RESPOND Study Design and Methodology:
*Suboptimal response=perceived suboptimal efficacy, intolerance,
or poor adherence to Copaxone, as determined by the
Adapted with permission from Elsevier Inc.
†Estimated PPR is based on Kaplan-Meier curve (8% of TECFIDERA patients relapsed in the 12 months after TECFIDERA initiation compared with 41% who relapsed in the 12 months before TECFIDERA initiation).
‡Observed PPR. Over 12 months of treatment with TECFIDERA, 7% (22/318) of patients relapsed.
Mean changes in PRO scores from baseline to month 12
Mean (SD) Change in Score:
*Suboptimal response=perceived suboptimal efficacy, intolerance, or poor adherence to Copaxone, as determined by the prescribing physician. †Assessment was performed only for those patients working. ‡A PRO score was considered stable if it had little or no change in either direction. SF-36=36-item Short Form Health Survey. Higher score indicates improved functioning (range 0–100); MFIS-5=5-item Modified Fatigue Impact Scale. Lower score indicates improved functioning (range 0–20); TSQM-14=14-item Treatment Satisfaction Questionnaire for Medication. Higher score indicates satisfaction (range 0–100); WPAI-MS=Work Productivity and Activity Impairment Questionnaire: Multiple Sclerosis. Higher score indicates higher impairment and lower productivity; BDI-7=7-item Beck Depression Inventory. Lower score indicates less severe depressive symptoms (range 0–21); PR-EDSS=Patient-Reported Expanded Disability Status Scale. Mean change in PROs from baseline to 12 months was assessed using a Wilcoxon signed-rank test.