IngentaConnect Post-thymectomy combined treatment of prednisone and tacrolimus v...

Authors: Ponseti, José M.¹; Gamez, Josep²; Azem, Jamal¹; Fort, José M.¹; López-Cano, Manuel¹; Vilallonga, Ramón¹; Buera, Martín¹; Armengol, Manuel¹

Source: Current Medical Research and Opinion, Volume 23, Number 6, June 2007 , pp. 1269-1278(10)

Publisher: Informa Healthcare

Abstract:

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.

Keywords: CHOLINERGIC RECEPTORS; IMMUNOSUPPRESSIVE AGENTS; MYASTHENIA GRAVIS; NEUROMUSCULAR JUNCTION; PREDNISONE; REMISSION; TACROLIMUS (FK506); THYMECTOMY

Document Type: Research article

DOI: 10.1185/030079907X188080

Affiliations: 1: Unit of Myasthenia Gravis, Department of Surgery, Hospital General Universitari Vall d'Hebrón, Autonomous University of Barcelona, Barcelona, Spain 2: Service of Neurology, Hospital General Universitari Vall d'Hebrón, Barcelona, Spain

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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