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Jerry S Wolinsky - One of the best experts on this subject based on the ideXlab platform.

  • ocrelizumab treatment for relapsing remitting multiple sclerosis after a suboptimal response to previous Disease Modifying Therapy a nonrandomized controlled trial
    Multiple Sclerosis Journal, 2021
    Co-Authors: Bianca Weinstockguttman, Gary Cutter, Bruno Musch, Robert Bermel, Mark S Freedman, Deidre Kile, Anthony T Reder, Thomas Leist, Jerry S Wolinsky
    Abstract:

    Background:Many patients with multiple sclerosis (MS) experience suboptimal Disease control despite the use of Disease-Modifying Therapy (DMT).Objective:To assess the efficacy and safety of ocreliz...

  • sj-docx-1-msj-10.1177_13524585211035740 – Supplemental material for Ocrelizumab treatment for relapsing-remitting multiple sclerosis after a suboptimal response to previous Disease-Modifying Therapy: A nonrandomized controlled trial
    2021
    Co-Authors: Bianca Weinstock-guttman, Gary Cutter, Bruno Musch, Robert Bermel, Mark S Freedman, Thomas P Leist, Deidre Kile, Anthony T Reder, Jerry S Wolinsky
    Abstract:

    Supplemental material, sj-docx-1-msj-10.1177_13524585211035740 for Ocrelizumab treatment for relapsing-remitting multiple sclerosis after a suboptimal response to previous Disease-Modifying Therapy: A nonrandomized controlled trial by Bianca Weinstock-Guttman, Robert Bermel, Gary Cutter, Mark S Freedman, Thomas P Leist, Xiaoye Ma, Deidre Kile, Bruno Musch, Anthony T Reder and Jerry S Wolinsky in Multiple Sclerosis Journal

  • sj-pdf-2-msj-10.1177_13524585211035740 – Supplemental material for Ocrelizumab treatment for relapsing-remitting multiple sclerosis after a suboptimal response to previous Disease-Modifying Therapy: A nonrandomized controlled trial
    2021
    Co-Authors: Bianca Weinstock-guttman, Gary Cutter, Bruno Musch, Robert Bermel, Mark S Freedman, Thomas P Leist, Deidre Kile, Anthony T Reder, Jerry S Wolinsky
    Abstract:

    Supplemental material, sj-pdf-2-msj-10.1177_13524585211035740 for Ocrelizumab treatment for relapsing-remitting multiple sclerosis after a suboptimal response to previous Disease-Modifying Therapy: A nonrandomized controlled trial by Bianca Weinstock-Guttman, Robert Bermel, Gary Cutter, Mark S Freedman, Thomas P Leist, Xiaoye Ma, Deidre Kile, Bruno Musch, Anthony T Reder and Jerry S Wolinsky in Multiple Sclerosis Journal

  • two year results of the phase iiib chords study evaluating ocrelizumab effectiveness and safety in patients with relapsing remitting multiple sclerosis who had a suboptimal response with prior Disease Modifying Therapy 2906
    Neurology, 2020
    Co-Authors: Bianca Weinstockguttman, Gary Cutter, Robert Bermel, Mark S Freedman, Anthony T Reder, Thomas Leist, Csilla Csoboth, B Musch, James Stankiewicz, Jerry S Wolinsky
    Abstract:

