Extavia (IFN-β-1b) / Novartis - LARVOL DELTA

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

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

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

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

[VIRTUAL] Interferon beta for the treatment of multiple sclerosis in the Campania Region of Italy: merging the real-life to routinely collected healthcare data (ECTRIMS 2021) - "Adherence was lower for Betaferon®/Extavia® (Coeff=-0.05; 95%CI=-0.10, -0.01; p=0.02), and Avonex® (Coeff=-0.06; 95%CI=-0.11, -0.02; p<0.01), when compared with Rebif® and Plegridy® (Coeff=0.08; 95%CI=0.01, 0.16; p=0.02)... We have showed the feasibility of merging routinely-collected healthcare data to a clinical registry for future MS research, and have confirmed interferon beta formulations play an important role in the management of MS, with positive clinical outcomes. Differences between interferon beta formulations are mostly driven by adherence and healthcare resource utilization."

Clinical • CNS Disorders • Multiple Sclerosis

[VIRTUAL] Interferon beta for the treatment of multiple sclerosis in the Campania Region of Italy: merging the real-life to routinely collected healthcare data (ECTRIMS 2021) - "Adherence was lower for Betaferon®/Extavia® (Coeff=-0.05; 95%CI=-0.10, -0.01; p=0.02), and Avonex® (Coeff=-0.06; 95%CI=-0.11, -0.02; p<0.01), when compared with Rebif® and Plegridy® (Coeff=0.08; 95%CI=0.01, 0.16; p=0.02)... We have showed the feasibility of merging routinely-collected healthcare data to a clinical registry for future MS research, and have confirmed interferon beta formulations play an important role in the management of MS, with positive clinical outcomes. Differences between interferon beta formulations are mostly driven by adherence and healthcare resource utilization."

Clinical • CNS Disorders • Multiple Sclerosis

Interferon beta for the treatment of multiple sclerosis in the Campania Region of Italy: Merging the real-life to routinely collected healthcare data. (PubMed, PLoS One) - "We have showed the feasibility of merging routinely-collected healthcare data to a clinical registry for future MS research, and have confirmed interferon beta formulations play an important role in the management of MS, with positive clinical outcomes. Differences between interferon beta formulations are mostly driven by adherence and healthcare resource utilization."

Clinical • Journal • CNS Disorders • Multiple Sclerosis

Drugs for multiple sclerosis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • 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 2023 ➔ Sep 2026; Trial primary completion date: Dec 2022 ➔ Dec 2025

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

PLENO: Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy (clinicaltrials.gov) - P4; N=80; Completed; Sponsor: Biogen; Active, not recruiting ➔ Completed

Clinical • Trial completion • 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=300; Not yet recruiting; Sponsor: Biogen; Trial completion date: Jul 2023 ➔ Sep 2024; Trial primary completion date: Jul 2023 ➔ Sep 2024

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

Infectious risk mitigation in patients with multiple sclerosis under disease-modifying treatment: the experience of a Portuguese tertiary care hospital (ECCMID 2019) - "Background: Disease-modifying therapies (DMT) for Multiple Sclerosis (MS), especially non-BRACE (Betaseron, Rebif, Avonex, Copaxone, Extavia), raise concerns about infectious risk... We found 149 patients (107 females) planned to start a non-BRACE DMT (natalizumab, fingolimod, dimethyl fumarate (DMF), teriflunomide or rituximab): 19 were naïve, 95 were previously on BRACE and 35 were already under non-BRACE DMT... We underline the need for infectious screening, ideally before DMT, followed by appropriate chemoprophylaxis and vaccines. In this cohort, we point the high number of LTB diagnosis and the need for its treatment before starting most of these drugs. Immunoprophylaxis and some chemoprophylaxis reduce the infectious risk and allow a more confident use of the chosen DMT."

