Background/Purpose: Tumor necrosis factor α (TNF-α) inhibitor therapy has been widely used worldwide as a potent immunosuppressant for a variety of rheumatological diseases. Induction of antinuclear antibodies (ANA) and systemic lupus erythematosus (SLE) in patients receiving anti-TNF-α therapy have been previously documented¹. It is known that up to 15% of healthy individuals have a positive ANA test². In this study we examined the frequency and safety outcomes of ANA and SLE induction following initiation of anti-TNF-α therapy.

Methods: Patients, age >18 years, from January 2012 – December 2020 who were newly prescribed the following TNF-α inhibitor were included in this study: golimumab, cetrolizumab, adalimumab, etanercept, infliximab and inflectra. They were categorized into two groups based on immune fluorescence ANA assay performed either before or after anti-TNF-α therapy was started. The ANA tested cohort was sub-categorized to ANA-positive and ANA-negative result. ANA positive patients were sub-categorized for ANA ‘positivity before’ or ‘positivity after’ TNF-α inhibitor start date. Fisher’s exact two tailed test and two tailed chi-square was calculated on the GraphPad Prism 9.0 statistical software; two-tailed p values < 0.05 were considered significant.

Results: 2803 patients met inclusion criteria. 1120 were and 1683 were not tested for ANA. Of 1120, 742 had a positive test and 378 had a negative test result. From 742, 508 and 234 had a positive ANA test before and after the initiation of a TNF-α inhibitor, respectively. Percentage developing a positive ANA test following anti-TNF-α was 20.8% (234/1120). 83 patients had SLE before and 32 developed clinician diagnosed SLE after TNF-α inhibitor. There was a statistically significant difference on the impact on ANA induction and development of SLE (Table 1).

32 patients met ACR or SLICC criteria for SLE (Table 2). Arthritis and synovitis had to be present before TNF-α inhibitor was started in these 32 patients. TNF-α was discontinued in 22 and continued in 10 (Table 3). No life-threatening SLE complications, hospitalizations, or death were noted in patients with TNF-α inhibitor-induced SLE.

Conclusion: The data from our cohort newly prescribed anti-TNF-α therapy demonstrate the autoimmunity which should be carefully monitored for adverse events attributable to the development of SLE. Timely discontinuation, less than a week from identification of TNF-α induced SLE, appears to have prevented serious SLE-related adverse events. Additionally, we show that compared to healthy persons that the prevalence of a positive ANA test is higher in TNF-α treated patients, 15% vs. 20.8%.

References:
1. Williams VL, Cohen PR. TNF alpha antagonist-induced lupus-like syndrome: report and review of the literature with implications for treatment with alternative TNF alpha antagonists. Int J Dermatol 2011; 50:619.

2. Bhana,S.(2019). Antinuclear Antibodies (ANA). ACR. Retrieved from https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Antinuclear-Antibodies-ANA

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/development-of-antinuclear-antibodies-and-systemic-lupus-erythematosus-in-patients-on-tumor-necrosis-factor-%ce%b1-inhibitor-therapy/