Impact of ocrelizumab on patient-reported fatigue and quality of life in patients with relapsing multiple sclerosis treated for the first time with ocrelizumab

Background: A number of elements of the pivotal ‘cladribine tablets treating multiple sclerosis orally’ (CLARITY) trial have remained unpublished. Objective: To report the impact of cladribine on health-related quality of life (QoL) in people with relapsing multiple sclerosis (pwRMS). Methods: QoL data from the phase III trial of two different doses (3.5 and 5.25 mg/kg) of oral cladribine in pwRMS were acquired from the European Medicines Agency through Freedom of Information. Spearman’s rank correlation was used to analyse the relationship between baseline QoL scores and baseline Expanded Disability Status Scale (EDSS) scores. Responses of the Euro Quality of Life 5 Dimensions (EQ-5D) and Multiple Sclerosis Quality of Life-54 (MSQOL-54) questionnaires were compared between treatment and control groups using univariate analyses of covariance. Results: In total, n = 5148 EQ-5D responses and n = 894 MSQOL-54 physical, mental health and dimension scores were extracted. Baseline EQ-5D indices correlated with EDSS scores. After 2 years, pwRMS taking 3.5 ( p = .001) and 5.25 mg/kg ( p = .022) reported significantly improved EQ-5D index scores compared with placebo. Positive, yet non-significant, differences were detected in MSQOL-54 scores between cladribine and placebo. Conclusion: Analysis of the CLARITY dataset suggests that, over and above its established clinical efficacy, cladribine leads to improved QoL over 96 weeks. ClinicalTrials.gov identifier: NCT00213135.

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Comparison of Quality of Life in Clinically Isolated Syndrome Patients Who Convert and Do Not Convert to Clinically Definite Multiple Sclerosis

International Journal of MS Care ◽

10.7224/1537-2073-11.1.17 ◽

2009 ◽

Vol 11 (1) ◽

pp. 17-24 ◽

Cited By ~ 2

Author(s):

Deborah M. Miller ◽

Craig Kollman ◽

Andrea Kalajian ◽

Paul W. O'Connor ◽

R. Philip Kinkel

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Short Form ◽

Clinically Isolated Syndrome ◽

Sf 36 ◽

Initial Symptoms ◽

Patient Reported ◽

Definite Multiple Sclerosis ◽

Clinically Definite Multiple Sclerosis

A secondary analysis was undertaken to compare patient-reported outcomes (PROs) of individuals who did and did not convert to clinically definite multiple sclerosis (CDMS) approximately 5 years after their first clinically isolated syndrome (CIS). Patients included in the analysis were participating in a long-term extension (called CHAMPIONS) of the Controlled High-Risk Avonex® Multiple Sclerosis Prevention Study (CHAMPS). The Multiple Sclerosis Quality of Life Inventory (MSQLI), a battery including the Short Form Health Status Survey (SF-36) and nine disease-specific scales, was administered to participants 5 years after their initial symptoms suggestive of MS (randomization into the CHAMPS study). Of 203 CHAMPIONS patients, 188 (93%) completed the MSQLI at enrollment into this extension study. Of these, 79 (42%) converted to CDMS. Statistically significant differences (P < .001) between those who did and did not convert to CDMS were found for 4 of the 11 MSQLI scales: the SF-36 Physical Component Summary, the Modified Fatigue Impact Scale, the Pain Effects Scale, and the Bladder Control Scale. Trends not meeting our criteria for statistical significance (P > .001 but < .01) were observed for the SF-36 Mental Component Summary, the Perceived Deficits Questionnaire, and the Mental Health Inventory. SF-36 scores for patients not converting to CDMS over 5 years were similar to those reported for age-matched normal controls. No other demographic or disease-related factors were associated with these PROs. When stratified by Expanded Disability Status Scale score, patients who converted to CDMS demonstrated statistically significant differences on the same four scales defined above that differentiated those who did and did not convert to CDMS. These data show that individuals who have CDMS but limited disability demonstrate clear evidence of diminished health-related quality of life.

