Latest news with #WorldCongressonOsteoarthritis
Medscape
15-05-2025
- Health
- Medscape
Young Veteran Amputees Have Higher Hip Osteoarthritis Risk
INCHEON, South Korea — Young veterans who have lost lower limbs in combat are at particularly high risk for developing hip osteoarthritis, but even uninjured veterans of similar age and service history also have elevated risk for the disease, according to research presented at the World Congress on Osteoarthritis (OARSI) 2025 Annual Meeting. Fraje Watson, PhD, research associate in bioengineering at Imperial College London, London, England, presented an analysis of data from the ongoing prospective longitudinal ADVANCE cohort study in UK military personnel who served in Afghanistan. The analysis involved 1141 participants who had hip x-rays available at the study baseline, which was a mean of 8 years after injury or deployment. Around half of the participants had experienced severe enough injury during combat to require aeromedical evacuation, while the other half were a control group of military personnel who had not required aeromedical evacuation for injury and were matched for age, time and duration of deployment, and role. Of the 577 veterans exposed to serious injury, 142 had experienced one or both lower limb amputations, 28 had experienced hip injury (with or without lower limb loss), and 407 did not experience any limb loss. The study found that at baseline, just over 14% of veterans who had lower limb loss had hip osteoarthritis of Kellgren and Lawrence grade ≥ 2 compared with 4.4% of the control group who did not experience serious injury requiring aeromedical evacuation, representing a 3.88-fold higher likelihood of developing hip osteoarthritis. Among those who experienced serious hip injury with or without limb loss, 28.6% met the criteria for hip osteoarthritis at baseline, representing 7.18-fold higher odds of developing hip osteoarthritis than those in the control group. At the 3-year follow-up from baseline, the study didn't find any significantly greater increases in overall incidence of new hip osteoarthritis in the exposed groups compared with controls. But they did see significant differences in the risk for progression to more severe disease: 38.5% of the individuals who had experienced hip injury and 24.3% of those who experienced lower limb loss had progressed compared with 17% without limb loss and 14.1% of those who did not experience severe injury. Fraje Watson, PhD 'General trauma doesn't appear to increase the risk, but hip injuries and lower limb loss do, and they also result in an increased risk of progression over time, within 8-11 years post-injury,' Watson told the conference. She suggested that the effect could be the result of altered gait biomechanics and increased contact forces on the contralateral limb, although the cohort also included individuals who had lost both limbs. Watson also drew attention to the relatively high rate of hip osteoarthritis at baseline and follow-up even among the military veterans who had not experienced serious injury. The mean age of participants was around 34 years, and nearly two thirds were of junior rank. 'For such a young group that's much less reported in the literature, they had quite a high baseline prevalence,' Watson told the conference. 'Even if we take out the injured group and we just look at the group that served in Afghanistan but didn't experience a significant injury, they still had a 4.4% baseline prevalence.' In comparison to this, reports suggested a prevalence of 1.4% among men younger than 40 years in the general population, she said. Watson commented to Medscape Medical News that the higher rate of hip osteoarthritis among military personnel may reflect the physical demands of military service. 'They have a really high level of activity, and the loading of their joints is potentially higher for a sustained period of time as well as being extremely active,' she said. 'They might also be slightly more at higher risk of sustaining those kinds of low-level twisted ankles or meniscal injuries during training.' An audience member asked whether the study was looking at the sacroiliac joints and low back pain in these patients, given their mechanical axis and weight-bearing might also shift with the loss of a limb. Watson noted that a paper currently under review was examining low back pain in individuals with lower limb loss, and that there were a number of mechanical changes that happen around both the hip and lower back with limb loss.
