#ECTRIMS2019 — Biogen Presents New Real-world Data Demonstrating Clinical Benefits of Tysabri, Plegridy, and Avonex

Biogen is presenting new data highlighting the potential clinical benefits of Tysabri (natalizumab), Plegridy (peginterferon beta-1a), and Avonex (interferon beta-1a) for the treatment of specific groups of individuals with multiple sclerosis (MS), including pregnant women and patients with relapsing forms of the disease.

The new findings, based on real-world clinical practice data, were presented at the 35^th Congress of the European Committee for Treatment and Research in MS (ECTRIMS), held Sept. 11-13 in Stockholm.

“Biogen’s longstanding leadership in MS presents an opportunity to continue evolving the paradigm of care through continued research of some of our most widely prescribed MS therapies, including Tysabri, Plegridy, and Avonex,” Alfred Sandrock Jr., MD, PhD, executive vice president and chief medical officer at Biogen, said in a press release.

“Through thoughtful and rigorous exploration of potential new approaches, like Tysabri extended interval dosing, we are working to optimize patient outcomes,” Sandrock said.

In a poster titled, “Natalizumab is Associated with No Evidence of Disease Activity and with Improvement in Disability and Cognitive Performance in Anti-JC Virus Seronegative Patients with Early Relapsing-Remitting Multiple Sclerosis: STRIVE 4-Year Results,” researchers present data supporting the real-world long-term effectiveness of Tysabri in patients with early relapsing-remitting MS (RRMS) who do not have antibodies against the John Cunningham (JC) virus — the causative agent of progressive multifocal leukoencephalopathy, a rare brain infection associated with Tysabri treatment.

According to four-year data from the observational, open-label STRIVE trial (NCT01485003), in two to four years of treatment with Tysabri, 70.1% of the patients (110 of 157) achieved a disease-free status, called NEDA (no evidence of disease activity) — defined as no relapses and no confirmed disability progression.

In addition, 83.7% of the patients also achieved MRI NEDA — defined as having no new or enlarged gadolinium-enhancing (GdE) MRI lesions (active lesions), or T2-hyperintense MRI lesions (lesions caused largely by the loss of myelin). In total, 58% achieved overall NEDA, which includes both clinical and MRI NEDA.

Findings also indicated that Tysabri was linked to significant improvements in disability and cognitive performance.

Overall, the results support Tysabri’s “long-term effectiveness in early RRMS patients,” the researchers stated.

In a second poster, titled “No Significant Difference in Relapse Outcomes in Patients Switching to Natalizumab Extended Interval Dosing or Remaining on Standard Interval Dosing: Propensity Score Comparative Effectiveness Analysis of Patients in the TYSABRI Observational Program,” researchers presented data demonstrating the effectiveness of Tysabri when administered every six weeks to RRMS patients.

The findings were obtained based on data from the Tysabri Observational Program (NCT00493298), a real-world, ongoing study on patients treated with Tysabri.

The analyses focused on comparing the clinical outcomes of RRMS patients who had switched to the new extended dosing schedule (every six weeks), after receiving Tysabri at the standard dosing schedule (every four weeks) for at least one year, to those who remained on the standard dosing regimen.

Results indicated there were no significant differences in the annual number of relapses or in the risk of having a relapse between the two groups — 0.231 in the extended regimen, and 0.254 in the standard regimen.

Of note, Biogen recently completed patient enrollment for the randomized, prospective, Phase 3b NOVA trial (NCT03689972), which will continue to assess the effectiveness of the two different dosing regimens of Tysabri.

In two other posters, researchers presented data demonstrating that treatment with Plegridy or Avonex in women who are trying to conceive, or even during pregnancy, is not expected to pose health risks for the mother or compromise fetal development.

The findings were obtained from two large real-world observational studies.

The first poster, “Prevalence of Infant Outcomes at Birth After Exposure to Interferon Beta Prior to or During Pregnancy: A Register-based Cohort Study in Finland and Sweden Among Women with MS,” was based on healthcare data gathered from Nordic registers (Finland and Sweden) in which the clinical outcomes of infants whose mothers had received Avonex before or while they were pregnant were compared to those of children whose mothers had not been exposed to disease-modifying therapies prior to or during pregnancy.

No significant differences were found between the two groups of children, indicating that exposure to Avonex before or during pregnancy does not have a significant impact on the weight or head circumference of newborns at birth.

The second poster, “Safety, Pregnancy Outcomes, and Clinical Effectiveness of Peginterferon Beta-1a for Patients with Newly Diagnosed and Non-Newly Diagnosed Relapsing Multiple Sclerosis: Third Interim Analysis of the Plegridy Observational Program,” was based on pregnancy outcomes that have been collected as part of the ongoing five-year Plegridy Observational Program (POP; NCT02230969), a long-term study evaluating the safety and effectiveness of Plegridy in more than 1,200 relapsing MS patients worldwide.

The results obtained were consistent with previous reports of pregnancy outcomes.

“Real-world data from POP show a safety profile consistent with clinical trials; no new safety signals were observed,” the researchers said, adding that the data “demonstrate that [Plegridy] may be an effective therapy in the treatment of RRMS.”