Efficacy of different rituximab therapeutic strategies in patients with neuromyelitis optica spectrum disorders

被引:73
作者
Novi, Giovanni [1 ,2 ]
Bovis, Francesca [3 ]
Capobianco, Marco [4 ,5 ]
Frau, Jessica [6 ]
Mataluni, Giorgia [7 ]
Curti, Erica [8 ]
Zuliani, Luigi [9 ]
Cavalla, Paola [10 ]
Brambilla, Laura [11 ]
Annovazzi, Pietro [12 ]
Repice, Anna Maria [13 ]
Lanzillo, Roberta [14 ]
Esposito, Sabrina [15 ]
Benedetti, Luana [1 ,2 ]
Maietta, Ilaria [3 ]
Sica, Francesco [16 ]
Buttari, Fabio [16 ]
Malucchi, Simona [4 ,5 ]
Fenu, Giuseppe [6 ]
Landi, Doriana [7 ]
Bosa, Chiara [17 ]
Realmuto, Sabrina [4 ,5 ]
Malentacchi, Maria [18 ]
Granella, Franco [8 ]
Signori, Alessio [3 ]
Bonavita, Simona [15 ]
Uccelli, Antonio [1 ,2 ]
Sormani, Maria Pia [2 ,3 ]
Nozzolillo, Agostino [19 ]
Gallo, Fabio [20 ]
Signoriello, Elisabetta [21 ]
Clerici, Valentina Torri [22 ]
La Gioia, Sara [23 ]
Cocco, Eleonora [6 ]
Sartori, Arianna [24 ]
Rasia, Sarah [25 ]
Cordioli, Cinzia [25 ]
Barone, Stefania [26 ]
Solaro, Claudio [27 ]
Nociti, Viviana [28 ]
Gobbi, Claudio [29 ]
机构
[1] Univ Genoa, Dept Neurosci Rehabil Ophthalmol Genet Maternal &, Genoa, Italy
[2] Osped Policlin San Martino IRCCS, Genoa, Italy
[3] Univ Genoa, Dept Hlth Sci DISSAL, Sect Biostat, Genoa, Italy
[4] AOU San Luigi, SCDO Neurol, Orbassano, Italy
[5] AOU San Luigi, Ctr Riferimento Reg Sclerosi Multipla, Orbassano, Italy
[6] Univ Cagliari, Dept Med Sci & Publ Hlth, Cagliari, Italy
[7] Univ Roma Tor Vergata, Dept Syst Med, Multiple Sclerosis Unit, Rome, Italy
[8] Univ Parma, Dept Med & Surg, Neurosci Unit, Parma, Italy
[9] Ca Foncello Hosp, ULSS Marca Trevigiana 2, Neurol Unit, Treviso, Italy
[10] City Hlth & Sci Univ Hosp Turin, MS Ctr, Dept Neurosci, Turin, Italy
[11] IRCCS Fdn, Neurol Inst C Besta, Dept Neuroimmunol & Neuromuscular Dis, Milan, Italy
[12] ASST Valle Olona, MS Ctr, PO Gallarate, Gallarate, VA, Italy
[13] Univ Hosp Careggi, Reg MS Ctr, Florence, Italy
[14] Univ Naples Federico II, Naples, Italy
[15] Univ Campania, Dept Neurol, Naples, Italy
[16] IRCCS Ist Neurol Mediterraneo Neurorned, Pozzilli, IS, Italy
[17] Univ Turin, Turin, Italy
[18] Univ Palermo, Expt Biomed & Clin Neurosci Dept BioNeC, Palermo, Italy
[19] Univ Naples Federico II, Multiple Sclerosis Ctr, Dept Neurosci Reprod Sci & Odontostomatol, Naples, Italy
[20] Univ Genoa, Dept Hlth Sci, Sect Biostat, Genoa, Italy
[21] Univ Campania Luigi Vanvitelli, Div Neurol 2, Multiple Sclerosis Ctr, Naples, Italy
[22] IRCCS Fdn, Neuroimmunol & Neuromuscolar Dis Unit, Carlo Besta Neurol Inst, Milan, Italy
[23] Ctr Sclerosi Multipla ASST Papa Giovanni XXIII Be, Bergamo, Italy
[24] Univ Trieste, Neurol Clin, Dept Med Surg & Hlth Sci, Trieste, Italy
[25] ASST Spedali Civili, Multiple Sclerosis Ctr, PO Montichiari BS, Brescia, Italy
[26] Magna Graecia Univ Catanzaro, Inst Neurol, Catanzaro, Italy
[27] Mons Luigi Novarese, Dept Rehabil, Moncrivello, VC, Italy
[28] Univ Cattolica Sacro Cuore, Fdn Policlin Univ A Gemelli IRCCS, Rome, Italy
[29] Osped Regionale Lugano, Neuroctr Southern Switzerland, Lugano, Switzerland
关键词
Efficacy; Neuromyelitis optica; Rituximab; CLINICAL-COURSE; OUTCOMES; SAFETY;
D O I
10.1016/j.msard.2019.101430
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Objective: To evaluate disease activity according to rituximab (RTX) induction and maintenance regimens in a multicenter real-life dataset of NMOSD patients. Methods: This is an observational-retrospective multicentre study including patients with NMOSD treated with RTX in 21 Italian and 1 Swiss centers. Demographics, relapse rate and adverse events over the follow-up were summarized taking into account induction strategy (two-1 g infusions at a 15-day interval (IND-A) vs. 375 mg/m2/week infusions for one month (IND-B)) and maintenance therapy (regimen A (M-A) with fixed time-points infusions vs. regimen B (M-B) based on cytofluorimetric driven reinfusion regimens, the least further subdivided according to CD19 + B cells (M-B1) or CD27 + memory B cells (M-B2) monitoring). Results: 131 subjects were enrolled, 127 patients completed the induction regimen and 119 patients had at least one follow-up visit and were included in the outcome analysis. Median follow-up was 1.7 years (range 0.1-11.6). Annualized relapse rate (ARR) was 1.7 in the year before RTX start and decreased to 0.19 during the follow-up. Both ARR and Time to first relapse ( raR) analysis showed a trend toward an increased disease activity for IND-B and M-A. No patients with MT-B2 experienced relapses during the follow-up. Number of relapses in the year before RTX initiation and having received a previous treatment were significantly associated with higher ARR and reduced TTFR in the multivariate analysis. Interpretation: We confirm RTX efficacy in NMOSD patients. Use of specific induction and maintenance protocols is warranted in order to foster RTX efficacy and to reduce costs and side effects.
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页数:9
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