Ofatumumab for treating autoimmune nodopathy.

Abstract

Background and aims: To investigate the treatment of ofatumumab in autoimmune nodopathy (AN).

Methods: An open-label, prospective, observational study was conducted in patients with AN. The regimen was 20 mg ofatumumab subcutaneously on day 0, 7, 14, 28, and subsequently every 4 weeks in a total of 24 weeks. The primary endpoint of the study was the proportion of patients with confirmed clinical improvement.

Results: All of the eight patients (100%) improved at Week 24. The median time to improvement was 8 (IQR: 7-10) weeks. The four patients previously treated with rituximab and two with irregular injections of ofatumumab (OFA) improved. At Week 24, the adjusted INCAT score, MRC sum score, cI-RODS, and grip strength in nondominant hand significantly improved from baseline. In nerve conduction studies, all of the six patients with available data (100%) improved. The median sNfL significantly reduced from baseline at Week 8. Anti-paranodal antibody in seven patients with anti-NF155 antibodies reduced from baseline at Week 20. In seven of the eight patients, CD19+ B cells were significantly reduced at Week 4. No serious adverse events were reported.

Interpretation: The regimen was 20 mg ofatumumab subcutaneously on day 0, 7, 14, 28, and every 4 weeks from Week 4, in a total of 24 weeks. The ofatumumab therapy may provide a more convenient and safer treatment for patients with AN, while serving as an effective alternative for those who did not respond to rituximab.