- Final safety and efficacy results from the Phase 3 EVOLVE-MS-1 trial demonstrate decreases in disease activity and favorable tolerability for VUMERITY® (diroximel fumarate) consistent with previous assessments
- Patient-reported outcomes favored TYSABRI® (natalizumab) compared to Ocrevus® (ocrelizumab); new insights on subcutaneous administration one year after approval in Germany
- Data on interferon exposure during pregnancy showed that treatment with PLEGRIDY® (peginterferon beta-1a) or AVONEX® (interferon beta-1a) did not negatively impact child development
CAMBRIDGE, Mass., Oct. 26, 2022 (GLOBE NEWSWIRE) — Biogen Inc. (NASDAQ:BIIB) announced new data from its industry-leading portfolio of multiple sclerosis (MS) therapies being presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting October 26-28, 2022. The presentations include the final safety and efficacy results of the VUMERITY® (diroximel fumarate) EVOLVE-MS-1 study, as well as a matching analysis comparing treatment with VUMERITY to Ponvory® (ponesimod) and Aubagio® (teriflunomide); patient-reported outcomes and an analysis of the proprietary StratifyJCV™ assay for TYSABRI® (natalizumab); a study evaluating treatment with TECFIDERA® (dimethyl fumarate) to prevent first clinical manifestation of MS for people with radiologically isolated syndrome; and studies assessing the impact of PLEGRIDY® (peginterferon beta-1a) and AVONEX® (interferon beta-1a) on pregnancy, breastfeeding and child development.
“Presentations at this year’s ECTRIMS meeting highlight Biogen’s commitment to pursuing research that has a meaningful impact on patients,” said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen. “These new data provide patients and healthcare professionals with further insight on the safety and efficacy of Biogen’s robust MS portfolio to help inform treatment decisions throughout the lifelong MS journey, from the earliest phase of the disease to important milestones such as pregnancy.”
Final Safety and Efficacy Results of VUMERITY EVOLVE-MS-1 Study Reported
Presentations including data from EVOLVE-MS-1 and OPTIMUM clinical studies further support the safety and efficacy of VUMERITY:
- Final safety and efficacy results from EVOLVE-MS-1 demonstrate decreases in disease activity and favorable tolerability for VUMERITY in 1,057 patients over 96 weeks, in line with previous assessments. The reduction in annualized relapse rate (ARR) was 81.6%, the estimated proportion of patients who were relapse-free was 82.4%, and the estimated proportion with no evidence of disease activity (NEDA-3) was 41.1%. While 24.3% of patients discontinued treatment, discontinuation due to gastrointestinal adverse events (0.7%) and flushing (0.5%) were low.
- A matching-adjusted indirect comparison was done between VUMERITY (EVOLVE-MS-1) and Ponvory and Aubagio (OPTIMUM) clinical studies for ARR, 12-week confirmed disability progression (CDP), 24-week CDP, absence of gadolinium-enhancing (Gd+) T1 lesions and absence of new/enlarging T2 lesions. After weighting for cross-trial differences, VUMERITY was associated with a higher proportion of patients free of Gd+ T1 lesions and new/enlarging T2 lesions at the end of follow-up compared to Ponvory, with similar efficacy for ARR and 12- and 24-week CDP. VUMERITY had greater efficacy than Aubagio for all clinical and radiological outcome measures, except for 24-week CDP, in which there was similar efficacy.
Studies Highlight Patient-Reported Outcomes for TYSABRI; Analysis Shows Impact of StratifyJCV Assay
Two presentations highlight improvements in patient-reported outcomes following treatment with TYSABRI along with preference and satisfaction for the TYSABRI subcutaneous (SC) route of administration:
- The results of recent survey analysis, which included TYSABRI [n=52] and Ocrevus (ocrelizumab)-treated [n=92] relapsing-remitting multiple sclerosis (RRMS) patients aged 21 and older who had taken at least one prior disease modifying treatment (DMT), found more patients treated with TYSABRI versus Ocrevus reported improvements in disease activity (84.6% vs 59.8%), emotional symptoms (73.1% vs 35.9%), physical symptoms (69.2% vs 43.5%), cognitive symptoms (61.5% vs 32.6%) and social roles/activities (71.2% vs 35.9%). In addition, more patients treated with TYSABRI reported their DMT met or exceeded treatment expectations in comparison to those treated with Ocrevus (96.2% vs 72.8%).
- In the first interim analysis of 206 patients in the observational, prospective, multi-center SISTER study in Germany, the TYSABRI SC route of administration was preferred by individuals (89.6%; 163 patients) compared with intravenous administration; nearly all patients receiving SC treatment expressed satisfaction with their choice (98.7%; 156 patients) and the most frequent reasons for SC preference were shorter and more convenient administration. The TYSABRI SC administration is available in 26 countries and over 16,000 patients have been treated with SC therapy.1
“Given the recent introduction of natalizumab subcutaneous administration in Europe, these findings validate clinical study data with real-world insights,” said Prof. Ralf Gold, Ruhr-University Bochum, Bochum, Germany. “In our study, we found that nearly 90% of patients prefer subcutaneous administration given its shorter duration and convenience of dosing.”
