Title :

Expert Narrative Review of the Safety of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis

Author(s) :

Clavelou, Pierre [Auteur]
Service Neurologie [CHU Clermont-Ferrand]
Castelnovo, Giovanni [Auteur]
Service de Neurologie [CHU Nimes] [Pôle NIRR]
Pourcher, Valérie [Auteur]
Institut Pierre Louis d'Epidémiologie et de Santé Publique [iPLESP]
De Sèze, Jérôme [Auteur]
Service de Neurologie [Strasbourg]
Vermersch, Patrick [Auteur]
Lille Neurosciences & Cognition (LilNCog) - U 1172
Ben-Amor, Ali-Frederic [Auteur]
Savarin, Carine [Auteur]
Defer, Gilles [Auteur]
Service de Neurologie [CHU Caen]

Journal title :

Neurology and Therapy

Volume number :

12

Pages :

1457–1476

Publisher :

Springer Healthcare

Publication date :

2023-06-29

ISSN :

2193-8253

English keyword(s) :

Multiple sclerosis
Cladribine tablets
Disease-modifying therapy
Immune reconstitution therapy
Drug safety

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Cladribine tablets (CladT) is a highly active oral disease-modifying therapy (DMT) for the management of relapsing multiple sclerosis (RMS). CladT acts as an immune reconstitution therapy, in that two short courses of ...
Show more >Cladribine tablets (CladT) is a highly active oral disease-modifying therapy (DMT) for the management of relapsing multiple sclerosis (RMS). CladT acts as an immune reconstitution therapy, in that two short courses of treatment 1 year apart have been shown to suppress disease activity for a prolonged period in most patients, without need for continued DMT. Each course of CladT induces a profound reduction in B lymphocytes that recovers over months, and serious lymphopenia (Grade 3–4) is uncommon. Smaller reductions in levels of T lymphocytes occur slightly later: on average, these remain within the normal range and repopulate progressively. A larger effect occurs on CD8 vs. CD4 cells. Reactivation of latent or opportunistic infections (e.g. varicella zoster, tuberculosis) is mostly associated with very low lymphocyte counts (< 200/mm3). Screening and managing pre-existing infections, vaccinating non-exposed patients and delaying the 2nd year of treatment with CladT to allow lymphocytes to recover to > 800/mm3 (if necessary) are important for avoiding infections and higher-grade lymphopenia. There was no demonstrable or apparent effect of CladT on the efficacy of vaccinations, including against Covid-19. Adverse events consistent with drug-induced liver injury (DILI) represent a rare but potentially serious complication of CladT therapy in spontaneous adverse event reporting; patients should be screened for liver dysfunction before starting treatment. Ongoing hepatic monitoring is not required, but CladT must be withdrawn if signs and symptoms of DILI develop. There was a numerical imbalance for malignancies when comparing cladribine to placebo in the clinical programme, particularly in short-term data, but recent evidence shows that the risk of malignancy with CladT is similar to the background rate in the general population and to that with other DMTs. Overall, CladT is well tolerated with a favorable safety profile appropriate for the management of RMS.Show less >

Language :

Anglais

Peer reviewed article :

Oui

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Lille Neurosciences & Cognition (LilNCog) - U 1172

Research team(s) :

Neuroinflammation & Multiple Sclerosis (NEMESIS)

Submission date :

2024-01-15T22:44:09Z
2024-11-22T15:44:29Z