1. Minimal manifestation status and prednisone withdrawal in the MGTX trial
- Author
-
Lee, I., Kuo, H.C., Aban, I.B., Cutter, G.R., McPherson, T., Kaminski, H.J., Sussman, J., Strobel, P., Oger, J., Cea, G., Heckmann, J.M., Evoli, A., Nix, W., Ciafaloni, E., Antonini, G., Witoonpanich, R., King, J.O., Beydoun, S.R., Chalk, C.H., Barboi, A.C., Amato, A.A., Shaibani, A.I., Katirji, B., Lecky, B.R.F., Buckley, C., Vincent, A., Dias-Tosta, E., Yoshikawa, H., Waddington-Cruz, M., Pulley, M.T., Rivner, M.H., Kostera-Pruszczyk, A., Pascuzzi, R.M., Jackson, C.E., Verschuuren, J.J.G., Massey, J.M., Kissel, J.T., Werneck, L.C., Benatar, M., Barohn, R.J., Tandan, R., Mozaffar, T., Conwit, R., Minisman, G., Sonett, J.R., Wolfe, G.I., and MGTX Study Grp
- Subjects
Male ,medicine.medical_treatment ,Azathioprine ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,Prednisone ,law ,Medicine ,Single-Blind Method ,030212 general & internal medicine ,Young adult ,Middle Aged ,Thymectomy ,Combined Modality Therapy ,Substance Withdrawal Syndrome ,3. Good health ,Settore MED/26 - NEUROLOGIA ,6.1 Pharmaceuticals ,Anesthesia ,adolescent ,adult ,animals ,combined modality therapy ,female ,humans ,immunosuppressive agents ,male ,middle aged ,myasthenia gravis ,prednisone ,rats ,single-blind method ,substance withdrawal syndrome ,thymoma ,thymus neoplasms ,young adult ,thymectomy ,Cognitive Sciences ,Female ,Immunosuppressive Agents ,medicine.drug ,Adult ,Thymoma ,Adolescent ,Clinical Trials and Supportive Activities ,Clinical Sciences ,MGTX study group ,Autoimmune Disease ,Article ,Young Adult ,03 medical and health sciences ,Rare Diseases ,Clinical Research ,Myasthenia Gravis ,Post-hoc analysis ,Animals ,Humans ,Neurology & Neurosurgery ,business.industry ,Neurosciences ,Evaluation of treatments and therapeutic interventions ,Thymus Neoplasms ,medicine.disease ,Myasthenia gravis ,Rats ,Neurology (clinical) ,business ,030217 neurology & neurosurgery - Abstract
ObjectiveTo examine whether sustained minimal manifestation status (MMS) with complete withdrawal of prednisone is better achieved in thymectomized patients with myasthenia gravis (MG).MethodsThis study is a post hoc analysis of data from a randomized trial of thymectomy in MG (Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy [MGTX]). MGTX was a multicenter, randomized, rater-blinded 3-year trial that was followed by a voluntary 2-year extension for patients with acetylcholine receptor (AChR) antibody–positive MG without thymoma. Patients were randomized 1:1 to thymectomy plus prednisone vs prednisone alone. Participants were age 18–65 years at enrollment with disease duration less than 5 years. All patients received oral prednisone titrated up to 100 mg on alternate days until they achieved MMS, which prompted a standardized prednisone taper as long as MMS was maintained. The achievement rate of sustained MMS (no symptoms of MG for 6 months) with complete withdrawal of prednisone was compared between the thymectomy plus prednisone and prednisone alone groups.ResultsPatients with MG in the thymectomy plus prednisone group achieved sustained MMS with complete withdrawal of prednisone more frequently (64% vs 38%) and quickly compared to the prednisone alone group (median time 30 months vs no median time achieved, p < 0.001) over the 5-year study period. Prednisone-associated adverse symptoms were more frequent in the prednisone alone group and distress level increased with higher doses of prednisone.ConclusionsThymectomy benefits patients with MG by increasing the likelihood of achieving sustained MMS with complete withdrawal of prednisone.Clinicaltrials.gov identifierNCT00294658.Classification of evidenceThis study provides Class II evidence that for patients with generalized MG with AChR antibody, those receiving thymectomy plus prednisone are more likely to attain sustained MMS and complete prednisone withdrawal than those on prednisone alone.
- Published
- 2020