Table 6.
Predictive Value for Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis Risk of HLA-C*04:01, B*53:01:01|*04:01, and DQB1*05:01:01 Carriage
| SJS/TEN | Tolerant | Total | |||
|---|---|---|---|---|---|
| HLA-C*04:01 | |||||
| Positive | 23 | 39 | 62 | PPV = 2.6% | |
| Negative | 13 | 114 | 127 | NPV = 99.2% | |
| All | 36 | 153 | |||
| Sensitivity = 63.9% | Specificity = 74.4% | OR = 5.17 (95% CI, 2.39–11.18), P < .0001 | |||
| HLA-B*53:01:01|HLA-C*04:01 | |||||
| Positive | 11 | 12 | 33 | PPV = 4.2% | |
| Negative | 25 | 141 | 176 | NPV = 91.6% | |
| All | 36 | 153 | |||
| Sensitivity = 31.4% | Specificity = 92.2% | OR = 5.17 (95% CI, 1.83–14.28), P = .0002 | |||
| HLA-DQB1*05:01:01 | |||||
| Positive | 3 | 47 | 50 | PPV = 0.3% | |
| Negative | 32 | 88 | 120 | NPV = 98.6% | |
| All | 35 | 135 | |||
| Sensitivity = 0.9% | Specificity = 65.1% | OR = 0.17 (95% CI, .05–.60), P = .0024 | |||
Positive and negative predictive values as well as sensitivity and specificity are shown. Prevalence of SJS/TEN is assumed at 1.07% based on an incidence of 12 of 1117 observed in the prospective study. Odds ratio with 95% confidence and P value are determined using a 2 × 2 χ2 test.
Abbreviations: CI, confidence interval; HLA, human leukocyte antigen; NPV, negative predictive value; OR, odds ratio; PPV, positive predictive value; SJS, Stevens-Johnson syndrome; TEN, toxic epidermal necrolysis.