Abstract
ObjectiveThe aim of the RIN-2 study was a compassionate use of rituximab (RTX) for patients who completed the RIN-1 study, a multicentre, randomised, double-blind, placebo-controlled trial of RTX. We also investigated the long-term safety and efficacy of RTX. MethodsA study design was a prospective open-label extension study following the RIN-1 study. RTX was infused repeatedly under monthly monitoring of CD19-positive and CD 20-positive B cell lymphocyte subsets from 24 weeks after an infusion. ResultsThirty-three (87%) of 38 patients of the RIN-1 study were enrolled from February 2016 to March 2019 at six sites in Japan. In RIN-2, RTX was administered three times (median, range 1–5 times), and the interval of RTX administrations were 9.5 [2.5] months (mean [SD]). The observation period was 20.5 [10.1] months. During the trial, three patients dropped out due to two withdrawals and one adverse event. During the study, 28 (90%) of 31 patients were treated with RTX monotherapy. Neuromyelitis optica (NMO) relapses were observed in two patients. The annualized relapse rate (ARR) was 0.035 counts per person-years, ∼1/10th compared with 0.321 in the placebo arm of the RIN-1 study. We observed 14 severe adverse events in six (18%) and 156 adverse events, of which 135 were grade 1, 11 were grade 2 and 10 were grade 3. ConclusionsUnder B cell monitoring, the interval of RTX re-infusion was elongated to nine months, and NMO relapses were suppressed with 0.035 of ARR.
Highlights
B cell depletion therapy by rituximab (RTX), an anti-CD20 mono clonal antibody, has been therapeutically recognised for over a decade for patients with neuromyelitis optica (NMO)
In addition to the RIN-1 study, other randomized controlled trials of newly developed drugs for NMO spectrum disorders (NMOSD) have been conducted: eculizumab, satralizumab and inebilizumab were approved as new drugs for NMOSD (Pittock et al, 2019; Yamamura et al, 2019; Traboulsee et al, 2020; Cree et al, 2019)
Thirty-three (87%) patients of 38 from the RIN-1 study were enrolled into RIN-2
Summary
B cell depletion therapy by rituximab (RTX), an anti-CD20 mono clonal antibody, has been therapeutically recognised for over a decade for patients with neuromyelitis optica (NMO). After the first report of RTX in 2005 (Cree et al, 2005), several retrospective and open-label studies were published, with a systematic review showing RTX effi cacy and tolerability (Damato et al, 2016). Based on this accumulated evidence, NMO guidelines, including the European Federation Neuro logical Society (EFNS) (Sellner et al, 2010), Neuromyelitis Optica Study Group (NEMOS) (Trebst et al, 2014), and NOMADMUS group (Ciron et al, 2018), have regarded RTX as first-line maintenance therapy. We previously conducted a RIN-1 study, a randomized controlled trial against relapses in patients NMO spectrum disorders (NMOSD) with anti-aquaporin-4 (AQP4) antibody for receiving approval in Japan (Tahara et al, 2020a). In addition to the RIN-1 study, other randomized controlled trials of newly developed drugs for NMOSD have been conducted: eculizumab, satralizumab and inebilizumab were approved as new drugs for NMOSD (Pittock et al, 2019; Yamamura et al, 2019; Traboulsee et al, 2020; Cree et al, 2019)
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