Single center prospective study of tacrolimus efficacy and safety in the treatment of various manifestations in systemic lupus erythematosus

Suzuki, Katsuya; Kameda, Hideto; Amano, Koichi; Nagasawa, Hayato; Takei, Hiroyuki; Nishi, Eiko; Okuyama, Atsushi; Tsuzaka, Kensei; Takeuchi, Tsutomu

doi:10.1007/s00296-010-1366-9

Cited by 29 publications

(22 citation statements)

References 36 publications

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“…Two studies assessed the efficacy and/or safety of TAC in the treatment of nonrenal manifestations of SLE; both were cohort studies () that included 31 patients. In the open‐label prospective 24‐week study by Suzuki et al (), 21 patients with mild active SLE treated with oral TAC (1–6 mg/day) were studied. The mean SLEDAI score decreased significantly at 24 weeks ( P < 0.01).…”

Section: Resultsmentioning

confidence: 99%

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Efficacy and Safety of Nonbiologic Immunosuppressants in the Treatment of Nonrenal Systemic Lupus Erythematosus: A Systematic Review

Pego-Reigosa

Cobo‐Ibáñez

Calvo‐Alén

et al. 2013

Arthritis Care & Research

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Objective. To analyze the efficacy and safety of nonbiologic immunosuppressants in the treatment of nonrenal systemic lupus erythematosus (SLE).Methods. We conducted a sensitive literature search in Medline, Embase, and the Cochrane Central Register of Controlled Trials up to October 2011. The selection criteria were studies including adult patients with SLE, a treatment intervention with nonbiologic immunosuppressants, a placebo or active comparator group, and outcome measures assessing efficacy and/or safety. Meta-analyses, systematic reviews, clinical trials, and cohort studies were included. The quality of each study was evaluated using Jadad's scale and the Oxford Levels of Evidence. Results. In total, 158 of the 2,827 initially found articles were selected for detailed review; 65 studies fulfilled the predetermined criteria. Overall, the studies were low quality, with only 11 randomized controlled trials (RCTs). Cyclophosphamide demonstrated efficacy for neuropsychiatric SLE, preventing relapses with an additional steroidsparing effect, although its use was associated with cumulative damage, development of cervical intraepithelial neoplasia, and ovarian failure. Other immunosuppressants (azathioprine, methotrexate, leflunomide, mycophenolate mofetil, and cyclosporin A) demonstrated efficacy in reducing nonrenal activity and flares with a steroid-sparing effect, although only on occasion in non-placebo-controlled RCTs of small numbers of patients. Conclusion. Several immunosuppressants demonstrated their safety and efficacy in nonrenal SLE. A specific drug for each particular manifestation cannot be recommended, although cyclophosphamide may be used in more severe cases, and methotrexate may be the first option in most cases of moderately active SLE. High-quality RCTs of larger numbers of patients are needed.

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Section: Resultsmentioning

confidence: 99%

“…There is very little evidence for the use of calcineurin inhibitors because CSA was assessed in 2 small unblinded, non–placebo‐controlled RCTs () and TAC was assessed in 2 small low‐quality non‐RCTs (). The withdrawal rate was high for both drugs; therefore, concern about their side effects is a barrier to generalizing their use.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Nonbiologic Immunosuppressants in the Treatment of Nonrenal Systemic Lupus Erythematosus: A Systematic Review

Pego-Reigosa

Cobo‐Ibáñez

Calvo‐Alén

et al. 2013

Arthritis Care & Research

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“…Missing clinical data (from 3 patients at 24 months and 5 patients at 36 months of treatment) were substituted using the last observation carried forward method [27]. Sustained long-term favorable changes in each clinical parameter were observed at 24 and 36 months and at the last on-treatment observation point, and the serum creatinine levels remained unchanged.…”

Section: Resultsmentioning

confidence: 99%

Long-Term Tacrolimus-Based Immunosuppressive Treatment for Young Patients with Lupus Nephritis: A Prospective Study in Daily Clinical Practice

