The risk of tuberculosis infection in 410 Saudipatients receiving adalimumab therapy.

BACKGROUND

Adalimumab is a fully humanized monoclonal antibody inhibitor of tumor necrosis factor-a used to treat various autoimmune disorders. Adalimumab poses a risk for tuberculosis (TB) infection, especially in countries where TB is endemic.

OBJECTIVE

Determine the rate of TB infection after adalimumab therapy in Saudi Arabia.

DESIGN

Medical record review.

SETTINGS: Tertiary care center in Riyadh.

PATIENTS AND

METHODS

Demographic and clinical data were retrieved from the electronic healthcare records of all patients who received adalimumab treatment from 2015 to 2019.

MAIN OUTCOME MEASURES: Occurrence of TB after adalimumab therapy.

SAMPLE SIZE: 410 patients (median ([QR] age, 37 [28], range 4-81 years), 40% males

RESULTS

Rheumatoid arthritis was the most frequent indication (n=153, 37%). The patients were followed for a mean of 36 (8.9) months. No case of TB infection or reactivation was observed. An inter-feron-gamma release assay (IGRA) was requested in 353/391 (90.3%) patients, prior to initiating therapy. The IGRA was positive in 26 cases (6.6%). The IGRA-positive patients received isoniazid prophylactically. Bacterial infectious complications of adalimumab therapy occurred in 12 (2.9%) patients. Urinary tract infection was the most frequent complication (culture requested in 48 patients, positive in 8).

CONCLUSION

Adalimumab treatment was not associated with a risk of TB disease or TB reactivation in our cohort over the follow-up observation period. No TB reactivation occurred with adalimumab therapy when TB prophylaxis was used. The positive IGRA rate in patients on adalimumab treatment was low (7%).

LIMITATIONS: Single center and one geographical area in Saudi Arabia.

CONFLICT OF INTEREST: None.