Retrospective Chart Review of the Amount of IV Fluids Administered and the Infusion Reactions Occurring in Patients Receiving Course One of Lemtrada

Background: Alemtuzumab received FDA approval for treatment of relapsing forms of Multiple Sclerosis in December 2014.  In clinical studies, 92% of patients receiving Alemtuzumab 12 mg experienced Infusion Associated Reactions (IAR)⁴.  Serious IAR's occurred in 3% of patients receiving alemtuzumab⁴.  Recommendations have been made to minimize severity and frequency of these reactions, including hydration and premedication with corticosteroids ^1,2,3.  No specifics regarding IV fluid hydration during infusions of alemtuzumab have been identified in the literature to date.  A PubMed literature search performed on 12/8/16 with the key words "intravenous fluids" and "alemtuzumab" did not yeild any results.  Furthermore, corticosteroids are associated with risk of sodium retention and resultant edema and potassium loss ^5.

Objectives: The purpose of this study is to determine if differing rates of concomitant IVF administration influence frequency and severity of IAR's.

Methods: Following IRB approval, we accessed the list of patients with Multiple Sclerosis that have been evaluated and treated with alemtuzumab by the physicians at Carolinas Healthcare System Multiple Sclerosis Center through the REMS program.  A total of 39 patients received alemtuzumab course one between the dates of 2/1/2015 and 1/31/2017.  A retrospective chart review identified basic clinical data such as daily total of concurrent IVF administration, dosages of corticosteroids, and the presence and severity of IAR's.  Parametric and non-parametric tests were used to analyze possible association between IV fluid hydration, concomitant medication and infusion reactions.  The tests were selected based on the question being asked of the database.

Results:  None of the factors identified were significantly associated with the presence or grade of an IAR.  Odds of a reaction were three times more likely on day 4 than day 1, but this was not statistically significant.  Odds of a reaction were greater when concurrent IVF amounts were greater than 500ml, but this was not statistically significant.  This study was limited by small sample size.

Conclusions: More research is needed to determine the optimal concurrent IVF administration with alemtuzumab.  

Resources available upon request and will be included with poster should this abstract be accepted.