Tolerance of intravenous methylprednisolone for relapse treatment in demyelinating CNS disease

Lienert, Carmen; Schawalder, Gabriela; Findling, Oliver; Kamm, Christian P.; Humpert, Sebastian; Mugglin, Anne; Mathis, Johannes; Sturzenegger, Matthias; Mattle, Heinrich

doi:10.4414/smw.2013.13783

Cited by 9 publications

(21 citation statements)

References 19 publications

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“…The available data support an association between corticosteroid treatment and mood disorders as well as other neuropsychiatric disorders such as sleep disturbances, cognitive impairment, and psychosis in some patients [Iacovides and Andreoulakis, 2011;Klein, 1992;Lewis and Smith, 1983;Lienert et al 2013;Martinelli et al 2009;Paparrigopoulos et al 2010;Sellebjerg et al 1998;Sorensen et al 2009;Tsang and Macdonell 2011;Warrington and Bostwick, 2006]. Commonly occurring nonpsychiatric AEs for corticotropin injection are similar to those of corticosteroids, as related to stimulation of cortisol release, and include fluid retention and edema, possible change in glucose tolerance, elevated blood pressure, and increased appetite and weight gain.…”

Section: Introductionmentioning

confidence: 99%

“…Regardless of the potential causes, patients with MS should be evaluated for mood disorders and neuropsychiatric symptoms and the findings should be taken into account when determining treatment [Lienert et al 2013;Marrie et al 2009;Paparrigopoulos et al 2010]. When possible, therapeutic options for MS exacerbations should be chosen for each patient with the goals of minimizing the risks of neuropsychiatric side effects or exacerbation of pre-existing conditions.…”

Section: Introductionmentioning

confidence: 99%

“…Treatment for exacerbations of MS has generally consisted of intravenous (IV) corticosteroids, usually methylprednisolone (MP), oral steroids, or repository corticotropin injection (HP Acthar ® gel, Mallinckrodt ARD Inc., Hazelwood, MO, USA) [Filippini et al 2000;Tsang and Macdonell, 2011]. Both MP and corticotropin (adrenocorticotrophic hormone [ACTH]) have demonstrated efficacy in reducing short-term disability after exacerbations of MS [Filippini et al 2000;Iacovides and Andreoulakis, 2011;Lienert et al 2013;Martinelli et al 2009;Paparrigopoulos et al 2010;Tsang and Macdonell, 2011].…”

Section: Introductionmentioning

confidence: 99%

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Clinical experience with repository corticotropin injection in patients with multiple sclerosis experiencing mood changes with intravenous methylprednisolone: a case series

Murray¹,

Woo²

2015

Ther Adv Neurol Disord

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The elevated prevalence of neuropsychiatric symptoms and disorders among patients with multiple sclerosis (MS) is well recognized, as are potential neuropsychiatric side effects of treatment with corticosteroids. Both methylprednisolone (MP) and repository corticotropin injection (HP Acthar® gel) have demonstrated efficacy in reducing short-term disability after exacerbations of MS. Although historical data are limited, repository corticotropin injection has not generally been associated with detrimental neuropsychiatric effects. We describe six cases of patients with relapsing-remitting MS who had previously experienced detrimental mood changes with MP treatment. Some of these patients had previous histories of mood disorders or other neuropsychiatric symptoms prior to MS diagnosis. All six patients were subsequently treated with repository corticotropin injection for MS exacerbations and each demonstrated improvements in MS symptoms. This clinical experience suggests that repository corticotropin injection should be considered as an alternative for patients who do not tolerate corticosteroids or have difficulties associated with intravenous medication. Furthermore, the rate of neuropsychiatric side effects observed in these patients was low. These observations support repository corticotropin injection as a viable alternative for the treatment of acute exacerbations of MS, particularly in patients who have a history of neuropsychiatric disorders or symptoms either independently or in response to MP treatment. In reviewing both the published data and our own clinical experience regarding potential neuropsychiatric adverse events with treatment for MS exacerbations, we hope to stimulate further research into the potential efficacy and safety of repository corticotropin injection among patients with some form of neuropsychiatric complications that must be considered when establishing a treatment plan for MS.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Clinical experience with repository corticotropin injection in patients with multiple sclerosis experiencing mood changes with intravenous methylprednisolone: a case series

Murray¹,

Woo²

2015

Ther Adv Neurol Disord

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“…Historically, periodic or monthly administration of systemic corticosteroids, such as intravenous methylprednisolone (IVMP) pulse therapy, was one of the first strategies for management of worsening or breakthrough MS and is still employed to enhance the effects of DMTs for MS [Myhr and Mellgren, 2009;Sorensen et al 2009;Lienert et al 2013;Zivadinov et al 2008Zivadinov et al , 2012Piri Cinar et al 2013;Mezei et al 2013;Shaygannejad et al 2013]. This approach developed after systemic corticosteroids were approved for MS relapse treatment.…”

Section: Introductionmentioning

confidence: 99%

“…However, despite the overall reliability of corticosteroids, they are not always effective or well tolerated [Myhr and Mellgren, 2009;Sorensen et al 2009;Lienert et al 2013;Zivadinov et al 2008;Shaygannejad et al 2013;Filippini et al 2000]. Common adverse reactions, both with short-and long-term use, include osteoporosis, steroid-induced diabetes, hypertension, gastritis and gastrointestinal ulcer, weight gain, edema, and psychological or psychiatric impairments.…”

Section: Introductionmentioning

confidence: 99%

Adrenocorticotropic hormone versus methylprednisolone added to interferon β in patients with multiple sclerosis experiencing breakthrough disease: a randomized, rater-blinded trial

Berkovich

Bakshi

Amezcua

et al. 2016

Ther Adv Neurol Disord

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Background:The objective of this study was to evaluate monthly intramuscular adrenocorticotropic hormone (ACTH) gel versus intravenous methylprednisolone (IVMP) add-on therapy to interferon β for breakthrough disease in patients with relapsing forms of multiple sclerosis. Methods: This was a prospective, open-label, examiner-blinded, 15-month pilot study evaluating patients with Expanded Disability Status Scale (EDSS) score 3.0-6.5 and at least one clinical relapse or new T2 or gadolinium-enhanced lesion in the previous year. Twentythree patients were randomized to ACTH (n = 12) or IVMP (n = 11) and completed the study. The primary outcome measure was the cumulative number of relapses. Secondary outcomes included EDSS, Mental Health Inventory (MHI), plasma cytokines, MS Functional Composite (MSFC), Quality-of-Life (MS-QOL) score, bone mineral density (BMD), and new or worsened psychiatric symptoms per month. Brain magnetic resonance imaging was analyzed post hoc. This was a preliminary and small-scale study. Results: Relapse rates differed significantly [ACTH 0.08, 95% confidence interval (CI) 0.01-0.54 versus IVMP 0.80, 95% CI 0.36-1.75; rate ratio, IVMP versus ACTH: 9.56, 95% CI 1.23-74.6; p = 0.03]. ACTH improved (p = 0.03) MHI (slope 0.95 ± 0.38 points/month; p = 0.02 versus slope −0.38 ± 0.43 points/month; p = 0.39). On-study decreases (all p < 0.05) in eight cytokine levels occurred only in the ACTH group. However, on-study EDSS, MSFC, MS-QOL, BMD, and MRI lesion changes were not significant between groups. Psychiatric symptoms per patient were greater with IVMP than ACTH (0.55, 95% CI 0.12-2.6 versus 0; p < 0.0001). Other common adverse events were insomnia and urinary tract infections (IVMP, seven events each) and fatigue or flu symptoms (ACTH, five events each). Conclusions: This study provided class II evidence that ACTH produced better examinerassessed cumulative rates of relapses per patient than IVMP in the adjunctive treatment of breakthrough disease in multiple sclerosis.

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Liver injury after pulsed methylprednisolone therapy in multiple sclerosis patients

Nociti

Biolato

Fino³

et al. 2018

Brain and Behavior

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ObjectivesHigh‐dose pulsed methylprednisolone‐related liver injury cases have been reported in the literature, but a prospective study in patients with multiple sclerosis (MS) has never been performed. The aim of this study was to evaluate the prevalence and severity of liver injury in patients with MS after pulsed methylprednisolone therapy.MethodsWe performed a prospective observational single‐center study on patients with MS treated with i.v. methylprednisolone 1,000 mg/day for 5 days. We tested the liver functionality before and 2 weeks after the treatment. In case of severe liver injury, defined according to “Hy's law,” a comprehensive hepatologic workup was performed.ResultsDuring a 12‐month observation period, we collected data on 251 cycles of i.v. steroid treatment of 175 patients with MS. After excluding eight cycles presenting a basal alteration of the biochemical liver tests, we observed a prevalence of 8.6% of liver injury in MS patients treated with pulsed methylprednisolone for clinical and neuroradiological relapses. In 2.5% of the patients, the liver injury was severe according to Hy's law; after a comprehensive hepatologic workup, three of them received a diagnosis of drug‐induced liver injury and the other three of autoimmune hepatitis.ConclusionsLiver injury after pulsed methylprednisolone therapy in patients with MS is not infrequent, and a close monitoring of aminotransferase level before treatment and 2 weeks later seems advisable.

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Tolerance of intravenous methylprednisolone for relapse treatment in demyelinating CNS disease

Cited by 9 publications

References 19 publications

Clinical experience with repository corticotropin injection in patients with multiple sclerosis experiencing mood changes with intravenous methylprednisolone: a case series

Clinical experience with repository corticotropin injection in patients with multiple sclerosis experiencing mood changes with intravenous methylprednisolone: a case series

Adrenocorticotropic hormone versus methylprednisolone added to interferon β in patients with multiple sclerosis experiencing breakthrough disease: a randomized, rater-blinded trial

Liver injury after pulsed methylprednisolone therapy in multiple sclerosis patients

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