    Objective: To report the 2-year Phase IIIb CHORDS study (NCT02637856) results evaluating ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS) and suboptimal response to previous Disease-Modifying Therapy (DMT). Background: Ocrelizumab was superior to interferon β-1a in patients with relapsing MS (OPERA I and II). Evaluating ocrelizumab effectiveness in patients with suboptimal response to DMT is needed. Design/Methods: The CHORDS intention-to-treat (ITT) population (N=608) had suboptimal response (≥1 relapse, ≥1 T1 gadolinium-enhancing lesion(s) or ≥2 new/enlarging T2 lesions) to previous DMT after stable use (≥6 months). Patients received ocrelizumab 600 mg every 24 weeks for ≤96 weeks. The primary endpoint was the proportion of patients free of protocol-defined clinical or MRI activity (event), evaluated in a modified ITT population which imputed patients who terminated early for lack of efficacy or death as had an event and excluded patients who discontinued for other reasons without an event. Key secondary endpoints included annualized relapse rate (ARR) and Expanded Disability Status Scale (EDSS) change from baseline. Safety was assessed in the ITT population. Results: A total of 555 patients completed treatment (baseline mean [SD] duration since first MS symptom and diagnosis, 5.4 [3.24] and 4.2 [3.03] years, respectively). At Week 96, 48.1% of patients were free of protocol-defined events. Most did not experience protocol-defined relapse (89.6%), any T1 gadolinium-enhancing lesions (95.5%) or new/enlarging T2 lesions (59.5%) or 24-week confirmed disability progression (89.6%). The ITT adjusted ARR was 0.046. Seventy-one relapses were observed (Year 1, 50; Year 2, 21). At Week 96, most patients had stable ( Conclusions: This analysis demonstrates ocrelizumab treatment responses over 2 years in patients with RRMS who are relatively early in the Disease course and experienced suboptimal response to another DMT. Disclosure: Dr. Weinstock-Guttman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, , Novartis, Genentech, EMD Serono, Abbvie, Mallickrodt, Bristol Myers.. Dr. Weinstock-Guttman has received research support from Biogen, Novartis, Genentech, and EMD Serono..Dr. Bermel has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Genzyme, Genentech, Novartis. Dr. Bermel has received royalty, license fees, or contractual rights payments from intellectual property underlying the Multiple Sclerosis Performance Test, currently licensed to Qr8 Health and Biogen. Dr. Bermel has received research support from Biogen, Genentech, and Novartis. Dr. Csoboth has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd.. Dr. Cutter has received personal compensation from AMO Pharma, Argenix, Atara Bio-therapeutics, Axon, Biogen, BioLineRx, Bio-therapeutics, Brainstorm Cell Therapeutics, Charleston Laboratories, Inc., Click Therapeutics, Genentech, Genzyme, GW Pharma, Horizon Pharmaceuticals, Klein Buendel Inc., MedDay, MedImmune, Merck, Merck/Pfizer, Neurim, Novartis OPKO Biologics, Orphazyme, Pythagoras, Inc, Reata Pharmaceuticals, Receptos/ Celgene, Sanofi- Aventis, Roche, SciFluor, Somahlution, Teva Pharma-ceuticals, TG Therapeutics, UTHealth Houston Teva NeuroscienceDr. Freedman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion, Bayer Healthcare, Biogen Idec, Chugai, Clene Nanomedicine, EMD Serono Canada, Genzyme, Merck Serono, Novartis, F. Hoffmann-La Roche Ltd, Sanofi-Aventis and Teva Canada Innovation. Dr. Freedman has received compensation for serving on the Board of Directors of Actelion, Bayer Healthcare, Biogen Idec, Clene Nanomedicine, F. Hoffmann-La Roche Ltd, Merck Serono, MedDay Pharmaceuticals, Novartis and Sanofi-Aventis. Dr. Freedman has received research support from Genzyme Canada. Dr. Leist has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with received consultancy fees or clinical research grants from Acorda, Bayer, Biogen, Daiichi, EMD Serono, Novartis, ONO, Pfizer, Teva Neuroscience. Dr. Leist has received research support from received consultancy fees or clinical research grants from Acorda, Bayer, Biogen, Daiichi, EMD Serono, Novartis, ONO, Pfizer, Teva Neuroscience. Dr. Ma has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd.. Dr. Musch has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd.. Dr. Reder has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer, Biogen, F. Hoffmann-La Roche Ltd, Genentech, Inc., Merck Serono, Novartis and TG Therapeutics. Dr. Reder has received personal compensation in an editorial capacity for MedLink. Dr. Reder has received research support from Bayer, Biogen, F. Hoffmann-La Roche Ltd, Genentech, Inc., Mallinckrodt, Merck Serono and Novartis. Dr. Stankiewicz has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen Idec, Genzyme, Genentech, Inc., EMD Serono, Novartis, and Celgene.Dr. Wolinsky has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Received compensation for consulting, scientific advisory boards, or other activities with Alkermes, Actelion, Acorda Therapeutics, Celgene, EMD Serono, GeNeuro, GW Pharma, MedDay Pharmaceuticals, Novartis, Otsuka, PTC Therapeutics, Roche/Genentech, Sanof. Dr. Wolinsky has received royalty, license fees, or contractual rights payments from Royalties are received for out-licensed monoclonal antibodies through UTHealth from Millipore Corporation.

