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85 Diseases |  |
29 Trials |
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29 Trials |  |
4783 News |  |
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- || Soliris (eculizumab) / Alexion Pharma
Clinical, Journal: Complement-mediated oxidative damage of red cells impairs response to eculizumab in a G6PD-deficient patient with PNH. (Pubmed Central) - Apr 7, 2021
No abstract available
- || Soliris (eculizumab) / Alexion Pharma
Clinical, Journal: Pediatric Catastrophic Antiphospholipid Syndrome Successfully Treated with Eculizumab. (Pubmed Central) - Apr 7, 2021
No abstract available No abstract available
- | Soliris (eculizumab) / Alexion Pharma
Journal: Broadly effective metabolic and immune recovery with C5 inhibition in CHAPLE disease. (Pubmed Central) - Apr 7, 2021
We found that patients rapidly renormalized immunoglobulin concentrations and other serum proteins as revealed by aptamer profiling, re-established a healthy gut microbiome, discontinued immunoglobulin replacement and other treatments and exhibited catch-up growth. Thus, we show that blockade of C5 by eculizumab effectively re-establishes regulation of the innate immune complement system to substantially reduce the pathophysiological manifestations of CD55 deficiency in humans.
- || Soliris (eculizumab) / Alexion Pharma
Clinical, P4 data, Journal: Safety and effectiveness of eculizumab in Japanese patients with generalized myasthenia gravis: interim analysis of post-marketing surveillance. (Pubmed Central) - Apr 7, 2021
P3
In a real-world setting, eculizumab was effective and well tolerated for the treatment of AChR+ gMG in adult Japanese patients whose disease was refractory to IVIg or plasmapheresis. These findings are consistent with the efficacy and safety results from the global phase III REGAIN study of eculizumab.
- || Soliris (eculizumab) / Alexion Pharma
Clinical, Review, Journal: A Narrative Review of the W, X, Y, E, and NG of Meningococcal Disease: Emerging Capsular Groups, Pathotypes, and Global Control. (Pubmed Central) - Apr 7, 2021
However, the use of mono-, bi-, and quadrivalent-polysaccharide-conjugate vaccines, the introduction of protein-based vaccines for group B, natural disease fluctuations, new drugs (e.g., eculizumab) that increase meningococcal susceptibility, changing transmission dynamics and meningococcal evolution are impacting the incidence of the capsular groups causing IMD...In addition, group E and nongroupable meningococci have appeared as a cause of invasive disease, and a nongroupable N. meningitidis pathotype of the hypervirulent clonal complex 11 is causing sexually transmitted urethritis cases and outbreaks. Carriage and IMD of the previously "minor" N. meningitidis are reviewed and the need for polyvalent meningococcal vaccines emphasized.
- || Soliris (eculizumab) / Alexion Pharma
Clinical, Review, Journal: Difficult Cases of Paroxysmal Nocturnal Hemoglobinuria: Diagnosis and Therapeutic Novelties. (Pubmed Central) - Apr 7, 2021
Besides current treatment with the anti-C5 eculizumab, which reduced PNH-related morbidity and mortality, new complement inhibitors will likely fulfill unmet clinical needs in terms of patients' quality of life and better response rates (i.e., responses in subjects with C5 polymorphisms; reduction of extravascular hemolysis and breakthrough hemolysis episodes)...Lastly, long-term safety needs to be assessed in real-life studies. In this review, we describe some clinical vignettes illustrating practical aspects of PNH diagnosis and management; moreover, we discuss recent advances in PNH diagnostic and therapeutic approaches.
- || Soliris (eculizumab) / Alexion Pharma
Clinical, Review, Journal: New Therapeutic Landscape in Neuromyelitis Optica. (Pubmed Central) - Apr 7, 2021
Reliable biomarkers to guide therapy decisions are urgently needed. There is a plethora of promising investigational therapies currently in the pipeline with exciting and novel mechanisms of action.
- Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] Terminal Complement Inhibition Therapy for Severe COVID-19 () - Apr 4, 2021 - Abstract #PEGS2021PEGS_485;
Eculizumab is being provided for patients with severe COVID-19 to requesting physicians through Experimental Emergency Treatment/Expanded Access programs. We present data demonstrating the pharmacodynamics and clinical outcomes following eculizumab therapy in patients with severe COVID-19.
- || Soliris (eculizumab) / Alexion Pharma
Review, Journal: Complement in Sickle Cell Disease: Are We Ready for Prime Time? (Pubmed Central) - Apr 2, 2021
Until now, eculizumab-mediated complement inhibition has shown beneficial effects in DHTR, with limited reports in patients with VOC. In the meantime, several innovative agents are under clinical development Our state-of-the-art review summarizes current data on 1) complement activation in SCD both in steady state and crisis, 2) underlying mechanisms of complement over-activation for the clinician in the context of SCD, 3) actions of hydroxyurea and new therapeutic approaches including indirect involvement in complement activation, and 4) novel paradigms in complement inhibition.
- | Soliris (eculizumab) / Alexion Pharma, pegcetacoplan SC (APL-2 SC) / Apellis, SOBI
Journal: Pegcetacoplan versus Eculizumab in Paroxysmal Nocturnal Hemoglobinuria. (Pubmed Central) - Mar 31, 2021
P3
Pegcetacoplan was superior to eculizumab in improving hemoglobin and clinical and hematologic outcomes in patients with PNH by providing broad hemolysis control, including control of intravascular and extravascular hemolysis. (Funded by Apellis Pharmaceuticals; PEGASUS ClinicalTrials.gov, NCT03500549.).
- || Soliris (eculizumab) / Alexion Pharma
Clinical, Journal: Cocaine-associated atypical haemolytic uraemic syndrome in a genetically susceptible individual. (Pubmed Central) - Mar 30, 2021
The patient was found to have a rare genetic variant in the CFI gene which may have been unmasked by first-time exposure to cocaine. The patient stabilised and improved with early administration of eculizumab, supporting the notion of an underlying immunological pathogenesis and the importance of early intervention.
- | Soliris (eculizumab) / Alexion Pharma
Journal: Unraveling the Effect of a Potentiating Anti-Factor H Antibody on Atypical Hemolytic Uremic Syndrome-Associated Factor H Variants. (Pubmed Central) - Mar 30, 2021
This Ab could serve as a potential new drug for aHUS patients and alternative to C5 blockade by eculizumab...The potentiating anti-FH Ab is able to restore the surface regulatory function of most of the tested FH mutants to WT FH levels on a human HAP-1 cell line and on sheep erythrocytes. In conclusion, our potentiating anti-FH is broadly active and able to enhance both WT FH function as well as most aHUS-associated FH variants tested in this study.
- || Soliris (eculizumab) / Alexion Pharma
Review, Journal: Drug Treatment of Neuromyelitis Optica Spectrum Disorders: Out with the Old, in with the New? (Pubmed Central) - Mar 30, 2021
We are fortunate to have these new drugs available now, but they will not immediately supersede established off-label drugs in this indication. It is still too early to definitively revise the treatment algorithms for NMOSD - although we are probably on the way.
- || Soliris (eculizumab) / Alexion Pharma
Conveniently left out a bunch of other studies on Soliris. https://t.co/iT4CUIwgfc https://t.co/CoFrbFnvvS (Twitter) - Mar 28, 2021
- | Soliris (eculizumab) / Alexion Pharma
Journal: Emerging Targeted Therapies for Neuromyelitis Optica Spectrum Disorders. (Pubmed Central) - Mar 27, 2021
Monoclonal antibodies targeting terminal complement (eculizumab), CD19 (inebilizumab), and the interleukin-6 receptor (satralizumab) have demonstrated efficacy in NMOSD attack prevention in recent phase 3 trials and have gained subsequent regulatory approval in the USA and other countries. We aim to review the evidence supporting the efficacy of these new drugs.
