The OPTIC trial was terminated early when four thromboembolic events prompted unblinding of the multicenter, randomized, double-blind, placebo-controlled trial, revealing all four events occurred in the combination arm. Despite the setback, study investigators were positive about the study's results.
These findings prompted the OPTIC trial, in which all patients started on a loading dose of IVIg 2 g/kg with randomization to an additional loading dose of placebo or MP 1 g, and then further 18 weeks of MP or placebo plus a IVIg 1 g/kg every 3 weeks. However, there were statistically significant improvements in favor of the combination treatment on multiple domains of improvement, which were most significantly for the I-RODS, Medical Research Council-sumscore, and grip strength.Important Study, Important Findings
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