- |||||||||| Tysabri (natalizumab) / Biogen, Royalty, Lemtrada (alemtuzumab) / Sanofi
Enrollment closed, Trial completion date: Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis (clinicaltrials.gov) - Oct 14, 2019
P4, N=40, Active, not recruiting,
Obtained data indicate the potential of neutrophil-derived proteases to modify (partially degrade) circulating immune complexes leading to exposure of internal glycoepitops. Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> Dec 2020
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Retrospective data, Review, Journal: Disease-Modifying Therapies for Relapsing-Remitting Multiple Sclerosis: A Network Meta-Analysis. (Pubmed Central) - Oct 13, 2019
High-quality evidence shows that alemtuzumab, natalizumab and ocrelizumab present the highest efficacy among DMTs, and other meta-analyses are required regarding adverse events frequency, to better understand the safety of therapies. Based on efficacy profile, guidelines should consider a three-category classification (i.e. high, intermediate and low efficacy).
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal: Effects of multiple sclerosis disease-modifying therapies on employment measures using patient-reported data. (Pubmed Central) - Oct 9, 2019
However, we recommend prompt referral to specialist endocrinology services following diagnosis of any IRT-induced TD diagnosis, and in particular for pregnant women and those considering pregnancy. Those using the higher efficacy (category 3) DMTs, particularly fingolimod and natalizumab, reported significant increases in amount of work, work attendance and work productivity, suggesting they have important beneficial effects on work life in people with MS.
- |||||||||| Clinical, Review, Journal: Cancer Risk in Patients with Multiple Sclerosis: Potential Impact of Disease-Modifying Drugs. (Pubmed Central) - Oct 8, 2019
Because of their action on the immune system, and due to a lack of available long-term data, a special warning of the potential risk of cancer accompanies the use of recent IS such as cladribine, fingolimod, natalizumab or alemtuzumab...For fingolimod, natalizumab, alemtuzumab, dimethyl fumarate, teriflunomide, daclizumab and ocrelizumab, risk management plans outlined by regulatory agencies are mandatory...We review the current evidence behind the increased risk of malignancy in MS patients receiving DMTs, and provide an overview of the DMTs that are currently in use and those in clinical trials. The known risks and benefits of these therapies will be considered.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Biomarker, Clinical, Review, Journal: Newer Treatment Approaches in Pediatric-Onset Multiple Sclerosis. (Pubmed Central) - Sep 29, 2019
The only FDA- and EMA-approved disease-modifying therapy in POMS is fingolimod; however, dimethyl fumarate, teriflunomide, natalizumab, ocrelizumab, and alemtuzumab either have been evaluated in observational studies or are being currently investigated in formal randomized controlled trials for use in POMS and appear to be safe in this group...Fingolimod is the only FDA-approved medication for use in POMS. Outcome measures and biomarkers used in AOMS are being studied in POMS and are greatly needed to quantify treatment response in this group.
- |||||||||| Tysabri (natalizumab) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Journal: Alemtuzumab following natalizumab in highly active paediatric-onset multiple sclerosis. (Pubmed Central) - Sep 27, 2019
Natalizumab followed by alemtuzumab proved to be a well-tolerated therapeutic course in paediatric-onset multiple sclerosis. Moreover, paediatric-onset multiple sclerosis maintained the no evidence of disease activity 3 status throughout the follow-up.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Review, Journal: Immune reconstitution therapy (IRT) in multiple sclerosis: the rationale. (Pubmed Central) - Sep 1, 2019
...IRT modalities were shown to induce long-term remission of MS that, in some cases, is close to the definition of a "cure." There are cohorts of patients having been treated with the IRTs, alemtuzumab, and HSCT, who experience-under these modalities-no evidence of disease activity (NEDA) for over 10 years...The "Holy grail" of the treatment of autoimmunity, which is to re-induce the disrupted self-tolerance, seems to be achievable-at least in part-with this approach. Moreover, the benefits of IRT, administered in short pulses, include significantly higher adherence to treatment and lower risks for accumulative side effects that are typically associated with chronic immunosuppression.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Journal: Immediate transient thrombocytopenia at the time of alemtuzumab infusion in multiple sclerosis. (Pubmed Central) - Aug 30, 2019
In total, 3 of 22 paitents developed mild self-limited bruising associated with a drop in platelet count from their baseline during the intial 5-day course of alemtuzumab. Upon chart review, all 22 patients who received alemtuzumab developed an immediate mostly asymptomatic drop in platelet count which returned to normal within 2 months post-infusion.
