Interferon beta in relapsing-remitting multiple sclerosis: an independent                 postmarketing study in southern Italy

Trojano, María; Liguori, Maria; Paolicelli, Damiano; Zimatore, Giovanni Bosco; Robertis, Francesca De; Avolio, Carlo; Giuliani, Fabrizio; Fuiani, Aurora; Livrea, Paolo

doi:10.1191/1352458503ms948oa

Cited by 64 publications

(54 citation statements)

References 13 publications

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“…These results are in line with other short- and long-term real-world postmarketing studies [11,12,13,14,15,16,17,18,19,20,21]. Nevertheless, 2 previous head-to-head trials, EVIDENCE [9] and INCOMIN [10], showed superior efficacy for SC IFNβ compared with IM IFNβ in terms of time to the first clinical MS relapse on study.…”

Section: Discussionsupporting

confidence: 73%

“…Benson and Hartz [26] reported that the estimates of treatment effects from observational studies and randomized controlled trials are similar. The value of observational studies should therefore not be underestimated since phase 4 studies and retrospective chart reviews can also reveal important differences among drugs in the same class that were not detected in controlled phase 2 or 3 clinical trials [17]. In addition, in Switzerland all DMTs are approved first-line treatments for MS patients.…”

Section: Discussionmentioning

confidence: 99%

“…Several open-label, postmarketing, observational studies have reported similar efficacy for the three different IFNβ preparations [11,12,13,14,15,16,17,18,19], but only a few have compared these DMTs and GA [20,21]. There is only one report in the literature comparing the effects of all four different immunomodulatory therapies on MS disease progression in patients with relapsing-remitting MS (RRMS); however, the study groups were quite imbalanced, and the reported differences in hazard ratios between the DMTs were attributed to selection bias [22].…”

Section: Introductionmentioning

confidence: 99%

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Swiss Analysis of Multiple Sclerosis: A Multicenter, Non-Interventional, Retrospective Cohort Study of Disease-Modifying Therapies

Gobbi

Zecca

Linnebank³

et al. 2013

Eur Neurol

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Background: There is a scarcity of reports comparing efficacy and tolerability of the multiple sclerosis (MS) disease-modifying therapies [DMTs; intramuscular interferon-β1a (IM IFNβ-1a), subcutaneous (SC) IFNβ-1a, SC IFNβ-1b, SC glatiramer acetate (GA)] in a real-world setting. Methods: This multicenter, non-interventional, retrospective cohort study analyzed data from 546 patients with clinically isolated or relapsing-remitting MS constantly treated with one DMT for 2 years. Annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) scores, and DMT tolerability were assessed. Results: Demographic data were comparable across DMTs. There were no significant differences between DMT groups in ARR during study year 1 (p = 0.277) or study year 2 (p = 0.670), or in EDSS change between years 1 and 2 (p = 0.624). Adverse events were frequent (39-56%) in all groups. Flu-like symptoms were less frequent with GA treatment (2.3% vs. IM IFNβ-1a, 46.7%; SC IFNβ-1a, 39.8%; SC IFNβ-1b, 25.8%; p < 0.05). Injection site reactions were less often reported with IM IFNβ-1a (10.5% vs. SC IFNβ-1a, 33.9%; SC IFNβ-1b, 38.3%; GA, 26.1%; p < 0.05). Conclusions: All DMTs showed comparable effects on MS relapse rate and EDSS change, with IM IFNβ-1a and GA being more tolerable with respect to injection site reactions and flu-like symptoms, respectively.

