Patients treated with satralizumab had a 79% lower risk of severe relapse and were less likely to receive acute relapse therapy compared with placebo, in addition to having a lower relapse risk overall . This was the main conclusion from a pooled analysis of results across the double-blind periods of two phase 3 trials, SAkuraSky and SAkuraStar.
Satralizumab reduced relapse frequency and had a favourable safety profile in the placebo-controlled trials SAkuraSky (satralizumab + baseline immunosuppressants) and SAkuraStar (satralizumab monotherapy) trials. In both studies, participants were randomised to satralizumab 120 mg or placebo at weeks 0, 2, 4, and Q4W thereafter for 24 weeks.
The pooled analysis used data from the intention-to-treat (ITT) populations in the double-blind periods of 24 weeks (n=178). The impact of treatment on relapse severity was assessed by comparing the EDSS score at relapse and prior to relapse. A similar analysis was performed using visual Functional Systems Score (FSS) to assess impact on optic neuritis relapses. A protocol-defined relapse was severe if it resulted in a change of ≥2 points on the EDSS or visual FSS.
In the ITT-population, 27 of 104 patients (26%) in the satralizumab group had a protocol-defined relapse versus 34 of 74 patients (46%) in the placebo group. In the subgroup of aquaporin-4-positive patients, 12 of 68 patients (18%) versus 25 of 51 patients (49%) had a protocol-defined relapse, respectively. The proportion of severe protocol-defined relapses was also lower in patients receiving satralizumab: 5 of 27 events (19%) versus 12 of 34 events (35%) in the placebo group. This equals a relative risk reduction of 79% (OR 0.21; 95% CI 0.07–0.61; P=0.002). In aquaporin-4-positive patients, 4 of 12 events (33%) in the satralizumab group and 11 of 25 events (44%) in the placebo group were severe (OR 0.18; 95% CI 0.06–0.58; P=0.002). Optic neuritis relapses were severe in 2 of 8 events (25%) versus 5 of 13 events (39%). In the ITT population, acute relapse rescue therapy was prescribed in 39 of 104 patients in the satralizumab group (38%) versus 43 of 74 patients (58%) in the placebo group (OR 0.46; P=0.015). As the number of patients with severe protocol-defined relapses was low, results should be interpreted with caution.
- Palace J, et al. Effect of satralizumab on relapse severity in neuromyelitis optica spectrum disorder (NMOSD): results from the Phase III SAkura studies. MSVirtual 2020, Abstract FC01.03.
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