Figure 4. Change in HAM-D-17 Scores from Baseline to Week 12 in Infliximab- or Placebo-Treated TRD Patients with a Baseline CRP>5 mg/L versus ≤5mg/L.
An intent-to-treat MMRM analysis of patients with treatment resistant depression (TRD) administered the TNF-alpha antagonist infliximab or placebo was separately conducted in patients with a baseline high sensitivity c-reactive protein (hs-CRP)>5mg/L (n=22)(Panel A) and those with a baseline hs-CRP ≤5mg/L (n=48)(Panel B). In general, opposite effects of infliximab were found depending on baseline hs-CRP. Subjects with baseline hs-CRP>5 mg/L tended to do better than placebo whereas the opposite effect was seen in subjects with a baseline hs-CRP≤5mg/L. Although there was a main effect of time on change in HAM-D-17 scores in patients with a baseline hs-CRP>5mg/L, there were no effects of treatment assignment or a treatment by time interaction. In addition, no main effects of treatment assignment, time or their interaction were found in subjects with a baseline hs-CRP ≤5mg/L. Depicted is least squares (LS) Mean [standard error of the mean (SEM)] Change in HAM-D-17 from Baseline to the indicated week using an unstructured covariance matrix with time as a categorical variable.