CI 0.57-0.78), and overall response rate (odds ratio 2.05; 95% CI 1.76-2.40). However, it was associated with a higher incidence of grade ≥ 3 immune effector cell-associated neurotoxicity syndrome (odds ratio 3.95; 95% CI 3.05-5.11).

Study details: This comparative meta-analysis of 14 real-world cohorts included patients with relapsed or refractory LBCL who received axi-cel (n = 2432) or tisagenlecleucel (n = 1514) chimeric antigen receptor T-cell therapy.

Disclosures: This study was funded by Kite, a Gilead Company. Six authors declared being employees of or holding leadership positions and stocks in Kite or Gilead. Several authors reported receiving honoraria, travel fees, research funding, etc., from various sources, including Kite.

Source: Jacobson CA et al. Real-world outcomes with CAR T-cell therapies in large B-cell lymphoma: A systematic review and meta-analysis. Transplant Cell Ther. 2023 (Oct 25). doi: 10.1016/j.jtct.2023.10.017

Key clinical point: Compared with tisagenlecleucel, axicabtagene ciloleucel (axi-cel) was associated with improved treatment outcomes but increased the risk for grade ≥ 3 neurologic events in patients with relapsed or refractory large B-cell lymphoma (LBCL) in real-world settings.

Major finding: Axi-cel vs tisagenlecleucel improved the overall survival (adjusted hazard ratio [aHR] 0.60; 95% CI 0.47-0.77), progression-free survival (aHR 0.67; 95% CI 0.57-0.78), and overall response rate (odds ratio 2.05; 95% CI 1.76-2.40). However, it was associated with a higher incidence of grade ≥ 3 immune effector cell-associated neurotoxicity syndrome (odds ratio 3.95; 95% CI 3.05-5.11).

Study details: This comparative meta-analysis of 14 real-world cohorts included patients with relapsed or refractory LBCL who received axi-cel (n = 2432) or tisagenlecleucel (n = 1514) chimeric antigen receptor T-cell therapy.

Disclosures: This study was funded by Kite, a Gilead Company. Six authors declared being employees of or holding leadership positions and stocks in Kite or Gilead. Several authors reported receiving honoraria, travel fees, research funding, etc., from various sources, including Kite.

Source: Jacobson CA et al. Real-world outcomes with CAR T-cell therapies in large B-cell lymphoma: A systematic review and meta-analysis. Transplant Cell Ther. 2023 (Oct 25). doi: 10.1016/j.jtct.2023.10.017

Key clinical point: Total metabolic tumor volume (MTV) is an independent prognostic factor for treatment response and survival in patients receiving loncastuximab tesirine for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) treated with ≥2 prior systemic therapy lines.

Major finding: An MTV ≥ 96 mL was significantly associated with failure to achieve a complete metabolic response (adjusted odds ratio 5.42; P  =  .002). Patients with an MTV ≥ 96 mL vs < 96 mL had shorter progression-free survival (adjusted hazard ratio [aHR] 2.68; P  =  .002) and overall survival (aHR 3.09; P < .0001).L

Study details: This post hoc analysis reviewed the screening PET/CT scans of 138 patients with relapsed or refractory DLBCL treated with ≥2 prior systemic therapy lines who received loncastuximab tesirine in LOTIS-2.

Disclosures: This study was supported by ADC Therapeutics, SA, and the Sylvester Comprehensive Cancer Center, Miami. Some authors declared serving as consultants, advisors, etc., for or receiving research funding or honoraria from ADC Therapeutics and others. J Radford declared owing stocks in ADC Therapeutics.

Source: Alderuccio JP et al. PET/CT-biomarkers enable risk stratification of patients with relapsed/refractory diffuse large B-cell lymphoma enrolled in the LOTIS-2 clinical trial. Clin Cancer Res. 2023 (Oct 19). doi: 10.1158/1078-0432.CCR-23-1561

Key clinical point: Total metabolic tumor volume (MTV) is an independent prognostic factor for treatment response and survival in patients receiving loncastuximab tesirine for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) treated with ≥2 prior systemic therapy lines.

Major finding: An MTV ≥ 96 mL was significantly associated with failure to achieve a complete metabolic response (adjusted odds ratio 5.42; P  =  .002). Patients with an MTV ≥ 96 mL vs < 96 mL had shorter progression-free survival (adjusted hazard ratio [aHR] 2.68; P  =  .002) and overall survival (aHR 3.09; P < .0001).L

Study details: This post hoc analysis reviewed the screening PET/CT scans of 138 patients with relapsed or refractory DLBCL treated with ≥2 prior systemic therapy lines who received loncastuximab tesirine in LOTIS-2.

Disclosures: This study was supported by ADC Therapeutics, SA, and the Sylvester Comprehensive Cancer Center, Miami. Some authors declared serving as consultants, advisors, etc., for or receiving research funding or honoraria from ADC Therapeutics and others. J Radford declared owing stocks in ADC Therapeutics.

Source: Alderuccio JP et al. PET/CT-biomarkers enable risk stratification of patients with relapsed/refractory diffuse large B-cell lymphoma enrolled in the LOTIS-2 clinical trial. Clin Cancer Res. 2023 (Oct 19). doi: 10.1158/1078-0432.CCR-23-1561

Key clinical point: Total metabolic tumor volume (MTV) is an independent prognostic factor for treatment response and survival in patients receiving loncastuximab tesirine for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) treated with ≥2 prior systemic therapy lines.

Major finding: An MTV ≥ 96 mL was significantly associated with failure to achieve a complete metabolic response (adjusted odds ratio 5.42; P  =  .002). Patients with an MTV ≥ 96 mL vs < 96 mL had shorter progression-free survival (adjusted hazard ratio [aHR] 2.68; P  =  .002) and overall survival (aHR 3.09; P < .0001).L

Study details: This post hoc analysis reviewed the screening PET/CT scans of 138 patients with relapsed or refractory DLBCL treated with ≥2 prior systemic therapy lines who received loncastuximab tesirine in LOTIS-2.

Disclosures: This study was supported by ADC Therapeutics, SA, and the Sylvester Comprehensive Cancer Center, Miami. Some authors declared serving as consultants, advisors, etc., for or receiving research funding or honoraria from ADC Therapeutics and others. J Radford declared owing stocks in ADC Therapeutics.