Separately, an analysis assessed utilization of Biogen’s StratifyJCV™ — a proprietary antibody assay used to detect the presence of anti-JC virus (JCV) antibodies in serum and to quantify antibody index values, which are correlated to progressive multifocal leukoencephalopathy (PML) risk in patients treated with TYSABRI. More than 2 million StratifyJCV tests have been conducted worldwide. Aggregated data of the results of 845,498 StratifyJCV tests conducted from January 2015 to December 2021 showed a decrease in percentage of JCV-positive index results >1.5 in retests, from 15% in 2015 to 8% in 2021, demonstrating that healthcare professionals are using the assay to appropriately identify, monitor and manage patients on TYSABRI.
Effect of TECFIDERA on Radiologically Isolated Syndrome Reported for the First Time
Results of the Assessment of TECFIDERA in Radiologically Isolated Syndrome (ARISE) study, a placebo-controlled, multi-center, double-blinded clinical trial, will be presented in the late-breaking section. ARISE investigated the impact of therapeutic intervention in preventing the first clinical manifestation of MS for people with radiologically isolated syndrome (RIS). ARISE enrolled 87 patients who were randomized to TECFIDERA or placebo and treated for up to 96 weeks. Researchers found treatment with TECFIDERA resulted in an 82% risk reduction relative to placebo in the prevention of a first clinical event related to CNS demyelination.
Impact of PLEGRIDY and AVONEX on Pregnancy, Breastfeeding and Child Development
Two presentations assessed the impact of interferon exposure on pregnancy, breastfeeding and child development. Data from the PRIMA post-authorization safety study was consistent with results from previous studies showing that exposure to PLEGRIDY or AVONEX during pregnancy or lactation did not negatively impact child development or intrauterine growth. Further, a preliminary analysis of the German Multiple Sclerosis and Pregnancy Registry assessed child development in infants born to mothers with AVONEX or PLEGRIDY exposure during pregnancy, and treatment did not negatively impact children’s development.
Title and Times of Data Presentations Featured at ECTRIMS:
- Natalizumab-Treated RRMS Patients with Prior DMT Use Report Better Outcomes, Treatment Satisfaction and Unique Benefits Than Similar Patients Treated with Ocrelizumab – EP0851 – October 26, 8 a.m. CET / 2 a.m. ET
- Disease Activity and Pregnancy Outcomes After Long-Term Exposure to Natalizumab During Pregnancy – 0039 – October 26, 2:56 p.m. CET / 8:56 a.m. ET
- SISTER – Subcutaneous: Non-Interventional, Observational, Prospective, German Multicentre, Open Label Study Over 12-Months for TYSABRI Patient Preference – Experience from Real-World – Preliminary Results of the 1st Interim Analysis – P365 – October 26, 8 a.m. CET / 2 a.m. ET
- Long-Term Effectiveness of Natalizumab for RRMS: Dutch and Global Interim Results from TYSABRI Observational Program – P373 – October 26, 8 a.m. CET / 2 a.m. ET
- Exploratory Magnetic Resonance Imaging Endpoints from NOVA: A Randomized Controlled Study of the Efficacy of 6-Week Dosing of Natalizumab vs Continued 4-Week Treatment for Multiple Sclerosis – P350 – October 26, 8 a.m. CET / 2 a.m. ET
- Interferon- or Peginterferon-Beta 1a Exposure During Pregnancy in Women with Multiple Sclerosis: Outcomes on Child Development – P075 – October 26, 8 a.m. CET / 2 a.m. ET and October 27, 1:05 p.m. CET / 7:05 a.m. ET
- StratifyJCV™ Serum Anti-JCV Antibody Assay for Natalizumab Patients: Unilabs Global Cohort Data Descriptive Analysis and Unilabs Customer Satisfaction Survey Results – P750 – October 26, 8 a.m. CET / 2 a.m. ET
- Matching-Adjusted Indirect Comparisons of Diroximel Fumarate, Ponesimod, and Teriflunomide for Relapsing Multiple Sclerosis – P708 – October 26, 8 a.m. CET / 2 a.m. ET
- Diroximel Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: Final Safety and Efficacy Results from the Phase 3 EVOLVE-MS-1 Study – P712 – October 26, 8 a.m. CET / 2 a.m. ET
- Interferon-Beta Exposure During Pregnancy and Breastfeeding: Impact on Birth Outcome and Child Development – Results from the Post-Authorisation Safety Study PRIMA – P478 – October 26, 8 a.m. CET / 2 a.m. ET
- Multi-Center, Randomized, Double-Blinded Assessment of Dimethyl Fumarate in Extending the Time to a First Clinical Demyelinating Event in Radiologically Isolated Syndrome (ARISE) – 0179 – October 28, 3:49 p.m. CET / 9:49 a.m. ET
