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2 Diseases |  |
12 Trials |
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12 Trials |  |
490 News |  |
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- || Actemra IV (tocilizumab) / Roche, JW Pharma, Enspryng (satralizumab) / Roche, Rituxan (rituximab) / Roche
Review, Journal: The pharmacological management of myelin oligodendrocyte glycoprotein-immunoglobulin G associated disease (MOGAD): an update of the literature. (Pubmed Central) - Sep 20, 2024
Maintenance therapies include mycophenolate mofetil, azathioprine, IVIG, oral corticosteroids, rituximab, and interleukin-6 receptor (IL6-R) antagonists...Larger prospective studies with longer follow-ups are needed to confirm whether the blockage of the IL6-R is an effective and safe option. Since there is no evidence of major safety issues related to the new available therapies, the authors believe that waiting for disease activity to consider a possible treatment change, is an unwise approach.
- | Enspryng (satralizumab) / Roche
Journal: Visual improvement in a case of neuromyelitis optica spectrum disorder-related optic neuritis after 18 months of treatment with satralizumab: A case report. (Pubmed Central) - Aug 19, 2024
Satralizumab was found to effectively control relapses in this patient and visual improvement was found after 18 months of treatment. Given to that, satralizumab may have a potential longitudinal effect on visual improvement in NMOSD-ON.
- | Enspryng (satralizumab) / Roche
Journal: Dysthyroid Optic Neuropathy Complicated by Neuromyelitis Optica Spectrum Disorder: A Case Report. (Pubmed Central) - Aug 15, 2024
Following this treatment, no NMOSD recurrences were reported. This case highlights the necessity of considering the possible coexistence of DON and NMOSD in patients with autoimmune diseases.
- || Enspryng (satralizumab) / Roche
P4 data, Journal: Safety and Effectiveness of Satralizumab in Japanese Patients with Neuromyelitis Optica Spectrum Disorder: A 6-month Interim Analysis of Post-marketing Surveillance. (Pubmed Central) - Jul 16, 2024
The results are consistent with those of previous clinical trials. The safety and effectiveness of satralizumab in Japanese patients with NMOSD will be analyzed over the 6-year surveillance period.
- Enspryng (satralizumab) / Roche
Experience with satralizumab in neuromyelitis optica spectrum patients in southeast Spain (Posters) - Jul 7, 2024 - Abstract #ECTRIMS2024ECTRIMS_1460;
- Soliris (eculizumab) / AstraZeneca, Enspryng (satralizumab) / Roche, Ultomiris (ravulizumab-cwvz) / AstraZeneca
Real-world treatment adherence and persistence with eculizumab or ravulizumab (C5 inhibitors) or satralizumab in patients with neuromyelitis optica spectrum disorder in Japan (Posters) - Jul 7, 2024 - Abstract #ECTRIMS2024ECTRIMS_1403;
- Enspryng (satralizumab) / Roche
Effectiveness and Safety of Satralizumab in a Real-world Clinical Setting in Japan: Interleukin-6 Receptor Inhibition in Neuromyelitis Optica Spectrum Disorders: A Six-month Interim Analysis of Multicenter Medical Chart Review (D3) - Jul 7, 2024 - Abstract #ECTRIMS2024ECTRIMS_1372;
- | Enspryng (satralizumab) / Roche
Journal, IO biomarker: Interleukin-6 Signaling Blockade Induces Regulatory Plasmablasts in Neuromyelitis Optica Spectrum Disorder. (Pubmed Central) - Jun 18, 2024
Treatment with IL-6 signaling blockade elicited a regulatory phenotype in B cells and PBs. CD200+ PBs may be a marker of treatment responsiveness in the context of NMOSD pathophysiology.
- || Enspryng (satralizumab) / Roche
New P2 trial: SHIELD DMD: An Open-label Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (clinicaltrials.gov) - Jun 10, 2024
P2, N=50, Not yet recruiting, Sponsor: Hoffmann-La Roche
- || Ultomiris (ravulizumab-cwvz) / AstraZeneca
Retrospective data, Review, Journal: Network Meta-analysis of Ravulizumab and Alternative Interventions for the Treatment of Neuromyelitis Optica Spectrum Disorder. (Pubmed Central) - May 9, 2024
CD200+ PBs may be a marker of treatment responsiveness in the context of NMOSD pathophysiology. In the absence of head-to-head randomized controlled trials, NMA results suggest ravulizumab, a C5 inhibitor, is likely to be more effective in preventing NMOSD relapse in patients with AQP4-Ab+ NMOSD when compared with other treatments having different methods of action.
