Understanding Concepts Important to Natalizumab Patients: A Qualitative Interview Study

Background: In the US, natalizumab is indicated for treating relapsing forms of MS, with over a decade of real-world evidence demonstrating reduction of relapses and delaying disability progression. Clinical trials have shown an improvement of patient-reported outcomes, including fatigue and quality of life, for patients treated with natalizumab. It is important to gain insights directly from natalizumab patients on the concepts that are meaningful to them. This will inform a better understanding of the full benefit-risk profile that may guide treatment decisions.

Objectives: To conduct a concept elicitation study to understand concepts that are the most meaningful to MS patients treated with natalizumab and how patients weigh the benefits/risks of treatment.

Methods: In person interviews were conducted using a semi-structured guide with patients recruited from 3 US clinical sites. Interviews were conducted in batches until concept saturation, no new concepts, was achieved. Concepts were tracked using a saturation matrix to document conceptual coverage and provide evidence of saturation. Subgroup analyses were conducted by duration of natalizumab therapy and JC virus (JCV) status.

Results: This study included 33 patients (79% female, 12.5 years mean disease duration, and 32.5 years mean age). About 50% were JCV+ (n=17) and duration on natalizumab ranged from 6 months-2 years (n=8), 2-4 years (n=12), and 4+ years (n=13). Patient-reported benefits included improvements in: symptoms (improved energy, walking/balance, cognition, vision), response to and management of medication (method/frequency of administration, lack of side-effects, monitoring), perception of health wellness (halting progression of disease, reassurance of being in-control of disease, feeling normal), and social functioning (increased freedom, improved social life/relationships/family life). The majority trusted their physician’s assessment and monitoring of progressive multifocal leukoencephalopathy (PML) risk, and most were either not concerned (n=15) or had become less concerned (n=13) about PML. Patients expressed that benefits outweighed risks (n=25).

Conclusions: The study provided insights into the concepts that are most meaningful to MS patients treated with natalizumab. Patient-reported benefits of natalizumab included symptom and functional improvements, which outweighed risks regardless of JCV status and treatment duration. Additional research is required to further understand and quantify concepts that are meaningful to patients.