A series of nurse-led interventions and patient education, along with titrated drug initiation, were the key components of a successful initiation protocol for patients with multiple sclerosis starting therapy on dimethyl fumarate. The new protocol resulted in fewer discontinuations than the standard initiation protocol.
Dimethyl fumarate (DMF) is a disease-modifying agent approved for use in the United States for treating relapsing forms of multiple sclerosis. It has the convenience of oral administration, but for some, gastrointestinal side effects and flushing are sufficiently bothersome to cause discontinuation.
A series of nurse-led interventions and patient education, along with titrated drug initiation, were key components of a successful initiation protocol for patients new to dimethyl fumarate. The new protocol, which resulted in fewer discontinuations than the standard initiation protocol recommended by the drug’s manufacturer, was trialed at New York University’s Langone MS Comprehensive Care Center for patients with relapsing multiple sclerosis as they began taking DMF.
Carrie Sammarco, DNP, FNP-C, and Lisa Laing, BSN, RN, MSCN, presented the center’s findings at a poster session of the sixth triennial Joint ECTRIMS-ACTRIMS meeting MS 2014, in Boston on September 11, 2014. The organizations are the European and Americas Committees for Treatment and Research in Multiple Sclerosis, respectively.
The investigators set the background for their work by citing the phase 3 DEFINE and CONFIRM clinical trials of DMF, in which approximately one-third of patients experienced flushing while on the twice-daily dose, while about 15% experienced nausea, diarrhea, or both at that dosing frequency.
The NYU initiation protocol (NYU-IP) developed by the investigators included: pre-initiation patient education about possible side effects from the medication, including the likelihood that symptoms would eventually abate; dietary instructions; and information about adjunct medications and dosing to help symptom management. Additionally, the protocol included dose titration, with patients beginning with 120 mg of DMF once daily for 14 days, progressing to 240 mg once daily for 14 days, then finally reaching the target dose of 240 mg twice daily.
Patients were advised to take their medication in the evening while on the once-daily dose, and to consume a modest amount of a high-fat, plant-based food, such as avocado or peanut butter, just before taking DMF or along with their dose. Pre-medicating with aspirin was presented as a strategy to manage flushing for those patients who were bothered by this symptom. All patients were screened for food and medication allergies. Patient education was modified to account for any allergies.
At the pre-initiation visit, nurses advised patients that they could take an over-the-counter antacid for gastrointestinal upset if needed. However, Sammarco said most patients did not require this intervention if they followed the dietary recommendations. “We really had to be specific in our recommendations about taking the medication right after the higher-fat food,” she said.
Patients seen at NYU’s center were randomized either to the pharmaceutical recommendations (PR-IP), n= 124, or to the NYU-IP, n=205. At six weeks after initiation, 14 patients on the PR-IP had discontinued their medication, compared with five in the NYU-IP group (12% vs. 2.5%, p=.0029). The side effects that had prompted discontinuation were gastrointestinal in nature for 10 PR-IP patients and four in the NYU-IP group (8% vs. 1.9%, p=.0215), and related to flushing for four PR-IP patients compared with one in the NYU-IP group (3.2% vs. 0.5%, p=.0733).
Discussion with the authors at the poster session highlighted the importance of helping patients be realistic about their therapy experience. “It’s all about managing expectations.” said Laing. Further, the study plays to the strengths of nurses. “This protocol lets nurses do what we do best — communicate with and teach the patient,” said Sammarco.