Improved treatment satisfaction after switching therapy to rituximab in relapsing–remitting MS

2016 ◽  
Vol 23 (9) ◽  
pp. 1249-1257 ◽  
Author(s):  
Pierre de Flon ◽  
Katarina Laurell ◽  
Lars Söderström ◽  
Martin Gunnarsson ◽  
Anders Svenningsson
Keyword(s):  
Multiple Sclerosis ◽  
Disease Progression ◽  
Treatment Satisfaction ◽  
Treatment Strategies ◽  
First Line ◽  
Open Label ◽  
Immunomodulating Therapy ◽  
Patient Reported ◽  
Relapsing Remitting ◽  
Perceived Impact

Objective: New disease-modifying treatment strategies in multiple sclerosis offer possibilities for individualised treatment. In this study, we evaluated patient-reported outcome measures before and after a switch in therapy from first-line injectable treatments to rituximab. Method: A total of 75 patients with clinically stable relapsing–remitting multiple sclerosis (RRMS) receiving ongoing first-line injectable treatment at three Swedish centres had their treatment switched to rituximab in this open-label phase II multicentre study. Assessment of treatment satisfaction, patient-perceived impact of the disease on daily life, fatigue, cognitive symptoms and disease progression was performed 3 months before and at the time of the treatment shift and then for a subsequent 2-year period. Results: The overall treatment satisfaction rating improved significantly from a mean of 4.8 (scale range: 1–7), while on injectable therapies, to a mean of 6.3 after 1 year of rituximab treatment ( p < 0.001). This improvement was sustained after 2 years. There was no significant change in scores for patient-perceived impact of disease, fatigue or disease progression. Conclusion: A shift in therapy from first-line injectables to rituximab in a cohort of clinically stable RRMS patients was followed by improved treatment satisfaction. This is clinically relevant as it may influence long-term adherence to immunomodulating therapy.

THUR 172 Phase iv study of cladribine tablets and quality of life: clarify-ms

2018 ◽  
Vol 89 (10) ◽  
pp. A22.2-A22 ◽  
Author(s):  
S Schippling ◽  
D Langdon ◽  
A Solari ◽  
B Brochet ◽  
R Hupperts ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Treatment Satisfaction ◽  
Depression Scale ◽  
Size Estimation ◽  
Open Label ◽  
T2 Lesions ◽  
Patient Reported ◽  
Phase Iv

Authors Disclaimer: http://medpub-poster.merckgroup.com/ABN2018DISC_CLARIFY.pdfBackgroundRelapsing multiple sclerosis (RMS) negatively affects health-related quality of life (HRQoL).ObjectiveAn open-label, single-arm, exploratory Phase IV study in centres in Europe and Australia will assess HRQoL in RMS patients receiving CT 3.5 mg/kg (CT3.5).MethodsEligible patients will receive CT 3.5 (cumulative) over 2 years. HRQoL (Multiple Sclerosis Quality of Life-54 [MSQoL-54]) and other patient-reported outcomes (Fatigue Severity Scale; Hospital Anxiety and Depression Scale; Treatment Satisfaction Questionnaire for Medication v1.4) will be assessed at baseline, and at 6, 12, 24 months.Other outcomes include AEs, MRI measures (T1 Gd+ lesions, T2 lesions, brain atrophy), number of relapses, and disability/functioning measures (EDSS; 9-Hole Peg Test; Timed 25-Foot Walk and Brief International Cognitive Assessment for Multiple Sclerosis). The sample size estimation is based on the power to detect a mean difference of 5 points in MSQoL-54 composite score at 24 months vs baseline.ResultsThe study aims to recruit 356 adults with RMS by 2019. Final data are anticipated in 2022.ConclusionsThis study will explore the effects of CT on HRQoL outcomes, and describe the effects of CT on treatment satisfaction and disability/functioning.Disclosure statementThe trial is sponsored by Merck KGaA, Darmstadt, Germany.

scholarly journals The low adherence and disability outcomes of disease-modifying drugs in Multiple Sclerosis in Saskatchewan, a cohort study, 1997-2014

2015 ◽  
Vol 42 (S1) ◽  
pp. S32-S32
Author(s):  
WJ Hader
Keyword(s):  
Multiple Sclerosis ◽  
Disease Progression ◽  
Descriptive Analysis ◽  
Open Label ◽  
Disease Modifying Drugs ◽  
Relapsing Remitting ◽  
Disease Modifying ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis ◽  
The Impact

Background: The beneficial effects of the injected disease-modifying drugs (DMDs) in relapsing-remitting Multiple Sclerosis have been previously reported. However the results related to disability outcomes and the reduction of disease progression in the pivotal trials and few longer studies are variable and inconclusive. Objectives: To determine the utilization and the disability outcomes of the DMDs on relapsing-remitting Multiple Sclerosis over fifteen years. Methods: A prospective open-label cohort of 262 clinical definite patients, 78 men and 184 women, with two attacks in the past two years and a disability level DSS≤5.5 were enrolled consecutively from December 1997 to November 1999. A descriptive analysis of the cohort and individual drugs outcomes were performed. The results were compared to natural history studies of Multiple Sclerosis as controls. Results: At 15 years, one-seventh, 38/262 (14.5%) remain on the initial prescription, Betaseron, 15/131 (11.5%), Copaxone, 16/102 (15.5%) and Rebif 7/28 (25%), Avonex 0/1. 223(63.6%) had discontinued at a mean duration of 5.5(SD=4.7) years. 95/262 (36.4%) remain on a drug after switches. The DSS levels of the individual DMDs were analyzed. Conclusion: One-seventh of participants remained on their first prescription. Because of low adherence, the impact of DMDs on disease progression in the longer term cannot be verified.

