The researchers also looked at predictors of 6-month confirmed disability progression or relapses during the first year. “The idea is that year 1 might tell you what happens next,” Dr. Repovic said. The number of confirmed relapses (OR, 2.788) and MRI lesion activity (OR, 1.638), were predictive.
“So breakthrough disease in year 1 predicts more disease down the road.”
In the TRANSFORMS trial, previous treatment for MS (OR, 1.613) and EDSS score at baseline (OR, 1.228) predicted who would do worse. The number of confirmed relapses in the first year of the study was the only predictor (OR, 1.774). There was a trend for MRI lesion activity that approached statistical significance.
The confirmed number of relapses in the first year was the common predictor among all the phase 3 studies. “So with people who relapse, we really need to watch out for them,” Dr. Repovic said.