Bioniche Life Sciences Inc presented final results of a French Pharmacoeconomic study into the Bioniche-developed proprietary product Suplasyn for the treatment of osteoarthritis (OA) of the knee at the European League Against Rheumatism Conference in Berlin, Germany, according to a company release.
In addition, two presentations were made describing the effectiveness of Suplasyn in the treatment of patients with OA.
Dr Bernard Mazières, study coordinator, presented the results of an open-label study comparing clinical improvement, quality of life, and medical costs in patients with OA of the knee three months before and six months after the intra-articular injection of Suplasyn, a hyaluronic acid-based product.
"About 310 patients participated in this study," said Dr. Bard, "most of whom had moderate osteoarthritis of the knee. We are pleased to report that, using both the Lequesne and WOMAC indices, our study showed a significant reduction in pain and improved function levels as early as the third month, which were maintained at six months."
"We also saw an improvement in the physical health and mental well-being of the patients. Analgesic consumption and Non-Steroidal Anti-Inflammatory (NSAID) consumption decreased significantly after Suplasyn treatment. Suplasyn led to an absolute decrease in the total median of medical and non-medical costs per patient of approximately 30 per cent. The differences reported in the study were statistically significant," he added.
"The results of this study are very encouraging," said Albert Beraldo, president & CEO, Bioniche Pharma Group. "They confirm that Suplasyn is a very effective treatment for patients with osteoarthritis of the knee, providing them pain reduction and an improved quality of life at a significantly lower cost," he said.
Dr. Robert Petrella, associate professor of Medicine at the University of Western Ontario and medical director at the Canadian Centre for Activity and Aging in London, Ontario described the latest findings from two ongoing studies using Suplasyn, to treat osteoarthritis of the knee.
Dr. Petrella showed that treatment of the osteoarthritic knee with HA (Suplasyn) resulted in improved clinical outcomes at rest and walking pain; high treatment satisfaction; and an excellent product safety profile. These results were obtained in three repeated series of three Suplasyn treatments in 537 patients representing 4,833 intra-articular injections.
"This research provides preliminary evidence for possible disease-modifying activity in osteoarthritis, as well as data on the long-term benefits of Suplasyn among typical patients. This is a very unique cohort of patients in terms number of patients, experience in HA treatment with Suplasyn, and duration of the follow-up," said Dr. Petrella.
"These studies, conducted by respected clinicians, are providing additional evidence of the efficacy of Suplasyn in the treatment of patients with osteoarthritis," said Graeme McRae, president & CEO of Bioniche Life Sciences Inc.
Suplasyn is a sterile, sodium hyaluronate solution injected into synovial joints such as the knee to replace or augment synovial fluid, the naturally occurring lubricant in the joint. Suplasyn reduces joint pain and increases mobility. The product is manufactured at Bioniche facilities in Inverin, Co. Galway, Ireland.
The study was coordinated by Dr. Mazières, in collaboration with Dr Hervé Bard and Dr Claude LePen, and was sponsored by Bioniche Pharma Group Ltd. and Chiesi France.