Effects of daclizumab injection: A Synthesis of Findings from 24 Studies

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Original Abstract of the Article

Major Research Findings

Daclizumab is a humanized monoclonal antibody that targets CD25, a component of the interleukin-2 receptor, to modulate the immune system. 7 The SELECT TRILOGY of studies (SELECT/SELECTION/SELECTED) examined the safety and efficacy of daclizumab in patients with relapsing-remitting multiple sclerosis (RRMS). Long-term safety and efficacy of daclizumab 150 mg subcutaneous every 4 weeks were observed in RRMS patients in the SELECTED open-label extension study. 7 However, 2 reported severe neurological deterioration and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) in two women with multiple sclerosis (MS) after receiving 2 and 4 subcutaneous injections of daclizumab, respectively. Daclizumab has shown potential benefits in RRMS treatment by reducing the annualized relapse rate and decreasing the number of contrast-enhancing lesions on brain magnetic resonance imaging (MRI). 12 15 14 4 Daclizumab is administered subcutaneously once a month. 3 It is approved by the US Food and Drug Administration (FDA) for the treatment of relapsing-remitting multiple sclerosis. 3

Benefits and Risks

Benefits Summary

Daclizumab is a potential treatment for relapsing-remitting multiple sclerosis (RRMS) and may help reduce relapses and the number of brain lesions detected on MRI. 7 12 15 Daclizumab's subcutaneous administration once a month can be more convenient for patients compared to other treatments. 3 Daclizumab has shown promise in clinical trials and may be more effective than some other treatment options. 3

Risks Summary

Daclizumab carries potential risks, including liver abnormalities, infections, and autoimmune reactions. 3 Cases of serious neurological deterioration and DRESS have been reported following daclizumab injections. 2 Daclizumab should not be used by pregnant or breastfeeding women. 3 Individuals with certain medical conditions may not be suitable candidates for this treatment. It is crucial to carefully consider the risks and benefits of daclizumab and consult with a healthcare professional before starting this medication.

Comparison of Studies

Commonalities

Several studies have demonstrated the efficacy of daclizumab in RRMS treatment. Daclizumab has been shown to reduce relapses and the number of brain lesions detected on MRI scans. 7 12 15 14 The convenience of a monthly subcutaneous injection is a common advantage highlighted in studies. 3

Differences

The efficacy of daclizumab may vary among patients. 16 Furthermore, studies have identified potential serious adverse effects associated with daclizumab, including liver abnormalities, infections, and autoimmune reactions. 3 2 These factors emphasize the importance of a careful risk-benefit assessment and close monitoring under the guidance of a healthcare professional when considering daclizumab treatment.

Consistency and Contradictions in Results

While multiple studies support the effectiveness of daclizumab in RRMS treatment, some studies have raised concerns regarding its safety. 2 Further research is needed to fully understand the long-term safety and efficacy of daclizumab.

Practical Applications and Considerations

Daclizumab can be a potential treatment option for patients with RRMS, but it's essential to discuss its risks and benefits with a healthcare professional. 7 12 15 3

Limitations of Current Research

Additional research is required to fully understand the long-term safety and efficacy of daclizumab. The available data on long-term safety is still limited.

Future Research Directions

Further studies are needed to investigate the long-term safety and efficacy of daclizumab. Research on strategies to mitigate potential side effects of daclizumab is also important.

Conclusion

Daclizumab is a promising treatment option for relapsing-remitting multiple sclerosis (RRMS). 7 12 15 14 However, it's essential to consider the potential risks and consult with a healthcare professional to make an informed decision about treatment. Daclizumab's long-term safety and efficacy require further research, particularly on strategies to manage potential side effects. 3

Literature analysis of 24 papers
Positive Content
22
Neutral Content
1
Negative Content
1
Article Type
6
0
0
10
23
1.

Management of MS Patients Treated With Daclizumab - a Case Series of 267 Patients.

Author: RommerPaulus S, BergerKlaus, EllenbergerDavid, FneishFiras, SimbrichAlexandra, StahmannAlexander, ZettlUwe K

Multiple sclerosis treatment
Brain inflammation

This study examines the therapy management of patients who received daclizumab, a drug that was previously used to treat multiple sclerosis (MS), after it was withdrawn from the market due to safety concerns. The study found that most patients switched to other treatments shortly after discontinuing daclizumab.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

2.

Drug reaction with eosinophilia and systemic symptoms after daclizumab therapy.

Author: RauerSebastian, StorkLidia, UrbachHorst, StathiAngeliki, MarxAnna, SüßPatrick, PrinzMarco, BrückWolfgang, MetzImke

DRESS
Neurologic deterioration

Two women with multiple sclerosis (MS) developed severe neurologic deterioration and a drug reaction with eosinophilia and systemic symptoms (DRESS) after treatment with daclizumab.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

No evidence of disease activity in patients receiving daclizumab versus intramuscular interferon beta-1a for relapsing-remitting multiple sclerosis in the DECIDE study.

