Assessing the long-term clinical benefit of prolonged-release fampridine tablets in a real-world setting: a review of 67 cases
Patient #2 was a 49-year-old white woman with a 27-year history of MS and secondary-progressive MS for the past 2 years. She had previously received intramuscular interferon β-1a, steroids, and rehabilitation therapy, but not compounded 4-AP. She was only receiving rehabilitation therapy once weekly at the time of the baseline visit. Patient #2 reported several MS-related symptoms (fatigue; imbalance; heat intolerance; and loss of sensation, weakness, muscle tightness, and spasticity in her lower limbs) and that her walking speed and distance had deteriorated over the past 2 years. She sometimes tripped and felt her walking was powerless and exhausting, which aggravated her existing fatigue. Her walking impairment made activities of daily living more difficult and exhausting to perform. Clinical examination at baseline revealed an EDSS score of 4.0; walking impairments that impacted distance, endurance, and balance; spastic paresis in her left leg, and slightly diminished left leg strength (LEMMT grade 4 out of 5); and a T25FW time of 7.1 seconds (walking speed, 1.07 m/second: see ).\nAfter 4 weeks of treatment with PR-fampridine, the patient reported that some days she noticed improvement in her walking speed and balance and experienced less exhaustion, but there were other days where she did not notice these improvements. She reported no change in fatigue. She wanted to continue treatment despite the lack of a consistent benefit. Clinical assessment at the 4-week follow-up visit found slight (7.5%) improvement in T25FW walking speed, a clinically meaningful 27-point improvement in MSWS-12 score ( and see ), and no changes in leg spasticity and strength. Based on physician assessment and patient report, this patient was considered to demonstrate modest clinical benefit with PR-fampridine treatment. It was agreed that the patient should continue treatment with PR-fampridine and be re-evaluated at the next visit.\nAt the 3-month visit, the patient showed a 15% improvement in T25FW walking speed versus baseline and sustained improvements in MSWS-12 score (). Furthermore, the patient reported that her walking endurance and balance had more clearly improved, her walking was smoother, and overall she felt more confident and powerful in her walking. She could now walk for 30 minutes without interruption, resting, or stopping. She reported that her fatigue had improved and she could participate more actively in daily tasks and leisure activities, which made her happy. Physician assessment showed no change in lower limb spasticity and strength from baseline, further improvement in T25FW walking speed versus baseline, and sustained improvement in MSWS-12 score (). Additionally, improvements in FSS score at 3 months compared with baseline reflected the patient’s verbal report of improvements in fatigue. The patient reported that mild dizziness, which she had initially reported at the 4-week visit, had resolved; however, she still experienced exacerbation of constipation that was an issue before starting PR-fampridine.\nAt the 6-month visit the patient reported that previous improvements in walking were sustained over the last 3 months of treatment and overall her walking was better with improved balance and self-confidence. Clinical assessments confirmed the patient report, which showed additional improvement in walking speed after 6 months of treatment (20.6% versus baseline), maintenance of benefits on patient-perceived walking ability, and fatigue (), and smoother walking as assessed by the treating physician versus baseline (see ). The patient also reported that her constipation was better and she was no longer experiencing dizziness.