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54. Supplementary_Materials – Supplemental material for Effects of cladribine tablets on lymphocyte subsets in patients with multiple sclerosis: an extended analysis of surface markers

Author

Stuve, Olaf, Soerensen, Per Soelberg, Leist, Thomas, Giovannoni, Gavin, Hyvert, Yann, Damian, Doris, Dangond, Fernando, and Boschert, Ursula

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 110904 Neurology and Neuromuscular Diseases
Abstract

Supplemental material, Supplementary_Materials for Effects of cladribine tablets on lymphocyte subsets in patients with multiple sclerosis: an extended analysis of surface markers by Olaf Stuve, Per Soelberg Soerensen, Thomas Leist, Gavin Giovannoni, Yann Hyvert, Doris Damian, Fernando Dangond and Ursula Boschert in Therapeutic Advances in Neurological Disorders

Published
2019
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58. Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferonβ-1a versus subcutaneous interferonβ-1b: results of the randomized, multicenter, Phase IIIb REFORMS study

Author

Singer Barry, Bandari Daniel, Cascione Mark, LaGanke Christopher, Huddlestone John, Bennett Randy, and Dangond Fernando

Subjects
Randomized controlled trial, Interferonβ-1a, Interferonβ-1b, Relapsing–remitting multiple sclerosis, Subcutaneous injections, Injection-site pain, Pain measurement, Neurology. Diseases of the nervous system, RC346-429
Abstract

Abstract Background In patients with relapsing–remitting multiple sclerosis (RRMS), subcutaneous (sc) interferon (IFN)β-1a and IFNβ-1b have been shown to reduce relapse rates. A formulation of IFNβ-1a has been produced without fetal bovine serum and without human serum albumin as an excipient (not currently approved for use in the US). The objectives of this study were to evaluate tolerability, injection-site redness, subject-reported satisfaction with therapy, and clinical safety and efficacy of the serum-free formulation of IFNβ-1a versus IFNβ-1b in IFNβ-treatment-naïve patients with RRMS. The objectives of the extension phase were to evaluate long-term safety and tolerability of IFNβ-1a. Methods This randomized, parallel-group, open-label study was conducted at 27 clinical sites in the US. Eligible patients aged 18–60 years were randomized to receive either IFNβ-1a, titrated to 44 μg sc three times weekly (tiw) (n = 65), or IFNβ-1b, titrated to 250 μg sc every other day (n = 64) over 12 weeks. Following this, all patients received IFNβ-1a 44 μg tiw for 82–112 weeks. Primary endpoint was mean change in patient-reported pain, as assessed by visual analog scale (VAS) diary pain score (from 0 mm [no pain] to 100 mm [worst possible pain]) at the injection site, from pre-injection to 30 min post-injection over the first 21 full-dose injections. Secondary assessments included proportion of patients pain-free as recorded by VAS diary and the Short-Form McGill Pain questionnaire VAS. Results A total of 129 patients were included in the intent-to-treat analysis. Mean (standard deviation) change in VAS diary pain score was not significantly different between groups, although numerically lower with IFNβ-1a versus IFNβ-1b from pre-injection to immediately post-injection (1.46 [2.93] vs. 4.63 [10.57] mm), 10 min post-injection (0.70 [1.89] vs. 1.89 [5.75] mm), and 30 min post-injection (0.67 [2.32] vs. 1.14 [4.94] mm). Proportion of patients pain-free at all time periods post-injection was also not significantly different between groups. Adverse events were consistent with the known safety profiles of these treatments. Conclusions In IFNβ-treatment-naïve patients with RRMS, both the serum-free formulation of IFNβ-1a and IFNβ-1b treatments were generally accompanied by low-level injection-site pain and were well tolerated. Trial registration ClinicalTrials.gov NCT00428584

Published
2012
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59. Additional file 6: of Predictive value of early magnetic resonance imaging measures is differentially affected by the dose of interferon beta-1a given subcutaneously three times a week: an exploratory analysis of the PRISMS study

Author

Traboulsee, Anthony, Li, David, Cascione, Mark, Juanzhi Fang, Dangond, Fernando, and Miller, Aaron

Abstract

Figure S5. Proportion progressed at each year by ≥2 versus 0–1 active T2 lesions at 12 months. (a) Placebo/delayed treatment, ≥2 versus 0–1 T2 lesions at 12 months; (b) IFN β-1a 22 μg SC tiw, ≥2 versus 0–1 T2 lesions at 12 months; (c) IFN β-1a 44 μg SC tiw, ≥2 versus 0–1 T2 lesions at 12 months. (PDF 183 kb)

Published
2018
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60. Additional file 1: of Effect of interferon beta-1a subcutaneously three times weekly on clinical and radiological measures and no evidence of disease activity status in patients with relapsingâ remitting multiple sclerosis at year 1

