Comparison of Intravenous Low Molecular Weight Iron Dextran and Intravenous Iron Sucrose to Treat Iron Deficiency Anemia: A Single Center Experience

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PURPOSE

To evaluate if low molecular weight iron dextran (LMWID) is a safe and effective alternative to iron sucrose for intravenous iron administration.

BACKGROUND

In recent years, intravenous iron administration has increased due to clinical indications and rapid iron repletion. Early IV iron formulations had safety concerns that precluded widespread use. High molecular weight iron dextran was removed from the US market in 2009 due to safety concerns. Since then, several new IV formulations including LMWID and iron sucrose have been approved with a favorable benefit risk profile. While recent evidence and guidelines indicate that LMWID and other iron formulations have comparable safety profiles, no head-to-head comparisons exist. Both iron sucrose and LMWID are used for the treatment of IDA in Veterans Affairs hospitals. Iron sucrose is given 200 mg weekly for 5 weeks, while LMWID is given as a single 1-gram dose over 3 hours. We conducted a retrospective crosssectional analysis to compare the safety and efficacy of IV LMWID to IV iron sucrose.

METHODS

We identified 129 patients (LMWID: n=29, iron sucrose: n=100) who received intravenous iron from 01/01/2022 to 03/03/2023. To match the sample size, we selected every 3rd patient from the iron sucrose group (n=33). We captured data on infusion-related reactions, history of asthma/inflammatory bowel disease/> 2 drug allergies, overall and ≥ 2 g/dL hemoglobin increase, and treatment cost. Descriptive statistics were used to describe the safety and efficacy parameters. An unpaired t-test was used to calculate statistical significance of the cost.

RESULTS

We found that 82.7% of the patients who received LMWID had an increase in hemoglobin vs. 60.6% in the iron sucrose group. 48.3% of patients in LMWID had ≥ 2 hemoglobin increases vs. 27.3% in the iron sucrose group. The cost for LMWID administration was $2016.10, compared to $2315.40 for administration of IV iron sucrose cost. Two-tailed p value < 0.0001 indicating the observed difference to be statistically significant. No infusion reactions were observed in both groups.

CONCLUSIONS

In this single center analysis, IV LMWID administered provided comparable safety, and improved effectiveness, and cost-effectiveness to iron sucrose.

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PURPOSE

To evaluate if low molecular weight iron dextran (LMWID) is a safe and effective alternative to iron sucrose for intravenous iron administration.

BACKGROUND

In recent years, intravenous iron administration has increased due to clinical indications and rapid iron repletion. Early IV iron formulations had safety concerns that precluded widespread use. High molecular weight iron dextran was removed from the US market in 2009 due to safety concerns. Since then, several new IV formulations including LMWID and iron sucrose have been approved with a favorable benefit risk profile. While recent evidence and guidelines indicate that LMWID and other iron formulations have comparable safety profiles, no head-to-head comparisons exist. Both iron sucrose and LMWID are used for the treatment of IDA in Veterans Affairs hospitals. Iron sucrose is given 200 mg weekly for 5 weeks, while LMWID is given as a single 1-gram dose over 3 hours. We conducted a retrospective crosssectional analysis to compare the safety and efficacy of IV LMWID to IV iron sucrose.

METHODS

We identified 129 patients (LMWID: n=29, iron sucrose: n=100) who received intravenous iron from 01/01/2022 to 03/03/2023. To match the sample size, we selected every 3rd patient from the iron sucrose group (n=33). We captured data on infusion-related reactions, history of asthma/inflammatory bowel disease/> 2 drug allergies, overall and ≥ 2 g/dL hemoglobin increase, and treatment cost. Descriptive statistics were used to describe the safety and efficacy parameters. An unpaired t-test was used to calculate statistical significance of the cost.

RESULTS

We found that 82.7% of the patients who received LMWID had an increase in hemoglobin vs. 60.6% in the iron sucrose group. 48.3% of patients in LMWID had ≥ 2 hemoglobin increases vs. 27.3% in the iron sucrose group. The cost for LMWID administration was $2016.10, compared to $2315.40 for administration of IV iron sucrose cost. Two-tailed p value < 0.0001 indicating the observed difference to be statistically significant. No infusion reactions were observed in both groups.

CONCLUSIONS

In this single center analysis, IV LMWID administered provided comparable safety, and improved effectiveness, and cost-effectiveness to iron sucrose.

