Update on therapy of chronic immune-mediated neuropathies

Briani, Chiara; Cocito, Dario; Campagnolo, Marta; Doneddu, Pietro Emiliano; Nobile‐Orazio, Eduardo

doi:10.1007/s10072-020-04998-y

Cited by 17 publications

(17 citation statements)

References 105 publications

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“…Despite its strong evidence for the treatment of CIDP and the low incidence of side effects, finding the optimal dose of IVIg for individual CIDP patients remains challenging [ 12 , 13 , 14 , 15 ]. Considering the shortage of IVIg we had recently experienced, the high health-care costs of IVIg therapy and, furthermore, the reduced independence of the patients caused by treatment administration settings, an evaluation which patients can be reduced faster and which factors are more likely to lead to a higher IVIg dose is extremely important.…”

Section: Discussionmentioning

confidence: 99%

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Parameters Associated with the Required Drug Dose of Intravenous Immunoglobulin in Stable Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Feyen

Schaub

Zimmermann

et al. 2023

Neurology International

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Background: Intravenous immunoglobulin (IVIg) is efficient and one of very few treatment options for patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). However, finding the optimal dose of IVIg for individual CIDP patients remains challenging. The dose of IVIg needs to be adjusted individually. Considering the high healthcare costs of IVIg therapy, the overtreatment of some patients seen in placebo studies and the shortage of IVIg we recently experienced, as well as identifying factors associated with the required dose of IVIg in maintenance treatment, is extremely important. Thus, in this retrospective study, we analyze characteristics of patients with stable CIDP, which are associated with the required drug dose. Methods: 32 patients with stable CIDP treated with IVIg between July 2021 and July 2022 were identified from our database and included in this retrospective study. Patients’ characteristics were registered, and parameters were identified that were associated with the IVIg dose. Results: Age, cerebrospinal fluid protein elevation, disease duration, delay between symptom onset/diagnosis, Inflammatory Neuropathy Cause and Treatment (INCAT) score, and Medical Research Council Sum Score (MRC SS) were significantly associated with the required drug dose. In addition, an association of age, sex, elevated CSF protein, time interval between symptom onset and diagnosis, and the MRC SS with the required IVIg dose could be demonstrated in the multivariable regression analysis. Conclusions: Our model, which is based on routine parameters that are simple to address in the clinical practice, can be useful in adjusting the IVIg dose in patients with stable CIDP.

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Section: Discussionmentioning

confidence: 99%

“…Although there is strong evidence supporting the use of IVIg in treating CIDP, finding the optimal dose of IVIg for individual CIDP patients remains challenging [ 12 , 13 , 14 , 15 ]. The usual induction treatment is 2 g/kg IVIg in CIDP patients.…”

Section: Introductionmentioning

confidence: 99%

Parameters Associated with the Required Drug Dose of Intravenous Immunoglobulin in Stable Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Feyen

Schaub

Zimmermann

et al. 2023

Neurology International

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“…Eine wichtige Differenzialdiagnose besteht noch in der multifokalen motorischen Neuropathie (MMN), wobei elektrophysiologisch keine pathognomischen Leitungsblöcke vorlagen und die GM1-Antikörper unauffällig blieben 7 .…”

Section: Diskussionunclassified

Klinische Erstmanifestation einer chronischen Hepatitis C bei schmerzloser progredienter atrophischer Monoparese des rechten Beines

Etgen

Winklmaier

2022

Dtsch Med Wochenschr

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Zusammenfassung Anamnese und klinischer Befund Ein 60-jähriger Patient wurde bei einer seit 6 Monaten zunehmenden schmerzlosen Umfangsverminderung der rechten Wade mit leichter Gangstörung eingewiesen. Neurologisch fand sich eine atrophische Monoparese des rechten Unterschenkels mit erhaltenen Muskeleigenreflexen ohne sensible Störungen. Untersuchungen Elektrophysiologisch bzw. neuroradiologisch zeigte nur der rechte M. triceps surae Zeichen einer kombinierten frischen und chronischen Schädigung bzw. eine ausgeprägte Atrophie mit diffusem Muskelödem. Bei erhöhten Leberwerten war bei bisher nicht bekannter positiver Hepatitis-C-Serologie und hoher Hepatitis-C-Viruslast im Serum sogar im Liquor eine Pleozytose mit sehr niedriger Viruslast nachweisbar. Diagnose Es wurde die Diagnose einer Hepatitis-C-assoziierten Mononeuropathie des rechten N. ischiadicus mit Schwerpunktbeteiligung des rechten N. tibialis gestellt. Therapie und Verlauf Nach Therapie mit Sofosbuvir und Velpatasvir trat im Verlauf keine weitere Progredienz der Monoparese mehr auf. Folgerung Eine chronische Hepatitis C kann in seltenen Fällen mit einer schmerzlosen progredienten Monoparese assoziiert sein. Der Stellenwert von Liquor bezüglich der Pathogenese erfordert weitere Studien.

