Thymalin in immune modulation and adjunctive immunotherapy — evidence extract
The Institute's graded assessment of Thymalin 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
- Thymalin, intramuscular in the approved russian presentation
- 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
Table 1. Trials contributing to the assessment of Thymalin in immune modulation and adjunctive immunotherapy.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| THYMALIN-RU-1 | — | Observational | — | Not recorded | — |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | Serious | The primary endpoint is patient-reported in a setting where blinding cannot be maintained. |
| Inconsistency | Serious | Direction is consistent; magnitude varies with the intensity of the background intervention. |
| Indirectness | Serious | The enrolled population differs materially from the population of the assessment question. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| 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.
- United States Pharmacopeial Convention. General Chapter ⟨85⟩ Bacterial Endotoxins Test. United States Pharmacopeia — National Formulary (USP–NF) 2024;USP 2024 Issue 1. identifier not held by the Institute
- United States Pharmacopeial Convention. General Chapter ⟨71⟩ Sterility Tests. United States Pharmacopeia — National Formulary (USP–NF) 2024;USP 2024 Issue 1. identifier not held by the Institute
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
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.