TY - JOUR
KW - Dapsone hypersensitivity syndrome
KW - leprosy
KW - HLA-B*13:01
KW - HLA
AU - Linuwih Menaldi S
AU - Rahayu T
AU - Gibran K
AU - Widaty S
AU - Handaru Priyanto M
AU - Friska D
AU - Andayani Adriono G
AU - Kartika E
AU - Amalia V
AU - Irawati Y
AB - <p><strong>Objectives</strong></p>

<p>To investigate the association between the HLA-B<sup>*</sup>13:01 allele and dapsone hypersensitivity syndrome (DHS) in leprosy patients undergoing dapsone therapy.</p>

<p><strong>Methods</strong></p>

<p>A systematic review and meta-analysis were conducted following PRISMA guidelines. Databases, including MEDLINE, Embase, Cochrane, Scopus, and SpringerLink, were searched up to March 2025. Eligible studies were case-control or cohort designs reporting HLA-B*13:01 frequencies in DHS cases versus dapsone tolerant controls. Data extraction, quality assessment via the Newcastle-Ottawa Scale, and statistical synthesis using RevMan 5.4 were performed.</p>

<p><strong>Results</strong></p>

<p>Three eligible case-control studies were included, comprising 130 DHS cases, 1188 dapsone-tolerant leprosy patients, and 2040 healthy controls. A strong association was found between HLA-B13:01 and DHS, with a pooled OR of 82.28 [95% CI: 23.38–289.56]. HLA-B13:01 was present in 85.5%–91.2% of DHS cases compared to 3.85%–14.3% of dapsone-tolerant controls. Diagnostic accuracy was high, with sensitivity of 85.5%–91.2%, specificity of 85.7%–96.2%, and negative predictive values &gt;97%. The AUC ranged from 0.89 to 0.95. Heterogeneity was moderate (I<sup>2</sup>&nbsp;= 62%, P = 0.07), and all studies showed low risk of bias.</p>

<p><strong>Conclusions</strong></p>

<p>HLA-B<sup>*</sup>13:01 is strongly associated with DHS in leprosy patients. Its high diagnostic accuracy supports routine screening before dapsone initiation, particularly in endemic regions, to reduce the risk of severe hypersensitivity reactions.</p>

BT - Leprosy Review
DO - 10.47276/lr.96.3.2025047
IS - 3
LA - ENG
M3 - Systematic Review
N2 - <p><strong>Objectives</strong></p>

<p>To investigate the association between the HLA-B<sup>*</sup>13:01 allele and dapsone hypersensitivity syndrome (DHS) in leprosy patients undergoing dapsone therapy.</p>

<p><strong>Methods</strong></p>

<p>A systematic review and meta-analysis were conducted following PRISMA guidelines. Databases, including MEDLINE, Embase, Cochrane, Scopus, and SpringerLink, were searched up to March 2025. Eligible studies were case-control or cohort designs reporting HLA-B*13:01 frequencies in DHS cases versus dapsone tolerant controls. Data extraction, quality assessment via the Newcastle-Ottawa Scale, and statistical synthesis using RevMan 5.4 were performed.</p>

<p><strong>Results</strong></p>

<p>Three eligible case-control studies were included, comprising 130 DHS cases, 1188 dapsone-tolerant leprosy patients, and 2040 healthy controls. A strong association was found between HLA-B13:01 and DHS, with a pooled OR of 82.28 [95% CI: 23.38–289.56]. HLA-B13:01 was present in 85.5%–91.2% of DHS cases compared to 3.85%–14.3% of dapsone-tolerant controls. Diagnostic accuracy was high, with sensitivity of 85.5%–91.2%, specificity of 85.7%–96.2%, and negative predictive values &gt;97%. The AUC ranged from 0.89 to 0.95. Heterogeneity was moderate (I<sup>2</sup>&nbsp;= 62%, P = 0.07), and all studies showed low risk of bias.</p>

<p><strong>Conclusions</strong></p>

<p>HLA-B<sup>*</sup>13:01 is strongly associated with DHS in leprosy patients. Its high diagnostic accuracy supports routine screening before dapsone initiation, particularly in endemic regions, to reduce the risk of severe hypersensitivity reactions.</p>

PB - Lepra
PY - 2025
SP - 1
EP - 14
T2 - Leprosy Review
TI - The role of the HLA-B*13:01 allele in leprosy patients with dapsone hypersensitivity syndrome (DHS): A systematic review and meta-analysis
UR - https://leprosyreview.org/article/96/3/20-25047
VL - 96
SN - 2162-8807
ER -