Minimal manifestation status and prednisone withdrawal in the MGTX trial
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Abstract
Objective To examine whether sustained minimal manifestation status (MMS) with complete withdrawal of prednisone is better achieved in thymectomized patients with myasthenia gravis (MG).
Methods This 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.
Results Patients 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.
Conclusions Thymectomy benefits patients with MG by increasing the likelihood of achieving sustained MMS with complete withdrawal of prednisone.
Clinicaltrials.gov identifier NCT00294658.
Classification of evidence This 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.
Glossary
- BMI=
- body mass index;
- IVIg=
- IV immunoglobulin;
- MG=
- myasthenia gravis;
- MG-ADL=
- Myasthenia Gravis Activities of Daily Living;
- MGFA=
- Myasthenia Gravis Foundation of America;
- MGTX=
- Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy;
- MMS=
- minimal manifestation status;
- PLEX=
- plasmapheresis;
- QMG=
- Quantitative Myasthenia Gravis;
- SAE=
- serious adverse event;
- TAC=
- treatment-associated complications;
- TAS=
- treatment-associated symptoms
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Coinvestigators are listed at links.lww.com/WNL/B137.
Class of Evidence: NPub.org/coe
- Received June 14, 2019.
- Accepted in final form February 12, 2020.
- © 2020 American Academy of Neurology
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