- || Review, Journal, Immunomodulating: Novel immunomodulatory therapies in myasthenia gravis (Pubmed Central) - Apr 26, 2024
This review explores new immunosuppressive therapies and ongoing clinical trials in MG, including depletion of B lymphocytes with agents such as rituximab and inebilizumab, as well as the use of eculizumab, efgartigimod, satralizumab, tocilizumab, and CAR-T (Chimeric Antigen Receptor-T) cell therapy. These advancements aim to improve disease control and patients' quality of life.
- | Enspryng (satralizumab) / Roche
Journal: Perioperative management of patients treated with satralizumab (Pubmed Central) - Apr 24, 2024
These advancements aim to improve disease control and patients' quality of life. No abstract available
- | Enspryng (satralizumab) / Roche
Journal: Perioperative management of patients treated with satralizumab (Pubmed Central) - Apr 24, 2024
No abstract available No abstract available
- Enspryng (satralizumab) / Roche
Optimizing the diagnosis of NMOSD and MOGAD in North Macedonia (Poster Zone) - Apr 21, 2024 - Abstract #EAACI2024EAACI_2669;
In our country there are 21 patients diagnosed with NMOSD, and only 5 of them are on treatment with Satralizumab as part of a compassionate use program. Our institute together with the University Clinic of Neurology Skopje works on a project to include all of the patients diagnosed with NMOSD in a program from the Ministry of Health for biological therapy with Satralizumab.
- | Journal: Monoclonal antibody therapies for aquaporin-4-immunoglobulin G-positive neuromyelitis optica spectrum disorder and myelin oligodendrocyte glycoprotein antibody-associated disease. (Pubmed Central) - Apr 17, 2024
Most recently, ravulizumab (anti-C5 complement inhibitor) was also shown to be highly efficacious in an open-label, external-controlled trial...Observational studies showed that tocilizumab was associated with a decrease in relapses, whereas rituximab seemed to have less robust effectiveness in MOGAD compared to AQP4-IgG+NMOSD. Herein, we review the evidence on the efficacy and safety of each monoclonal antibody therapy used in AQP4-IgG+NMOSD and MOGAD, including special considerations in children and women of childbearing potential.
- || Enspryng (satralizumab) / Roche
Clinical, Journal, Real-world evidence, Claims database, Real-world: Real-world management of patients with neuromyelitis optica spectrum disorder using satralizumab: Results from a Japanese claims database. (Pubmed Central) - Apr 1, 2024
P3
The number of glucocorticoid-free patients without relapse increased over time under continuous satralizumab prescription. Further studies are needed to confirm if satralizumab can be used as a potential immunosuppressant- and glucocorticoid-sparing agent.
- || Review, Journal: Disease-modifying treatments for neuromyelitis optica spectrum disorder in the context of a new generation of biotherapies. (Pubmed Central) - Mar 30, 2024
Since 2015, evidence has accumulated to support off-label biotherapies (rituximab and tocilizumab) and to approve satralizumab, inebilizumab, eculizumab, and ravulizumab...The current consensus proposes positioning the approved drugs as first-line treatments for newly-diagnosed patients and as alternative therapies in case of failure of historical treatment. Yet, there has been limited acceptance in practice due to high drug prices.
- || Enspryng (satralizumab) / Roche
Trial completion date: A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease (clinicaltrials.gov) - Mar 15, 2024
P3, N=120, Recruiting, Sponsor: Hoffmann-La Roche
Yet, there has been limited acceptance in practice due to high drug prices. Trial completion date: May 2025 --> May 2026
- Enspryng (satralizumab) / Roche
Long-term Efficacy of Satralizumab in Patients with Aquaporin-4-IgG-seropositive (AQP4-IgG+) Neuromyelitis Optica Spectrum Disorder (NMOSD): Updated Analysis from the Open-label SAkuraMoon Study (Colorado Convention Center | Mile High 1EF) - Mar 8, 2024 - Abstract #AAN2024AAN_4342;
P3
These results demonstrate the effective long-term management of NMOSD with satralizumab over 5.5 years of treatment. The ARR remained consistently low in satralizumab-treated patients, with high proportions of patients remaining free from relapse, severe relapse, and worsening disability.
