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

Subjects
MAGNETIC resonance imaging, MULTIPLE sclerosis
Abstract

Background: In the CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) study, Cladribine Tablets significantly improved clinical and magnetic resonance imaging (MRI) outcomes (vs placebo) in patients with relapsing-remitting multiple sclerosis. Objective: Describe two clinically relevant definitions for patients with high disease activity (HDA) at baseline of the CLARITY study (utility verified in patients receiving placebo) and assess the treatment effects of Cladribine Tablets 3.5 mg/kg compared with the overall study population. Methods: Outcomes of patients randomised to Cladribine Tablets 3.5 mg/kg or placebo were analysed for subgroups using HDA definitions based on high relapse activity (HRA; patients with ⩾2 relapses during the year prior to study entry, whether on DMD treatment or not) or HRA plus disease activity on treatment (HRA + DAT; patients with ⩾2 relapses during the year prior to study entry, whether on DMD treatment or not, PLUS patients with ⩾1 relapse during the year prior to study entry while on therapy with other DMDs and ⩾1 T1 Gd+ or ⩾9 T2 lesions). Results: In the overall population, Cladribine Tablets 3.5 mg/kg reduced the risk of 6-month-confirmed Expanded Disability Status Scale (EDSS) worsening by 47% vs placebo. A risk reduction of 82% vs placebo was seen in both the HRA and HRA + DAT subgroups (vs 19% for non-HRA and 18% for non-HRA + DAT), indicating greater responsiveness to Cladribine Tablets 3.5 mg/kg in patients with HDA. There were consistent results for other efficacy endpoints. The safety profile in HDA patients was consistent with the overall CLARITY population. Conclusion: Patients with HDA showed clinical and MRI responses to Cladribine Tablets 3.5 mg/kg that were generally better than, or at least comparable with, the outcomes seen in the overall CLARITY population. [ABSTRACT FROM AUTHOR]

Published
2019
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109. Safety and efficacy of cladribine tablets in patients with relapsing–remitting multiple sclerosis: Results from the randomized extension trial of the CLARITY study.

Author

Giovannoni, Gavin, Soelberg Sorensen, Per, Cook, Stuart, Rammohan, Kottil, Rieckmann, Peter, Comi, Giancarlo, Dangond, Fernando, Adeniji, Abidemi K., and Vermersch, Patrick

Subjects
MULTIPLE sclerosis, MAGNETIC resonance imaging, LYMPHOPENIA, DEOXYADENOSINE, NEUTROPHILS
Abstract

Background: In the 2-year CLARITY study, cladribine tablets significantly improved clinical and magnetic resonance imaging (MRI) outcomes (vs placebo) in patients with relapsing–remitting multiple sclerosis (MS). Objective: To assess the safety and efficacy of cladribine treatment in a 2-year Extension study. Methods: In this 2-year Extension study, placebo recipients from CLARITY received cladribine 3.5 mg/kg; cladribine recipients were re-randomized 2:1 to cladribine 3.5 mg/kg or placebo, with blind maintained. Results: A total of 806 patients were assigned to treatment. Adverse event rates were generally similar between groups, but lymphopenia Grade ⩾ 3 rates were higher with cladribine than placebo (Grade 4 lymphopenia occurred infrequently). In patients receiving cladribine 3.5 mg/kg in CLARITY and experiencing lymphopenia Grade ⩾ 3 in the Extension, >90% of those treated with cladribine 3.5 mg/kg and all treated with placebo in the Extension, recovered to Grade 0–1 by study end. Cladribine treatment in CLARITY produced efficacy improvements that were maintained in patients treated with placebo in the Extension; in patients treated with cladribine 3.5 mg/kg in CLARITY, approximately 75% remained relapse-free when given placebo during the Extension. Conclusion: Cladribine tablets treatment for 2 years followed by 2 years’ placebo treatment produced durable clinical benefits similar to 4 years of cladribine treatment with a low risk of severe lymphopenia or clinical worsening. No clinical improvement in efficacy was apparent following further treatment with cladribine tablets after the initial 2-year treatment period in this trial setting. [ABSTRACT FROM AUTHOR]

