Objectives: The goal of our pilot case series was to use ACTH to reduce inflammation after discontinuing natalizumab and before symptoms or new enhancing MS lesions occurred (an off-label use).
Methods: Patients who discontinued natalizumab due to JCV antibody positive status (alone or in combination with length of time on infusion) were treated with ACTH gel 80 units SQ QD x 5 days at Week 4, Month 2, and Month 3 after discontinuing natalizumab. Disease-modifying therapy (DMT) was initiated at Week 4 with glatiramer acetate (Copaxone®) or Week 6 with intravenous immunoglobulin (IVIG). Data collected included information from patient records, MRIs, and neurological exam.
Results: We report results for 5 patients (4 female, 1 male; aged 35-57 years) who have been treated with the ACTH protocol following discontinuation of natalizumab treatment (duration of 8-31 months); 4 patients also received glatiramer acetate and 1 received IVIG. At varying intervals for MRI surveillance (2 patients at 4 months; 1 patient each at 6, 7, and 12 months), patients did not develop symptoms of a clinical MS relapse or develop new enhancing lesions on MRI using a 3 Tesla magnet with gadolinium.
Conclusions: Patients who were treated using a protocol of monthly pulse ACTH and a DMT following discontinuation of natalizumab showed no increase in new enhancing T2 lesions on MRI and no new clinical relapse symptoms during up to 12 months of follow up.