| Autor: |
Yuan, Zhao, Oksana, Mokliatchouk, Nancy F, Ramia, Maria L, Naylor, Cherié L, Butts |
| Rok vydání: |
2022 |
| Předmět: |
|
| Zdroj: |
Med. 3:612-621.e3 |
| ISSN: |
2666-6340 |
| Popis: |
Black/African American participants are underrepresented in clinical trials for multiple sclerosis but can experience a greater burden of disease than other racial groups in the United States. A phase 1, open-label, crossover study that demonstrated bioequivalence of subcutaneous and intramuscular injection of peginterferon β-1a in healthy volunteers enrolled similar proportions of Black and White participants, enabling a post hoc subgroup analysis comparing these groups.Peginterferon β-1a (125 μg) was administered by subcutaneous or intramuscular injection, followed by a washout period before a second injection using the alternative method. The primary pharmacokinetic and pharmacodynamic endpoints were maximum observed concentration (CThis analysis included 70 (51.5%) Black and 59 (43.3%) White participants. Peginterferon β-1a CNo clinically meaningful differences were identified between Black and White participants related to peginterferon β-1a administration, supporting the approved dose of 125 μg/mL peginterferon β-1a. Future clinical studies should include sufficiently diverse populations to ensure accurate assessments of treatment response.Funding for medical writing support was provided by Biogen (Cambridge, MA, USA). |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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