  • the efficacy of teriflunomide in patients who received prior Disease Modifying treatments subgroup analyses of the teriflunomide phase 3 temso and tower studies
    Multiple Sclerosis Journal, 2018
    Co-Authors: Mark S Freedman, Ludwig Kappos, Tomas Olsson, Aaron E. Miller, P. Truffinet, Giancarlo Comi, Myriam Benamor, Jerry S Wolinsky, Karthinathan Thangavelu, Paul Oconnor
    Abstract:

    Teriflunomide is a once-daily oral immunomodulator approved for relapsing-remitting multiple sclerosis (MS). The objective of this post hoc analysis of the phase 3, pooled TEMSO (NCT00134563) and TOWER (NCT00751881) dataset is to evaluate the effect of teriflunomide treatment on annualised relapse rate and disability worsening across patient subgroups defined according to prior Disease-Modifying Therapy exposure. This analysis provides further supportive evidence for a consistent effect of teriflunomide across a broad range of patients with relapsing MS, including patients who have used and discontinued other Disease-Modifying therapies.

Gerianne Holzman - One of the best experts on this subject based on the ideXlab platform.

  • Contralateral Cruciate Survival in Dogs with Unilateral Non-Contact Cranial Cruciate Ligament Rupture
    2013
    Co-Authors: Peter Muir, Zeev Schwartz, Sarah Malek, Abigail Kreines, Sady Y Cabrera, Nicole J Buote, Susan L Schaefer, Gerianne Holzman, Jason A, Zhengling Hao
    Abstract:

    Background: Non-contact cranial cruciate ligament rupture (CrCLR) is an important cause of lameness in client-owned dogs and typically occurs without obvious injury. There is a high incidence of bilateral rupture at presentation or subsequent contralateral rupture in affected dogs. Although stifle synovitis increases risk of contralateral CrCLR, relatively little is known about risk factors for subsequent contralateral rupture, or whether therapeutic intervention may modify this risk. Methodology/Principal Findings: We conducted a longitudinal study examining survival of the contralateral CrCL in clientowned dogs with unilateral CrCLR in a large baseline control population (n = 380), and a group of dogs that received Disease-Modifying Therapy with arthroscopic lavage, intra-articular hyaluronic acid and oral doxycycline (n = 16), and were followed for one year. Follow-up in treated dogs included analysis of mobility, radiographic evaluation of stifle effusion and arthritis, and quantification of biomarkers of synovial inflammation. We found that median survival of the contralateral CrCL was 947 days. Increasing tibial plateau angle decreased contralateral ligament survival, whereas increasing age at diagnosis increased survival. Contralateral ligament survival was reduced in neutered dogs. Our Disease-Modifying Therapy did not significantly influence contralateral ligament survival. Correlative analysis of clinical and biomarker variables with development of subsequent contralateral rupture revealed few significant results. However, increased expression of T lymphocyte-associated genes in the index unstable stifle at diagnosis was significantly related to development o

  • Contralateral cranial cruciate ligament (CrCL) survival after post-operative treatment with provisional Disease-Modifying Therapy.
    2013
    Co-Authors: Peter Muir, Zeev Schwartz, Sarah Malek, Abigail Kreines, Sady Y Cabrera, Nicole J Buote, Jason A Bleedorn, Susan L Schaefer, Gerianne Holzman, Zhengling Hao
    Abstract:

    Kaplan-Meier plot for contralateral CrCL survival in a population of client-owned dogs treatment with oral doxycycline after TPLO stabilization of unilateral CrCLR. Arthroscopic examination and associated lavage of the contralateral stable stifle, together with intra-articular hyaluronic acid and oral doxycycline did not significantly influence CrCL survival (p = 0.87). Complete – dogs that experienced contralateral CrCLR during the study period; Censored – dogs that did not experience contralateral CrCLR during the study period.

