Mark Gudesblatt, Barbara Bumstead, Marijean Buhse, Myassar Zarif, Sarah A. Morrow, Jacqueline A. Nicholas, Laura M. Hancock, Jeffrey Wilken, Joanna Weller, Nicole Scott, Anne Gocke, James B. Lewin, Olivia Kaczmarek, Jason P. Mendoza, Daniel Golan
{"title":"出于安全考虑，降低多发性硬化症患者病情缓解疗法的等级：从奥克立珠单抗转为富马酸双嘧达莫的 25 名患者的 1 年疗效特征。","authors":"Mark Gudesblatt, Barbara Bumstead, Marijean Buhse, Myassar Zarif, Sarah A. Morrow, Jacqueline A. Nicholas, Laura M. Hancock, Jeffrey Wilken, Joanna Weller, Nicole Scott, Anne Gocke, James B. Lewin, Olivia Kaczmarek, Jason P. Mendoza, Daniel Golan","doi":"10.1007/s12325-024-02902-0","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>Switching disease-modifying therapy (DMT) may be considered for relapsing–remitting multiple sclerosis (RRMS) if a patient’s current therapy is no longer optimal. This was particularly important during the recent COVID-19 pandemic because of considerations around immune deficiency and impaired vaccine response associated with B cell-depleting DMTs. This real-world, single-center study aimed to evaluate change or decline in functional ability and overall disease stability in people with RRMS who were switched from B cell-depleting ocrelizumab (OCRE) to diroximel fumarate (DRF) because of safety concern related to the COVID-19 pandemic.</p><h3>Methods</h3><p>Adults with RRMS were included if they had been clinically stable for ≥ 1 year on OCRE. Data collected at baseline and 1 year post switch included relapse rate, magnetic resonance imaging (MRI), blood work for assessment of peripheral immune parameters, the Cognitive Assessment Battery (CAB), optical coherence tomography (OCT), and patient-reported outcomes (PROs).</p><h3>Results</h3><p>Participants (<i>N</i> = 25) had a mean (SD) age of 52 (9) years, and a mean (SD) duration of 26 (8) months’ treatment with OCRE before the switch to DRF. Median washout duration since the last OCRE infusion was 7 months (range 4–18 months). No participants relapsed on DRF during follow-up, and all remained persistent on DRF after 1 year. There were no significant changes in peripheral immune parameters, other than an increase in the percentage of CD19<sup>+</sup> cells 1 year after switching (<i>p</i> < 0.05). Similarly, there were no significant changes in CAB, OCT, and PROs.</p><h3>Conclusion</h3><p>These preliminary findings suggest that transition to DRF from OCRE may be an effective treatment option for people with RRMS who are clinically stable but may need to switch for reasons unrelated to effectiveness. Longer follow-up times on larger samples are needed to confirm these observations.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":null,"pages":null},"PeriodicalIF":3.4000,"publicationDate":"2024-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263251/pdf/","citationCount":"0","resultStr":"{\"title\":\"De-escalation of Disease-Modifying Therapy for People with Multiple Sclerosis Due to Safety Considerations: Characterizing 1-Year Outcomes in 25 People Who Switched from Ocrelizumab to Diroximel Fumarate\",\"authors\":\"Mark Gudesblatt, Barbara Bumstead, Marijean Buhse, Myassar Zarif, Sarah A. Morrow, Jacqueline A. Nicholas, Laura M. Hancock, Jeffrey Wilken, Joanna Weller, Nicole Scott, Anne Gocke, James B. Lewin, Olivia Kaczmarek, Jason P. Mendoza, Daniel Golan\",\"doi\":\"10.1007/s12325-024-02902-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>Switching disease-modifying therapy (DMT) may be considered for relapsing–remitting multiple sclerosis (RRMS) if a patient’s current therapy is no longer optimal. This was particularly important during the recent COVID-19 pandemic because of considerations around immune deficiency and impaired vaccine response associated with B cell-depleting DMTs. This real-world, single-center study aimed to evaluate change or decline in functional ability and overall disease stability in people with RRMS who were switched from B cell-depleting ocrelizumab (OCRE) to diroximel fumarate (DRF) because of safety concern related to the COVID-19 pandemic.</p><h3>Methods</h3><p>Adults with RRMS were included if they had been clinically stable for ≥ 1 year on OCRE. Data collected at baseline and 1 year post switch included relapse rate, magnetic resonance imaging (MRI), blood work for assessment of peripheral immune parameters, the Cognitive Assessment Battery (CAB), optical coherence tomography (OCT), and patient-reported outcomes (PROs).</p><h3>Results</h3><p>Participants (<i>N</i> = 25) had a mean (SD) age of 52 (9) years, and a mean (SD) duration of 26 (8) months’ treatment with OCRE before the switch to DRF. Median washout duration since the last OCRE infusion was 7 months (range 4–18 months). No participants relapsed on DRF during follow-up, and all remained persistent on DRF after 1 year. There were no significant changes in peripheral immune parameters, other than an increase in the percentage of CD19<sup>+</sup> cells 1 year after switching (<i>p</i> < 0.05). Similarly, there were no significant changes in CAB, OCT, and PROs.</p><h3>Conclusion</h3><p>These preliminary findings suggest that transition to DRF from OCRE may be an effective treatment option for people with RRMS who are clinically stable but may need to switch for reasons unrelated to effectiveness. 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De-escalation of Disease-Modifying Therapy for People with Multiple Sclerosis Due to Safety Considerations: Characterizing 1-Year Outcomes in 25 People Who Switched from Ocrelizumab to Diroximel Fumarate
Introduction
Switching disease-modifying therapy (DMT) may be considered for relapsing–remitting multiple sclerosis (RRMS) if a patient’s current therapy is no longer optimal. This was particularly important during the recent COVID-19 pandemic because of considerations around immune deficiency and impaired vaccine response associated with B cell-depleting DMTs. This real-world, single-center study aimed to evaluate change or decline in functional ability and overall disease stability in people with RRMS who were switched from B cell-depleting ocrelizumab (OCRE) to diroximel fumarate (DRF) because of safety concern related to the COVID-19 pandemic.
Methods
Adults with RRMS were included if they had been clinically stable for ≥ 1 year on OCRE. Data collected at baseline and 1 year post switch included relapse rate, magnetic resonance imaging (MRI), blood work for assessment of peripheral immune parameters, the Cognitive Assessment Battery (CAB), optical coherence tomography (OCT), and patient-reported outcomes (PROs).
Results
Participants (N = 25) had a mean (SD) age of 52 (9) years, and a mean (SD) duration of 26 (8) months’ treatment with OCRE before the switch to DRF. Median washout duration since the last OCRE infusion was 7 months (range 4–18 months). No participants relapsed on DRF during follow-up, and all remained persistent on DRF after 1 year. There were no significant changes in peripheral immune parameters, other than an increase in the percentage of CD19+ cells 1 year after switching (p < 0.05). Similarly, there were no significant changes in CAB, OCT, and PROs.
Conclusion
These preliminary findings suggest that transition to DRF from OCRE may be an effective treatment option for people with RRMS who are clinically stable but may need to switch for reasons unrelated to effectiveness. Longer follow-up times on larger samples are needed to confirm these observations.
期刊介绍：
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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