- | Nplate (romiplostim) / Amgen, Kyowa Hakko Kirin, Soliris (eculizumab) / Alexion Pharma
Journal: Transplant-associated Thrombotic Microangiopathy Treated with Eculizumab and Romiplostim. (Pubmed Central) - Mar 27, 2021
This case adds to the evidence that TA-TMA is triggered by complement dysregulation and suggests possible interventions for refractory cases. Transplant-associated thrombotic microangiopathy (TA-TMA) may occur in solid organ transplant patients.Eculizumab may be used for the treatment of TA-TMA.
- || Soliris (eculizumab) / Alexion Pharma
Clinical, Journal: Low efficacy of vaccination against serogroup B meningococci in patients with atypical hemolytic uremic syndrome. (Pubmed Central) - Mar 26, 2021
Response to vaccination seems to be hampered by immunosuppression. Therefore, implementation of adequate antibiotic prophylaxis seems pivotal.
- ||| Soliris (eculizumab) / Alexion Pharma
Recurrent C3GN post Transplant. Improved Cr and proteinuria with pred. Already on Tac/Myfortic/ACEi. Functional assay with low C3, Low FB and high C5b-9. Q1) Pred how long? Q2) Pursue Eculizumab? @anuja_java @ssfarouk @SamiAlasfar #askrenal #NephTwitter (Twitter) - Mar 24, 2021
- ||| Soliris (eculizumab) / Alexion Pharma, Ultomiris IV (ravulizumab IV) / Alexion Pharma
Clinical, P3 data, PK/PD data, Journal: Pharmacokinetic and pharmacodynamic effects of ravulizumab and eculizumab on complement component 5 in adults with paroxysmal nocturnal haemoglobinuria: results of two phase 3 randomised, multicentre studies. (Pubmed Central) - Mar 23, 2021
In a minority of patients, free C5 concentrations <0·5 µg/ml were not consistently achieved with eculizumab in either study. Ravulizumab q8w was more consistent in providing immediate, complete, sustained C5 inhibition than eculizumab every-2-weeks in patients with PNH.
- || Actemra IV (tocilizumab) / Roche, JW Pharma, Soliris (eculizumab) / Alexion Pharma
Review, Journal: Advances in the Treatment of Neuromyelitis Optica Spectrum Disorder. (Pubmed Central) - Mar 23, 2021
These trials support the efficacy of rituximab and tocilizumab and led to the FDA approval of eculizumab, satralizumab and inebilizumab for NMOSD. Our review provides an update on these evidence-based disease-modifying therapies and discussed the treatment of acute relapses in NMOSD.
- || Soliris (eculizumab) / Alexion Pharma
Clinical, Journal: The use of eculizumab in Capnocytophaga canimorsus associated thrombotic microangiopathy: a case report. (Pubmed Central) - Mar 23, 2021
Our review provides an update on these evidence-based disease-modifying therapies and discussed the treatment of acute relapses in NMOSD. We discuss the possible interactions between complement activation and other findings in severe infection and argue that complement inhibition proved beneficial to this patient's rapid recovery.
- Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] COMPLEMENT INHIBITION FOR REFRACTORY GLOMERULONEPHRITIS IN SYSTEMIC VASCULITIS (Mini-Orals Hall) - Mar 19, 2021 - Abstract #ERAEDTA2021ERA_EDTA_1329;
All patients were previously treated with three or more drugs included: corticosteroids (n=8), mycophenolate (n=8), rituximab (n=7), immunoglobulins (n=5), therapeutic plasma exchange (n=4), cyclophosphamide (n=1), and belimumab (n=1). The coadyuvant complement inhibition with eculizumab stabilized renal function and decreased proteinuria in six out of the eight previously refractory patients and represents a promising tool in treating lupus and ANCA vasculitis nephritis.
- Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] CLINICOPATHOLOGICAL FEATURES OF THROMBOTIC MICROANGIOPATHY (Mini-Orals Hall) - Mar 19, 2021 - Abstract #ERAEDTA2021ERA_EDTA_1041;
Most of them had only with mild or even absent clinical and laboratory features. Therefore, a high index of suspicion is required to diagnose TMA, allowing targeted treatment to preserve of kidney function.
- Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] A CASE OF ALPORT SYNDROME WITH PREGNANCY-RELATED ATYPICAL HEMOLYTIC UREMIC SYNDROME, AND CRESCENTIC GLOMERULONEPHRITIS (Mini-Orals Hall) - Mar 19, 2021 - Abstract #ERAEDTA2021ERA_EDTA_645;
Here we presented a case with AS complicated by aHUS and crescentic GN. Given this complex combination of rare causes of acute kidney injury, detailed clinical evaluation is of great importance in the evaluation of acute kidney injury during pregnancy.
- Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] ATYPICAL HEMOLYTIC UREMIC SYNDROME IN LUNG TRANSPLANTATION: TREATMENT WITH ECULIZUMAB, OUR EXPERIENCE. (Mini-Orals Hall) - Mar 19, 2021 - Abstract #ERAEDTA2021ERA_EDTA_637;
Patients are at risk of end stage renal disease. Eculizumab treatment appears promising.
- Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] FIFTY-NINE CASES OF CANCER-ASSOCIATED THROMBOTIC MICROANGIOPATHY: TYPICAL PRESENTATION AND TREATMENT (Mini-Orals Hall) - Mar 19, 2021 - Abstract #ERAEDTA2021ERA_EDTA_540;
Typical presentation included old age, bone pain, dyspnea, and DIVC. These symptoms, when associated with TMA, should therefore suggest a diagnosis of cancer.
- Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] CLINICAL CHARACTERISTICS OF A PATIENT POPULATION WITH ATYPICAL HAEMOLYTIC URAEMIC SYNDROME AND MALIGNANT HYPERTENSION: THE GLOBAL AHUS REGISTRY ANALYSIS (Mini-Orals Hall) - Mar 19, 2021 - Abstract #ERAEDTA2021ERA_EDTA_414;
P=N/A
These symptoms, when associated with TMA, should therefore suggest a diagnosis of cancer. In this analysis of patients with aHUS and MHT, the observed high prevalence of pathogenic variants in complement genes or anti-CFH antibodies, alongside the high proportion of patients with extrarenal manifestations and/or requiring kidney transplant, indicate a high severity of presentation and poor prognosis of aHUS associated with MHT.
- | Soliris (eculizumab) / Alexion Pharma
Journal: Antibiotic prophylaxis in vaccinated eculizumab recipients who developed meningococcal disease: Antibiotic prophylaxis and eculizumab. (Pubmed Central) - Mar 19, 2021
In this analysis of patients with aHUS and MHT, the observed high prevalence of pathogenic variants in complement genes or anti-CFH antibodies, alongside the high proportion of patients with extrarenal manifestations and/or requiring kidney transplant, indicate a high severity of presentation and poor prognosis of aHUS associated with MHT. No abstract available
- || Soliris (eculizumab) / Alexion Pharma
Clinical, Journal: Eculizumab treatment of thrombotic microangiopathy in a patient with ulcerative colitis. (Pubmed Central) - Mar 18, 2021
Genetic screening showed a heterozygous mutation in diacylglycerol kinase ε (DGKE). Eculizumab resulted in complete resolution of TMA, however UC relapsed after cessation of eculizumab.
- ||||| Soliris (eculizumab) / Alexion Pharma
Clinical: Bravo R. Peffault de Latour et al. for this study conducted in our Clinical Investigation Center #CIC1427 @HopSaintLouis @APHP @Univ_Paris @Filiere_MaRIH @Institut_IRSL @NEJM Pegcetacoplan versus Eculizumab in Paroxysmal Nocturnal Hemoglobinuria | NEJM https://t.co/qrXAPnxsnv (Twitter) - Mar 18, 2021
- Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] Long-term efficacy and safety of eculizumab monotherapy in AQP4+ neuromyelitis optica spectrum disorder () - Mar 18, 2021 - Abstract #AAN2021AAN_3319;
P3
A very high proportion of patients who had experienced 1–2 relapses in the pre-study year remained relapse-free through 192 weeks of eculizumab monotherapy. Long-term eculizumab monotherapy was well tolerated and effective in reducing relapse risk in AQP4+ NMOSD.
- Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] Neuromuscular Clinician Preferences and Experience in the Management of Myasthenic Crisis () - Mar 18, 2021 - Abstract #AAN2021AAN_1932;
Long-term eculizumab monotherapy was well tolerated and effective in reducing relapse risk in AQP4+ NMOSD. Our survey indicates that there is considerable variability in the acute and ongoing treatment of myasthenic crisis, and escalated therapy continues into the post-discharge recovery period.
- Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] Clinical Experience with Eculizumab in Treatment-Refractory Acetylcholine Receptor Antibody-Positive Generalized Myasthenia Gravis () - Mar 18, 2021 - Abstract #AAN2021AAN_1899;
Our survey indicates that there is considerable variability in the acute and ongoing treatment of myasthenic crisis, and escalated therapy continues into the post-discharge recovery period. This real-world study demonstrated improvement in outcome measures and decreased concomitant drug requirement within 12 months of eculizumab initiation in patients with treatment-refractory AChR+ gMG.
- Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] Review of Dispensing Data and Patient Reported Outcome Measures (PROMs) in Myasthenia Gravis (MG) and Lambert-Eaton Syndrome (LES) Patients Prescribed Immunoglobulin (Ig) and Eculizumab by a Specialty Infusion Pharmacy Using SoleMetricsTM () - Mar 18, 2021 - Abstract #AAN2021AAN_1894;
By reviewing SoleMetricsTM data, providers may be able to optimize therapy and clinical outcomes in patients with MG and LES. Other PROMs in the process of being collected and analyzed in future publications include pain, Myasthenia Gravis Activities of Daily Living (MG-ADL), and Modified Rasch-built Fatigue Severity Scale (mfSS).
- Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] The potential impact of long-term relapse reduction: a disease model of eculizumab in neuromyelitis optica spectrum disorder () - Mar 18, 2021 - Abstract #AAN2021AAN_1525;
Other PROMs in the process of being collected and analyzed in future publications include pain, Myasthenia Gravis Activities of Daily Living (MG-ADL), and Modified Rasch-built Fatigue Severity Scale (mfSS). The benefits associated with eculizumab in the PREVENT trial were extrapolated over a 20-year time horizon and demonstrated substantial, long-term improvements in clinical outcomes and HRQoL among patients with NMOSD.
- Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] Real-World Use of Eculizumab in Generalized Myasthenia Gravis in the United States: Results From a Pilot Retrospective Chart-Review Study () - Mar 18, 2021 - Abstract #AAN2021AAN_287;
Results from this pilot study suggest that real-world eculizumab treatment is associated with substantial reductions in MG crises/exacerbations and related hospitalizations in patients with gMG, consistent with outcomes of the Phase 3 REGAIN study and its open-label extension. A larger real-world study of longer duration is underway to confirm these findings.
- |||||| Soliris (eculizumab) / AstraZeneca
New trial: COVID-19 Soliris Expanded Access Protocol (clinicaltrials.gov) - Mar 17, 2021
P, N=0, Available, Sponsor: Alexion Pharmaceuticals
- || Soliris (eculizumab) / Alexion Pharma
Clinical, Journal: Eculizumab-induced late erythroid maturation arrest: a case report. (Pubmed Central) - Mar 17, 2021
A larger real-world study of longer duration is underway to confirm these findings. No abstract available
- | Soliris (eculizumab) / Alexion Pharma
Clinical, Journal: Outcome of children with Shiga toxin-associated haemolytic uraemic syndrome treated with eculizumab: a matched cohort study. (Pubmed Central) - Mar 16, 2021
However, efficacy and safety are not best assessed by the observational design and small sample size of our study. Randomized controlled trials are thus required to determine the efficacy of eculizumab in this indication.