  • contralateral cruciate survival in dogs with unilateral non contact cranial cruciate ligament rupture
    PLOS ONE, 2011
    Co-Authors: Peter Muir, Zeev Schwartz, Sarah Malek, Abigail Kreines, Sady Y Cabrera, Nicole J Buote, Jason A Bleedorn, Susan L Schaefer, Gerianne Holzman
    Abstract:

    BACKGROUND: Non-contact cranial cruciate ligament rupture (CrCLR) is an important cause of lameness in client-owned dogs and typically occurs without obvious injury. There is a high incidence of bilateral rupture at presentation or subsequent contralateral rupture in affected dogs. Although stifle synovitis increases risk of contralateral CrCLR, relatively little is known about risk factors for subsequent contralateral rupture, or whether therapeutic intervention may modify this risk. METHODOLOGY/PRINCIPAL FINDINGS: We conducted a longitudinal study examining survival of the contralateral CrCL in client-owned dogs with unilateral CrCLR in a large baseline control population (n = 380), and a group of dogs that received Disease-Modifying Therapy with arthroscopic lavage, intra-articular hyaluronic acid and oral doxycycline (n = 16), and were followed for one year. Follow-up in treated dogs included analysis of mobility, radiographic evaluation of stifle effusion and arthritis, and quantification of biomarkers of synovial inflammation. We found that median survival of the contralateral CrCL was 947 days. Increasing tibial plateau angle decreased contralateral ligament survival, whereas increasing age at diagnosis increased survival. Contralateral ligament survival was reduced in neutered dogs. Our Disease-Modifying Therapy did not significantly influence contralateral ligament survival. Correlative analysis of clinical and biomarker variables with development of subsequent contralateral rupture revealed few significant results. However, increased expression of T lymphocyte-associated genes in the index unstable stifle at diagnosis was significantly related to development of subsequent non-contact contralateral CrCLR. CONCLUSION: Subsequent contralateral CrCLR is common in client-owned dogs, with a median ligament survival time of 947 days. In this naturally occurring model of non-contact cruciate ligament rupture, cranial tibial translation is preceded by development of synovial inflammation. However, treatment with arthroscopic lavage, intra-articular hyaluronic acid and oral doxycycline does not significantly influence contralateral CrCL survival.

Ginger Janow - One of the best experts on this subject based on the ideXlab platform.

  • anakinra as first line Disease Modifying Therapy in systemic juvenile idiopathic arthritis report of forty six patients from an international multicenter series
    Arthritis & Rheumatism, 2011
    Co-Authors: Peter A Nigrovic, Melissa L Mannion, Femke H M Prince, Andrew Zeft, Egla C Rabinovich, Marion A J Van Rossum, Elisabetta Cortis, Manuela Pardeo, Paivi Miettunen, Ginger Janow
    Abstract:

    Objective To examine the safety and efficacy of the interleukin-1 (IL-1) receptor antagonist anakinra as first-line Therapy for systemic juvenile idiopathic arthritis (JIA). Methods Patients with systemic JIA receiving anakinra as part of initial Disease-Modifying antirheumatic drug (DMARD) Therapy were identified from 11 centers in 4 countries. Medical records were abstracted using a standardized instrument, and resulting data were analyzed to characterize concomitant therapies, clinical course, adverse events, and predictors of outcome. Results Among 46 patients meeting inclusion criteria, anakinra monoTherapy was used in 10 patients (22%), while 67% received corticosteroids and 33% received additional DMARDs. Outcomes were evaluated at a median followup interval of 14.5 months. Fever and rash resolved within 1 month in >95% of patients, while C-reactive protein and ferritin normalized within this interval in >80% of patients. Active arthritis persisted at 1 month in 39% of patients, at 3 months in 27%, and at >6 months of followup in 11%. Approximately 60% of patients, including 8 of 10 receiving anakinra monoTherapy, attained a complete response without escalation of Therapy. Disease characteristics and treatment were similar in partial and complete responders, except that partial responders were markedly younger at onset (median age 5.2 years versus 10.2 years; P = 0.004). Associated adverse events included documented bacterial infection in 2 patients and hepatitis in 1 patient. Tachyphylaxis was not observed. Conclusion Anakinra as first-line Therapy for systemic JIA was associated with rapid resolution of systemic symptoms and prevention of refractory arthritis in almost 90% of patients during the interval examined. These results justify further study of IL-1 inhibition as first-line, rather than rescue, Therapy in systemic JIA.

