Multiple sclerosisTuesday, June 23, 2009, 11:30 - 13:00Change in patient-reported disability, functional status and disease-specific quality of life in multiple sclerosis patients receiving natalizumab in the USAJ. Stephenson, K. Rajagopalan, S. Agarwal, S. Kamat (Wilmington, Boston, US)
Objective: To assess the overall change in patient-reported disability, functional status and disease-specific QoL in multiple sclerosis (MS) patients receiving natalizumab in the USA.
Methods: In the USA, natalizumab is available only through the TOUCH Prescribing Program, a restricted distribution program focused on safety and developed in conjunction with the USA Food and Drug Administration. One must be enrolled in TOUCH to either prescribe or receive natalizumab. A subset of MS patients newly enrolled in the TOUCH program are participating in a longitudinal study of their experiences with natalizumab and complete assessments prior to treatment initiation and after the 3rd, 6th and 12th infusions. At each assessment, patients report their disability using the disease steps (DS) scale, functional status (FS) and disease-specific QoL using the Multiple Sclerosis Impact Scale (MSIS-29). The DS scale is a patient-reported measure that has been validated against the Expanded Disability Status Scale (EDSS) with lower scores indicating greater ambulation. Functional status is assessed with a single question with lower scores indicating a greater ability to carry out the functions of daily living. There are two MSIS-29 summary subscale scores, physical and psychological, with lower scores on each indicating better QoL. This analysis reports changes in all three measures between baseline and after the 3rd natalizumab infusion. Paired t-tests were used to compare differences in scores.
Results: Results of this ongoing study are presented for 504 patients completing the baseline (BL) and 3rd infusion assessments. The mean age is 46.1 (SD=10.7) and the majority of patients are female (78%). The mean number of years since MS diagnosis is 10.0 (SD=8.3). Patient-reported DS improved significantly from baseline (BL 2.9 versus 2.7; p<0.001) as did FS (BL 2.6 versus 2.3; p<0.001). For the MSIS-29 subscales, there were significant improvements from baseline for the physical (BL 48.6 versus 40.3; p<0.001) and psychological (BL 43.6 versus 34.6; p<0.001) scores.
Conclusions: Rather than just maintaining their baseline disease status and disease-specific QoL, patients entering into treatment with natalizumab reported significant, broad-based improvements in ambulation, functional status and MS-related QoL as early as after three natalizumab infusions.
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