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Evaluating Efficacy and Safety of Ocrelizumab Biosimilar (Xacrel) Compared to the Originator (Ocrevus) in Relapsing Multiple Sclerosis: A Phase Iii, Randomized, Equivalency, Clinical Trial Publisher Pubmed



Sahraian MA1 ; Abolfazli R2 ; Shaygannejad V3 ; Ashtari F3 ; Majdinasab N4 ; Navardi S1 ; Baghbanian SM5 ; Sedighi B6 ; Naser Moghadasi A1 ; Nahayati MA7 ; Ghalyanchi Langroodi H8 ; Mohammadianinejad SE9 ; Beladi Moghadam N10 ; Ayromlou H11 Show All Authors
Authors
  1. Sahraian MA1
  2. Abolfazli R2
  3. Shaygannejad V3
  4. Ashtari F3
  5. Majdinasab N4
  6. Navardi S1
  7. Baghbanian SM5
  8. Sedighi B6
  9. Naser Moghadasi A1
  10. Nahayati MA7
  11. Ghalyanchi Langroodi H8
  12. Mohammadianinejad SE9
  13. Beladi Moghadam N10
  14. Ayromlou H11
  15. Nikseresht A12
  16. Ghiasian M13
  17. Razazian N14
  18. Asadollahzadeh E1
  19. Sabzvari A15
  20. Kafi H16
  21. Albooyeh S16
Show Affiliations
Authors Affiliations
  1. 1. Multiple Sclerosis Research Center, Neuroscience Institute, Sina Hospital, Tehran University of Medical Sciences, Hasan Abad Square, Imam Khomeini Avenue, Tehran, Iran
  2. 2. Department of Neurology, Amiralam Hospital, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Isfahan Neurosciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
  4. 4. Musculoskeletal Rehabilitation Research Center, Jundishapur University of Medical Sciences, Ahvaz, Iran
  5. 5. Neurology Department, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
  6. 6. Neurology Research Centre, Kerman University of Medical Sciences, Kerman, Iran
  7. 7. Department of Neurology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
  8. 8. Clinical Development and Research Unit, Ghaem Hospital, Guilan University of Medical Sciences, Rasht, Iran
  9. 9. Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran
  10. 10. Neurology Department, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  11. 11. Neurosciences Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
  12. 12. Neurology Department, Shiraz University of Medical Sciences, Shiraz, Iran
  13. 13. Department of Neuroimmunology, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran
  14. 14. Neurology Department, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran
  15. 15. CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran
  16. 16. Medical Department, Orchid Pharmed Company, Tehran, Iran

Source: Scientific Reports Published:2024


Abstract

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. © The Author(s) 2024.
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