Lupus-like reactions in patients with inflammatory bowel disease treated with anti-TNFs are insidious adverse events: data from a large single-center cohort

Objectives: Very few data on the incidence, predictors, and clinical outcomes of lupus-like reactions (LLRs) in patients with inflammatory bowel disease (IBD) treated with anti-TNFs have been reported. Materials and methods: All records of consecutive IBD patients who started a treatment with an anti-TNF from January 2006 to June 2018 were retrospectively reviewed. Patients were defined as having LLR by the presence of immunologic abnormalities (positivity for ANA and/or anti-ds-DNA), along with clinical features that included at least two of the following: arthralgia, fatigue, fever, cutaneous manifestations, or serositis, which had a clear temporal association with exposure to the anti-TNFs, and resolved without recurrence once the drug was discontinued. Results: 760 patients (1059 total treatments with anti-TNFs) were included. Participants contributed a total of 2863.5 person-years of follow-up, during which 16 cases of LLRs (2.1% of patients) were reported, accounting for an incidence rate of 5.6 per 1000 person-years. Female gender and being former smokers were more prevalent in the LLR group (75.0% versus 44.1%, p = .02; and 18.8% versus 5.4%, p = .037, respectively), with a hazard ratio of 4.40 (95% CI: 1.40-13.81; p = .011) and 4.87 (95% CI: 1.37-17.38; p = .015), respectively, at Cox regression analysis. All LLRs resolved following discontinuation of the drug after a mean of 8.1 +/- 4.2 weeks. Ten patients required corticosteroids to control severe symptoms. Conclusions: In this large cohort of patients treated with anti-TNFs with long follow-up, LLRs were rare adverse events, more common in women and former smokers, occurring with nonspecific and insidious clinical features.