Medscape
06-05-2025
- Health
- Medscape
Novel Shoes May Cut Low Back Pain, Delay Knee Arthroplasty
INCHEON, South Korea — A shoe-based biomechanical intervention worn for a short time each day may achieve greater improvements in low back pain and greater reductions in the risk for total knee replacement surgery than standard physical therapy, according to two studies presented at the World Congress on Osteoarthritis (OARSI) 2025 Annual Meeting. 'If you've ever watched somebody who has pain — whether it's knee pain, hip pain, back pain — they walk a little strange,' said presenter Matthew Bartels, MD, MPH, director of Rehabilitation Medicine and professor of physical medicine and rehabilitation at Montefiore Medical Center and Albert Einstein College of Medicine in New York City. But walking differently to compensate for pain can actually make the problem worse, directing the ground force through the affected area of the body, whether the knee or lower back. Bartels presented data from two studies of the US Food and Drug Administration–cleared shoe-based intervention, which 'alters the foot's pressure points to reduce loads, minimize symptoms, and promote neuromuscular control training using adjustable, convex pods under the sole,' according to the researchers. The first was a randomized controlled trial comparing the effects of the intervention and standard physical therapy on pain in 162 patients with low back pain. Participants were randomized in a 2:1 ratio either to the shoe-based intervention from AposHealth — which was individually tailored and calibrated six times over 1 year — or to standard physical therapy. In addition to being presented at OARSI, the trial was recently published in Global Spine Journal . At 1 year after randomization, those who used the shoe-based intervention reported a significantly greater mean 3.5-point reduction in their pain scores, as measured on a 10-point numeric rating scale, compared with a mean 1.8-point reduction in those who received physical therapy. The participants in the intervention also reported better secondary outcomes, including greater improvements in their Patient-Reported Outcomes Measurement Information System function scores, gait speed, and overall quality of life. Bartels told Medscape Medical News that the intervention was likely to have greater compliance than physical therapy because patients could use it at home for as little as 15 minutes at a time and feel the benefits pretty quickly. 'We all know that if you have knee or back pain, physical therapy will make you better, but the problem is, people don't keep the exercises up,' he said. 'This is a treatment that you put the shoes on, and you just wear them doing normal activities for a period, so it doesn't take time out of your day.' Bartels' own experience of his patients using the shoes was that even if patients did stop wearing them once their symptoms improved, they often started using them again if their symptoms returned, 'so they kind of self-dose,' he said. The second study Bartels presented was a poster detailing the results of a retrospective registry review of 95 patients with knee osteoarthritis (OA) who had been prescribed the shoe intervention after exhausting other nonsurgical options to see whether it was associated with a reduction in the likelihood of total knee replacement surgery. The study was also published last year in the Journal of Musculoskeletal Research . After an average follow-up time of 5.6 years, 12.6% of the patients using the shoe had undergone total knee replacement compared with 34.3% of a control group of patients from the same period who received traditional physical therapy. 'Increased use of biomechanical intervention to treat knee OA may help reduce some of the burden on healthcare and society associated with end-stage knee OA by delaying or avoiding surgery,' the researchers wrote. Commenting on the two studies, physical therapist and epidemiologist Garrett Bullock, PhD, DPT, of Wake Forest University School of Medicine, Winston-Salem, North Carolina, said, 'For a specific type of patient that has tried exercise interventions, has tried medication interventions, and a combination of both, that has a decent amount of physical activity, it may be something to explore, particularly to maintain neutral balance or create a better line through the foot.' Bullock told Medscape Medical News that there was always a risk that patients wouldn't adhere to physical therapy, so an intervention that provided education and the tools for self-efficacy could help them to manage their own symptoms.
Medscape
06-05-2025
- Health
- Medscape
Early Osteoarthritis Needs Better Definition(s)