Source: Alderuccio JP et al. PET/CT-biomarkers enable risk stratification of patients with relapsed/refractory diffuse large B-cell lymphoma enrolled in the LOTIS-2 clinical trial. Clin Cancer Res. 2023 (Oct 19). doi: 10.1158/1078-0432.CCR-23-1561

Key clinical point: The outcomes of autologous stem cell transplantation (ASCT) are not superior to those of anti-CD20 radioimmunotherapy, which offers a less toxic consolidation approach, in patients with relapsed or refractory (R/R) follicular lymphoma (FL) receiving rituximab-based induction and maintenance.

Major finding: At a 77-month median follow-up, both treatment groups had estimated 3-year progression-free survival rates of 62% (hazard ratio [HR] 1.11; P  =  .6662) and similar 3-year overall survival (HR 0.94; P  =  .8588). ASCT vs radioimmunotherapy led to higher rates of grade ≥ 3 hematological toxicity and grade ≥ 3 neutropenia (both P < .001).

Study details: This phase 3 FLAZ12 trial included 159 patients with R/R FL after ≤2 chemotherapy lines (≥1 lines containing rituximab) who received rituximab-based induction chemoimmunotherapy, with those showing a partial or complete response being randomized 1:1 to receive ASCT or radioimmunotherapy, both followed by rituximab maintenance.

Disclosures: This study was funded by the Agenzia Italiana del Farmaco (AIFA) and Fondazione Italiana Linfomi. Some authors declared receiving honoraria or research funding from AIFA and others.

Source: Ladetto M, Tavarozzi  R, et al. Radioimmunotherapy versus autologous hematopoietic stem cell transplantation in relapse/refractory follicular lymphoma: A Fondazione Italiana Linfomi multicenter, randomized, phase 3 trial. Ann Oncol. 2023 (Nov 1). doi: 10.1016/j.annonc.2023.10.095

Key clinical point: The outcomes of autologous stem cell transplantation (ASCT) are not superior to those of anti-CD20 radioimmunotherapy, which offers a less toxic consolidation approach, in patients with relapsed or refractory (R/R) follicular lymphoma (FL) receiving rituximab-based induction and maintenance.

Major finding: At a 77-month median follow-up, both treatment groups had estimated 3-year progression-free survival rates of 62% (hazard ratio [HR] 1.11; P  =  .6662) and similar 3-year overall survival (HR 0.94; P  =  .8588). ASCT vs radioimmunotherapy led to higher rates of grade ≥ 3 hematological toxicity and grade ≥ 3 neutropenia (both P < .001).

Study details: This phase 3 FLAZ12 trial included 159 patients with R/R FL after ≤2 chemotherapy lines (≥1 lines containing rituximab) who received rituximab-based induction chemoimmunotherapy, with those showing a partial or complete response being randomized 1:1 to receive ASCT or radioimmunotherapy, both followed by rituximab maintenance.

Disclosures: This study was funded by the Agenzia Italiana del Farmaco (AIFA) and Fondazione Italiana Linfomi. Some authors declared receiving honoraria or research funding from AIFA and others.

Source: Ladetto M, Tavarozzi  R, et al. Radioimmunotherapy versus autologous hematopoietic stem cell transplantation in relapse/refractory follicular lymphoma: A Fondazione Italiana Linfomi multicenter, randomized, phase 3 trial. Ann Oncol. 2023 (Nov 1). doi: 10.1016/j.annonc.2023.10.095

Key clinical point: The outcomes of autologous stem cell transplantation (ASCT) are not superior to those of anti-CD20 radioimmunotherapy, which offers a less toxic consolidation approach, in patients with relapsed or refractory (R/R) follicular lymphoma (FL) receiving rituximab-based induction and maintenance.

Major finding: At a 77-month median follow-up, both treatment groups had estimated 3-year progression-free survival rates of 62% (hazard ratio [HR] 1.11; P  =  .6662) and similar 3-year overall survival (HR 0.94; P  =  .8588). ASCT vs radioimmunotherapy led to higher rates of grade ≥ 3 hematological toxicity and grade ≥ 3 neutropenia (both P < .001).

Study details: This phase 3 FLAZ12 trial included 159 patients with R/R FL after ≤2 chemotherapy lines (≥1 lines containing rituximab) who received rituximab-based induction chemoimmunotherapy, with those showing a partial or complete response being randomized 1:1 to receive ASCT or radioimmunotherapy, both followed by rituximab maintenance.

Disclosures: This study was funded by the Agenzia Italiana del Farmaco (AIFA) and Fondazione Italiana Linfomi. Some authors declared receiving honoraria or research funding from AIFA and others.

Source: Ladetto M, Tavarozzi  R, et al. Radioimmunotherapy versus autologous hematopoietic stem cell transplantation in relapse/refractory follicular lymphoma: A Fondazione Italiana Linfomi multicenter, randomized, phase 3 trial. Ann Oncol. 2023 (Nov 1). doi: 10.1016/j.annonc.2023.10.095

Key clinical point: TP53 mutations detected by clinical laboratory mutation analysis (CLMA) can independently predict poor outcomes in patients with newly diagnosed diffuse large B cell lymphoma (DLBCL) or high-grade B cell lymphoma (HGBL) treated with first-line immunochemotherapy.

Major finding: TP53 mutations significantly predicted disease progression at 2 years (adjusted hazard ratio 2.3; P  =  .03). Patients with vs without TP53 mutations had significantly lower overall response (71% vs 90%; P  =  .009), complete response (55% vs 77%, P  =  .01), estimated 2-year progression-free survival (57% vs 77%; P  =  .006), and estimated 2-year overall survival (70% vs 91%; P  =  .001) rates.

Study details: This study included 122 patients with newly diagnosed DLBCL or HGBL receiving first-line immunochemotherapy whose diagnostic biopsies underwent CLMA, of whom 42 patients had TP53 mutations.

Disclosures: This study did not disclose any funding source. All authors, except A Bagg, declared receiving honoraria, travel grants, or research funding from or having other ties with various sources.

Source: Landsburg DJ et al. TP53 mutations predict for poor outcomes in patients with newly-diagnosed aggressive B cell lymphomas in the current era. Blood Adv. 2023 (Oct 18). doi: 10.1182/bloodadvances.2023011384

Key clinical point: TP53 mutations detected by clinical laboratory mutation analysis (CLMA) can independently predict poor outcomes in patients with newly diagnosed diffuse large B cell lymphoma (DLBCL) or high-grade B cell lymphoma (HGBL) treated with first-line immunochemotherapy.

Major finding: TP53 mutations significantly predicted disease progression at 2 years (adjusted hazard ratio 2.3; P  =  .03). Patients with vs without TP53 mutations had significantly lower overall response (71% vs 90%; P  =  .009), complete response (55% vs 77%, P  =  .01), estimated 2-year progression-free survival (57% vs 77%; P  =  .006), and estimated 2-year overall survival (70% vs 91%; P  =  .001) rates.

