Immune modulation and adjunctive immunotherapy — indication assessment
Pharmacological modification of innate or adaptive immune function, assessed by cell counts, functional assays and clinical infection or oncological endpoints.
§1Assessment
§1.1Definition
Pharmacological modification of innate or adaptive immune function, assessed by cell counts, functional assays and clinical infection or oncological endpoints.
§1.2Anchor and additional outcomes
The Institute designates one anchor outcome per indication so that estimates for different compounds are reported on a common measure. The anchor for this indication is the first outcome below.
- CD4 and CD8 counts
- Response to vaccination
- Infection incidence
- Tumour response where applicable
§1.3State of the evidence
The Institute assesses 5 compounds in this indication, drawing on 24 trial records and 5 evidence syntheses. [1,2]
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Garaci E, Pica F, Serafino A, Balestrieri E, Matteucci C, Moroni G, Sorrentino R, Zonfrillo M, Pierimarchi P, Sinibaldi-Vallebona P. Thymosin α1 and cancer: action on immune effector and tumor target cells. Annals of the New York Academy of Sciences 2007;1112:225–234. doi:10.1196/annals.1415.025 · PMID 17567944
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.