Background: Systemic Lupus Erythematosus (SLE) is a highly complex chronic autoimmune disease that affects multiple organs. SLE patients are more susceptible to infection, due to their immune dysregulation as well as the use of immunosuppressants and glucocorticoids. One of the most common infections affecting SLE patients is tuberculosis (TB), especially in patients who live in TB-endemic areas. The role of isoniazid prophylaxis for prevention of TB in SLE patients is still controversial [1, 2]. Currently there is no consensus yet on prophylaxis of TB in SLE patients.

Objectives: This study aimed to determine the safety of Isoniazid (INH) administration in the prevention of TB in SLE patients against liver toxicity and disease recurrence.

Methods: This was a clinical trial, involving SLE patients in the rheumatology outpatient clinic, at Dr. Hasan Sadikin General Hospital, Bandung, Indonesia. We included SLE female patients 18 years or above, having mild disease activity, and normal liver function, free of TB, Hepatitis, malignancy or pregnancy. These patients were randomly allocated into two groups of those receiving INH and pyridoxine for 9 months, and those acquiring placebo, beside their regular medicines. Signs and symptoms of drug-induced hepatotoxicity and SLE disease activity were assessed in first 2 weeks then monthly for the first three months, and then every three months for up to one year. Safe was defined as no increasing in the levels of liver function test or SLEDAI score. The descriptive statistical analysis was used to compare both groups.

Results: We randomly enrolled 64 female SLE patients. There was no different in age between INH group (n34) and non-INH group (n30) (36.0 ±8.4 vs 35.3 ±9.5 years old, p = 0.709) and disease duration (5.6 ±4.3 vs 6.0 ±4.0 years, p = 0.637). None of both groups had increased in liver function (ALT/AST) during the study, SLEDAI scores remained consistently at mild levels in INH groups from baseline to 12 ^th month follow-up and no related flare. One patient, from non-INH group died due heart failure. Four patients from INH group developed nausea and vomiting after taking the INH prophylaxis.

Conclusion: The administration of isoniazid as a TB prevention in SLE was safe against liver toxicity and disease recurrence. Further studies with larger sample size are needed to evaluate the efficacy of isoniazid in preventing TB.

REFERENCES: [1] Mok MY, Lo Y, Chan TM, Wong WS, Lau CS. Tuberculosis in systemic lupus erythematosus in an endemic area and the role of isoniazid prophylaxis during corticosteroid therapy. J Rheumatol. 2005 Apr;32(4):609-15.

[2] Gaitonde S, Pathan E, Sule A, Mittal G, Joshi VR. Efficacy of isoniazid prophylaxis in patients with systemic lupus erythematosus receiving long term steroid treatment. Ann Rheum Dis. 2002 Mar;61(3):251-3.

Acknowledgements: Internal Research Funding from Universitas Padjadjaran.

Disclosure of Interests: None declared.

© The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.