Post-thymectomy combined treatment of prednisone and tacrolimus versus prednisone alone for consolidation of complete stable remission in patients with myasthenia gravis: a non-randomized, non-controlled study.
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.


OBJECTIVE
A single-centre, non-randomized, non-controlled study was conducted to compare rates of complete stable remission (CSR) to post-thymectomy early treatment with prednisone alone or prednisone combined with tacrolimus, in 80 patients with MG.


METHODS
Thirty-nine consecutive patients underwent elective transsternal extended thymectomy in 1997-1999 and received prednisone alone (1.5 mg/kg/day) postoperatively, whereas 41 patients operated on in 2000-2002 received prednisone combined with tacrolimus (0.1 mg/kg per day b.i.d. starting 24 hours after thymectomy).


RESULTS
The mean follow-up was 59 months (SD 32.9) in the prednisone group and 35.9 months (SD 17.1) in the tacrolimus group (p = 0.003). CSR was achieved in 47.5% of patients in the tacrolimus group and in 41.0% in the prednisone group (p = 0.60). The estimated median follow-up to obtain a CSR in non-thymomatous MG was 38.2 months (95% confidence interval [CI] 30.1-46.4 months) for the tacrolimus group and 64.6 months (95% CI 50.9-78.2 months) for the prednisone group, and in patients with hyperplasia, 32.2 months (95% CI 23-41.5 months) and 62.9 months (95% CI 45.7-80.1 months), respectively (log-rank test, p = 0.03). The behavior of the two study groups stratified by thymic histology were significantly different (log-rank test, p = 0.006).


CONCLUSIONS
Post-thymectomy administration of tacrolimus combined with prednisone was more effective than prednisone alone for the consolidation of CSR in a substantially shorter period of time in patients with MG.
Ponseti
José M
JM
Unit of Myasthenia Gravis, Department of Surgery, Hospital General Universitari Vall d'Hebrón, Autonomous University of Barcelona, Barcelona, Spain. jmponseti@vhebron.net
Gamez
Josep
J
Azem
Jamal
J
Fort
José M
JM
López-Cano
Manuel
M
Vilallonga
Ramón
R
Buera
Martín
M
Armengol
Manuel
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D053580:Muscle Strength / Q000187:drug effects / Q000502:physiology; D009157:Myasthenia Gravis / Q000188:drug therapy* / Q000601:surgery*; D011241:Prednisone / Q000627:therapeutic use*; D012074:Remission Induction; D016559:Tacrolimus / Q000627:therapeutic use*; D013934:Thymectomy; D013997:Time Factors
D000893:Anti-Inflammatory Agents; D007166:Immunosuppressive Agents; D011241:Prednisone; D016559:Tacrolimus