Session Information
Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment: Treatment and Management Studies
Session Type: Abstract Submissions (ACR)
Background/Purpose
Although effectiveness of tacrolimus (TAC) for remission induction or maintenance treatment of patients with lupus nephritis has been reported, there are few reports about its efficacy for the flares of patients with systemic lupus erythematosus (SLE).
Methods
Medical records of 313 outpatients with SLE who fulfilled the revised ACR criteria in Okayama university hospital visited from 2006 to 2013 were assessed retrospectively. We recruited the patients treated with add-on TAC without the intensification of glucocorticoids (GC) for the minor flares (TAC group). The minor flare was defined as an increase of SLE disease activity index (SLEDAI) ranged from 3 to 11 in the patients maintained remission for over 3 months within 10 mg/day of predonisolone and/or immunosuppressants except calcineurin inhibitors. As controls, we also recruited the patients administered with the increased doses of GC for minor flares (GC group). We collected clinical and laboratory data at baseline, 1 month, 3 months, 6 months, and 12 months. We defined responders as the patients whose SLEDAI was improved to the level before the flares within 1 year. We also evaluated the development of the second flare in the responders. The second flare was defined as the reinforcement with other immunosuppressants or higher doses of GC.
Results
There were 14 eligible patients in the TAC group and 20 eligible patients in the GC group. Although SLEDAI at the flare was higher in the TAC group than the GC group (8.2 vs. 6.2, p<0.05), other baseline characteristics (sex, age, serological markers, and the dose of GC) were comparable between the two groups. The initial dose of TAC for the flare was 1.6 mg/day in the TAC group, while the dose of GC for the flare was 13.7 mg/day in the GC group. The proportion of responders was 79% in the TAC group and 75% in the GC group (p=0.92). In the responders, 2 of 11 (18%) patients in the TAC group and 4 of 16 (25%) patients in the GC group developed the second flare (p=0.68). The dose of GC was higher in the GC group than in the TAC group at 12 months (9.7 mg/day vs. 7.1 mg/day, p<0.05). Only 1 patient withdrew TAC because of fatigue after three months.
Conclusion
Adding TAC without increased dose of glucocorticoids may be an effective treatment option for minor flares of patients with SLE.
Disclosure:
H. Watanabe,
None;
R. Yamanaka,
None;
K. E. Sada,
None;
E. Katsuyama,
None;
T. Katsuyama,
None;
M. Narazaki,
None;
N. Tatebe,
None;
K. Sugiyama,
None;
K. S. Watanabe,
None;
H. Wakabayashi,
None;
T. Kawabata,
None;
J. Wada,
Astellas,
5,
Boehringer Ingelheim,
5,
Novartis Pharmaceutical Corporation,
8,
Novo Nordisk,
8,
Boehringer Ingelheim,
8;
H. Makino,
AbbVie,
5,
Astellas,
5,
Teijin,
5,
Boehringer Ingelheim,
8,
Chugai,
8,
Daiichi Sankyo,
8,
Dainippon Sumitomo,
8,
Kyowa Hakko Kirin,
8,
MSD,
8,
Novartis Pharmaceutical Corporation,
8,
Pfizer Inc,
8,
Takeda,
8,
Tanabe Mitsubish,
8,
Astellas,
2,
Boehringer Ingelheim,
2,
Daiichi Sankyo,
2,
Dainippon Sumitomo,
2,
Kyowa Hakko Kirin,
2,
Mochida,
2,
MSD,
2,
Novartis Pharmaceutical Corporation,
2,
Novo Nordisk,
2,
Pfizer Inc,
2,
Takeda,
2,
Tanabe Mitsubishi,
2,
Astellas,
8.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-effectiveness-of-tacrolimus-for-minor-flares-of-the-patients-with-systemic-lupus-erythematosus/