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Rituximab De-escalation in Patients With Neuromyelitis Optica Spectrum Disorder
Stanislas Demuth1, Nicolas Collongues1, Bertrand Audoin1
1From the Department of Neurology (S.D., N.C., J.D.S.); Clinical Investigation Center (N.C., J.D.S.), Strasbourg University Hospital; Department of Neurology (B.A.), APHM, Hôpital de la Timone, Pôle de Neurosciences Cliniques, Marseille; Department of Neurology (X.A.), Montpellier University Hospital; Department of Neurology (B.B.), Rouen University Hospital; Department of Neurology CRC-SEP (J.C.), CHU Toulouse; Department of Neurology, CHU Poitiers (J.C.); Department of Neurology (M.C.), CHU de Nice, UR2CA-URRIS, Nice Côte d'Azur University; Department of Neurology (R.D.), Hôpital Fondation Adolphe de Rothschild, Paris; Department of Neurology (F.D.U.R.A.N.D.-D.U.B.I.E.F.), Sclérose en Plaques, Pathologies de la Myéline et Neuro-inflammation, Hôpital Neurologique, Hospices Civils de Lyon; Department of Neurology (E.M., C.P.), AP-HP, Pitié-Salpêtrière Hospital, Paris; Department of Neurology (Groupe Hospitalier Pellegrin) (A.R.), Centre Hospitalier Universitaire de Bordeaux; Université de Bordeaux (A.R.), INSERM U1215, Neurocentre Magendie; Department of Neurology (H.Z.), University Hospital of Lille, UFR3S Univ-Lille, Inserm U 1172; Service de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuro Inflammation (R.M.), and Centre de Référence des Maladies Inflammatoires Rares du Cerveau et de la Moelle (MIRCEM), Hôpital Neurologique Pierre Wertheimer, Bron; Centre des Neurosciences de Lyon-FORGETTING Team (R.M.), INSERM 1028 and CNRS UMR5292; and Université Claude Bernard Lyon 1 (R.M.), France.
Background And Objectives:
Exit strategies such as de-escalations have not been evaluated for rituximab in patients with neuromyelitis optica spectrum disorder (NMOSD). We hypothesized that they are associated with disease reactivations and aimed to estimate this risk.
Methods:
We describe a case series of real-world de-escalations from the French NMOSD registry (NOMADMUS). All patients met the 2015 International Panel for NMO Diagnosis (IPND) diagnostic criteria for NMOSD. A computerized screening of the registry extracted patients with rituximab de-escalations and at least 12 months of subsequent follow-up. We searched for 7 de-escalation regimens: scheduled discontinuations or switches to an oral treatment after single infusion cycles, scheduled discontinuations or switches to an oral treatment after periodic infusions, de-escalations before pregnancies, de-escalations after tolerance issues, and increased infusion intervals. Rituximab discontinuations motivated by inefficacy or for unknown purposes were excluded. The primary outcome was the absolute risk of NMOSD reactivation (one or more relapses) at 12 months. AQP4+ and AQP4- serotypes were analyzed separately.
Results:
We identified 137 rituximab de-escalations between 2006 and 2019 that corresponded to a predefined group: 13 discontinuations after a single infusion cycle, 6 switches to an oral treatment after a single infusion cycle, 9 discontinuations after periodic infusions, 5 switches to an oral treatment after periodic infusions, 4 de-escalations before pregnancies, 9 de-escalations after tolerance issues, and 91 increased infusion intervals. No group remained relapse-free over the whole de-escalation follow-up (mean: 3.2 years; range: 0.79-9.5), except pregnancies in AQP+ patients. In all groups combined and within 12 months, reactivations occurred after 11/119 de-escalations in patients with AQP4+ NMOSD (9.2%, 95% CI [4.7-15.9]), from 0.69 to 10.0 months, and in 5/18 de-escalations in patients with AQP4- NMOSD (27.8%, 95% CI [9.7-53.5]), from 1.1 to 9.9 months.
Discussion:
There is a risk of NMOSD reactivation whatever the rituximab de-escalation regimen.
Trial Registration Information:
Registered on ClinicalTrials.gov: NCT02850705.
Classification Of Evidence:
This study provides Class IV evidence that de-escalation of rituximab increases the probability of disease reactivation.
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