Autoimmune glomerulonephritis in a multiple sclerosis patient after cladribine treatment

Schönfelder, Kristina; Schuh, Helene; Pfister, Frederick; Krämer, Julia; Eisenberger, Ute; Škuljec, Jelena; Hackert, Jana; Ruck, Tobias; Pfeuffer, Steffen; Fleischer, Michael; Gäckler, Anja; Hagenacker, Tim; Kribben, Andreas; Meuth, Sven G.; Kleinschnitz, Christoph; Pul, Refik

doi:10.1177/13524585211022719

Cited by 6 publications

(3 citation statements)

References 13 publications

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“…Since no other explanatory triggers were identified, the authors hypothesized that these AE are autoimmune complications related to CLAD therapy [31]. Another possible secondary autoimmune AE following treatment with CLAD is a case of histologically proven antibody-mediated glomerulonephritis (44year-old woman) [33]. Shortly after the fourth CLAD cycle, she developed renal failure and subsequently hemolysis and thrombocytopenia.…”

Section: Real-world Evidence For Safetymentioning

confidence: 99%

Real-world evidence for cladribine tablets in multiple sclerosis: further insights into efficacy and safety

Moser

Ziemssen

Sellner

2022

Wien Med Wochenschr

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SummaryCladribine (CLAD) is a purine nucleoside analog approved in tablet form to treat highly active multiple sclerosis (MS). CLAD tablets are the first oral therapy with an infrequent dosing schedule, administered in two annual treatment courses, each divided into two treatment cycles comprising 4–5 days of treatment. The efficacy and safety of CLAD tablets have been verified in randomized controlled clinical trials. Clinical observational studies are performed in more representative populations and over more extended periods, and thus provide valuable complementary insights. Here, we summarize the available evidence for CLAD tablets from post-marketing trials, including two observational, four long-term extensions, and two comparative studies. The patients in the post-marketing setting differed from the cohort recruited in the pivotal phase III trials regarding demographics and MS-related disability. The limited number of studies with small cohorts corroborate the disease-modifying capacity of oral CLAD and report on a durable benefit after active treatment periods. Skin-related adverse events were common in the studies focusing on safety aspects. In addition, single cases of CLAD-associated autoimmune events have been reported. Lastly, CLAD tablets appear safe regarding COVID-19 concerns, and patients mount a robust humoral immune response to SARS-CoV‑2 vaccination. We conclude that the current real-world evidence for CLAD tablets as immune reconstitution therapy for treatment of MS is based on a small number of studies and a population distinct from the cohorts randomized in the pivotal phase III trials. Further research should advance the understanding of long-term disease control after active treatment periods and the mitigation of adverse events.

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Section: Real-world Evidence For Safetymentioning

confidence: 99%

Real-world evidence for cladribine tablets in multiple sclerosis: further insights into efficacy and safety

Moser

Ziemssen

Sellner

2022

Wien Med Wochenschr

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“…In line with this finding, the CLARITY and ORACLE studies reported increases in ALT more frequently than increases in AST. Moreover, in the literature, there are mentioned cases of MS patients treated with cladribine who have increased GGT (gamma-glutamyl transferase) after treatment [ 5 ]. However, in phase III trials, it was noticed that abnormal liver function tests were uncommon.…”

Section: Discussionmentioning

confidence: 99%

“…Among the disease-modifying therapies (DMTs) authorized for the treatment of MS, cladribine was approved in 2017 [ 3 ]. The drug is approved for the treatment of relapsing multiple sclerosis (RMS), secondary progressive MS (SPMS) and relapsing–remitting multiple sclerosis (RRMS) in adult patients [ 4 , 5 ]. Cladribine is an anti-pyrimidine and anti-metabolite agent [ 6 ] that is biologically active in selected cell types.…”

Section: Introductionmentioning

confidence: 99%

Hepatobiliary Adverse Reactions during Treatment with Cladribine: Analysis of Data from the European Spontaneous Reporting System

Velișcu,

Liguori,

Anatriello

et al. 2023

Pharmaceuticals

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Background. Cladribine belongs to the group of disease-modifying therapies (DMTs) used to treat multiple sclerosis (MS). According to the highlights of a meeting held by the Pharmacovigilance Risk Assessment Committee (PRAC) on 14 January 2022, cladribine may be associated with the occurrence of liver injury, and thus liver function monitoring is recommended. Objectives and methods. Using data from the European spontaneous reporting database (EudraVigilance-EV), we aimed to describe the main characteristics of Individual Case Safety Reports (ICSRs) reporting cases of hepatobiliary disorders related to cladribine. The reporting odds ratio (ROR) was calculated to provide the probability of reporting hepatobiliary ICSRs among DMTs used to treat MS. Results. Overall, 118 ICSRs described the occurrence of cladribine-induced hepatobiliary ADRs. The majority of the ICSRs reported ADRs that were classified as serious (93%), and the outcome was mostly reported as “unknown” (50.8%). The most reported hepatobiliary disorders were drug-induced liver injury, abnormal hepatic function, ALT increases, liver disorders, hepatic failure, jaundice, lymphocyte count decreases, hepatotoxicity and hypertransaminasemia. The majority of cladribine-induced hepatic ADRs occurred in female patients belonging to the age group of 18–65 years. Conclusion. Considering the seriousness of cladribine-induced hepatic ADRs, a close monitoring of patients receiving this drug is highly recommended. In this context, further pharmacovigilance studies evaluating the hepatic safety profile of cladribine are strongly needed.

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Multiple Sclerosis: Switching from Natalizumab to Other High-Efficacy Treatments to Mitigate Progressive Multifocal Leukoencephalopathy Risk

et al. 2021

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Autoimmune glomerulonephritis in a multiple sclerosis patient after cladribine treatment

Cited by 6 publications

References 13 publications

Real-world evidence for cladribine tablets in multiple sclerosis: further insights into efficacy and safety

Real-world evidence for cladribine tablets in multiple sclerosis: further insights into efficacy and safety

Hepatobiliary Adverse Reactions during Treatment with Cladribine: Analysis of Data from the European Spontaneous Reporting System

Multiple Sclerosis: Switching from Natalizumab to Other High-Efficacy Treatments to Mitigate Progressive Multifocal Leukoencephalopathy Risk

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