The efficacy and safety of daclizumab and its potential role in the treatment of multiple sclerosis
Open accessAbstract
Daclizumab is a humanized monoclonal antibody of the immunoglobulin G1 (IgG1) isotype that binds to the α-subunit (CD25) of the high-affinity interleukin-2 (IL-2) receptor expressed on activated T cells and CD4+CD25+FoxP3+ regulatory T cells. Based on the assumption that it would block the activation and expansion of autoreactive T cells that are central to the immune pathogenesis of multiple sclerosis (MS), daclizumab was tested in several small open-label clinical trials in MS and demonstrated a profound inhibition of inflammatory disease activity. Surprisingly, accompanying mechanistic studies revealed that the most important biological effect of daclizumab was rather a dramatic expansion and activation of immunoregulatory CD56 bright natural-killer (NK) cells that correlated with treatment response, while there was no or only minor effect on peripheral T-cell activation and function. These CD56 bright NK cells were able to gain access to the central nervous system in MS and kill autologous activated T cells. Additional and relatively large phase IIb clinical trials showed that daclizumab, as add-on or monotherapy in relapsing–remitting (RR) MS, was highly effective in reducing relapse rate, disability progression, and the number and volume of gadolinium-enhancing, T1 and T2 lesions on brain magnetic resonance imaging (MRI), and reproduced the expansion of CD56 bright NK cells as a biomarker for daclizumab activity. Daclizumab is generally very well tolerated and has shown a favorable adverse event (AE) profile in transplant recipients. However, several potentially serious and newly emerging AEs (mainly infections, skin reactions, elevated liver function tests and autoimmune phenomena in several body organs) may require strict safety monitoring programs in future clinical practice and place daclizumab together with other new and highly effective MS drugs as a second-line therapy. Ongoing phase III clinical trials in RRMS are expected to provide definite information on the efficacy and safety of daclizumab and to determine its place in the fast-growing armamentarium of MS therapies.
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Daclizumab is a humanized monoclonal antibody targeting CD25 present on interleukin-2 receptor commonly found in activated T cells and CD4+CD25+FoxP3+.
“Daclizumab is a humanized monoclonal antibody targeting CD25 present on interleukin-2 receptor commonly found in activated T cells and CD4+CD25+FoxP3+ (96).”
From Immunomodulation in Administration of RAAV: Preclinical and Clinical Adjuvant Pharmacotherapies (2021) · cites this paper as [96]
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- Authors
- Milo, R.
- Affiliations
- Ben-Gurion University of the Negev (IL)
- Corresponding author
- Milo, Ron
- ORCID
- Milo, Ron
- Venue
- Therapeutic Advances in Neurological Disorders
- Publisher
- SAGE Publications
- Published
- 2013-09-12
- Volume
- 7
- Issue
- 1
- Pages
- 7-21
- ISSN
- 1756-2856 (ISSN-L)
- 1756-2864
- PMC
- PMC3886384
- OpenAlex
- W2140848986
- Cited by
- 38
- References
- 55
- Citations by year
- 2025: 3 · 2024: 3 · 2021: 1 · 2020: 3 · 2019: 2 · 2018: 5 · 2017: 3 · 2016: 9 · 2015: 6 · 2014: 3
- FWCI
- 0.88
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Therapeutic Advances in Neurological Disorders (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Multiple Sclerosis Research Studies
- Life Sciences › Immunology and Microbiology › Immunology › T-cell and B-cell Immunology
- Life Sciences › Immunology and Microbiology › Immunology › Psoriasis: Treatment and Pathogenesis
- Keywords
- daclizumab, multiple sclerosis, relapsing-remitting multiple sclerosis, CD25, interleukin-2 receptor, regulatory T cells, autoreactive T cells, immune regulation, relapse rate, disability progression, gadolinium-enhancing lesions, drug safety, adverse events, second-line therapy, transplant recipients
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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