Subcutaneous delivery of Tysabri favored over IV in patients with relapsing-remitting MS

Nearly 90% of patients with relapsing-remitting MS in a multicenter study in Germany preferred subcutaneous administration of Tysabri rather than IV, citing shorter duration of delivery and convenience, per a presentation at ECTRIMS 2022.

“Interim results of the observational, multicenter SISTER study provide real-world evidence on patient preference regarding Tysabri subcutaneous or IV administration, complementing available clinical study data,” Monica Mann, vice president of medical affairs for global MS and pipeline at Biogen, told Healio.

Researchers sought to assess patient preference for route of administration between subcutaneous and IV Tysabri (natalizumab, Biogen) at 6- and 12-month intervals. Other outcomes of interest included immunogenicity, disease specific parameters (expanded disability status scale [EDSS]) and pharmacoeconomic aspects.

They conducted an ongoing, prospective, open-label study in Germany and included roughly 500 adults with relapsing-remitting MS, who were divided into three cohorts: patients switching from IV to subcutaneous natalizumab (switcher, n = 300), those newly started on IV natalizumab (new starter IV, n = 100) and those newly started on subcutaneous natalizumab (new starter SC, n = 100).

According to interim analysis, 116 switcher patients (mean age, 39.3 years; 84.5% women; mean EDSS, 2), 11 new starter IV (mean age, 35.4 years; 100% women; mean EDSS, 2.6) and 14 new starter SC (mean age, 30.4 years; 100% women; mean EDSS, 0.6) were enrolled. Researchers reported that anti-JC virus antibody status was negative in 81.5% of patients, and the most frequent MS therapies used before natalizumab were fingolimod (n = 23), dimethyl fumarate (n = 18) and glatiramer acetate (n = 17).

According to Mann, 89.6% of patients preferred subcutaneous administration of natalizumab, with most (98.7%) expressing satisfaction with their choice. The most frequent reasons for selecting this option were shorter duration of administration and convenience.

"For those countries where it is available, subcutaneous administration has the potential to offer patients a more convenient treatment experience, with a shorter administration time than intravenous," Mann told Healio.