Comparing Neuro-QOL Outcomes in a 2 year longitudinal assessment of new users of natalizumab and fingolimod with MS (P3.340)

Objective: Longitudinal evaluation of Neuro-QoL PROs between new users of fingolimod (FTY) and natalizumab (NAT) with relapsing forms of MS over a 24 month period at two MS centers. Background: Patient reported outcomes (PROs) complement clinician-observed measures. Neuro-QoL item banks assess patient functioning for MS using newer Item Response Theory methods Design/Methods: Two cohorts were identified: adult MS patients; new starts on NAT or FTY in 2013. On the index date a patient started their first prescription or infusion. PRO measures were collected at first dose, 3, 6, 12, 18, 24 months electronically. PRO scales included: a) Neuro-QoL short form measures, b) Patient-Determined Disease Steps (PDDS) and c) Modified Fatigue Impact Score (MFIS). Chart review one year prior to the index date assessed disease characteristics. Current analysis examined differences within group using mixed linear models adjusted for age, gender, PDDS, MS disease duration, number of clinical relapses and lesion activity prior to first dose. Findings are presented for 12 months post index. Correlation between the Neuro-QOL Fatigue scale and overall MFIS score was examined at the index date and intervals up to 12 months Results: At 12 months, n=53 (NAT); n=50 (FTY). At index date mean age was 43 years; mean MS disease duration was 7 years, over 70% were female. Mean PDDS (2.11 NAT vs 1.62 FTY p=0.1342) was similar. NAT had a higher relapse rate (0.73 vs 0.36 p =0.0027) pre index. Improvement in Neuro-QoL fatigue severity for NAT users (3.63%; p=0.0363) was reported 12 months post index. FTY patients reported worsening in both sleep disturbance (3.49% p=0.0324), lower and upper extremity function (2.72%; p=0.0482; 4.51%; p=0.0064 respectively) at 12 months post index. Overall MFIS score correlated well with Neuro-QoL Fatigue score at all intervals. Conclusions: Findings suggest after 12 months of starting drug FTY users report worsening in some PROs. NAT users report improvements in fatigue. Study Supported by: Biogen Disclosure: Dr. Nair has received personal compensation for activities with Astellas. Dr. Nair has received research support from Novartis, Biogen, Gilead Sciences, and Genentech. Dr. Sillau has nothing to disclose. Dr. Fairclough has nothing to disclose. Dr. Miller has received personal compensation in an editorial capacity for Quality of Life Research. Dr. Miller has received research support from Novartis. Dr. Foley received personal compensation for activities with Biogen Idec, Genzyme, Teva and Genentech Pharmaceuticals as a consultant. Dr. Valdez has nothing to disclose. Dr. Hosford has nothing to disclose. Dr. Hoyt has nothing to disclose. Dr. Seawright has nothing to disclose. Dr. Corboy has received personal compensation for activities with Novartis, Genentech, and Prime Education. Dr. Corboy has received personal compensation in an editorial capacity for Neurology: Clinical Practice. Dr. Corboy has received research support from Novartis and Sun Pharma. Dr. Alvarez has received personal compensation from Teva Neuroscience, Biogen, Genzyme, Genentech, and Novartis. Dr. Alvarez has received research support from Biogen, Teva, and Novartis. Dr. Livingston has received personal compensation for activities with Biogen as an employee.