Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years.
Mult Scler
; 28(10): 1576-1590, 2022 09.
Article
in English
| MEDLINE | ID: covidwho-1997275
ABSTRACT
BACKGROUND:
Ofatumumab is approved for the treatment of relapsing multiple sclerosis (RMS). Ongoing safety reporting is crucial to understand its long-term benefit-risk profile.OBJECTIVE:
Report the safety and tolerability of ofatumumab in RMS after extended treatment up to 3.5 years.METHODS:
Patients completing ASCLEPIOS I/II (phase 3), APLIOS, or APOLITOS (phase 2) trials could enter ALITHIOS, a phase 3b, open-label, long-term safety study. We analyzed cumulative data of continuous ofatumumab treatment and of patients newly switched from teriflunomide.RESULTS:
The safety population had 1969 patients 1292 continuously treated with ofatumumab (median time-at-risk 35.5 months, 3253 patient-years) and 677 newly switched (median time-at-risk 18.3 months, 986 patient-years). A total of 1650 patients (83.8%) had ⩾1 adverse events and 191 (9.7%) had ⩾1 serious adverse events. No opportunistic infections or progressive multifocal leukoencephalopathy events were identified; the risk of malignancies was low. Mean serum immunoglobulin (Ig) G levels remained stable. Mean IgM levels decreased but remained above the lower limit of normal in most. Serious infection incidence was low; decreased Ig levels were not associated with serious infections.CONCLUSION:
In patients with up to 3.5 years' exposure, ofatumumab was well tolerated, with no new safety risks identified. These findings, with its established effectiveness, support a favorable benefit-risk profile of ofatumumab in RMS.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Multiple Sclerosis, Relapsing-Remitting
/
Multiple Sclerosis
Type of study:
Observational study
/
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Language:
English
Journal:
Mult Scler
Journal subject:
Neurology
Year:
2022
Document Type:
Article
Affiliation country:
13524585221079731
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