Plegridy (PEG-interferon β-1a) / Biogen - LARVOL DELTA

Outcomes of older patients with multiple sclerosis treated with interferon beta-1a or peginterferon beta-1a in MS PATHS. (PubMed, Neurodegener Dis Manag) - "Mean change in Patient-Determined Disease Steps (PDDS) from baseline-24 months was -0.13 (1.08) in older interferon-treated patients vs 0.20 (1.30) in older no-DMT patients. Over 24 months ARR remained low and disability progression was stable for interferon-treated patients aged ≥ 60 years."

Journal • 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

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 Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis (clinicaltrials.gov) - P3 | N=142 | Active, not recruiting | Sponsor: Biogen | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jul 2024 ➔ May 2027

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

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

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis (clinicaltrials.gov) - P3 | N=142 | Recruiting | Sponsor: Biogen | Trial completion date: Nov 2029 ➔ May 2027 | Trial primary completion date: Nov 2029 ➔ Jul 2024

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

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

Safety and clinical effectiveness of peginterferon beta-1a for relapsing multiple sclerosis in a real-world setting: Final results from the Plegridy Observational Program. (PubMed, Mult Scler J Exp Transl Clin) - P=N/A | "Peginterferon beta-1a is an effective therapy for managing relapsing multiple sclerosis. The identification of predictors of discontinuation can help inform strategies to enhance treatment persistence."

Journal • Real-world • Real-world evidence • CNS Disorders • Multiple Sclerosis

Evaluating the Use and Efficacy of Avonex and Plegridy in Pediatric Patients (AAN 2024) - "Objective:Summarize the demographic/clinical characteristics and efficacy outcomes of individuals with pediatric-onset multiple sclerosis (POMS) who were treated with Avonex or PlegridyBackground:IM interferon beta-1a (Avonex®) and peginterferon beta-1a (Plegridy®) have been shown to be effective in placebo-controlled randomized trials and real-world evidence for adults with relapsing forms of multiple sclerosis (MS). The data from this registry are consistent with previously reported clinical and MRI effects of approved interferon beta therapies more traditionally utilized in adult populations. Biogen provided funding for this study."

Clinical • CNS Disorders • Multiple Sclerosis • Pediatrics

Evaluating the Use and Efficacy of Avonex and Plegridy in Pediatric Patients (ACTRIMS Forum 2024) - "Background: IM interferon beta-1a (Avonex®) and peginterferon beta-1a (Plegridy®) have been shown to be effective in placebo-controlled randomized trials and real-world evidence for adults with relapsing forms of multiple sclerosis (MS). The data from this registry are consistent with previously reported clinical and MRI effects of approved interferon beta therapies more traditionally utilized in adult populations."

Clinical • CNS Disorders • Multiple Sclerosis • Pediatrics

Pregnancy outcomes in female multiple sclerosis patients exposed to intramuscular interferon beta-1a or peginterferon beta-1a reported in a German Patient Support Programme - results from the non-interventional post-authorization safety study PRIMA. (PubMed, Ther Adv Neurol Disord) - P=N/A | "These real-world data from a PSP corroborate European and Scandinavian registry data. NCT04655222, EUPAS38347."

Journal • CNS Disorders • Multiple Sclerosis

A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate (clinicaltrials.gov) - P=N/A | N=1178 | Recruiting | Sponsor: Biogen | N=825 ➔ 1178

Enrollment change • 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

Interferon β-1a ring prophylaxis to reduce household transmission of SARS-CoV-2: a cluster randomised clinical trial. (PubMed, EClinicalMedicine) - P3 | "Biogen PTY Ltd. Supply of interferon as 'Plegridy (peginterferon beta-1a).' The study was substantially funded by BHP Holdings Pty Ltd."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNB1

"#Menstruation is happening. #Menopause #Plegridy #MS @biogen @ChrisStephens" (@alison_mcentee)

"Amazing. What happened to #plegridy ? It almost killed me. Can I get compensation?" (@alison_mcentee)

Impact of interferon beta exposure on birth outcome and child development - Results from the post-authorisation safety study PRIMA. (PubMed, Mult Scler Relat Disord) - P=N/A | "Study results confirmed former reports indicating that exposure to interferon beta therapies during pregnancy or lactation had no adverse effects on intrauterine growth and child development over the study period, which covered the first 4 years of life. These real-world data obtained within the scope of a patient support program for peginterferon beta-1a or IM interferon beta-1a corroborate German and Scandinavian registry data and support the label update of all interferon beta therapies."

Journal • CNS Disorders • Multiple Sclerosis

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

Prolonged Interferon-Stimulated Gene and Protein Signatures in Multiple Sclerosis Induced by PEGylated IFN-β-1a Compared to Non-PEGylated IFN-β-1a. (PubMed, J Interferon Cytokine Res) - "Interferon (IFN)-β-1a (Avonex) and longer half-life, polyethylene glycol-conjugated IFN-β-1a (PEG-IFN-β-1a, Plegridy), may generate different molecular responses. Both forms of IFN-β balanced correlations of expression among these genes and proteins, with positive correlations between Th1 and Th2 families, quelling the "cytokine storm" of untreated MS. Both IFNs induced long-term, potentially beneficial, molecular effects on immune and possibly neuroprotective pathways in MS."

Journal • CNS Disorders • Multiple Sclerosis • IFIH1 • IFNB1 • IFNG • IL15 • IL1B • IRF5 • IRF7 • JAK2 • RB1 • SMAD7 • STAT3 • TLR8 • TNFSF10

Recurrent encephalopathy associated with pegylated beta-interferon treatment. (PubMed, J Neuroimmunol) - "These episodes occurred about 3 days after administration of pegylated interferon-beta-1a (Plegridy®) and resolved spontaneously in around 4 days. She discontinued treatment with interferon and was started on teriflunomide, experiencing no recurrence of symptoms. We believe that interferon was responsible for this patient's recurrent encephalopathic syndrome, possibly due to its effects on inflammatory cytokines and endothelial dysfunction."

Journal • CNS Disorders • Epilepsy • Multiple Sclerosis

A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate (clinicaltrials.gov) - P=N/A | N=825 | Recruiting | Sponsor: Biogen

New trial • CNS Disorders • Multiple Sclerosis

Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants (clinicaltrials.gov) - P3 | N=11 | Terminated | Sponsor: Biogen | Completed ➔ Terminated; Decision to stop the trial was based on long-term difficulties in fulfilling our enrolment commitments and changes in paediatric MS landscape which no longer support placebo-controlled trials.Decision to stop study was not based on safety concerns.

Trial termination • CNS Disorders • Multiple Sclerosis • Pediatrics

New Data at ECTRIMS 2022 Highlight Biogen’s Commitment to Advancing Individualized Disease Management for People Living with MS (GlobeNewswire) - "'Given the recent introduction of natalizumab subcutaneous administration in Europe, these findings validate clinical study data with real-world insights,' said Prof. Ralf Gold..."

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