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!
Diagnoses: When Are Several Opinions Better Than One?
19.07.2016 | Max-Planck-Institut für Bildungsforschung
High in calories and low in nutrients when adolescents share pictures of food online
07.04.2016 | University of Gothenburg
Scientists and engineers striving to create the next machine-age marvel--whether it be a more aerodynamic rocket, a faster race car, or a higher-efficiency jet...
Waveguides are widely used for filtering, confining, guiding, coupling or splitting beams of visible light. However, creating waveguides that could do the same for X-rays has posed tremendous challenges in fabrication, so they are still only in an early stage of development.
In the latest issue of Acta Crystallographica Section A: Foundations and Advances , Sarah Hoffmann-Urlaub and Tim Salditt report the fabrication and testing of...
Electrochemists at TU Graz have managed to use monocrystalline semiconductor silicon as an active storage electrode in lithium batteries. This enables an integrated power supply to be made for microchips with a rechargeable battery.
Small electrical gadgets, such as mobile phones, tablets or notebooks, are indispensable accompaniments of everyday life. Integrated circuits in the interiors...
Recent findings indicating the possible discovery of a previously unknown subatomic particle may be evidence of a fifth fundamental force of nature, according...
A nanocrystalline material that rapidly makes white light out of blue light has been developed by KAUST researchers.
24.08.2016 | Event News
12.08.2016 | Event News
02.08.2016 | Event News
24.08.2016 | Event News
24.08.2016 | Physics and Astronomy
24.08.2016 | Physics and Astronomy