Publication:
Comparison of disease activity between tacrolimus and mycophenolate mofetil in lupus nephritis: a randomized controlled trial

1
0

Issued Date

2018

Resource Type

Article

File Type

application/pdf

ISSN

9612033

DOI

10.1177/0961203317739131

Other identifier(s)

2-s2.0-85044406119

Rights Holder(s)

มหาวิทยาลัยศรีนครินทรวิโรฒ

Bibliographic Citation

Lupus. Vol 27, No.4 (2018), p.647-656

Suggested Citation

Kamanamool N., Ingsathit A., Rattanasiri S., Ngamjanyaporn P., Kasitanont N., Chawanasuntorapoj R., Pichaiwong W., Anutrakulchai S., Sangthawan P., Ophascharoensuk V., Avihingsanon Y., Sumethkul V. Comparison of disease activity between tacrolimus and mycophenolate mofetil in lupus nephritis: a randomized controlled trial. Lupus. Vol 27, No.4 (2018), p.647-656. doi:10.1177/0961203317739131 Retrieved from: https://hdl.handle.net/20.500.14740/6074

Title

Comparison of disease activity between tacrolimus and mycophenolate mofetil in lupus nephritis: a randomized controlled trial

Author(s)

Kamanamool N.
 Ingsathit A.
 Rattanasiri S.
 Ngamjanyaporn P.
 Kasitanont N.
 Chawanasuntorapoj R.
 Pichaiwong W.
 Anutrakulchai S.
 Sangthawan P.
 Ophascharoensuk V.
 Avihingsanon Y.
 Sumethkul V.

Abstract

We conducted a prospective multicenter, opened-label, parallel, randomized, controlled trial to compare tacrolimus (TAC) and mycophenolate mofetil (MMF) for induction and maintenance therapy in lupus nephritis (LN). Adult patients with biopsy-proven LN International Society of Nephrology/Renal Pathology Society classes III–V and active nephritis were to receive prednisolone (0.7–1.0 mg/kg/day for four weeks of run-in period and tapered) and randomly assigned to receive TAC (0.1 mg/kg/day) or MMF (1.5–2 g/day) as induction therapy for six months. All patients who had remission received azathioprine (AZA) 1–2 mg/kg/day as standard treatment in the maintenance phase. The primary outcome was Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) at six and 12 months, and the secondary outcomes included renal SLEDAI, non-renal SLEDAI, modified SLEDAI-2K, immunity SLEDAI, and disease activity remission. Eighty-four patients were randomized. One patient who was randomized to the TAC group withdrew from the study immediately after randomization. Therefore, 42 patients received MMF and 41 patients received TAC. Disease activity remission rate and time to disease activity remission were similar in both groups. Twelve patients (28.57%) in the MMF group and 10 patients (24.39%) in the TAC group achieved disease activity remission. For disease activity scores, both regimens significantly improved SLEDAI-2K during induction and maintenance therapy. Overall, SLEDAI-2K score in the MMF group decreased more compared with the TAC group. In the MMF group, mean SLEDAI-2K decreased from 11.6 ± 4.8 to 6.3 ± 3.9 after induction therapy and to 5.4 ± 4.4 after maintenance therapy. In the TAC group, mean SLEDAI-2K decreased from 9.0 ± 3.7 to 6.3 ± 5.1 after induction therapy and to 7.1 ± 5.4 after maintenance therapy. Renal SLEDAI and modified SLEDAI-2K showed a similar pattern with SLEDAI-2K. In non-renal SLEDAI and immunity SLEDAI, both regimens also resulted in decreased disease activity scores during the first two months. After that the scores were slightly increased. In the MMF group, the scores were still lower than baseline but in the TAC group were not. In conclusion, disease activity remission rate was similar in the MMF and TAC groups. For disease activity score as measured by SLEDAI-2K, TAC was comparable with MMF during induction but MMF was more effective on disease activity of active LN classes III and IV at 12 months, especially in the renal system. © 2017, © The Author(s) 2017.

Subject(s)

Antinuclear antibody
 Azathioprine
 Creatinine
 Double stranded DNA antibody
 Mycophenolate mofetil
 Prednisolone
 Prednisone
 Tacrolimus
 Immunosuppressive agent
 Mycophenolic acid
 Tacrolimus
 Adult
 Article
 Clinical outcome
 Controlled study
 Creatinine blood level
 Disease activity
 Disease activity score
 Disease severity
 Drug blood level
 Drug dose reduction
 Female
 Hematuria
 Histopathology
 Human
 Human tissue
 Large intestine perforation
 Lupus erythematosus nephritis
 Maintenance therapy
 Major clinical study
 Male
 Multicenter study
 Nocardiosis
 Open study
 Plasmablastic lymphoma
 Pneumocystis pneumonia
 Priority journal
 Prospective study
 Proteinuria
 Randomized controlled trial
 Remission
 Septic shock
 SLEDAI
 Treatment outcome
 Biopsy
 Clinical trial
 Comparative study
 Immunology
 Kaplan Meier method
 Lupus erythematosus nephritis
 Middle aged
 Severity of illness index
 Thailand
 Time factor
 Young adult
 Adult
 Biopsy
 Female
 Humans
 Immunosuppressive Agents
 Kaplan-Meier Estimate
 Lupus Nephritis
 Male
 Middle Aged
 Mycophenolic Acid
 Prospective Studies
 Remission Induction
 Severity of Illness Index
 Tacrolimus
 Thailand
 Time Factors
 Treatment Outcome
 Young Adult

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URI

https://hdl.handle.net/20.500.14740/6074

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Scopus: Year 1983-2021

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