The study, ”Long-term natalizumab treatment is associated with sustained improvements in quality of life in patients with multiple sclerosis,” appeared in the journal “Patient Preference and Adherence”.
Patients with MS experience a progressive deterioration of their health-related quality of life (HRQoL). Current treatments for MS aim at alleviating inflammation. However, the information on clinical effectiveness would benefit from the use of patient-reported data on treatment satisfaction and HQRoL.
Tysabri is a disease-modifying therapy for RMS, previously shown in the AFFIRM Phase 3 trial (NCT00027300) to reduce relapses, risk of disease progression, and disease activity. Over the course of two years, patients treated with Tysabri showed further improvements in physical disability and in physical and mental HQRoL. Although these results also were observed in the clinical setting for more than one year of therapy with Tysabri, long-term data of HRQoL have yet to be analyzed.
The research was led by John F. Foley, MD, a neurologist and founder of the Rocky Mountain MS Research Group, in Salt Lake City, Utah. The study was funded by Biogen, the Cambridge, Massachusetts, company that developed Tysabri.
The scientists evaluated Tysabri treatment satisfaction and HQRoL for three years. Additionally, the study determined whether baseline disease level, years since diagnosis, or age at treatment initiation, influenced the effect of Tysabri on HRQoL.
Treatment consisted of an intravenous 300 mg dose of Tysabri every four weeks. A total of 333 eligible RMS patients were enrolled in the study. Patients completed three surveys every six months for three years – one regarding their physical and mental health, another analyzing MS-specific physical and psychological impact from the patient’s perspective, and the third survey on the patient’s satisfaction with medication.
The results revealed significant improvements in physical and mental health components from baseline to year three. Furthermore, MS-specific physical and psychological impacts were reduced by treatment.
The data also showed that patients with less physical disability (0-2 in a scale that goes up to 6) had significant improvement in physical scores throughout the study. MS patients with more severe physical disability (3-6) at baseline remained stable over three years.
The research also demonstrated that younger patients (less than 48 years old) and patients who were diagnosed less than 10 years prior to the study had significant improvement in HQRoL. Disease-related scores for patients older than 48 years, or with more than 10 years since MS diagnosis, were unchanged.
Importantly, satisfaction with the effectiveness and convenience of treatment increased significantly from baseline to year one and remained stable in the following two years. This result suggests preference over prior therapies and matches data from the literature.
Overall, the results support the use of Tysabri in the clinical setting and “underscore the importance of treating patients early in the disease course, before the accumulation of physical disability,” the researchers wrote.
The analysis showed significant improvements in psychological scores from baseline, irrespective of baseline MS severity, time since diagnosis, or age. These findings indicate that Tysabri “has a beneficial effect on mental and psychological HRQoL in MS patients regardless of their baseline level of functional disability,” the researchers concluded.
Future studies, they suggested, should include patients outside the U.S., assess reasons from therapy dropout, and include patients who did not complete the three-year protocol to avoid selecting only those with greater improvements and/or greater satisfaction.