Rebif (human IFN-β-1a) / EMD Serono - LARVOL DELTA

Patterns of autoantibody expression in multiple sclerosis identified through development of an autoantigen discovery technology. (PubMed, J Clin Invest) - "For autoantibody discovery, we assayed serum samples from CIS patients who received either placebo or treatment who were enrolled in the REFLEX clinical trial, which assessed the effects of IFN-β-1a (Rebif) clinical and MRI activity in patients with CIS...Further, 10 autoantibody biomarkers associated with disease activity and 17 associated with patient response to IFN-β-1a therapy. These findings indicate widespread autoantibody production in MS and provide biomarkers for continued study and prediction of disease progression."

Biomarker • Clinical • Journal • CNS Disorders • Immunology • Multiple Sclerosis • IFNB1

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

Pharmacovigilance insights into medication-induced risk of dural arteriovenous fistula. (PubMed, Int J Surg) - "These findings highlight the diverse range of drugs implicated in the occurrence or progression of DAVF. Drugs such as tamoxifen, corticosteroids, multiple sclerosis medications, and oral anticoagulants require particular attention. Future research should focus on elucidating the underlying mechanisms and risk factors, such as thrombosis, contributing to drug-induced DAVF to inform preventive strategies and optimize patient care."

Adverse events • Journal • Cardiovascular • CNS Disorders • Hematological Disorders • Multiple Sclerosis • Thrombosis • Vascular Neurology

The Effect of Metformin As an Adjuvant Therapy on Immunological Parameters in Egyptian Patients with RRMS: a Pilot Study (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: German University in Cairo

New P2 trial • CNS Disorders • Multiple Sclerosis • NEFL

Disease-modifying therapy during pregnancy and occurrence of postpartum relapses in women with multiple sclerosis: A register-based study among women undergoing assisted reproductive technology treatment (ECTRIMS 2024) - "Of these, 34 (30.6%) women used DMTs during pregnancy including interferon beta-1a (IFN β-1a) (52.9%), natalizumab and glatiramer acetate (GA) (each 17.7%)...The most common DMTs were IFN β-1a (28.6%), fingolimod, and GA (each 11.1%)... ART-treated women with RRMS who gave birth and were unexposed to DMT during pregnancy showed lower ARR than DMT users, which likely indicates their higher disease activity. There was no apparent difference in ARR before and during pregnancy vs postpartum irrespective of DMT exposure during pregnancy. Results are limited by small numbers of women with RRMS using ART who gave birth."

Clinical • CNS Disorders • Multiple Sclerosis • IFNB1

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

A Phase IIIb, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability of EK-12 in Patients With RRMS (clinicaltrials.gov) - P3 | N=301 | Terminated | Sponsor: Bosnalijek D.D | Recruiting ➔ Terminated; During the Covid-19 pandemic, the study was unable to enrol further patients.

Trial termination • 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

TLV-0326-24: Early Interferon-beta Treatment for West-Nile Virus Infection (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Tel-Aviv Sourasky Medical Center

New P2 trial • CNS Disorders • Infectious Disease

Interferon-Beta-1a (FP-1201) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Fred Hutchinson Cancer Center | N=24 ➔ 0 | Not yet recruiting ➔ Withdrawn

CAR T-Cell Therapy • Enrollment change • Trial withdrawal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

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

Interferon-Beta-1a (FP-1201) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy (clinicaltrials.gov) - P1/2 | N=24 | Not yet recruiting | Sponsor: Fred Hutchinson Cancer Center | Trial completion date: Nov 2026 ➔ Oct 2027 | Initiation date: May 2024 ➔ Apr 2025 | Trial primary completion date: Nov 2026 ➔ Oct 2027

CAR T-Cell Therapy • Trial completion date • Trial initiation date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Serum neurofilament light chain correlations in patients with a first clinical demyelinating event in the REFLEX study: a post hoc analysis. (PubMed, Ther Adv Neurol Disord) - P3 | "ClinicalTrials.gov identifier: NCT00404352. Date registered: 28 November 2006."

Journal • Reflex • Retrospective data • CNS Disorders • Multiple Sclerosis • IFNB1 • NEFL

REBISTART: Adherence of Patients with Multiple Sclerosis to Treatment with Subcutaneous Interferon Beta in the Context of a Patient Support Program. (PubMed, Neurol Ther) - "Very high adherence rates independent of the PSP nursing service over 1 year of treatment indicate that IFN beta-1a sc is an easy-to-use and well-tolerated disease-modifying drug."

Adherence • Clinical • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Fatigue • Multiple Sclerosis • Psychiatry

Preferences and Perspectives of Specialist Multiple Sclerosis Nurses and Patients with Multiple Sclerosis Regarding the New RebiSmart® 3.0 Autoinjector versus Other Assistive Devices. (PubMed, Med Devices (Auckl)) - "The incremental advances over previous versions of the device as well as in comparison with other currently available assistive devices were welcomed. The MS nurses identified key needs for patient education on the use of the device and the suitable approaches (training videos and educational leaflets) to support MS nurses and pwMS."