Published
2018
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110. Slowing of Disability Progression Based on 6-Month Confirmed EDSS in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) Treated with Cladribine Tablets in the CLARITY Study: A Post-Hoc Subgroup Analysis (P3.058)

Author

Cook, Stuart, primary, Rammohan, Kottil, additional, Rieckmann, Peter, additional, Soelberg-Sørensenn, Per, additional, Vermersch, Patrick, additional, Hicking, Christine, additional, Dangond, Fernando, additional, and Giovannoni, Gavin, additional

Published
2016
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112. Magnetic Resonance Imaging (MRI) Outcomes in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) Treated with Cladribine Tablets: Results from the 120-Week Phase IIIb Extension of the CLARITY Study (P2.114)

Author

Giancarlo, Comi, primary, Giovannoni, Gavin, additional, Cook, Stuart, additional, Rammohan, Kottil, additional, Soelberg-Soerensenn, Per, additional, Vermersch, Patrick, additional, Martin, Emily, additional, Dangond, Fernando, additional, and Rieckmann, Peter, additional

Published
2016
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116. Safety and Tolerability of Cladribine Tablets in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS): Final Results from the 120-Week Phase IIIb Extension Trial to the CLARITY Study (P3.095)

Author

Cook, Stuart, primary, Comi, Giancarlo, additional, Rieckmann, Peter, additional, Rammohan, Kottil, additional, Soelberg-Soerensenn, Per, additional, Vermersch, Patrick, additional, Martin, Emily, additional, Dangond, Fernando, additional, and Giovannoni, Gavin, additional

Published
2016
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118. Clinical Efficacy of Cladribine Tablets in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS): Final Results from the 120-Week Phase IIIb Extension Trial to the CLARITY Study (P3.028)

Author

Giovannoni, Gavin, primary, Comi, Giancarlo, additional, Cook, Stuart, additional, Rieckmann, Peter, additional, Rammohan, Kottil, additional, Soelberg-Soerensenn, Per, additional, Vermersch, Patrick, additional, Martin, Emily, additional, and Dangond, Fernando, additional

Published
2016
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120. Immunologic and MRI markers of the therapeutic effect of IFN-β-1a in relapsing-remitting MS

Author

Tao, Yazhong, primary, Zhang, Xin, additional, Zivadinov, Robert, additional, Dwyer, Michael G., additional, Kennedy, Cheryl, additional, Bergsland, Niels, additional, Ramasamy, Deepa, additional, Durfee, Jacqueline, additional, Hojnacki, David, additional, Hayward, Brooke, additional, Dangond, Fernando, additional, Weinstock-Guttman, Bianca, additional, and Markovic-Plese, Silva, additional

Published
2015
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121. Immunological and short-term brain volume changes in relapsing forms of multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: an open-label two-arm trial

Author

Dwyer, Michael G., primary, Zivadinov, Robert, additional, Tao, Yazhong, additional, Zhang, Xin, additional, Kennedy, Cheryl, additional, Bergsland, Niels, additional, Ramasamy, Deepa P., additional, Durfee, Jackie, additional, Hojnacki, David, additional, Weinstock-Guttman, Bianca, additional, Hayward, Brooke, additional, Dangond, Fernando, additional, and Markovic-Plese, Silva, additional

Published
2015
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122. Reduced brain atrophy rates are associated with lower risk of disability progression in patients with relapsing multiple sclerosis treated with cladribine tablets.

Author

De Stefano, Nicola, Giorgio, Antonio, Battaglini, Marco, De Leucio, Alessandro, Hicking, Christine, Dangond, Fernando, Giovannoni, Gavin, and Sormani, Maria Pia

Subjects
MULTIPLE sclerosis treatment, CEREBRAL atrophy, DISEASE relapse, DISABILITIES, MAGNETIC resonance imaging of the brain
Abstract

