In a new study in patients with osteoarthritis (OA) of the knee, at 12 months, total femorotibial cartilage thickness loss was reduced in sprifermin (recombinant human fibroblast growth factor 18)-treated knees compared to placebo-treated knees, with effects being significant in the lateral femorotibial compartment but not in the central femorotibial compartment.
Results published in Arthritis & Rheumatology, a journal of the American College of Rheumatology (ACR), showed that sprifermin dosed at 100µg reduced loss of cartilage thickness and volume in the total femorotibial joint and in the lateral knee compartment (outside of the knee).
The 2010 Global Burden of Disease Study estimates that OA affects 150 million people around the world, with the ACR reporting 27 million Americans over 25 years of age diagnosed with the disease. While OA is the most common cause of physical disability in older adults, studies suggest that the average age at diagnosis is 55 years. No medication or alternative treatment (glucosamine, chondroitin) has shown positive effects on preventing or reversing the structural changes of joint damage caused by OA.
"Currently, no structure-modifying treatment has been approved by U.S. or European Union regulatory bodies," says lead researcher L.S. Lohmander, M.D., Ph.D., from Lund University in Sweden. "Our trial investigates the safety and efficacy of sprifermin in preventing loss of cartilage due to OA in the knee."
This proof-of-concept double-blind trial recruited 192 knee OA patients who were randomized to single-ascending doses intra-articular injection of sprifermin or placebo (n= 24) or to multiple-ascending doses of sprifermin or placebo (n= 168). Doses of the drug were administered at 10, 30, and 100μg. Researchers measured cartilage thickness at 6 and 12 months using magnetic resonance imaging (MRI); joint space width by x-ray, and pain was scored using the Western Ontario McMaster Universities (WOMAC) OA index.
Of the patients recruited, 180 completed the trial and 168 were evaluated for cartilage changes. At 12 months, researchers found no change in the thickness of cartilage in the central medial femorotibial compartment in patients injected with sprifermin. However, a reduction in loss of total and lateral femorotibial cartilage thickness and volume was noted in patients injected with 100μg of sprifermin versus placebo. Narrowing of the joint space width was also reduced in the lateral femorotibial compartment for OA patients who received the same dose. The WOMAC pain score improved in all patients, with less improvement shown at 12 months for patients who received 100μg sprifermin compared to placebo.
Dr. Lohmander concludes, "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." The authors found no safety or injection-site issues with sprifermin. Additional clinical studies will be needed to replicate these findings and confirm the optimal dosing.
This clinical trial (.gov identification: NCT01033994) was sponsored by Merck Serono S.A. located in Geneva, Switzerland.
This study is published in Arthritis & Rheumatology. Media wishing to receive a PDF of this article may contact email@example.com.
Full citation: "Intra-articular Sprifermin (Recombinant Human Fibroblast Growth Factor 18) in Knee Osteoarthritis: Randomized, Double-blind, Placebo-controlled Trial." L. Stefan Lohmander, Scarlett Hellot, Don Dreher, Eduard F.W. Krantz, Dawie S. Kruger, Ali Guermazi and Felix Eckstein. Arthritis & Rheumatology; Published Online: April 17, 2014 (DOI: 10.1002/art.38614).
URL Upon Publication: http://doi.wiley.com/10.1002/art.38614
Author Contact: To arrange an interview with Dr. Lohmander, please contact Katrin Stahl with Lund University at firstname.lastname@example.org.
About the Journal
Arthritis & Rheumatology is an official journal of the American College of Rheumatology (ACR) and covers all aspects of inflammatory disease. The American College of Rheumatology is the professional organization whose members share a dedication to healing, preventing disability, and curing the more than 100 types of arthritis and related disabling and sometimes fatal disorders of the joints, muscles, and bones. Members include practicing physicians, research scientists, nurses, physical and occupational therapists, psychologists, and social workers. The journal is published by Wiley on behalf of the ACR. For more information, please visit http://wileyonlinelibrary.com/journal/art.
Wiley is a global provider of content-enabled solutions that improve outcomes in research, education, and professional practice. Our core businesses produce scientific, technical, medical, and scholarly journals, reference works, books, database services, and advertising; professional books, subscription products, certification and training services and online applications; and education content and services including integrated online teaching and learning resources for undergraduate and graduate students and lifelong learners.
Founded in 1807, John Wiley & Sons, Inc. (NYSE: JWa, JWb), has been a valued source of information and understanding for more than 200 years, helping people around the world meet their needs and fulfill their aspirations. Wiley and its acquired companies have published the works of more than 450 Nobel laureates in all categories: Literature, Economics, Physiology or Medicine, Physics, Chemistry, and Peace. Wiley's global headquarters are located in Hoboken, New Jersey, with operations in the U.S., Europe, Asia, Canada, and Australia. The Company's website can be accessed at http://www.wiley.com.
Dawn Peters | Eurek Alert!
Climate study finds evidence of global shift in the 1980s
26.11.2015 | Leibniz-Institut für Gewässerökologie und Binnenfischerei (IGB)
Network analysis shows systemic risk in mineral markets
16.11.2015 | International Institute for Applied Systems Analysis (IIASA)
Planet Earth experienced a global climate shift in the late 1980s on an unprecedented scale, fuelled by anthropogenic warming and a volcanic eruption, according to new research published this week.
Scientists say that a major step change, or ‘regime shift’, in the Earth’s biophysical systems, from the upper atmosphere to the depths of the ocean and from...
The Fraunhofer Institute for Solar Energy Systems ISE has installed 70 photovoltaic modules on the outer façade of one of its lab buildings. The modules were...
Nerve cells cover their high energy demand with glucose and lactate. Scientists of the University of Zurich now provide new support for this. They show for the first time in the intact mouse brain evidence for an exchange of lactate between different brain cells. With this study they were able to confirm a 20-year old hypothesis.
In comparison to other organs, the human brain has the highest energy requirements. The supply of energy for nerve cells and the particular role of lactic acid...
In laser material processing, the simulation of processes has made great strides over the past few years. Today, the software can predict relatively well what will happen on the workpiece. Unfortunately, it is also highly complex and requires a lot of computing time. Thanks to clever simplification, experts from Fraunhofer ILT are now able to offer the first-ever simulation software that calculates processes in real time and also runs on tablet computers and smartphones. The fast software enables users to do without expensive experiments and to find optimum process parameters even more effectively.
Before now, the reliable simulation of laser processes was a job for experts. Armed with sophisticated software packages and after many hours on computer...
Researchers at Heidelberg University have devised a new way to study the phenomenon of magnetism. Using ultracold atoms at near absolute zero, they prepared a...
25.11.2015 | Event News
17.11.2015 | Event News
21.10.2015 | Event News
27.11.2015 | Press release
27.11.2015 | Life Sciences
27.11.2015 | Materials Sciences