Long-Term Safety of Teriflunomide in Multiple Sclerosis Patients: Results of Prospective Comparative Studies in Three European Countries.
Pharmacoepidemiol Drug Saf
; 33(7): e5866, 2024 Jul.
Article
in En
| MEDLINE
| ID: mdl-39013832
ABSTRACT
BACKGROUND AND OBJECTIVES:
Teriflunomide is a disease-modifying therapy (DMT) for multiple sclerosis (MS). This post authorisation safety study assessed risks of adverse events of special interest (AESI) associated with teriflunomide use.METHODS:
Secondary use of individual data from the Danish MS Registry (DMSR), the French National Health Data System (SNDS), the Belgian national database of health care claims (AIM-IMA) and the Belgian Treatments in MS Registry (Beltrims). We included patients treated with a DMT at the date of teriflunomide reimbursement or initiating another DMT. Adjusted hazard rates (aHR) and 95% confidence intervals were derived from Cox models with time-dependent exposure comparing teriflunomide treatment with another DMT.RESULTS:
Of 81 620 patients (72% women) included in the cohort, 22 324 (27%) were treated with teriflunomide. After a median follow-up of 4 years, teriflunomide use compared to other DMT was not associated with a risk of all-cause mortality, severe infection, pneumoniae, herpes zoster reactivation, pancreatitis, cardiovascular condition and cancers. For opportunistic infections, aHR for teriflunomide versus other DMT was 2.4 (1.2-4.8) in SNDS, which was not bound to a particular opportunistic agent. The aHR was 2.0 (1.1-3.7) for renal failures in the SNDS, but no association was found in other data sources. A total of 187 SNDS patients had a history of renal failure prior to cohort entry. None of these patients (0%) had a renal failure recurrence when treated with teriflunomide for 19 (13%) recurrences reported for patients on another DMT.DISCUSSION:
We found no evidence that teriflunomide use would be associated with an increased risk of AESI. Trial Registration EUPAS register EU PAS 19610.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Toluidines
/
Crotonates
/
Hydroxybutyrates
/
Multiple Sclerosis
/
Nitriles
Limits:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Country/Region as subject:
Europa
Language:
En
Journal:
Pharmacoepidemiol Drug Saf
Journal subject:
EPIDEMIOLOGIA
/
TERAPIA POR MEDICAMENTOS
Year:
2024
Document type:
Article
Affiliation country:
Denmark
Country of publication:
United kingdom