Efficacy and safety of long-term repeated, intra-articular injections of hyaluronic acid in knee osteoarthritis: final results of the amelia trial

  • Navarro-Sarabia F
  • Coronel P
  • Blanco F
  • et al.
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Abstract

Purpose: A clear picture about the benefits of repeated courses of Hyaluronic Acid (HA) on osteoarthritis (OA) is pending to be drawn. AMELIA (Arthrosis Modifying Effects of Long‐term Intra‐articular Adant+/‐) is a recently completed multicentre, double‐blind, placebocontrolled clinical trial with a 40 months follow‐up to assess the efficacy and tolerability of repeated administration of intra‐articular injections of Adant+/‐ or placebo in knee osteoarthritis. Methods: Patients with primary knee osteoarthritis (ACR criteria), radiological grades II‐III according to Kellgren scale and joint space width >=2 mm were randomised 1:1 to receive 4 cycles of 5 intraarticular Adant+/‐ or placebo (saline) injections each one. The follow up periods were 6 months long after the first and second cycles and 1 year long after the third and fourth ones making total study duration of 40 months (Figure 1). OMERACT‐OARSI 2004 responder criteria were used for efficacy evaluation. Adverse events were recorded for safety purposes and monitored until resolution.). Results: From 446 screened, a total of 306 patients were randomized and allocated to Adant+/‐ or placebo. Both groups were homogeneous at baseline for demographics and OA characteristics (see ARD Nov 2011 for further details) and a total of 203 patients completed the study procedures. At the end of follow‐up, significantly more patients receiving Adant+/‐ responded to treatment in comparison to placebo according to OMERACT‐OARSI 2004 criteria (p=0.004), the number of responders being 22% higher in HA group (RR 1.22; CI 95% 1.07 to 1.41). Significant differences were also found in favour of HA for each individual component of the OMERACT‐OARSI 2004: pain, function and patient global assessment with p values of 0.025, 0.023 and 0.002 respectively. Responders to HA injections progressively increased after each treatment cycle (from 71.1% to 80.5%) whereas responders to placebo remained fairly stable (from 67.8% to 65.8%) providing statistically significant differences between both groups through the study period (Figure 2). Dropouts due to lack of efficacy were statistically significant lower in HA group (p=0.026). Paracetamol was consumed by 48% of the patients and the mean daily dose during the study experienced a 27% reduction in the HA group compared to baseline versus only a 4% in the placebo group. Twenty‐two patients (11 per group) experienced a total of 29 related adverse events, the rate of related adverse events/cycle being 0.029 in both groups. Most of them were related with the study intervention, such as local bleeding, pain of mild intensity or allergic reaction and none of them serious. Conclusions: AMELIA trial evidence the superiority of Adant+/‐ to placebo. Repeated cycles of intra‐articular injections of this HA not only improve knee OA symptoms during the in‐between cycle period, but also exert a marked carry over effect lasting for at least one year after the last cycle. Adverse reactions were scarce and related to the administration procedure. (Figure presented).

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Navarro-Sarabia, F., Coronel, P., Blanco, F., Rodriguez de la Serna, A., Gimeno, M., & Herrero-Beaumont, G. (2012). Efficacy and safety of long-term repeated, intra-articular injections of hyaluronic acid in knee osteoarthritis: final results of the amelia trial. Osteoarthritis and Cartilage, 20, S28–S29. https://doi.org/10.1016/j.joca.2012.02.550

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