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| Item Type: | Article |
|---|---|
| Title: | Interleukin-6 receptor blockade in treatment-refractory MOG-IgG-associated disease and neuromyelitis optica spectrum disorders |
| Creators Name: | Ringelstein, M., Ayzenberg, I., Lindenblatt, G., Fischer, K., Gahlen, A., Novi, G., Hayward-Könnecke, H., Schippling, S., Rommer, P.S., Kornek, B., Zrzavy, T., Biotti, D., Ciron, J., Audoin, B., Berthele, A., Giglhuber, K., Zephir, H., Kümpfel, T., Berger, R., Röther, J., Häußler, V., Stellmann, J.P., Whittam, D., Jacob, A., Kraemer, M., Gueguen, A., Deschamps, R., Bayas, A., Hümmert, M.W., Trebst, C., Haarmann, A., Jarius, S., Wildemann, B., Grothe, M., Siebert, N., Ruprecht, K., Paul, F., Collongues, N., Marignier, R., Levy, M., Karenfort, M., Deppe, M., Albrecht, P., Hellwig, K., Gold, R., Hartung, H.P., Meuth, S.G., Kleiter, I. and Aktas, O. |
| Abstract: | BACKGROUND AND OBJECTIVES: To evaluate the long-term safety and efficacy of tocilizumab (TCZ), a humanized anti-interleukin-6 receptor antibody in myelin oligodendrocyte glycoprotein-IgG-associated disease (MOGAD) and neuromyelitis optica spectrum disorders (NMOSD). METHODS: Annualized relapse rate (ARR), Expanded Disability Status Scale score, MRI, autoantibody titers, pain, and adverse events were retrospectively evaluated in 57 patients with MOGAD (n = 14), aquaporin-4 (AQP4)-IgG seropositive (n = 36), and seronegative NMOSD (n = 7; 12%), switched to TCZ from previous immunotherapies, particularly rituximab. RESULTS: Patients received TCZ for 23.8 months (median; interquartile range 13.0-51.1 months), with an IV dose of 8.0 mg/kg (median; range 6-12 mg/kg) every 31.6 days (mean; range 26-44 days). For MOGAD, the median ARR decreased from 1.75 (range 0.5-5) to 0 (range 0-0.9; p = 0.0011) under TCZ. A similar effect was seen for AQP4-IgG+ (ARR reduction from 1.5 [range 0-5] to 0 [range 0-4.2]; p < 0.001) and for seronegative NMOSD (from 3.0 [range 1.0-3.0] to 0.2 [range 0-2.0]; p = 0.031). During TCZ, 60% of all patients were relapse free (79% for MOGAD, 56% for AQP4-IgG+, and 43% for seronegative NMOSD). Disability follow-up indicated stabilization. MRI inflammatory activity decreased in MOGAD (p = 0.04; for the brain) and in AQP4-IgG+ NMOSD (p < 0.001; for the spinal cord). Chronic pain was unchanged. Regarding only patients treated with TCZ for at least 12 months (n = 44), ARR reductions were confirmed, including the subgroups of MOGAD (n = 11) and AQP4-IgG+ patients (n = 28). Similarly, in the group of patients treated with TCZ for at least 12 months, 59% of them were relapse free, with 73% for MOGAD, 57% for AQP4-IgG+, and 40% for patients with seronegative NMOSD. No severe or unexpected safety signals were observed. Add-on therapy showed no advantage compared with TCZ monotherapy. DISCUSSION: This study provides Class III evidence that long-term TCZ therapy is safe and reduces relapse probability in MOGAD and AQP4-IgG+ NMOSD. |
| Keywords: | Aquaporin 4, CNS Demyelinating Autoimmune Diseases, Health Care Outcome Assessment, Humanized Monoclonal Antibodies, Interleukin-6 Receptors, Myelin-Oligodendrocyte Glycoprotein, Neuromyelitis Optica, Secondary Prevention |
| Source: | Neurology Neuroimmunology & Neuroinflammation |
| ISSN: | 2332-7812 |
| Publisher: | American Academy of Neurology |
| Volume: | 9 |
| Number: | 1 |
| Page Range: | e1100 |
| Date: | January 2022 |
| Official Publication: | https://doi.org/10.1212/NXI.0000000000001100 |
| PubMed: | View item in PubMed |
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