Sprifermin Improved Cartilage Morphology, Thickness in Knee Osteoarthritis
Sprifermin improved cartilage morphology and thickness and improved patellofemoral joint bone marrow lesions compared with placebo in patients with symptomatic knee osteoarthritis.
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An investigational drug known as sprifermin — a form of recombinant human fibroblast growth factor 18 — was found to improve cartilage morphology and thickness and improved patellofemoral joint (PFJ) bone marrow lesions (BMLs) compared with placebo in patients with symptomatic knee osteoarthritis (OA). Findings were presented at the European League Against Rheumatism (EULAR) Congress 2018, held in Amsterdam, June 13 to 16, 2018.
Following recent reports of successful dose-dependent femorotibial cartilage thickening, along with increases in lateral and medial compartment cartilage, investigators sought to evaluate this potential disease-modifying medication for its possible effects on other structural outcomes.
A post-hoc analysis (ClinicalTrials.gov identifier: NCT01033994) using semiquantitative magnetic resonance imaging (MRI) assessed 549 patients between 40 and 85 years with grade 2 or 3 Kellgren and Lawrence radiographic OA and target knee medial minimum joint space width ≥2.5 mm. Participants were randomly assigned in double-blinded fashion to receive either sprifermin 30 µg, 100 µg, or placebo, given as intraarticular injections once every week for 3 weeks in 6- or 12-month cycles. MRIs (1.5T or 3T) were performed at baseline and at 6, 12, 18, and 24 months.
Musculoskeletal radiologists read the images at baseline and at 12 and 24 months, using the Whole-Organ MRI Score system to analyze the whole knee, as well as the lateral, medial, and PF compartments. They used the delta-subregional and delta-sum approaches and assessed dose-response effects using the Jonckheere-Terpstra (asymptotic) test, without adjustment of P -values.
From baseline through 24 months, there was significantly less damage to cartilage of the whole knee in the treatment groups vs the placebo group and a dose-dependent effect on morphology, using both the delta sum and delta subregion approaches (delta sum, P =.0384; delta subregion, P =.0358). Dose-dependent improvement was shown in BMLs of the PFJ over the same period using both approaches (delta sum, P =.0171; delta subregion, P =.0186). No such treatment effects were observed in the other knee compartments during this period and there were no significant changes in osteophytes, menisci, effusion-synovitis, or Hoffa-synovitis. No safety issues were reported.
”This post-hoc analysis indicates that sprifermin has a positive effect on cartilage morphology, in addition to the previously reported effect on cartilage thickness. Sprifermin was also associated with BML improvement in the patello-femoral joint," concluded the authors.
Disclosures: F Roemer is a shareholder of Boston Imaging Core Lab (BICL), LLC; J Kraines is an employee of EMD Serono; A Aydemir is an employee of EMD Serono; S Wax is an employee of EMD Serono; M Crema is a shareholder of Boston Imaging Core Lab (BICL), LLC; M Hochberg is a consultant for Bioiberica SA, Bristol Myers Squibb, EMD Serono, Galapagos, IBSA Biotechniq SA, Novartis Pharma AG, Pfizer Inc., Plexxikon, Samumed LLC, Theralogix LLC, and TissueGene Inc; A Guermazi is a shareholder of Boston Imaging Core Lab (BICL), LLC and is a consultant for MerckSerono, TissueGene, GE, Pfizer, OrthoTrophix, AstraZeneca, and Sanofi.
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Roemer F, Kraines J, Aydemir A, et al. Structural effects of intra-articular sprifermin in symptomatic radiographic knee osteoarthritis: a post-hoc analysis of cartilage and non-cartilaginous tissue alterations of the 2-year data from a 5-year randomized, placebo-controlled, phase II study. Presented at: European League Against Rheumatism (EULAR) Congress 2018; June 13-16, 2018; Amsterdam, The Netherlands. Abstract FRI0538.