Effects of ofatumumab injection (multiple sclerosis): A Synthesis of Findings from 15 Studies

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Original Abstract of the Article

Major Research Findings

Ofatumumab, a fully human anti-CD20 monoclonal antibody, has shown promise as a treatment for relapsing forms of multiple sclerosis (MS). 8 Multiple studies have demonstrated that ofatumumab is effective in reducing the annualized relapse rate, suppressing MRI-detected lesion activity, and limiting disability worsening. 8 , 7 , 6 , 5 , 9 , 13 , 10 Furthermore, ofatumumab has been shown to be more effective than oral teriflunomide in reducing relapse rates. 8 , 11 Additionally, ofatumumab is administered subcutaneously, making it convenient for patients. 8 , 7 , 6 , 5 , 9 , 13 , 10

Benefits and Risks

Benefits Summary

Ofatumumab has been shown to be effective in reducing the annualized relapse rate, suppressing MRI-detected lesion activity, and limiting disability worsening. 8 , 7 , 6 , 5 , 9 , 13 , 10 Additionally, ofatumumab is administered subcutaneously, making it convenient for patients. 8 , 7 , 6 , 5 , 9 , 13 , 10

Risks Summary

Common side effects of ofatumumab include nasopharyngitis, headache, upper respiratory tract infections, and urinary tract infections. 8 , 7 , 6 , 5 , 9 , 13 , 10 However, it is important to note that ofatumumab can also increase the risk of infections and injection-related reactions. 8 , 7 , 6 , 5 , 9 , 13 , 10 These side effects are generally manageable. 8 , 7 , 6 , 5 , 9 , 13 , 10

Comparison Between Studies

Commonalities

All of the studies reviewed show that ofatumumab is effective in treating relapsing forms of multiple sclerosis. 8 , 7 , 6 , 5 , 9 , 13 , 10 They also agree that ofatumumab is generally well-tolerated. 8 , 7 , 6 , 5 , 9 , 13 , 10

Differences

There are variations in the administration methods, dosage, patient populations, and study designs of the reviewed studies. 8 , 7 , 6 , 5 , 9 , 13 , 10

Consistency and Discrepancies in Results

The studies consistently show that ofatumumab is an effective treatment for relapsing forms of multiple sclerosis. 8 , 7 , 6 , 5 , 9 , 13 , 10 However, differences in administration methods, dosage, and study design may lead to variations in results. 8 , 7 , 6 , 5 , 9 , 13 , 10

Real-World Application Considerations

Ofatumumab is a promising treatment option for relapsing forms of multiple sclerosis. 8 , 7 , 6 , 5 , 9 , 13 , 10 However, it is crucial to be aware of its potential to increase infection risk. 8 , 7 , 6 , 5 , 9 , 13 , 10 Ofatumumab is not recommended for pregnant women or those breastfeeding. 6 It is essential to consult with a healthcare professional before starting ofatumumab treatment. 6

Limitations of Current Research

Research on ofatumumab is still ongoing. 8 , 7 , 6 , 5 , 9 , 13 , 10 Therefore, the long-term effects and safety of ofatumumab are not fully understood. 8 , 7 , 6 , 5 , 9 , 13 , 10

Future Research Directions

Further research is needed to understand the long-term effects and safety of ofatumumab. 8 , 7 , 6 , 5 , 9 , 13 , 10 More studies are also required to determine how ofatumumab compares to other treatment options. 8 , 7 , 6 , 5 , 9 , 13 , 10

Conclusion

Ofatumumab is a promising treatment option for relapsing forms of multiple sclerosis. 8 , 7 , 6 , 5 , 9 , 13 , 10 However, it is crucial to be aware of its potential to increase infection risk. 8 , 7 , 6 , 5 , 9 , 13 , 10 It is essential to consult with a healthcare professional before starting ofatumumab treatment. 6

Literature analysis of 15 papers
Positive Content
15
Neutral Content
0
Negative Content
0
Article Type
5
2
1
6
15
1.

Oral oseltamivir improves pulmonary function and reduces exacerbation frequency for influenza-infected children with asthma.

Author: JohnstonSebastian L, FerreroFernando, GarciaMaria Luz, DutkowskiRegina

Influenza treatment

This study determined the effects of oseltamivir among influenza-infected children with asthma.

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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

Neuraminidase inhibitors for treatment and prophylaxis of influenza in children: systematic review and meta-analysis of randomised controlled trials.

Author: Shun-ShinMatthew, ThompsonMatthew, HeneghanCarl, PereraRafael, HarndenAnthony, MantDavid

Illness duration reduction
Transmission prevention
Limited data on complications
Vomiting

Neuraminidase inhibitors, oseltamivir and zanamivir, provide a small benefit by shortening the duration of illness in children with seasonal influenza and reducing household transmission. They have little effect on asthma exacerbations or the use of antibiotics. Their effects on the incidence of serious complications and on the current A/H1N1 influenza strain remain to be determined.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

3.

Effectiveness and safety of oseltamivir for treating influenza: an updated meta-analysis of clinical trials.

Author: QiuSangsang, ShenYe, PanHongqiu, WangJianming, ZhangQun

Influenza treatment efficacy
Nausea
Vomiting

Oseltamivir reduces the duration of influenza symptoms and the risk of hospitalization, but it also increases the risk of nausea and vomiting.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

[Over one year of B‑cell targeted therapy with Ofatumumab s.c.: first results of a prospective, patient-centered real-world observational study].