Study details: This study included 122 patients with newly diagnosed DLBCL or HGBL receiving first-line immunochemotherapy whose diagnostic biopsies underwent CLMA, of whom 42 patients had TP53 mutations.

Disclosures: This study did not disclose any funding source. All authors, except A Bagg, declared receiving honoraria, travel grants, or research funding from or having other ties with various sources.

Source: Landsburg DJ et al. TP53 mutations predict for poor outcomes in patients with newly-diagnosed aggressive B cell lymphomas in the current era. Blood Adv. 2023 (Oct 18). doi: 10.1182/bloodadvances.2023011384

Key clinical point: TP53 mutations detected by clinical laboratory mutation analysis (CLMA) can independently predict poor outcomes in patients with newly diagnosed diffuse large B cell lymphoma (DLBCL) or high-grade B cell lymphoma (HGBL) treated with first-line immunochemotherapy.

Major finding: TP53 mutations significantly predicted disease progression at 2 years (adjusted hazard ratio 2.3; P  =  .03). Patients with vs without TP53 mutations had significantly lower overall response (71% vs 90%; P  =  .009), complete response (55% vs 77%, P  =  .01), estimated 2-year progression-free survival (57% vs 77%; P  =  .006), and estimated 2-year overall survival (70% vs 91%; P  =  .001) rates.

Study details: This study included 122 patients with newly diagnosed DLBCL or HGBL receiving first-line immunochemotherapy whose diagnostic biopsies underwent CLMA, of whom 42 patients had TP53 mutations.

Disclosures: This study did not disclose any funding source. All authors, except A Bagg, declared receiving honoraria, travel grants, or research funding from or having other ties with various sources.

Source: Landsburg DJ et al. TP53 mutations predict for poor outcomes in patients with newly-diagnosed aggressive B cell lymphomas in the current era. Blood Adv. 2023 (Oct 18). doi: 10.1182/bloodadvances.2023011384

Key clinical point: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) led to acceptable survival outcomes in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), particularly in those achieving a partial or complete response to chemotherapy before allo-HSCT.

Major finding: At a median follow-up of 38.3 months, the estimated 5-year overall survival and event-free survival rates were 38.4% (95% CI 24.7%-51.8%) and 30.6% (95% CI 18.8%-43.3%), respectively, with patients who achieved a partial or complete response before allo-HSCT having overall survival and event-free survival rates of 54.1% (95% CI 34.2%-70.3%) and 46.4% (95% CI 28.1%-62.9%), respectively.

Study details: This retrospective study included 52 adult patients with relapsed or refractory DLBCL who either had an active disease status or achieved a partial or complete response before transplantation and underwent allo-HSCT.

Disclosures: This study did not disclose any funding source. The authors declared no conflicts of interest.

Source: Min GJ et al. The salvage role of allogeneic hematopoietic stem-cell transplantation in relapsed/refractory diffuse large B cell lymphoma. Sci Rep. 2023;13:17496 (Oct 15). doi: 10.1038/s41598-023-44241-0

Key clinical point: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) led to acceptable survival outcomes in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), particularly in those achieving a partial or complete response to chemotherapy before allo-HSCT.

Major finding: At a median follow-up of 38.3 months, the estimated 5-year overall survival and event-free survival rates were 38.4% (95% CI 24.7%-51.8%) and 30.6% (95% CI 18.8%-43.3%), respectively, with patients who achieved a partial or complete response before allo-HSCT having overall survival and event-free survival rates of 54.1% (95% CI 34.2%-70.3%) and 46.4% (95% CI 28.1%-62.9%), respectively.

Study details: This retrospective study included 52 adult patients with relapsed or refractory DLBCL who either had an active disease status or achieved a partial or complete response before transplantation and underwent allo-HSCT.

Disclosures: This study did not disclose any funding source. The authors declared no conflicts of interest.

Source: Min GJ et al. The salvage role of allogeneic hematopoietic stem-cell transplantation in relapsed/refractory diffuse large B cell lymphoma. Sci Rep. 2023;13:17496 (Oct 15). doi: 10.1038/s41598-023-44241-0

Key clinical point: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) led to acceptable survival outcomes in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), particularly in those achieving a partial or complete response to chemotherapy before allo-HSCT.

Major finding: At a median follow-up of 38.3 months, the estimated 5-year overall survival and event-free survival rates were 38.4% (95% CI 24.7%-51.8%) and 30.6% (95% CI 18.8%-43.3%), respectively, with patients who achieved a partial or complete response before allo-HSCT having overall survival and event-free survival rates of 54.1% (95% CI 34.2%-70.3%) and 46.4% (95% CI 28.1%-62.9%), respectively.

Study details: This retrospective study included 52 adult patients with relapsed or refractory DLBCL who either had an active disease status or achieved a partial or complete response before transplantation and underwent allo-HSCT.

Disclosures: This study did not disclose any funding source. The authors declared no conflicts of interest.

Source: Min GJ et al. The salvage role of allogeneic hematopoietic stem-cell transplantation in relapsed/refractory diffuse large B cell lymphoma. Sci Rep. 2023;13:17496 (Oct 15). doi: 10.1038/s41598-023-44241-0

Key clinical point: Fixed-duration ibrutinib-venetoclax vs chlorambucil-obinutuzumab continues to extend progression-free survival and leads to overall survival advantage at a 4-year follow-up in patients with previously untreated chronic lymphocytic leukemia (CLL).

Major finding: At a median follow-up of 46 months, the ibrutinib-venetoclax vs chlorambucil-obinutuzumab group continued to show better progression-free survival (hazard ratio [HR] 0.214; P < .0001) while also demonstrating overall survival benefit (HR 0.487; P  =  .021). One treatment-related death was reported in each group.

Study details: Findings are from a 4-year follow-up of the phase 3 GLOW trial including 211 patients with previously untreated CLL who were randomly assigned to receive ibrutinib-venetoclax or chlorambucil-obinutuzumab.

Disclosures: This study was funded by Janssen Research & Development and Pharmacyclics. Several authors declared serving on the boards of directors or advisory committees of or receiving consultancy fees, research funding, or honoraria from various sources, including Janssen. Nine authors declared being employees or equity holders of Janssen.

Source: Niemann CU et al. Fixed-duration ibrutinib–venetoclax versus chlorambucil–obinutuzumab in previously untreated chronic lymphocytic leukaemia (GLOW): 4-Year follow-up from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2023 (Nov 6). doi: 10.1016/S1470-2045(23)00452-7

Key clinical point: Fixed-duration ibrutinib-venetoclax vs chlorambucil-obinutuzumab continues to extend progression-free survival and leads to overall survival advantage at a 4-year follow-up in patients with previously untreated chronic lymphocytic leukemia (CLL).