  • anakinra as first line Disease Modifying Therapy in systemic juvenile idiopathic arthritis report of forty six patients from an international multicenter series
    Arthritis & Rheumatism, 2011
    Co-Authors: Peter A Nigrovic, Melissa L Mannion, Femke H M Prince, Andrew Zeft, Egla C Rabinovich, Marion A J Van Rossum, Elisabetta Cortis, Manuela Pardeo, Paivi Miettunen, Ginger Janow
    Abstract:

    To examine the safety and efficacy of the interleukin-1 (IL-1) receptor antagonist anakinra as first-line Therapy for systemic juvenile idiopathic arthritis (JIA). Patients with systemic JIA receiving anakinra as part of initial Disease-Modifying antirheumatic drug (DMARD) Therapy were identified from 11 centers in 4 countries. Medical records were abstracted using a standardized instrument, and resulting data were analyzed to characterize concomitant therapies, clinical course, adverse events, and predictors of outcome. Among 46 patients meeting inclusion criteria, anakinra monoTherapy was used in 10 patients (22%), while 67% received corticosteroids and 33% received additional DMARDs. Outcomes were evaluated at a median followup interval of 14.5 months. Fever and rash resolved within 1 month in >95% of patients, while C-reactive protein and ferritin normalized within this interval in >80% of patients. Active arthritis persisted at 1 month in 39% of patients, at 3 months in 27%, and at >6 months of followup in 11%. Approximately 60% of patients, including 8 of 10 receiving anakinra monoTherapy, attained a complete response without escalation of Therapy. Disease characteristics and treatment were similar in partial and complete responders, except that partial responders were markedly younger at onset (median age 5.2 years versus 10.2 years; P = 0.004). Associated adverse events included documented bacterial infection in 2 patients and hepatitis in 1 patient. Tachyphylaxis was not observed. Anakinra as first-line Therapy for systemic JIA was associated with rapid resolution of systemic symptoms and prevention of refractory arthritis in almost 90% of patients during the interval examined. These results justify further study of IL-1 inhibition as first-line, rather than rescue, Therapy in systemic JIA

Peter Muir - One of the best experts on this subject based on the ideXlab platform.

  • Contralateral Cruciate Survival in Dogs with Unilateral Non-Contact Cranial Cruciate Ligament Rupture
    2013
    Co-Authors: Peter Muir, Zeev Schwartz, Sarah Malek, Abigail Kreines, Sady Y Cabrera, Nicole J Buote, Susan L Schaefer, Gerianne Holzman, Jason A, Zhengling Hao
    Abstract:

    Background: Non-contact cranial cruciate ligament rupture (CrCLR) is an important cause of lameness in client-owned dogs and typically occurs without obvious injury. There is a high incidence of bilateral rupture at presentation or subsequent contralateral rupture in affected dogs. Although stifle synovitis increases risk of contralateral CrCLR, relatively little is known about risk factors for subsequent contralateral rupture, or whether therapeutic intervention may modify this risk. Methodology/Principal Findings: We conducted a longitudinal study examining survival of the contralateral CrCL in clientowned dogs with unilateral CrCLR in a large baseline control population (n = 380), and a group of dogs that received Disease-Modifying Therapy with arthroscopic lavage, intra-articular hyaluronic acid and oral doxycycline (n = 16), and were followed for one year. Follow-up in treated dogs included analysis of mobility, radiographic evaluation of stifle effusion and arthritis, and quantification of biomarkers of synovial inflammation. We found that median survival of the contralateral CrCL was 947 days. Increasing tibial plateau angle decreased contralateral ligament survival, whereas increasing age at diagnosis increased survival. Contralateral ligament survival was reduced in neutered dogs. Our Disease-Modifying Therapy did not significantly influence contralateral ligament survival. Correlative analysis of clinical and biomarker variables with development of subsequent contralateral rupture revealed few significant results. However, increased expression of T lymphocyte-associated genes in the index unstable stifle at diagnosis was significantly related to development o

