| Autor: |
Felix Eckstein, Susanne Maschek, Wolfgang Wirth, Christoph Ladel, Asger Reinstrup Bihlet, Chris Knight, Kenneth Somberg, Luping Zhao |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
Osteoarthritis and Cartilage Open, Vol 6, Iss 4, Pp 100513- (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2665-9131 |
| DOI: |
10.1016/j.ocarto.2024.100513 |
| Popis: |
Objective: Post-treatment cartilage morphometry in the FORWARD study was performed without blinding to MRI acquisition order, involving potential reader bias. Here we obtained unbiased estimates of cartilage change post-treatment, reading year (Y)2 and Y5 MRIs with blinding to time point. We studied whether post-treatment cartilage thickness change differed between sprifermin- and placebo-treated knees. Methods: FORWARD was a 5-year randomized control trial in 549 knee osteoarthritis patients. Here, Y2/Y5 images were analyzed with blinding to relative temporal order and treatment group. Cartilage change during Y2→Y5 was obtained in 337 participants: n = 57 treated with placebo intra-articular injections every 6 months (q6M); n = 69 with 30 μg sprifermin every 12 months (q12 M), n = 67 with 30 μg q6M, n = 73 with 100 μg q12 M, and n = 71 with 100 μg q6M between baseline (BL) and 18 M. Total femorotibial joint (TFTJ) cartilage thickness was the primary analytic focus. Results: TFTJ cartilage thickness change during Y2→Y5 was −26μm (SD64; 95%CI -32,-19) across the cohort; no statistically significant difference (p = 0.80) was observed between Sprifermin treated or placebo arms (one-way ANOVA). All groups lost cartilage, but the treatment-related difference in cartilage thickness in Sprifermin arms relative to placebo at Y2 was maintained until Y5. Annualized cartilage change in placebo participants was −8.2 μm (SD21; 95%CI -14,-2.5) during Y2→Y5 vs. −5.4 μm (SD27; 95%CI -13,1.8) during BL→Y2; no significant difference was identified (t-test). Conclusion: FORWARD is the first study evaluating post-treatment benefits of a potential disease modifying osteoarthritis drug. Cartilage thickness gained with 100 μg sprifermin at Y2 is maintained to Y5 and thus appears viable and sustainable.This is a post-hoc analysis of the FORWARD trial: ClinicalTrials.gov Identifier: NCT01919164. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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