Study: Sprifermin reduces femorotibial cartilage thickness loss in OA knees

In patients with osteoarthritis of the knee, sprifermin-treated knees reduced total femorotibial cartilage thickness loss compared with placebo-treated knees, according to a recently published study.

“Currently, no structure-modifying treatment has been approved by U.S. or European Union regulatory bodies,” L.S. Lohmander, MD, PhD, of Lund University in Sweden, stated in a press release. “Our trial investigates the safety and efficacy of sprifermin in preventing loss of cartilage due to [osteoarthritis] OA in the knee.”

Researchers randomly assigned 192 patients with OA of the knee to single-ascending or multiple-ascending doses intra-articular injection of sprifermin (recombinant human fibroblast growth factor 18) or placebo in 10 μg, 30 μg and 100 μg. Primary efficacy endpoint included a change in central medial femorotibial compartment cartilage thickness at 6 months and 12 months using MRI. Overall, 180 patients completed the trial and 168 were evaluated for cartilage changes.

Primary safety endpoints included nature, incidence and severity of adverse events, acute inflammatory reactions and laboratory assessments, while secondary endpoints included changes in total and compartment femorotibial cartilage thickness and volume measured by MRI, joint space width from radiographs and WOMAC scores.

Overall, researchers found no statistically significant dose-response in change in central medial femorotibial compartment cartilage thickness. Patients in the sprifermin group had dose-dependent reductions in loss of total and lateral femorotibial cartilage thickness and volume, as well as in joint space width narrowing in the lateral femorotibial compartment. WOMAC pain improved in all groups; however, patients receiving 100 μg of sprifermin showed less improvement at 12 months compared to the placebo group. Researchers found no significant differences in adverse events or acute inflammatory reactions between the groups.

“While our trial found no reduction in cartilage thickness in the central femorotibial compartment among subjects in the treatment group, dose-dependent reductions in structural changes were found in participants treated with sprifermin,” Lohmander stated.

Reference:

Lohmander LS. Arthritis Rheumatol. 2014;doi:10.1002/art.38614.

Disclosure: Lohmander receives consulting fees from Merck Serono, Flexion and Össur.