Randomized double-blind placebo-controlled trial of the corticosteroid-sparing effects of immunoglobulin in myasthenia gravis
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00843989%3A_____%2F23%3AE0110162" target="_blank" >RIV/00843989:_____/23:E0110162 - isvavai.cz</a>
Alternative codes found
RIV/00216224:14110/23:00131012 RIV/65269705:_____/23:00077929
Result on the web
<a href="https://n.neurology.org/content/neurology/100/7/e671.full.pdf" target="_blank" >https://n.neurology.org/content/neurology/100/7/e671.full.pdf</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1212/WNL.0000000000201501" target="_blank" >10.1212/WNL.0000000000201501</a>
Alternative languages
Result language
angličtina
Original language name
Randomized double-blind placebo-controlled trial of the corticosteroid-sparing effects of immunoglobulin in myasthenia gravis
Original language description
ackground and objectives: Myasthenia 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. Methods: In 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 Patients were withdrawn if worsening failed to improve within 6 weeks or if a second CS increase was required.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. Results: The 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. Discussion: In 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 may be mechanistically different. Trial registration information: The trial was registered on clinicaltrialsregister.eu (EudraCT #: 2013-005099-17) and clinicaltrials.gov (...
Czech name
—
Czech description
—
Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
—
OECD FORD branch
30210 - Clinical neurology
Result continuities
Project
—
Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2023
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Neurology
ISSN
0028-3878
e-ISSN
1526-632X
Volume of the periodical
100
Issue of the periodical within the volume
7
Country of publishing house
US - UNITED STATES
Number of pages
1
Pages from-to
e671-e682
UT code for WoS article
000983098800016
EID of the result in the Scopus database
2-s2.0-85148113088