Additional FORWARD data support sprifermin as a disease-modifying osteoarthritis drug
medwireNews: Sprifermin, also known as recombinant human fibroblast growth factor 18, increases cartilage thickness and reduces cartilage loss in patients with knee osteoarthritis (OA) independent of location in the femorotibial joint, shows a post-hoc analysis of the FORWARD study.
Primary data from the phase 2 trial showed that treatment with intra-articular sprifermin modified cartilage in the total femorotibial joint (TFTJ), medial and lateral femorotibial joints, and central medial and lateral TFTJ subregions in a dose-dependent manner.
However, Felix Eckstein (Paracelsus Medical University, Salzburg, Austria) and co-investigators note that “region-specific analysis cannot elucidate whether cartilage loss is reduced, wherever it occurs in an individual joint.”
They therefore performed a location-independent analysis of the magnetic resonance imaging data to “provide a more sensitive and informative analysis of cartilage loss and thickening independent of the location where it occurs.”
For the study, 434 patients aged 40–85 years with symptomatic knee OA were randomly assigned to receive three once-weekly intra-articular injections of sprifermin at a dose of 30 µg every 6 months (n=83), 30 µg every 12 months (n=92), 100 µg every 6 months (n=86), or 100 µg every 12 months (n=90), while the remaining 83 patients received placebo.
At 24 months, the researchers found that the participants who received sprifermin had, on average, less cartilage thinning than those who received placebo, regardless of dose, although only significantly so for sprifermin 100 µg every 6 months, at –432 µm versus –766 µm, giving a mean difference of 334 µm.
In addition, cartilage thickening was significantly greater with sprifermin 100 µg every 6 months, 100 µg every 12 months, and 30 µg every 6 months than with placebo, at a mean of 856 µM, 881 µM, and 571 µm, respectively, versus 431 µm, and corresponding mean differences of 425 µm, 450 µm, and 139 µm.
Eckstein and co-authors report in the Annals of the Rheumatic Diseases that, when compared with healthy participants of the Osteoarthritis Initiative, the patients who received sprifermin 100 µg every 6 months had a similar amount of cartilage thinning (–432 vs –355 µm, respectively) and more than double the amount of thickening (856 vs 356 µm) at 24 months.
This finding provides “strong support for substantial cartilage modification by sprifermin,” they say.
The authors also point out that there are no disease- (or structure-) modifying osteoarthritis drugs (DMOADs) currently approved for use in Europe or the USA.
They therefore conclude: “Primary results from the FORWARD study combined with findings from this post-hoc analysis suggest that sprifermin should be evaluated further in clinical trials as a potential DMOAD therapy for knee osteoarthritis that can substantially reduce cartilage loss.”
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