Major finding: At a median follow-up of 46 months, the ibrutinib-venetoclax vs chlorambucil-obinutuzumab group continued to show better progression-free survival (hazard ratio [HR] 0.214; P < .0001) while also demonstrating overall survival benefit (HR 0.487; P  =  .021). One treatment-related death was reported in each group.

Study details: Findings are from a 4-year follow-up of the phase 3 GLOW trial including 211 patients with previously untreated CLL who were randomly assigned to receive ibrutinib-venetoclax or chlorambucil-obinutuzumab.

Disclosures: This study was funded by Janssen Research & Development and Pharmacyclics. Several authors declared serving on the boards of directors or advisory committees of or receiving consultancy fees, research funding, or honoraria from various sources, including Janssen. Nine authors declared being employees or equity holders of Janssen.

Source: Niemann CU et al. Fixed-duration ibrutinib–venetoclax versus chlorambucil–obinutuzumab in previously untreated chronic lymphocytic leukaemia (GLOW): 4-Year follow-up from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2023 (Nov 6). doi: 10.1016/S1470-2045(23)00452-7

Key clinical point: Fixed-duration ibrutinib-venetoclax vs chlorambucil-obinutuzumab continues to extend progression-free survival and leads to overall survival advantage at a 4-year follow-up in patients with previously untreated chronic lymphocytic leukemia (CLL).

Major finding: At a median follow-up of 46 months, the ibrutinib-venetoclax vs chlorambucil-obinutuzumab group continued to show better progression-free survival (hazard ratio [HR] 0.214; P < .0001) while also demonstrating overall survival benefit (HR 0.487; P  =  .021). One treatment-related death was reported in each group.

Study details: Findings are from a 4-year follow-up of the phase 3 GLOW trial including 211 patients with previously untreated CLL who were randomly assigned to receive ibrutinib-venetoclax or chlorambucil-obinutuzumab.

Disclosures: This study was funded by Janssen Research & Development and Pharmacyclics. Several authors declared serving on the boards of directors or advisory committees of or receiving consultancy fees, research funding, or honoraria from various sources, including Janssen. Nine authors declared being employees or equity holders of Janssen.

Source: Niemann CU et al. Fixed-duration ibrutinib–venetoclax versus chlorambucil–obinutuzumab in previously untreated chronic lymphocytic leukaemia (GLOW): 4-Year follow-up from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2023 (Nov 6). doi: 10.1016/S1470-2045(23)00452-7

Key clinical point: Brexucabtagene autoleucel (brexu-cel) provides survival benefit over non-chimeric antigen receptor (CAR) T-cell standard of care (SOC) in patients with relapsed or refractory mantle cell lymphoma (MCL) treated with covalent Bruton tyrosine kinase inhibitors (BTKi).

Major finding: Inverse probability weighting showed that brexu-cel vs SOC led to a significantly reduced risk for death (adjusted hazard ratio 0.38; P < .001), with the findings being similar for other adjusted comparisons.

Study details: This indirect comparison study analyzed the individual patient data of BTKi-treated patients with relapsed or refractory MCL who received brexu-cel in ZUMA-2 (n = 68) and non-CAR T-cell SOC in SCHOLAR-2 (n = 149).

Disclosures: This study was sponsored by Kite, a Gilead Company. Some authors declared participating in the data safety monitoring or advisory boards of or receiving grants, consulting fees, travel support, or honoraria for lectures, etc., from Kite, Gilead, and others. Five authors declared being employees or stockowners of Kite, Gilead, or PRECISIONheor.

Source: Hess G et al. Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma. Leuk Lymphoma. 2023 (Oct 16). doi: 10.1080/10428194.2023.2268228

Key clinical point: Brexucabtagene autoleucel (brexu-cel) provides survival benefit over non-chimeric antigen receptor (CAR) T-cell standard of care (SOC) in patients with relapsed or refractory mantle cell lymphoma (MCL) treated with covalent Bruton tyrosine kinase inhibitors (BTKi).

Major finding: Inverse probability weighting showed that brexu-cel vs SOC led to a significantly reduced risk for death (adjusted hazard ratio 0.38; P < .001), with the findings being similar for other adjusted comparisons.

Study details: This indirect comparison study analyzed the individual patient data of BTKi-treated patients with relapsed or refractory MCL who received brexu-cel in ZUMA-2 (n = 68) and non-CAR T-cell SOC in SCHOLAR-2 (n = 149).

Disclosures: This study was sponsored by Kite, a Gilead Company. Some authors declared participating in the data safety monitoring or advisory boards of or receiving grants, consulting fees, travel support, or honoraria for lectures, etc., from Kite, Gilead, and others. Five authors declared being employees or stockowners of Kite, Gilead, or PRECISIONheor.

Source: Hess G et al. Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma. Leuk Lymphoma. 2023 (Oct 16). doi: 10.1080/10428194.2023.2268228

Key clinical point: Brexucabtagene autoleucel (brexu-cel) provides survival benefit over non-chimeric antigen receptor (CAR) T-cell standard of care (SOC) in patients with relapsed or refractory mantle cell lymphoma (MCL) treated with covalent Bruton tyrosine kinase inhibitors (BTKi).

Major finding: Inverse probability weighting showed that brexu-cel vs SOC led to a significantly reduced risk for death (adjusted hazard ratio 0.38; P < .001), with the findings being similar for other adjusted comparisons.

Study details: This indirect comparison study analyzed the individual patient data of BTKi-treated patients with relapsed or refractory MCL who received brexu-cel in ZUMA-2 (n = 68) and non-CAR T-cell SOC in SCHOLAR-2 (n = 149).

Disclosures: This study was sponsored by Kite, a Gilead Company. Some authors declared participating in the data safety monitoring or advisory boards of or receiving grants, consulting fees, travel support, or honoraria for lectures, etc., from Kite, Gilead, and others. Five authors declared being employees or stockowners of Kite, Gilead, or PRECISIONheor.

Source: Hess G et al. Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma. Leuk Lymphoma. 2023 (Oct 16). doi: 10.1080/10428194.2023.2268228

Key clinical point: Patients with relapsed or refractory large B-cell lymphoma (LBCL) who were recently exposed to preapheresis bendamustine showed negative treatment outcomes, hematologic toxicity, and severe infections after CD19-targeted chimeric antigen receptor (CAR) T-cell therapy.

