Ponseti JM, Azem J, Fort JM, Lopez-Cano M, Vilallonga R, Gamez
J, Armengol M.Experience with starting Tacrolimus
postoperatively after transsternal extended thymectomy in
patients with myasthenia gravis.
Curr Med Res Opin. 2006 May;22(5):885-95
Unit of Myasthenia Gravis, Department of Surgery, Hospital
General Universitari Vall d'Hebrón, Autonomous University of
Barcelona, Spain.
jmponseti@vhebron.net
BACKGROUND: Thymectomy is a standard treatment of myasthenia
gravis (MG). Immunomodulating agents are frequently given during
the post-thymectomy latency period until complete remission is
fully consolidated, but serious side effects is a relevant
clinical problem for patients on long-term immunomodulating
treatment. OBJECTIVE: To assess the effectiveness of starting
tacrolimus in the immediate postoperative period in MG patients
undergoing transsternal extended thymectomy, with complete
stable remission (CSR) as the primary outcome of the study.
METHODS: Forty-eight MG patients received tacrolimus, 0.1 mg/kg
per day b.i.d. (started 24 h after thymectomy) and prednisone
1.5 mg/kg/day. Histologically, 34 patients had hyperplasia, 20
thymic involution, and 14 thymoma. Of the 48 patients, 40
completed 1 year of tacrolimus therapy, 38 completed 2 years, 27
completed 3 years, 21 completed 4 years, and 9 more than 5
years. Mean dose of tacrolimus was 4.9 mg/day (range 2-8 mg/day)
with a mean plasma drug concentration of 7.6 ng/mL (range 7-9
ng/mL). Prednisone could be withdrawn after the first year in
93.7% of patients and at 2 years in 100%. RESULTS: The mean
follow-up was 24.4 months, SD 17.3 (range 6-60 months).
Improvement of muscular strength and decrease of anti-AChR
antibodies were statistically significant (p < 0.001) shortly
after operation. CSR was obtained in 33.4% of patients,
pharmacological remission in 62.6%; 4% of patients had minimal
symptoms. None of the patients with thymoma achieved CSR. The
estimated median follow-up to obtain a CSR was 37.9 months (95%
confidence interval [CI] 26.4-49.5 months). The overall crude
CSR rate was 33.4%, with 47% for non-thymoma patients. The
probability to achieve CSR at 3 years was 67% for the
non-thymomatous group. CONCLUSIONS: Long-term immune-directed
treatment with tacrolimus to improve the effectiveness of
thymectomy in MG is feasible and was associated with a high rate
of CSR in patients without thymoma.
PMID: 16709310
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