Heel’s Traumeel® and Zeel® T shown to reduce pain of OA of the knee by more than 60% in MOZArT trial – the first double blind, randomized, controlled clinical trial to assess efficacy and safety of intra-articular injections of Traumeel® and Zeel® T compared with placebo

Baden-Baden, Germany/Rome, Italy – Clinical data released at the 2015 European League Against Rheumatism (EULAR) congress show Traumeel® and Zeel® T co-administered intra-articular (IA) injections provide a new first line injection treatment option in the management of moderate to severe osteoarthritis of the knee, where oral pain management failed.

Treatment with Traumeel® and Zeel® T resulted in a clinically relevant reduction in pain for patients with OA of the knee over a three-month period, and in considerable improvement of function for patients with OA of the knee.1

Lead author Carlos Lozada MD of University of Miami Miller School of Medicine, Miami, FL, explained, “The global burden of hip and knee OA is considerable.2 The MOZArT study findings are, therefore, especially interesting since existing therapies, such as NSAIDs, don’t always meet patients’ needs in terms of pain relief and may also carry some tolerability risks.3,4 In our presentation, Traumeel® and Zeel® T were seen to produce a favorable risk benefit profile, adding a potentially useful option to our armamentarium when treating OA.”1

Osteoarthritis of the knee is a chronic disease that causes moderate to severe pain in an estimated 250 million people worldwide, representing 83% of the total osteoarthritis disability burden.5 Oral treatments such as NSAIDs including selective COX-2 inhibitors may not be suitable for patients with comorbidities or who are at risk of developing serious adverse events or may end in treatment failure.3,4 Subsequent current intra-articular treatment options include corticosteroids and hyaluronic acid but clinical trial results and opinions on efficacy vary, while treatment costs can be high and duration of effect can be short.3

The MOZArT trial (Management of Osteoarthritis of the Knee with Zeel And Traumeel Injections) was conducted across 24 centers involving 232 patients, and sought to evaluate the superiority of Traumeel® and Zeel® T co-administered intra-articular injections versus placebo intra-articular injections on the change in knee pain1 based on WOMAC index (section A 1-5).6 Secondary objectives, among others, were to evaluate joint stiffness and change in physical function.

Overall, the Traumeel® and Zeel® T combination is an effective and safe first line injection treatment option and has the potential to provide significant improvement in patient activity levels due to the pain relief provided.

References

1 Lozada C, del Rio E, Reitberg DP, Smith R, Moskowitz RW. Risk-benefit of co-administered Traumeel® (TR14) and Zeel® (ZE14) intra-articular (IA) injections in patients with moderate-to-severe pain associated with OA of the knee (OAK). EULAR15-4268.

2 Cross M et al. The global burden of hip and knee osteoarthritis: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis 2014;73:1323–1330

3 McAlindon TE et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage 2014;22(3):363–388.

4 Bruyère O et al. An algorithm recommendation for the management of knee osteoarthritis in Europe and internationally: a report from a task force of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Semin Arthritis Rheum 2014;44(3):253–263.

5 Vos T et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380(9859):2163–2196.

6 WOMAC Osteoarthritis Index http://www.womac.org/womac/index.htm (accessed 29 May 2015).

Professor Carlos Lozada, rheumatologist, Miami, USA (ri.) presents the results of the MOZArT trial at the satellite symposium “Breaking with tradition – proving new treatment approaches in Osteoarthritis” at the EULAR 2015 (Europ. League against Rheumatism) congress in Rome.
Professor Carlos Lozada, rheumatologist, Miami, USA (ri.) presents the results of the MOZArT trial at the satellite symposium “Breaking with tradition – proving new treatment approaches in Osteoarthritis” at the EULAR 2015 (Europ. League against Rheumatism) congress in Rome.