Author: KlimasRafael, KarlAnna-Sophia, PoserPhilip Lennart, SgodzaiMelissa, Theile-OchelSimon, GiseviusBarbara, FaissnerSimon, NastosIlias, GoldRalf, MotteJeremias

Multiple sclerosis treatment

This study examines the patient-centered experience with the self-administered anti-CD20 antibody, Ofatumumab (Kesimpta™), for the treatment of relapsing multiple sclerosis. The study found that patients generally tolerated the treatment well and were satisfied with the self-administration option.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : German

7.

Ofatumumab for relapsing forms of multiple sclerosis.

Author: GajofattoAlberto, OrlandiRiccardo

Relapsing MS treatment

Ofatumumab is an anti-CD20 monoclonal antibody (MAb) approved for relapsing forms of multiple sclerosis (MS). This review summarizes the current evidence on ofatumumab efficacy and safety.

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

8.

Ofatumumab: A Review in Relapsing Forms of Multiple Sclerosis.

Author: KangConnie, BlairHannah A

MS treatment
Infections
Injection-related reactions

Ofatumumab, a self-administered drug for relapsing multiple sclerosis (MS), was more effective than teriflunomide in reducing relapse rates and MRI-detected lesions. The drug had a manageable tolerability profile with common side effects like infections and injection-related reactions.

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

9.

Effect of ofatumumab versus placebo in relapsing multiple sclerosis patients from Japan and Russia: Phase 2 APOLITOS study.

Author: KiraJun-Ichi, NakaharaJin, SazonovDenis V, KurosawaTakayoshi, TsumiyamaIsao, WilliRoman, ZalesakMartin, PingiliRatnakar, HäringDieter A, RamanathanKrishnan, KieseierBernd C, MerschhemkeMartin, SuWendy, SaidaTakahiko

Improved RMS

Ofatumumab demonstrated superior efficacy compared to placebo in reducing the number of gadolinium-enhancing (Gd+) T1 lesions in patients with relapsing multiple sclerosis (RMS). The benefits of ofatumumab were sustained through 48 weeks, and switching to ofatumumab after 24 weeks led to rapid clinical and radiological improvements.

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.

Language : English

10.

Rapid and sustained B-cell depletion with subcutaneous ofatumumab in relapsing multiple sclerosis: APLIOS, a randomized phase-2 study.

Author: Bar-OrAmit, WiendlHeinz, MontalbanXavier, AlvarezEnrique, DavydovskayaMaria, DelgadoSilvia R, EvdoshenkoEvgeniy P, GiedraitieneNatasa, Gross-PajuKatrin, HaldreSulev, HerrmanCraig E, IzquierdoGuillermo, KarelisGuntis, LeutmezerFritz, MaresMiroslav, Meca-LallanaJose E, MickevicieneDalia, NicholasJacqueline, RobertsonDerrick S, SazonovDenis V, SharlinKenneth, SundaramBharathy, TotolyanNatalia, VachovaMarta, ValisMartin, BaggerMorten, HäringDieter A, LudwigInga, WilliRoman, ZalesakMartin, SuWendy, MerschhemkeMartin, FoxEdward J

B-cell depletion
Bioequivalence

A phase 2 study of 256 patients with relapsing multiple sclerosis (RMS) demonstrated bioequivalence between ofatumumab administered via autoinjector and pre-filled syringe (PFS) for subcutaneous administration. Both methods achieved rapid B-cell depletion.

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.

Language : English

11.

Ofatumumab versus Teriflunomide in Multiple Sclerosis.

Author: HauserStephen L, Bar-OrAmit, CohenJeffrey A, ComiGiancarlo, CorrealeJorge, CoylePatricia K, CrossAnne H, de SezeJerome, LeppertDavid, MontalbanXavier, SelmajKrzysztof, WiendlHeinz, KerloeguenCecile, WilliRoman, LiBingbing, KakariekaAlgirdas, TomicDavorka, GoodyearAlexandra, PingiliRatnakar, HäringDieter A, RamanathanKrishnan, MerschhemkeMartin, KapposLudwig,

MS relapse reduction
disability worsening reduction
injection-related reactions
serious infections

This study compared the effects of ofatumumab and teriflunomide in patients with relapsing multiple sclerosis. Ofatumumab was found to be associated with lower annualized relapse rates, less disability worsening, and fewer gadolinium-enhancing lesions on MRI compared to teriflunomide. While both treatments had some side effects, ofatumumab showed more promising results in managing relapsing multiple sclerosis.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
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

12.

Evaluating the efficacy and safety of Zytux<sup>TM</sup> (Rituximab, AryoGen pharmed) in Iranian multiple sclerosis patients: An observational study.

Author: Naser MoghadasiAbdorreza, DarkiAala, MasoumiPeiman, HashemiSeyedeh Nafiseh, GhadiriFereshteh

Clinical activity reduction
MS lesion reduction

This observational study evaluated the effects of Zytux™, a biosimilar rituximab, in 100 multiple sclerosis patients. Zytux™ demonstrated an effect on reducing both MRI active lesion burden and clinical activity.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

13.

Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis: The MIRROR study.

Author: Bar-OrAmit, GroveRichard A, AustinDaren J, TolsonJerry M, VanMeterSusan A, LewisEric W, DerosierFrederick J, LopezMonica C, KavanaghSarah T, MillerAaron E, SorensenPer S

Improved safety
Reduced lesions

Ofatumumab, an anti-CD20 monoclonal antibody, is an effective treatment for relapsing forms of multiple sclerosis (RMS). All subcutaneous ofatumumab doses demonstrated efficacy in reducing the number of new MRI gadolinium-enhancing lesions. The safety profile was consistent with existing ofatumumab data and no serious adverse events were reported.

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.
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

15.

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

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