Journal • CNS Disorders • Multiple Sclerosis

Effectiveness, Self-Reported Adherence, and Safety of Cladribine Tablets in Patients With Relapsing Multiple Sclerosis After Suboptimal Response to Prior Injectable Disease-Modifying Therapy: 12-Month Interim Analysis From the US-Based Phase 4 CLICK-MS Study (ACTRIMS Forum 2024) - P | "The most common injectable DMTs used prior to initiating CladT were glatiramer acetate (48.4%) and interferon beta-1a (25.8%)... The results from this 12-month interim analysis of patients with RMS after switching from injectable DMTs are similar to the outcomes of other company-sponsored studies with regard to efficacy, stable EDSS scores, high self-reported adherence, safety, and tolerability with CladT. Results from the CLICK-MS study may help inform treatment decisions in real-world clinical practice."

Adherence • Clinical • P4 data • CNS Disorders • Infectious Disease • Multiple Sclerosis • Nephrology • Novel Coronavirus Disease

Twenty Years of Subcutaneous Interferon-Beta-1a for Multiple Sclerosis: Contemporary Perspectives. (PubMed, Neurol Ther) - "Among them was IFN-β-1a for subcutaneous (sc) injection (Rebif), which was approved for the treatment of MS in Europe and Canada in 1998 and in the USA in 2002...Today, IFN-β-1a sc remains an important therapeutic option in clinical use, especially around pregnancy planning and lactation, and may also be considered for aging patients, in which MS activity declines and long-term immunosuppression associated with some alternative therapies is a concern. In addition, IFN-β-1a sc is used as a comparator in many clinical studies and provides a framework for research into the mechanisms by which MS begins and progresses."

Journal • Review • CNS Disorders • Inflammation • Multiple Sclerosis • IFNB1

Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "We are highly confident that, compared to placebo, two-year treatment with natalizumab, cladribine, or alemtuzumab decreases relapses more than with other DMTs. We are moderately confident that a two-year treatment with natalizumab may slow disability progression. Compared to those on placebo, people with RRMS treated with most of the assessed DMTs showed a higher frequency of treatment discontinuation due to AEs: we are moderately confident that this could happen with fingolimod, teriflunomide, interferon beta-1a, laquinimod, natalizumab and daclizumab, while our certainty with other DMTs is lower. We are also moderately certain that treatment with alemtuzumab is associated with fewer discontinuations due to adverse events than placebo, and moderately certain that interferon beta-1b probably results in a slight reduction in people who experience serious adverse events, but our certainty with regard to other DMTs is lower. Insufficient evidence is available to evaluate..."

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

Phase I/II Study to Evaluate the Safety, Feasibility, and Efficacy of FP-1201 (Intravenous Interferon-Beta-1a) to Prevent Toxicities after CD19-Directed CAR T-Cell Therapy: Trial in Progress (ASH 2023) - P1/2 | "STUDY DESIGN AND METHODS Objectives and endpoints: Primary objective: To evaluate the safety and feasibility of FP-1201 in patients undergoing treatment with axi-cel or brexu-cel with two co-primary endpoints: i) to estimate the incidence of dose-limiting toxicity rates within the first 14 days following the last administration of FP-1201; ii) to study the type, frequency, and severity of adverse events according to the NCI CTCAE v5.0 from the first administration of FP-1201 and until day +28 after CAR T-cell infusion Secondary objectives: i) To decrease the incidence and severity of ICANS; ii) to decrease the incidence and severity of CRS; iii) to decrease corticosteroid usage; iv) to evaluate the effect of FP-1201 on anti-tumor efficacy Exploratory objectives: To characterize the in vivo effects of FP-1201 on endothelial function, the systemic cytokine milieu, and CAR T-cell function Key inclusion criteria: Adults ≥18 years of age with Karnofsky performance..."

CAR T-Cell Therapy • Clinical • P1/2 data • Acute Respiratory Distress Syndrome • CNS Disorders • Hematological Malignancies • Immunology • Lymphoma • Multiple Sclerosis • Non-Hodgkin’s Lymphoma • Oncology • CD73 • IFNA1 • IL6 • NT5E

Adherence to subcutaneous interferon beta-1a treatment among patients with relapsing multiple sclerosis: the MAIN-MS study. (PubMed, Front Neurol) - P=N/A | "No new safety concerns to sc IFN β-1a treatment were observed. https://clinicaltrials.gov/study/NCT02921035, NCT02921035."

Adherence • Journal • CNS Disorders • Multiple Sclerosis • IFNB1

Interferon-Beta-1a (FP-1201) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy (clinicaltrials.gov) - P1/2 | N=24 | Not yet recruiting | Sponsor: Fred Hutchinson Cancer Center | Initiation date: Dec 2023 ➔ Mar 2024

Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "We found mostly low and very low-certainty evidence that drugs used to treat MS may not increase SAEs, but may increase withdrawals compared with placebo. The results suggest that there is no important difference in the occurrence of SAEs between first- and second-line drugs and between oral, injectable, or infused drugs, compared with placebo. Our review, along with other work in the literature, confirms poor-quality reporting of adverse events from RCTs of interventions. At the least, future studies should follow the CONSORT recommendations about reporting harm-related issues. To address adverse effects, future systematic reviews should also include non-randomized studies."

Adverse events • Journal • Retrospective data • Review • CNS Disorders • Multiple Sclerosis

DisCoVeRy: Trial of Treatments for COVID-19 in Hospitalized Adults (clinicaltrials.gov) - P3 | N=1552 | Completed | Sponsor: Institut National de la Santé Et de la Recherche Médicale, France | Active, not recruiting ➔ Completed | N=2416 ➔ 1552

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease