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Sprifermin shows dose, treatment effects in knee OA at 3 years
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LIVERPOOL, England — Novel recombinant human fibroblast growth factor-18 sprifermin was associated with ongoing treatment effect at 3 years in individuals with knee OA, according to findings presented here.
Marc C. Hochberg, MD, MPH, division head of Rheumatology and Clinical Immunology, vice chair of the Department of Medicine, University of Maryland School of Medicine, presented findings of a pre-specified analysis, which was conducted 18 months after the last injection of the drug.
The primary endpoint of the study was the change from baseline in tibiofemoral joint cartilage thickness as assessed by quantitative MRI at 3 years.
Treatment regimens included 100 micrograms of sprifermin (Merck, Nordic Biosciences) every 6 months, 100 mcg every 12 months, 30 mcg every 6 months, and 30 mcg every 12 months. Participants underwent MRI at 6, 12, 18, 24 and 36 months, and X-ray at 12, 24 and 36 months.
Compared with placebo, the 100-mcg dose given either every 6 or 12 months yielded a significant treatment effect (P < .001) and dose response (P = .001), according to Hochberg. “There are also statistically significant treatment effects for the 100-mcg dose every 6 months at the 3-year time point,” he said.
Other findings showed a significant treatment effect at 3 years for the medial femorotibial cartilage (P = .010), along with a dose response (P < .001) in this region. A similar outcome was reported for the lateral femorotibial cartilage, with sprifermin yielding both a treatment response (P < .001) and a dose response (P < .001).
“We observed marked symptomatic improvement in all treatment groups, including the placebo group,” Hochberg said. “This was the contextual response to intra-articular therapy.”
The frequency and nature of adverse events between years 2 and 3 were the same as those seen between years 0 and 2, according to Hochberg. There were no serious events and no treatment-emergent adverse events. More than 80% of patients initially randomized to sprifermin completed 3 years of follow-up, he added.
“Although cartilage thickness declined in all treatment groups between year 2 and year 3, the difference in cartilage thickness observed at year 2 with sprifermin at the highest dose vs. placebo persisted through year 3,” Hochberg said. “Based on the imaging outcomes, sprifermin appears to be effective at modifying changes in articular cartilage in a dose-dependent manner in patients with knee osteoarthritis, with an acceptable safety profile.” – by Rob Volansky
Reference:
Hochberg MC, et al. Abstract #32. Presented at: OARSI 2018 World Congress on Osteoarthritis; April 26-29, 2018; Liverpool, England.
Disclosure: Hochberg reports being a consultant for EMD Serono, the sponsor of the study.