et al. 2013

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Background: The optimal long-term treatment for lupus nephritis (LN) in pubertal patients remains to be determined. Tacrolimus (Tac) inhibits T cell activation, and is therefore expected to be effective in patients with LN. However, little has been published about the long-term efficacy and safety of Tac-based immunosuppressive treatment of young patients with LN in daily clinical practice. Methods: Nineteen consecutive patients with biopsy-proven LN were recruited for an open-label, prospective, long-term Tac-based treatment regimen. Tac was administered once daily at a dose of 3 mg as induction- or reinduction-maintenance treatment. Four patients (21%) with new-onset LN received mizoribine at a dose of 150 mg once daily in addition to Tac. Treatment outcomes were defined by the European Consensus Lupus Activity Measurement (ECLAM) index, urinary protein/creatinine ratio (Up/cr), serum creatinine and serological lupus markers (complement C3, complement hemolytic activity, CH₅₀, and anti-dsDNA antibody titer). Data on these parameters were collected prospectively. The median follow-up was 42 months. Results: Baseline characteristics of the patients were as follows: mean age, 18 years; Up/cr, 0.89 ± 1.17; serum C3, 68.1 ± 23.2 mg/dl (normal, 79–152 mg/dl); serum CH₅₀, 26.4 ± 10.5 U/ml (normal, 23–46 U/ml); serum anti-dsDNA antibody titer, 69.3 ± 67.5 IU/ml (normal, <12.0 IU/ml); serum creatinine, 0.55 ± 0.18 mg/dl, and ECLAM index, 4.6 ± 1.9. Despite gradually tapering the dose of concomitantly administered prednisolone, a marked improvement compared with baseline values was observed in all outcome measures as early as 3 months after the initiation of treatment, and the favorable changes persisted throughout the treatment period in most of the patients. Sustained improvements in the outcome measures compared with the baseline values were confirmed after a mean of 42 months of treatment: ECLAM index, 1.1 ± 1.1; serum CH₅₀, 36.0 ± 12.8 U/ml, anti-dsDNA antibody titer, 22.5 ± 26.5 IU/ml (all p < 0.01); Up/cr ratio, 0.35 ± 0.58, and serum C3 level, 79.7 ± 17.6 mg/dl (both p < 0.05). Serum creatinine level remained within the normal range in all the study participants. Complete response was achieved in 12 patients (63%), and a partial response was achieved in 5 patients (26%). The remaining 2 patients showed no response. No serious adverse effects were observed. Conclusion: The data suggest that long-term, relatively low-dose Tac-based immunosuppressive treatment is beneficial and has low cytotoxicity, and therefore represents an attractive option for the treatment of young patients with LN in daily clinical practice. Further studies involving a larger number of patients are needed to confirm these results.

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“…Tacrolimus can therefore be considered both effective and safe for treating mild manifestations of LE, including skin dermatosis, in systemic LE patients. However, for severe active conditions, its efficacy is limited at current dose settings and usage [56]. …”

Section: Resultsmentioning

confidence: 99%

Clinical Application of Development of Nonantibiotic Macrolides That Correct Inflammation-Driven Immune Dysfunction in Inflammatory Skin Diseases

Rodríguez-Cerdeira

Sánchez-Blanco

Molares-Vila

2012

Mediators of Inflammation

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Background. Inflammation-driven immune dysfunction supports the development of several chronic human disorders including skin diseases. Nonantibiotic macrolides have anti-inflammatory and/or immunomodulatory activity that suggests the exploitation of these in the treatment of skin diseases characterized by inflammatory disorders. Materials and Methods. We performed an extensive review of the nonantibiotic macrolide literature published between 2005 and 2012, including cross-references of any retrieved articles. We also included some data from our own experience. Results. Calcineurin antagonists such as tacrolimus and ascomycins (e.g., pimecrolimus) act by inhibiting the activation of the nuclear factor for activated T cells (NFAT). There are new applications for these macrolides that have been available for several years and have been applied to skin and hair disorders such as atopic dermatitis, oral lichen planus, vitiligo, chronic autoimmune urticaria, rosacea, alopecia areata, pyoderma gangrenosum, Behcet's disease, neutrophilic dermatosis, and lupus erythematosus. We also reviewed new macrolides, like rapamycin, everolimus, and temsirolimus. In addition to the literature review, we report a novel class of nonantibiotic 14-member macrocycle with anti-inflammatory and immunomodulatory effects. Conclusions. This paper summarizes the most important clinical studies and case reports dealing with the potential benefits of nonantibiotic macrolides which have opened new avenues in the development of anti-inflammatory strategies in the treatment of cutaneous disorders.

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Single center prospective study of tacrolimus efficacy and safety in the treatment of various manifestations in systemic lupus erythematosus

Cited by 29 publications

References 36 publications

Efficacy and Safety of Nonbiologic Immunosuppressants in the Treatment of Nonrenal Systemic Lupus Erythematosus: A Systematic Review

Efficacy and Safety of Nonbiologic Immunosuppressants in the Treatment of Nonrenal Systemic Lupus Erythematosus: A Systematic Review

Long-Term Tacrolimus-Based Immunosuppressive Treatment for Young Patients with Lupus Nephritis: A Prospective Study in Daily Clinical Practice

Clinical Application of Development of Nonantibiotic Macrolides That Correct Inflammation-Driven Immune Dysfunction in Inflammatory Skin Diseases

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