| Autor: |
Levy, Michael, Parks, Becky, Allen, Kerstin, Mujeebuddin, Arshad, Taney, Melissa, Mashhoon, Yasmin, de Sèze, Jerome |
| Předmět: |
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| Zdroj: |
International Journal of MS Care; 2024 Supplement, Vol. 26, p39-40, 2p |
| Abstrakt: |
BACKGROUND: Rituximab (RTX) is often prescribed off-label in early lines of therapy for patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder (AQP4+ + NMOSD); however, patients frequently need to be transitioned to more efficacious therapies, such as C5 complement inhibitors (C5ITs), to prevent relapses. Safety outcomes in patients who transition from RTX to a C5IT is an important consideration. PREVENT (NCT01892345) and CHAMPION-NMOSD (NCT04201262) were phase 3 C5IT studies evaluating safety and efficacy of eculizumab and ravulizumab, respectively, in adult patients with AQP4+ + NMOSD (Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381(7):614-625. doi:10.1056/NEJMoa1900866; Pittock SJ, Barnett M, Bennett JL, et al. Ravulizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. Ann Neurol. 2023;93(6):1053-1068. doi:10.1002/ana.26626). OBJECTIVES: To assess safety outcomes in patients who initiated C5IT treatment within 1 year of last RTX exposure in the PREVENT and CHAMPION-NMOSD studies. METHODS: A post hoc analysis was conducted in C5IT-treated patients from both PREVENT and CHAMPION-NMOSD comparing safety outcomes between those who had or had not received prior RTX treatment within > 3 to ≤ 12 months of firstdose eculizumab or ravulizumab. Patients who received RTX within ≤ 3 months of screening were not permitted to enroll in either trial. Treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and deaths or withdrawals due to TEAEs were analyzed. RESULTS: Thirty-eight patients received RTX within > 3 to ≤ 12 months prior to first C5IT dose and 116 patients did not. In prior RTX-treated patients, mean time from last RTX dose to first C5IT dose was 6.53 months (SD 1.96). The incidence of patients experiencing TEAEs (94.7% vs 90.5%) and TESAEs (21.2% vs 24.1%) was similar in both groups. Most events were mild or moderate in severity and were assessed by investigators as unrelated to C5IT. Infections and infestations were the most common type of TEAE in both groups (71.1% vs 71.6%, respectively). In the prior RTX-treated group, no deaths occurred, and no patients experienced a TEAE or TESAE leading to C5IT withdrawal. When analyzed by time since last RTX use, no differences in TEAE/TESAE incidence rates were detected in patients who had RTX within 3 to 6 months of receiving C5IT versus those who received RTX within 6 to 9 or 9 to 12 months. CONCLUSIONS: No differences in safety outcomes were observed among patients with RTX use within > 3 to ≤ 12 months prior to first C5IT in the PREVENT and CHAMPION-NMOSD studies. These findings provide important information to guide clinical decision-making when considering a switch from RTX to C5IT in patients with AQP4+ + NMOSD who received RTX within the preceding 3 to 12 months. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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