Pooled safety results from SPIRITT: A multicenter, open-label, randomized, phase II study of FOLFIRI with panitumumab (pmab) or bevacizumab (bev) as second-line treatment (tx) in patients (pts) with metastatic colorectal cancer (mCRC).

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 477-477 ◽  
Author(s):  
J. R. Hecht ◽  
S. R. Dakhil ◽  
M. N. Saleh ◽  
B. Piperdi ◽  
M. Cline-Burkhardt ◽  
...  
Keyword(s):  
Disease Progression ◽  
Phase Ii ◽  
Human Monoclonal Antibody ◽  
Objective Response ◽  
Phase Iii ◽  
Second Line ◽  
First Line ◽  
Open Label ◽  
Randomized Phase Ii ◽  
Patient Reported

477 Background: Pmab is a fully human monoclonal antibody against the epidermal growth factor receptor (EGFR) approved as monotherapy in pts with chemorefractory mCRC. Many pts with mCRC who have progressed on a bev-containing regimen receive second-line bev + chemotherapy despite the lack of prospective, randomized data supporting this approach. A phase III study recently showed that pmab + second-line FOLFIRI improved progression-free survival (PFS) in pts with wild-type (WT) KRAS tumors vs chemotherapy alone. This study was amended after enrollment began to focus hypothesis testing on the WT KRAS population and is evaluating the safety and efficacy of pmab + FOLFIRI vs bev + FOLFIRI in pts who received first-line therapy with an oxaliplatin-based regimen + bev. Methods: This is a randomized, phase II, open-label study in pts with mCRC with disease progression or intolerability after ≥ 4 doses of first-line oxaliplatin-based chemotherapy + bev. Pts are randomized 1:1 to receive either 6 mg/kg pmab Q2W + FOLFIRI or bev (given at institutional standard dose Q2W) + FOLFIRI. Tx is administered until disease progression (PD), death, or withdrawal from study. The primary endpoint is PFS in patients with WT KRAS tumors. Other endpoints include objective response rate, overall survival, safety, and patient-reported outcomes. Results: At the time of data cutoff, 216 of 277 planned pts were enrolled. 175 (81%) pts discontinued study tx and 39 (18%) pts remain on tx. Any grade adverse events (AEs) were reported in 197 (92%) pts. 38 (18%) pts had AEs that led to withdrawal from tx or study. Serious AEs were reported in 66 (31%) pts and included gastrointestinal disorders (13%), infections and infestations (8%), respiratory disorders (7%), and metabolism and nutrition disorders (7%). Fatal AEs were reported in 18 (8%) pts of which 9 (4%) were related to disease progression. Conclusions: The aggregate safety profile is consistent with expected toxicities of FOLFIRI in combination with an anti-EGFR or an anti-VEGF targeted therapy in second-line mCRC. Detailed pooled safety results will be presented at the meeting. [Table: see text]

A randomized, multicentre, open-label, parallel-group trial of the tolerability of interferon beta-1a (Rebif®) administered by autoinjection or manual injection in relapsing-remitting multiple sclerosis

2005 ◽  
Vol 11 (5) ◽  
pp. 585-591 ◽  
Author(s):  
D Mikol ◽  
M Lopez-Bresnahan ◽  
S Taraskiewicz ◽  
P Chang ◽  
J Rangnow ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Interferon Beta ◽  
Study Endpoint ◽  
Primary Study ◽  
Open Label ◽  
Patient Reported ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

Injection site reactions (ISRs) are a common side effect of subcutaneous interferon beta therapy, particularly during initiation of therapy. Retrospective analysis of two clinical trials showed that patients using an autoinjector experienced fewer ISRs than patients administering interferon beta manually. This randomized, open-label trial compared the occurrence of ISRs in relapsing-remitting multiple sclerosis patients subcutaneously injecting interferon beta-1a manually or with autoinjector. In total, 1825 patients (autoinjector, 932; manual injection, 893) were included in the intention-to-treat analysis. Significantly fewer patients using the autoinjector experienced ISRs, based on physician assessment, compared with manual injection (78.7% versus 85.4%; p<0.001). There was no statistical difference on primary study endpoint: number of patients experiencing moderate to severe ISRs after 12 weeks’ therapy (25.3% versus 23.2%, P=0.449). The patient-reported proportion of any ISR during the treatment period was significantly greater for the manual injection group (71.8% versus 66.1%; p<0.001). The decreased incidence of ISRs with the autoinjector compared to manual injection seen in this short-term study, coupled with ease of use of the autoinjector, suggest that it could improve compliance, and therefore therapeutic outcomes in some patients.

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