Major finding: Patients recently exposed to bendamustine (<9 months) vs those naive to it before apheresis had a significantly lower overall response rate (40% vs 66%; P  =  .01) and shorter overall survival (adjusted hazard ratio [aHR] 2.11; P < .01) and progression-free survival (aHR 1.82; P < .01) after CAR T-cell infusion.

Study details: This retrospective multicenter study included 439 patients with relapsed or refractory LBCL who received CD19-targeted commercial CAR T-cell therapy after ≥2 prior treatment lines, of whom 80 patients had received bendamustine before apheresis.

Disclosures: This study was supported by the Carlos III Health Institute, Spain, and others. Some authors declared serving in consulting or advisory roles for or as members of speakers’ bureaus of or receiving honoraria, research funding, or travel or accommodation expenses from various sources.

Source: Iacoboni G et al. Recent bendamustine treatment before apheresis has a negative impact on outcomes in patients with large B-cell lymphoma receiving chimeric antigen receptor T-cell therapy. J Clin Oncol. 2023 (Oct 24). doi: 10.1200/JCO.23.01097

Key clinical point: Patients with relapsed or refractory large B-cell lymphoma (LBCL) who were recently exposed to preapheresis bendamustine showed negative treatment outcomes, hematologic toxicity, and severe infections after CD19-targeted chimeric antigen receptor (CAR) T-cell therapy.

Major finding: Patients recently exposed to bendamustine (<9 months) vs those naive to it before apheresis had a significantly lower overall response rate (40% vs 66%; P  =  .01) and shorter overall survival (adjusted hazard ratio [aHR] 2.11; P < .01) and progression-free survival (aHR 1.82; P < .01) after CAR T-cell infusion.

Study details: This retrospective multicenter study included 439 patients with relapsed or refractory LBCL who received CD19-targeted commercial CAR T-cell therapy after ≥2 prior treatment lines, of whom 80 patients had received bendamustine before apheresis.

Disclosures: This study was supported by the Carlos III Health Institute, Spain, and others. Some authors declared serving in consulting or advisory roles for or as members of speakers’ bureaus of or receiving honoraria, research funding, or travel or accommodation expenses from various sources.

Source: Iacoboni G et al. Recent bendamustine treatment before apheresis has a negative impact on outcomes in patients with large B-cell lymphoma receiving chimeric antigen receptor T-cell therapy. J Clin Oncol. 2023 (Oct 24). doi: 10.1200/JCO.23.01097

Key clinical point: Patients with relapsed or refractory large B-cell lymphoma (LBCL) who were recently exposed to preapheresis bendamustine showed negative treatment outcomes, hematologic toxicity, and severe infections after CD19-targeted chimeric antigen receptor (CAR) T-cell therapy.

Major finding: Patients recently exposed to bendamustine (<9 months) vs those naive to it before apheresis had a significantly lower overall response rate (40% vs 66%; P  =  .01) and shorter overall survival (adjusted hazard ratio [aHR] 2.11; P < .01) and progression-free survival (aHR 1.82; P < .01) after CAR T-cell infusion.

Study details: This retrospective multicenter study included 439 patients with relapsed or refractory LBCL who received CD19-targeted commercial CAR T-cell therapy after ≥2 prior treatment lines, of whom 80 patients had received bendamustine before apheresis.

Disclosures: This study was supported by the Carlos III Health Institute, Spain, and others. Some authors declared serving in consulting or advisory roles for or as members of speakers’ bureaus of or receiving honoraria, research funding, or travel or accommodation expenses from various sources.

Source: Iacoboni G et al. Recent bendamustine treatment before apheresis has a negative impact on outcomes in patients with large B-cell lymphoma receiving chimeric antigen receptor T-cell therapy. J Clin Oncol. 2023 (Oct 24). doi: 10.1200/JCO.23.01097

ANAHEIM, CALIF. – Gargling and nasal rinsing with saltwater several times a day appeared to be associated with significantly lower COVID-19 hospitalization rates in a small, randomized, double-blind, controlled study.

“The hypothesis was that interventions that target the upper respiratory tract may reduce the frequency and duration of upper respiratory symptoms associated with COVID-19,” said Sebastian Espinoza, first author of the study; he is with Trinity University, San Antonio.

Adults aged 18-65 years who tested positive for SARS-CoV-2 on polymerase chain reaction (PCR) testing between 2020 and 2022 were randomly selected to use low- or high-dose saltwater regimens for 14 days at the Harris Health System, Houston. For patients to be included in the study, 14 days had to have elapsed since the onset of any symptoms associated with COVID.

The low dose was 2.13 grams of salt dissolved in 8 ounces of warm water, and the high dose was 6 grams. Participants gargled the saltwater and used it as a nasal rinse for 5 minutes four times a day.

Primary outcomes included frequency and duration of symptoms associated with SARS-CoV-2 infection; secondary outcomes included admission to the hospital or the intensive care unit, mechanical ventilatory support, or death.

The findings were presented in a poster at the annual meeting of the American College of Allergy, Asthma, and Immunology.

Fifty-eight people were randomly assigned to either the low-saline (n = 27) or the high-saline (n = 28) group; three patients were lost to follow-up in both these groups. The reference control population consisted of 9,398 people with confirmed SARS-CoV-2 infection. Rates of vaccination were similar for all participants.

Hospitalization rates in the low- (18.5%) and high- (21.4%) saline groups were significantly lower than in the reference control population (58.8%; P < .001). No significant differences were noted in other outcomes among these groups.

The average age of patients in the control population (n = 9,398) was 45 years. The average age was similar in the low- and high-saline groups. In the low-saline group (n = 27), the average age was 39, and in the high-saline group, the average age was 41.

In all three groups, body mass index was between 29.6 and 31.7.

Exclusion criteria included chronic hypertension or participation in another interventional study.
 

‘Low risk, small potential benefit’

Allergist Zach Rubin, MD, a spokesperson for the ACAAI, said in an interview that the findings are in line with other small studies that previously reported some benefit in using nasal saline irrigation and gargling to treat a SARS-CoV-2 infection.

“This is a type of intervention that is low risk with some small potential benefit,” he said.

The researchers did not evaluate the potential reason for the saline regimen’s association with fewer hospitalizations, but Dr. Rubin said, “It may be possible that nasal saline irrigation and gargling help improve viral clearance and reduce the risk of microaspiration into the lungs, so it may be possible that this intervention could reduce the risk of pneumonia, which is a major cause of hospitalization.”

