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| Item Type: | Article |
|---|---|
| Title: | International delphi consensus on the management of AQP4-IgG+ NMOSD: recommendations for eculizumab, inebilizumab, and satralizumab |
| Creators Name: | Paul, F., Marignier, R., Palace, J., Arrambide, G., Asgari, N., Bennett, J.L., Cree, B.A.C., De Sèze, J., Fujihara, K., Kim, H.J., Hornby, R., Huda, S., Kissani, N., Kleiter, I., Kuwabara, S., Lana-Peixoto, M., Law, L., Leite, M.I., Pandit, L., Pittock, S.J., Quan, C., Ramanathan, S., Rotstein, D., Saiz, A., Sato, D.K. and Vaknin-Dembinsky, A. |
| Abstract: | BACKGROUND AND OBJECTIVES: Neuromyelitis optica spectrum disorder (NMOSD) is a rare debilitating autoimmune disease of the CNS. Three monoclonal antibodies were recently approved as maintenance therapies for aquaporin-4 immunoglobulin G (AQP4-IgG)-seropositive NMOSD (eculizumab, inebilizumab, and satralizumab), prompting the need to consider best practice therapeutic decision-making for this indication. Our objective was to develop validated statements for the management of AQP4-IgG-seropositive NMOSD, through an evidence-based Delphi consensus process, with a focus on recommendations for eculizumab, inebilizumab, and satralizumab. METHODS: We recruited an international panel of clinical experts in NMOSD and asked them to complete a questionnaire on NMOSD management. Panel members received a summary of evidence identified through a targeted literature review and provided free-text responses to the questionnaire based on both the data provided and their clinical experience. Responses were used to generate draft statements on NMOSD-related themes. Statements were voted on over a maximum of 3 rounds; participation in at least 1 of the first 2 rounds was mandatory. Panel members anonymously provided their level of agreement (6-point Likert scale) on each statement. Statements that failed to reach a predefined consensus threshold (≥67%) were revised based on feedback and then voted on in the next round. Final statements were those that met the consensus threshold (≥67%). RESULTS: The Delphi panel comprised 24 experts, who completed the Delphi process in November 2021 after 2 voting rounds. In round 1, 23/25 statements reached consensus and were accepted as final. The 2 statements that failed to reach consensus were revised. In round 2, both revised statements reached consensus. Twenty-five statements were agreed in total: 11 on initiation of or switching between eculizumab, inebilizumab, and satralizumab; 3 on monotherapy/combination therapy; 7 on safety and patient population considerations; 3 on biomarkers/patient-reported outcomes; and 1 on research gaps. DISCUSSION: An established consensus method was used to develop statements relevant to the management of AQP4-IgG-seropositive NMOSD. These international statements will be valuable for informing individualized therapeutic decision-making and could form the basis for standardized practice guidelines. |
| Keywords: | Aquaporin 4, Consensus, Delphi Technique, Immunoglobulin G, Neuromyelitis Optica |
| Source: | Neurology Neuroimmunology & Neuroinflammation |
| ISSN: | 2332-7812 |
| Publisher: | American Academy of Neurology |
| Volume: | 10 |
| Number: | 4 |
| Page Range: | e200124 |
| Date: | July 2023 |
| Official Publication: | https://doi.org/10.1212/NXI.0000000000200124 |
| PubMed: | View item in PubMed |
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