  • Contralateral cranial cruciate ligament (CrCL) survival after post-operative treatment with provisional Disease-Modifying Therapy.
    2013
    Co-Authors: Peter Muir, Zeev Schwartz, Sarah Malek, Abigail Kreines, Sady Y Cabrera, Nicole J Buote, Jason A Bleedorn, Susan L Schaefer, Gerianne Holzman, Zhengling Hao
    Abstract:

    Kaplan-Meier plot for contralateral CrCL survival in a population of client-owned dogs treatment with oral doxycycline after TPLO stabilization of unilateral CrCLR. Arthroscopic examination and associated lavage of the contralateral stable stifle, together with intra-articular hyaluronic acid and oral doxycycline did not significantly influence CrCL survival (p = 0.87). Complete – dogs that experienced contralateral CrCLR during the study period; Censored – dogs that did not experience contralateral CrCLR during the study period.

  • contralateral cruciate survival in dogs with unilateral non contact cranial cruciate ligament rupture
    PLOS ONE, 2011
    Co-Authors: Peter Muir, Zeev Schwartz, Sarah Malek, Abigail Kreines, Sady Y Cabrera, Nicole J Buote, Jason A Bleedorn, Susan L Schaefer, Gerianne Holzman
    Abstract:

    BACKGROUND: Non-contact cranial cruciate ligament rupture (CrCLR) is an important cause of lameness in client-owned dogs and typically occurs without obvious injury. There is a high incidence of bilateral rupture at presentation or subsequent contralateral rupture in affected dogs. Although stifle synovitis increases risk of contralateral CrCLR, relatively little is known about risk factors for subsequent contralateral rupture, or whether therapeutic intervention may modify this risk. METHODOLOGY/PRINCIPAL FINDINGS: We conducted a longitudinal study examining survival of the contralateral CrCL in client-owned dogs with unilateral CrCLR in a large baseline control population (n = 380), and a group of dogs that received Disease-Modifying Therapy with arthroscopic lavage, intra-articular hyaluronic acid and oral doxycycline (n = 16), and were followed for one year. Follow-up in treated dogs included analysis of mobility, radiographic evaluation of stifle effusion and arthritis, and quantification of biomarkers of synovial inflammation. We found that median survival of the contralateral CrCL was 947 days. Increasing tibial plateau angle decreased contralateral ligament survival, whereas increasing age at diagnosis increased survival. Contralateral ligament survival was reduced in neutered dogs. Our Disease-Modifying Therapy did not significantly influence contralateral ligament survival. Correlative analysis of clinical and biomarker variables with development of subsequent contralateral rupture revealed few significant results. However, increased expression of T lymphocyte-associated genes in the index unstable stifle at diagnosis was significantly related to development of subsequent non-contact contralateral CrCLR. CONCLUSION: Subsequent contralateral CrCLR is common in client-owned dogs, with a median ligament survival time of 947 days. In this naturally occurring model of non-contact cruciate ligament rupture, cranial tibial translation is preceded by development of synovial inflammation. However, treatment with arthroscopic lavage, intra-articular hyaluronic acid and oral doxycycline does not significantly influence contralateral CrCL survival.

Mark S Freedman - One of the best experts on this subject based on the ideXlab platform.

  • ocrelizumab treatment for relapsing remitting multiple sclerosis after a suboptimal response to previous Disease Modifying Therapy a nonrandomized controlled trial
    Multiple Sclerosis Journal, 2021
    Co-Authors: Bianca Weinstockguttman, Gary Cutter, Bruno Musch, Robert Bermel, Mark S Freedman, Deidre Kile, Anthony T Reder, Thomas Leist, Jerry S Wolinsky
    Abstract:

    Background:Many patients with multiple sclerosis (MS) experience suboptimal Disease control despite the use of Disease-Modifying Therapy (DMT).Objective:To assess the efficacy and safety of ocreliz...