Author

Traboulsee, Anthony, Li, David, Cascione, Mark, Juanzhi Fang, Dangond, Fernando, and Miller, Aaron

Abstract

Table S1. Baseline characteristics of patients in the PRISMS-2 study (adapted from PRISMS Study Group. Lancet. 1998;352:1498â 504). (DOCX 15 kb)

Published
2018
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61. Supplementary Material, MSJ771875_supplementary_material – Efficacy of Cladribine Tablets in high disease activity subgroups of patients with relapsing multiple sclerosis: A post hoc analysis of the CLARITY study

Author

Giovannoni, Gavin, Sorensen, Per Soelberg, Cook, Stuart, Kottil W Rammohan, Rieckmann, Peter, Comi, Giancarlo, Dangond, Fernando, Hicking, Christine, and Vermersch, Patrick

Subjects
FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 110904 Neurology and Neuromuscular Diseases
Abstract

Supplementary Material, MSJ771875_supplementary_material for Efficacy of Cladribine Tablets in high disease activity subgroups of patients with relapsing multiple sclerosis: A post hoc analysis of the CLARITY study by Gavin Giovannoni, Per Soelberg Sorensen, Stuart Cook, Kottil W Rammohan, Peter Rieckmann, Giancarlo Comi, Fernando Dangond, Christine Hicking and Patrick Vermersch in Multiple Sclerosis Journal

Published
2018
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62. Additional file 2: of Predictive value of early magnetic resonance imaging measures is differentially affected by the dose of interferon beta-1a given subcutaneously three times a week: an exploratory analysis of the PRISMS study

Author

Traboulsee, Anthony, Li, David, Cascione, Mark, Juanzhi Fang, Dangond, Fernando, and Miller, Aaron

Abstract

Figure S2. Proportion with EDSS progression at each year in the placebo/delayed treatment and IFN β-1a 44 μg SC tiw groups by ≥4 versus 0 active T2 lesions at 6 months. (PDF 189 kb)

Published
2018
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64. Additional file 3: of Predictive value of early magnetic resonance imaging measures is differentially affected by the dose of interferon beta-1a given subcutaneously three times a week: an exploratory analysis of the PRISMS study

Author

Traboulsee, Anthony, Li, David, Cascione, Mark, Juanzhi Fang, Dangond, Fernando, and Miller, Aaron

Abstract

Table S1. (a) Performance of T2 lesions on predicting EDSS progression at Year 2 and Year 4. (b) Performance of T2 lesions on predicting relapse at Year 2 and Year 4. (DOCX 15Â kb)

Published
2018
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66. 056 Efficacy and safety of the Bruton’s tyrosine kinase inhibitor evobrutinib (M2951) in patients with relapsing multiple sclerosis over 48 weeks: a randomized, placebo-controlled, phase 2 study

Author

Montalban, Xavier, primary, Arnold, Douglas L, additional, Weber, Martin S, additional, Staikov, Ivan, additional, Piasecka-Stryczynska, Karolina, additional, Gillett, Alan, additional, Martin, Emily C, additional, Syed, Sana, additional, Dangond, Fernando, additional, and Wolinsky, Jerry S, additional

Published
2019
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72. Efficacy and Safety of the Bruton’s Tyrosine Kinase Inhibitor Evobrutinib (M2951) in Patients with Relapsing Multiple Sclerosis over 48 Weeks: a Randomized, Placebo-Controlled, Phase 2 Study (S56.004)

Author

Montalban, Xavier, primary, Arnold, Douglas L., additional, Weber, Martin S., additional, Staikov, Ivan, additional, Piasecka-Stryczynska, Karolina, additional, Martin, Emily C., additional, Dangond, Fernando, additional, and Wolinsky, Jerry S., additional

Published
2019
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82. 067 Efficacy of cladribine tablets in patients with highly active relapsing-remitting multiple sclerosis: analysis of pooled double-blind data from the clarity and onward studies

Author

Giovannoni, Gavin, primary, Montalban, Xavier, additional, Rammohan, Kottil, additional, Cook, Stuart, additional, Comi, Giancarlo, additional, Rieckmann, Peter, additional, Soelberg-Sorensen, Per, additional, Vermersch, Patrick, additional, Dangond, Fernando, additional, King, John, additional, and Damian, Doris, additional

Published
2018
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100. Durable efficacy of cladribine tablets in patients with multiple sclerosis: analysis of relapse rates and relapse-free patients in the CLARITY and CLARITY Extension studies (P6.353)

Author

Soelberg-Sorensen, Per, primary, Giovannoni, Gavin, additional, Comi, Giancarlo, additional, Cook, Stuart, additional, Rammohan, Kottil, additional, Rieckmann, Peter, additional, Vermersch, Patrick, additional, Hicking, Christine, additional, Adeniji, Abidemi, additional, and Dangond, Fernando, additional

Published
2017
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