INCHEON, South Korea — Defining early knee osteoarthritis (OA) as people who do not have symptoms but do have radiographic or MRI changes could offer greater opportunity for interventions to prevent symptomatic or structural decline, a speaker argued at the World Congress on Osteoarthritis (OARSI) 2025 Annual Meeting. Grace Hsiao-Wei Lo, MD, MS Rheumatologist and Epidemiologist Grace Hsiao-Wei Lo, MD, MS, an associate professor in the Section of Immunology, Allergy, and Rheumatology at Baylor College of Medicine, Houston, explored how the concepts of early OA and pre-OA could be defined, and what those definitions mean for understanding, research, and prevention of the disease. 'Early osteoarthritis is a term that means a lot in the research community,' Lo said. 'However, there's not a consensus on what this construct should mean.' That lack of consensus could be impeding the development of disease-modifying OA drugs, if it meant that interventions were being tested in individuals who actually had late disease, not early disease. 'If we change our focus to an earlier part of the natural history of the disease, then we might be more successful,' she said. However, the challenge is that there are a range of possible definitions for early OA, and it's not clear which ones are mostly predictive of progression to clinical disease, defined as Kellgren and Lawrence (KL) grade 2 or above: Formation of osteophytes, narrowing of the joint cartilage, and sclerosis of the subchondral bone. Early MRI Changes In people with KL grade disease of 0 or 1, numerous studies have found pathological evidence of disease on x-ray or MRI, Lo said. For example, a 2014 MRI study by Leena Sharma and colleagues found that among people who had a KL grade of 0 for both knees, 76% had articular cartilage damage, 61% had bone marrow lesions, and 21% had meniscal tear. Those with more evidence of disease on MRI were more likely to have persistent symptoms of knee OA and cartilage damage. Lo said this indicated that even people without radiographic evidence of disease could have changes on MRI. 'It tells us that we know there are radiographic changes that are typical for osteoarthritis, that there are MRI features of osteoarthritis that can be seen in these without radiographic evidence of disease, that these features are meaningful and that there's no one MRI feature that seemed to be the penultimate predictor for developing KL grade 2,' Lo told the audience. Another MRI study by Alison H. Chang and colleagues from 2024 took individuals at increased risk of developing symptomatic radiographic knee OA — by virtue of injury, symptoms, family history, or overweight or obesity — and looked at whether MRI evidence at baseline predicted their progression to symptomatic radiographic disease. 'The context here is to look for people who have a particular pathology on MRI, ideally looking for people without symptoms and limitations, and generally we're looking for people with early disease who don't meet the definition of radiographic osteoarthritis,' Lo said. This study found that some combinations of MRI changes were associated with progression but not everyone with those combinations did progress. 'I would argue that we expect people to go through the different phases of the disease,' Lo said. 'But the hope is that if we can identify people earlier in the natural history, what we're trying to do is stop the progression of disease.' Radiographic Changes Plus Crepitus Another phenotype of early disease is in individuals who did have radiographic evidence of disease but without symptoms. Here, Lo cited a study she was involved in, which looked at the predictive value of crepitus in individuals without symptomatic knee OA at baseline. This study found that patient-reported knee crepitus predicted the development of symptomatic OA, and most of those who went on to symptomatic disease were those with preexisting radiographic evidence of disease. 'This made sense if you believe that people have to have some pathology before they develop symptoms,' Lo said. Other Early Disease Concepts Another possible phenotype of early OA is in people without MRI changes, without radiographic changes, and without symptoms, but who have elevated levels of an as-yet unidentified biomarker. Lo also touched on the idea of pre-OA, and whether it might be possible to find people in whom interventions could prevent symptoms or structural progression. One possible group are those who have experienced anterior cruciate ligament injury, as there was growing evidence they were at elevated risk for knee OA. 'Targeting the people who have had ACL tear is an opportunity to address people who have pre-OA,' she said. Lo told the audience that these definitions of early OA weren't the only ones out there, but did give an opportunity to potentially enrich clinical trials and observational studies with individuals who were most likely to have outcomes of interest. 'The only way that we can really clarify which definition, or maybe definitions, are the most useful is for us to really systematically evaluate many of them,' she said. Speaking to Medscape Medical News , Lo said part of the problem is that we don't know what counts as the beginning of OA. 'People pretty uniformly agree that once you have KL2, everybody agrees that that's established disease, but before that there's a lot of disagreement on what counts as a diagnosis of early osteoarthritis,' she said. But finding individuals with early disease has opened the door to early interventions, she said, pointing to evidence that something as simple as walking might reduce the risk of people progressing to clinical OA. Commenting on the presentation, Physiotherapist Brooke Patterson, PhD, of La Trobe University in Melbourne, Australia, said there was great interest in defining early OA and pre-OA, particularly for younger individuals with sports-related knee injuries that might increase their risk for OA. 'For these young people that are getting the burden of the disease in their 30s and 40s and then having knee replacements,' it's important for us to talk about it, she said to Medscape Medical News .