  • sj-docx-1-msj-10.1177_13524585211035740 – Supplemental material for Ocrelizumab treatment for relapsing-remitting multiple sclerosis after a suboptimal response to previous Disease-Modifying Therapy: A nonrandomized controlled trial
    2021
    Co-Authors: Bianca Weinstock-guttman, Gary Cutter, Bruno Musch, Robert Bermel, Mark S Freedman, Thomas P Leist, Deidre Kile, Anthony T Reder, Jerry S Wolinsky
    Abstract:

    Supplemental material, sj-docx-1-msj-10.1177_13524585211035740 for Ocrelizumab treatment for relapsing-remitting multiple sclerosis after a suboptimal response to previous Disease-Modifying Therapy: A nonrandomized controlled trial by Bianca Weinstock-Guttman, Robert Bermel, Gary Cutter, Mark S Freedman, Thomas P Leist, Xiaoye Ma, Deidre Kile, Bruno Musch, Anthony T Reder and Jerry S Wolinsky in Multiple Sclerosis Journal

  • sj-pdf-2-msj-10.1177_13524585211035740 – Supplemental material for Ocrelizumab treatment for relapsing-remitting multiple sclerosis after a suboptimal response to previous Disease-Modifying Therapy: A nonrandomized controlled trial
    2021
    Co-Authors: Bianca Weinstock-guttman, Gary Cutter, Bruno Musch, Robert Bermel, Mark S Freedman, Thomas P Leist, Deidre Kile, Anthony T Reder, Jerry S Wolinsky
    Abstract:

    Supplemental material, sj-pdf-2-msj-10.1177_13524585211035740 for Ocrelizumab treatment for relapsing-remitting multiple sclerosis after a suboptimal response to previous Disease-Modifying Therapy: A nonrandomized controlled trial by Bianca Weinstock-Guttman, Robert Bermel, Gary Cutter, Mark S Freedman, Thomas P Leist, Xiaoye Ma, Deidre Kile, Bruno Musch, Anthony T Reder and Jerry S Wolinsky in Multiple Sclerosis Journal

  • two year results of the phase iiib chords study evaluating ocrelizumab effectiveness and safety in patients with relapsing remitting multiple sclerosis who had a suboptimal response with prior Disease Modifying Therapy 2906
    Neurology, 2020
    Co-Authors: Bianca Weinstockguttman, Gary Cutter, Robert Bermel, Mark S Freedman, Anthony T Reder, Thomas Leist, Csilla Csoboth, B Musch, James Stankiewicz, Jerry S Wolinsky
    Abstract:

