Betaseron (IFN-β-1b) / Bayer - LARVOL DELTA

Association of Ultra-Processed Food Intake with Increased MS Disease Activity: Findings from the BENEFIT Trial (ECTRIMS 2025) - " We included 451 clinically isolated syndrome (CIS) patients randomized to interferon beta-1b or placebo and followed for 5 years in the BENEFIT trial (Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment)... Higher UPF intake, as inferred from the plasma metabolome at baseline, was linked to increased inflammatory disease activity over 2 to 5 years of follow-up. Targeted dietary strategies may help mitigate early MS disease activity."

CNS Disorders • Inflammation • Multiple Sclerosis

DELIVER-MS: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (clinicaltrials.gov) - P4 | N=800 | Active, not recruiting | Sponsor: The Cleveland Clinic | Trial completion date: Sep 2030 ➔ Jul 2027

Trial completion date • CNS Disorders • Multiple Sclerosis

TREAT-MS: Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial (clinicaltrials.gov) - P=N/A | N=900 | Active, not recruiting | Sponsor: Johns Hopkins University | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

In brief: Anaphylaxis with glatiramer acetate. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Leptospira Meningoencephalitis in a Patient with MS Treated with Betaferon (AECF 2024) - No abstract available

Clinical • CNS Disorders

Geopharm Healthcare-Bayer Korea Multiple Sclerosis Drug 'Betaferon' Partnership [Google translation] (Hankyung) - "Geopharm Healthcare announced on the 15th that it has entered into a strategic partnership with Bayer Korea regarding the multiple sclerosis drug 'betaferon injection'. Through this partnership, GeoPharm Healthcare will be in charge of the nationwide promotion of Betaferon to hospitals and clinics starting in October."

Commercial • CNS Disorders • Multiple Sclerosis

The role ofBetaseron mediated neuroprotection in an animal model of multiple sclerosis by regulating mitochondrial and oxidative stress (Neuroscience 2024) - "The dynamic factors regulated by IFN-β may constitute a beneficial microenvironment against EAE. This gene delivery approach may have implications in the future for treatment of MS."

Oxidative stress • Preclinical • CNS Disorders • IFNB1

Autoantibodies to Oligodendrocyte Myelin Glycoprotein Antibody (OMGp) are Detected in Patients with Atypical Demyelination (ECTRIMS 2024) - "Autoantibodies to OMGp are present in serum in a proportion of patients with atypical demyelinating diseases."

Clinical • CNS Disorders • Immunology • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • Solid Tumor

Immunomodulators and immunosuppressants for progressive multiple sclerosis: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "The number of people with PMS with relapses is probably slightly reduced with rituximab at two years, and interferon beta-1b at three years, compared to placebo. Both drugs are also probably associated with a slightly higher proportion of withdrawals due to adverse events, as are immunoglobulins, glatiramer acetate, natalizumab, fingolimod, siponimod, and ocrelizumab; we have high confidence that this is the case with interferon beta-1a. We found only low or very low certainty evidence relating to disability progression for the included disease-modifying treatments compared to placebo, largely due to imprecision. We are also uncertain about the effect of interventions on serious adverse events, also because of imprecision. These findings are due in part to the short follow-up of the included RCTs, which lacked detection of less common severe adverse events. Moreover, the funding source of many included studies may have introduced bias into the results. Future research on..."

Clinical • Immunomodulating • Journal • Retrospective data • Review • CNS Disorders • Multiple Sclerosis

DELIVER-MS: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (clinicaltrials.gov) - P4 | N=800 | Active, not recruiting | Sponsor: The Cleveland Clinic | Trial primary completion date: Apr 2030 ➔ Jul 2027

Trial primary completion date • CNS Disorders • Multiple Sclerosis

INFORM: An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden (clinicaltrials.gov) - P=N/A | N=4 | Active, not recruiting | Sponsor: Bayer | Not yet recruiting ➔ Active, not recruiting | N=100 ➔ 4 | Initiation date: Sep 2024 ➔ Mar 2024

Enrollment change • Enrollment closed • Trial initiation date • CNS Disorders • Multiple Sclerosis

DELIVER-MS: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (clinicaltrials.gov) - P4 | N=800 | Active, not recruiting | Sponsor: The Cleveland Clinic | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Multiple Sclerosis

INFORM: An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: Bayer | Initiation date: May 2024 ➔ Sep 2024

Trial initiation date • CNS Disorders • Multiple Sclerosis

Long-term clinical outcomes in patients with CIS treated with interferon beta-1b: results from the 15-year follow up of the BENEFIT trial. (PubMed, J Neurol) - "The objective of this study is to describe the long-term outcomes and healthcare utilization of patients with clinically isolated syndrome (CIS) included in the Betaferon®/Betaseron® in Newly Emerging MS for Initial Treatment (BENEFIT) randomized, parallel group trial...66.3% of patients were still employed at Year 15 versus 74.7% at baseline. In conclusion, results 15 years from initial randomization support long-term benefits of early treatment with IFNB-1b."

