Oral versus intravenous methylprednisolone for the treatment of multiple sclerosis relapses: A meta-analysis of randomized controlled trials

Liu, Shuo; Liu, Xiaoqiang; Chen, Shuying; Xiao, Yingxiu; Zhuang, Weiduan

doi:10.1371/journal.pone.0188644

Cited by 14 publications

(25 citation statements)

References 36 publications

(48 reference statements)

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Section: Introductionmentioning

confidence: 99%

“…Corticosteroids (CS), including self-administered oral CS (OCS) and provider-administered intravenous methylprednisolone (IVMP), are first-line MS relapse treatments with purportedly similar efficacy [3, 6, 7]. Treatment with IVMP requires multiple infusions, which can be more costly and less convenient than OCS and may impact daily life [6, 7]. Given the majority of clinical studies for the treatment of MS relapse [8–16] were conducted before the widespread availability and diversification of disease-modifying therapy (DMT), updated effectiveness information is lacking [5].…”

Section: Introductionmentioning

confidence: 99%

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Treatment Effectiveness for Resolution of Multiple Sclerosis Relapse in a US Health Plan Population

Nazareth

Datar²,

2019

Neurol Ther

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IntroductionTimely and effective resolution of multiple sclerosis (MS) relapse is critical to minimizing residual deficits, which can result in neurologic disability. Oral corticosteroids (OCS) and intravenous corticosteroids [intravenous methylprednisolone (IVMP)] are earlier line treatments; alternatives include repository corticotropin injection (RCI; H.P. Acthar® Gel), plasmapheresis (PMP), and intravenous immunoglobulin (IVIG). Contemporary insight into the use of relapse treatments and their effectiveness is needed.ObjectiveTo evaluate relapse rates, frequency of treatments used, and treatment effectiveness (i.e., relapse resolution).MethodsA retrospective analysis of patients ages 18–89 years experiencing MS relapse from 1 January 2008 to 30 June 2015 was conducted using administrative claims data. MS relapse was defined based on established claims-based methodology. The first claim for relapse treatment (i.e., prescription or administration) was used to designate the treatment group and relapse date, respectively. Relapses occurring ≤ 30 days were considered an episode. The first relapse episode was identified for every patient. Treatment was deemed effective in resolving the relapse if no additional relapses followed within the episode; otherwise, the relapse was considered unresolved. A 5-day OCS taper following IVMP administration, designated IVMP ± OCS, was allowed. Relapse frequency, treatment use, and relapse resolution were quantified. Relapse resolution was likewise evaluated in patients continuously enrolled for 12 months before and after first treatment with RCI or PMP/IVIG, with PMP/IVIG administrations within 7 days of each other being considered a single course of therapy.ResultsDuring the study period, 9574 patients experienced ≥ 1 relapse; 26.0% of patients had ≥ 2 relapses/year. The mean number of relapse episodes was 2.6 over a mean follow-up of 2.7 years for an annualized relapse rate of 1.0. Corticosteroids were the first treatment used in 90.4% of relapses (OCS = 51.8%, IVMP = 38.6%), followed by IVIG (6.0%), RCI (2.2%) and PMP (1.5%). The proportion of patients achieving relapse resolution with their first treatment was 90.5% with OCS (n = 5710), 47.8% with IVMP ± OCS (n = 3425), 96.9% with RCI (n = 195), 50.7% with PMP (n = 73), and 43.9% with IVIG (n = 171). Among continuously enrolled patients (n = 373), relapse resolution was 95.7% with RCI (n = 232) and 66.0% with PMP/IVIG (n = 141); significant cohort differences were observed.ConclusionsAs demonstrated in other studies, OCS were generally effective. However, real-world effectiveness varied with other treatments. Relapse resolution of the first treatment with OCS was higher than with IVMP ± OCS; similarly, relapse resolution was higher with RCI as the first treatment than with PMP/IVIG. Results demonstrate RCI’s effectiveness in appropriate patients. Limitations pertaining to claims-based research apply.FundingMallinckrodt Pharmaceuticals (Bedminster, NJ).

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Treatment Effectiveness for Resolution of Multiple Sclerosis Relapse in a US Health Plan Population

Nazareth

Datar²,

2019

Neurol Ther

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“…We administrated MPS-NPMOF via intravitreous injection. It avoided the lower efficiency and adverse effects caused by systemic administration and prolonged the retention time of the drug 36,37. That’s why retinas revealed smaller scale of lesioned site, milder injury and faster recovery following MPS-NPMOF injection.…”

Section: Resultsmentioning

confidence: 99%

<p>The Application of Methylprednisolone Nanoscale Zirconium-Porphyrin Metal-Organic Framework (MPS-NPMOF) in the Treatment of Photoreceptor Degeneration</p>

Wang¹,

Liu²,

Yuan³

et al. 2019

IJN

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BackgroundPhotoreceptor degeneration is one of the most refractory oculopathy in the world, leading to vision loss in severe cases. Methyprednisolone is one of the most commonly prescribed medications for the treatment of retinal degenerative diseases, either by oral administration or repeated intraocular injections. However, the efficacy was unsatisfactory due to its systemic or local side effects and short retention time within the retina.MethodsNanoscale zirconium-porphyrin metal-organic framework (NPMOF) was synthesized and characterized. The biotoxicity and imaging capability of NPMOF were evaluated using zebrafish embryos and larvae. NPMOF was then used as a skeleton and loaded with methylprednisolone (MPS) to prepare a novel kind of nanoparticle, MPS-NPMOF. Photoreceptor degeneration was induced by high-intensity light exposure in adult zebrafish. MPS-NPMOF was delivered to the injured retina by intraocular injection. The photoreceptor regeneration and its underlying mechanism were explored by immunohistochemistry, quantitative real-time polymerase chain reaction and behavioral test.ResultsNPMOF not only had low biotoxicity but also emitted bright fluorescence. Following a single MPS-NPMOF intraocular injection, the injured retina exhibited the faster photoreceptor regeneration with better visual function by promoting the cell proliferation.ConclusionNPMOF is an ideal carrier and could be applied in tracking and delivering medications. By intraocular injection, the novel drug delivery system, MPS-NPMOF, accomplishes the sustained release of drug and plays a therapeutic role in photoreceptor degeneration.

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“…Current first-line treatments for MS relapse exacerbations include corticosteroids (CS) that may be prescribed to patients to be taken orally or administered intravenously in a clinical setting. Intravenous administration of CS requires multiple infusions and, in addition to interfering with a patient's daily life, is more costly than oral CS [6][7][8]. In both cases, high doses of CS are accompanied by a number of adverse effects that may not be tolerated well among MS patients [9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Consequences of Insurance Denials Among U.S. Patients Prescribed Repository Corticotropin Injection for Acute Exacerbations of Multiple Sclerosis

et al. 2020

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Introduction Repository corticotropin injection (RCI; Acthar ® Gel) is indicated for the treatment of acute exacerbations of multiple sclerosis (MS) in adults. Despite the well-documented clinical and economic benefits of RCI, many patients are denied use of the therapy by third-party payers. This study aims to understand the demographic and clinical characteristics of MS relapse patients who received a prescription for RCI from their physicians and then were either approved or denied treatment by their insurers. The study compares measurable clinical outcomes and healthcare resource utilization (HCRU) between approved and denied cohorts. Methods A retrospective analysis of adults experiencing MS relapse from January 2015 to December 2018 was conducted using a de-identified open-source claims database [Symphony Health Integrated Dataverse ® (IDV)]. Patients were identified using ICD codes for MS and considered to have relapsing/remitting type according to established claims-based methodology. Clinical characteristics and HCRU were analyzed during the year preceding (“baseline”) and the year following (“follow-up”) each patient’s index date, defined as the date of a patient’s first approved RCI claim (for patients with ≥ 1 approved claim) or first denied RCI claim (for patients with only denied claims). Baseline characteristics were reported with unadjusted differences and p values indicating the significance of characteristics between the two cohorts. For outcomes, match-adjusted results were reported using propensity matching to account for underlying differences between cohorts. Results The study sample included 1902 MS relapse patients with at least one claim for RCI. At baseline, approved patients were slightly older compared to denied patients (mean age 48.0 vs. 47.2), had higher rates of hemiplegia/paraplegia (6.7% vs. 3.3%), greater mobility impairment (17% vs. 11.5%), more exacerbation episodes (66.2% vs. 59.9%), and a higher number of physical therapy/rehab claims (23.5 vs. 14.0), respectively. Outcomes among the matched sample show an increased use of corticosteroids for patients denied access to RCI compared to approved patients (51.1% vs. 42.4%), more exacerbation episodes (36.6% vs. 28.2%), and an increased number of physical therapy/rehab claims (11.5% vs. 9.9%), respectively. Conclusion The results of this study may aid providers and payers in evaluating scenarios where RCI may be beneficial and improve quality of care for patients experiencing MS relapse.

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Oral versus intravenous methylprednisolone for the treatment of multiple sclerosis relapses: A meta-analysis of randomized controlled trials

Cited by 14 publications

References 36 publications

Treatment Effectiveness for Resolution of Multiple Sclerosis Relapse in a US Health Plan Population

Treatment Effectiveness for Resolution of Multiple Sclerosis Relapse in a US Health Plan Population

<p>The Application of Methylprednisolone Nanoscale Zirconium-Porphyrin Metal-Organic Framework (MPS-NPMOF) in the Treatment of Photoreceptor Degeneration</p>

Consequences of Insurance Denials Among U.S. Patients Prescribed Repository Corticotropin Injection for Acute Exacerbations of Multiple Sclerosis

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