
Contributions
Abstract: EP1569
Type: ePoster
Abstract Category: Therapy - symptomatic - Quality of life
Background: Patient reported outcomes (PROs) complement clinician-observed measures. PROs can detect changes in symptoms longitudinally not captured by standard assessments. Neuro-QoL item banks assess patient functioning for MS using newer Item Response Theory methods. We are conducting a longitudinal evaluation of Neuro-QoL PROs comparing new users of fingolimod (FTY) and natalizumab (NAT) who have relapsing forms of MS over a 24 month period at two MS centers.
Methods: Two cohorts were identified: adult MS patients who were new users on either NAT or FTY in 2013. Index date was the date a patient started their first prescription or infusion. PRO measures were collected at six intervals: first dose, 3, 6, 12, 18 and 24 months: electronically via email links or through iPads at clinic visits. Key PRO scales included: a) Neuro-QoL short form measures, and b) Patient-Determined Disease Steps (PDDS). Retrospective chart review for the 12 month period prior to the index date assessed MS disease characteristics. Current analysis examined differences within drug group using mixed linear models adjusted for age, gender, PDDS, MS disease duration, number of clinical relapses and lesion activity prior to first dose. PRO data is only modeled for 12 months post index.
Results: Total of 76 NAT and 68 FTY patients completed at least one assessment. At 12 months sample sizes were 32 (NAT); 40 (FTY). Mean age was 42 years; mean MS disease duration was 7 years, over 70% were female; over 90% were Caucasian. Mean PDDS was similar (2.13NAT vs 1.63FTY p=0.1342). Both groups had used one prior DMT. However, NAT had a higher number of relapses (0.71 vs 0.37p =0.0027). Differences between baseline and all six intervals were examined. Those from index date to 12 months are presented. No differences were reported in fatigue, cognition and most emotional and social domains. Lower and upper extremity function scores were slightly worse for FTY patients (3.7%p=0.0017; 3.0%p=0.0030 relative change from baseline). FTY patients reported lower scores on satisfaction with involvement in social roles and activities (8.3% change from baseline; p=0.0297). FTY patients reported more sleep disturbance (9.5% change from baseline; p=0.0166) compared to NAT patients.
Conclusion: Early evidence suggests some differences exist within newly initiated users of FTY compared to NAT users in a longitudinal evaluation of Neuro-QoL domains. Larger sample sizes are necessary to confirm these findings.
Disclosure: Funded by Biogen Idec
Conflicts of Interests:
Kavita. V. Nair, PhD: Research grants from Novartis, Biogen, Gilead Sciences, Astra Zeneca,
Consultant for Astellas, Genentech
John C. Corboy, MD:
Research grants from
Novartis
National Multiple Sclerosis Society
PCORI
Diogenix
NIH
UCLA
Consultant for
Novartis
Teva Neuroscience
Biogen Idec
Prime CME
John. Foley, MD:Speakers´ Bureaus for Biogen, Genentech-Roche, Genzyme and Accorda. Dr. Foley advices for Biogen, Genentech-Roche, and Genzyme
Terrie Livingston: employee of Biogen Idec
Sharon Cahoon Metzger: employee of Biogen Idec
Stefan Sillau: nothing to disclose
Diane Fairclough: nothing to disclose
Deborah Miller: nothing to disclose
Brooke Valdez: nothing to disclose
Eric Engebretson: nothing to disclose
Brittany Wedeman: nothing to disclose
Tammy Hoyt: nothing to disclose
Laura Seawright: nothing to disclose
Abstract: EP1569
Type: ePoster
Abstract Category: Therapy - symptomatic - Quality of life
Background: Patient reported outcomes (PROs) complement clinician-observed measures. PROs can detect changes in symptoms longitudinally not captured by standard assessments. Neuro-QoL item banks assess patient functioning for MS using newer Item Response Theory methods. We are conducting a longitudinal evaluation of Neuro-QoL PROs comparing new users of fingolimod (FTY) and natalizumab (NAT) who have relapsing forms of MS over a 24 month period at two MS centers.
Methods: Two cohorts were identified: adult MS patients who were new users on either NAT or FTY in 2013. Index date was the date a patient started their first prescription or infusion. PRO measures were collected at six intervals: first dose, 3, 6, 12, 18 and 24 months: electronically via email links or through iPads at clinic visits. Key PRO scales included: a) Neuro-QoL short form measures, and b) Patient-Determined Disease Steps (PDDS). Retrospective chart review for the 12 month period prior to the index date assessed MS disease characteristics. Current analysis examined differences within drug group using mixed linear models adjusted for age, gender, PDDS, MS disease duration, number of clinical relapses and lesion activity prior to first dose. PRO data is only modeled for 12 months post index.
Results: Total of 76 NAT and 68 FTY patients completed at least one assessment. At 12 months sample sizes were 32 (NAT); 40 (FTY). Mean age was 42 years; mean MS disease duration was 7 years, over 70% were female; over 90% were Caucasian. Mean PDDS was similar (2.13NAT vs 1.63FTY p=0.1342). Both groups had used one prior DMT. However, NAT had a higher number of relapses (0.71 vs 0.37p =0.0027). Differences between baseline and all six intervals were examined. Those from index date to 12 months are presented. No differences were reported in fatigue, cognition and most emotional and social domains. Lower and upper extremity function scores were slightly worse for FTY patients (3.7%p=0.0017; 3.0%p=0.0030 relative change from baseline). FTY patients reported lower scores on satisfaction with involvement in social roles and activities (8.3% change from baseline; p=0.0297). FTY patients reported more sleep disturbance (9.5% change from baseline; p=0.0166) compared to NAT patients.
Conclusion: Early evidence suggests some differences exist within newly initiated users of FTY compared to NAT users in a longitudinal evaluation of Neuro-QoL domains. Larger sample sizes are necessary to confirm these findings.
Disclosure: Funded by Biogen Idec
Conflicts of Interests:
Kavita. V. Nair, PhD: Research grants from Novartis, Biogen, Gilead Sciences, Astra Zeneca,
Consultant for Astellas, Genentech
John C. Corboy, MD:
Research grants from
Novartis
National Multiple Sclerosis Society
PCORI
Diogenix
NIH
UCLA
Consultant for
Novartis
Teva Neuroscience
Biogen Idec
Prime CME
John. Foley, MD:Speakers´ Bureaus for Biogen, Genentech-Roche, Genzyme and Accorda. Dr. Foley advices for Biogen, Genentech-Roche, and Genzyme
Terrie Livingston: employee of Biogen Idec
Sharon Cahoon Metzger: employee of Biogen Idec
Stefan Sillau: nothing to disclose
Diane Fairclough: nothing to disclose
Deborah Miller: nothing to disclose
Brooke Valdez: nothing to disclose
Eric Engebretson: nothing to disclose
Brittany Wedeman: nothing to disclose
Tammy Hoyt: nothing to disclose
Laura Seawright: nothing to disclose