Efficacy of pulse intravenous methylprednisolone in epileptic encephalopathy: a randomised controlled trial

Rangarajan, Anush; Mundlamuri, Ravindranadh Chowdary; Kenchaiah, Raghavendra; Prathyusha, Parthipulli Vasuki; Viswanathan, Lakshminarayanapuram Gopal; Asranna, Ajay; Chatterjee, Aparajita; Nagappa, Madhu; Seshagiri, Doniparthi V; Kulanthaivelu, Karthik; Bharath, Rose Dawn; Saini, Jitender; Thennarasu, Kandavel; Sinha, Sanjib

doi:10.1136/jnnp-2022-329027

Cited by 4 publications

(11 citation statements)

References 18 publications

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“…The first‐ever published randomized cross‐over study with only four of five patients treated failed to meet our inclusion criteria 58 . However, we identified one recently published, prospective, randomized, open‐label parallel study comparing intravenous methylprednisolone (ivMP) with ongoing ASM treatment (Rangarajan, 2022) 20 . A second prospective, open‐label parallel trial compared oral hydrocortisone to deflazacort with alternating allocation 21 .…”

Section: Resultsmentioning

confidence: 99%

“…Low (green) – moderate (yellow) – serious (orange) – critical (red): estimated risk of bias as compared to a theoretical prospective randomized study on the same intervention (following ROBINS‐I). The only randomized controlled trial 20 was assessed with the ROB‐2 tool 5,20‐57 …”

Section: Resultsmentioning

confidence: 99%

“…58 However, we identified one recently published, prospective, randomized, open-label parallel study comparing intravenous methylprednisolone (ivMP) with ongoing ASM treatment (Rangarajan, 2022). 20 A second prospective, open-label parallel trial compared oral hydrocortisone to deflazacort with alternating allocation. 21 Another five studies prospectively enrolled patients in single-arm, open-label single-center trials [22][23][24][25] (Qian 2016).…”

Section: Methodsmentioning

confidence: 99%

“…Only six studies reported systematic MRI examinations in all included patients. 20,21,23,26,27,28 Although more than half of the studies classified a symptomatic etiology in their patients further as perinatal, malformative, or postinfectious, nine studies merely distinguished "symptomatic" from idiopathic or cryptogenic, and six did not report an etiology at all. These basic features were addressed in most reports; however, potentially important intercurrent variables such as non-ASM co-medications, acute illness, or adherence to treatment were rarely mentioned in the retrospective series.…”

Section: Confounding Variablesmentioning

confidence: 99%

“…A recently published randomized-controlled study compared pulsed treatment with ivMP with standard ASM. 20 After the screening of 100, a total of 91 children meeting the inclusion criteria entered the study. Central nervous system (CNS) imaging, short-term EEG including a nap, and Vineland Social Maturity Scale (VSMS) as a developmental test were performed in all.…”

Section: Description Of Selected Prospective Controlled Trialsmentioning

confidence: 99%

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Efficacy and safety of corticosteroids and ACTH in epileptic syndromes beyond Infantile Epileptic Spasms Syndrome (IESS): A systematic review and meta‐analysis

Korinthenberg,

Bast,

Haberlandt

et al. 2024

Epilepsia

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We conducted a systematic review investigating the efficacy and tolerability of adrenocorticotropic hormone (ACTH) and corticosteroids in children with epilepsies other than infantile epileptic spasm syndrome (IESS) that are resistant to anti‐seizure medication (ASM). We included retrospective and prospective studies reporting on more than five patients and with clear case definitions and descriptions of treatment and outcome measures. We searched multiple databases and registries, and we assessed the risk of bias in the selected studies using a questionnaire based on published templates. Results were summarized with meta‐analyses that pooled logit‐transformed proportions or rates. Subgroup analyses and univariable and multivariable meta‐regressions were performed to examine the influence of covariates. We included 38 studies (2 controlled and 5 uncontrolled prospective; 31 retrospective) involving 1152 patients. Meta‐analysis of aggregate data for the primary outcomes of seizure response and reduction of electroencephalography (EEG) spikes at the end of treatment yielded pooled proportions (PPs) of 0.60 (95% confidence interval [CI] 0.52–0.67) and 0.56 (95% CI 0.43–0.68). The relapse rate was high (PP 0.33, 95% CI 0.27–0.40). Group analyses and meta‐regression showed a small benefit of ACTH and no difference between all other corticosteroids, a slightly better effect in electric status epilepticus in slow sleep (ESES) and a weaker effect in patients with cognitive impairment and “symptomatic” etiology. Obesity and Cushing's syndrome were the most common adverse effects, occurring more frequently in trials addressing continuous ACTH (PP 0.73, 95% CI 0.48–0.89) or corticosteroids (PP 0.72, 95% CI 0.54–0.85) than intermittent intravenous or oral corticosteroid administration (PP 0.05, 95% CI 0.02–0.10). The validity of these results is limited by the high risk of bias in most included studies and large heterogeneity among study results. This report was registered under International Prospective Register of Systematic Reviews (PROSPERO) number CRD42022313846. We received no financial support.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Confounding Variablesmentioning

confidence: 99%

Section: Description Of Selected Prospective Controlled Trialsmentioning

confidence: 99%

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Efficacy and safety of corticosteroids and ACTH in epileptic syndromes beyond Infantile Epileptic Spasms Syndrome (IESS): A systematic review and meta‐analysis