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Section: Discussionsupporting

confidence: 73%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Swiss Analysis of Multiple Sclerosis: A Multicenter, Non-Interventional, Retrospective Cohort Study of Disease-Modifying Therapies

Gobbi

Zecca

Linnebank³

et al. 2013

Eur Neurol

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“…In the literature, over a follow-up period ranging from 2 to 4 years, the proportion of patients switching is between 3 and 13% [5, 8, 10, 11, 13]. …”

Section: Introductionmentioning

confidence: 99%

Long-Term Adherence to Interferon β Therapy in Relapsing-Remitting Multiple Sclerosis

et al. 2007

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Background/Aims: To assess the proportion and the reasons of drop-outs in relapsing-remitting multiple sclerosis patients treated with interferon-β (IFNB) and the outcome of switching subjects. Methods: Patients stopping IFNB were classified according to the reason of drop-out: perceived lack of efficacy (PLE) side effects (SE) and other reasons. Long-term adherence was described using the Kaplan-Meier curves. Results: We evaluated 225 subjects (158 women; age = 36.6 ± 9.2 years, disease duration = 8.0 ± 6.1 years, Expanded Disability Status Scale score = 1.9 ± 1.2) who received Betaferon (46), Avonex (88) and Rebif (91) therapy. The mean follow-up duration was 4.2 ± 2.7 years. Forty-six percent of patients suspended therapy, 29% because of PLE, 15% because of SE and the remaining 2% due to other reasons. Twenty-five out of 33 subjects who suspended IFNB because of SE and 62 out of 65 patients who suspended the therapy due to PLE were switched to another disease-modifying drug. At the end of the follow-up, the majority of these patients could continue the treatment. Conclusions: When starting IFNB therapy in relapsing-remitting multiple sclerosis, a relatively high proportion of discontinuation is to be expected over time. Switching from a treatment to another taking into account the reasons of drop-out and the disease activity is a suitable option.

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“…Three randomized double-blind placebo-controlled multicentric studies have shown that IFN-␤ reduces the relapse rate by about 30% [1][2][3] and slows the progression of disability in patients with RRMS. Several studies have suggested that the 3 IFN-␤ types available are equally efficacious [4][5][6][7] .…”

Section: Introductionmentioning

confidence: 99%

Clinical Parameters to Predict Response to Interferon in Relapsing Multiple Sclerosis

Fromont

Debouverie²,

Teuff³

et al. 2008

Neuroepidemiology

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Background: To identify clinical parameters of response to β-interferon (IFN-β) in relapsing-remitting multiple sclerosis (RRMS) from an East France cohort. Methods: Data from 2,645 patients, identified by Burgundy and Lorraine multiple sclerosis (MS) networks, were computerized by a neurologist using the European Database for MS software. Patient inclusion criteria were: clinically or laboratory-supported definite RRMS according to Poser’s diagnostic criteria and treatment with IFN-β for at least 6 months. Four criteria were chosen to predict a response to IFN-β. The first criterion was any patient who had a lower annualized relapse rate under IFN-β therapy than during the year preceding treatment; the second criterion was a lower relapse rate than during the 2 years preceding treatment. The third was any patient free of relapse during the first 2 years of IFN-β therapy. The last criterion concerned the variation in the degree of disability measured by the Disability Status Scale during the first year of treatment. Multivariate logistic regression analyses were performed. Results: 751 RRMS cases were included. A higher relapse rate in the year preceding IFN-β onset, an older age at MS onset and having a polysymptomatic onset of MS were significantly associated with a response for the first criterion. With the 3 other criteria, no parameter predicting response was identified. Conclusion: Only the relapse rate in the year before initiation of IFN-β treatment appears to be able to predict response to treatment but not the one of 2 years before.

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Interferon beta in relapsing-remitting multiple sclerosis: an independent postmarketing study in southern Italy

Cited by 64 publications

References 13 publications

Swiss Analysis of Multiple Sclerosis: A Multicenter, Non-Interventional, Retrospective Cohort Study of Disease-Modifying Therapies

Swiss Analysis of Multiple Sclerosis: A Multicenter, Non-Interventional, Retrospective Cohort Study of Disease-Modifying Therapies

Long-Term Adherence to Interferon β Therapy in Relapsing-Remitting Multiple Sclerosis

Clinical Parameters to Predict Response to Interferon in Relapsing Multiple Sclerosis

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