HLA-B*15:11 status and carbamazepine-induced severe cutaneous adverse drug reactions in HLA-B*15:02 negative Chinese.

BACKGROUND

HLA-B15:11 is associated with carbamazepine (CBZ)-induced severe cutaneous adverse drug reactions (SCARs) in Japanese and some Asian populations, but such data remains relatively limited in Chinese. Routine HLA-B15:02 screening is mandatory before CBZ commencement, however, SCARs related to CBZ were still observed in non-HLA*B-15:02 carriers.

OBJECTIVE

We aimed to find out the prevalence of HLA-B*15:11 in Chinese patients and its associations with CBZ-induced SCARs.

METHOD

We screened 8,328 blood samples collected for HLA allele typing before CBZ commencement during the period of January 2014 to December 2019. In HLA-B15:02 negative Chinese patients, HLA-B15:11 status were further screened, and the incidence of SCARs in the CBZ group was compared with the control group without CBZ use.

RESULT

In this cohort, 1416 out of 8328 patients (17%) tested HLA-B15:02 positive and were advised to avoid CBZ, while 80 (0.96%) were found to be HLA-B15:11 positive. In 6911 (83%) patients who tested HLA-B15:02 negative, 70 (1.01%) were HLA-B15:11 positive. Five out of 70 (7.14%) patients had SCARs. The incidence of SCARs in HLA-B15:11 carriers who received CBZ was significantly higher than those without CBZ (17.4% [4/23] vs. 2.13% [1/47], P = 0.037). The odds ratio was 9.68 (95% CI 1.02-92.4, P = 0.048*). These included: one Stevens-Johnson syndrome (SJS), two DRESS, and one MPE after CBZ use, while one developed MPE after phenytoin use in control.

CONCLUSION

HLA-B15:11 is a potential risk factor of CBZ-induced SCARs in HLA-B15:02 negative Chinese patients. Further screening of HLA-B15:11 status in those HLA-B15:02 negative patients is recommended to avoid undesirable SCARs.