Abstract
This study evaluated efficacy of subcutaneous (sc) interferon beta-1a (IFN β-1a) 44 µg 3 × weekly (tiw) in patients appearing to transition from relapsing–remitting multiple sclerosis (RRMS) to secondary progressive MS (SPMS). The PRISMS study included 560 patients with RRMS (EDSS 0–5.0; ≥ 2 relapses in previous 2 years), and the SPECTRIMS study included 618 patients with SPMS (EDSS 3.0–6.5 and ≥ 1-point increase in previous 2 years [≥ 0.5 point if 6.0–6.5]) randomly assigned to sc IFN β-1a 44 or 22 µg or placebo for 2–3 years, respectively. These post hoc analyses examined five subgroups of MS patients with EDSS 4.0–6.0: PRISMS (n = 59), PRISMS/SPECTRIMS (n = 335), PRISMS/SPECTRIMS with baseline disease activity (n = 195; patients with either ≥ 1 relapse within 2 years before baseline or ≥ 1 gadolinium-enhancing lesion at baseline), PRISMS/SPECTRIMS without baseline disease activity (n = 140), and PRISMS/SPECTRIMS with disease activity during the study (n = 202). In the PRISMS and PRISMS/SPECTRIMS subgroups, sc IFN β-1a delayed disability progression, although no significant effect was observed in PRISMS/SPECTRIMS subgroups with activity at baseline or activity during the study (regardless of baseline activity). In the PRISMS/SPECTRIMS subgroup, over year 1 (0–1) and 2 (0–2), sc IFN β-1a 44 µg tiw significantly reduced annualized relapse rate (p ≤ 0.001), and relapse risk (p < 0.05) versus placebo. Similar results were seen for the PRISMS/SPECTRIMS with baseline disease activity subgroup. Subcutaneous IFN β-1a reduced T2 burden of disease and active T2 lesions in the PRISMS/SPECTRIMS subgroups overall, with and without baseline activity. In conclusion, these post hoc analyses indicate that effects of sc IFN β-1a 44 µg tiw on clinical/MRI endpoints are preserved in a patient subgroup appearing to transition between RRMS and SPMS.
Highlights
Relapsing–remitting multiple sclerosis (RRMS) is characterized by defined attacks separated by periods of stability
As in the overall trial population [6], PRISMS patients with Expanded Disability Status Scale (EDSS) 4.0–5.0 treated with sc IFN β-1a (n = 31) had significantly reduced relapses, T2 burden of disease, number of active T2 lesions, and delayed time to confirmed 3-month disability progression versus placebo (n = 28) (Table 3)
A total of 335 patients with EDSS 4.0–6.0 were included in the pooled PRISMS/SPECTRIMS subgroup (PRISMS, n = 59; SPECTRIMS, n = 276; Table 1)
Summary
Relapsing–remitting multiple sclerosis (RRMS) is characterized by defined attacks separated by periods of stability. The majority of patients with MS present with the relapsing form of the disease, relapses can continue to occur during the gradual transition to the progressive USA. Journal of Neurology (2020) 267:64–75 form of the disease, secondary progressive MS (SPMS) [1]. Disease severity is assessed using the Expanded Disability Status Scale (EDSS) score, which ranges from 0 (normal) to 10 (death due to MS) and is based on assessment of clinical deficits in various central nervous system functions. There is no one agreedupon definition of SPMS, it is usually defined as an initial relapsing–remitting disease course followed by progression with or without occasional relapses, minor remissions, and plateaus [3]. Patients with an EDSS score 4.0–6.0 may be transitioning to SPMS; the disease course varies between patients [2, 4]
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