Author Of 1 Presentation
LB1151 - Clinical outcomes in patients with COVID-19 infection during phase IV studies of cladribine tablets for treatment of multiple sclerosis (ID 947)
Abstract
Background
The COVID-19 pandemic has become a significant concern for patients (pts) with multiple sclerosis (MS) and their healthcare providers, prompting various guidelines on the appropriate use of disease-modifying drugs (DMDs) such as cladribine tablets.
Objectives
We report on clinical outcomes in pts who developed COVID-19 infection during two ongoing Phase IV studies of cladribine tablets (CLARIFY-MS [NCT03369665] and MAGNIFY-MS [NCT03364036]). Post-approval cases of COVID-19 infection are reported elsewhere.
Methods
CLARIFY-MS is investigating the impact of cladribine tablets on health-related quality of life in pts with highly active relapsing MS, while MAGNIFY-MS aims to determine the onset of action of cladribine tablets in such pts. Both studies utilize an open-label, single-arm, multicenter design, in which pts are treated with cladribine tablets 10 mg (3.5 mg/kg cumulative dose over 2 years). Some 680 pts are continuing in both studies. Cases of suspected COVID-19 infection were identified from adverse event reports and reviewed in terms of patient baseline characteristics, comorbidity, disease/treatment history (including most recent Extended Disability Status Scale [EDSS] score before COVID-19), and timing of cladribine tablets dosing/lymphocyte counts in relation to COVID-19 severity and outcomes.
Results
Three cases of suspected COVID-19 infection were identified (CLARIFY-MS, n=2; MAGNIFY-MS, n=1). Patient #1 (21-year history of MS; most recent EDSS score, 4.5; concomitant cardiovascular disease/asthma; prior DMD use) developed severe COVID-19 infection (confirmed) necessitating hospitalization but recovered and was discharged with residual cough/fatigue. Patient #2 (2-year history of MS; most recent EDSS score, 2; previous deep vein thrombosis during pregnancy; no prior DMDs) was also hospitalized for severe COVID-19 symptoms (not confirmed) but self-discharged and was recovering with chest tightness, fatigue, and neuropathic pain under self-isolation. The remaining patient (7-year history of MS; most recent EDSS score, 1; prior use of interferon β-1a) experienced mild symptoms of COVID-19 infection (confirmed); hospitalization was not required and the patient recovered under self-isolation. None of the pts required mechanical ventilation or died.
Conclusions
All 3 pts who developed COVID-19 infection during two ongoing Phase IV studies of cladribine tablets recovered or were recovering, and none required mechanical ventilation.
Presenter Of 1 Presentation
LB1151 - Clinical outcomes in patients with COVID-19 infection during phase IV studies of cladribine tablets for treatment of multiple sclerosis (ID 947)
Abstract
Background
The COVID-19 pandemic has become a significant concern for patients (pts) with multiple sclerosis (MS) and their healthcare providers, prompting various guidelines on the appropriate use of disease-modifying drugs (DMDs) such as cladribine tablets.
Objectives
We report on clinical outcomes in pts who developed COVID-19 infection during two ongoing Phase IV studies of cladribine tablets (CLARIFY-MS [NCT03369665] and MAGNIFY-MS [NCT03364036]). Post-approval cases of COVID-19 infection are reported elsewhere.
Methods
CLARIFY-MS is investigating the impact of cladribine tablets on health-related quality of life in pts with highly active relapsing MS, while MAGNIFY-MS aims to determine the onset of action of cladribine tablets in such pts. Both studies utilize an open-label, single-arm, multicenter design, in which pts are treated with cladribine tablets 10 mg (3.5 mg/kg cumulative dose over 2 years). Some 680 pts are continuing in both studies. Cases of suspected COVID-19 infection were identified from adverse event reports and reviewed in terms of patient baseline characteristics, comorbidity, disease/treatment history (including most recent Extended Disability Status Scale [EDSS] score before COVID-19), and timing of cladribine tablets dosing/lymphocyte counts in relation to COVID-19 severity and outcomes.
Results
Three cases of suspected COVID-19 infection were identified (CLARIFY-MS, n=2; MAGNIFY-MS, n=1). Patient #1 (21-year history of MS; most recent EDSS score, 4.5; concomitant cardiovascular disease/asthma; prior DMD use) developed severe COVID-19 infection (confirmed) necessitating hospitalization but recovered and was discharged with residual cough/fatigue. Patient #2 (2-year history of MS; most recent EDSS score, 2; previous deep vein thrombosis during pregnancy; no prior DMDs) was also hospitalized for severe COVID-19 symptoms (not confirmed) but self-discharged and was recovering with chest tightness, fatigue, and neuropathic pain under self-isolation. The remaining patient (7-year history of MS; most recent EDSS score, 1; prior use of interferon β-1a) experienced mild symptoms of COVID-19 infection (confirmed); hospitalization was not required and the patient recovered under self-isolation. None of the pts required mechanical ventilation or died.
Conclusions
All 3 pts who developed COVID-19 infection during two ongoing Phase IV studies of cladribine tablets recovered or were recovering, and none required mechanical ventilation.