Prevention and Management of Infusion-Associated Reactions in the Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis (CARE-MS) Program

Caon, Christina; Namey, Marie; Meyer, Cathy; Mayer, Lori; Oyuela, Pedro; Margolin, David; Rizzo, Marco

doi:10.7224/1537-2073.2014-030

Cited by 40 publications

(43 citation statements)

References 15 publications

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“…The main result of this study was a sustained effect of alemtuzumab after a completed 1-year treatment cycle. Finally, in a recent international study on behalf of the MSBase Study Group (published in February 2017), alemtuzumab proved superior to IFN β and fingolimod in reducing relapse rate, demonstrating similar effect to that of natalizumab 17. This cohort study compared alemtuzumab with 3 other agents, namely, natalizumab, fingolimod and IFN β 1a, in patients with RRMS treated for up to 5 years.…”

Section: Methodsmentioning

confidence: 89%

Alemtuzumab: a review of efficacy and risks in the treatment of relapsing remitting multiple sclerosis

Guarnera¹,

Bramantı²,

Mazzon³

2017

TCRM

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Alemtuzumab is a selective humanized monoclonal antibody directed against the CD52 antigen, and has been found to be a powerful treatment for relapsing remitting multiple sclerosis. Alemtuzumab demonstrated high efficacy in several clinical studies. The risk of relapse and sustained accumulation of disability showed significant reduction in the Phase II CAMMS223 and the Phase III clinical trials CARE MS I and CARE MS II. The data presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis confirmed these results. After completion of a 1-year treatment cycle, alemtuzumab showed a sustained effect. Although the efficacy of alemtuzumab has been widely proven, several severe adverse effects have been reported with its use. Infusion-associated reactions, increased risk of infections, and secondary autoimmunity have been associated with alemtuzumab. Autoimmune disease – mainly of the thyroid – has been reported. Immune thrombocytopenic purpura and autoimmune nephropathies have been observed less frequently. These adverse effects, given the short period of alemtuzumab marketing for relapsing remitting multiple sclerosis, require strict monitoring.

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Section: Methodsmentioning

confidence: 89%

Alemtuzumab: a review of efficacy and risks in the treatment of relapsing remitting multiple sclerosis

Guarnera¹,

Bramantı²,

Mazzon³

2017

TCRM

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“…The most frequently reported AEs in clinical trials were infusion-associated reactions (IARs), experienced by >90% of patients, which peaked immediately following the initial alemtuzumab course and then decreased with subsequent courses [21, 22]. Few (≤3%) serious IARs were reported [9, 11–13, 21, 23, 24].…”

Section: Clinical Trial Experience With Alemtuzumabmentioning

confidence: 99%

Alemtuzumab Use in Clinical Practice: Recommendations from European Multiple Sclerosis Experts

et al. 2016

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Alemtuzumab (Lemtrada™) is a humanized monoclonal antibody approved in more than 50 countries. Within the European Union, alemtuzumab is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features; in the USA, the indication states that alemtuzumab should generally be reserved for the treatment of patients with relapsing forms of multiple sclerosis who have had an inadequate response to two or more disease-modifying therapies (DMTs). In clinical trials, alemtuzumab demonstrated efficacy in treatment-naïve patients with active RRMS and those relapsing on prior DMTs, with a consistent and manageable safety and tolerability profile. The European Union indication provides physicians with significant flexibility regarding treatment decisions, affording the opportunity for individualized treatment. Thus, alemtuzumab may be an appropriate treatment choice across a broad range of patients with RRMS, including, for example, treatment-naïve patients with active disease, patients with highly active disease, or for patients relapsing on prior DMTs. There are several practicalities to consider when using alemtuzumab, including the unique dosing regimen, administered via intravenous infusion on 5 consecutive days at baseline and on 3 consecutive days 12 months later, and as-needed retreatment (3 consecutive days at least 12 months after the last course) in cases of disease recurrence. Additionally, routine monthly monitoring is required for up to 48 months after the last infusion to promptly identify potentially serious autoimmune adverse events. Given these considerations, it is beneficial to gain insight into how alemtuzumab is being used in the real-world clinical setting. Here, we report recommendations from European multiple sclerosis experts regarding best practices for alemtuzumab treatment, including management of adverse events and compliance with ongoing safety monitoring requirements.

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“…The day before Alemtuzumab infusion, H1 and H2 blockade should be initiated which could be applied beyond the infusion week if necessary [30,50]. An antipyretic, given 30-60 min before infusion, may help to reduce the infusion reaction.…”

Section: Alemtuzumab Infusion Managementmentioning

confidence: 99%

“…Pivotal studies not using standardized infusion procedure and methylprednisolone pre-treatment demonstrated higher levels of serum cytokines and significant more IARs after initial alemtuzumab infusions [51]. Pre-and concomitant methylprednisolone treatment incorporated into the standard infusion protocol may attenuate cytokine release syndrome and help reduce infusion-associated reactions to enhance patient tolerance [50]. This protocol is based on the procedure in pivotal studies.…”

Section: Alemtuzumab Infusion Managementmentioning

confidence: 99%

“…Other infusions could be applied using the same intravenous port as Alemtuzumab, a paravenous infusion is not critical as Alemtuzumab is a monoclonal antibody and not a chemotherapy. The infusion-associated reactions (IAR) occur in up to 90 % of patients treated with Alemtuzumab [50]. Skin reactions are observed predominantly.…”

Section: Alemtuzumab Infusion Managementmentioning

confidence: 99%

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Hands on Alemtuzumab-experience from clinical practice: whom and how to treat

Hassoun

Eisele

Thomas

et al. 2016

Mult Scler Demyelinating Disord

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Alemtuzumab is a monoclonal antibody, which was recently approved for the treatment of active relapsing remitting multiple sclerosis. Its main mechanism of action is based on targeting CD52, an antigen of unknown function which is found on B and T lymphocytes, leading to depletion followed by repopulation of these cells. The high efficacy of Alemtuzumab in controlling relapsing remitting MS has been shown in several clinical trials. This new therapy approach is associated with a specific side effects profile requiring regular longterm monitoring. The most important side effects are infusion-associated reactions, a slight increase of infections as well as autoimmune events in almost one third of treated patients. Based on two years of clinical experience in Germany, this review covers the first steps with the careful patient selection to be treated with Alemtuzumab over the preparation steps and the infusion courses up to the longterm monitoring after Alemtuzumab treatment.

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Prevention and Management of Infusion-Associated Reactions in the Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis (CARE-MS) Program

Abstract: Nurses played an invaluable role in the detection and management of IARs in the CARE-MS studies. Best practices for management of IARs associated with alemtuzumab include patient and caregiver education, medication to lessen IAR severity, infusion monitoring, and discharge planning.

Cited by 40 publications

References 15 publications

Alemtuzumab: a review of efficacy and risks in the treatment of relapsing remitting multiple sclerosis

Alemtuzumab: a review of efficacy and risks in the treatment of relapsing remitting multiple sclerosis

Alemtuzumab Use in Clinical Practice: Recommendations from European Multiple Sclerosis Experts

Hands on Alemtuzumab-experience from clinical practice: whom and how to treat

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