Author: KapposLudwig, HavrdovaEva, GiovannoniGavin, KhatriBhupendra O, GauthierSusan A, GreenbergSteven J, YouXiaojun, WangPing, GiannattasioGiorgio

MS treatment
NEDA improvement

This study assessed the proportion of patients with relapsing-remitting MS achieving NEDA in the DECIDE study of daclizumab 150 mg subcutaneous versus intramuscular interferon beta-1a 30 µg for 96-144 weeks. The study found that more daclizumab versus intramuscular interferon beta-1a patients achieved NEDA early in DECIDE, with effects increasing over time.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

7.

Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study.

Author: GoldRalf, RadueErnst-Wilhelm, GiovannoniGavin, SelmajKrzysztof, HavrdovaEva, StefoskiDusan, SprengerTill, MontalbanXavier, CohanStanley, UmansKimberly, GreenbergSteven J, OzenGulden, ElkinsJacob

Multiple sclerosis treatment

Daclizumab is a humanized monoclonal antibody against CD25 that modulates interleukin 2 signaling. It was found to be safe and effective in patients with relapsing-remitting multiple sclerosis (RRMS).

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

The synergistic effect of ω3 and Vit D3 on glycemia and TNF-α in islet transplantation.

Author: GurolA O, Okten-KursunA, KasapogluP, SuzergozF, KucuksezerU C, CevikA, TutuncuY, YenturS P, GurolS D, KucukM, YilmazM T

Improved glycemia
Reduced TNF-α

Omega-3 and vitamin D3 have been shown to improve the success of islet allo-transplantation (ITX), reducing glycemia levels and TNF-α production.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Population pharmacokinetics of daclizumab high-yield process in healthy volunteers: integrated analysis of intravenous and subcutaneous, single- and multiple-dose administration.

Author: OthmanAhmed A, TranJonathan Q, TangMeina T, DuttaSandeep

High bioavailability
Slow clearance
Suitable for monthly administration

Daclizumab HYP is a humanized monoclonal antibody that blocks the α-subunit of the interleukin-2 receptor. In a study of 70 healthy volunteers, daclizumab HYP showed slow clearance, linear pharmacokinetics, high subcutaneous bioavailability, and a half-life suitable for monthly administration.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

12.

An update on new and emerging therapies for relapsing-remitting multiple sclerosis.

Author: Weinstock-GuttmanBianca

Improved adherence
MS treatment
Oral administration
Progressive multifocal leukoencephalopathy
Side effects

Disease-modifying therapies (DMTs) have been used for over a decade to treat relapsing-remitting multiple sclerosis (RRMS). While first-line DMTs have shown only partial benefits and often have inadequate patient adherence, newer DMTs offer more efficacious treatment, more favorable methods of administration, and lower infusion frequencies, which may improve adherence and clinical outcomes.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

13.

Effect of daclizumab high-yield process in patients with highly active relapsing-remitting multiple sclerosis.

Author: GiovannoniGavin, RadueErnst-Wilhelm, HavrdovaEva, RiesterKatherine, GreenbergSteven, MehtaLahar, ElkinsJacob

Multiple sclerosis treatment

Daclizumab high-yield process (DAC HYP) reduced the annualized relapse rate by 50% in patients with highly active relapsing-remitting multiple sclerosis (RRMS) and 51% in patients with less active RRMS. DAC HYP also reduced new/newly-enlarging T2 lesions by 76% in highly active RRMS patients and 73% in less active RRMS patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Emerging injectable therapies for multiple sclerosis.

Author: OhJiwon, CalabresiPeter A

MS treatment
Adverse events

Multiple sclerosis (MS) treatment options have expanded in recent years, and several injectable therapies are under development. This review summarizes emerging injectable therapies for relapsing-remitting MS, including alemtuzumab, pegylated interferon beta-1a, daclizumab, ocrelizumab, ofatumumab, and anti-LINGO1 antibody. These drugs show promising efficacy but require careful monitoring due to potential adverse events.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

15.

Drugs in development for relapsing multiple sclerosis.

Author: AliRehiana, NicholasRichard St John, MuraroPaolo Antonio

Convenient administration
MS treatment
Cardiovascular complications
Macular edema
Progressive multifocal leukoencephalopathy
Secondary autoimmunity
Teratogenicity

Multiple sclerosis (MS) is a challenging disease to treat, with many drugs failing in development. This review discusses recent and developing treatments for relapsing MS, including the pros and cons of each treatment.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

16.

Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial.