- |||||||||| Campath (alemtuzumab) / Sanofi, Lemtrada (alemtuzumab) / Sanofi
Journal: Vitiligo after alemtuzumab treatment: Secondary autoimmunity is not all about B cells. (Pubmed Central) - Aug 30, 2019
The prevailing concept of unleashed B-cell responses might therefore not cover all facets of alemtuzumab-related secondary autoimmunity. Mechanistic studies, especially on TCR repertoire, might help clarify the underlying mechanisms.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
GABA A receptor autoimmunity induced by Alemtuzumab treatment for MS: a case report (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1605;
Accurate laboratory diagnosis is critical for the correct identification of neuronal antibodies. Consideration of this treatable conditions is of utmost clinical importance to avoid invasive diagnostic procedure and allow prompt diagnosis and appropriate immunotherapy.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Effect of Alemtuzumab (LEMTRADA (R) ) treatment on the peripheral immune repertoire in multiple sclerosis patients (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1604;
Results analyzed so far show remarkably characteristic patterns of clonal expansion, clonal abundance and clonal evolution/persistence over time of individual lymphocyte subpopulations, which are differentially affected by Alemtuzumab treatment. Further data analysis and correlation with clinical data is ongoing to better understand which of the observed effects are responsible for maintaining immune competence, a beneficial “remolding'' of autoaggressive immune components or the development of secondary autoimmune conditions under Alemtuzumab treatment.
- |||||||||| Tysabri (natalizumab) / Biogen, Rituxan (rituximab) / Roche, Biogen, Lemtrada (alemtuzumab) / Sanofi
Comparison of the effectiveness of rituximab versus alemtuzumab and natalizumab in active relapsing-remitting MS (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1571;
Among patients with moderately active relapsing-remitting MS, alemtuzumab provides a mildly superior control of relapses and a higher chance of recovery from disability than rituximab. In patients with highly active disease, the effects of rituximab and natalizumab on relapse frequency are similar, while the rate of recovery from disability is higher on natalizumab.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Adverse events with fatal outcome associated with alemtuzumab treatment in multiple sclerosis in Europe (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1555;
Six of these patients died within one month after treatment; one from intracerebral hemorrhage, two from acute multiple organ failure and septic shock, one from listeriosis, one from pneumonia and one from agranulocytosis. Four patients died several months after administration of alemtuzumab from either autoimmune hepatitis, immune-mediated thrombocytopenia, autoimmune hemolytic anemia or agranulocytosis.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Alemtuzumab improves disability and quality of life outcomes over 8 years in patients with RRMS (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1304;
P3, P4
Four patients died several months after administration of alemtuzumab from either autoimmune hepatitis, immune-mediated thrombocytopenia, autoimmune hemolytic anemia or agranulocytosis. Alemtuzumab-treated patients who achieved 6-month CDI showed a high rate of improvement on EDSS at Y8 versus baseline, regardless of baseline EDSS, and had improvements in QoL outcomes which were maintained over 8 y. These results support the use of CDI as a meaningful endpoint for assessing long-term outcomes in RRMS patients.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Medication use and relapse rates in RRMS patients in the United States treated with the first course of alemtuzumab (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1294;
This real-world, retrospective analysis of MS patients in the United States treated with alemtuzumab Course 1 showed decreases in DMT use, relapse rates, and inpatient hospital admissions, and similar levels of medication use for MS symptoms, compared with the baseline period. Longer-term follow-up of this insured cohort of alemtuzumab-treated patients will help assess the clinical efficacy and cost effectiveness of alemtuzumab in a real-world setting.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Iatrogenesis in multiple sclerosis: what is the therapeutic risk of our disease modifying therapies? (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1125;
Current patient exposures for injectable, oral, and infusible MS medications range from 2,000 to over 500,000 while patient years range from 10,000 to over 2.5 million. A comparison of the above (and additional) SAE rates by patient exposure will be presented.