Clinical • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Hepatitis B • Herpes Zoster • Infectious Disease • Multiple Sclerosis • Nephrology • Tuberculosis • Varicella Zoster

"أدوية إنترفيرون بيتا المضادة للفيروسات. تندرج هذه الأدوية ضمن أول أدوية DMTs المعتمدة المستخدمة لحالات انتكاس التصلب المتعدد والتي لا تزال تستخدم كخط علاج أولي. وتشمل: Avonex (إنترفيرون بيتا-1a) Betaseron (إنترفيرون بيتا-1b) Extavia (إنترفيرون بيتا-1b) Rebif (إنترفيرون بيتا-1a)" (@JFoziah)

Persistence, adherence, healthcare resource utilisation and costs for interferon Beta in multiple sclerosis: a population-based study in the Campania region (southern Italy). (PubMed, BMC Health Serv Res) - "Interferon Beta formulations presented with different prescription patterns, persistence, adherence, healthcare resource utilisation and costs, with Rebif® being used in younger patients and with less MS-related hospital admissions."

Clinical • HEOR • Journal • CNS Disorders • Multiple Sclerosis

Using Twitter to investigate opinions about multiple sclerosis treatments: a descriptive, exploratory study. (PubMed) - "Many tweets about MS treatments have a non-neutral sentiment. The analysis of social media appears to be a potential avenue for exploring patient opinion about MS treatments."

Journal • Biosimilar • Immunology • Inflammation • Multiple Sclerosis

Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial. (PubMed) - "FSS scores were found to be superior for fingolimod versus remaining on subcutaneous interferon beta-1a and interferon beta-1b, BDI-II scores were significantly improved for fingolimod except for the comparison with intramuscular interferon beta-1a, and SF-36 scores were superior with fingolimod compared with remaining on interferon beta-1b (MCS and PCS; p =0.030 and p =0.022, respectively) and subcutaneous interferon beta-1a (PCS only; p =0.024). Mean CGI-I scores were superior with fingolimod when compared with continuing treatment with any of the iDMTs (all p <0.001).ConclusionsAfter 6months, a switch to fingolimod showed superiority compared with remaining on each iDMT for a range of patient- and physician-reported outcomes, including global satisfaction with treatment."

Journal • Biosimilar • Hematological Malignancies • Immunology • Inflammation • Multiple Sclerosis • Oncology

Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS) (clinicaltrials.gov) - P2; N=300; Not yet recruiting; Sponsor: Biogen; Trial completion date: Oct 2022 ➔ Jul 2023; Initiation date: Jun 2020 ➔ Sep 2020; Trial primary completion date: Oct 2022 ➔ Jul 2023

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

Adherence to Disease Modifying Drugs among Patients with Multiple Sclerosis in Germany: A Retrospective Cohort Study. (PubMed) - "Two years after initiating MS-modifying therapy, only 30-40% of patients were adherent to DMDs."

Journal • Biosimilar • Multiple Sclerosis

[VIRTUAL] Interferon-beta for the treatment of multiple sclerosis in the Campania Region of Italy: a retrospective analysis based on routinely collected healthcare data (EAN 2020) - " Subcutaneous Interferon-beta1a was the most- commonly prescribed formulation in the Campania Region (Rebif 22µg and 44µg; 784 patients), followed by intramuscular Interferon-beta1a (Avonex; 618 patients), Interferon-beta1b (Betaferon and Extavia; 417 patients), and pegylated Interferon-beta1a (Plegridy; 259 patients). From 2015 to 2017, Interferon-beta formu- lations, and especially Rebif, were largely used in the management of MS in the Campania Region of Italy. Rebif was specifically prescribed in younger and possibly more active patients, and was associated with lower MS-related complications and costs, suggesting an overall better disease control."

Retrospective data • CNS Disorders • Multiple Sclerosis

Treatment patterns associated with relapsing-remitting multiple sclerosis patients on 1st-line injectable disease modifying therapies (CMSC 2016) - "MRI evidence of disease progression (13%), and acute exacerbation (7%),were the main reasons for switching between 12-24 months. Only 4% of patients re-started on their initial treatment during the 24-month follow-up period."

Retrospective data • Multiple Sclerosis

Patient satisfaction with the BETACONNECT™ autoinjector for interferon beta-1b. (PubMed) - "The vast majority of patients rated the BETACONNECT™ device as very helpful or helpful for their treatment with interferon beta-1b, and many considered most features as "very important". In conclusion, usage of the BETACONNECT™ autoinjector may facilitate interferon beta-1b therapy and support adherence to long-term therapeutic regimen."

Journal • Biosimilar • Multiple Sclerosis