Dr. Rubin, who is an allergist at Oak Brook Allergists, Ill., said, “I generally recommend nasal saline irrigation to my patients for allergic rhinitis and viral upper respiratory infections already. It can help reduce symptoms such as nasal congestion, rhinorrhea, postnasal drip, and sinus pain and pressure.”

The intervention may be reasonable beyond an adult population, he said.

“This could be used for pediatric patients as well, if they are developmentally ready to try this intervention,” he said.

Mr. Espinoza said further study is warranted, but he said that if confirmed in later trials, the simple intervention may be particularly helpful in low-resource settings.

Mr. Espinoza and Dr. Rubin have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

ANAHEIM, CALIF. – Gargling and nasal rinsing with saltwater several times a day appeared to be associated with significantly lower COVID-19 hospitalization rates in a small, randomized, double-blind, controlled study.

“The hypothesis was that interventions that target the upper respiratory tract may reduce the frequency and duration of upper respiratory symptoms associated with COVID-19,” said Sebastian Espinoza, first author of the study; he is with Trinity University, San Antonio.

Adults aged 18-65 years who tested positive for SARS-CoV-2 on polymerase chain reaction (PCR) testing between 2020 and 2022 were randomly selected to use low- or high-dose saltwater regimens for 14 days at the Harris Health System, Houston. For patients to be included in the study, 14 days had to have elapsed since the onset of any symptoms associated with COVID.

The low dose was 2.13 grams of salt dissolved in 8 ounces of warm water, and the high dose was 6 grams. Participants gargled the saltwater and used it as a nasal rinse for 5 minutes four times a day.

Primary outcomes included frequency and duration of symptoms associated with SARS-CoV-2 infection; secondary outcomes included admission to the hospital or the intensive care unit, mechanical ventilatory support, or death.

The findings were presented in a poster at the annual meeting of the American College of Allergy, Asthma, and Immunology.

Fifty-eight people were randomly assigned to either the low-saline (n = 27) or the high-saline (n = 28) group; three patients were lost to follow-up in both these groups. The reference control population consisted of 9,398 people with confirmed SARS-CoV-2 infection. Rates of vaccination were similar for all participants.

Hospitalization rates in the low- (18.5%) and high- (21.4%) saline groups were significantly lower than in the reference control population (58.8%; P < .001). No significant differences were noted in other outcomes among these groups.

The average age of patients in the control population (n = 9,398) was 45 years. The average age was similar in the low- and high-saline groups. In the low-saline group (n = 27), the average age was 39, and in the high-saline group, the average age was 41.

In all three groups, body mass index was between 29.6 and 31.7.

Exclusion criteria included chronic hypertension or participation in another interventional study.
 

‘Low risk, small potential benefit’

Allergist Zach Rubin, MD, a spokesperson for the ACAAI, said in an interview that the findings are in line with other small studies that previously reported some benefit in using nasal saline irrigation and gargling to treat a SARS-CoV-2 infection.

“This is a type of intervention that is low risk with some small potential benefit,” he said.

The researchers did not evaluate the potential reason for the saline regimen’s association with fewer hospitalizations, but Dr. Rubin said, “It may be possible that nasal saline irrigation and gargling help improve viral clearance and reduce the risk of microaspiration into the lungs, so it may be possible that this intervention could reduce the risk of pneumonia, which is a major cause of hospitalization.”

Dr. Rubin, who is an allergist at Oak Brook Allergists, Ill., said, “I generally recommend nasal saline irrigation to my patients for allergic rhinitis and viral upper respiratory infections already. It can help reduce symptoms such as nasal congestion, rhinorrhea, postnasal drip, and sinus pain and pressure.”

The intervention may be reasonable beyond an adult population, he said.

“This could be used for pediatric patients as well, if they are developmentally ready to try this intervention,” he said.

Mr. Espinoza said further study is warranted, but he said that if confirmed in later trials, the simple intervention may be particularly helpful in low-resource settings.

Mr. Espinoza and Dr. Rubin have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

ANAHEIM, CALIF. – Gargling and nasal rinsing with saltwater several times a day appeared to be associated with significantly lower COVID-19 hospitalization rates in a small, randomized, double-blind, controlled study.

“The hypothesis was that interventions that target the upper respiratory tract may reduce the frequency and duration of upper respiratory symptoms associated with COVID-19,” said Sebastian Espinoza, first author of the study; he is with Trinity University, San Antonio.

Adults aged 18-65 years who tested positive for SARS-CoV-2 on polymerase chain reaction (PCR) testing between 2020 and 2022 were randomly selected to use low- or high-dose saltwater regimens for 14 days at the Harris Health System, Houston. For patients to be included in the study, 14 days had to have elapsed since the onset of any symptoms associated with COVID.

The low dose was 2.13 grams of salt dissolved in 8 ounces of warm water, and the high dose was 6 grams. Participants gargled the saltwater and used it as a nasal rinse for 5 minutes four times a day.

Primary outcomes included frequency and duration of symptoms associated with SARS-CoV-2 infection; secondary outcomes included admission to the hospital or the intensive care unit, mechanical ventilatory support, or death.

The findings were presented in a poster at the annual meeting of the American College of Allergy, Asthma, and Immunology.

Fifty-eight people were randomly assigned to either the low-saline (n = 27) or the high-saline (n = 28) group; three patients were lost to follow-up in both these groups. The reference control population consisted of 9,398 people with confirmed SARS-CoV-2 infection. Rates of vaccination were similar for all participants.

Hospitalization rates in the low- (18.5%) and high- (21.4%) saline groups were significantly lower than in the reference control population (58.8%; P < .001). No significant differences were noted in other outcomes among these groups.

The average age of patients in the control population (n = 9,398) was 45 years. The average age was similar in the low- and high-saline groups. In the low-saline group (n = 27), the average age was 39, and in the high-saline group, the average age was 41.

In all three groups, body mass index was between 29.6 and 31.7.

Exclusion criteria included chronic hypertension or participation in another interventional study.
 

‘Low risk, small potential benefit’

Allergist Zach Rubin, MD, a spokesperson for the ACAAI, said in an interview that the findings are in line with other small studies that previously reported some benefit in using nasal saline irrigation and gargling to treat a SARS-CoV-2 infection.

“This is a type of intervention that is low risk with some small potential benefit,” he said.

The researchers did not evaluate the potential reason for the saline regimen’s association with fewer hospitalizations, but Dr. Rubin said, “It may be possible that nasal saline irrigation and gargling help improve viral clearance and reduce the risk of microaspiration into the lungs, so it may be possible that this intervention could reduce the risk of pneumonia, which is a major cause of hospitalization.”

