ECTRIMS eLearning

Comparing neuro-QoL patient reported outcomes in a two year longitudinal assessment of newly initiated users of natalizumab and fingolimod with relapsing forms of MS
Author(s): ,
K.V Nair
Affiliations:
University of Colorado Anschutz Medical Campus
,
S Sillau
Affiliations:
Neurology
,
D.L Fairclough
Affiliations:
Biostatistics and Informatics, University of Colorado Anschutz Medical Campus, Aurora, CO
,
D.M Miller
Affiliations:
Neurology, Cleveland Clinic, Cleveland, OH
,
J.F Foley
Affiliations:
Rocky Mountain Multiple Sclerosis Clinic, Salt Lake City, UT
,
B Valdez
Affiliations:
Neurology
,
E Engebretson
Affiliations:
Neurology
,
B.M Wedeman
Affiliations:
Neurology
,
L Hosford
Affiliations:
Neurology
,
T Hoyt
Affiliations:
Rocky Mountain Multiple Sclerosis Clinic, Salt Lake City, UT
,
L Seawright
Affiliations:
Rocky Mountain Multiple Sclerosis Clinic, Salt Lake City, UT
,
J.R Corboy
Affiliations:
Neurology
,
S Metzger-Cahoon
Affiliations:
Biogen, Boston, MA, United States
T Livingston
Affiliations:
Biogen, Boston, MA, United States
ECTRIMS Learn. Nair KV. 09/14/16; 145664; EP1569
Prof. Kavita Nair
Prof. Kavita Nair
Contributions
Abstract

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



By clicking “Accept Terms & all Cookies” or by continuing to browse, you agree to the storing of third-party cookies on your device to enhance your user experience and agree to the user terms and conditions of this learning management system (LMS).

Cookie Settings
Accept Terms & all Cookies