Efficacy of Intra-Articular Hyaluronic Acid Injections with INNORYOS 2.2% in Patients with Knee Osteoarthritis

Abstract

Lola Hofweber, Wolfgang Kemmler, Jorg Nurnberger and Simon von Stengel

Introduction: We determined the effectiveness and safety of INNORYOS 2.2% hyaluronic acid (HA) containing 1.5% of niacinamide on knee pain, stiffness and function in people with knee osteoarthritis (OA) compared with an established agent. Further study objectives were to monitor side effects during the study period.

Methods: The 26-week prospective non-interventional open clinical trial tested on non-inferiority of INNORYOS 2.2% compared to an established HA product (Synvisc 0.8%, 2.0 ml). Briefly, 90 patients with knee OA (Kellgren-Lawrence grade I to III), 40-85 years old, were allocated randomly to the two groups. HA injections were carried out at baseline and after 1 and 2 weeks. Additional visits for data collection were made after 14 and 26 weeks. Changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), pain visual analogue scale (VAS), side effects and confounders were assessed.

Results: None of the 90 participants (65.0±10.5 years, BMI: 30.2±5.5 kg/m2 ) quit the study or was lost to follow-up. After 26 weeks, in both groups the WOMAC total score had developed positively with no significant between-group difference (-37.1% treatment vs -29.2% control). WOMAC pain and function subscores did not differ significantly between the groups, but WOMAC stiffness developed in favor of INNORYOS 2.2% group (p=.009). Pain, as assessed by VAS reduced to a similar extent in both groups (-35.2% treatment vs. -31% control). No adverse effects were observed or reported by the participants. No changes of co-medication with impact on the study outcomes were observed.

Conclusion: We did not determine significantly lower effects of INNORYOS 2.2% compared with the established, high molecular weight, cross-linked product Synvisc. In contrast, INNORYOS 2.2% tendentially revealed more favorable effect on all WOMAC categories (significant for “stiffness”). Thus, the present study provided further evidence for the effectiveness and safety of INNORYOS 2.2% in patients with early to advanced knee OA.

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