Background/Purpose: Rheumatoid Arthritis (RA) patients have a higher risk of post-operative complications compared with the general population, especially considering the risk of infection. It remains unclear whether use of biological DMARDs, including Tocilizumab (TCZ), is an independent risk factor for post-operative complications. The aim of this study was to evaluate safety and predictive factors of complications after surgery in rheumatoid arthritis patients receiving Tocilizumab in routine care.

Methods: Patients treated with TCZ for RA included in the French REGATE registry were included if they underwent surgery. When TCZ was interrupted more than 12 weeks prior to surgery, patients were excluded. Post-operative complications were defined as an adverse event occurring in the 12 weeks after surgery. Frequency of post-surgery complications was collected and compared in patients with and without complications in order to identify factors associated with complications. A second analyze was achieved in patients with post-operative infection (local or general). Qualitative variables were compared by Fisher’s test and quantitative variables were compared by the Mann-Whitney test.

Results: Out of 1499 patients from the REGATE registry, a total of 167 patients underwent 175 surgical procedures. These patients were mainly women (84%), the mean age was 58.11 +/- 12.83 years, and the disease duration of 14.96+/- 11.29 years. The mean delay between surgery and the last TCZ infusion was 4.94+/-1.74 weeks (median 4 weeks). Fifteen patients experienced 15 complications (8.9%) with 10 severe infections, 1 intestinal obstruction, 1 RA flare, 1 delayed wound healing, 1 thromboembolic disorder and 1 hemorrhagic complication. Postoperative complications occurred after 7.8% of orthopedic surgeries (8 of 103). The 10 severe infections occurred mostly after orthopedic surgery (7/10). There was 7 surgical site infections (46.7%) and 3 general infections. In 5 patients, TCZ treatment was definitely stopped. On univariate analysis, no risk factor was significantly associated with post–operative complications. However, corticosteroids (p=0.096), previous biological treatment (p=0.096) and previous RTX treatment (p=0.074) almost reached statistically significancy.In multivariate analysis, only previous RTX treatment was close to be significant in multivariate analysis (OR: 3.27, IC95% 0.92-11.49, p=0.052). Concerning infectious complications, no risk factor was found statistically associated with post-operative complications on univariate analysis. Only diabetes mellitus (p=0.091), foot surgery (p=0.095) and number of TCZ infusions before surgery (p=0.084), were almost statistically significant. In multivariate analysis, only foot surgery (OR: 3.17, IC95% 0.82-12.21 p=0.078) and diabetes mellitus (OR: 3.73, IC95% 0.88-15.79, p=0.057) tended to be associated with infectious post-operative complications.

Conclusion:

In routine practice, the postoperative period in TCZ treated patients seem to be safe when TCZ is stopped 1 month before surgery. Diabetes was significantly associated with an increased risk of post-operative infection in RA patients treated with TCZ.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-of-surgery-in-patients-treated-with-tocilizumab-for-rheumatoid-arthritis-data-from-a-french-registry/