Filgotinib shows consistent efficacy in rheumatoid arthritis, regardless of BMI changes
The rheumatoid arthritis (RA) medication filgotinib demonstrated consistent efficacy across various body mass index (BMI) ranges, according to a study that found that changes in BMI were minimal for most patients, and these variations did not significantly impact the effectiveness of filgotinib.
However, it was noted that with higher doses of filgotinib, there was an increased risk of certain serious adverse events associated with higher BMI levels.
A recent post hoc analysis of the Phase 3 rheumatoid arthritis (RA) filgotinib clinical trial program included 3452 patients with RA, and assessed BMI changes over time, alongside key efficacy measures including American College of Rheumatology (ACR) 20/50/70 responses and disease activity levels based on Disease Activity Score 28 using C-reactive protein.
The mean change in BMI from baseline was consistent across all treatment arms. Most patients experienced modest BMI increases of 1-2 kg/m2 at both the 12 and 24-week marks, irrespective of their assigned treatment or initial BMI levels. Only a minority of patients demonstrated significant increases of 4 kg/m2 or more.
The study found that for most efficacy measures, the higher dose of filgotinib (200 mg) exhibited greater efficacy compared to the lower dose (100 mg) and other active comparators or placebos, regardless of BMI subgroup. However, it was observed that with the higher filgotinib dose, there was an increase in the exposure-adjusted incident rate of serious treatment-emergent adverse events, specifically venous thrombotic and embolic events, and major adverse cardiovascular events with higher BMI levels.
Balsa A, Wassenberg S, Tanaka Y, et al. Effect of Filgotinib on Body Mass Index (BMI) and Effect of Baseline BMI on the Efficacy and Safety of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023;doi: 10.1007/s40744-023-00599-1. Epub ahead of print. PMID: 37747626.