Intest Res.  2018 Apr;16(2):273-281. 10.5217/ir.2018.16.2.273.

Evaluation of the drug-induced lymphocyte stimulation test for diagnosing mesalazine allergy

• Saito D
• Hayashida
• Sato T
• Minowa S
• Ikezaki O
• Mitsui T
• Miura M
• Sakuraba A
• Hisamatsu

• KMID: 2417679
• DOI: http://doi.org/10.5217/ir.2018.16.2.273

Abstract

BACKGROUND/AIMS
Mesalazine is an effective drug for treating ulcerative colitis (UC), but causes allergic symptoms in a few cases. Therefore, the objective of this study was to evaluate the usefulness of the drug-induced lymphocyte stimulation test (DLST) for the diagnosis of mesalazine allergy.
METHODS
Patients with UC treated with mesalazine with or without a history of associated adverse events (AEs) were enrolled at Kyorin University Hospital from July 2016 to April 2017.
RESULTS
The DLST was performed in 104 patients with UC, of which 24 had a history of AEs due to mesalazine treatment. The control value of DLST was 337.4±296.3 counts per minute (cpm) in the AE+ group and 408.0±371.9 cpm in the AE− group. The measured value of DLST was 578.8±424.7 cpm in the AE+ group and 476.5±471.8 cpm in the AE− group. The stimulation index (SI) was 243.9%±291.1% in the AE+ group and 119.8%±53.0% in the AE− group. The SI value and DLST positivity were significantly higher in the AE+ group than in the AE− group (P=0.030 and P=0.029, respectively). The test sensitivity and specificity were 0.240 and 0.805, respectively, and the false-positive and false-negative rate was 0.195 and 0.760, respectively.
CONCLUSIONS
The DLST for mesalazine showed low sensitivity and high specificity, suggesting that it may be useful for the definitive diagnosis of allergy to mesalazine.

Keyword

Mesalamine; Drug-induced lymphocyte stimulation test; Colitis, ulcerative

MeSH Terms

Colitis, Ulcerative
Diagnosis
Humans
Hypersensitivity*
Lymphocyte Activation*
Lymphocytes*
Mesalamine*
Sensitivity and Specificity
Mesalamine

Figure

• 

  Fig. 1 Flow chart of the study protocol. Drug-induced lymphocyte stimulation test (DLST) was performed in 105 patients receiving mesalazine without side effects or having previously received mesalazine with adverse events (AEs). Patients receiving corticosteroids, patients with a history of total colectomy, and patients who could not provide informed consent were excluded (n=1). Where there was a history of AE associated with 2 types of mesalazine preparation in the same patient, DLST was evaluated for the first preparation to cause AE and overlapping was excluded (10 Pentasa® and 13 Asacol®). DLST positivity was 6 out of 24 cases in AE+ (with AEs) and 6 out of 80 cases in AE− (without AEs) patients. aAEs were defined as symptoms that appeared within 30 days of the first administration of mesalazine and disappeared after discontinuation of mesalazine.

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