title: TAC-TIC use of tacrolimus-based regimens in lupus nephritis.
abstract: Current guidelines do not mention tacrolimus (TAC) as a treatment option and no consensus has been reported on the role of TAC in lupus nephritis (LN). The present study aimed to guide clinical judgement on the use of TAC in patients with LN. A meta-analysis was performed for clinical studies investigating TAC regimens in LN on the basis of treatment target (induction or maintenance), concomitant immunosuppression and quality of the data. 23 clinical studies performed in patients with LN were identified: 6 case series, 9 cohort studies, 2 case-control studies and 6 randomised controlled trials (RCTs). Of the 6 RCTs, 5 RCTs investigated TAC regimens as induction treatment and 1 RCT as maintenance treatment. Five RCTs investigated TAC in combination with steroids and 2 TAC with mycophenolate plus steroids. All RCTs were performed in patients of Asian ethnicity. In a meta-analysis, TAC regimens achieved a significantly higher total response (relative risk (RR) 1.23, 95% CI 1.12 to 1.34, p<0.05) and significantly higher complete response (RR 1.48, 95% CI 1.23 to 1.77, p<0.05). The positive outcome was predominantly defined by the largest RCT investigating TAC with mycophenolate plus steroids. Regarding safety, the occurrence of leucopoenia was significantly lower, while the occurrence of increased creatine was higher. Clinical studies on TAC regimens for LN are limited to patients of Asian ethnicity and hampered by significant heterogeneity. The positive results on clinical efficacy of TAC as induction treatment in LN cannot be extrapolated beyond Asian patients with LN. Therefore, further confirmation in multiethnic, randomised trials is mandatory. Until then, TAC can be considered in selected patients with LN.
authors.affiliation: Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands; Clinic for Lupus-, Vasculitis and Complement-Mediated Systemic Diseases, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Tineke
authors.identifier: 0000-0002-0874-3365
authors.initials: T
authors.lastname: Kraaij
authors.affiliation: Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands; Clinic for Lupus-, Vasculitis and Complement-Mediated Systemic Diseases, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Obbo W
authors.initials: OW
authors.lastname: Bredewold
authors.affiliation: Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, The Netherlands; Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Stella
authors.initials: S
authors.lastname: Trompet
authors.affiliation: Clinic for Lupus-, Vasculitis and Complement-Mediated Systemic Diseases, Leiden University Medical Center, Leiden, The Netherlands; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Tom W J
authors.initials: TW
authors.lastname: Huizinga
authors.affiliation: Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands; Clinic for Lupus-, Vasculitis and Complement-Mediated Systemic Diseases, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Ton J
authors.initials: TJ
authors.lastname: Rabelink
authors.affiliation: Department of Gerontology and Geriatrics , Leiden University Medical Center , Leiden , The Netherlands.
authors.forename: Anton J M
authors.initials: AJ
authors.lastname: de Craen
authors.affiliation: Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands; Clinic for Lupus-, Vasculitis and Complement-Mediated Systemic Diseases, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Y K Onno
authors.initials: YK
authors.lastname: Teng
keywords: Autoimmune Diseases; Lupus Nephritis; Systemic Lupus Erythematosus