Abstract
BackgroundIn daily clinical setting, some patients affected by relapsing-remitting Multiple Sclerosis (RRMS) are switched from the low-dose to the high-dose Interferon beta (IFNB) in order to achieve a better control of the disease.PurposeIn this observational, post-marketing study we reported the 2-year clinical outcomes of patients switched to the high-dose IFNB; we also evaluated whether different criteria adopted to switch patients had an influence on the clinical outcomes.MethodsPatients affected by RRMS and switched from the low-dose to the high-dose IFNB due to the occurrence of relapses, or contrast-enhancing lesions (CELs) as detected by yearly scheduled MRI scans, were followed for two years. Expanded Disability Status Scale (EDSS) scores, as well as clinical relapses, were evaluated during the follow-up period.ResultsWe identified 121 patients switched to the high-dose IFNB. One hundred patients increased the IFNB dose because of the occurrence of one or more relapses, and 21 because of the presence of one or more CELs, even in absence of clinical relapses. At the end of the 2-year follow-up, 72 (59.5%) patients had a relapse, and 51 (42.1%) reached a sustained progression on EDSS score. Overall, 85 (70.3%) patients showed some clinical disease activity (i.e. relapses or disability progression) after the switch.Relapse risk after increasing the IFNB dose was greater in patients who switched because of relapses than those switched only for MRI activity (HR: 5.55, p = 0.001). A high EDSS score (HR: 1.77, p < 0.001) and the combination of clinical and MRI activity at switch raised the risk of sustained disability progression after increasing the IFNB dose (HR: 2.14, p = 0.01).ConclusionIn the majority of MS patients, switching from the low-dose to the high-dose IFNB did not reduce the risk of further relapses or increased disability in the 2-year follow period.Although we observed that patients who switched only on the basis on MRI activity (even in absence of clinical attacks) had a lower risk of further relapses, larger studies are warranted before to recommend a switch algorithm based on MRI findings.
Highlights
In daily clinical setting, some patients affected by relapsing-remitting Multiple Sclerosis (RRMS) are switched from the low-dose to the high-dose Interferon beta (IFNB) in order to achieve a better control of the disease.Purpose: In this observational, post-marketing study we reported the 2-year clinical outcomes of patients switched to the high-dose IFNB; we evaluated whether different criteria adopted to switch patients had an influence on the clinical outcomes
In daily clinical setting some patients starting with the low-dose (i.m., o.w. 30 mcg, or s.c., t.p.w. 22 mcg IFNB-1a) are routinely switched to the high-dose IFNB (s.c., e.o.d. 250 mcg IFNB-1b, or s.c., t.p.w. 44 mcg IFNB-1a) in case of breakthrough disease, according to suggestions coming from therapeutic recommendation of consensus groups [12,13]
There was no well-defined protocol for switching patients to the high-dose IFNB, but it was a decision taken by the neurologist depending on the growing availability over years of new drugs active against MS (i.e., Natalizumab, experimental treatment, etc)
Summary
Some patients affected by relapsing-remitting Multiple Sclerosis (RRMS) are switched from the low-dose to the high-dose Interferon beta (IFNB) in order to achieve a better control of the disease.Purpose: In this observational, post-marketing study we reported the 2-year clinical outcomes of patients switched to the high-dose IFNB; we evaluated whether different criteria adopted to switch patients had an influence on the clinical outcomes. Some patients affected by relapsing-remitting Multiple Sclerosis (RRMS) are switched from the low-dose to the high-dose Interferon beta (IFNB) in order to achieve a better control of the disease. Post-marketing studies suggest a long-term benefit of IFNB treatment on disease activity and disability progression [7,8,9,10]. In daily clinical setting some patients starting with the low-dose (i.m., o.w. 30 mcg, or s.c., t.p.w. 22 mcg IFNB-1a) are routinely switched to the high-dose IFNB (s.c., e.o.d. 250 mcg IFNB-1b, or s.c., t.p.w. 44 mcg IFNB-1a) in case of breakthrough disease, according to suggestions coming from therapeutic recommendation of consensus groups [12,13]
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