- |||||||||| Campath (alemtuzumab) / Sanofi, Lemtrada (alemtuzumab) / Sanofi
Alemtuzumab as induction versus escalation therapy: efficacy and adverse events in the real-world (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1117;
In addition, we found that escalation group was more likely to experience secondary autoimmunity. Real world population treated with ATZ differs from the pivotal trials and using ATZ as an escalation therapy may underlie the increased recognition of adverse events.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Efficacy of aHSCT and Alemtuzumab: A Case-Control Study in Hamburg MS-patients (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1112;
This case-control study suggests that aHSCT suppresses inflammatory activity in MS more effectively than alemtuzumab. Despite longer disease duration and lower pre-treatment relapse activity in the alemtuzumab group, which hypothetically should be associated with less inflammatory activity, more MRI activity and relapses were observed in this group in comparison to aHSCT treated patients.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
First Treatment Choices for Relapsing Remitting Multiple Sclerosis: the Italian Registry experience (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1079;
Fingolimod (n= 384, 3.6%), Alemtuzumab (n=14, 0.2%)...The highest persistence rates were observed for patients oral DMTs: n=464, 77.8% on Dimethyl fumarate, n=201 (77.1%) on Teriflunomide, n=261, 67.9% on Fingolimod... This large registry study showed that Interferons and Glatiramer acetate remain a valid first therapeutic option for newly diagnosed RRMS patients but also that new oral licensed DMTs showed the highest persistence rates.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Evaluation of a shared decision-making process in MS (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1062;
Our patients have high rates of confidence and satisfaction with their DMT. This could have important implications in quality of life and adherence, although more studies are needed
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Alemtuzumab treatment in Denmark: a national study based on the Danish MS Registry (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1053;
The mean age at the onset of alemtuzumab was 38±8.7 years (18-69 years), and the mean disease duration from diagnosis to alemtuzumab start was 7.9±5.9 years. The mean EDSS at the time of alemtuzumab initiation was 3.8±1.8.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Comparative Effectiveness of Delayed-release Dimethyl Fumarate vs. Other Disease-modifying Therapies in Patients with Multiple Sclerosis: A Network Meta-analysis of Real-world Evidence (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1048;
RWE NMAs suggest that, for RRMS pts, DMF is significantly more effective than GA, IFN, and TERI, and comparable to FTY, but not ALEM, and NTZ in reducing ARR and delaying TTFR. This NMA minimised confounding inherent to RWE by selecting robust, adjusted studies.
- |||||||||| A real-world study of Alemtuzumab in a cohort of Italian patients (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1043;
Alemtuzumab decreases ARR independent of previous therapy, including patients with disease activity during Natalizumab. Relapses between treatment courses are associated with higher disease activity during follow-up.
- |||||||||| Campath (alemtuzumab) / Sanofi, Lemtrada (alemtuzumab) / Sanofi
Myasthenia gravis presenting in pregnancy in a woman treated with Alemtuzumab (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1021;
There is a danger that the symptoms of myasthenia may be mistaken for MS relapse. In this case the relevance of making the diagnosis was particularly important because of the risk of transfer of maternal antibodies and the risk of myasthenia in the newborn.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Cerebrospinal fluid growth-associated protein 43 in multiple sclerosis (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_762;
CSF GAP-43 concentrations are lower during progressive MS and in patients with higher disability. Interestingly, higher GAP-43 concentration in CSF seemed to occur during inflammatory active stages but treatment with highly active DMTs did not influence GAP-43 levels.
- |||||||||| Campath (alemtuzumab) / Sanofi, Lemtrada (alemtuzumab) / Sanofi
Pharmacovigilance of urinary tract infections in Alemtuzumab cohort (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_749;
WBC count did not predict the presence of symptoms. Our data suggests clinical judgement should guide UTI management in pwMS.
- |||||||||| A case of severe polyarthritis after a treatment with alemtuzumab: when disability is not only neurological (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_729;
Currently, she is treated with secukinumab, MTX, hydroxychloroquine, sulfasalazine, and oral methylprednisolone with a moderate response...The temporal evolution is in concordance with previous reports regarding other secondary autoimmune diseases, corresponds to the mean time of B cell hyperproliferation after alemtuzumab, and is usually accompanied by suppression of regulatory CD4 T cells, making the patients particularly susceptible for autoimmune phenomena. The flow cytometry results from our patients support this hypothesis.
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