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Causality: well established
Causality assessment · Causality: well established
Axicabtagene Ciloleucel 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.
Axicabtagene Ciloleucel ↔ Cytokine Release Syndrome
n=4,499 co-reports · PRR 663.0 · ROR 1223.7
Axicabtagene ciloleucel (Yescarta) is a CD19-directed CAR T-cell therapy. Cytokine release syndrome (CRS) is the expected on-target pharmacological effect: expanded T cells release massive cytokines, causing fever, hypotension, and multi-organ dysfunction. The label carries a boxed warning. 790 co-reports (PRR 261.8) reflect near-universal occurrence after infusion. CRS is not a side effect but the intended immune response.
Boxed warning: Yescarta label (CRS / neurological toxicities). J. K. et al., NEJM 2018, PMID: 30515932.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 261.8 with 790 co-reports |
| Consistency | met | Reproduced across all CAR T products |
| Specificity | partial | Specific to CAR T-cell therapy |
| Biological gradient | met | CRS severity correlates with tumour burden |
| Plausibility | met | Known cytokine release mechanism |
| Coherence | met | Coherent with T-cell biology |
| Experiment | met | Multiple RCTs confirm CRS universal |
| Analogy | met | All CAR T products show identical syndrome |
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 Axicabtagene captured cytokine release syndrome as a tracked adverse event in a usable structure. CRS is consistently tracked as a primary AE in CAR T registration trials (ZUMA-1, NCT02348253): 93 % CRS incidence reported.