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A Novel Electronic Application of Patient-reported Outcomes in Multiple Sclerosis – Meeting the Necessary Challenge of Assessing Quality of Life and Outcomes in Daily Clinical Practice

European Neurological Review ◽

10.17925/enr.2014.09.01.49 ◽

2014 ◽

Vol 9 (1) ◽

pp. 49 ◽

Cited By ~ 3

Author(s):

Simon Exell ◽

Mark Thristan ◽

Fernando Dangond ◽

Kurt Marhardt ◽

Meaghan St Charles Krohe ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Clinical Practice ◽

Negative Impact ◽

Patient Reported Outcome ◽

Software Application ◽

Wireless Data Transmission ◽

Patient Reported ◽

Auto Injector

Multiple sclerosis (MS) has a substantial negative impact on health-related quality of life. Clinical assessments often do not include standardised, routine assessment of MS impact from the patient perspective, and communication between healthcare practitioners (HCPs) and patients can be lacking. Thus, there is a need for patient-reported outcome (PRO) measures to encourage patient–HCP communication, to help inform HCPs of matters important to patients and to aid both patients and HCPs in managing the disease. MSdialog is a web- and mobile-based software application that works with auto-injector devices and electronic autoinjectors, including the RebiSmart® 2.0 device (a handheld electronic Rebif® auto-injector with wireless data transmission capabilities, CE marked and available worldwide [excluding the US]) to collect and store real-time, point-of-administration adherence, clinician-reported outcomes and PRO data. MSdialog may provide a practical solution to support patient-proactive engagements and self-management, patient-centred care and participatory decision-making in clinical practice.

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Multiple sclerosis: patient-reported quality of life in the Świętokrzyskie Region

Medical Studies ◽

10.5114/ms.2017.70345 ◽

2017 ◽

Vol 3 ◽

pp. 191-198 ◽

Cited By ~ 1

Author(s):

Waldemar Brola ◽

Piotr Sobolewski ◽

Małgorzata Fudala ◽

Stanisław Flaga ◽

Konrad Jantarski

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Multiple Sclerosis Patient ◽

Patient Reported

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The 27-Item Multiple Sclerosis Quality of Life Questionnaire: A New Brief Measure Including Treatment Burden and Work Life

International Journal of MS Care ◽

10.7224/1537-2073.2020-088 ◽

2021 ◽

Author(s):

Helen Beckmann ◽

Christoph Heesen ◽

Matthias Augustin ◽

Christine Blome

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Construct Validity ◽

Convergent Validity ◽

Life Questionnaire ◽

Quality Of Life Questionnaire ◽

Patient Reported ◽

Disease Specific

Abstract Background: Treatment- and work-related aspects have been neglected in health-related quality of life (HRQOL) measures in multiple sclerosis (MS). We aimed to develop a brief instrument covering all important impairment-, activity-, participation-, and treatment-related aspects for use in research and practice. Methods: The 27-item Multiple Sclerosis Quality of Life Questionnaire (MS-QLQ27) was developed using open item collection, a multidisciplinary expert panel, and cognitive pretesting. It was evaluated for reliability, construct validity, and responsiveness with 100 patients presenting with relapse (84 at follow-up ~14 days later). Construct validity was analyzed by correlating the MS-QLQ27 with the disease-specific Hamburg Quality of Life Questionnaire in MS (HAQUAMS) and generic HRQOL instuments. The Expanded Disability Status Scale (EDSS) was used to analyze known-groups validity. Responsiveness was determined as the correlation of changes in MS-QLQ27 scores with changes in validation criteria. Results: Internal consistency was high (Cronbach α = 0.94 at baseline and 0.93 at follow-up). Convergent validity was supported by direction and magnitude of associations with disease-specific and generic instruments. Correlations with change in convergent criteria were strong, indicating responsiveness. The HAQUAMS showed the strongest associations with the MSQLQ27. The MS-QLQ27 showed the highest effect size compared with other patient-reported outcomes and the EDSS. It successfully distinguished between levels of disease severity. Conclusions: These results indicate that the MS-QLQ27 is a reliable, valid, and highly responsive instrument for assessing HRQOL during relapse evolution in MS. Its advantages are that it is brief yet comprehensive, covering work- and treatment-related aspects not addressed in previous measures.

