- |||||||||| Uplizna (inebilizumab) / Horizon Therapeutics, Mitsubishi Tanabe, Soliris (eculizumab) / AstraZeneca, Enspryng (satralizumab) / Roche
Biomarker, Review, Journal: Neuromyelitis Optica Spectrum Disorders. (Pubmed Central) - Aug 9, 2022
As our understanding regarding the immune pathophysiology of NMOSD expands, emerging biomarkers, including serum neurofilament light chain and glial fibrillary acidic protein (GFAP), may facilitate earlier relapse detection and inform long-term treatment decisions. Future research focal points should include strategies to optimize relapse management, restorative treatments that augment neurologic recovery, and practical solutions that promote equitable access to approved therapies for all patients with NMOSD.
- |||||||||| Review, Journal: Antibody Therapies in Autoimmune Encephalitis. (Pubmed Central) - Jul 23, 2022
Newer mAbs might be added as a third-line therapy in the future, or be given even earlier if shown effective. In this chapter, we will discuss mAbs targeting B cells (rituximab, ocrelizumab, inebulizumab, daratumumab), IL-6 (tocilizumab, satralizumab), the neonatal Fc receptor (FCRn) (efgartigimod, rozanolixizumab), and the complement cascade (eculizumab).
- |||||||||| Review, Journal: Monoclonal Antibody Therapies Beyond Complement for NMOSD and MOGAD. (Pubmed Central) - Jul 23, 2022
Aquaporin-4 (AQP4)-IgG seropositive neuromyelitis optica spectrum disorders (AQP4-IgG seropositive NMOSD) and myelin oligodendrocyte glycoprotein (MOG)-IgG-associated disease (MOGAD) are inflammatory demyelinating disorders distinct from each other and from multiple sclerosis (MS).While anti-CD20 treatments can be used to treat MS and AQP4-IgG seropositive NMOSD, some MS medications are ineffective or could exacerbate AQP4-IgG seropositive NMOSD including beta-interferons, natalizumab, and fingolimod...Rituximab, eculizumab, inebilizumab, and satralizumab all have class 1 evidence for use in AQP4-IgG seropositive NMOSD, and the latter three have been approved by the US Food and Drug Administration (FDA)...Observational benefit has been suggested from oral immunosuppressants, intravenous immunoglobulin (IVIg), rituximab, and tocilizumab. Randomized placebo-controlled trials are urgently needed in this area.
- |||||||||| Uplizna (inebilizumab) / Horizon Therapeutics, Mitsubishi Tanabe, Soliris (eculizumab) / AstraZeneca, Enspryng (satralizumab) / Roche
Journal: Contemporary management challenges in seropositive NMOSD. (Pubmed Central) - Jul 12, 2022
Importantly, seronegative patients continue to have limited therapeutic options. Moving forward, areas of research exploration should include relapse prevention, restorative therapies, and initiatives that promote equitable access to approved therapies for all people living with NMOSD.
- |||||||||| Clinical, Review, Journal: Pharmacotherapy of Generalized Myasthenia Gravis with Special Emphasis on Newer Biologicals. (Pubmed Central) - Jun 23, 2022
Among novel targets, interleukin 6 (IL6) inhibitors such as satralizumab are promising and currently undergoing evaluation...While MG treatment is moving beyond conventional agents towards target-specific biologicals, lack of knowledge as to the initiation, maintenance, switching, tapering and long-term safety profile necessitates further research. These concerns and the high financial burden of novel agents may hamper widespread clinical use in the near future.
- |||||||||| How and when to treat AQP4-IgG-positive NMOSD (Elicium) - Jun 22, 2022 - Abstract #ECTRIMS2022ECTRIMS_313;
The international randomized controlled trials and the open label extension studies of 3 monoclonal antibodies (eculizumab, satralizumab and inebilizumab) in spNMOSD have proven their sustained efficacy and relative safety...3) Symptomatic therapy for pain, tonic spasm, bowel-bladder disturbance, etc should be done to relive the sequelae. In this presentation, the therapeutic evidence and issues of spNMOSD will be reviewed and the challenges that lie ahead will be discussed.
- |||||||||| Uplizna (inebilizumab) / Horizon Therapeutics, Mitsubishi Tanabe, Soliris (eculizumab) / AstraZeneca, Enspryng (satralizumab) / Roche
Health Resource Utilization (HRU) and Cost of Care (CoC) in Neuromyelitis Optica Spectrum Disorders in the US (Gaylord National Resort & Convention Center - Prince George's Exhibit Hall) - May 9, 2022 - Abstract #CMSC2022CMSC_106;
Highly active disease adds significant cost and resource utilization. New NMOSD indicated drugs that reduce attack frequency, hospitalization and disability accrual may positively impact HRU and lifetime CoC.
- |||||||||| Review, Journal, Adverse events: Adverse Events in NMOSD Therapy. (Pubmed Central) - Apr 30, 2022
Infections, cytopenias, and infusion-related reactions are most common, but the data are as heterogeneous as the manifestations are diverse. Nevertheless, knowledge of safety issues may facilitate treatment choices for individual patients.
- |||||||||| Soliris (eculizumab) / AstraZeneca
Clinical, Journal: A case of neuromyelitis optica associated with pulmonary Mycobacterium avium complex disease (Pubmed Central) - Mar 29, 2022
Exacerbation of the pulmonary MAC disease and the following internal counteraction with IL-6 may have resulted in a NMO relapse. The present patient was therefore administered eculizumab but not satralizumab, a humanized anti-IL-6 receptor antibody, for prevention of NMO recurrence.
- |||||||||| Soliris (eculizumab) / AstraZeneca
Immune Reconstitution Therapy in NMOSD (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_3905;
In NMO, as a 1st step control the complement (eculizumab), with subsequent reconstitution of the immune system (AHSCBMT),and then ultimately transition to immunomodulation (satralizumab) and reserve immunosuppression (inebilizumab) as 4th line. Also utilize AHSCBMT as salvage therapy for severe breakthrough disease during or after NMO-DMTs.
- |||||||||| Enspryng (satralizumab) / Roche, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Interleukin-6 as a Potential Prognostic Biomarker in Relapsing MOG Antibody Disease (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_3878;
We report case of relapsing MOGAD refractory to rituximab who was successfully treated with Satralizumab, consistent with research that shows upregulation of CSF IL-63. Targeted treatment with Satralizumab can block IL-6 differentiation of T cells and stimulation of autoantibody production and highlights IL-6 as potential prognostic marker in MOGAD with therapeutic implications.
- |||||||||| Enspryng (satralizumab) / Roche
SAkuraBONSAI: A Prospective, Open-label Study of Satralizumab Investigating Novel Imaging, Biomarker, and Clinical Outcomes in Patients with Aquaporin-4-IgG-seropositive (AQP4-IgG+) Neuromyelitis Optica Spectrum Disorder (NMOSD) (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_3568;
Objective: SAkuraBONSAI is a 2-year, prospective, multicenter, open-label study to assess the efficacy and safety of satralizumab in aquaporin-4-IgG seropositive (AQP4-IgG+) NMOSD patients who are treatment naïve or have failed prior rituximab (RTX) treatment. This study will provide additional evidence for the use of satralizumab in patients with AQP4-IgG+ NMOSD who are treatment-naïve or responded inadequately to RTX, with insights into disease pathology and progression, treatment response, and the mechanism of action of satralizumab.
- |||||||||| Soliris (eculizumab) / AstraZeneca
Indirect Comparison Analysis of FDA-Approved Treatment Options for Adults with Aquaporin-4 Immunoglobulin G-positive Neuromyelitis Optica Spectrum Disorder (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_3563;
This study will provide additional evidence for the use of satralizumab in patients with AQP4-IgG+ NMOSD who are treatment-naïve or responded inadequately to RTX, with insights into disease pathology and progression, treatment response, and the mechanism of action of satralizumab. Using available RCT data, NMA results showed that eculizumab monotherapy and eculizumab ± IST demonstrated greater efficacy in prolonging time-to-first relapse when compared with either satralizumab or inebilizumab in adults with AQP4-IgG+ NMOSD.
- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Soliris (eculizumab) / AstraZeneca
Clinical, Journal: Targeting Neuromyelitis Optica Pathogenesis: Results from Randomized Controlled Trials of Biologics. (Pubmed Central) - Mar 4, 2022
According to recent phase II-III trials, biologics significantly reduced the risk of relapses in aquaporin-4-seropositive patients, whereas results were less striking in the small cohorts of aquaporin-4-seronegative patients. Most adverse events were mild to moderate, with systemic symptoms (headache, arthralgia) or infections (upper respiratory and urinary tracts) being most commonly reported.
- |||||||||| Enspryng (satralizumab) / Roche
Review, Journal: Satralizumab for neuromyelitis optica spectrum disorder. (Pubmed Central) - Mar 3, 2022
Most adverse events were mild to moderate, with systemic symptoms (headache, arthralgia) or infections (upper respiratory and urinary tracts) being most commonly reported. No abstract available
- |||||||||| Enspryng (satralizumab) / Roche
SAkuraBONSAI: A Prospective, Open-label Study of Satralizumab Investigating Novel Imaging, Biomarker, and Clinical Outcomes in Patients with Aquaporin-4-IgG-seropositive (AQP4-IgG+) Neuromyelitis Optica Spectrum Disorder (NMOSD) (Virtual Poster Hall) - Feb 20, 2022 - Abstract #ACTRIMSForum2022ACTRIMS_Forum_381;
Objectives: SAkuraBONSAI is a 2-year, prospective, multicenter, open-label study to assess the efficacy and safety of satralizumab in aquaporin-4-IgG seropositive (AQP4-IgG+) NMOSD patients who are treatment naïve or have failed prior rituximab (RTX) treatment. This study will provide additional evidence for the use of satralizumab in patients with AQP4-IgG+ NMOSD who are treatment-naïve or responded inadequately to RTX, with insights into disease pathology and progression, treatment response, and the mechanism of action of satralizumab.