Korinthenberg,

Bast,

Haberlandt

et al. 2024

Epilepsia

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Kortikosteroide und adrenocorticotropes Hormon bei Epilepsien der frühen Kindheit jenseits des Säuglingsalters

Korinthenberg,

Bast,

Haberlandt

et al. 2024

Clin Epileptol

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ZusammenfassungIn diesem Bericht fassen wir die Ergebnisse eines systematischen Reviews (SR) zusammen, in dem Daten zur Wirksamkeit und Verträglichkeit von ACTH (adrenocorticotropes Hormon) und Kortikosteroiden (KST) bei Kindern mit anderen Epilepsien als dem infantilen epileptischen Spasmussyndrom (IESS) ausgewertet wurden, die auf Anfallssuppressiva (ASM) nicht angesprochen hatten. Der SR umfasste retrospektive und prospektive Studien, die über mehr als 5 Patienten berichteten und klare Falldefinitionen sowie Beschreibungen der Behandlung und der Ergebnisse enthielten. Achtunddreißig (2 kontrollierte und 5 unkontrollierte prospektive, 31 retrospektive) Studien mit 1152 Patienten wurden eingeschlossen. Die Metaanalyse der aggregierten Daten zur Anfallsreduktion > 50 % und zur Verringerung der EEG(Elektroenzephalogramm)-Spikes am Ende der Initialbehandlung ergab gepoolte Raten (PR) von 0,60 (95 %-KI [Konfidenzintervall] 0,52–0,67) und 0,56 (95 %-KI 0,43–0,68). Die Rückfallquote war hoch (PR 0,33, 95 %-KI 0,27–0,40). Subgruppenanalysen und eine Metaregression zeigten keinen signifikanten Unterschied zwischen den eingesetzten Substanzen, eine etwas bessere Wirkung bei entwicklungsbedingter und/oder epileptischer Enzephalopathie mit Spike-and-Wave-Aktivierung im Schlaf (DEE-SWAS) und eine schwächere Wirkung bei Patienten mit kognitiver Beeinträchtigung und „symptomatischer“ Ätiologie. Die Höhe der kumulativen Dosis der initialen Behandlungsphase hatte keinen Einfluss auf die Behandlungsergebnisse. Adipositas und Cushing-Syndrom waren die häufigsten unerwünschten Wirkungen, die oft in Studien mit kontinuierlicher ACTH- (PR 0,73, 95 %-KI 0,48–0,89) oder KST-Gabe (PR 0,72, 95 %-KI 0,54–0,85), aber selten bei intermittierender intravenöser oder oraler KST-Gabe (PR 0,05, 95 %-KI 0,02–0,10) auftraten. Die Aussagekraft dieser Ergebnisse wird durch ein hohes Verzerrungsrisiko der meisten eingeschlossenen Studien und eine große Heterogenität zwischen den Studiendaten eingeschränkt. Der volle SR wurde unter https://doi.org/10.1111/epi.17918 publiziert.

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Efficacy and Safety of Pulse Intravenous Methylprednisolone in Pediatric Epileptic Encephalopathies: Timing and Networks Consideration

Russo,

Mazzone,

Landolina

et al. 2024

Preprint

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Background: epileptic encephalopathies (EE) are characterized by severe drug-resistant seizures, early-onset, and unfavorable developmental outcome. We describe a cohort of pediatric patients with EE who underwent intravenous methylprednisolone (IVMP) pulse therapy to examine its efficacy/tolerability. Methods: This is a retrospective study from 2020 to 2023. Inclusion criteria were: ≤18 years at the time of IVMP pulse therapy and at least 6 months of follow-up. Efficacy and outcome, defined as seizure reduction >50% (responder rate), were evaluated at 6 and 9 months of therapy, and 6 months after therapy suspension; quality of Life (QoL) was also assessed. Variables predicting positive post-IVMP outcomes were identified using statistical analysis. Results: Twenty-one patients were included. The responding rate was 85.7% at 6 and 9 months of therapy, and 80.9% at 6 months after therapy suspension. Genetic etiology and encephalopathy related to status epilepticus during NREM sleep (ESES) were predictive of efficacy (p=0.0475). The fourth month of therapy was the minimum time point to establish the effectiveness of the treatment. All patients showed improvements in QoL, EEG tracing and postural-motor development. No relevant adverse events were observed. Conclusions: Our study confirms the efficacy and tolerability of pulse IVMP treatment in pediatric patients with EE, especially with genetic etiology and ESES. The fourth month of therapy was the minimum time point to establish its effectiveness. QoL, EEG and postural-motor development also showed improvement.

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Efficacy of pulse intravenous methylprednisolone in epileptic encephalopathy: a randomised controlled trial

Cited by 4 publications

References 18 publications

Efficacy and safety of corticosteroids and ACTH in epileptic syndromes beyond Infantile Epileptic Spasms Syndrome (IESS): A systematic review and meta‐analysis

Efficacy and safety of corticosteroids and ACTH in epileptic syndromes beyond Infantile Epileptic Spasms Syndrome (IESS): A systematic review and meta‐analysis

Kortikosteroide und adrenocorticotropes Hormon bei Epilepsien der frühen Kindheit jenseits des Säuglingsalters

Efficacy and Safety of Pulse Intravenous Methylprednisolone in Pediatric Epileptic Encephalopathies: Timing and Networks Consideration

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