- Trends in Management Practices of Seropositive Neuromyelitis Optica Spectrum Disorder: Lessons from a Multicenter Academic Cohort (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_4270;
Treatment decisions appeared based primarily on disease activity and therapy-specific features, with no apparent association with patient race. Further work in the larger geographically diverse collaborative cohort will explore the potential impact of race/ethnicity and other sociodemographic factors on early access to NMOSD specialist care and its impact on disease outcomes.
- Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen, Soliris (eculizumab) / AstraZeneca, Enspryng (satralizumab) / Roche
Matching-adjusted Indirect Comparison of Current Treatments for NMOSD and Evaluation of Long-term Effectiveness (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_4266;
Additionally, treatment with inebilizumab yields better results for expected life years and quality adjusted life years compared to either satralizumab or eculizumab. Relative efficacy and discontinuation were the key drivers of the results.
- Ultomiris (ravulizumab-cwvz) / AstraZeneca
Indirect Treatment Comparison of Ravulizumab Versus Approved Treatment Options for Adults with Aquaporin-4 Immunoglobulin G-Positive (AQP4-IgG+) Neuromyelitis Optica Spectrum Disorder (NMOSD) (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_4265;
Ravulizumab is more efficacious at preventing relapse than satralizumab and inebilizumab and comparable with eculizumab among adults with AQP4-IgG+ NMOSD when used as monotherapy. In combination with IST, ravulizumab was more efficacious than satralizumab and comparable to eculizumab.
- Enspryng (satralizumab) / Roche
Infection in NMOSD: Analyzing the Patterns of Infection in the SAkura Studies, Satralizumab Post-marketing Data, and NMOSD US PharMetrics Claims Data (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_4263;
US claims data indicates infections are major comorbidities in NMOSD. The incidence of infection, serious infection, and sepsis was consistently lower in satralizumab-treated patients than in US claims data.
- Enspryng (satralizumab) / Roche
LUMINESCE, a Phase 3 Study of Satralizumab in Generalized Myasthenia Gravis (gMG): Baseline Characteristics (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_4255;
P3
LUMINESCE, the first study of IL-6R antagonism with satralizumab in gMG, has enrolled 186 participants who are representative of a broad gMG population. LUMINESCE will evaluate the efficacy, safety, and PK/PD profiles of satralizumab in gMG.
- Enspryng (satralizumab) / Roche
Primary and Secondary Results of LUMINESCE, a Phase 3 Study of Interleukin-6 Signaling Inhibition by Satralizumab in Generalized Myasthenia Gravis (Colorado Convention Center | Bluebird 1A) - Mar 8, 2024 - Abstract #AAN2024AAN_2658;
LUMINESCE will evaluate the efficacy, safety, and PK/PD profiles of satralizumab in gMG. BackgroundObjectiveDesign/MethodsConclusions
- | Journal: Impact of neuromyelitis optica spectrum disorder on employment and income in the United States. (Pubmed Central) - Feb 20, 2024
BackgroundObjectiveDesign/MethodsConclusions We provide a structured analysis of the impact of NMOSD on employment, work hours, and income in the United States, demonstrating its major effect on the livelihoods of patients and their caregivers.
- || Uplizna (inebilizumab) / Mitsubishi Tanabe, Amgen, Soliris (eculizumab) / AstraZeneca, Enspryng (satralizumab) / Roche
Review, Journal: Advances in the long-term treatment of neuromyelitis optica spectrum disorder. (Pubmed Central) - Feb 5, 2024
We will also discuss the extension trials of each of these medications and what lead to their approval in AQP4-IgG seropositive NMOSD patients. We will then examine treatments in the pipeline for adult and pediatric NMOSD patients and conclude with discussions on treatment considerations in pregnant patients and how to approach treatment of NMOSD patients during COVID.