Cision Canada
28-04-2025
- Health
- Cision Canada
KOLON TISSUEGENE HIGHLIGHTS LONG-TERM SAFETY DATA AND POTENTIAL U.S. FDA PATHWAY FOR TG-C AT OARSI WORLD CONGRESS
THE WORLD'S MOST PRESTIGIOUS OSTEOARTHRITIS SOCIETY (OARSI) HELD FOR THE FIRST TIME IN KOREA LONG-TERM SAFETY DATA FROM OVER 1 5 YEARS SUPPORT THE SAFETY PROFILE OF TG-C, WITH PRELIMINARY SIGNS OF POTENTIAL EFFICACY BENEFITS ROCKVILLE, Md., April 28, 2025 /CNW/ -- Kolon TissueGene participated in the 2025 Osteoarthritis Research Society International (OARSI) World Congress on Osteoarthritis, which took place in Songdo, South Korea, from April 24-27, 2025. This year marked the first time the globally prestigious osteoarthritis society hosted its annual congress in Korea. During the event, Kolon TissueGene presented new long-term data supporting the safety and efficacy of its investigational therapy, TG-C — the world's first cell and gene therapy for osteoarthritis — while highlighting its potential for U.S. FDA approval. On April 25, Kolon TissueGene delivered a presentation titled "TG-C, the First Potential DMOAD * 1 Therapy: Intra-Articular Cell-Based Gene Therapy with Long-Term Safety and Insight into Delaying Total Knee Arthroplasty (TKA)". The presentation focused on TG-C's long-term safety profile and its potential to delay total knee arthroplasty (TKA), using long-term follow-up data (US LTS) as a basis. The study included data from 33 subjects who participated in the U.S. Phase 2 trial and 110 subjects from the Phase 3 trial who completed two years of follow-up. The ongoing Phase 3 trial data were analyzed in a blinded manner, including both TG-C and placebo arms, allowing for an objective evaluation of the long-term safety and treatment effects. Safety Results: No treatment-related tumor cases were reported in TG-C enrolled subjects during nearly 15 years of long-term clinical observation in the United States. Moreover, age-specific cancer incidence among TG-C subjects consistently showed lower rates compared to the general U.S. population, based on SEER (Surveillance, Epidemiology, and End Results) data from the U.S. National Cancer Institute — a compelling indicator of TG-C's safety. Efficacy Results: Kolon TissueGene also presented data comparing the rate and timing of knee replacement surgery among TG-C–treated subjects versus the broader osteoarthritis population *2 in the U.S. According to the Osteoarthritis Initiative (OAI), which includes 11 years of longitudinal data sponsored by the U.S. National Institutes of Health (NIH), 15.5% of 595 patients meeting TG-C–eligible criteria underwent TKA at a median of 5.1 years after osteoarthritis onset. In contrast, only 7.0% of TG-C–treated subjects underwent TKA, with the median time to surgery extended to 5.7 years. These findings suggest that TG-C may either replace or significantly delay the need for surgical intervention — a hallmark of a disease-modifying osteoarthritis drug (DMOAD). The data supports TG-C's potential to slow structural progression of osteoarthritis and offers a meaningful therapeutic alternative. Executive Commentary: Dr. Moon Jong Noh, Co-CEO of Kolon TissueGene, stated, "We are honored to share meaningful TG-C data at the first-ever OARSI congress held in Korea. This opportunity reinforces our optimism for FDA approval and recognition of TG-C as the world's first DMOAD therapy." Co-CEO Seng Ho Jeon, who joined the company in March, added, "The scientific data presented strongly supports the safety and efficacy of TG-C. We are pursuing parallel strategies for both regulatory approval and commercialization to establish TG-C as a global blockbuster treatment." About OARSI: Headquartered in New Jersey, USA, the Osteoarthritis Research Society International (OARSI) is the world's leading organization for scientists and healthcare professionals working in the field of osteoarthritis prevention and treatment. Each year, the society holds its global congress in major cities worldwide, drawing over 1,500 experts from more than 50 countries, including clinical researchers, orthopedic specialists, radiologists, and physical therapists. About TG-C: TG-C is the world's first cell and gene therapy developed for knee osteoarthritis and is classified as a first-in-class investigational drug. It is currently undergoing follow-up in a U.S. Phase 3 trial following completion of dosing. As of 2024, the osteoarthritis market in the seven major countries (U.S., France, Germany, Italy, Spain, U.K., and Japan) is estimated at KRW 3.8 trillion, with a projected compound annual growth rate of 5.3%, reaching KRW 5.5 trillion by 2031. The global market is expected to exceed KRW 12 trillion. Currently dominated by low-cost analgesics, the introduction of effective disease-modifying therapies like TG-C could significantly expand market potential. (Source: GlobalData, Osteoarthritis: Epidemiology Forecast to 2031, June 17, 2022)
