Long-term structural and symptomatic effects of intra-articular sprifermin in patients with knee osteoarthritis: 5-year results from the FORWARD study
| Autor: | Felix Eckstein, M. Michaelis, Hans Guehring, Philip G Conaghan, Marc C. Hochberg, Christoph Ladel, Asger Reinstrup Bihlet, Benjamin Daelken, Oliver Guenther, Jeppe Ragnar Andersen, Inger Byrjalsen, Victor Ona, F. Moreau |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Cartilage
Articular medicine.medical_specialty WOMAC Immunology knee Pain Osteoarthritis Placebo General Biochemistry Genetics and Molecular Biology law.invention Injections Intra-Articular Intra articular Rheumatology Randomized controlled trial Double-Blind Method law therapeutics Immunology and Allergy Medicine Humans In patient medicine.diagnostic_test business.industry Magnetic resonance imaging Osteoarthritis Knee medicine.disease Magnetic Resonance Imaging Fibroblast Growth Factors Treatment Outcome biological therapy Physical therapy business Sprifermin |
| Zdroj: | Annals of the Rheumatic Diseases |
| ISSN: | 0191-9164 0003-4967 |
| Popis: | ObjectiveThe 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.MethodsPatients 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.Results378 (69%) patients completed the 5-year follow-up. A significant dose-response in total femorotibial joint cartilage thickness with sprifermin (trend test, pConclusionIn the longest DMOAD trial reported to date, sprifermin maintained long-term structural modification of articular cartilage over 3.5 years post-treatment. Potential translation to clinical benefit was observed in the SAR.Trial registration numberNCT01919164 |
| Databáze: | OpenAIRE |
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