Corrigendum to “Changes in patient-reported outcomes between continuers and discontinuers of disease modifying therapy in patients with multiple sclerosis over age 60” [Multiple Sclerosis and Related Disorders 30 (2019) 252–256]

2019 ◽  
Vol 30 ◽  
pp. 293
Author(s):  
Le H. Hua ◽  
Haleigh Harris ◽  
Devon Conway ◽  
Nicolas R. Thompson
Keyword(s):  
Multiple Sclerosis ◽  
Patient Reported Outcomes ◽  
Disease Modifying Therapy ◽  
Patient Reported ◽  
Disease Modifying

scholarly journals Patient-Reported Disease-Modifying Therapy Adherence in the Clinic: A Reliable Metric?

2018 ◽  
Vol 4 (2) ◽  
pp. 205521731877789 ◽  
Author(s):  
Devon S Conway ◽  
Maria Cecilia Vieira ◽  
Nicolas R Thompson ◽  
Kaila N Parker ◽  
Xiangyi Meng ◽  
...  
Keyword(s):  
Regression Models ◽  
Patient Reported Outcomes ◽  
Patient Reporting ◽  
Lesion Formation ◽  
Logistic Regression Models ◽  
Disease Modifying Therapy ◽  
Patient Reported ◽  
Relapsing Remitting ◽  
Disease Modifying ◽  
The Relationship

Background Adherence to multiple sclerosis (MS) disease-modifying therapy (DMT) is commonly assessed through patient reporting, but patient-reported adherence is rarely studied. Objective To determine rates of DMT adherence reported from patient to clinician, reasons for nonadherence, and relationships between adherence and outcomes. Methods We identified relapsing–remitting MS patients on DMT for ≥3 months. DMT adherence was defined as taking ≥80% of doses. Linear and logistic regression models were created used to determine the association of baseline adherence with several patient reported outcomes and the timed 25-foot walk at 6 months, 1 year, 2 years, and 3 years after the index visit. Results The analysis included 1148 patients, of whom 501 had data at 6 months, 544 at 1 year, 331 at 2 years, and 247 at 3 years. Baseline adherence was 94.9% and overall adherence was 93.1%. Forgetting was the most common reason for missed doses. In the adjusted models, adherence was not associated with the outcomes. Conclusions Higher than expected adherence and a lack of association between adherence and outcomes suggests patient reported adherence may not be reliable. Further research is needed to clarify the relationship between patient-reported adherence and relapses or new lesion formation.

Discontinuation of disease-modifying therapy in patients with multiple sclerosis over age 60

2018 ◽  
Vol 25 (5) ◽  
pp. 699-708 ◽  
Author(s):  
Le H Hua ◽  
Tracey H Fan ◽  
Devon Conway ◽  
Nicolas Thompson ◽  
Tyler G Kinzy
Keyword(s):  
Multiple Sclerosis ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Clinical Relapse ◽  
Real World Data ◽  
Disease Modifying Therapy ◽  
Patient Reported ◽  
Relapsing Remitting ◽  
Patient Health ◽  
Disease Modifying

Background: The risk–benefit ratio of continuing immunomodulating disease-modifying therapy (DMT) in older multiple sclerosis (MS) patients is unknown. Objective: To evaluate clinical and patient-reported outcomes after stopping DMT in older MS patients. Methods: Retrospective, observational study identifying patients from our MS clinics who were aged over 60 and on DMT > 2 years. Cause-specific Cox proportional hazards regression modeled time to discontinuation and time to reinitiation of therapy. Pre- and post-discontinuation comparisons of Performance Scales (PS), Timed 25-Foot Walk, and Patient Health Questionnaire-9 (PHQ9) were analyzed using linear mixed models. Results: A total of 600 patients were included, with 178 (29.7%) discontinuing. Discontinuers were 2.2 years older, had 3.2 years longer disease duration, and 1.6 years lesser treatment exposure. Providers initiated discontinuation more than patients (68.0%). Only one clinical relapse occurred in discontinuers. A proportion (10.7%) reinitiated DMT. Provider-initiated discontinuers restarted less often (hazard ratio (HR): 0.34; 95% confidence interval (CI): 0.12–0.9). In discontinuers, relapsing-remitting patients had lower PS on average than primary progressive. Provider-initiated discontinuation was associated with lower PS than patient- initiated discontinuation. PHQ9 scores appeared higher in those stopping intravenous (IV) therapies than interferons. Lower PS and PHQ9 indicate better outcomes. Conclusion: Most patients over age 60, who discontinued DMT, remained off DMT. This study provides real-world data that may guide clinicians considering discontinuing DMT.

scholarly journals CLICK-MS and MASTER-2 Phase IV trial design: cladribine tablets in suboptimally controlled relapsing multiple sclerosis

2021 ◽  
Author(s):  
Augusto A Miravalle ◽  
Joshua Katz ◽  
Derrick Robertson ◽  
Brooke Hayward ◽  
Danielle E Harlow ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Patient Reported Outcomes ◽  
Real World Data ◽  
Disease Modifying Drugs ◽  
Secondary Progressive ◽  
Patient Reported ◽  
Relapsing Remitting ◽  
Registration Number ◽  
Disease Modifying ◽  
Phase Iv

Cladribine tablets 10 mg (3.5 mg/kg cumulative dose over 2 years) are approved for the treatment of relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS and active secondary progressive MS. However, real-world data on cladribine tablets are limited. CLICK-MS and MASTER-2 are single arm, observational, 30-month, Phase IV studies in the US evaluating the effectiveness and safety of cladribine tablets 3.5 mg/kg in patients with relapsing-remitting MS or active secondary progressive MS who had suboptimal response to prior injectable (CLICK-MS), or infusion/oral (MASTER-2) disease-modifying therapy. The primary end point is 24-month annualized relapse rate. Key secondary end points include patient-reported outcomes on quality of life measures, treatment adherence and adverse events. Studies began in 2019 and are expected to be completed in 2023. Trial registration number • CLICK-MS: NCT03933215 (ClinicalTrials.gov) Full title; CLadribine tablets: observational evaluation of effectIveness and patient-reported outcomes in suboptimally Controlled patients previously taKing injectable disease-modifying drugs for relapsing forms of Multiple Sclerosis • MASTER-2: NCT03933202 (ClinicalTrials.gov) Full title; Cladribine tablets: observational evaluation of effectiveness and patient-reported outcomes in suboptiMAlly controlled patientS previously Taking oral or infusion disEase-modifying dRugs for relapsing forms of multiple sclerosis

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