Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients
What it found
The main measure showed a statistically significant benefit.
“ARR after intervention minus ARR before intervention [mean (SD)] was 1.09 (0.72) in RIT group and 0.49 (0.59) in AZA group (P value <0.001).”Read by software from the paper's abstract
12 months
| Group | n | Value |
|---|---|---|
| Rituximab | 33 | ARR decreased from 1.30 (0.68) to 0.21 (0.42); change 1.09 (0.72) |
| Azathioprine | 35 | ARR decreased from 1 (0.38) to 0.51 (0.55); change 0.49 (0.59) |
p = <0.001
Total participants: 86
Read by software from the paper's abstract
What was tested
Treatment tested
- Azathioprine
Amidophosphoribosyltransferase inhibitor|DNA inhibitor
- Rituximab
B-lymphocyte antigen CD20 binding agent
Results by group
Annual Relapse Rate
one year
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Azathioprine | 1 Number of relapses | 0.38 (Standard Deviation) | 35 |
| Rituximab | 1.30 Number of relapses | 0.68 (Standard Deviation) | 33 |
| Azathioprine | 0.51 Number of relapses | 0.55 (Standard Deviation) | 35 |
| Rituximab | 0.21 Number of relapses | 0.42 (Standard Deviation) | 33 |
Azathioprine
Rituximab
Azathioprine
Rituximab
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Azathioprine | 46 | 1 (2.2%) | 0 |
| Rituximab | 40 | 1 (2.5%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Annual Relapse Rate
one year
Relapses
Other measures (1)
Expanded Disability Status Scale
one year
Disability progression
Who could take part
NMOSD · 18 to 50
Inclusion Criteria: * Diagnosis of neuromyelitis optica spectrum disorder based on the recent guidelines in 2015 * Expanded disability status scale between 0 and 7 * Age between 18 and 50 years old Exclusion Criteria: * Pregnancy or lactation during the study * Deciding to leave the study by patient * Lack of consent to enter the study * Lack of cooperation for follow up * Severe side effect of the medication * Treatment with other immunosuppressant medications (including but not limited to cyclophosphamide, mycophenolate mofetil, methotrexate, others) within two months before intervention * Taking any other immunosuppressant or other type of medication (including herbal drugs) without permission of the physician during the study. * Presence of other autoimmune disease (including but not limited to Behcet disease, systemic lupus erythematosus, rheumatoid arthritis, and others) * Presence of liver disorders * Presence of hematologic disorders * Presence of heart failure * Receipt of a live vaccine within 4 weeks prior to intervention * Previous treatment with Azathioporine or Rituximab * History of HIV, hepatitis B, or hepatitis C * Ongoing daily steroid use * History of severe allergic or anaphylactic reaction to monoclonal antibodies
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to compare annual relapse rate, expanded disability status scale, and side effects of azathioprine and rituximab in patients with neuromyelitis optica spectrum disorder during a one year follow up through a randomized clinical trial.
Papers
Results
Comparison of the efficacy of azathioprine and rituximab in neuromyelitis optica spectrum disorder: a randomized clinical trial.J Neurol · 2017
ARR after intervention minus ARR before intervention [mean (SD)] was 1.09 (0.72) in RIT group and 0.49 (0.59) in AZA group (P value <0.001).
Read by software from the paper's abstract
Background
Sato DK, Lana-Peixoto MA, Fujihara K, de Seze J. Clinical spectrum and treatment of neuromyelitis optica spectrum disorders: evolution and current status. Brain Pathol. 2013 Nov;23(6):647-60. doi: 10.1111/bpa.12087.Background
Morrow MJ, Wingerchuk D. Neuromyelitis optica. J Neuroophthalmol. 2012 Jun;32(2):154-66. doi: 10.1097/WNO.0b013e31825662f1.Background
Costanzi C, Matiello M, Lucchinetti CF, Weinshenker BG, Pittock SJ, Mandrekar J, Thapa P, McKeon A. Azathioprine: tolerability, efficacy, and predictors of benefit in neuromyelitis optica. Neurology. 2011 Aug 16;77(7):659-66. doi: 10.1212/WNL.0b013e31822a2780. Epub 2011 Aug 3.Background
Trebst C, Jarius S, Berthele A, Paul F, Schippling S, Wildemann B, Borisow N, Kleiter I, Aktas O, Kumpfel T; Neuromyelitis Optica Study Group (NEMOS). Update on the diagnosis and treatment of neuromyelitis optica: recommendations of the Neuromyelitis Optica Study Group (NEMOS). J Neurol. 2014 Jan;261(1):1-16. doi: 10.1007/s00415-013-7169-7. Epub 2013 Nov 23.Background
Kim SH, Huh SY, Lee SJ, Joung A, Kim HJ. A 5-year follow-up of rituximab treatment in patients with neuromyelitis optica spectrum disorder. JAMA Neurol. 2013 Sep 1;70(9):1110-7. doi: 10.1001/jamaneurol.2013.3071.Background
Katz Sand I. Neuromyelitis Optica Spectrum Disorders. Continuum (Minneap Minn). 2016 Jun;22(3):864-96. doi: 10.1212/CON.0000000000000337.
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History
Started
Sept 2015
Main results due
Nov 2016
Finished
Dec 2016
Results posted
Sept 2020
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