BRIL, Vera, Andrzej SZCZUDLIK, Antanas VAITKUS, Csilla ROZSA, Anna KOSTERA-PRUSZCZYK, Petr HON, Josef BEDNAŘÍK, Michaela TYBLOVA, Wolfgang KOEHLER, Toomas TOOMSOO, Richard J NOWAK, Tahseen MOZAFFAR, Miriam L FREIMER, Michael W NICOLLE, Tim MAGNUS, Michael T PULLEY, Michael RIVNER, Mazen M DIMACHKIE, B Jane DISTAD, Robert M PASCUZZI, Donna BABIAR, Jiang LIN, Querolt Coll MONTSE, Rhonda GRIFFIN and Elsa MONDOU. Randomized Double-Blind Placebo-Controlled Trial of the Corticosteroid-Sparing Effects of Immunoglobulin in Myasthenia Gravis. Neurology. Philadelphia: LIPPINCOTT WILLIAMS & WILKINS, 2023, vol. 100, No 7, p. "E671"-"E682", 12 pp. ISSN 0028-3878. Available from: https://dx.doi.org/10.1212/WNL.0000000000201501. |
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@article{2292837, author = {Bril, Vera and Szczudlik, Andrzej and Vaitkus, Antanas and Rozsa, Csilla and KosteraandPruszczyk, Anna and Hon, Petr and Bednařík, Josef and Tyblova, Michaela and Koehler, Wolfgang and Toomsoo, Toomas and Nowak, Richard J and Mozaffar, Tahseen and Freimer, Miriam L and Nicolle, Michael W and Magnus, Tim and Pulley, Michael T and Rivner, Michael and Dimachkie, Mazen M and Distad, B Jane and Pascuzzi, Robert M and Babiar, Donna and Lin, Jiang and Montse, Querolt Coll and Griffin, Rhonda and Mondou, Elsa}, article_location = {Philadelphia}, article_number = {7}, doi = {http://dx.doi.org/10.1212/WNL.0000000000201501}, keywords = {Myasthenia Gravis; Immunoglobulin; Corticosteroid-Sparing Effects}, language = {eng}, issn = {0028-3878}, journal = {Neurology}, title = {Randomized Double-Blind Placebo-Controlled Trial of the Corticosteroid-Sparing Effects of Immunoglobulin in Myasthenia Gravis}, url = {https://n.neurology.org/content/100/7/e671}, volume = {100}, year = {2023} }
TY - JOUR ID - 2292837 AU - Bril, Vera - Szczudlik, Andrzej - Vaitkus, Antanas - Rozsa, Csilla - Kostera-Pruszczyk, Anna - Hon, Petr - Bednařík, Josef - Tyblova, Michaela - Koehler, Wolfgang - Toomsoo, Toomas - Nowak, Richard J - Mozaffar, Tahseen - Freimer, Miriam L - Nicolle, Michael W - Magnus, Tim - Pulley, Michael T - Rivner, Michael - Dimachkie, Mazen M - Distad, B Jane - Pascuzzi, Robert M - Babiar, Donna - Lin, Jiang - Montse, Querolt Coll - Griffin, Rhonda - Mondou, Elsa PY - 2023 TI - Randomized Double-Blind Placebo-Controlled Trial of the Corticosteroid-Sparing Effects of Immunoglobulin in Myasthenia Gravis JF - Neurology VL - 100 IS - 7 SP - "E671"-"E682" EP - "E671"-"E682" PB - LIPPINCOTT WILLIAMS & WILKINS SN - 00283878 KW - Myasthenia Gravis KW - Immunoglobulin KW - Corticosteroid-Sparing Effects UR - https://n.neurology.org/content/100/7/e671 N2 - Background and ObjectivesMyasthenia gravis (MG) is an autoimmune disease characterized by dysfunction at the neuromuscular junction. Treatment frequently includes corticosteroids (CSs) and IV immunoglobulin (IVIG). This study was conducted to determine whether immune globulin (human), 10% caprylate/chromatography purified (IGIV-C) could facilitate CS dose reduction in CS dependent patients with MG.MethodsIn this randomized double-blind placebo-controlled trial, CS-dependent patients with MG (Myasthenia Gravis Foundation of America Class II-Iva; AChR+) received a loading dose of 2 g/kg IGIV-C over 2 days (maximum 80 g/d) or placebo at week 0 (baseline). Maintenance doses (1 g/kg IGIV-C or placebo) were administered every 3 weeks through week 36. Tapering of CS was initiated at week 9 and continued through week 36 unless the patient worsened (quantitative MG score .4 points from baseline). CS doses were increased (based on the current CS dose) in patients who worsened. Patients were withdrawn if worsening failed to improve within 6 weeks or if a second CS increase was required. The primary efficacy end point (at week 39) was a .50% reduction in CS dose. Secondary and safety end points were assessed throughout the study and follow-up (weeks 42 and 45). The study results and full protocol are available at clinicaltrials.gov/ct2/show/NCT02473965. ResultsThe primary end point (.50% reduction in CS dose) showed no significant difference between the IGIV-C treatment (60.0% of patients) and placebo (63.3%). There were no significant differences for secondary end points. Safety data indicated that IGIV-C was well tolerated.DiscussionIn this study, IGIV-C was not more effective than placebo in reducing daily CS dose. These results suggest that the effects of IGIV-C and CS are not synergistic and maybe mechanistically different. ER -
BRIL, Vera, Andrzej SZCZUDLIK, Antanas VAITKUS, Csilla ROZSA, Anna KOSTERA-PRUSZCZYK, Petr HON, Josef BEDNAŘÍK, Michaela TYBLOVA, Wolfgang KOEHLER, Toomas TOOMSOO, Richard J NOWAK, Tahseen MOZAFFAR, Miriam L FREIMER, Michael W NICOLLE, Tim MAGNUS, Michael T PULLEY, Michael RIVNER, Mazen M DIMACHKIE, B Jane DISTAD, Robert M PASCUZZI, Donna BABIAR, Jiang LIN, Querolt Coll MONTSE, Rhonda GRIFFIN and Elsa MONDOU. Randomized Double-Blind Placebo-Controlled Trial of the Corticosteroid-Sparing Effects of Immunoglobulin in Myasthenia Gravis. \textit{Neurology}. Philadelphia: LIPPINCOTT WILLIAMS \&{} WILKINS, 2023, vol.~100, No~7, p.~''E671''-''E682'', 12 pp. ISSN~0028-3878. Available from: https://dx.doi.org/10.1212/WNL.0000000000201501.
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