Ponseti JM, Azem J, Fort JM, Lopez-Cano M, Vilallonga R, Gamez
J, Armengol M.Experience with starting Tacrolimus (FK506)
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
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could be withdrawn after the first year in 93.7% of patients and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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