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Patient-reported outcomes

MabThera® treatment improves patient-reported outcomes and quality of life

Rheumatoid arthritis (RA) patients’ measures of treatment success, such as noticeable improvement in daily function or improvements in health-related quality of life (HRQOL) may be as important as improvements in clinical signs and symptoms. Quality of life may be substantially impaired in RA patients: at entry to the REFLEX trial of MabThera® + methotrexate (MTX) in TNF inhibitor inadequate responders, patients had substantially lower HRQOL than the general US population, with baseline SF-36 scores at or below the 10th percentile.1

In the REFLEX trial, MabThera® + MTX produced rapid, sustained and clinically meaningful improvements in a variety of patient-reported outcomes including fatigue (Functional Assessment of Chronic Illness Therapy [FACIT]), patient-reported pain (visual analogue score), functional disability (Health Assessment Questionnaire − Disability Index [HAQ-DI]) and disease activity (patient global assessment) (p<0.05 for all). Significant improvements in SF-36 physical and mental component HRQOL measures were also observed, with final scores on four scales (role physical, bodily pain, vitality and role emotional) approaching the median score of the general US population aged 45–54 years.

Table 1: Unadjusted mean changes (baseline to week 24) in patient-reported outcomes*

Table 1: Unadjusted mean changes (baseline to week 24) in patient-reported outcomes*

Significant improvements in patient-reported outcomes in MabThera® + MTX versus placebo + MTX-treated patients were evident after 8 weeks after 2 single infusions of MabThera® 1000mg.  Improvements in patient-reported outcomes were sustained at 24 weeks, consistent with the sustained efficacy of MabThera® against clinical signs and symptoms.

The ability of MabThera® + MTX to produce rapid, sustained and clinically meaningful improvements in HRQOL, in addition to demonstrable benefits for symptoms and functional outcomes, indicates that meaningful improvements in patients’ perceptions of their disease are an achievable goal in the treatment of RA.

Figure 1: Mean change in Functional Assessment of Chronic Illness Therapy (FACIT) over time

Figure 1: Mean change in Functional Assessment of Chronic Illness Therapy (FACIT) over time

References:

  1. Keystone et al. Arthritis Rheum 2008;59:785–793.