Clinical data • Journal • CNS Disorders • Multiple Sclerosis

INFORM: An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: Bayer

New trial • CNS Disorders • Multiple Sclerosis

DELIVER-MS: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (clinicaltrials.gov) - P4 | N=800 | Recruiting | Sponsor: The Cleveland Clinic | Trial completion date: Sep 2026 ➔ Sep 2030 | Trial primary completion date: Dec 2025 ➔ Apr 2030

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

"Hi Aaron, can anyone sign? @Natasha57932694" (@pauliec80859931)

Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS) (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Biogen | N=300 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • CNS Disorders • Multiple Sclerosis

MS Times Machine: The Story of Multiple Sclerosis in the 19th and 20th Century Through the Eyes of the Times Reader (AAN 2023) - "Early 1980’s reported on possible successful trials with prednisone, cyclophosphamide and ACTH, advent of MRI (1982) and even a failed vaccine. Late 80’s and early 90’s reported the advent of present day DMTs culminating in the approval of the first DMT “Betaseron” (1993) and bizarreness of the drug lottery. Chronological timeline will be provided. Conclusions This review aims to highlight the public perception of MS and continued misconceptions despite significant strides in the understanding of the disease."

CNS Disorders • Immunology • Infectious Disease • Multiple Sclerosis

New list of reimbursed drugs from November 2022. See which drugs you can buy cheaper now at the National Health Fund and what are the new oncological therapies (StronaZDROWIA.pl) - "Drug reimbursement makes it possible to purchase at lower prices not only pharmaceuticals, but also medical products and foodstuffs for particular nutritional uses. It is the responsibility of the National Health Fund (NFZ) on the basis of the list created by the Ministry of Health....New non-oncological indications from November 2022, and drugs used in the treatment program for patients with multiple sclerosis . The list includes: Betaferon (interferon beta-1b), Mayzent (siponimod), Kesimpta (ofatumumab), Ponvory (ponesimod), Zeposia (ozanimod), Gilenya (fingolimod), Mavenclad (cladribine), Tysabri (natalizumab), Ocrevus (ocrelizumab)."

Reimbursement • Immunology • Multiple Sclerosis

A Randomized, Double-blind Controlled Clinical Study to Determine the Effectiveness, Safety and Tolerability of Actoferon® Compared to Betaferon® in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) (ECTRIMS 2022) - "There was no significant difference between Betaferon®and Actoferon®in aspects of efficacy, safety and tolerability. This study showed the non-inferiority of Actoferon®to Betaferon®."

Clinical • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis

Capturing qualitative follow up data in a “real-world” study to assess disease modifying therapy use in the Multiple Sclerosis population before the pandemic and after: An update from the OPTIMISE:MS pharmacovigilance study (ECTRIMS 2022) - "The results showed the frequency of follow up visits that had been carried out on the OPTIMISE:MS study for patients recruited to date.The data showed that more work has to be done to ensure that participating sites consistently update the follow up records of their patient cohorts in a timely manner.The OPTIMISE:MS study remained open throughout the pandemic and it was encouraging to see that the DMT prescribing methods for MS patients remained consistently high before, during and after the pandemic."

Adverse events • Clinical • Real-world evidence • CNS Disorders • Infectious Disease • Multiple Sclerosis • Novel Coronavirus Disease

"Yo tardé 4 años en empezar con Tysabri...una pena con lo bien que me fue empezar tan tarde y tener el betaferon que no hizo nada" (@mt_elena)

TnP Peptide Suppresses Experimental Autoimmune Encephalomyelitis (EAE) in a Preclinical Mouse Model. (PubMed, Front Immunol) - "We demonstrated that prophylactic treatment with TnP generated similar protection to betaseron (30%) or was more effective than glatiramer (44% versus 6%) or fingolimod (50% versus 19%) against the development of clinical symptoms. Also, when compared to glatiramer, TnP was more efficient in reversing leukocytes infiltration into the spinal cord (55% versus 24%), as well as induced a higher percentage of regulatory cells in spleen (2.9-fold versus 2.3-fold increase over vehicle-treated EAE mice) an in the spinal cord (8-fold versus 6-fold increase over vehicle-treated EAE mice). This specialized TnP profile for inducing immune tolerance and neuronal regeneration has significant therapeutic potential for the treatment of MS and other autoimmune diseases."

Journal • Preclinical • CNS Disorders • Immune Modulation • Immunology • Inflammation • Multiple Sclerosis

Interferon-β Suppresses Transcriptionally Active Parvovirus B19 Infection in Viral Cardiomyopathy: A Subgroup Analysis of the BICC-Trial. (PubMed, Viruses) - "We aimed to evaluate B19V replicative status (viral RNA) and beneficial effects in a sub-collective of the prospective randomized placebo-controlled phase II multi-center BICC-Trial (Betaferon In Chronic Viral Cardiomyopathy) after interferon beta-1b (IFN-β) treatment...We could show for the first-time the beneficial effects from treatment with IFN-ß, suppressing B19V viral RNA and improving the hemodynamic course. Our results need further verification in a larger prospective randomized controlled trial."

Journal • Cardiomyopathy • Cardiovascular • Infectious Disease • BICC1 • IFNB1