Dr. Rubin, who is an allergist at Oak Brook Allergists, Ill., said, “I generally recommend nasal saline irrigation to my patients for allergic rhinitis and viral upper respiratory infections already. It can help reduce symptoms such as nasal congestion, rhinorrhea, postnasal drip, and sinus pain and pressure.”

The intervention may be reasonable beyond an adult population, he said.

“This could be used for pediatric patients as well, if they are developmentally ready to try this intervention,” he said.

Mr. Espinoza said further study is warranted, but he said that if confirmed in later trials, the simple intervention may be particularly helpful in low-resource settings.

Mr. Espinoza and Dr. Rubin have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

SAN FRANCISCO – A large observational registry study of almost 100,000 eyes has found that the diabetes drug semaglutide, a GLP-1 agonist recently approved for weight loss, does not worsen the progression of potentially vision-threatening diabetic retinopathy in the long term in patients taking the drug. However, the researchers said, the findings do not obviate the need for providers to have a conversation about the potential risks to vision posed by the drug.

“In patients that have either no or early or relatively nonadvanced diabetic retinopathy, the absolute risk of having a worsening in their retinopathy is variable,” Zeeshan Haq, MD, a retina specialist at Retinal Consultants of Minnesota, told this news organization. Dr. Hag presented the findings Nov. 3 at the annual meeting of the American Academy of Ophthalmology.

“Based on this preliminary evidence and what we know so far, it suggests that there is a risk of worsening, but it’s quite low for most patients, and so a conversation needs to be had between anyone considering prescribing the drug, such as a general practitioner or a nurse practitioner, and that patient’s optometrist or comprehensive ophthalmologist or retina specialist.”
 

Methodology and results

Dr. Haq reported on a retrospective case series of 96,462 eyes from the Intelligent Research in Sight (IRIS) registry. Patients had type 2 diabetes and began taking injectable semaglutide between January 2013 and December 2021.

The study evaluated eyes with three levels of retinopathy:

• No retinopathy or background retinopathy (71.8%).
• Mild or moderate nonproliferative diabetic retinopathy (NPDR) (18.4%).
• Severe NPDR or proliferative diabetic retinopathy (PDR) (9.8%).

In eyes with no or background retinopathy, 1.3%, 1.2%, 1.6%, and 2.2% experienced a worsening in status of the condition at 3, 6, 12, and 24 months, respectively.

In eyes with mild or moderate NPDR, 2.4%, 3%, 3.4%, and 3.5% showed worsening retinopathy at the respective time intervals.

Improvement of retinopathy rather than worsening was evaluated in the eyes with severe NPDR or PDR. At 3, 6, 12, and 24 months, improvement was observed in 40%, 37.8%, 47.7%, and 58.7% of these eyes, respectively.

Most patients were aged 51-75 years (77.2%), female (55.0%), and White (63.8%).

The study found low rates of the following complications across the same time intervals: vitreous hemorrhage (from 0.1% to 0.15%); traction retinal detachment (0.02% to 0.05%); and neovascular glaucoma (0.03% to –0.04%), Dr. Haq reported.

Dr. Haq noted that understanding the possible consequences that semaglutide has on vision is important as the drug becomes more widely available for both diabetes and weight control. The Centers for Disease Control and Prevention reports that 37.3 million people in the United States have diabetes; 28.7 million cases have been diagnosed, and 8.5 million are undiagnosed.
 

Clinical implications

“Any patient in the United States with diabetes has to undergo screening for diabetic eye disease, and so they’re usually plugged into the eye-care system,” Dr. Haq said. “But if they’re going to be starting this drug and they don’t have any existing diabetic retinopathy, the discussion should be had between their doctor and the eye-care provider, and if they do have a history of DR, an evaluation with the eye-care provider should probably happen upon starting the drug.”

Vaidehi Dedania, MD, a retina specialist at NYU Langone Health in New York, said the findings underscore the importance of counseling patients who are taking semaglutide about potential vision outcomes.

“We know that when patients get rapid control of their diabetes, their diabetic retinopathy can worsen in the short term, although it always ends up doing better in long term anyway,” Dr. Dedania said in an interview. “We always educate our patients that if they get control of the diabetes to not feel discouraged if their diabetic retinopathy worsens despite getting good control, because we know in the long run it always get better.”

The new findings, however, may have masked some worsening of retinopathy because of how the researchers categorized the condition. “It’s hard to assess changes within a designation because they’re so broad,” Dr. Dedania said.

She also noted potential limitations with the IRIS database itself. “The data collected from it are not always as complete as you might need for the purpose of understanding this, so that’s a limitation,” she said. While the high number of patients is a strength of the study, she added, “I still think the limitations are pretty significant.”

Dr. Haq has disclosed no relevant financial relationships. Dr. Dedania has relationships with Genentech/Roche and Regeneron Pharmaceuticals.

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

SAN FRANCISCO – A large observational registry study of almost 100,000 eyes has found that the diabetes drug semaglutide, a GLP-1 agonist recently approved for weight loss, does not worsen the progression of potentially vision-threatening diabetic retinopathy in the long term in patients taking the drug. However, the researchers said, the findings do not obviate the need for providers to have a conversation about the potential risks to vision posed by the drug.

“In patients that have either no or early or relatively nonadvanced diabetic retinopathy, the absolute risk of having a worsening in their retinopathy is variable,” Zeeshan Haq, MD, a retina specialist at Retinal Consultants of Minnesota, told this news organization. Dr. Hag presented the findings Nov. 3 at the annual meeting of the American Academy of Ophthalmology.

“Based on this preliminary evidence and what we know so far, it suggests that there is a risk of worsening, but it’s quite low for most patients, and so a conversation needs to be had between anyone considering prescribing the drug, such as a general practitioner or a nurse practitioner, and that patient’s optometrist or comprehensive ophthalmologist or retina specialist.”
 

Methodology and results

Dr. Haq reported on a retrospective case series of 96,462 eyes from the Intelligent Research in Sight (IRIS) registry. Patients had type 2 diabetes and began taking injectable semaglutide between January 2013 and December 2021.

The study evaluated eyes with three levels of retinopathy:

• No retinopathy or background retinopathy (71.8%).
• Mild or moderate nonproliferative diabetic retinopathy (NPDR) (18.4%).
• Severe NPDR or proliferative diabetic retinopathy (PDR) (9.8%).

In eyes with no or background retinopathy, 1.3%, 1.2%, 1.6%, and 2.2% experienced a worsening in status of the condition at 3, 6, 12, and 24 months, respectively.

In eyes with mild or moderate NPDR, 2.4%, 3%, 3.4%, and 3.5% showed worsening retinopathy at the respective time intervals.