    Objective: To report the 2-year Phase IIIb CHORDS study (NCT02637856) results evaluating ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS) and suboptimal response to previous Disease-Modifying Therapy (DMT). Background: Ocrelizumab was superior to interferon β-1a in patients with relapsing MS (OPERA I and II). Evaluating ocrelizumab effectiveness in patients with suboptimal response to DMT is needed. Design/Methods: The CHORDS intention-to-treat (ITT) population (N=608) had suboptimal response (≥1 relapse, ≥1 T1 gadolinium-enhancing lesion(s) or ≥2 new/enlarging T2 lesions) to previous DMT after stable use (≥6 months). Patients received ocrelizumab 600 mg every 24 weeks for ≤96 weeks. The primary endpoint was the proportion of patients free of protocol-defined clinical or MRI activity (event), evaluated in a modified ITT population which imputed patients who terminated early for lack of efficacy or death as had an event and excluded patients who discontinued for other reasons without an event. Key secondary endpoints included annualized relapse rate (ARR) and Expanded Disability Status Scale (EDSS) change from baseline. Safety was assessed in the ITT population. Results: A total of 555 patients completed treatment (baseline mean [SD] duration since first MS symptom and diagnosis, 5.4 [3.24] and 4.2 [3.03] years, respectively). At Week 96, 48.1% of patients were free of protocol-defined events. Most did not experience protocol-defined relapse (89.6%), any T1 gadolinium-enhancing lesions (95.5%) or new/enlarging T2 lesions (59.5%) or 24-week confirmed disability progression (89.6%). The ITT adjusted ARR was 0.046. Seventy-one relapses were observed (Year 1, 50; Year 2, 21). At Week 96, most patients had stable ( Conclusions: This analysis demonstrates ocrelizumab treatment responses over 2 years in patients with RRMS who are relatively early in the Disease course and experienced suboptimal response to another DMT. Disclosure: Dr. Weinstock-Guttman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, , Novartis, Genentech, EMD Serono, Abbvie, Mallickrodt, Bristol Myers.. Dr. Weinstock-Guttman has received research support from Biogen, Novartis, Genentech, and EMD Serono..Dr. Bermel has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Genzyme, Genentech, Novartis. Dr. Bermel has received royalty, license fees, or contractual rights payments from intellectual property underlying the Multiple Sclerosis Performance Test, currently licensed to Qr8 Health and Biogen. Dr. Bermel has received research support from Biogen, Genentech, and Novartis. Dr. Csoboth has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd.. Dr. Cutter has received personal compensation from AMO Pharma, Argenix, Atara Bio-therapeutics, Axon, Biogen, BioLineRx, Bio-therapeutics, Brainstorm Cell Therapeutics, Charleston Laboratories, Inc., Click Therapeutics, Genentech, Genzyme, GW Pharma, Horizon Pharmaceuticals, Klein Buendel Inc., MedDay, MedImmune, Merck, Merck/Pfizer, Neurim, Novartis OPKO Biologics, Orphazyme, Pythagoras, Inc, Reata Pharmaceuticals, Receptos/ Celgene, Sanofi- Aventis, Roche, SciFluor, Somahlution, Teva Pharma-ceuticals, TG Therapeutics, UTHealth Houston Teva NeuroscienceDr. Freedman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion, Bayer Healthcare, Biogen Idec, Chugai, Clene Nanomedicine, EMD Serono Canada, Genzyme, Merck Serono, Novartis, F. Hoffmann-La Roche Ltd, Sanofi-Aventis and Teva Canada Innovation. Dr. Freedman has received compensation for serving on the Board of Directors of Actelion, Bayer Healthcare, Biogen Idec, Clene Nanomedicine, F. Hoffmann-La Roche Ltd, Merck Serono, MedDay Pharmaceuticals, Novartis and Sanofi-Aventis. Dr. Freedman has received research support from Genzyme Canada. Dr. Leist has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with received consultancy fees or clinical research grants from Acorda, Bayer, Biogen, Daiichi, EMD Serono, Novartis, ONO, Pfizer, Teva Neuroscience. Dr. Leist has received research support from received consultancy fees or clinical research grants from Acorda, Bayer, Biogen, Daiichi, EMD Serono, Novartis, ONO, Pfizer, Teva Neuroscience. Dr. Ma has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd.. Dr. Musch has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd.. Dr. Reder has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer, Biogen, F. Hoffmann-La Roche Ltd, Genentech, Inc., Merck Serono, Novartis and TG Therapeutics. Dr. Reder has received personal compensation in an editorial capacity for MedLink. Dr. Reder has received research support from Bayer, Biogen, F. Hoffmann-La Roche Ltd, Genentech, Inc., Mallinckrodt, Merck Serono and Novartis. Dr. Stankiewicz has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen Idec, Genzyme, Genentech, Inc., EMD Serono, Novartis, and Celgene.Dr. Wolinsky has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Received compensation for consulting, scientific advisory boards, or other activities with Alkermes, Actelion, Acorda Therapeutics, Celgene, EMD Serono, GeNeuro, GW Pharma, MedDay Pharmaceuticals, Novartis, Otsuka, PTC Therapeutics, Roche/Genentech, Sanof. Dr. Wolinsky has received royalty, license fees, or contractual rights payments from Royalties are received for out-licensed monoclonal antibodies through UTHealth from Millipore Corporation.

  • the efficacy of teriflunomide in patients who received prior Disease Modifying treatments subgroup analyses of the teriflunomide phase 3 temso and tower studies
    Multiple Sclerosis Journal, 2018
    Co-Authors: Mark S Freedman, Ludwig Kappos, Tomas Olsson, Aaron E. Miller, P. Truffinet, Giancarlo Comi, Myriam Benamor, Jerry S Wolinsky, Karthinathan Thangavelu, Paul Oconnor
    Abstract:

    Teriflunomide is a once-daily oral immunomodulator approved for relapsing-remitting multiple sclerosis (MS). The objective of this post hoc analysis of the phase 3, pooled TEMSO (NCT00134563) and TOWER (NCT00751881) dataset is to evaluate the effect of teriflunomide treatment on annualised relapse rate and disability worsening across patient subgroups defined according to prior Disease-Modifying Therapy exposure. This analysis provides further supportive evidence for a consistent effect of teriflunomide across a broad range of patients with relapsing MS, including patients who have used and discontinued other Disease-Modifying therapies.