Impact of Nursing Interventions on Reducing Adverse Events Related to Tecfidera
Oral dimethyl fumarate (DMF) is approved in the United States for the treatment of relapsing forms of multiple sclerosis (MS). In the Phase 3 DEFINE and CONFIRM studies, the most common adverse events associated with DMF included flushing and gastrointestinal (GI) events. For most patients, these events were mild or moderate in severity and decreased in incidence after the first month of treatment. In clinical practice, DMF-associated adverse events have been largely related to medication tolerability rather than serious safety concerns. Tolerability of a medication may affect adherence, which in turn may affect efficacy of the drug. However, tolerability-related adverse events of DMF can often be overcome with time. If adverse events due to tolerability are not managed early, appropriate patients may discontinue therapy prematurely.
To investigate the impact of a structured nursing initiation protocol (IP) on DMF adverse effects and adherence.
We are providing detailed written instructions and measure tolerability and adherence in a real world population anticipating that setting expectations early will have beneficial effects compared to what has been seen in other practices and as compared to the clinical trial experience. Additionally, we believe that even patients who have a difficult initial experience taking tecfidera, once on therapy and having overcome tolerability issues are very happy with their experience on the drug. A measure of patient satisfaction at this point in time will quantify this experience.
Patients are sent home with a Tecfdiera Patient Information Sheet, a Food Suggestion List, a Tecfidera Weekly Diary that tracks whether they took their medication with food, and what mitigation strategies they took (aspirin, Pepto-bismol, or other OTC medication); and whether or not they have flushing, diarrhea, nausea, vomiting, headache, rash or other symptoms. Measures are taken daily. In addition, our clinical practice utilizes an alternate titration schedule of 120 mg once a day for week 1 week and 2, followed by 240 mg once a day for week 3 and 4, followed by 240 mg twice a day.
To date 30 patients (N=50) have been enrolled and 18 have started medication using this protocol. Preliminary results show both GI and flushing side effects appear to be mitigated using the NYU Titration Protocol for Tecfidera. There have been no discontinuations to date.
The NYU Nursing Titration Protocol for Tecfidera appears to mitigate tolerability related side effects thus resulting in patience adherence. The study will be completed by March 2015 at which time we will have final results.