Improvement of retinopathy rather than worsening was evaluated in the eyes with severe NPDR or PDR. At 3, 6, 12, and 24 months, improvement was observed in 40%, 37.8%, 47.7%, and 58.7% of these eyes, respectively.

Most patients were aged 51-75 years (77.2%), female (55.0%), and White (63.8%).

The study found low rates of the following complications across the same time intervals: vitreous hemorrhage (from 0.1% to 0.15%); traction retinal detachment (0.02% to 0.05%); and neovascular glaucoma (0.03% to –0.04%), Dr. Haq reported.

Dr. Haq noted that understanding the possible consequences that semaglutide has on vision is important as the drug becomes more widely available for both diabetes and weight control. The Centers for Disease Control and Prevention reports that 37.3 million people in the United States have diabetes; 28.7 million cases have been diagnosed, and 8.5 million are undiagnosed.
 

Clinical implications

“Any patient in the United States with diabetes has to undergo screening for diabetic eye disease, and so they’re usually plugged into the eye-care system,” Dr. Haq said. “But if they’re going to be starting this drug and they don’t have any existing diabetic retinopathy, the discussion should be had between their doctor and the eye-care provider, and if they do have a history of DR, an evaluation with the eye-care provider should probably happen upon starting the drug.”

Vaidehi Dedania, MD, a retina specialist at NYU Langone Health in New York, said the findings underscore the importance of counseling patients who are taking semaglutide about potential vision outcomes.

“We know that when patients get rapid control of their diabetes, their diabetic retinopathy can worsen in the short term, although it always ends up doing better in long term anyway,” Dr. Dedania said in an interview. “We always educate our patients that if they get control of the diabetes to not feel discouraged if their diabetic retinopathy worsens despite getting good control, because we know in the long run it always get better.”

The new findings, however, may have masked some worsening of retinopathy because of how the researchers categorized the condition. “It’s hard to assess changes within a designation because they’re so broad,” Dr. Dedania said.

She also noted potential limitations with the IRIS database itself. “The data collected from it are not always as complete as you might need for the purpose of understanding this, so that’s a limitation,” she said. While the high number of patients is a strength of the study, she added, “I still think the limitations are pretty significant.”

Dr. Haq has disclosed no relevant financial relationships. Dr. Dedania has relationships with Genentech/Roche and Regeneron Pharmaceuticals.

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

SAN FRANCISCO – A large observational registry study of almost 100,000 eyes has found that the diabetes drug semaglutide, a GLP-1 agonist recently approved for weight loss, does not worsen the progression of potentially vision-threatening diabetic retinopathy in the long term in patients taking the drug. However, the researchers said, the findings do not obviate the need for providers to have a conversation about the potential risks to vision posed by the drug.

“In patients that have either no or early or relatively nonadvanced diabetic retinopathy, the absolute risk of having a worsening in their retinopathy is variable,” Zeeshan Haq, MD, a retina specialist at Retinal Consultants of Minnesota, told this news organization. Dr. Hag presented the findings Nov. 3 at the annual meeting of the American Academy of Ophthalmology.

“Based on this preliminary evidence and what we know so far, it suggests that there is a risk of worsening, but it’s quite low for most patients, and so a conversation needs to be had between anyone considering prescribing the drug, such as a general practitioner or a nurse practitioner, and that patient’s optometrist or comprehensive ophthalmologist or retina specialist.”
 

Methodology and results

Dr. Haq reported on a retrospective case series of 96,462 eyes from the Intelligent Research in Sight (IRIS) registry. Patients had type 2 diabetes and began taking injectable semaglutide between January 2013 and December 2021.

The study evaluated eyes with three levels of retinopathy:

• No retinopathy or background retinopathy (71.8%).
• Mild or moderate nonproliferative diabetic retinopathy (NPDR) (18.4%).
• Severe NPDR or proliferative diabetic retinopathy (PDR) (9.8%).

In eyes with no or background retinopathy, 1.3%, 1.2%, 1.6%, and 2.2% experienced a worsening in status of the condition at 3, 6, 12, and 24 months, respectively.

In eyes with mild or moderate NPDR, 2.4%, 3%, 3.4%, and 3.5% showed worsening retinopathy at the respective time intervals.

Improvement of retinopathy rather than worsening was evaluated in the eyes with severe NPDR or PDR. At 3, 6, 12, and 24 months, improvement was observed in 40%, 37.8%, 47.7%, and 58.7% of these eyes, respectively.

Most patients were aged 51-75 years (77.2%), female (55.0%), and White (63.8%).

The study found low rates of the following complications across the same time intervals: vitreous hemorrhage (from 0.1% to 0.15%); traction retinal detachment (0.02% to 0.05%); and neovascular glaucoma (0.03% to –0.04%), Dr. Haq reported.

Dr. Haq noted that understanding the possible consequences that semaglutide has on vision is important as the drug becomes more widely available for both diabetes and weight control. The Centers for Disease Control and Prevention reports that 37.3 million people in the United States have diabetes; 28.7 million cases have been diagnosed, and 8.5 million are undiagnosed.
 

Clinical implications

“Any patient in the United States with diabetes has to undergo screening for diabetic eye disease, and so they’re usually plugged into the eye-care system,” Dr. Haq said. “But if they’re going to be starting this drug and they don’t have any existing diabetic retinopathy, the discussion should be had between their doctor and the eye-care provider, and if they do have a history of DR, an evaluation with the eye-care provider should probably happen upon starting the drug.”

Vaidehi Dedania, MD, a retina specialist at NYU Langone Health in New York, said the findings underscore the importance of counseling patients who are taking semaglutide about potential vision outcomes.

“We know that when patients get rapid control of their diabetes, their diabetic retinopathy can worsen in the short term, although it always ends up doing better in long term anyway,” Dr. Dedania said in an interview. “We always educate our patients that if they get control of the diabetes to not feel discouraged if their diabetic retinopathy worsens despite getting good control, because we know in the long run it always get better.”

The new findings, however, may have masked some worsening of retinopathy because of how the researchers categorized the condition. “It’s hard to assess changes within a designation because they’re so broad,” Dr. Dedania said.

She also noted potential limitations with the IRIS database itself. “The data collected from it are not always as complete as you might need for the purpose of understanding this, so that’s a limitation,” she said. While the high number of patients is a strength of the study, she added, “I still think the limitations are pretty significant.”

Dr. Haq has disclosed no relevant financial relationships. Dr. Dedania has relationships with Genentech/Roche and Regeneron Pharmaceuticals.

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