New data for Ocrevus show that after 10 years of treatment 77% of people with relapsing multiple sclerosis were free from disability progression and 92% continue to walk unaided.- Roche

Ocrevus is the first and only disease-modifying treatment (DMT) in MS to benefit both people with RMS and PPMS and now has 10 years of follow-up data from its three Phase III trials.

“Ocrevus is the first B-cell therapy approved for RMS and PPMS and it’s remarkable to see that after 10 years of treatment, a great majority of RMS patients remain free from disease progression,” said Stephen Hauser, M.D., chair of the Scientific Steering Committee of the OPERA studies and director of the Weill Institute for Neurosciences at the University of California, San Francisco. “These results signify that people with both RMS and PPMS have more years to spend their days living independently without the need for walking aids or wheelchairs.”

10-year disability outcomes from Phase III Ocrevus open-label extension (OLE) trials: After 10 years of continuous Ocrevus treatment, 77% were free from disability progression based on 48-week confirmed disability progression (CDP) events and 92% of patients with RMS were still walking unassisted. In patients with PPMS, 36% were free from disability progression based on 48-week CDP events and 80% of those patients treated continuously with Ocrevus over 10 years were still able to walk. The long-term data reinforce the critical importance of early treatment in preserving function across the MS spectrum, showing a lower risk of reaching disability events in patients with RMS and PPMS who initiated Ocrevus treatment earlier (initiating at the start of the double-blind studies vs. the start of the OLEs).

10-year safety profile of Ocrevus:New safety data from 6,155 patients with 28,269 patient-years of exposure to Ocrevus across 12 clinical trials further support the medicine’s favourable benefit-risk profile, which has remained consistent over 10 years. The risk characteristics of Ocrevus in the all-exposure population (RMS and PMS) remained consistent with the characteristics observed during the controlled treatment periods. Serious infections and malignancy rates remain within the range reported for patients with MS in real-world registries. Longer exposure to Ocrevus did not lead to an increased risk of serious infections regardless of the immunoglobulin G (IgG) status of the patients (normal levels or levels below the lower limit of normal). No new or unexpected safety signals were seen in patients treated with Ocrevus in ongoing clinical trials.

''Some women affected by MS may be thinking about starting a family, so it is important to understand how their treatment prior to pregnancy may impact them and their unborn child,'' said Levi Garraway. ''With more than 300,000 people treated globally and 30 ongoing trials, we continue to accrue robust evidence for how Ocrevus may benefit many underrepresented groups including pregnant women and people of Black or Hispanic heritage.”

Real-world analyses on pregnancy & infant outcomes and postpartum relapses : Family planning is an essential aspect in the care of women living with MS, many of whom are of child-bearing age. Roche safety data from 3,253 cumulative pregnancies in women with MS do not suggest an increased risk of adverse pregnancy or infant outcomes in women with MS treated with Ocrevus. Outcomes were known for 1,145 prospectively reported pregnancies and 512 of these had in utero exposure to Ocrevus. Respective outcomes from these two groups were: 83.6% and 84.2% live births (1.3% and 1.6% with major congenital anomalies); 1.2% and 0.8% ectopic pregnancy; 5.1% and 7.4% elective terminations; 10.0% and 7.4% spontaneous abortions; <0.1% and 0.2% still birth. in utero exposure to ocrevus did not increase the risk of adverse pregnancy or infant outcomes compared with epidemiological background of both the ms and general populations.></0.1%>

Furthermore, a real-world analysis from the international MSBase registry based on data from 1,722 women living with MS receiving different DMTs suggests that women who conceived during Ocrevus treatment or soon after their last dose are at low risk for relapse during pregnancy and postpartum. During pregnancy, the annualised relapse rate (ARR) was 0.00 for women previously treated with Ocrevus vs. 0.05 to 0.32 for other DMTs. The postpartum ARR was 0.09 for women treated with Ocrevus vs. 0.10 to 0.74 for other DMTs. Roche is committed to generating further data on family planning priorities by assessing pregnancy and infant outcomes including infant B cell levels through routine pharmacovigilance activities, post-marketing commitments and two ongoing Phase IV studies, MINORE (placental transfer and infant outcomes) and SOPRANINO (breastmilk transfer and infant outcomes).

One-year efficacy and safety outcomes from Phase IV CHIMES study : Black and Hispanic / Latinx people with MS experience more severe disease, faster disease progression and greater disability than white people living with MS. CHIMES is the first-ever clinical trial focused exclusively on broadening understanding of MS disease biology among Black and Hispanic / Latinx people with MS. One-year data from the trial show that Ocrevus controlled disease activity and disability progression in these populations, demonstrating a safety and efficacy profile consistent with the large body of clinical evidence from other Ocrevus trials. Approximately half of 182 patients enrolled in the CHIMES trial achieved no evidence of disease activity (NEDA) at one year (46% of Black patients and 58% of Hispanic / Latinx patients at 48 weeks), with approximately 95% of patients experiencing no relapses (95% of Black patients and 96% of Hispanic / Latinx patients), no 24-week CDP (95% of Black patients and 94% of Hispanic / Latinx patients) and no T1 gadolinium-enhancing (T1-Gd+) lesions (95% of Black patients and 97% of Hispanic / Latinx patients). No new or enlarging T2 lesions were observed in about half of Black patients (46%) and more than half of Hispanic / Latinx patients (64%). No new safety signals were observed. The results also provide new insight into the role of social determinants of health in the recruitment and retention of diverse patient populations for clinical research, a critical first step in breaking the cycle of inequity.

More than 300,000 people with MS have been treated with Ocrevus globally. Ocrevus is approved in more than 100 countries across North America, South America, the Middle East, Eastern Europe, Asia as well as in Australia, Switzerland, the United Kingdom and the EU.