- Data highlight benefits and risks of TYSABRI® (natalizumab) treatment in relapsing remitting multiple sclerosis (RRMS) for achieving NEDA (no evidence of disease activity) and improving disability and cognition1
- An analysis of data from the TYSABRI Observational Program (TOP) supports real-world effectiveness of extended interval dosing (every six weeks) with natalizumab2
- Safety was consistent with the natalizumab well-established profile2
- Additional findings showed exposure to interferon beta, including PLEGRIDY® (peginterferon beta-1a) and AVONEX® (interferon beta-1a), is not expected to impact pregnancy or infant outcomes3, 4
Biogen has highlighted data that support the potential additional effectiveness of treatment with natalizumab, peginterferon beta-1a and interferon beta-1a in RRMS patient populations.1, 2, 3, 4 Results obtained in real-world clinical practice were presented at the 35th Congress of the European Committee for Treatment and 24th Annual Conference of Research in MS (ECTRIMS) in Stockholm (September 11-13).
Biogen’s commitment to improving the lives of people with neurological conditions means that we are always looking for the opportunity to use real word evidence to build a wider picture of multiple sclerosis (MS), beyond clinical trials. Through thoughtful and rigorous exploration of potential new approaches, including natalizumab extended interval dosing and interferon beta treatment before conception and/or during pregnancy, we are using research to evolve the paradigm of care – keeping patients at the centre of our focus.
Dr. Simon Beck, Medical Director, Biogen UK & Ireland
Data Further Support Early Treatment with natalizumab and Extended Interval Dosing
Four-year data from the observational, open-label, single-arm, multicentre STRIVE study in the US support the real-world long-term effectiveness of natalizumab in patients with early RRMS, who are within three years from diagnosis and are anti-JC virus antibody negative.1 Over the first two to four years of treatment (N=110/157), 70.1 percent (95%CI) of patients in the study achieved clinical NEDA (no evidence of disease activity), defined as no relapses or 24-week confirmed disability worsening, which was the primary endpoint.1 Additionally, 83.7 percent (95%CI) achieved MRI NEDA, defined as no gadolinium-enhancing or new/newly enlarging T2 lesions, and more than half (58 percent) achieved overall NEDA, which encompassed both clinical and MRI NEDA.1 Results also show natalizumab was associated with improvements in disability and cognitive performance.1
The effectiveness of every six weeks (Q6W) dosing with natalizumab was evaluated using data from the “TYSABRI Observational Program” (TOP), an ongoing, real-world study of natalizumab-treated patients.
Analyses compared relapse outcomes in patients who switched to natalizumab (Q6W) dosing after at least one year on every four weeks (Q4W) dosing to those who remained on the (Q4W) dosing, which is the current marketing authorisation label dosing.2 After propensity score matching, results indicate there was no significant difference in annualised relapse rate or risk of relapse between the two groups.2 These data complement the previously presented TOUCH database safety analysis showing that natalizumab extended interval dosing (EID; average of approximately six weeks) was associated with a lower risk of the brain infection progressive multifocal leukoencephalopathy (PML), compared to (Q4W) dosing.2, 5 Biogen recently completed enrollment for the Phase 3b NOVA study, a two-year, randomised, prospective trial that will compare the effectiveness of natalizumab (Q4W) versus (Q6W) after at least one year of (Q4W) dosing.
Real-World Data Indicate Interferon Beta Treatment May Not Impact Some Pregnancy/Infant Outcomes
As women with MS are often diagnosed and treated at child-bearing age6, family planning is frequently an important consideration for clinicians and patients when choosing a treatment path. The current marketing authorisation labels indicate that: “There is limited information on the use of Interferon Beta in pregnancy. Available data indicates that there may be an increased risk of spontaneous abortion. Initiation of treatment is contraindicated during pregnancy”.7, 8 New data from two real-world observational studies showed that exposure to interferon beta treatment, including peginterferon beta-1a and interferon beta-1a, before conception and/or during pregnancy is not expected to have an adverse effect on pregnancy or infant growth outcomes.3, 4
Researchers utilised healthcare data from Nordic registers (Finland and Sweden) to retrospectively analyse infant outcomes for women with MS treated with interferon beta compared to women with MS unexposed to disease-modifying therapies. Results show outcomes were similar between the two groups, with no evidence that exposure to interferon beta treatment before and/or during pregnancy affected the weight or head circumference of infants at birth.3 Data on pregnancy outcomes collected during the ongoing five-year “PLEGRIDY Observational Program” (POP), which is evaluating the long-term safety and effectiveness of peginterferon beta-1a in more than 1,200 relapsing MS patients worldwide, were consistent with previously reported pregnancy outcomes from both the Nordic registers study and the European Interferon Beta Pregnancy Registry.3, 4, 9
Featured data presentation details:
- 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 (P1348; Poster Session 3, Friday, September 13, 12:15-2:15 p.m. CET)
- 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 (P1033, Poster Session 2, Thursday, September 12, 5:15-7:15 p.m. CET)
- 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 (P1144; Poster Session 3, Friday, September 13, 12:15-2:15 p.m. CET)
- 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 (P1019; Poster Session 2, Thursday, September 12, 5:15-7:15 p.m. CET)
Biogen has submitted applications to the European Medicines Agency (EMA) to update products labels with the new data included in this press release
1 STRIVE 4-Year Results (P1348; Poster Session 3, Friday, September 13, 12:15-2:15 p.m. CET)
2 Propensity Score Comparative Effectiveness Analysis of Patients in the TYSABRI Observational Program
(P1033, Poster Session 2, Thursday, September 12, 5:15-7:15 p.m. CET)
3 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 (P1144; Poster Session 3,
Friday, September 13, 12:15-2:15 p.m. CET)
4 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 (P1019; Poster Session 3, Friday, September 13, 12:15-2:15 p.m. CET)
5 Reduced Risk of Progressive Multifocal Leukoencephalopathy (PML) Associated with Natalizumab
Extended Interval Dosing (EID): Updated Analysis of the TOUCH® Prescribing Program Database, 71st Annual Meeting of the American Academy of Neurology, Philadelphia, PA. May 4-10, 2019. S26.006.
6 Role of Family Planning in Women With Multiple Sclerosis in Switzerland: Results of the Women With Multiple Sclerosis Patient Survey. Christian P. Kamm et al. 10 October 2018. Frontiers in Neurology.
7 AVONEX 30 micrograms/0.5 ml solution for injection. SmPC.
8 Plegridy 125 micrograms solution for injection in pre-filled pen. SmPC.
https://www.medicines.org.uk/emc/product/3409/smpchttps://www.medicines.org.uk/emc/product/3409/smpc Last accessed: September 2019
9 Pregnancy and Infant Outcomes with Interferon Beta: Data from the European Interferon Beta Pregnancy Registry and Population Based Registries in Finland and Sweden. Presented at ECTRIMS 2018; 10-12 October; Berlin, Germany. Abstract No. A-0950-0000-02658.