LL-37 in immune modulation and adjunctive immunotherapy — evidence extract
The Institute's graded assessment of LL-37 for immune modulation and adjunctive immunotherapy, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Immune modulation and adjunctive immunotherapy
§1.1Question and anchor outcome
- Population
- Pharmacological modification of innate or adaptive immune function, assessed by cell counts, functional assays and clinical infection or oncological endpoints.
- Intervention
- LL-37, topical and intralesional in clinical studies
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- CD4 and CD8 counts
Additional outcomes the Institute extracts for this indication: Response to vaccination; Infection incidence; Tumour response where applicable.
§1.2Contributing trials
No trial has been identified for LL-37 in immune modulation and adjunctive immunotherapy. The rating below reflects that absence.
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | Serious | Too few contributing studies to assess consistency formally. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | Serious | The event count falls below the optimal information size. |
| Publication bias | Serious | Registered trials without posted results were identified for this question. |
| Overall rating: Very low certainty. The Institute has very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate. In this series a very low rating most often reflects an absence of controlled human evidence rather than conflicting evidence. | ||
§1.4What this extract does not establish
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.
- 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
- Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256
- Wang W, Nema S, Teagarden D. Protein aggregation — pathways and influencing factors. International Journal of Pharmaceutics 2010;390(2):89–99. doi:10.1016/j.ijpharm.2010.02.025 · PMID 20188795
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.