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Causality: well established
Causality assessment · Causality: well established
Tisagenlecleucel and Cytokine Release Syndrome: is the FAERS signal real?
A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.
Tisagenlecleucel ↔ Cytokine Release Syndrome
n=1,757 co-reports · PRR 467.9 · ROR 760.9
Tisagenlecleucel (Kymriah) is a CD19-directed CAR T-cell therapy. CRS is the expected pharmacological consequence of CAR T activation; the label includes a boxed warning. 1,698 co-reports (PRR 82.5) confirm that CRS is near-universal. The same mechanistic rationale applies as for all CAR T products.
Boxed warning: Kymriah label (CRS / neurological toxicities). Lancet 2019, PMID: 31010165.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 82.5 with 1,698 co-reports |
| Consistency | met | Reproduced across all CAR T products |
| Specificity | partial | Specific to CAR T class |
| Biological gradient | met | Correlates with tumour burden |
| Plausibility | met | Known cytokine release mechanism |
| Coherence | met | Coherent with T-cell biology |
| Experiment | met | Registration trials confirm |
| Analogy | met | Analogous to other CAR T products |
This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for Tisagenlecleucel captured cytokine release syndrome as a tracked adverse event in a usable structure. CRS is a primary AE endpoint in CAR T registration trials (ELIANA, NCT02265068).