Background/Purpose: there is no consensus on the use of Tacrolimus (TAC) in patients with SLE; clinical studies on TAC, including all the RCT, are mostly limited to patients of Asian ethnicity and hampered by significant heterogeneity. To analyze the real-life practice on the use of TAC in SLE from 3 European referral centers.

Methods: this is a retrospective analysis of prospectively collected data. Adult patients with SLE, according to the 1997 ACR criteria, followed at 3 European referral centers were included. For each patient, demographics, organ involvement and treatment history were collected; concomitant medications, SLEDAI, laboratory features and physician’s global assessment (PGA) were collected at baseline and at 3-6-12 months after starting TAC. Renal response was defined as complete (CR) in case of 24-hour proteinuria <500 mg/dl + inactive urinary sediment + normal creatinine.

Results: 29 patients were included in this analysis (89% female, mean age 38±9 years, mean disease duration 12.9±6 years). Ethnicity was White (82%), Black (14.5%), Hispanic (3.5%). The main indication for TAC prescription was renal involvement (79%), joint (7%), skin (7%), hematological (7%), serositis (3.5%). The median daily dose of TAC was 4.5 mg (IQR 3-5.5). When renal involvement was the main indication, TAC was prescribed for a renal flare in 72% of cases, and for renal disease onset in the remaining cases. In 65.5% of patients, TAC was a second-choice treatment either for the failure of, or for the intolerance of a previous IS therapy. The median number of previous IS was 2 (IQR 1-3). Concomitant medications at TAC institution included GC (89.6 %; median daily dose 7.5 IQR 3.75-12.5), HCQ (67%), MMF (30%), AZA (11%), RTX (3%), belimumab (14%). At 3 months, according to the PGA, there was a complete resolution of symptoms in 8 pts (32%), partial resolution in 11 pts (44%) and no improvement in 6 pts (24%). This corresponds to: 1) a significant decrease in the mean SLEDAI, (p=0.0006); 2) a significant decrease in the mean 24-hour proteinuria (p=0.001); a significant increase in C3 (p=0.009) and stable creatinine values. In patients with renal involvement, a CR was documented in 6 pts (27.3%), a PR in 7 (31.8%) and no response in 7 (31.8%). At 6 months, the physician declared a complete resolution in 47%, a partial resolution in 29% and no improvement in 23%. The same trend was maintained at 12 months of follow-up. Four patients discontinued the therapy before 3 months. At the time of this analysis, TAC was discontinued in 9 pts (31%); reasons for discontinuation were inefficacy (13 %), drug intolerance (10%), disease remission (6.8 %) and infections (3.4 %), (table 1).

Conclusion: this study describes the use of TAC in a multicenter cohort of non-Asian SLE patients. Despite the limitation due to the small number of patients and the uncontrolled nature of the study, these data show that TAC can be considered a valid therapeutic option in SLE patients, especially in renal involvement.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/tacrolimus-in-non-asian-systemic-lupus-erythematosus-patients-a-real-life-experience-from-three-european-centers/