Patient-Reported Outcomes in Patients with Varying Clinical Disease Activity of Relapsing-Remitting Multiple Sclerosis in the DECIDE Study
Objectives: To evaluate PROs in RRMS patients grouped according to clinical disease activity based on CDP in the absence or presence of prior relapse in DECIDE.
Methods: DECIDE was a randomized, double-blind, active-controlled study of daclizumab high-yield process (DAC HYP) 150mg subcutaneous every 4 wks vs interferon (IFN) beta-1a 30mcg intramuscular (IM) once weekly in RRMS. Patients were divided into 4 groups with increasing level of clinical disease activity: no relapses or CDP, relapses without CDP, CDP without prior relapses, and CDP with prior relapses (defined as onset of 24-wk CDP [≥1.0- or ≥1.5-point increase in EDSS score from baseline EDSS score ≥1.0 or 0.0, respectively, confirmed after 24 wks] within 90 days following a relapse). Mean change from baseline in MSIS-29 physical subscale (PHYS) score at Wk 96 was evaluated post hoc. Negative changes indicate improvement. MSIS-29 PSYCH and EQ-5D were also assessed.
Results: At Wk 96, mean change in MSIS-29 PHYS for combined treatment groups was: −1.4 in patients with no relapses or CDP (n=1112); 1.3 in patients with relapses without CDP (n=528); 4.8 in patients with CDP without prior relapses (n=106); and 9.3 in patients with CDP with prior relapses (n=72). DAC HYP-treated patients generally reported numerically greater improvement or less worsening in MSIS-29 PHYS score vs IM IFN beta-1a-treated patients across disease activity subgroups, with greatest worsening in patients with CDP with prior relapses in both treatment groups. Similar patterns were observed with the other PRO measures.
Conclusions: These findings were consistent with DECIDE clinical outcomes. PRO outcomes worsened as severity of clinical disease activity increased and DAC HYP showed greater improvement/less worsening in PROs across most clinical disease activity groups vs IM IFN beta-1a. PROs provided information on functional changes beyond that shown by clinical outcomes.