Evaluating efficacy and safety of ocrelizumab biosimilar (Xacrel) compared to the originator (Ocrevus) in relapsing multiple sclerosis: a phase III, randomized, equivalency, clinical trial
Multiple sclerosis is an inflammatory demyelinating disease and represents a global health concern. Ocrelizumab, a humanized IgG monoclonal antibody, selectively targets CD20 on B cells and CD20-expressing T cells. This study aimed to compare the efficacy and safety of the biosimilar ocrelizumab candidate (Xacrel) to the originator product (Ocrevus) in Relapsing Multiple Sclerosis (RMS) patients. In this randomized trial, patients received either Xacrel or Ocrevus for 96 weeks. The primary endpoint was the equivalency of the medications in reducing the annualized relapse rate (ARR) at week 48. The secondary endpoints included time to the onset of disability progression confirmed at 12 and 24 weeks, the proportion of relapse-free patients, magnetic resonance imaging (MRI) evaluations, safety assessments, and immunogenicity over 96 weeks. A total of 170 patients were randomized (1:1 ratio). In the per protocol analysis, the upper and lower limits of 95% two-sided confidence intervals of difference between treatments in the 48-week ARR rate were in the predefined margin of - 0.2 to 0.2 (- 0.002; 95% CI - 0.080 to 0.075). The two products were also comparable in terms of other efficacy parameters, safety, and immunogenicity. The results confirmed that Xacrel is equivalent to Ocrevus in terms of 48-week ARR in RMS patients, with no considerable difference in other efficacy parameters and the safety profile during the 96 weeks. The trial was registered in Iranian registry of clinical trials (IRCT) on 10/06/2019 with the registration number of IRCT20150303021315N13 and in Clinicaltrials.gov on 19/07/2021 with the registration code of NCT04966338.
Authors
- Hormoz Ayromlou
- Nazanin Razazian (ORCID: https://orcid.org/0000-0001-5527-6387)
- Elnaz Asadollahzadeh (ORCID: https://orcid.org/0000-0001-8552-4783)
- Samira Navardi (ORCID: https://orcid.org/0000-0002-6533-4437)
- Nastaran Majdinasab (ORCID: https://orcid.org/0000-0001-5163-7210)
- Mohammadali Nahayati (ORCID: https://orcid.org/0000-0001-8373-6053)
- Araz Sabzvari
- Vahid Shaygannejad (ORCID: https://orcid.org/0000-0002-9732-4153)
- Behnaz Sedighi (ORCID: https://orcid.org/0000-0002-4230-0955)
- Seyed Mohammad Baghbanian (ORCID: https://orcid.org/0000-0002-8138-7504)
- Mohammad Ali Sahraian (ORCID: https://orcid.org/0000-0002-3224-8807)
- Roya Abolfazli (ORCID: https://orcid.org/0000-0002-3506-7200)
- Masoud Ghiasian (ORCID: https://orcid.org/0000-0003-1648-8728)
- Sogol Albooyeh
- Hamidreza Ghalyanchi Langroodi
- Alireza Nikseresht (ORCID: https://orcid.org/0000-0003-1266-5897)
- Seyed Ehsan Mohammadianinejad (ORCID: https://orcid.org/0009-0000-8100-0210)
- Hamidreza Kafi (ORCID: https://orcid.org/0009-0008-1246-8969)
- Abdorreza Naser Moghadasi
- Nahid Beladi Moghadam
- Fereshteh Ashtari (ORCID: https://orcid.org/0000-0002-4881-958X)
Institutions
- Hamedan University of Medical Sciences (IR)
- Isfahan University of Medical Sciences (IR)
- Ahvaz Jundishapur University of Medical Sciences (IR)
- Tabriz University of Medical Sciences (IR)
- Mashhad University of Medical Sciences (IR)
- Shiraz University of Medical Sciences (IR)
- Guilan University of Medical Sciences (IR)
- Kerman University of Medical Sciences (IR)
- Imam Khomeini Hospital (IR)
- Kermanshah University of Medical Sciences (IR)
- Biotechnology Research Center (IR)
- Sina Hospital (IR)
- Imam Reza Hospital (IR)
- Ghaem Hospital (IR)
- Alborz University of Medical Sciences (IR)
- Shahid Beheshti University of Medical Sciences (IR)
- Tehran University of Medical Sciences (IR)
- Mazandaran University of Medical Sciences (IR)
Publication Details
- Journal
- Scientific Reports
- Published
- 2024-10-22
- DOI
- https://doi.org/10.1038/s41598-024-75745-y
- Citations
- 4
- Primary Topic
- Multiple Sclerosis Research Studies
- Type
- article
- Field-Weighted Citation Impact
- 1.70
Funders
- CinnaGen