Background: Neuroimaging studies have used magnetic resonance imaging-derived methods to assess brain volume loss in multiple sclerosis (MS) as a reliable measure of diffuse tissue damage. Methods: In the CLARITY study (ClinicalTrials.gov NCT00213135), the effect of 2 years' treatment with cladribine tablets on annualized percentage brain volume change (PBVC/y) was evaluated in patients with relapsing MS (RMS). Results: Compared with placebo (-0.70% ± 0.79), PBVC/y was reduced in patients treated with cladribine tablets 3.5 mg/kg (-0.56% ± 0.68, p = 0.010) and 5.25 mg/kg (-0.57% ± 0.72, p = 0.019). After adjusting for treatment group, PBVC/y showed a significant correlation with the cumulative probability of disability progression (HR = 0.67, 95% CI = 0.571, 0.787; p < 0.001), with patients with lower PBVC/y showing the highest probability of remaining free from disability progression at 2 years and vice versa. Conclusions: Cladribine tablets given annually for 2 years in short-duration courses in patients with RMS in the CLARITY study significantly reduced brain atrophy in comparison with placebo treatment, with residual rates in treated patients being close to the physiological rates. [ABSTRACT FROM AUTHOR]

Published
2018
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131. A pilot, longitudinal, 24-week study to evaluate the effect of interferon beta-1a subcutaneous on changes in susceptibility-weighted imaging-filtered phase assessment of lesions and subcortical deep-gray matter in relapsing–remitting multiple sclerosis

Author

Zivadinov, Robert, primary, Dwyer, Michael, additional, Markovic-Plese, Silva, additional, Hayward, Brooke, additional, Bergsland, Niels, additional, Heininen-Brown, Mari, additional, Carl, Ellen, additional, Kennedy, Cheryl, additional, Dangond, Fernando, additional, and Weinstock-Guttman, Bianca, additional

Published
2015
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132. Functional characterization of JMJD2A, a histone deacetylase- and retinoblastoma-binding protein

Author

Gray, Steven G., Iglesias, Antonio H., Lizcano Losada, Fernando, Villanueva, Raul, Camelo, Sandra, Jingu, Hisaka, Teh T., Bin, Koibuchi, Noriyuki, W. Chin, William, Kokkotou, Efi, and Dangond, Fernando

Subjects
Retinoblastoma, Neoplasmas de los ojos
Abstract

To effectively direct targeted repression, the class I histone deacetylases (HDACs) associate with many important regulatory proteins. In this paper we describe the molecular characterization of a member of the Jumonji domain 2 (JMJD2) family of proteins, and demonstrate its binding to both class I HDACs and the retinoblastoma protein (pRb). JMJD2 proteins are characterized by the presence of two leukemia-associated protein/plant homeodomain (LAP/PHD) zinc fingers, one JmjN, one JmjC (containing an internal retinoblastoma-binding protein 2 (RBBP2)-like sequence), and two Tudor domains. The first member of this group, JMJD2A, is widely expressed in human tissues and cell lines, and high endogenous expression of JMJD2A mRNA was found in several cell types, including human T-cell lymphotropic virus 1 (HTLV-1)-infected cell lines. JMJD2A and JMJD2B exhibit cell type-specific responses to the HDAC inhibitor trichostatin A. We show that the JMJD2A protein associates in vivo with pRb and class I HDACs, and mediates repression of E2F-regulated promoters. In HTLV-1 virus-infected cells, we find that JMJD2A binds to the viral Tax protein. Antibodies to JMJD2A recognize the native protein but also a half-sized protein fragment, the latter up-regulated in THP-1 cells during the G2/M phase of the cell cycle. The ability of JMJD2A to associate with pRb and HDACs and potentiate pRb-mediated repression of E2F-regulated promoters implies an important role for this protein in cell proliferation and oncogenesis. Según Sherpa Romeo el autor no puede archivar la versión del editor / PDF

Published
2005

133. Relationship between Immunological Markers and Short-Term Brain Volume Changes in Patients with Relapsing-Remitting Multiple Sclerosis Receiving Interferon Beta-1a (P3.146)

Author

Dwyer, Michael, primary, Zivadinov, Robert, additional, Tao, Yazhong, additional, Zhang, Xin, additional, Kennedy, Cheryl, additional, Bergsland, Niels, additional, Ramasamy, Deepa, additional, Durfee, Jackie, additional, Hojnacki, David, additional, Weinstock-Guttman, Bianca, additional, Hayward, Brooke, additional, Dangond, Fernando, additional, and Markovic-Plese, Silva, additional

