Assessment of local adverse reactions to subcutaneous immunoglobulin (SCIG) in clinical trials
In their recent paper on the North American pivotal trial of a new 20% immunoglobulin (Ig) for subcutaneous (SC) use, Suez et al. report an incidence of local adverse events (AE) of 0.015 events/infusion and compared this to rates reported in other studies of different products. Comparison of differ...
| Main Authors: | , , , , , |
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| Format: | Journal article |
| Language: | English |
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Springer
2017
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| _version_ | 1797068117264826368 |
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| author | Ballow, M Wasserman, R Jolles, S Chapel, H Berger, M Misbah, S |
| author_facet | Ballow, M Wasserman, R Jolles, S Chapel, H Berger, M Misbah, S |
| author_sort | Ballow, M |
| collection | OXFORD |
| description | In their recent paper on the North American pivotal trial of a new 20% immunoglobulin (Ig) for subcutaneous (SC) use, Suez et al. report an incidence of local adverse events (AE) of 0.015 events/infusion and compared this to rates reported in other studies of different products. Comparison of different products is inappropriate unless the products are studied contemporaneously within the same study using the same methodology, the same investigators, and the same patient populations. Judging the relative tolerability of different products accurately and determining whethermanufacturing procedures, excipients, infusion supplies, pumps, and/or infusion techniques influence local site tolerability or more systemic adverse events ideally require blinded head-tohead comparisons. Crossover designs, in a targeted disease population of subjects with X-linked agammaglobulinemia and common variable immunodeficiency disorders would be preferable, and assessments should be done by the same group of investigators using a standardized grading system. In addition, consideration should be given to collecting and recording the long-term local infusion adverse events that have been described. We suggest that comparing different products using different patient populations, different inclusion/exclusion criteria, and different protocols is not scientifically possible. More importantly, it is inappropriate to compare preparations and practices that have not been evaluated in the same clinical trial. |
| first_indexed | 2024-03-06T22:06:04Z |
| format | Journal article |
| id | oxford-uuid:502d7ebb-33b0-4883-a7f1-fe4112bd139e |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T22:06:04Z |
| publishDate | 2017 |
| publisher | Springer |
| record_format | dspace |
| spelling | oxford-uuid:502d7ebb-33b0-4883-a7f1-fe4112bd139e2022-03-26T16:12:05ZAssessment of local adverse reactions to subcutaneous immunoglobulin (SCIG) in clinical trialsJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:502d7ebb-33b0-4883-a7f1-fe4112bd139eEnglishSymplectic Elements at OxfordSpringer2017Ballow, MWasserman, RJolles, SChapel, HBerger, MMisbah, SIn their recent paper on the North American pivotal trial of a new 20% immunoglobulin (Ig) for subcutaneous (SC) use, Suez et al. report an incidence of local adverse events (AE) of 0.015 events/infusion and compared this to rates reported in other studies of different products. Comparison of different products is inappropriate unless the products are studied contemporaneously within the same study using the same methodology, the same investigators, and the same patient populations. Judging the relative tolerability of different products accurately and determining whethermanufacturing procedures, excipients, infusion supplies, pumps, and/or infusion techniques influence local site tolerability or more systemic adverse events ideally require blinded head-tohead comparisons. Crossover designs, in a targeted disease population of subjects with X-linked agammaglobulinemia and common variable immunodeficiency disorders would be preferable, and assessments should be done by the same group of investigators using a standardized grading system. In addition, consideration should be given to collecting and recording the long-term local infusion adverse events that have been described. We suggest that comparing different products using different patient populations, different inclusion/exclusion criteria, and different protocols is not scientifically possible. More importantly, it is inappropriate to compare preparations and practices that have not been evaluated in the same clinical trial. |
| spellingShingle | Ballow, M Wasserman, R Jolles, S Chapel, H Berger, M Misbah, S Assessment of local adverse reactions to subcutaneous immunoglobulin (SCIG) in clinical trials |
| title | Assessment of local adverse reactions to subcutaneous immunoglobulin (SCIG) in clinical trials |
| title_full | Assessment of local adverse reactions to subcutaneous immunoglobulin (SCIG) in clinical trials |
| title_fullStr | Assessment of local adverse reactions to subcutaneous immunoglobulin (SCIG) in clinical trials |
| title_full_unstemmed | Assessment of local adverse reactions to subcutaneous immunoglobulin (SCIG) in clinical trials |
| title_short | Assessment of local adverse reactions to subcutaneous immunoglobulin (SCIG) in clinical trials |
| title_sort | assessment of local adverse reactions to subcutaneous immunoglobulin scig in clinical trials |
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