Author Of 2 Presentations
P0371 - Practice improvement by retrospective analysis of changes in lymphocyte levels in patients with multiple sclerosis on dimethyl fumarate. (ID 394)
Abstract
Background
There are currently no recommendations on lymphocyte subset monitoring as best practice for patients on disease-modifying therapies, including dimethyl fumarate (DMF). Instead, patients are monitored for general lymphocyte count, which may mask changes in subsets of clinically relevant cell populations. There have been several cases of patients on DMF without severe lymphopenia but did have a high CD4+:CD8+ T cell ratio who went on to develop progressive multifocal leukoencephalopathy (PML), caused by the reactivation of John Cunningham virus (JCV). These incidents suggest that monitoring changes in subpopulations is clinically relevant and important. Since CD3+CD8+ (CD8+) T cells and CD3-CD56+ Natural Killer (NK) cells are primarily responsible for eliminating cells with actively replicating viruses., changes in circulating levels of these specific populations of cells may put patients at risk of developing recurring infections, including JCV.
Objectives
Our objective was to characterize the changes in immune profile associated with use of DMF. We hypothesized that CD4+ T cells counts would remain relatively stable while CD8+T cells and NK cell levels would decrease. Demonstrating changes in the relevant lymphocyte populations in our cohort will promote monitoring and assessment of lymphocyte subpopulations of patients on DMF.
Methods
A retrospective analysis of longitudinal data from 299 patients who have been treated with dimethyl fumarate at the Fraser Health Multiple Sclerosis clinic in British Columbia, Canada. The blood test results date range from January 1 2013- April 1 2020. The following cell populations were analysed: white blood cells, neutrophils, lymphocytes, CD3+CD4+ T cells, CD3+CD8+ T cells, CD3+ cells, CD19+ B cells and CD3-CD56+ NK cells. We created a linear regression model to estimate average changes in lymphocyte subpopulation counts.
Results
On average, our patients remain on DMF for 31 months, after which time CD8+ T cell count decreases by -67% and reaching lower range after 21 months. CD4:CD8 T cell ratio increases 41.6% and reaches upper range only 2 months after treatment start. White blood cells, lymphocytes, CD4+ T cells and NK cells also decrease (-29%, -49%, -48% and -52%, respectively) but at a much slower rate. During recovery, while CD8+ T cells, CD4+ T cells, NK cells and lymphocytes were able to recover in 3-4 months, CD4:CD8 T cell ratio would not recover until 9 months after treatment end.
Conclusions
Our results suggest that lymphocyte count may not be sensitive enough to detect early and critical changes to lymphocyte subsets that may be important for preventing viral infection.
P0842 - Changes in Copaxone usage of MS patients within British Columbia upon recommended switch to generic. (ID 424)
Abstract
Background
Recently, BC Pharmacare decided to discontinue coverage of Copaxone, a first line disease modifying therapy (DMT), in place of Glatect, a new bio-similar glatiramer that has a lower cost. Our clinic informed each patient of the change in coverage and asked whether they would prefer to remain on Copaxone, switch to the biosimilar or switch to a different DMT all together.
Objectives
We looked to investigate whether the traditional forces, those being patient and physician collaborative decision making, would still be in use for patients using Copaxone, or if other forces would result in decision making of medication usage. Our objective was to determine which forces guide a patient’s decision to use DMTs when faced with an opportunity to switch.
Methods
A chart review study was conducted to identify patterns and causes for changes in medication usage among patients with MS at the Fraser Health Multiple Sclerosis Clinic in British Columbia, Canada.
Results
A total of 79 patients that had been using or have previously and recently used Copaxone as of November 2018 were reviewed. Of these 79 patients, 51 (65%) had documented their primary rationale for discontinuing use of Copaxone in favour of another drug as due to the BC Pharmacare coverage changes. Of those 52 patients, 34 patients had already started or planned to start Glatect, 5 patients chose to remain on Copaxone, while 7 patients chose to remain on Copaxone if their insurance covered it, and if not would begin Glatect. Of the remaining patients, 4 chose to not use any DMT, while the other 23 had already switched or were planning to switch to an oral DMT, Ocrelizumab or Tysabri. Those that chose to not use Copaxone or Glatect did so because they either wanted to use an oral medication or needed to use a stronger medication due to progression of their disease while on Copaxone.
Conclusions
Traditionally changes in medication management occur as a collaborative effort between patient and physician. Our review points to a new force, the BC Pharmacare coverage drop of Copaxone, as a factor that influences DMT decision-making. It is clear in this scenario that this change was influenced not only by a medical necessity but also by financial decision and thus this variable should be considered during DMT decision-making.