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“…In this context, Novex ® is the first rituximab biosimilar that has gained marketing authorization for all the approved indications of the innovator product by the Argentinean health authority and other middle-income countries based on analytical quality, nonclinical studies, immunogenicity, and adequate safety in adult patients (Milone et al, 2016;Milone et al, 2017). Emerging evidence suggests that the use of the anti-CD20 antibody rituximab as part of the standard-of-care treatment of hematologic conditions, rheumatic and neurologic diseases, and kidney disorders has shown to be effective and safe in adults (Jung et al, 2014;Chauhan and Mehta, 2019;Abboud et al, 2021;Briani et al, 2021;Narayanaswami et al, 2021). In addition, and due to limited available therapeutic alternatives in a variety of difficult-to-treat conditions in pediatrics, such as immune thrombocytopenia, neuromyelitis optica spectrum disorder, and post-transplant lymphoproliferative disorders, rituximab has been extensively evaluated and proven effective supporting its off-label indications.…”

Section: Introductionmentioning

confidence: 99%

Intensive Safety Monitoring of Rituximab (Biosimilar Novex® and the Innovator) in Pediatric Patients With Complex Diseases

et al. 2022

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Although rituximab is widely used off-label for complex pediatric diseases, safety reports are limited. We aimed to report evidence of its use in clinical practice, to describe the incidence of adverse drug reactions (ADR) to rituximab biosimilar Novex® and innovator, and to identify risk factors for the development of ADR in a real-life follow-up cohort of pediatric patients with complex diseases. We conducted a prospective, longitudinal, observational, single-centre study in patients that received rituximab for any complex disease, and as part of an intensive pharmacovigilance program. Demographic, pharmacological, clinical, and drug-related data were collected for all patients. ADR-free survival, including infusion-related reactions (IRR) and delayed ADR (dADR), was estimated using Kaplan-Meier curves. Risk factors were evaluated by multivariable Cox regression models. In total, 77 patients (<19 y.o.) received 187 infusions of rituximab Novex® (n = 155) or innovator rituximab (n = 32) for neurologic (Neu), immune-hematologic-rheumatic (IHR), oncologic (O) diseases, and hematopoietic stem-cell transplantation (HSCT) or solid-organ transplantation (SOT). We recorded 29 IRR and 58 dADR that occurred in 27 (35.1%) and 29 (37.7%) patients, respectively. The respiratory tract was the most affected during IRR (29.6%) and hypogammaglobulinemia (37.9 %) was the most frequent dADR. First versus subsequent infusions (HR 5.4, CI95% 2.4–12.1, p<0.05), sex (boys vs. girls, HR 0.3, CI95% 0.1–0.8, and p<0.05), and diagnosis (Neu-IHR diseases vs. O-HSCT-SOT, HR 2.3, CI95% 1.02–5.4, and p < 0.05) were significantly associated with the development of IRR. For dADR, risk factors were diagnosis (Neu-IHR diseases vs. O-HSCT-SOT, HR 0.4, CI95% 0.2–0.9, and p < 0.05) and cumulative body surface area-normalized dosage (HR 1.0003, CI95% 1.0001–1.0006, and p < 0.05). The present is the largest real-world safety assessment of rituximab in Latin-American children with complex diseases supporting its use based on the overall acceptable safety. Identification of risk factors may contribute to optimization of off-label rituximab treatment in pediatrics.

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Update on therapy of chronic immune-mediated neuropathies

Cited by 17 publications

References 105 publications

Parameters Associated with the Required Drug Dose of Intravenous Immunoglobulin in Stable Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Parameters Associated with the Required Drug Dose of Intravenous Immunoglobulin in Stable Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Klinische Erstmanifestation einer chronischen Hepatitis C bei schmerzloser progredienter atrophischer Monoparese des rechten Beines

Intensive Safety Monitoring of Rituximab (Biosimilar Novex® and the Innovator) in Pediatric Patients With Complex Diseases

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