osteoarthritis

FORWARD Clinical Trial: Sprifermin Improves Cartilage Thickness in Knee OA

Annual or biannual intra-articular administration of sprifermin, 100 μg, can significantly improve femorotibial joint cartilage thickness among patients with knee osteoarthritis (OA), according to results of the FGF-18 Osteoarthritis Randomized Trial with Administration of Repeated Doses (FORWARD). The findings suggest significant improvement after 2 years of sprifermin treatment. However, the clinical importance and durability of response remain uncertain.

The researchers randomly assigned 549 participants with symptomatic, radiographic knee OA and a Kellgren-Lawrence score of grade 2 or 3 to 1 of the following groups:

  • Intra-articular injections of sprifermin, 100 μg, every 6 months (n=110)
  • Intra-articular injections of sprifermin, 100 μg, every 12 months (n=110)
  • Intra-articular injections of sprifermin, 30 μg, every 6 months (n=111)
  • Intra-articular injections of sprifermin, 30 μg, every 12 months (n=110)
  • Placebo every 6 months (n=108)

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Each participant received weekly injections of sprifermin over 3 weeks.

To evaluate the effectiveness of sprifermin as a disease-modifying OA agent, the researchers used quantitative magnetic resonance imaging to measure the change in total femorotibial joint cartilage thickness in the more symptomatic knee of the participants.

Of the participants, 474 completed the 2-year follow-up.

Compared with placebo, the changes in total femorotibial joint cartilage thickness from baseline to 2 years were as follows:

  • 0.05 mm among patients receiving sprifermin, 100 μg, every 6 months
  • 0.04 mm among patients receiving sprifermin, 100 μg, every 12 months
  • 0.02 mm among patients receiving sprifermin, 30 μg, every 6 months
  •  0.01 mm among patients receiving sprifermin, 30 μg, every 12 months

 

There were no statistically significant differences in mean absolute change from baseline in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores for any of the patients who received treatment with sprifermin compared with placebo.

Among all groups, the most frequently reported treatment-emergent adverse event was arthralgia.

—Colleen Murphy

Reference:

Hochberg MC, Guermazi A, Guehring H, et al. Effect of intra-articular sprifermin vs placebo on femorotibial joint cartilage thickness in patients with osteoarthritis: the FORWARD randomized clinical trial. JAMA. 2019;322(14):1360-1370. doi:10.1001/jama.2019.14735.