Utilizing the dry spot method to monitor the concentrations of biologic agents in breast milk Article Swipe
Yuji Mukai
,
Kosuke Doki
,
Yoshiharu Suzuki
,
Masato Homma
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1111/bcp.15929
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1111/bcp.15929
To the Editor: We read with great interest the recent article by Saito et al., who developed a method to quantify six biologic agents in dried milk spots.1 The study provides new insights into the pharmacokinetic properties of these biologics. It also provides clinically important information for their safe use. Our comments on the paper include the following four points. First, we believe that additional data on analyte stability in the filter paper are required to interpret the results. As the authors stated that the dried milk spot samples were transported by regular mail, an additional stability test under extreme conditions2 should have been performed to improve the reliability of the quantification results. We found that dried filter paper samples are exposed to temperatures >30°C during postal transport in Japan3; however, the authors did not perform stability tests under this condition. The resulting data from such tests would be critical for interpreting the drug concentrations in dried milk spots obtained in the study because high-temperature and high-humidity conditions can cause degradation of the analytes in the filter paper.4 In this context, the selectivity of the analytical method should be further evaluated. Enzyme-linked immunosorbent assay (ELISA) is a standard method for quantifying the concentrations of biologics in human serum and plasma. As the application of ELISA for monitoring the concentrations of compounds in breast milk is still limited, a careful validation process is required. We believe that testing the integrity of the analytes (i.e., whether they are intact or fragmented) extracted from breast milk would provide new insights into predicting the effects of biologics on breastfed infants. Our second comment is related to the conclusions drawn from the study. The authors concluded that “this might help collect information on the concentrations of drugs in breastfed infants”1; however, they did not measure the drug concentrations in the infants' blood. As discussed in the article, biologic agents are generally extensively digested in the gastrointestinal tract after oral administration. One study in which 152–1120 mg/day of immunoglobulin G (IgG) solution was administered orally to low-birth-weight infants reported that the serum IgG levels on day five after therapy initiation were 67% to 106% of the pretreatment levels,5 suggesting that a negligible amount of IgG from breast milk can be absorbed by the gastrointestinal tract of infants. The highest concentration of biologics in breast milk observed in Saito et al.’s study was approximately 200 ng/mL (in Case 3).1 Assuming that the infants' feed volume and body weight were 150 mL/kg/day6 and 5 kg, respectively, the amount of these agents ingested through breast milk was calculated to be 150 μg/day, which is at least less than 1/1000 of that reported in the other study.5 The authors cited a study by Goonatilleke et al.7 to discuss the absorption of monoclonal antibodies through the gastrointestinal tract of infants. However, Goonatilleke et al.7 reported that the IgG concentrations in breast milk remained constant throughout lactation (from colostrum to 24 weeks) and discussed the physiological role of immunoglobulins in infants. It should be noted that these findings do not support the intestinal absorption of IgG antibodies or biologics. In contrast, another study reported that tocilizumab was undetectable in the serum of a breastfed infant immediately after maternal administration of tocilizumab and at 22.9 and 28 days after the last administration.8 These results suggest that the absorption of biologics from breast milk in infants is likely negligible. However, we believe that the strength of Saito et al.'s study1 is that it provides valuable data for the rational use of biologics during lactation, along with previous reports, which have revealed that the milk-to-serum concentration ratio of tocilizumab ranges from 0.00045 to 0.0015.8-10 Third, as shown in fig. 3 of Saito et al.'s article, relatively large fluctuations were observed at some time points in Cases 1, 4–7, and 9 compared to the within-run variability reported in their tab. 1. The authors stated that the homogeneity of the dried spots was not sufficiently evaluated. In addition, the components of breast milk showed inter- and intra-variability.7 We suggest that the effects of these factors be evaluated before future clinical applications. Finally, the authors compared the drug concentrations between dried and liquid breast milk specimens by using a single Bland–Altman plot based on pooled data from patients treated with different drugs. The assay performance of the measurement method would vary among the drugs studied. Therefore, this analysis should be performed separately for each drug. In conclusion, further analytical validation and careful evaluation of the clinical relevance of monitoring concentrations of biologics in breast milk are required to apply the method established by Saito et al.1 in future clinical trials or clinical practice. All authors declare that they have no conflict of interest regarding this manuscript.