Associated Press
26-04-2025
- Health
- Associated Press
Levicept Presents Positive Phase II Data for Novel Neurotrophin-3 Inhibitor, LEVI-04, at 2025 World Congress on Osteoarthritis
SANDWICH, United Kingdom, April 26, 2025 (GLOBE NEWSWIRE) -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis, is presenting key data from its positive Phase II trial of LEVI-04 at the 2025 World Congress on Osteoarthritis (OARSI) in Seoul, South Korea. LEVI-04 is a proprietary p75 neurotrophin receptor fusion protein (p75NTR-Fc) that provides analgesia via inhibition of NT-3 activity, supplementing the endogenous p75NTR binding protein and modulating excess neurotrophin levels present in osteoarthritis. The data being presented at the conference are from Levicept's multiarm, multicentre, randomized, double-blind, placebo-controlled, Phase II study which enrolled 518 participants with pain and disability due to osteoarthritis of the knee ( ID: NCT05618782 ). Professor Philip Conaghan, MBBS, PhD, Director NIHR Leeds Biomedical Research Centre, Principal Investigator, has been invited to give a plenary presentation of efficacy data from the trial. LEVI-04 demonstrated significant differences to placebo for the primary endpoint for all doses: In addition, Professor Ali Guermazi, Boston University, will present the imaging data from the study which showed that LEVI-04 was not associated with deleterious effects on joint structure. There was no increase in the observed incidence of joint-related events at any dose of LEVI-04 compared with placebo, supporting the safety of the novel NT-3 inhibition mechanism of action of LEVI-04. Professor Philip Conaghan said, 'We are excited to be presenting these truly exceptional results from a robust and well-designed study at OARSI. Safe and effective pain management is of critical importance in osteoarthritis with existing treatments limited by adverse effects, addiction liabilities and poor efficacy. LEVI-04 demonstrated significant and clinically meaningful improvement in pain, function and other outcomes. 'Also, importantly, the imaging data showed that LEVI-04 was not associated with damage to joint structure. Previous analgesic therapies selectively targeting excess neurotrophins have demonstrated analgesia but were associated with significant joint pathologies including rapidly progressive osteoarthritis. We continue to believe LEVI-04 has the potential to offer a vital new treatment option to millions of patients in need.' Eliot Forster, CEO of Levicept, said, 'The significant interest in the results of our Phase II results at the highest calibre medical conferences around the world underlines their importance. We are confident that LEVI-04 could represent a genuine, and much needed, breakthrough in the treatment of osteoarthritis. We continue to advance our strategy for LEVI-04's further development and for ensuring the best opportunity for it to reach the many patients who may benefit.' Presentation details: LEVI-04, a Novel Neurotrophin-3 Inhibitor, Substantially Improves Pain and Function in People with Knee Osteoarthritis: a Randomised Controlled Phase II Trial. Authors: Conaghan, Philip G; Guermazi, Ali; Katz, Nathaniel; Bihlet, Asger R; Rom, Dror; Perkins, C Michael; Hughes, Bernadette; Herholdt, Claire; Bombelka, Iwona; Westbrook, Simon. Presentation: Oral plenary presentation – 26 April 2025, 10:45 - 10:55 AM KST LEVI-04, a novel neurotrophin-3 inhibitor, is not associated with deleterious effects on joint structure in people with knee osteoarthritis: data from a Phase II RCT. Guermazi, Ali; Conaghan, Philip G; Katz, Nathaniel; Bihlet, Asger R; Rom, Dror; Perkins, C Michael; Hughes, Bernadette; Herholdt, Claire; Bombelka, Iwona; Westbrook, Simon. Presentation: Poster #410 – 25 April and 26 April 4:15 – 5:00 PM KST Levicept Eliot Forster, CEO – [email protected] Media Enquiries Charles Consultants Sue Charles - [email protected] +44 (0)7968 726585 Chris Gardner - [email protected] +44 (0)7956 031077 About Levicept – Levicept Ltd is a UK-based biotechnology company developing the first in a new class of novel, safe and efficacious biological therapies, LEVI-04 [p75NTR-Fc], for the treatment of osteoarthritis and chronic pain. LEVI-04 inhibits NT-3, one of the neurotrophin family of proteins. LEVI-04 has completed a Phase II clinical trial in more than 500 patients with osteoarthritis. It is estimated that the market opportunity for drugs that treat osteoarthritis is worth in excess of $10 billion. LEVI-04 was discovered by Levicept's founder, Simon Westbrook. Levicept's investors include Medicxi, Advent Life Sciences, Gilde Healthcare and Pfizer Ventures. Follow us on LinkedIn - _________________________________ i The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale – a recognised standard pain scale