Author: GoldRalf, GiovannoniGavin, SelmajKrzysztof, HavrdovaEva, MontalbanXavier, RadueErnst-Wilhelm, StefoskiDusan, RobinsonRandy, RiesterKatherine, RanaJitesh, ElkinsJacob, O'NeillGilmore,

Effective for multiple sclerosis
None mentioned

This study assessed the efficacy of daclizumab high-yield process (HYP) as monotherapy for a 1-year treatment period in patients with relapsing-remitting multiple sclerosis.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

17.

Intrathecal effects of daclizumab treatment of multiple sclerosis.

Author: BielekovaB, RichertN, HermanM L, OhayonJ, WaldmannT A, McFarlandH, MartinR, BlevinsG

Expansion of CD56(bright) NK cells
Reduced CEL

This study investigated the effects of daclizumab, a humanized monoclonal antibody against CD25, on contrast-enhancing lesions (CEL) in patients with relapsing-remitting multiple sclerosis (RRMS).

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., IntramuralFunding provided by the NIH for research projects within the NIH.

Language : English

18.

Long-term daclizumab therapy for the treatment of noninfectious ocular inflammatory disease.

Author: WroblewskiKeith, SenH Nida, YehSteven, FaiaLisa, LiZhuging, SranPushpa, GangaputraSapna, VitaleSusan, SherryPatti, NussenblattRobert

Uveitic flare prevention
Uveitis treatment
Visual acuity stabilization
Cancer
Dermatologic complications

Daclizumab was effective in reducing concomitant immunosuppressive medication, stabilizing visual acuity, and preventing uveitic flares in most patients with chronic, noninfectious intermediate and/or posterior uveitis. However, it was associated with dermatologic complications and four patients developed solid tumor malignancies.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

19.

Emerging therapies in relapsing-remitting multiple sclerosis.

Author: MarriottJames J, O'ConnorPaul W

Convenience
RRMS treatment
Fatal complications
Side effects

This study reviewed the current and future of disease-modifying therapies (DMTs) for relapsing-remitting multiple sclerosis (RRMS). The researchers highlighted the need to weigh the convenience of oral DMTs against the relative inconvenience but long-term safety of current first-line injectable therapies.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

20.

Therapeutic monoclonal antibodies in ophthalmology.

Author: RodriguesEduardo B, FarahMichel E, MaiaMaurício, PenhaFernando M, RegatieriCaio, MeloGustavo B, PinheiroMarcelo M, ZanettiCarlos R

Control inflammation
Control neovascularization
Treat angiogenic diseases
Treat inflammatory diseases
Systemic complications

Monoclonal antibodies (mAbs) are used in ophthalmology to treat various diseases with high specificity. Bevacizumab and ranibizumab (anti-VEGF), infliximab, etanercept, and adalimumab (anti-TNF) are FDA-approved mAbs for angiogenic and inflammatory ocular diseases. Other mAbs show promising results for ocular lymphoma or inflammation, and their role in ophthalmology will be determined by future clinical trials.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

21.

Effective treatment of a murine model of adult T-cell leukemia using depsipeptide and its combination with unmodified daclizumab directed toward CD25.

Author: ChenJing, ZhangMeili, JuWei, WaldmannThomas A

ATL treatment efficacy

Depsipeptide, a histone deacetylase inhibitor, showed antitumor effects in a murine model of adult T-cell leukemia (ATL) and enhanced the efficacy when combined with daclizumab. These findings support clinical trials for this combination therapy in ATL patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., IntramuralFunding provided by the NIH for research projects within the NIH.

Language : English

23.

Humanized anti-interleukin-2 (IL-2) receptor alpha therapy: long-term results in uveitis patients and preliminary safety and activity data for establishing parameters for subcutaneous administration.

Author: NussenblattRobert B, ThompsonDarby J S, LiZhuqing, ChanChi Chao, PetersonJan S, RobinsonRandy R, ShamesRichard S, NagarajanSudha, TangMeina Tao, MailmanMichelle, VelezGisela, RoyChandra, Levy-ClarkeGrace A, SuhlerEric B, DjalilianAli, SenHatice Nida, Al-KhatibShadi, UrseaRoxana, SrivastavaSunil, BamjiAllison, MellowSusan, SranPushpa, WaldmannThomas A, BuggageRonald R

Treat severe uveitis

Long-term daclizumab therapy, an anti-IL-2 receptor alpha treatment, was found to be effective in treating severe uveitis in lieu of standard immunosuppression. Subcutaneous daclizumab administration was also found to be a viable treatment strategy.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

24.

[Antibodies and immunomodulation].

Author: BerthouxF

This abstract reviewed the efficacy of immunosuppressor induction agents, including daclizumab, basiliximab, and efalizumab, compared with anti-lymphocyte globulins and anti-OKT3 agents.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : French

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