Published
2014
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134. Associations Between Changes in Ferritin Levels and Susceptibility-Weighted Imaging Filtered Phase in Patients with Relapsing-Remitting Multiple Sclerosis over Six Months Therapy with Interferon Beta-1a (P6.115)

Author

Dwyer, Michael, primary, Zivadinov, Robert, additional, Markovic-Plese, Silva, additional, Bergsland, Niels, additional, Heininen-Brown, Mari, additional, Carl, Ellen, additional, Kennedy, Cheryl, additional, Weinstock-Guttman, Bianca, additional, Hayward, Brooke, additional, and Dangond, Fernando, additional

Published
2014
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135. Correlations between Immunological Biomarkers and Conventional and Advanced MRI Measures Following Interferon Beta-1a Treatment for Relapsing-Remitting Multiple Sclerosis (P3.147)

Author

Markovic Plese, Silva, primary, Tao, Yazhong, additional, Zhang, Xin, additional, Dwyer, Michael, additional, Kennedy, Cheryl, additional, Bergsland, Niels, additional, Ramasamy, Deepa, additional, Durfee, Jacqueline, additional, Hojnacki, David, additional, Weinstock-Guttman, Bianca, additional, Hayward, Brooke, additional, Dangond, Fernando, additional, and Zivadinov, Robert, additional

Published
2014
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140. Effect of Treatment with Interferon Beta-1a on Changes in Voxel-Wise Magnetization Transfer Ratio in Normal Appearing Brain Tissue and Lesions of Patients with Relapsing–Remitting Multiple Sclerosis: A 24-Week, Controlled Pilot Study

Author

Zivadinov, Robert, primary, Dwyer, Michael G., additional, Markovic-Plese, Silva, additional, Kennedy, Cheryl, additional, Bergsland, Niels, additional, Ramasamy, Deepa P., additional, Durfee, Jacqueline, additional, Hojnacki, David, additional, Hayward, Brooke, additional, Dangond, Fernando, additional, and Weinstock-Guttman, Bianca, additional

Published
2014
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141. Ease of use of two autoinjectors in patients with multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: results of the randomized, crossover REDEFINE study

Author

Wray, Sibyl, Hayward, Brooke, Dangond, Fernando, and Singer, Barry

Abstract

ABSTRACTBackground: For interferon beta-1a subcutaneously three times weekly (IFN β-1a SC tiw), administration options include manually injected prefilled syringes; a preassembled, single-use autoinjector; and a reusable autoinjector. This study evaluated patient-perceived ease of use of two injection devices.Research design and methods: REDEFINE, a Phase IV, multicenter crossover study, randomized patients with multiple sclerosis and ≥5 weeks’ IFN β-1a 44 μg SC tiw use to 4 weeks using a single-use autoinjector, then 4 weeks using a reusable autoinjector, or vice versa. The primary endpoint was the proportion rating each ‘easy’ or ‘very easy’, with/without regard to previous device experience.Results: Of 97 randomized patients, 29 had most recent experience with manual injection; 23 with single-use autoinjector; and 45 with reusable autoinjector. 68.4% found using the single-use autoinjector very easy or easy, versus 77.9% for the reusable device (difference −9.5%; p = 0.200). 40.0% versus 29.5% found the respective devices very easy (difference 10.5%; p = 0.203).Conclusions: Most patients found both autoinjectors easy or very easy to use. Having two viable options may help accommodate patient preferences. Ease of administration and patient satisfaction relates to adherence; satisfied patients may more likely be adherent.Trial registration: The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT02019550).

Published
2018
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149. Sodium phenylbutyrate prolongs survival and regulates expression of anti-apoptotic genes in transgenic amyotrophic lateral sclerosis mice

Author

Ryu, Hoon, primary, Smith, Karen, additional, Camelo, Sandra I., additional, Carreras, Isabel, additional, Lee, Junghee, additional, Iglesias, Antonio H., additional, Dangond, Fernando, additional, Cormier, Kerry A., additional, Cudkowicz, Merit E., additional, Brown, Robert H., additional, and Ferrante, Robert J., additional

Published
2006
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