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Causality: well established
Causality assessment · Causality: well established
Glofitamab 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.
Glofitamab ↔ Cytokine Release Syndrome
n=747 co-reports · PRR 359.2 · ROR 522.7
Glofitamab is a CD20-directed CD3-bispecific T-cell engager (BiTE) for lymphoma. CRS is the expected pharmacological consequence of T-cell engagement: the bispecific antibody brings T cells to CD20-expressing B cells, triggering cytokine release. The label carries a boxed warning. 912 co-reports (PRR 222.7) reflect near-universal occurrence.
Boxed warning: glofitamab label (CRS). Registration trial.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 222.7 with 912 co-reports |
| Consistency | met | Reproduced across BiTE/CAR T class |
| Specificity | partial | Specific to T-cell-engaging therapies |
| Biological gradient | met | CRS severity correlates with tumour burden |
| Plausibility | met | Known T-cell activation mechanism |
| Coherence | met | Coherent with immunology |
| Experiment | met | Trials confirm |
| Analogy | met | Analogous to CAR T and other BiTEs |
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 Glofitamab captured cytokine release syndrome as a tracked adverse event in a usable structure. CRS is tracked as primary AE in BiTE registration trials.