PURPOSE

To evaluate if low molecular weight iron dextran (LMWID) is a safe and effective alternative to iron sucrose for intravenous iron administration.

BACKGROUND

In recent years, intravenous iron administration has increased due to clinical indications and rapid iron repletion. Early IV iron formulations had safety concerns that precluded widespread use. High molecular weight iron dextran was removed from the US market in 2009 due to safety concerns. Since then, several new IV formulations including LMWID and iron sucrose have been approved with a favorable benefit risk profile. While recent evidence and guidelines indicate that LMWID and other iron formulations have comparable safety profiles, no head-to-head comparisons exist. Both iron sucrose and LMWID are used for the treatment of IDA in Veterans Affairs hospitals. Iron sucrose is given 200 mg weekly for 5 weeks, while LMWID is given as a single 1-gram dose over 3 hours. We conducted a retrospective crosssectional analysis to compare the safety and efficacy of IV LMWID to IV iron sucrose.

METHODS

We identified 129 patients (LMWID: n=29, iron sucrose: n=100) who received intravenous iron from 01/01/2022 to 03/03/2023. To match the sample size, we selected every 3rd patient from the iron sucrose group (n=33). We captured data on infusion-related reactions, history of asthma/inflammatory bowel disease/> 2 drug allergies, overall and ≥ 2 g/dL hemoglobin increase, and treatment cost. Descriptive statistics were used to describe the safety and efficacy parameters. An unpaired t-test was used to calculate statistical significance of the cost.

RESULTS

We found that 82.7% of the patients who received LMWID had an increase in hemoglobin vs. 60.6% in the iron sucrose group. 48.3% of patients in LMWID had ≥ 2 hemoglobin increases vs. 27.3% in the iron sucrose group. The cost for LMWID administration was $2016.10, compared to $2315.40 for administration of IV iron sucrose cost. Two-tailed p value < 0.0001 indicating the observed difference to be statistically significant. No infusion reactions were observed in both groups.

CONCLUSIONS

In this single center analysis, IV LMWID administered provided comparable safety, and improved effectiveness, and cost-effectiveness to iron sucrose.

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Association of Eosinophilia With Complete Response in Patients With Metastatic Solid Tumors Treated With Immunotherapy

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BACKGROUND: Immune-related eosinophilia is a new immune related adverse effect associated with anti- PD-1 or anti-PD-L1 treatment (Bernard-Tessier, 2017). It appears to be a rare adverse effect with estimated frequency of 2.9% (Bernard-Tessier, 2017). There is evidence that changes in blood eosinophilia during anti- PD-1 therapy can be a predictor of long-term disease control in metastatic melanoma (Gaba, 2015). At least 3 studies have correlated immune mediated eosinophilia with high overall response rates up to 69% (Bernard- Tessier, 2017; Gaba, 2015; A, 2017). With this interesting observation, we retrospectively reviewed 36 patients in our center who were treated with PD-1 and anti PD-L1 agents. The Objective of our review was to assess the correlation of eosinophilia with the complete response rate.

METHODS: We retrospectively reviewed the medical records of 36 patients from May 2016 -May 2020 who had received anti PD-1 or anti PD-L1 treatment for metastatic solid tumors. Patients who had received consolidation immunotherapy were excluded from the review. Absolute Eosinophil Count (AEC) of over 500 per mm3 was used to define eosinophilia. Incidence rate of eosinophilia was estimated in comparison to the total number of patients who had received the above treatments.

RESULTS: In this small single center cohort of 36 male patients, eosinophilia was observed in 4/36 patients (11.11%). The median time to the absolute eosinophilia was 24 weeks (3 weeks - 52 weeks). Three out of the 4 patients had complete response. Complete response rates in patients with eosinophilia at any point after initiation of immunotherapy was 75% compared with 2.7% in the noneosinophila group. Overall response rate was 75% (3/4) in the eosinophilia group vs 12.5% (4/32) in the noneosinophilia group.

CONCLUSIONS: In our small retrospective cohort of patients, immune-related eosinophilia with anti-PD-1 and anti-PD-L1 treatments appear to be a biomarker and associated with beneficial clinical response. Additional, larger prospective studies are required to validate this. If validated in prospective studies, immune related eosinophilia could serve as a cost effective biomarker to identify responders likely to derive long-term disease control with immune therapies.

