- Title
- Efficacy and safety of monoclonal antibody therapy in patients with neuromyelitis optica spectrum disorder: A systematic review and network meta-analysis
- Creator
- Aungsumart, Saharat; Youngkong, Sitaporn; Dejthevaporn, Charungthai; Chaikledkaew, Usa; Thadanipon, Kunlawat; Tansawet, Amarit; Khieukhajee, Jedsada; Attia, John; McKay, Gareth J.; Thakkinstian, Ammarin
- Relation
- Frontiers in Neurology Vol. 14, no. 1166490
- Publisher Link
- http://dx.doi.org/10.3389/fneur.2023.1166490
- Publisher
- Frontiers Research Foundation
- Resource Type
- journal article
- Date
- 2023
- Description
- Introduction: Neuromyelitis optica spectrum disorder (NMOSD) is a devastating inflammatory CNS demyelinating disease. Two groups of monoclonal antibodies (mAbs) are used to prevent disease relapse, i.e., Food and Drug Administration (FDA)-approved mAbs (e.g., eculizumab satralizumab, inebilizumab), and off-label mAb drugs (e.g., rituximab and tocilizumab). The FDA-approved mAbs have high efficacy but more expensive compared to the off-labels, and thus are less accessible. This systematic review and network meta-analysis (NMA) was to assess the efficacy and safety of both classes of mAbs compared to the current standard treatments. Methods: Systematically searches were conducted in MEDLINE and SCOPUS from inception until July 2021. Randomized-controlled trials (RCTs) were eligible if they compared any pair of treatments (mAbs, immunosuppressive drugs, or placebo) in adult patients with NMOSD. Studies with AQP4-IgG positive or negative were used in the analysis. Probability of relapse and time to event were extracted from the Kaplan-Meier curves using Digitizer. These data were then converted into individual patient time-to-event data. A one-stage mixed-effect survival model was applied to estimate the median time to relapse and relative treatment effects using hazard ratios (HR). Two-stage NMA was used to determine post-treatment annualized relapse rate (ARR), expanded disability status score (EDSS) change, and serious adverse events (SAE). Risk of bias was assessed using the revised cochrane risk of bias tool. Results: A total of 7 RCTs with 776 patients were eligible in the NMA. Five of the seven studies were rated low risk of bias. Both FDA-approved and off-label mAbs showed significantly lower risk of relapse than standard treatments, with HR (95% CI) of 0.13 (0.07, 0.24) and 0.16 (0.07, 0.37) respectively. In addition, the FDA-approved mAbs had 20% lower risk of relapse than the off-label mAbs, but this did not reach statistical significance. The ARRs were also lower in FDA-approved and off-label mAbs than the standard treatments with the mean-difference of−0.27 (-0.37,−0.16) and−0.31(-0.46,−0.16), respectively. Conclusion: The off-label mAbs may be used as the first-line treatment for improving clinical outcomes including disease relapse, ARR, and SAEs for NMOSD in countries where resources and accessibility of the FDA-approved mAbs are limited.
- Subject
- neuromyelitis optica spectrum disorder (NMOSD); FDA-approved monoclonal antiboides (mAbs); off-label monoclonal antibodies; relapse; network-meta analysis
- Identifier
- http://hdl.handle.net/1959.13/1493245
- Identifier
- uon:53516
- Identifier
- ISSN:1664-2295
- Rights
- x
- Language
- eng
- Reviewed
- Hits: 1449
- Visitors: 1440
- Downloads: 0
| Thumbnail | File | Description | Size | Format |
|---|