Table 1.
Persistent symptoms and signs over two years following TGN1412-induced cytokine storm
| Categories | Symptoms and immune correlates (# of patients) | CTCAE grade |
|---|---|---|
| Neurocognitive and psychological | Memory impairment (6) | 1–2 |
| Impairment in attentional processing (6) | 1–2 | |
| Mild-moderate depression (3) | 1–2 | |
| Post-traumatic stress disorder (2) | 2 | |
| Anxiety requiring psychotherapy (4) | 1–3 | |
| Headaches (5) | 1–2 | |
| Blurred vision (5) | 1 | |
| Autoimmune and inflammatory | Mild neutropenia (3) | 1 |
| Arthralgias—knees, hands, back (6) | 1 | |
| Positive auto-antibodies (4) | 1 | |
| Ischemic extremities (1) | 3 | |
| Raynaud’s phenomenon (1) | 1 | |
| Immune mucosal barrier function | Diarrhea and ↑ γδT cells (3) | 1–2 |
| Skin dryness and ↑sensitivity (3) | 1–2 | |
| Pruritus (1) | 1–2 | |
| Peripheral blood eosinophilia (3) | 1 | |
| ↑ Serum IgE (4) | 1 | |
| Benign lipomas/angiolipomas (1) | 2 | |
| Immune cell subsets and cytokines | Gradual recovery of DC over 1 month (6) | 1 |
| Low-normal total CD4+ T cells (5) | 1 | |
| Low-normal total CD8+ T cells (6) | 1 | |
| ↑ sustained naïve CD8+ T cells (5) | 1 | |
| ↓ naïve CD4+ T cells over time (5) | 1 | |
| ↓ memory CD4+ T cells over time (4) | 1 | |
| ↓ memory CD8+ T cells over time (4) | 1 | |
| Normal Tregs with circannual cycle (6) | 1 | |
| Vβ repertoire normal (6) | – | |
| Normal immune responses in vitro (6) | – | |
| ↑ sustained erythropoietin level for 3 months (1) | 1 | |
| ↑ cytokine response from 3 months (1) | 1 | |
| IL-17 differences (6) | 1 |
CTCAE common terminology criteria for adverse events, version 4.03