Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis

Abstract

We disagree with redefining death "based on loss of clinical function of the heart and lungs or the brain," 1 because it deviates from the legal definition of irreversible cessation of cardiorespiratory function or of all functions of the brain, including the brainstem. The latter was intended to protect the general public from injury and harm due to incorrect death declaration. The contemporary clinical criteria have been challenged on scientific, philosophical, legal, and religious grounds. 2-4 Lewis et al. reduce this opposition to "moral or religious beliefs, hope that a patient will recover, or a lack of acceptance that a determination of brain death is the legal equivalent of Editors' note: An interdisciplinary response to contemporary concerns about brain death determination "An interdisciplinary response to contemporary concerns about brain death determination" generated several readers' responses. Commenting on the paper, Verheijde et al. argue that cardiopulmonary death is not the equivalent to brain death and add that public trust in brain death requires that there be zero false-positive determinations of death. Dr. Sethi suggests that lawsuits related to brain death may be linked more to breakdowns in communication between the medical teams and patient families rather than validity of determination of death by neurologic criteria. Machado et al. suggest that ancillary tests should have a decisive role in helping to delineate the brain death concept since clinical evaluation might have pitfalls. Finally, Dr. Shabtai feels that it is an error to frame the debate as one of religious or moral beliefs vs science, and suggests continued discussion, including broad public debate. Authors Lewis et al. defend their article citing several prominent American medical societies who support that brain death is equivalent to cardiopulmonary death. They add that when the American Academy of Neurology guidelines are appropriately applied, there are zero false-positive determinations of death. They suggest including a social worker, psychologist, palliative care specialist, chaplain, and religious figure in conversations about brain death. They explain that ancillary testing is recommended to assess for lack of intracranial blood flow or cerebral activity if a clinical evaluation cannot be completed, but the gold standard for determination of brain death is a full clinical evaluation. Further, they add that ancillary testing is imperfect and there are risks when performing testing and interpreting the results. Finally, they remind the reader that the 1981 President's Commission determined that death should be defined based on complete loss of function of the brain or the heart and lungs, but deferred to the medical community to establish the specific criteria for determination of death. They stress that it is the medical community's responsibility to ensure that it is clear what constitutes "accepted medical standards" for determination of death and that these criteria are adhered to consistently and accurately.

Meta‐analysis of the use of Ofatumumab in the treatment of relapsing‐remitting multiple sclerosis

“…Ofatumumab is a completely human anti-CD20 monoclonal antibody that appears to be a safe and effective disease-modifying medication for patients with relapsing-remitting multiple sclerosis, according to the findings of this meta-analysis. Ofatumumab is also unique in that patients can selfadminister it at home, making it a convenient treatment option for patients [17,18]. It may be preferable for patients with more active disease, for those who prioritize efficacy highly, and for those who can tolerate risk.…”

“…Ofatumumab is a recently approved medication that serves as a disease-modifying therapy (DMT). Disease-modifying therapy (DMT) refers to a class of drugs used to treat multiple sclerosis (MS) that alter the underlying disease process rather than just treating symptoms [14][15][16][17][18]. These medications are designed to limit the progression of disability, lessen the frequency and severity of relapses, and slow down the start of secondary progressive MS [16,18].…”

“…These medications are designed to limit the progression of disability, lessen the frequency and severity of relapses, and slow down the start of secondary progressive MS [16,18]. Ofatumumab is the only monoclonal antibody that is available for patients to selfadminister at home [15][16][17]19]. This systematic review and meta-analysis use data from randomized clinical trials to assess the safety and effectiveness of ofatumumab in the treatment of relapsing-remitting multiple sclerosis.…”