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- Type
- letter
- Language
- en
- Landing Page
- https://doi.org/10.1111/bcp.15929
- https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/bcp.15929
- OA Status
- bronze
- Cited By
- 1
- References
- 10
- Related Works
- 10
- OpenAlex ID
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All OpenAlex metadata
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- OpenAlex ID
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https://openalex.org/W4387898493Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1111/bcp.15929Digital Object Identifier
- Title
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Utilizing the dry spot method to monitor the concentrations of biologic agents in breast milkWork title
- Type
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letterOpenAlex work type
- Language
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enPrimary language
- Publication year
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2023Year of publication
- Publication date
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2023-10-24Full publication date if available
- Authors
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Yuji Mukai, Kosuke Doki, Yoshiharu Suzuki, Masato HommaList of authors in order
- Landing page
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https://doi.org/10.1111/bcp.15929Publisher landing page
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/bcp.15929Direct link to full text PDF
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YesWhether a free full text is available
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bronzeOpen access status per OpenAlex
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/bcp.15929Direct OA link when available
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Analyte, Context (archaeology), Dried blood, Chromatography, Spots, Filter paper, Breast milk, Chemistry, Computer science, Biology, Biochemistry, Physical chemistry, PaleontologyTop concepts (fields/topics) attached by OpenAlex
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1Total citation count in OpenAlex
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2024: 1Per-year citation counts (last 5 years)
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.variability | 639 |
| abstract_inverted_index.Goonatilleke | 453, 470 |
| abstract_inverted_index.administered | 337 |
| abstract_inverted_index.fluctuations | 622 |
| abstract_inverted_index.infants”1; | 294 |
| abstract_inverted_index.interpreting | 151 |
| abstract_inverted_index.pretreatment | 360 |
| abstract_inverted_index.sufficiently | 657 |
| abstract_inverted_index.temperatures | 123 |
| abstract_inverted_index.undetectable | 525 |
| abstract_inverted_index.Enzyme-linked | 191 |
| abstract_inverted_index.applications. | 683 |
| abstract_inverted_index.approximately | 396 |
| abstract_inverted_index.concentration | 383, 600 |
| abstract_inverted_index.high-humidity | 166 |
| abstract_inverted_index.immunosorbent | 192 |
| abstract_inverted_index.milk-to-serum | 599 |
| abstract_inverted_index.physiological | 493 |
| abstract_inverted_index.respectively, | 417 |
| abstract_inverted_index.Bland–Altman | 702 |
| abstract_inverted_index.administration | 536 |
| abstract_inverted_index.concentrations | 154, 202, 218, 289, 302, 477, 690, 751 |
| abstract_inverted_index.immunoglobulin | 332 |
| abstract_inverted_index.quantification | 111 |
| abstract_inverted_index.administration. | 324 |
| abstract_inverted_index.immunoglobulins | 496 |
| abstract_inverted_index.pharmacokinetic | 35 |
| abstract_inverted_index.administration.8 | 548 |
| abstract_inverted_index.gastrointestinal | 320, 377, 465 |
| abstract_inverted_index.high-temperature | 164 |
| abstract_inverted_index.low-birth-weight | 340 |
| abstract_inverted_index.intra-variability.7 | 669 |
| cited_by_percentile_year.max | 94 |
| cited_by_percentile_year.min | 90 |
| corresponding_author_ids | https://openalex.org/A5015394777 |
| countries_distinct_count | 1 |
| institutions_distinct_count | 4 |
| corresponding_institution_ids | https://openalex.org/I4210114927 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.6600000262260437 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.74758149 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | True |