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!
High in calories and low in nutrients when adolescents share pictures of food online
07.04.2016 | University of Gothenburg
Brain connectivity reveals hidden motives
04.03.2016 | Universität Zürich
A biological and energy-efficient process, developed and patented by the University of Innsbruck, converts nitrogen compounds in wastewater treatment facilities into harmless atmospheric nitrogen gas. This innovative technology is now being refined and marketed jointly with the United States’ DC Water and Sewer Authority (DC Water). The largest DEMON®-system in a wastewater treatment plant is currently being built in Washington, DC.
The DEMON®-system was developed and patented by the University of Innsbruck 11 years ago. Today this successful technology has been implemented in about 70...
Permanent magnets are very important for technologies of the future like electromobility and renewable energy, and rare earth elements (REE) are necessary for their manufacture. The Fraunhofer Institute for Mechanics of Materials IWM in Freiburg, Germany, has now succeeded in identifying promising approaches and materials for new permanent magnets through use of an in-house simulation process based on high-throughput screening (HTS). The team was able to improve magnetic properties this way and at the same time replaced REE with elements that are less expensive and readily available. The results were published in the online technical journal “Scientific Reports”.
The starting point for IWM researchers Wolfgang Körner, Georg Krugel, and Christian Elsässer was a neodymium-iron-nitrogen compound based on a type of...
In the Beyond EUV project, the Fraunhofer Institutes for Laser Technology ILT in Aachen and for Applied Optics and Precision Engineering IOF in Jena are developing key technologies for the manufacture of a new generation of microchips using EUV radiation at a wavelength of 6.7 nm. The resulting structures are barely thicker than single atoms, and they make it possible to produce extremely integrated circuits for such items as wearables or mind-controlled prosthetic limbs.
In 1965 Gordon Moore formulated the law that came to be named after him, which states that the complexity of integrated circuits doubles every one to two...
Characterization of high-quality material reveals important details relevant to next generation nanoelectronic devices
Quantum mechanics is the field of physics governing the behavior of things on atomic scales, where things work very differently from our everyday world.
When current comes in discrete packages: Viennese scientists unravel the quantum properties of the carbon material graphene
In 2010 the Nobel Prize in physics was awarded for the discovery of the exceptional material graphene, which consists of a single layer of carbon atoms...
24.05.2016 | Event News
20.05.2016 | Event News
19.05.2016 | Event News
30.05.2016 | Materials Sciences
30.05.2016 | Materials Sciences
30.05.2016 | Trade Fair News