Etude : Amélioration de patients MG après une thymectomie

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Etude : Amélioration de patients MG après une thymectomie

Message par Pboulanger » 14 août 2016 14:56

:hi:

Lu sur http://www.raredr.com/news/thymectomy-clinical-trial
Traduction disponible directement en cliquant en bas à droite de ce message sur notre forum

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Patients with Myasthenia Gravis Improve Following Thymectomy
RDR Staff
Published Online: Thursday, Aug 11, 2016


New data by the National Institute of Neurological Disorders and Stroke (NINDS) indicates that Thymectomies in myasthenia gravis patients can improve patients’ need for immunosupressants.

The study was published in the New England Journal Of Medicine and was a multicenter, international, rater-blinded, randomized trial involving 126 participants. Some of the inclusion criteria included: patients with myasthenia gravis of less than 5 years; aged 18 to 65 years old; serum acetylcholine-receptor–antibody level of more than 1.00 nmol per liter, and; a Myasthenia Gravis Foundation of America clinical classification of II to IV (class I indicates weakness only in ocular muscles, class II mild generalized disease, class III moderate generalized disease, class IV severe generalized disease, and class V a crisis requiring intubation).

Patients were randomized to undergo thymectomy along with receiving the standardized prednisone protocol or to receive the same prednisone protocol alone. Patients who were not already receiving prednisone at baseline received an alternate-day dose of oral prednisone starting at 10 mg, and increased in 10-mg steps to 100 mg on alternate days. Patients who were who were already receiving prednisone, the dose was able to be increased up to 120 mg in those who did not reach minimal-manifestation status by the 4th month.

Efficacy Results

Patients who underwent the thymectomy had a lower time-weighted average Quantitative Myasthenia Gravis score over a 3-year period than those who received prednisone alone (thymectomy - 6.15/ predinisone-only 8.99, P < .001).

Patients in the group who received the thymectomy also had a lower average requirement for alternate-day dosing of prednisone (44 mg) vs those who didn’t (60 mg) p<0.001. In the group of patients who received the thymectomy, fewer patients than in the prednisone-only group required immunosuppression with azathioprine. (thymectomy -17% / prednisone only - 48%) P < .001.

Finally, patients receiving the thymectomy had reduced overall muscle weakness compared to those in the prednisone treatment alone.

Safety Results

Surgery reduced the occurrence of adverse events from 93 for patients taking prednisone alone to 48 for ones who the thymectomy and prednisone, primarily reflected in a reduction in hospitalizations.

The authors of the study concluded “this randomized, medication-controlled, rater-blinded trial showed a benefit of thymectomy in patients with myasthenia gravis over a period of 3 years with respect to clinical outcomes, requirements for prednisone and azathioprine therapy, the number of symptoms and the distress level related to immunosuppressive agents, and the need for hospitalization to manage disease exacerbations.”


Amicalement,
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