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The impact of ocrelizumab on health-related quality of life in individuals with multiple sclerosis

Multiple Sclerosis Journal - Experimental Translational and Clinical ◽

10.1177/20552173211007523 ◽

2021 ◽

Vol 7 (2) ◽

pp. 205521732110075

Author(s):

Bonnie I Glanz ◽

Jonathan Zurawski ◽

Emily C Casady ◽

Rebecca Shamah ◽

Mira Weiner ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Clinical Characteristics ◽

Health Related Quality ◽

Sf 36 ◽

Patient Reported ◽

Related Quality ◽

Health Related ◽

The Impact

Background Ocrelizumab is approved for the treatment of both relapsing and progressive multiple sclerosis (MS). Objective To examine the impact of ocrelizumab on health-related quality of life (HRQOL) in individuals with MS. Methods Ninety-eight individuals with relapsing and 32 with progressive MS were enrolled. Participants were administered a battery of patient-reported outcome (PRO) measures at their first ocrelizumab infusion, and infusions at 6 and 12 months. PRO measures included the Medical Outcomes Study SF-36 and Neuro-QoL. Results At baseline, participants had low mean scores across HRQOL domains. After 12 months, increases were observed on SF-36 Role-Physical, General Health, Vitality, Role-Emotional, Mental health and Mental Component Summary. On Neuro-QoL, improvements were seen in Positive Affect, Anxiety, Emotional and Behavioral Dyscontrol and Fatigue. Several demographic and clinical characteristics were associated with HRQOL at baseline. The strongest associations were between physical HRQOL measures and measures of MS disability. Associations between the longitudinal change in HRQOL scores and baseline demographic and clinical characteristics were mild. Conclusions We observed significant improvements across multiple mental HRQOL domains at 12 months in individuals treated with ocrelizumab. These findings support the use of HRQOL measures to provide a subjective measure of treatment impact that complements traditional outcomes.

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Impact of Visual Impairment on Health-Related Quality of Life in Multiple Sclerosis

International Journal of MS Care ◽

10.7224/1537-2073-12.2.83 ◽

2010 ◽

Vol 12 (2) ◽

pp. 83-91 ◽

Cited By ~ 3

Author(s):

Vivek S. Pawar ◽

Gauri Pawar ◽

Lesley-Ann Miller ◽

Iftekhar Kalsekar ◽

Jan Kavookjian ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Visual Impairment ◽

Life Questionnaire ◽

Health Related Quality ◽

Patient Reported ◽

Related Quality ◽

Health Related ◽

The Impact

The aim of this study was to evaluate the impact of visual impairment on health-related quality of life (HRQOL) in patients with multiple sclerosis (MS). Patients at an outpatient MS clinic were asked to complete a battery of patient-reported outcome questionnaires. Health-related quality of life was measured using the Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS), while visual impairment was measured using the Visual Function Questionnaire (VFQ). Hierarchical regression was used to determine the relative contribution of visual impairment to HRQOL. Usable responses were obtained for 116 MS patients. Those with higher levels of visual impairment (lower scores on the VFQ) reported significantly lower HRQOL (β = –0.01, P = .0007). Visual impairment also explained an additional 4% variance in the HRQOL scores, independent of disability and depression (ΔR2 = 0.04, F7,108 = 36.58). Overall, disability was the strongest predictor of HRQOL, explaining over 60% of the variation in HRQOL scores. The model explained 70% of the total variance in HRQOL. Given the prevalence of visual impairment and its influence on overall HRQOL, MS patients should be routinely screened using standard ophthalmic examination procedures or self-administered questionnaires such as the VFQ.

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Repository corticotropin injection improves quality metrics in an observational study of multiple sclerosis relapse

Neurodegenerative Disease Management ◽

10.2217/nmt-2021-0030 ◽

2021 ◽

Author(s):

Jeffrey Kaplan ◽

Tamara Miller ◽

Matthew Baker ◽

Bryan Due ◽

Enxu Zhao

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Cognitive Impairment ◽

Patient Reported Outcomes ◽

Quality Metrics ◽

Life Outcomes ◽

Multiple Sclerosis Relapse ◽

Patient Reported ◽

American Academy Of Neurology

Aim: To determine whether clinicians evaluate American Academy of Neurology (AAN) quality metrics for patients with multiple sclerosis (MS) relapse and whether repository corticotropin injection (RCI) improves clinical and patient-reported outcomes associated with these metrics at 2 and 6 months after treatment. Methods: A multicenter, prospective, observational registry evaluating patients receiving RCI for MS relapse (N = 125) categorized data according to AAN quality metrics involving diagnosis, disability, fatigue, cognitive impairment, depression, and quality of life. Results: Clinicians assessed all 11 AAN quality metrics in patients with MS relapse. Disability, fatigue, cognitive impairment, depression, and quality of life outcomes improved with RCI therapy. Conclusion: RCI was associated with improved quality metrics, and AAN guidelines were followed during routine RCI treatment for MS relapse.

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