- | Soliris (eculizumab) / Alexion Pharma
Journal: Editorial: Complement and Immunotherapeutics. (Pubmed Central) - Mar 16, 2021
Randomized controlled trials are thus required to determine the efficacy of eculizumab in this indication. No abstract available
- Actemra IV (tocilizumab) / Roche, JW Pharma, Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] Hyperhemolysis Syndrome Complicated by Acute Pulmonary Hypertension and Right Ventricular Failure in a Patient with Sickle Cell Disease () - Mar 14, 2021 - Abstract #ATS2021ATS_3936;
He received two doses of tocilizumab in an attempt to treat HS...He subsequently received two doses of eculizumab...Acute pulmonary hypertension can develop rapidly and present similarly to acute PE, a commoner cause of acute hypoxia and shock. Increased awareness of HS and its complications in SCD patients is vital for treatment and management of this potentially life-threatening condition.
- | cemdisiran (ALN-CC5) / Alnylam, Regeneron, Soliris (eculizumab) / AstraZeneca
Enrollment change, Trial withdrawal: DANCE: Eculizumab to Cemdisiran Switch in aHUS (clinicaltrials.gov) - Mar 10, 2021
P2, N=0, Withdrawn, Sponsor: Mario Negri Institute for Pharmacological Research
Increased awareness of HS and its complications in SCD patients is vital for treatment and management of this potentially life-threatening condition. N=12 --> 0 | Not yet recruiting --> Withdrawn
- | Soliris (eculizumab) / Alexion Pharma
Retrospective data, Journal: Retrospective Analysis of Eculizumab in Patients with Acetylcholine Receptor Antibody-Negative Myasthenia Gravis: A Case Series. (Pubmed Central) - Mar 9, 2021
This small retrospective analysis provides preliminary evidence for the efficacy of eculizumab in treatment-refractory gMG that was AChR-according to radioimmunoassay. Larger, more robust studies are warranted to evaluate this further.
- || Soliris (eculizumab) / Alexion Pharma
Clinical, PK/PD data, Journal: Author's Reply to Liu et al.: "Pharmacology, Pharmacokinetics and Pharmacodynamics of Eculizumab, and Possibilities for an Individualized Approach to Eculizumab". (Pubmed Central) - Mar 9, 2021
Larger, more robust studies are warranted to evaluate this further. No abstract available
- || Soliris (eculizumab) / Alexion Pharma
Clinical, PK/PD data, Journal: Comment on "Pharmacology, Pharmacokinetics and Pharmacodynamics of Eculizumab, and Possibilities for an Individualized Approach to Eculizumab". (Pubmed Central) - Mar 9, 2021
No abstract available No abstract available
- ||||| Soliris (eculizumab) / Alexion Pharma
Clinical: Cedars-Sinai Investigator Studies Monoclonal Antibody Eculizumab in Pregnant Women With COVID-19, Preeclampsia https://t.co/LMtvLDDlAG (Twitter) - Mar 6, 2021
- || Soliris (eculizumab) / Alexion Pharma
Clinical, Journal: Hemolytic crisis in a patient treated with eculizumab for paroxysmal nocturnal hemoglobinuria possibly triggered by SARS-CoV-2 (COVID-19): a case report. (Pubmed Central) - Mar 5, 2021
No abstract available No abstract available
- ||| Soliris (eculizumab) / Alexion Pharma, Ultomiris IV (ravulizumab IV) / Alexion Pharma
Eculizumab and ravulizumab for PNH and atypical HUS (Twitter) - Mar 4, 2021
- Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] Safety of eculizumab in MG and NMOSD – analysis of the phase 3 studies REGAIN and PREVENT and their extensions () - Mar 4, 2021 - Abstract #MDA2021MDA_172;
P3
No abstract available In AChR+ gMG and AQP4+ NMOSD, infection rates were similar in eculizumab and placebo groups, regardless of concomitant ISTs, and were consistent with eculizumab’s established safety profile.
- | Soliris (eculizumab) / Alexion Pharma
Journal: Complement system and kidney (Pubmed Central) - Mar 3, 2021
As for kidney transplantation, complement modulators may lead to a new perspective in the treatment of some complications, such as humoral rejection. However, complement modulators carry the side effects, especially the infectious, and high costs.