Long-term structural and symptomatic effects of intra-articular sprifermin in patients with knee osteoarthritis: 5-year results from the FORWARD study.

Annals of the Rheumatic Diseases
F EcksteinP G Conaghan

Abstract

The FORWARD (FGF-18 Osteoarthritis Randomized Trial with Administration of Repeated Doses) trial assessed efficacy and safety of the potential disease-modifying osteoarthritis drug (DMOAD) sprifermin in patients with knee osteoarthritis. Here, we report 5-year efficacy and safety results. Patients were randomised to intra-articular sprifermin 100 µg or 30 µg every 6 months (q6mo) or 12 months, or placebo, for 18 months. The primary analysis was at year 2, with follow-up at years 3, 4 and 5. Additional post hoc exploratory analyses were conducted in patients with baseline minimum radiographic joint space width 1.5-3.5 mm and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain 40-90, a subgroup at risk (SAR) of progression. 378 (69%) patients completed the 5-year follow-up. A significant dose-response in total femorotibial joint cartilage thickness with sprifermin (trend test, p<0.001) and a 0.05 mm mean difference with sprifermin 100 µg q6mo versus placebo (95% CI 0.00 to 0.10; p=0.015) were sustained to year 5. WOMAC pain scores improved ~50% from baseline in all groups. No patient in the 100 µg q6mo group had replacement of the treated knee. 96%-98% of patients receiving sprifermin and 98% placebo repor...Continue Reading

References

Nov 1, 2005·Arthritis and Rheumatism·Kenneth D Brandt, Steven A Mazzuca
Oct 14, 2016·Nature Reviews. Disease Primers·Johanne Martel-PelletierJean-Pierre Pelletier
Sep 7, 2017·Current Rheumatology Reviews·Walter HermannUlf Muller-Ladner
Dec 14, 2017·Journal of Translational Medicine·Ditte RekerAnne C Bay-Jensen
May 16, 2018·Journal of Orthopaedic Research : Official Publication of the Orthopaedic Research Society·Mackenzie L SennettGeorge R Dodge
Jul 7, 2019·Osteoarthritis and Cartilage·R R BannuruT E McAlindon
Aug 7, 2019·Therapeutic Advances in Musculoskeletal Disease·Asim Ghouri, Philip G Conaghan

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Citations

Jun 3, 2021·Nature Reviews. Rheumatology·Sarah Onuora
Aug 25, 2021·Expert Opinion on Investigational Drugs·Jia LiChanghai Ding

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