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A 40-month multicentre, randomised placebo-controlled study to assess the efficacy and carry-over effect of repeated intra-articular injections of hyaluronic acid in knee osteoarthritis: The AMELIA project
Annals of Rheumatic Diseases, 08/23/2011
Clinical Article
Navarro-Sarabia F et al. – The results of AMELIA offer pioneer evidence that repeated cycles of intra-articular injections of HA not only improve knee osteoarthritis symptoms during the in-between cycle period but also exert a marked carry-over effect for at least 1 year after the last cycle. In this respect, it is not possible to establish if this carry-over effect reflects true osteoarthritis remission or just a modification of the disease's natural course.
Methods- Multicentre, randomised, patient and evaluator-blinded, controlled study
- 306 patients fulfilling American College of Rheumatology criteria for knee OA, radiological grades II–III (Kellgren–Lawrence) and joint space width ≥2 mm
- Patients received 4 cycles of 5 intra-articular HA or placebo injections with follow-up of 6 months after first and second cycles, and 1 year after third and fourth cycles
- Osteoarthritis Research Society International (OARSI) 2004 responder criteria were used to assess efficacy
- Consumption of rescue medication was secondary outcome
- AEs were recorded for safety purposes
- At the 40-month visit significantly more patients responded to HA compared with placebo (OARSI 2004, p=0.004)
- Number of responders to HA increased through the study, whereas those to placebo did not change
- Significant differences were also found in favour of HA for each individual component of the OARSI 2004
- No safety problems were recorded
