Favourable additional safety data for ofatumumab

After up to 4 years of treatment, ofatumumab was still well tolerated in patients with relapsing multiple sclerosis (RMS); no new safety issues were identified. This was concluded from updated results of the ongoing, open-label, umbrella extension ALITHIOS trial.

Ofatumumab is a fully-human, anti-CD20 monoclonal antibody developed for the treatment of adult RMS patients; the 20 mg dose is self-administered subcutaneously once a month [1]. Ofatumumab treatment up to 30 months was previously shown to have a favourable safety profile and to be generally well tolerated [2].

Cumulative data for up to 4 years of ofatumumab treatment were presented by Prof. Stephen Hauser (University of California, CA, USA) [3,4]. Patients had completed the core ASCLEPIOS I/II (NCT02792218, NCT02792231), APOLITOS (NCT03249714), or APLIOS (NCT03560739) clinical trial, after which they could continue ofatumumab treatment by entering the ALITHIOS trial (NCT03650114), regardless of treatment received in the core trial. At data cut-off, the overall study population counted 1,969 patients. Of these, 1,292 had received ofatumumab from the start, while 677 switched from teriflunomide to ofatumumab in the extension.

Adverse events (AEs) were registered in percentages and as exposure-adjusted incidence rate (EAIR). The results showed that 83.8% of patients had ≥1 AEs (EAIR 148.7) and 9.7% had ≥1 serious AEs (EAIR 4.8). Low incidence of serious infections (2.9%; EAIR 1.4) and malignancies (0.6%; EAIR 0.3) were detected. No association was found between IgG/IgM antibody levels and the risk of a serious infection: Levels of IgG were stable, while IgM decreased, but remained within normal ranges. Prof. Hauser concluded: “This additional safety data helps to confirm ofatumumab’s longer-term safety profile and provides further confidence to the MS community.”

Prof. Hauser also presented long-term efficacy data of ofatumumab in 1,214 patients [5]. Annualised relapse rate (ARR) remained low. Comparing both groups revealed 43.4% less relapses over 4 years in the group that had used ofatumumab from the start (see Figure). In this group there was also a reduced risk of 3-month (21.1%) and 6-month (19.6%) confirmed disability worsening and less disease activity, compared with the group that switched therapies.

Figure: Within-group and between-group comparisons of long-term ofatumumab efficacy [1]



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

AAR, annualised relapse rate; TER, teriflunomide; OMB, ofatumumab; TER-OMB, switch from teriflunomide to ofatumumab; OMB-OMB, continuous ofatumumab.

1. Kang C & Blair HA. Drugs. 2022;82(1):55‒62.


2. Hauser SL, et al. N Engl J Med. 2020;383(6):546‒557.


3. Hauser SL, et al. Long-term safety of ofatumumab in patients with relapsing multiple sclerosis. S14.004, AAN 2022, 02–07 April, Seattle, USA.


4. Hauser SL, et al. Mult Scler. Mar 1, 2022. DOI: 10.1177/13524585221079731.


5. Hauser SL, et al. Long-term efficacy of ofatumumab in patients with relapsing multiple sclerosis. P5.004, AAN 2022, 02–07 April, Seattle, USA.

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Posted on 2 June, 202213 June, 2022