Patient-Reported Psychological Functioning in Natalizumab-Treated Patients with Multiple Sclerosis in US Clinical Practice (P4.183)

OBJECTIVE: To evaluate the impact of natalizumab treatment over 3 years on psychological functioning in patients with multiple sclerosis (MS) using patient-reported psychological assessment instruments in a clinical practice setting. BACKGROUND: In previous studies, natalizumab significantly improved psychological aspects of health related quality of life (HRQoL) of MS patients at 1 year. A longitudinal study was designed to evaluate psychological outcomes with natalizumab in the US over 3 years. DESIGN/METHODS: Psychological aspects of HRQoL were evaluated using general and MS-specific instruments: the mental component summary (MCS) of the Short Form-12 (SF-12) and the psychological impact score of the MS Impact Scale (MSIS-29), respectively. Better HRQoL is indicated by higher MCS scores and lower MSIS-29 psychological scores. An analysis of covariance was used to evaluate mean scores and changes from baseline (CFB) after controlling for baseline characteristics. Baseline assessments were conducted prior to initiating natalizumab. Scores were stratified by baseline disease step (DS) (DS 0−2 or DS 3−6). Disease steps correlate with disease severity with lower values indicating lower disability. RESULTS: A total of 333 patients (78% female; mean age 46.8 years) were evaluated, 120 of whom were on natalizumab at 3 years. Approximately half of the patients had a baseline DS 0−2 and half had DS 3−6. Overall mean MCS scores were 43.18 at baseline and 47.24 at 3 years (CFB 3.56; P =0.0038). Mean MCS scores improved from baseline to 3 years in patients with DS 0−2 (CFB 2.48; P =0.1563) and in patients with DS 3−6 (CFB 5.08; P =0.0012). Overall mean MSIS-29 psychological scores were 42.12 at baseline and 34.49 at 3 years (CFB −7.57; P =0.0001). Mean MSIS-29 psychological scores improved in patients with DS 0−2 (CFB −8.70; P =0.0022) and in patients with DS 3−6 (CFB −8.93; P =0.0004). CONCLUSIONS: MS patients treated with natalizumab for 3 years in a clinical practice setting reported improvement in psychological aspects of HRQoL. Study Supported by: Biogen Idec Inc. Disclosure: Dr. Foley has received personal compensation for activities with Biogen Idec, Genzyme Corp., and Teva Neuroscience as a consultant. Dr. Foley has received research support from Biogen Idec, Genzyme Corp., Avanir Pharmaceuticals, and Novartis. Dr. Nair has received personal compensation for activities with Janssen Pharmaceuticals Inc, and Biogen Idec as a consultant. Dr. Stephenson has received personal compensation for activities with HealthCore, Inc. as an employee. Dr. Vollmer has received personal compensation for activities with Cleveland Clinic, Novartis, Mandell Center for Multiple Sclerosis, Teva Neuroscience, Questcor Pharmaceuticals, Biogen Idec, Xenoport, University of Florida PeerView, and Krog & Partners. Dr. Vollmer has received research support from Biogen Idec, Teva Neuroscience, Genzyme Corp., Ono Pharmaceuticals, Elan Pharmaceuticals, Novartis, Avanir Pharmaceuticals, and Janssen Pharmaceutica. Dr. Nieckohas has received personal compensation for activities with Biogen Idec as a consultant. Dr. Agarwal has received personal compensation for activities with Biogen Idec as an employee. Dr. Agarwal holds stock and/or stock options in Biogen Idec. Dr. Watson has received personal compensation for activities with Biogen Idec as an employee. Dr. Watson holds stock and/or stock options in Biogen Idec which sponsored research in which Dr. Watson was involved as an investigator.