Thalamic volume ( TV ) change is a measure of disease progression in relapsing multiple sclerosis ( RMS ); the relationship between thalamic volume and quality of life ( QOL ) has not been well characterized.
In phase 3 RADIANCE, the sphingosine 1-phosphate receptor modulator Ozanimod ( Zeposia ) has reduced annualized relapse rate, magnetic resonance imaging disease activity, and rate of brain volume loss, including thalamic volume loss, compared with Interferon beta-1a ( IFN ) in patients with relapsing multiple sclerosis.
The objective of the trial was to explore the relationship between QOL and baseline thalamic volume quartile in patients treated with Ozanimod HCl 1 mg versus Interferon beta-1a in RADIANCE.
In the randomized, double-blind, RADIANCE study, RMS patients received oral Ozanimod HCl 1 or 0.5 mg/die or intramuscular Interferon beta-1a 30 microg/week for 24 months.
In this post hoc exploratory analysis, patients were stratified by median baseline thalamic volume quartile.
Changes from baseline to month 24 in Multiple Sclerosis QOL ( MSQOL )-54 measures ( overall QOL, Physical and Mental Health Composite [ PHC and MHC ] summary scores and Physical Function [ PF ] ) were reported in patients treated with Ozanimod HCl 1 mg or Interferon beta-1a with the smallest ( Q1 ) and largest ( Q4 ) baseline thalamic volume using descriptive statistics.
Baseline thalamic volume data were available for 1310 patients; mean thalamic volume in Q1 was 12.8 cm3 ( n=294 ) and in Q4 was 17.7 cm3 ( n=358 ).
Patients in Q1 vs Q4 were older ( mean age 38.1 vs 33.1 year ) and had lower overall QOL scores at baseline ( mean 65.4 vs 71.8 ).
At month 24, overall QOL scores improved from baseline with Ozanimod ( mean change, 0.30 and 0.36 in Q1 and Q4, respectively ), worsened with Interferon beta-1a in those with the smallest ( Q1 ) baseline thalamic volume ( -2.61 ), and improved with Interferon beta-1a in those with the largest ( Q4 ) baseline thalamic volume ( 0.62 ).
Physical scores ( PHC and PF ) in the Ozanimod group showed greater improvements from baseline in Q4; in the Interferon beta-1a group, decreases from baseline were greatest in those in Q1.
For both treatment groups, decreases in MHC summary scores were greater for Q1 vs Q4.
In conclusion, after 24 months of treatment with Ozanimod or Interferon beta-1a, RMS patients with smaller baseline thalamic volume generally had worse QOL outcomes than those with larger baseline thalamic volume.
In this exploratory analysis, Ozanimod had a beneficial impact on more QOL measures than Interferon beta-1a, particularly in those with the smallest baseline thalamic volume. ( Xagena )
Source: ACTRIMS ( Americas Committee for Treatment and Research in Multiple Sclerosis ) Forum 2020