- || Review, Journal, IO biomarker: Update on the diagnosis and treatment of neuromyelitis optica spectrum disorders (NMOSD) - revised recommendations of the Neuromyelitis Optica Study Group (NEMOS). Part II: Attack therapy and long-term management. (Pubmed Central) - Jan 8, 2024
We will then examine treatments in the pipeline for adult and pediatric NMOSD patients and conclude with discussions on treatment considerations in pregnant patients and how to approach treatment of NMOSD patients during COVID. Four preventive immunotherapies have now been approved for AQP4-IgG-positive NMOSD in many regions of the world: eculizumab,
- ||| Enspryng (satralizumab) / Roche
Trial primary completion date, Monotherapy: Meteoroid: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (clinicaltrials.gov) - Dec 15, 2023
P3, N=152, Recruiting, Sponsor: Hoffmann-La Roche
Four preventive immunotherapies have now been approved for AQP4-IgG-positive NMOSD in many regions of the world: eculizumab, Trial primary completion date: Apr 2026 --> Jul 2026
- | Enspryng (satralizumab) / Roche
Trial completion date, Trial primary completion date: Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial) (clinicaltrials.gov) - Dec 8, 2023
P2, N=20, Recruiting, Sponsor: International University of Health and Welfare
Trial primary completion date: Apr 2026 --> Jul 2026 Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Dec 2025 --> Jun 2026
- |||| Enspryng (satralizumab) / Roche
Enrollment open, Trial completion date: A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease (SatraGO-2) (clinicaltrials.gov) - Dec 4, 2023
P3, N=120, Recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Dec 2025 --> Jun 2026 Not yet recruiting --> Recruiting | Trial completion date: May 2027 --> May 2026
- || Enspryng (satralizumab) / Roche
Trial initiation date: SASH: Satralizumab in Aneurysmal Subarachnoid Hemorrhage (clinicaltrials.gov) - Dec 1, 2023
P1, N=15, Not yet recruiting, Sponsor: University of Florida
Not yet recruiting --> Recruiting | Trial completion date: May 2027 --> May 2026 Initiation date: Oct 2023 --> Jan 2024
- | Enspryng (satralizumab) / Roche, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Journal: Therapy challenges for NMOSD in a patient with HIV. (Pubmed Central) - Nov 30, 2023
After switching immunotherapy due to the lack of vaccination response to satralizumab, peripheral B cells reoccurred and a humoral immune response was observed after reapplication of SARS-CoV-2 vaccination. This case illustrates the challenges associated with the treatment of NMOSD in PLWH.
- | Enspryng (satralizumab) / Roche
Journal: Urosepsis Risk in Neuromyelitis Optica Spectrum Disorder Patients Administered Satralizumab. (Pubmed Central) - Nov 17, 2023
Discussion Safe satralizumab use requires risk factor assessment to minimize the incidence of severe infections. Management of UTIs is also recommended.
- | Enspryng (satralizumab) / Roche
Biomarker, Enrollment change, Trial completion date, Trial termination, Trial primary completion date: SAkuraBonsai: A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention (clinicaltrials.gov) - Nov 8, 2023
P4, N=4, Terminated, Sponsor: Hoffmann-La Roche
N=100 --> 4 | Trial completion date: Jan 2027 --> Oct 2023 | Recruiting --> Terminated | Trial primary completion date: May 2026 --> Oct 2023; Study has proved infeasible to recruit in sufficient numbers. There are insufficient eligible patients presenting to sites.
- || Enspryng (satralizumab) / Roche
Trial completion date: A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis (clinicaltrials.gov) - Nov 1, 2023
P3, N=185, Recruiting, Sponsor: Hoffmann-La Roche
There are insufficient eligible patients presenting to sites. Trial completion date: Dec 2025 --> Dec 2027
- |||||||| Enspryng (satralizumab) / Roche
New P3 trial: A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease (SatraGO-2) (clinicaltrials.gov) - Oct 29, 2023
P3, N=120, Not yet recruiting, Sponsor: Hoffmann-La Roche
- | Uplizna (inebilizumab) / Mitsubishi Tanabe, Amgen, Soliris (eculizumab) / AstraZeneca, Enspryng (satralizumab) / Roche
FDA event, Journal: Utilization of FDA approved treatments for neuromyelitis optica spectrum disorder in clinical practice: A survey study of academic neuroimmunologists. (Pubmed Central) - Oct 23, 2023
Neuromyelitis optica spectrum disorder (NMOSD) is a rare autoimmune condition for which three treatments have been approved since 2019: eculizumab, inebilizumab, and satralizumab. Following relapse, respondents were dichotomized, either switching 75-100
- | Uplizna (inebilizumab) / Horizon Therapeutics, Mitsubishi Tanabe
Journal, HEOR: Inebilizumab for neuromyelitis optica spectrum disorder in Italy: a budget impact model. (Pubmed Central) - Oct 5, 2023
Inebilizumab reduces the INHS expenditure for NMOSD drugs. Future research should explore the cost-effectiveness of inebilizumab vs other NMOSD-targeting drugs in Italy.