- |||||||||| Enspryng (satralizumab) / Roche, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Interleukin-6 as Potential Prognostic Biomarker in Relapsing MOG Antibody Disease (Exhibit Hall A) - Feb 20, 2022 - Abstract #ACTRIMSForum2022ACTRIMS_Forum_192;
Targeted treatment with Satralizumab can block IL-6 differentiation of T cells and stimulation of autoantibody production. This case underscores the role of cytokine profiling in MOGAD, and highlights IL-6 as potential prognostic marker in MOGAD with therapeutic implications.
- |||||||||| Enspryng (satralizumab) / Roche, MR16-1 / Roche
Journal: New BBB Model Reveals That IL-6 Blockade Suppressed the BBB Disorder, Preventing Onset of NMOSD. (Pubmed Central) - Feb 5, 2022
These results, generated from high-quality clinical trial data, demonstrated a strong and consistent relationship between disability and QoL in patients with NMOSD. These results suggest that (1) our triple-cultured in vitro and in ex vivo BBB models are ideal for evaluating barrier function, leukocyte transmigration, and intracerebral transferability; (2) NMO-IgG increased the intracerebral transferability of NMO-IgG via decreasing barrier function and induced secretion of IL-6 from astrocytes causing more dysfunction of the barrier and disrupting controlled cellular infiltration; and (3) satralizumab, which can pass through the BBB in the presence of NMO-IgG, suppresses the BBB dysfunction and the infiltration of inflammatory cells, leading to prevention of onset of NMOSD.
- |||||||||| Soliris (eculizumab) / AstraZeneca
Review, Journal: Neuromyelitis optica spectrum disorders: from pathophysiology to therapeutic strategies. (Pubmed Central) - Jan 27, 2022
Phase III studies have shown significant relapse reduction compared to placebo in AQP4-ab-positive patients treated with satralizumab, an interleukin-6 receptor (IL-6R) inhibitor, inebilizumab, an antibody against CD19 B cells; and eculizumab, an antibody blocking the C5 component of complement. In light of the new evidence on NMOSD pathophysiology and of preliminary results from ongoing trials with new drugs, we present this descriptive review, highlighting promising treatment modalities as well as auspicious preclinical and clinical studies.
- |||||||||| Soliris (eculizumab) / AstraZeneca
Clinical, Review, Journal: Hope for patients with neuromyelitis optica spectrum disorders - from mechanisms to trials. (Pubmed Central) - Jan 21, 2022
All four drugs were monoclonal antibodies: the complement C5 antibody eculizumab, the IL-6 receptor antibody satralizumab, the B cell-depleting antibody inebilizumab, which targets CD19, and rituximab, which targets CD20. We review the pathophysiology of NMOSD, the rationale for the development of these mechanism-based drugs, the methodology and outcomes of the five trials, and the implications of these findings for the treatment of NMOSD.
- |||||||||| Enspryng (satralizumab) / Roche
Enrollment open: A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis (clinicaltrials.gov) - Jan 19, 2022
P3, N=240, Recruiting,
We review the pathophysiology of NMOSD, the rationale for the development of these mechanism-based drugs, the methodology and outcomes of the five trials, and the implications of these findings for the treatment of NMOSD. Active, not recruiting --> Recruiting
- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Soliris (eculizumab) / AstraZeneca
Prognostic Biomarkers of NMOSD (Grand Ballroom) - Jan 15, 2022 - Abstract #ACTRIMSForum2022ACTRIMS_Forum_84;
sNfL may serve as a predictor of poor outcomes following attacks. Clinical NMO attacks are typically associated with new radiographic lesions; however, a strikingly large number of asymptomatic contrast-enhancing events, occur in NMO.
- |||||||||| Enspryng (satralizumab) / Roche
Enrollment closed: A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis (clinicaltrials.gov) - Dec 17, 2021
P3, N=240, Active, not recruiting,
Active, not recruiting --> Recruiting Not yet recruiting --> Active, not recruiting
- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Soliris (eculizumab) / AstraZeneca
Clinical, Review, Journal: Recent progress in maintenance treatment of neuromyelitis optica spectrum disorder. (Pubmed Central) - Nov 6, 2021
Tocilizumab and rituximab were also superior to azathioprine in head-to-head studies. Rituximab, tocilizumab and to some extent eculizumab have well-known safety profiles for other inflammatory diseases, and rituximab and azathioprine may be safe during pregnancy.
- |||||||||| Enspryng (satralizumab) / Roche, MR16-1 / Roche
Review, Journal: Interleukin-6: evolving role in the management of neuropathic pain in neuroimmunological disorders. (Pubmed Central) - Nov 4, 2021
Rituximab, tocilizumab and to some extent eculizumab have well-known safety profiles for other inflammatory diseases, and rituximab and azathioprine may be safe during pregnancy. Thus, anti-IL-6 therapies might have a potential to reduce neuropathic pain, but further investigations are warranted to clarify the effect of inhibition of IL-6 signaling on neuropathic pain associated with MS and NMOSD.
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