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Home > Other safety-related topics > Tolerability

Tolerability

Compliance in ASCLEPIOS I/II (core) and ALITHIOS (extension) studies

5_OFA_Compliance in ASCLEPIOS and_ALITHIOS_extension_studie_v2.jpg

 

Compliance and Persistence to  Ofatumumab Treatment in Patients With Relapsing Multiple Sclerosis in Clinical Trials for Up to 4 years (25-Sep-2021) 

Alvarez E, et al. AAN 2023.

 
  • Compliance was high in ASCLEPIOS I/II and remained high over the long term in ALITHIOS for the overall, continuous OMB and newly switched subgroups
    • The proportion of patients compliant with OMB therapy was 94.9% (1868/1969) in the overall group, 95.1% (1229/1292) in the continuous OMB group, and 94.4% (639/677) in the newly switched group and was comparable to the core ASCLEPIOS I/II studies (98.8%)
On-treatment period includes days from the first injection date until 30 days after the last injection date
*≥80% was defined as the threshold indicating a patient was compliant
n, number of patients; N, the number of patients entering the core ASCLEPIOS I/II trial and open-label ALITHIOS extension trial respectively; OMB, ofatumumab;
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Persistence in ASCLEPIOS I/II (core) and ALITHIOS (extension) studies*

6_OFA_Persistence in ASCLEPIOS I_II core and ALITHIOS extension studies_v2.jpg

 

Compliance and Persistence to  Ofatumumab Treatment in Patients With Relapsing Multiple Sclerosis in Clinical Trials for Up to 4 years.

Alvarez E, et al. AAN 2023.

 
  • Persistence with OMB therapy remained high over the long term
    • In the core ASCLEPIOS I/II studies, 82.9% of patients (784/946) randomised to OMB completed the study on treatment for up to 30 months
    • In the ongoing ALITHIOS studies, 88.5% of patients (1508/1703) remained on treatment at the time of the data cutoff (25th-September-2021)
*Due to study duration differences between the ASCLEPIOS I/II (up to 30 months), APLIOS (12 weeks) and APOLITOS (24 weeks) core studies, persistence was calculated for the pooled ASCLEPIOS I/II core studies only. In addition, patients who successfully completed the core studies could opt not to continue onto the extension study. Therefore, persistence calculations were restricted to each study epoch to ensure patients who were persistent in the core studies but did not enter the extension did not confound persistence in the overall population analysis; ǂ One patient who completed OMB but had an end-of-study status as discontinued was not counted. †Persistence in patients randomised to OMB in the core study; ††Persistence in patients entering ALITHIOS up to the cut-off date of 25th-September-2021
OMB, ofatumumab.
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