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Correspondence: Mamatha Prabhakar (mamatha.prabhakar@va.gov)

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Correspondence: Mamatha Prabhakar (mamatha.prabhakar@va.gov)

BACKGROUND: Immune-related eosinophilia is a new immune related adverse effect associated with anti- PD-1 or anti-PD-L1 treatment (Bernard-Tessier, 2017). It appears to be a rare adverse effect with estimated frequency of 2.9% (Bernard-Tessier, 2017). There is evidence that changes in blood eosinophilia during anti- PD-1 therapy can be a predictor of long-term disease control in metastatic melanoma (Gaba, 2015). At least 3 studies have correlated immune mediated eosinophilia with high overall response rates up to 69% (Bernard- Tessier, 2017; Gaba, 2015; A, 2017). With this interesting observation, we retrospectively reviewed 36 patients in our center who were treated with PD-1 and anti PD-L1 agents. The Objective of our review was to assess the correlation of eosinophilia with the complete response rate.

METHODS: We retrospectively reviewed the medical records of 36 patients from May 2016 -May 2020 who had received anti PD-1 or anti PD-L1 treatment for metastatic solid tumors. Patients who had received consolidation immunotherapy were excluded from the review. Absolute Eosinophil Count (AEC) of over 500 per mm3 was used to define eosinophilia. Incidence rate of eosinophilia was estimated in comparison to the total number of patients who had received the above treatments.

RESULTS: In this small single center cohort of 36 male patients, eosinophilia was observed in 4/36 patients (11.11%). The median time to the absolute eosinophilia was 24 weeks (3 weeks - 52 weeks). Three out of the 4 patients had complete response. Complete response rates in patients with eosinophilia at any point after initiation of immunotherapy was 75% compared with 2.7% in the noneosinophila group. Overall response rate was 75% (3/4) in the eosinophilia group vs 12.5% (4/32) in the noneosinophilia group.

CONCLUSIONS: In our small retrospective cohort of patients, immune-related eosinophilia with anti-PD-1 and anti-PD-L1 treatments appear to be a biomarker and associated with beneficial clinical response. Additional, larger prospective studies are required to validate this. If validated in prospective studies, immune related eosinophilia could serve as a cost effective biomarker to identify responders likely to derive long-term disease control with immune therapies.

BACKGROUND: Immune-related eosinophilia is a new immune related adverse effect associated with anti- PD-1 or anti-PD-L1 treatment (Bernard-Tessier, 2017). It appears to be a rare adverse effect with estimated frequency of 2.9% (Bernard-Tessier, 2017). There is evidence that changes in blood eosinophilia during anti- PD-1 therapy can be a predictor of long-term disease control in metastatic melanoma (Gaba, 2015). At least 3 studies have correlated immune mediated eosinophilia with high overall response rates up to 69% (Bernard- Tessier, 2017; Gaba, 2015; A, 2017). With this interesting observation, we retrospectively reviewed 36 patients in our center who were treated with PD-1 and anti PD-L1 agents. The Objective of our review was to assess the correlation of eosinophilia with the complete response rate.

METHODS: We retrospectively reviewed the medical records of 36 patients from May 2016 -May 2020 who had received anti PD-1 or anti PD-L1 treatment for metastatic solid tumors. Patients who had received consolidation immunotherapy were excluded from the review. Absolute Eosinophil Count (AEC) of over 500 per mm3 was used to define eosinophilia. Incidence rate of eosinophilia was estimated in comparison to the total number of patients who had received the above treatments.

RESULTS: In this small single center cohort of 36 male patients, eosinophilia was observed in 4/36 patients (11.11%). The median time to the absolute eosinophilia was 24 weeks (3 weeks - 52 weeks). Three out of the 4 patients had complete response. Complete response rates in patients with eosinophilia at any point after initiation of immunotherapy was 75% compared with 2.7% in the noneosinophila group. Overall response rate was 75% (3/4) in the eosinophilia group vs 12.5% (4/32) in the noneosinophilia group.

CONCLUSIONS: In our small retrospective cohort of patients, immune-related eosinophilia with anti-PD-1 and anti-PD-L1 treatments appear to be a biomarker and associated with beneficial clinical response. Additional, larger prospective studies are required to validate this. If validated in prospective studies, immune related eosinophilia could serve as a cost effective biomarker to identify responders likely to derive long-term disease control with immune therapies.

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