Evaluation of drug-induced lymphocyte stimulation test in mesalazine-associated allergic drug reaction.

BACKGROUND

5-Aminosalicylic acid (5-ASA) is a fundamental drug for UC management; however, adverse reactions can lead to poor clinical outcomes and increased health care costs. No objective tests currently exist to predict adverse reactions. This study thus investigated 5-ASA across 4 formulations and addressed a key issue in the treatment of mild to moderate ulcerative colitis (UC).

OBJECTIVE

We aimed to examine the utility of the drug-induced lymphocyte stimulation test (DLST) in predicting successful rotation from mesalazine to sulfasalazine (SASP) in patients with UC.

METHODS

We retrospectively analyzed the largest cohort to date of patients with UC who were suspected of 5-ASA-associated adverse reactions and underwent DLST. We evaluated the DLST positivity rate for the suspected formulation, cross-reactivity to nonsuspected formulations, and clinical outcomes after rotation from mesalazine to SASP.

RESULTS

Mesalazine formulations exhibited a DLST positivity rate of 22.0% (18/82), with 45.1% (37/82) of patients testing positive for at least one 5-ASA formulation. Cross-reactivity between mesalazine and SASP was lower at 12.2% (10/82), likely because of structural differences. Adverse reactions typically developed within 2 weeks of initiating 5-ASA and commonly included fever, diarrhea, and bloody stool. Among patients with mesalazine-associated adverse reactions with DLST-negative test result for SASP, 8 of 12 tolerated the rotation. Rotation failure was mainly associated with a positive or borderline DLST result for mesalazine.

CONCLUSIONS

DLST serves as a useful diagnostic tool for guiding treatment in patients with UC and suspected 5-ASA-associated hypersensitivity reactions. Prospective multicenter studies are needed to validate its clinical utility.