- |||| Enspryng (satralizumab) / Roche
Enrollment open: A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease (clinicaltrials.gov) - Oct 4, 2023
P3, N=120, Recruiting, Sponsor: Hoffmann-La Roche
Future research should explore the cost-effectiveness of inebilizumab vs other NMOSD-targeting drugs in Italy. Not yet recruiting --> Recruiting
- || Review, Journal: A Clinical Approach to Existing and Emerging Therapeutics in Neuromyelitis Optica Spectrum Disorder. (Pubmed Central) - Aug 31, 2023
Choosing a maintenance therapy remains nuanced depending on patient factors and accessibility. With over 100 putative agents in trials, disease-free survival is now a realistic goal for NMOSD patients.
- || Enspryng (satralizumab) / Roche
Trial initiation date: SASH: Satralizumab in Aneurysmal Subarachnoid Hemorrhage (clinicaltrials.gov) - Aug 28, 2023
P1, N=15, Not yet recruiting, Sponsor: University of Florida
With over 100 putative agents in trials, disease-free survival is now a realistic goal for NMOSD patients. Initiation date: Jul 2023 --> Oct 2023
- | Enspryng (satralizumab) / Roche
Trial completion date, Trial primary completion date: Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial) (clinicaltrials.gov) - Aug 24, 2023
P2, N=24, Recruiting, Sponsor: International University of Health and Welfare
Initiation date: Jul 2023 --> Oct 2023 Trial completion date: Mar 2025 --> Dec 2025 | Trial primary completion date: Mar 2025 --> Dec 2025
- |||| Enspryng (satralizumab) / Roche
Trial primary completion date: A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis (clinicaltrials.gov) - Aug 18, 2023
P3, N=240, Recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Mar 2025 --> Dec 2025 | Trial primary completion date: Mar 2025 --> Dec 2025 Trial primary completion date: Jul 2023 --> Jan 2024
- |||||||| Enspryng (satralizumab) / Roche
New P3 trial: A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease (clinicaltrials.gov) - Aug 14, 2023
P3, N=120, Not yet recruiting, Sponsor: Hoffmann-La Roche
- || Enspryng (satralizumab) / Roche
P2 data, Journal: SATISFY-JP, a phase II multicenter open-label study on Satralizumab, an anti-IL-6 receptor antibody, use for the treatment of pulmonary arterial hypertension in patients with an immune-responsive-phenotype: Study protocol. (Pubmed Central) - Jun 21, 2023
Including an IL-6 threshold ?2.73?pg/mL as inclusion criteria for reducing the risk of insufficient efficacy, an investigator-initiated clinical study using satralizumab, a recycling anti-IL6 receptor monoclonal antibody, for patients with an immune-responsive phenotype is underway. This study is intended to test whether use of patient biomarker profile can identify a phenotype responsive to anti-IL6 therapy.
- | Enspryng (satralizumab) / Roche, MR16-1 / Roche
Preclinical, Journal: Intradermal AQP4 peptide immunization induces clinical features of neuromyelitis optica spectrum disorder in mice. (Pubmed Central) - Jun 19, 2023
Administration of anti-IL-6 receptor antibody (MR16-1) inhibited the induction of clinical signs and prevented the loss of GFAP/AQP4 and deposition of complement factors in AQP4 peptide-immunized mice. This novel experimental model may contribute to further understanding the pathogenesis of NMOSD, elucidating the mechanism of action of therapeutic agents, and developing new therapeutic approaches.
- | Retrospective data, Journal: High-efficacy therapies reduce clinical and radiological events more effectively than traditional treatments in neuromyelitis optica spectrum disorder. (Pubmed Central) - Jun 16, 2023
This novel experimental model may contribute to further understanding the pathogenesis of NMOSD, elucidating the mechanism of action of therapeutic agents, and developing new therapeutic approaches. High-efficacy treatments maximize opportunity for preventing disease advancement in newly diagnosed and established pwNMOSD.
- Enspryng (satralizumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS
The first report of MSI-H gastric cancer with neuromyelitis optica treated by concurrent nivolumab and satralizumab (3F (Poster Viewing)) - Jun 1, 2023 - Abstract #IGCC2023IGCC_804;
- | Enspryng (satralizumab) / Roche
Trial completion date, Trial primary completion date: Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial) (clinicaltrials.gov) - Jun 1, 2023
P2, N=24, Recruiting, Sponsor: International University of Health and Welfare
High-efficacy treatments maximize opportunity for preventing disease advancement in newly diagnosed and established pwNMOSD. Trial completion date: Sep 2024 --> Mar 2025 | Trial primary completion date: Sep 2024 --> Mar 2025